Science.gov

Sample records for acceptable safety profiles

  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 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. PMID:25858606

  3. 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.

  4. 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

  5. Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON(®)-TB Gold (+) Kenyan adults without evidence of tuberculosis.

    PubMed

    Walsh, Douglas S; Owira, Victorine; Polhemus, Mark; Otieno, Lucas; Andagalu, Ben; Ogutu, Bernhards; Waitumbi, John; Hawkridge, Anthony; Shepherd, Barbara; Pau, Maria Grazia; Sadoff, Jerald; Douoguih, Macaya; McClain, J Bruce

    2016-05-01

    In a Phase 1 trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON(®)-TB Gold In-Tube test (QFT-G)(-) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G(-) and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4+ and CD8+ T cell responses to Mtb Ag85A/b peptide pools among both QFT-G(-) and (+) subjects, with trends in the CD4+ T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects. PMID:27026148

  6. 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.

  7. Leflunomide: a manageable safety profile.

    PubMed

    van Riel, Peit L C M; Smolen, Josef S; Emery, Paul; Kalden, Joachim R; Dougados, Maxime; Strand, C Vibeke; Breedveld, Ferdinand C

    2004-06-01

    The safety profile of leflunomide in the treatment of rheumatoid arthritis has been well documented in clinical trials, postmarketing surveillance, and epidemiological studies. Both postmarketing surveillance and epidemiological study results are consistent with the safety profile of leflunomide reported in clinical trials, and no increased risk was observed with leflunomide, compared with other disease modifying antirheumatic drugs; these studies have allowed a more precise representation of the incidence of adverse events occurring with leflunomide under normal conditions of care. The most common leflunomide-associated adverse events include diarrhea, elevated liver enzymes, alopecia, and rash. Ninety-five percent of the Expert Panel considered the adverse events associated with leflunomide to be manageable. If an adverse event required treatment to be stopped, many of the experts would consider subsequently restarting leflunomide. For minor adverse events, it was suggested that the physician might also consider using cholestyramine or charcoal to determine if the side effect is dose-related and, if it was, reduce the leflunomide dose accordingly. In addition to informing patients about the likelihood of side effects, it is important to emphasize that their incidence appears to diminish with continued treatment. It is also important to adequately support patients who are experiencing side effects and involve them in their disease management, for example, by offering the choice of reducing the leflunomide dose and/or having symptomatic treatment. Other patient management recommendations in this review reflect the views of the majority of participants as expressed in the meeting. PMID:15170904

  8. Ophthalmologic safety profile of antimalarial drugs.

    PubMed

    Rynes, R I; Bernstein, H N

    1993-02-01

    The ophthalmologic safety of antimalarial drugs is well established, but absolute safety cannot be assured. Three types of side effects may develop. Corneal deposits and neuromuscular-associated blurred vision are always reversible and therefore benign. Visual loss has occurred in patients with retinopathy. Retinopathy may be divided into true retinopathy and premaculopathy. It is true retinopathy that may be associated with visual loss, while premaculopathy consists of subtle visual field and funduscopic abnormalities. These premaculopathic changes are generally completely reversible with drug discontinuation and have not been shown to progress. Hydroxychloroquine appears safer than chloroquine when currently accepted equivalent doses are used. Fewer than 20 patients with true retinopathy caused by hydroxychloroquine have been reported; more patients have developed true retinopathy when taking chloroquine. The safety profile is most dependent on low daily dose and regular ophthalmologic monitoring. The optimal strategy of ophthalmologic testing has not yet been determined, but visual acuity, funduscopic examination and visual field examination should be monitored. Self-administered ophthalmologic testing with Amsler grids may contribute additional safety but is not a replacement for physician testing. PMID:8485566

  9. Safety profile of the triptans.

    PubMed

    Tepper, Stewart J; Millson, David

    2003-03-01

    The triptans are 5-HT(1B/1D) agonists used as migraine and cluster-specific agents. Seven are in commercial use worldwide; in order of release these are sumatriptan, zolmitriptan, rizatriptan, naratriptan, almotriptan, frovatriptan and eletriptan. Sumatriptan has been in clinical use since 1991, and although postmarketing studies have stimulated much debate of triptan strengths and weaknesses, their overall safety profile appears excellent. The most serious adverse events are cardiovascular, due to coronary artery narrowing as a consequence of coronary artery 5-HT(1B) receptor activity. Triptans are contraindicated in patients with vascular disease. Other events are even more rare, and include the potential for drug-drug interactions, based on metabolic elimination pathways. Serotonin syndrome has been a concern, but one large prospective study failed to document a single case, and reports are sporadic and not clearly causative. PMID:12904112

  10. 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. PMID:26769507

  11. Safety analysis, risk assessment, and risk acceptance criteria

    SciTech Connect

    Jamali, K.; Stack, D.W.; Sullivan, L.H.; Sanzo, D.L.

    1997-08-01

    This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities and that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.

  12. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as...

  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. Safety, functionality and acceptability of a prototype polyurethane condom.

    PubMed

    Farr, G; Katz, V; Spivey, S K; Amatya, R; Warren, M; Oliver, R

    1997-12-01

    Male condoms made from synthetic materials offer an alternative to latex condoms that may be more acceptable to users, thereby potentially resulting in more protected acts of intercourse. A prospective, noncomparative clinical study was conducted to evaluate the safety of using certain polyurethane materials to make condoms. Fifty-one healthy, contracepting, mutually monogamous couples were recruited between June 30 and November 24, 1993 to use a prototype roll-on polyurethane condom developed by Family Health International. Couples were to use the condoms for 10 consecutive acts of vaginal intercourse over a 4-week period. Baseline and postexposure genital examinations, including colposcopy for female participants, were performed. Fifty couples completed the study requirements and 517 acts of intercourse occurred using the condoms. Two adverse events were reported: irritation of introitus in a female participant and a small irritated erythematous lesion on a male participant's penis. Neither event was considered to be serious and both were resolved without treatment. Breakage and slippage rates were similar to those reported for latex condoms. These results suggest that polyurethane condoms represent a safe, functional and acceptable alternative to latex condoms. PMID:9404553

  15. 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…

  16. Trabectedin: Supportive care strategies and safety profile.

    PubMed

    Jordan, Karin; Jahn, Franziska; Jordan, Berit; Kegel, Thomas; Müller-Tidow, Carsten; Rüssel, Jörn

    2015-06-01

    Trabectedin is an approved antineoplastic agent for the treatment of adult patients with advanced soft tissue sarcomas or in combination with pegylated liposomal doxorubicin (PLD) in patients with relapsed platinum sensitive ovarian cancer. The mechanism of action is still not fully understood but many typical side effects seen with other chemotherapy drugs are less common, mild or unreported. Although this apparent favorable safety profile suggests a well-tolerated and manageable therapeutic option in the palliative care setting, trabectedin does have specific adverse side effects which can be hazardous for individual patients. The most commonly observed toxicities with trabectedin include neutropenia, nausea, vomiting, and increases in liver transaminases, anemia, fatigue, thrombocytopenia, anorexia and diarrhea. However, for most patients the appropriate use of supportive care strategies can reduce or overcome these side effects. We present a concise review of the safety data of trabectedin with the corresponding overview of the supportive care strategies. PMID:25794812

  17. 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.

  18. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product safety standards. 7.10 Section 7.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.10 MSHA acceptance of equivalent...

  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

    ... regarding seismic safety at the Los Alamos National Laboratory Plutonium Facility. ADDRESSES: U.S... Laboratory Plutonium Facility Seismic Safety, issued on October 26, 2009, and I accept the recommendation. In... new Documented Safety Analysis (DSA) for the Plutonium Facility at Los Alamos National...

  20. Acceptance test report, plutonium finishing plant life safety upgrade

    SciTech Connect

    Hodge, S.G.

    1994-12-02

    This acceptance Test Procedure (ATP) has been prepared to demonstrate that modifications to the Fir Protection systems function as required by project criteria. The ATP will test the Fire Alarm Control Panels, Flow Alarm Pressure Switch, Heat Detectors, Smoke Detectors, Flow Switches, Manual Pull Stations, and Gong/Door By Pass Switches.

  1. Space Reactor Launch Safety-An Acceptably Low Risk

    NASA Astrophysics Data System (ADS)

    Weitzberg, Abraham; Wright, Steven

    2008-01-01

    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*10-5 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.

  2. 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.

  3. 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

  4. Safety, efficacy, and patient acceptability of rifaximin for hepatic encephalopathy.

    PubMed

    Kimer, Nina; Krag, Aleksander; Gluud, Lise L

    2014-01-01

    Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production of ammonia by gut bacteria and, to some extent, other toxic derivatives from the gut. Clinical trials show that these effects improve episodes of hepatic encephalopathy. A large randomized trial found that rifaximin prevents recurrent episodes of hepatic encephalopathy. Most patients were treated concurrently with lactulose. Trials have varied greatly in design, outcomes, and duration of treatment regimes. Although a number of retrospective studies have indicated that long-term treatment with rifaximin is safe and possibly beneficial, high quality trials are needed to further clarify efficacy and safety of long-term treatment with rifaximin and evaluate effects of combination therapy with lactulose and branched-chain amino acids for patients with liver cirrhosis and hepatic encephalopathy. PMID:24672227

  5. Safety, efficacy, and patient acceptability of rifaximin for hepatic encephalopathy

    PubMed Central

    Kimer, Nina; Krag, Aleksander; Gluud, Lise L

    2014-01-01

    Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production of ammonia by gut bacteria and, to some extent, other toxic derivatives from the gut. Clinical trials show that these effects improve episodes of hepatic encephalopathy. A large randomized trial found that rifaximin prevents recurrent episodes of hepatic encephalopathy. Most patients were treated concurrently with lactulose. Trials have varied greatly in design, outcomes, and duration of treatment regimes. Although a number of retrospective studies have indicated that long-term treatment with rifaximin is safe and possibly beneficial, high quality trials are needed to further clarify efficacy and safety of long-term treatment with rifaximin and evaluate effects of combination therapy with lactulose and branched-chain amino acids for patients with liver cirrhosis and hepatic encephalopathy. PMID:24672227

  6. Child safety driver assistant system and its acceptance.

    PubMed

    Quendler, Elisabeth; Diskus, Christian; Pohl, Alfred; Buchegger, Thomas; Beranek, Ernst; Boxberger, Josef

    2009-01-01

    Farming machinery incidents frequently cause the injury and death of children on farms worldwide. The two main causes of this problem are the driver's view being restricted by construction and/or environmental factors and insufficient risk awareness by children and parents. It is difficult to separate working and living areas on family farms, and the adult supervision necessary to avoid work accidents is often lacking. For this reason, additional preventive measures are required to reduce the number of crushings. Electronic tools that deliver information about the presence of children in the blind spots surrounding vehicles and their attached machines can be very effective. Such an electronic device must cover all security gaps around operating agricultural vehicles and their attached machines, ensure collision-free stopping in risk situations, and be inexpensive. Wireless sensor network and electrical near-field electronic components are suited to the development of low-cost wireless detection devices. For reliable detection in a versatile environment, it is necessary for children to continuously wear a slumbering transponder. This means that children and adults must have a high acceptance of the device, which can be improved by easy usability, design, and service quality. The developed demonstrator achieved detection distances of up to 40 m in the far field and 2.5 m in the near field. Recognized far-field sensor detection weaknesses, determined by user-friendliness tests, are false alarms in farmyards and around buildings. The detection distance and reliability of the near-field sensor varied with the design of the attached machines' metallic components. PMID:19437262

  7. Safety and acceptability of a baggy latex condom.

    PubMed

    Macaluso, M; Blackwell, R; Carr, B; Meinzen-Derr, J; Montgomery, M; Roark, M; Lynch, M; Stringer, E M

    2000-03-01

    A total of 104 couples participated in a randomized crossover trial to compare a new baggy condom with a straight-shaft condom produced by the same manufacturer. Participants completed a coital log after using each condom. All couples used five condoms of each type. Among 102 couples who did not report major deviations from the protocol, the breakage rate was eight of 510 (1.6%) for the baggy condom, and six of 510 (1.2%) for the standard condom (rate difference, RD = 0. 4%, 95% confidence interval of the RD, CI = -1.0%; +1.8%). Slippage was reported in 50 baggy condom logs and in 58 standard condom logs; the slippage rate was 50 of 510 (9.8%) for the baggy condom, and 58 of 510 (11.4%) for the standard condom (RD = -1.6%, 95% CI = -5.4%; +2.2%). Slippage was most often partial (<1 inch) and may not indicate condom failure. Severe slippage rates were 11 of 510 (2.2%) for the baggy condom, and 18 of 510 (3.5%) for the standard condom (RD = -1.4%, 95% CI = -3.4%; +0.7%). The findings support the conclusion that the two condoms are equivalent with respect to breakage and slippage. The participants appeared to prefer the baggy condom, suggesting that the new product may be more acceptable to the public than the traditional straight-shaft condoms, and may be easier to use consistently over long time periods. PMID:10827336

  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. 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

  11. 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. PMID:25838891

  12. Safety and side effect profile of fluoxetine.

    PubMed

    Wernicke, Joachim F

    2004-09-01

    Fluoxetine was the first selective serotonin re-uptake inhibitor to be widely available for treatment of depression and numerous other neuropsychiatric disorders. Its attributes have been described in numerous scientific papers, and it has been the subject of a considerable volume of lay press. Fluoxetine is generally safe and well-tolerated. Common adverse events reported with the recommended dose of 20 mg/day are referable to the gastrointestinal system and the nervous system. The approved dose range is up to 80 mg/day, and when higher doses are used, adverse events are more common. The long half-life of fluoxetine and its active metabolite essentially preclude a withdrawal phenomenon. It is an inhibitor of cytochrome P450 (CYP) 2D6 and other CYP enzymes, which increases the potential for drug interactions. However, most of these are not clinically important. The purpose of this review is to provide an overview of some of the most important information related to safety and side effects of this drug. PMID:15335304

  13. A Computer Profile of Mobility Coverage and a Safety Index.

    ERIC Educational Resources Information Center

    Blasch, B. B.; De l'Aune, W. R.

    1992-01-01

    This article describes the Mobility Coverage Profile and Safety Index, which allows for computerized quantitative and qualitative evaluation of cane coverage by individuals with blindness. The mobility specialist inputs microcomponents of an individual's cane technique and a defined environmental situation, and the software generates a graphically…

  14. 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. PMID:24389453

  15. 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

  16. 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

  17. 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

  18. 41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (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 for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of...

  19. 41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (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 for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of...

  20. 41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (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 for... acceptability must include a review of the fire protection engineer's qualifications, the appropriateness of...

  1. 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.

  2. 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.

  3. 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

  4. Short communication: Sensory profile and acceptability of a cow milk cheese manufactured by adding jenny milk.

    PubMed

    Cosentino, C; Faraone, D; Paolino, R; Freschi, P; Musto, M

    2016-01-01

    The addition of jenny milk during cheesemaking has been recommended as a viable alternative to egg lysozyme for controlling late blowing defects. However, little is known on the sensory properties of the cheeses made with jenny milk. In this study, the effect of the addition of jenny milk during cheesemaking on sensory properties and consumer acceptability of cheese was evaluated. A sensory profile was carried out by 10 trained panelists on 4 cow milk cheese types. Two types of cheeses were made by adding jenny milk to cow milk during cheesemaking; the cheeses were then left to ripen for 45 and 120 d. The remaining 2 cheese types were made with only cow milk and were also left to ripen for 45 and 120 d. The attributes generated by a quantitative descriptive analysis sensory panel were effective for discriminating the 4 products. Among them, added jenny milk samples aged for 45 d had the highest intensity of some appearance descriptors (structure and color uniformity), as well as the highest intensity of sweetness. The analysis of acceptability data obtained from 89 consumers showed that added jenny milk aged for 45 d was the most preferred type of cheese, whereas no significant differences were found among the other products, which had higher intensity of bitter, salty, acid milk, and so on. PMID:26506544

  5. Biologic Therapy in Inflammatory Eye Conditions (Ophtalmology): Safety Profile.

    PubMed

    Neri, Piergiorgio; Arapi, Ilir; Nicolai, Michele; Pirani, Vittorio; Saitta, Andrea; Luchetti, Michele M; Giovannini, Alfonso; Mariotti, Cesare

    2016-01-01

    Non-infectious uveitis can be a potentially sight threatening disease. Very recently, therapeutic strategies have turned towards a new methodology, which includes biologic agents. The introduction of biologic drugs has started a Copernican revolution in ophthalmology: biologic therapies represent a revolutionary option for those patients who present non-responder, sight threatening uveitis. The availability of these therapies has improved the uveitis outcome. The present review shows the most relevant medical literature on biologic agents in ophthalmology, such as tumor necrosis factor blockers, anti-interleukins and other related biologics. Several papers reported the efficacy of biologic agents in a large number of refractory uveitides, which suggest a promising role of biologic drugs for selected cases. On the other hand, the medical literature does not have consistent numbers yet, which hopefully will validate the promising preliminary results. Biologic agents are not only promising drugs for the treatment of nonresponder uveitis, but also they show an apparently favourable safety profile, although several topics remain unsolved: it is still not clear when commencing the treatment, which agent to choose, and the length of biologic therapy. Moreover, the high costs and the still not clear safety profile have very often limited their use only for severe, non-responder uveitis in highly specialized uveitis centres. PMID:26463249

  6. Pharmacological profile, efficacy and safety of rupatadine in allergic rhinitis.

    PubMed

    Katiyar, Subodh; Prakash, Shivesh

    2009-06-01

    Allergic rhinitis (AR) is a disease with high prevalence. In AR, exposure to airborne allergens elicits an allergic response which involves epithelial accumulation of effector cells - e.g. mast cells and basophils - and subsequent inflammation. During the early response in AR, histamine has been found to be the most abundant mediator and it is associated with many symptoms of this disease mediated through the histamine H1 receptor. Therefore, anti-histamines have a role to play in the management of AR. However, the available antihistamines have certain well-known side effects like sedation and potential pro-arrythmic effects owing to their interactions with other drugs, as well as having poor or no effect on platelet activating factor (PAF) which also plays an important role in AR. This article is a qualitative systematic literature review on the pharmacological profile of rupatadine in order to evaluate its safety and efficacy in AR as compared to other anti-histamines. Rupatadine is a once-daily non-sedative, selective, long-acting H1 anti-histamine with antagonistic PAF effects through its interaction with specific receptors. Rupatadine significantly improves nasal symptoms in patients with AR. It has a good safety profile and is devoid of arrythmogenic effects. These properties make rupatadine a suitable first line anti-histamine for the treatment of AR. PMID:18695846

  7. A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study)

    PubMed Central

    Mcgowan, Ian; Cranston, Ross D.; Duffill, Kathryn; Siegel, Aaron; Engstrom, Jarret C.; Nikiforov, Alexyi; Jacobson, Cindy; Rehman, Khaja K.; Elliott, Julie; Khanukhova, Elena; Abebe, Kaleab; Mauck, Christine; Spiegel, Hans M. L.; Dezzutti, Charlene S.; Rohan, Lisa C.; Marzinke, Mark A.; Hiruy, Hiwot; Hendrix, Craig W.; Richardson-Harman, Nicola; Anton, Peter A.

    2015-01-01

    Objectives The CHARM-01 study characterized the safety, acceptability, pharmacokinetics (PK), and pharmacodynamics (PD) of three tenofovir (TFV) gels for rectal application. The vaginal formulation (VF) gel was previously used in the CAPRISA 004 and VOICE vaginal microbicide Phase 2B trials and the RMP-02/MTN-006 Phase 1 rectal safety study. The reduced glycerin VF (RGVF) gel was used in the MTN-007 Phase 1 rectal microbicide trial and is currently being evaluated in the MTN-017 Phase 2 rectal microbicide trial. A third rectal specific formulation (RF) gel was also evaluated in the CHARM-01 study. Methods Participants received 4 mL of the three TFV gels in a blinded, crossover design: seven daily doses of RGVF, seven daily doses of RF, and six daily doses of placebo followed by one dose of VF, in a randomized sequence. Safety, acceptability, compartmental PK, and explant PD were monitored throughout the trial. Results All three gels were found to be safe and acceptable. RF and RGVF PK were not significantly different. Median mucosal mononuclear cell (MMC) TFV-DP trended toward higher values for RF compared to RGVF (1136 and 320 fmol/106 cells respectively). Use of each gel in vivo was associated with significant inhibition of ex vivo colorectal tissue HIV infection. There was also a significant negative correlation between the tissue levels of TFV, tissue TFV-DP, MMC TFV-DP, rectal fluid TFV, and explant HIV-1 infection. Conclusions All three formulations were found to be safe and acceptable. However, the safety profile of the VF gel was only based on exposure to one dose whereas participants received seven doses of the RGVF and RF gels. There was a trend towards higher tissue MMC levels of TFV-DP associated with use of the RF gel. Use of all gels was associated with significant inhibition of ex vivo tissue HIV infection. Trial Registration ClinicalTrials.gov NCT01575405 PMID:25942472

  8. Cardiovascular safety profile of dapoxetine during the premarketing evaluation.

    PubMed

    Kowey, Peter R; Mudumbi, Ramagopal V; Aquilina, Joseph W; DiBattiste, Peter M

    2011-01-01

    The cardiovascular safety profile of dapoxetine, a novel selective serotonin reuptake inhibitor (SSRI) developed as an on-demand oral treatment for premature ejaculation (PE) in men, is evaluated. The cardiovascular assessment of dapoxetine was conducted throughout all stages of drug development, with findings from preclinical safety pharmacology studies, phase I clinical pharmacology studies investigating the effect of dapoxetine on QT/corrected QT (QTc) intervals in healthy men, and phase III, randomized, placebo-controlled studies evaluating the safety (and efficacy) of the drug. Preclinical safety pharmacology studies did not suggest an adverse electrophysiologic or hemodynamic effect with concentrations of dapoxetine up to 2-fold greater than recommended doses. Phase I clinical pharmacology studies demonstrated that dapoxetine did not prolong the QT/QTc interval and had neither clinically significant electrocardiographic effects nor evidence of delayed repolarization or conduction effects, with dosing up to 4-fold greater than the maximum recommended dosage. Phase III clinical studies of dapoxetine in men with PE indicated that dapoxetine was generally safe and well tolerated with the dosing regimens used (30 mg and 60 mg as required). Events of syncope were reported during the clinical development program, with the majority occurring during study visits (on site) on day 1 following administration of the first dose when various procedures (e.g. orthostatic maneuvers, venipunctures) were performed, suggesting that the procedures contributed to the incidence of syncope. This was consistent with previous reports showing that these and similar factors contribute to or trigger vasovagal syncope. Findings of the dapoxetine development program demonstrate that dapoxetine is associated with vasovagal-mediated (neurocardiogenic) syncope. No other associated significant cardiovascular adverse events were identified. PMID:21410293

  9. Relative safety profiles of high dose statin regimens

    PubMed Central

    Escobar, Carlos; Echarri, Rocio; Barrios, Vivencio

    2008-01-01

    Recent clinical trials recommend achieving a low-density lipoprotein cholesterol level of <100 mg/dl in high-risk and <70 mg/dl in very high risk patients. To attain these goals, however, many patients will need statins at high doses. The most frequent side effects related to the use of statins, myopathy, rhabdomyolysis, and increased levels of transaminases, are unusual. Although low and moderate doses show a favourable profile, there is concern about the tolerability of higher doses. During recent years, numerous trials to analyze the efficacy and tolerability of high doses of statins have been published. This paper updates the published data on the safety of statins at high doses. PMID:18827903

  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. Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi

    PubMed Central

    Tippett Barr, Beth A.; Kang'ombe, Anderson; Hofstee, Carola; Kilembe, Franklin; Galagan, Sean; Chilongozi, David; Namate, Dorothy; Machaya, Medson; Kabwere, Khuliena; Mwale, Mwawi; Msunguma, Wezi; Reed, Jason; Chimbwandira, Frank

    2016-01-01

    Introduction: Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi. Methods: A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering. Results: Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4–14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1–10) were 2 (interquartile range, 2–4) during application and removal, and 0 (interquartile range, 0–2) at all other time points. Conclusions: Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision. PMID:27331590

  13. Nomegestrol acetate: pharmacology, safety profile and therapeutic efficacy.

    PubMed

    Lello, Stefano

    2010-03-26

    This review summarizes the pharmacology, safety and clinical efficacy of nomegestrol acetate, based on the available published literature, and assesses the pharmacological characteristics that underlie a role in different gynaecological disorders and hormone replacement therapy (HRT), and a potential role in combination estrogen/progestogen oral contraception. Nomegestrol acetate is a potent, orally active progestogen with a favourable tolerability profile and neutral metabolic characteristics. Unlike the majority of older progestogens, which were 19-nortestosterone derivatives synthesized primarily for their antigonadotropic activity as a component of hormonal contraception in combination with an estrogen, nomegestrol acetate is a 19-norprogesterone derivative designed to bind specifically to the progesterone receptor, and is relatively lacking in affinity for other steroid receptors. Nomegestrol acetate exerts strong antiestrogenic effects at the level of the endometrium and has potent antigonadotropic activity, but without any residual androgenic or glucocorticoid properties. At a dosage of 1.25 mg/day, nomegestrol acetate inhibits ovulation while permitting follicle growth, whereas at dosages of 2.5 or 5 mg/day, both ovulation and follicle development are suppressed. The antigonadotropic action of nomegestrol acetate is mediated, like other progestins, at the hypothalamic and pituitary level. Moreover, nomegestrol acetate has partial antiandrogenic activity. Absorption of nomegestrol acetate is rapid after oral administration, reaching a peak serum concentration within 4 hours, with a terminal half-life of approximately 50 hours. Nomegestrol acetate has been used successfully for the treatment of some gynaecological disorders (menstrual disturbances, dysmenorrhoea, premenstrual syndrome) and as a component of HRT in combination with estradiol for the relief of menopausal symptoms; it has been approved in Europe as monotherapy for the treatment of the menopausal

  14. From technological acceptability to appropriation by users: methodological steps for device assessment in road safety.

    PubMed

    Bordel, Stéphanie; Somat, Alain; Barbeau, Hervé; Anceaux, Françoise; Greffeuille, Catherine; Menguy, Gaëlle; Pacaux, Marie-Pierre; Subirats, Peggy; Terrade, Florence; Gallenne, Marie-Line

    2014-06-01

    This article presents the methodology developed within the framework of the research project SARI (Automated Road Surveillance for Driver and Administrator Information). This methodology is based on the logic of action research. The article presents the different stages in the development of technological innovation addressing vehicle control loss when driving on a curve. The results observed in speed reduction illustrate that no matter how optimal an innovation may be technologically speaking, it is only as effective as it is acceptable from a user standpoint. This acceptability can only be obtained if the technology is developed by engineers in liaison with social science specialists. PMID:24508421

  15. 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…

  16. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The..., Electrical Safety Division, Approval and Certification Center, 765 Technology Drive, Triadelphia, WV 26059... sealing rings (grommets). If plugs and mating receptacles are mounted to an enclosure wall, they shall...

  17. Creatine Metabolism and Safety Profiles after Six-Week Oral Guanidinoacetic Acid Administration in Healthy Humans

    PubMed Central

    Ostojic, Sergej M.; Niess, Barbara; Stojanovic, Marko; Obrenovic, Milos

    2013-01-01

    Objectives; Guanidinoacetic acid (GAA) is a natural precursor of creatine, yet the potential use of GAA as a nutritional additive for restoring creatine availability in humans has been limited by unclear efficacy and safety after exogenous GAA administration. The present study evaluated the effects of orally administered GAA on serum and urinary GAA, creatine and creatinine concentration, and on the occurrence of adverse events in healthy humans. Methods and Results; Twenty-four healthy volunteers were randomized in a double-blind design to receive either GAA (2.4 grams daily) or placebo (PLA) by oral administration for 6 weeks. Clinical trial registration: www.clinicaltrials.gov, identification number NCT01133899. Serum creatine and creatinine increased significantly from before to after administration in GAA-supplemented participants (P < 0.05). The proportion of participants who reported minor side effects was 58.3% in the GAA group and 45.5% in the placebo group (P = 0.68). A few participants experienced serum creatine levels above 70 µmol/L. Conclusion; Exogenous GAA is metabolized to creatine, resulting in a significant increase of fasting serum creatine after intervention. GAA had an acceptable side-effects profile with a low incidence of biochemical abnormalities. PMID:23329885

  18. Acceptability of OCT and Abstinence Requirements among Women Participating in Microbicide Safety Trials

    PubMed Central

    Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen; Moench, Thomas; Stanberry, Lawrence R.; Rosenthal, Susan L.

    2011-01-01

    Background Developing effective and safe microbicides requires study procedures (e.g. technology used, abstinence requirements, and product use) that are acceptable to participants. Methods Thirty women completed 4 study visits including pelvic examination, colposcopy, optical coherence tomography (OCT), and semi-structured, qualitative interviews. Additional requirements included abstinence (for approximately 16 days) and twice daily vaginal product use (for 5.5 days). Interviews were audio-recorded, transcribed, and analyzed using framework analysis. Themes addressing OCT experiences, acceptability of abstinence, and vaginal product use were examined. Results OCT was viewed favorably as an imaging technology. Some women reported feeling the fiber-optic probe “poking” them and over one-third spontaneously reported feeling pressure or pinching upon rotation of the speculum in connection with the OCT evaluation. Compliance with vaginal gel use was high, but for many women assigned to use a product containing nonoxynol-9 (versus placebo), the post-product use exam was more uncomfortable, relative to the initial exam or one week following product discontinuation. Nearly all women experienced product leakage; acceptability of leakage varied. Two women were not abstinent and several more found abstinence challenging. Some women involved their partner in decision making regarding trial enrollment. Strategies to remain abstinent included participating when the partner was away, avoiding early intimacy, and engaging in alternative sexual activities. Conclusions Qualitative interviews in early-phase studies provide insights and capture information that would be missed by behavioral inference alone. Understanding participant’s experiences is important in order to provide anticipatory guidance and plan future microbicide studies that facilitate adherence with trial requirements. PMID:22183842

  19. 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

  20. A Phase 1 Randomized, Double Blind, Placebo Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel (MTN-007)

    PubMed Central

    Mcgowan, Ian; Hoesley, Craig; Cranston, Ross D.; Andrew, Philip; Janocko, Laura; Dai, James Y.; Carballo-Dieguez, Alex; Ayudhya, Ratiya Kunjara Na; Piper, Jeanna; Hladik, Florian; Mayer, Ken

    2013-01-01

    Objective Rectal microbicides are needed to reduce the risk of HIV acquisition associated with unprotected receptive anal intercourse. The MTN-007 study was designed to assess the safety (general and mucosal), adherence, and acceptability of a new reduced glycerin formulation of tenofovir 1% gel. Methods Participants were randomized 1∶1:1∶1 to receive the reduced glycerin formulation of tenofovir 1% gel, a hydroxyethyl cellulose placebo gel, a 2% nonoxynol-9 gel, or no treatment. Each gel was administered as a single dose followed by 7 daily doses. Mucosal safety evaluation included histology, fecal calprotectin, epithelial sloughing, cytokine expression (mRNA and protein), microarrays, flow cytometry of mucosal T cell phenotype, and rectal microflora. Acceptability and adherence were determined by computer-administered questionnaires and interactive telephone response, respectively. Results Sixty-five participants (45 men and 20 women) were recruited into the study. There were no significant differences between the numbers of ≥ Grade 2 adverse events across the arms of the study. Likelihood of future product use (acceptability) was 87% (reduced glycerin formulation of tenofovir 1% gel), 93% (hydroxyethyl cellulose placebo gel), and 63% (nonoxynol-9 gel). Fecal calprotectin, rectal microflora, and epithelial sloughing did not differ by treatment arms during the study. Suggestive evidence of differences was seen in histology, mucosal gene expression, protein expression, and T cell phenotype. These changes were mostly confined to comparisons between the nonoxynol-9 gel and other study arms. Conclusions The reduced glycerin formulation of tenofovir 1% gel was safe and well tolerated rectally and should be advanced to Phase 2 development. Trial Registration ClinicalTrials.gov NCT01232803. PMID:23573238

  1. 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

  2. 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.

  3. The levonorgestrel-releasing intrauterine system: Safety, efficacy, and patient acceptability

    PubMed Central

    Beatty, Megan N; Blumenthal, Paul D

    2009-01-01

    The levonorgestrel-releasing intrauterine system (LNG-IUS) is a safe, effective and acceptable form of contraception used by over 150 million women worldwide. It also has a variety of noncontraceptive benefits including treatment for menorrhagia, endometriosis, and endometrial hyperplasia. The LNG-IUS has also been used in combination with estrogen for hormone replacement therapy and as an alternative to hysterectomy. Overall, the system is very well tolerated and patient satisfaction is quite high when proper education regarding possible side effects is provided. However, despite all of the obvious benefits of the LNG-IUS, utilization rates remain quite low in the developed countries, especially in the United States. This is thought to be largely secondary to the persistent negative impressions from the Dalkon Shield intrauterine experience in the 1970s. This history continues to negatively influence the opinions of both patients and health care providers with regards to intrauterine devices. Providers should resolve to educate themselves and their patients on the current indications and uses for this device, as it, and intrauterine contraception in general, remains a largely underutilized approach to a variety of women’s health issues. PMID:19707273

  4. 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. PMID:25830470

  5. Biologic Therapy in Inflammatory and Immunomediated Skin Diseases: Safety Profile.

    PubMed

    Ganzetti, Giulia; Campanati, Anna; Molinelli, E; Offidani, A

    2016-01-01

    Biologic treatments have modified the therapeutic armamentarium in the treatment of many dermatological and non- dermatological diseases and data on literature have widely focused on the efficacy and safety of TNF-alpha inhibitors in psoriasis. Although the etiopathogenesis has not completely elucidated, inflammation appears the lait motif unifying the immune-pathogenesis of diverse skin disease, as atopic dermatitis, alopecia areata and hidradenitis suppurativa. Actually, data on the off-label use of biologics in cutaneous immune-mediated inflammatory diseases are scarce and restricted to anecdotal cases and case series. The present review aims to evidence the major off- label use of TNF-alpha inhibitors in dermatology. PMID:26463243

  6. 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. PMID:25156799

  7. Clinical utility, safety, acceptability and complications of transoesophageal echocardiography (TEE) in 901 patients.

    PubMed

    Chee, T S; Quek, S S; Ding, Z P; Chua, S M

    1995-10-01

    Transoesophageal echocardiography (TEE) has earned an important role in the evaluation of patients with cardiovascular diseases. We report our TEE experience in 901 patients who had suboptimal transthoracic echocardiographic studies performed between September 1989 and June 1993. The patient-population consisted of 459 females and 442 males, with an ethnic distribution of Chinese 76.5%, Malays 12.7%, Indians 8.5% and Others 2.3%. The mean age was 48 years. The main indications for TEE were: cardiac source of embolism (27.5%); native valve pathology (19.1%); atrial septal abnormality (9.7%); infective endocarditis (8.3%); intracardiac masses (7.0%); prosthetic valve dysfunction (6.3%); congenital heart diseases (4.6%); aortic diseases (3.4%) and miscellaneous (14.1%). The majority of the studies were done on in- and out-patients, with only 1.2% performed in the intensive care area and 1% intraoperatively. 82.6% of TEE intubation were accomplished within one minute and most of the TEE studies were completed within twenty minutes. There were ten failures (1.2%). Major complications occurred in 5 patients (0.6%) but there was no mortality. 90.5% of the studies were considered by the operators as additionally-informative or useful for clinical decision making. In a subgroup analysis, 90.6% of the patients who had undergone TEE indicated their willingness for repeat studies if required and TEE was able to increase the sensitivity of detecting a potential cardioembolic source from 10.3% to 29.5%. In conclusion, with increasing experience, TEE can be performed expeditiously and safely, with good acceptability by our local population. TEE provides useful or additional information that supplements standard transthoracic echocardiography in a wide-ranging spectrum of cardiac conditions. PMID:8882528

  8. Fasting during Ramadan: efficacy, safety, and patient acceptability of vildagliptin in diabetic patients

    PubMed Central

    Aziz, Kamran MA

    2015-01-01

    Diabetes management during Ramadan fasting is challenging to the physician in terms of minimizing the risk of hypoglycemia. As compared to oral hypoglycemic agents (OHAs) and sulfonylureas (SUs), which carry a higher and significant risk of hypoglycemia, newer antidiabetic agents such as dipeptidyl peptidase-4 (DPP-4) inhibitors have demonstrated lower risk of hypoglycemia during Ramadan fasting, with better patient compliance. In addition to diabetes education and pre-Ramadan assessments, the physician should also consider use of DPP-4 inhibitors (such as vildagliptin) during Ramadan fasting to minimize the risk of hypoglycemia in type 2 diabetic subjects. Severe episodes of hypoglycemia have been demonstrated in recent research and clinical trials with OHAs/SUs. Conversely, these research observations have also demonstrated comparative safety and efficacy with lower risk of hypoglycemia associated with vildagliptin. Current research review has collected evidence-based clinical trials and observations for the drug vildagliptin to minimize the risk of hypoglycemia during Ramadan fasting, while at the same time focusing the role of diabetes self-management education (DSME), pre-Ramadan assessments, and patient care. PMID:25931826

  9. Feasibility, Safety, Acceptability, and Preliminary Efficacy of Measurement-Based Care Depression Treatment for HIV Patients in Bamenda, Cameroon

    PubMed Central

    Pence, Brian W.; Gaynes, Bradley N.; Atashili, Julius; O'Donnell, Julie K.; Kats, Dmitry; Whetten, Kathryn; Njamnshi, Alfred K.; Mbu, Tabenyang; Kefie, Charles; Asanji, Shantal; Ndumbe, Peter

    2014-01-01

    Background Depression affects 18-30% of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Methods Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager (DCM) guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. Results We enrolled 55 participants; all started amitriptyline 25-50mg daily at baseline. By 12 weeks, most remained at 50mg daily (range 25-125mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87% achieved depression remission (PHQ9<5) by 12 weeks. Intervention fidelity was high: HIV providers followed MBC recommendations at 96% of encounters. Most divergences reflected a failure to increase dose when indicated. No serious and few bothersome side effects were reported. Most suicidality (prevalence: 62% at baseline; 8% at 12 weeks) was either passive or low-risk. Participant satisfaction was high (100%), and most participants (89%) indicated willingness to pay for medications if MBC were implemented in routine care. Conclusions The adapted MBC intervention demonstrated high feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting. PMID:24558099

  10. Safety profile of WinRho anti-D.

    PubMed

    Hong, F; Ruiz, R; Price, H; Griffiths, A; Malinoski, F; Woloski, M

    1998-01-01

    WinRho anti-D is manufactured with multiple processes to minimize the risk of transmitting blood-borne diseases such as viruses. These safety features include donor selection, plasma testing, solvent-detergent viral inactivation, and nanofiltration. To date, there has not been any case of viral transmission in association with use of WinRho anti-D. Adverse drug reactions are infrequent and generally mild; the most common are headache, fever, and chills. Some degree of hemolysis is inevitable due to the mechanism of action of WinRho anti-D, but this is predictable and transient. A few cases of intravascular hemolysis have been reported; hypersensitivity reactions are very rare. WinRho anti-D has been shown in both clinical trials and postmarketing surveillance to be safe and effective in the treatment of idiopathic thrombocytopenic purpura (ITP) and in the prevention of Rh isoimmunization. PMID:9523744

  11. Building on safety, feasibility, and acceptability: the impact and cost of community health worker provision of injectable contraception

    PubMed Central

    Chin-Quee, Dawn; Bratt, John; Malkin, Morrisa; Nduna, Mavis Mwale; Otterness, Conrad; Jumbe, Lydia; Mbewe, Reuben Kamoto

    2013-01-01

    ABSTRACT Background: A critical shortage of doctors, nurses, and midwives in many sub-Saharan African countries inhibits efforts to expand access to family planning services, especially in rural areas. One way to fill this gap is for community health workers (CHWs) to provide injectable contraceptives, an intervention for which there is growing evidence and international support. In 2009, with approval from the Government of Zambia (GoZ), FHI 360 collaborated with ChildFund Zambia to design and implement such an intervention as part of its existing CHW family planning program. Methods: The safety of CHW provision of injectable DMPA (depot medroxyprogesterone acetate) was measured by client reports and by a 21-item structured observation checklist. Feasibility and acceptability were measured by interviews with CHWs and a subset of DMPA clients. The impact of adding DMPA to pill and condom provision was assessed by family planning uptake among the clients of trained CHWs from February 2010 to February 2011. Costs were documented using spreadsheets over the period November 2009 to February 2011. Results: Scores were high on all measures of safety, feasibility, and acceptability. Couple-years of protection (CYP, protection from pregnancy for 1 year) was provided to 51 condom clients, 391 pill clients, and 2,206 DMPA clients. Of the 1,739 clients new to family planning, 85% chose injectable DMPA, while 13% chose pills and 2% chose condoms. Continuation rates were also high, at 63% after 1 year as compared with 47% for pill users. Incremental costs per couple-year were US$21.24 if 50% of users continue with CHW-provided DMPA. Conclusion: The study affirms that the provision of injectable contraceptives by CHWs is safe, acceptable, and feasible in the Zambian context, with very high rates of uptake in hard-to-reach areas. High continuation rates among clients mean that costs of the intervention can be low when added to an existing community-based distribution program

  12. Biologic Therapy in Inflammatory and Immunomediated Arthritis: Safety Profile.

    PubMed

    Luchetti, Michele Maria; Balloni, Andrea; Gabrielli, Armando

    2016-01-01

    The increasing insights into the pathogenetic mechanisms of inflammatory autoimmune arthritis and the development of innovative systems of industrial production have led to discover molecules that are able to target/block other molecules that play a critical role in the immune system functioning, and that have been introduced in clinical practice alone and/or in addiction with other "old" disease-modifying anti-rheumatic drugs. For this reason, such drugs are currently known as "biological drugs" and include molecules that induce the immunosuppression acting on several immune pathways. However, though the biological drugs have been employed from more than a decade, there still exist some drawbacks of their use, in particular about the high costs of this therapy and their overall safety, including the route of administration for the intravenous use. In this review we provide an update on the correct use and current therapeutic indications of such drugs, including some of the new biologic therapies that will be soon available for the clinical use, focusing on these biological drugs: • Tumor necrosis factor-alpha (TNF-alpha) inhibitors (adalimumab, certolizumab-pegol, etanercept, golimumab and infliximab); • The T cell co-stimulation inhibitor, abatacept; • The anti-CD20 receptor monoclonal B cell agent, rituximab; • The interlukin-6 (IL-6) receptor-blocking monoclonal antibody, tocilizumab; • The interlukin-1 (IL-1) inhibitor, anakinra; • The interlukin-IL17 (IL-17) pathway inhibitors (ustekinumab, secukinumab, brodalumab). PMID:26463246

  13. 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. PMID:26588183

  14. 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. PMID:9484877

  15. Comparative study on the efficacy, safety, and acceptability of imiquimod 5% cream versus cryotherapy for molluscum contagiosum in children.

    PubMed

    Al-Mutairi, Nawaf; Al-Doukhi, Azari; Al-Farag, Shahat; Al-Haddad, Ahmad

    2010-01-01

    To compare the efficacy, safety and acceptability of imiquimod (IMQ) 5% cream with cryotherapy for the treatment of molluscum contagiosum (MC) in children. Prospective, randomized, comparative, observer blinded study. A total of 74 children, with MC were divided randomly to receive treatment with either IMQ 5% cream (group A) 5 days a week or cryotherapy (group B) once a week until clinical cure or up to a maximum of 16 weeks. All the patients were followed up weekly during active treatment. The patients were followed-up for 6 months after clinical cure to look for recurrence. In the IMQ group (group A), the overall complete cure rate was 91.8% (34 of 37), 22 of the 37 patients cleared by the end of 6 weeks and 12 more patients cleared by the end of 12 weeks, while the remaining three patients (8.1%) did not clear even after 16 weeks. Whereas, in the cryotherapy group, all 37 patients achieved complete cure, 26 of 37 (70.27%) patients cleared after 3 weeks, and the remaining 11 (29.72%) cleared by the end of 6 weeks. No statistically significant difference was found between the overall complete cure rate in both groups at the end of maximum treatment period (16 weeks). Pain, bullae formation, pigmentary changes, and superficial scarring were more significantly common in the cryotherapy group compared with the IMQ group. Imiqimod 5% cream seems to be slow acting but an effective agent for the treatment of MC in children. IMQ appears to be practically painless and more cosmetically accepted treatment when compared with cryotherapy, and may be the preferred treatment of MC in children especially with numerous small lesions. Cryotherapy has the advantage of being rapidly effective, and is less expensive than IMQ and may be the preferred treatment for large solitary or few lesions. PMID:19804497

  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. PMID:12508467

  17. 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…

  18. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... ASTM F963-11 standard titled, Standard Consumer Safety Specifications for Toy Safety. Pursuant to... 110-314, made the provisions of ASTM F963-07, Standard Consumer Safety Specifications for Toy Safety... toy chests). The requirements of ASTM F963-08 became effective on August 16, 2009, except for...

  19. Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth

    PubMed Central

    Vidaeff, Alex C; Belfort, Michael A

    2013-01-01

    Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the “magic bullet” in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by

  20. Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

    PubMed Central

    2013-01-01

    Background Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. Methods A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. Results During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. Conclusions Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their

  1. Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes

    PubMed Central

    Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

    2016-01-01

    Objective. Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. Methods. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. Results. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. Conclusion. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. Trial registration: ClincialTrials.gov, clinicaltrials.gov, NCT00069329 PMID:27143789

  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. Safety and Acceptability of Couples HIV Testing and Counseling for US Men Who Have Sex with Men: A Randomized Prevention Study

    PubMed Central

    Sullivan, Patrick S.; White, Darcy; Rosenberg, Eli S.; Barnes, Jasper; Jones, Jeb; Dasgupta, Sharoda; O’Hara, Brandon; Scales, Lamont; Salazar, Laura F.; Wingood, Gina; DiClemente, Ralph; Wall, Kristin M.; Hoff, Colleen; Gratzer, Beau; Allen, Susan; Stephenson, Rob

    2013-01-01

    We tested a couples HIV testing and counseling (CHTC) intervention with male couples in Atlanta by randomizing eligible couples to receive either CHTC or separate individual voluntary HIV counseling and testing (iVCT). To evaluate the acceptability and safety of CHTC, main outcomes were satisfaction with the intervention and the proportions of couples reporting intimate partner violence (IPV) and relationship dissolution after the service. The results indicated that the service was very acceptable to men (median 7-item index of satisfaction was 34 for CHTC and 35 for iVCT, P = .4). There was no difference in either incident IPV (22% versus 17% for CHTC and iVCT, respectively, P = .6) or relationship dissolution (42% versus 51% for CHTC and iVCT, respectively, P = .5). Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners. PMID:23995295

  5. 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. PMID:8359313

  6. 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. PMID:23176754

  7. 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. PMID:24750802

  8. 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

  9. "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

  10. 41 CFR 102-80.125 - Who has the responsibility for determining the acceptability of each equivalent level of safety...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 102-80.125 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Who has...

  11. 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

    ... 102-80.125 Public Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Accident and... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Who has...

  12. On the CUSP: Stop BSI: Evaluating the relationship between central line–associated bloodstream infection rate and patient safety climate profile

    PubMed Central

    Weaver, Sallie J.; Weeks, Kristina; Pham, Julius Cuong

    2015-01-01

    Background Central line–associated bloodstream infection (CLABSI) remains one of the most common and deadly hospital acquired infections in the United States. Creating a culture of safety is an important part of healthcare–associated infection improvement efforts; however, few studies have robustly examined the role of safety climate in patient safety outcomes. We applied a pattern-based approach to measuring safety climate to investigate the relationship between intensive care unit (ICU) patient safety climate profiles and CLABSI rates. Methods Secondary analyses of data collected from 237 adult ICUs participating in the On the CUSP: Stop BSI project. Unit-level baseline scores on the Hospital Survey on Patient Safety, a survey designed to assess patient safety climate, and CLABSI rates, were investigated. Three climate profile characteristics were examined: profile elevation, variability, and shape. Results Zero-inflated Poisson analyses suggested an association between the relative incidence of CLABSI and safety climate profile shape. K-means cluster analysis revealed 5 climate profile shapes. ICUs with conflicting climates and nonpunitive climates had a significantly higher CLABSI risk compared with ICUs with generative leadership climates. Conclusions Relative CLABSI risk was related to safety climate profile shape. None of the climate profile shapes was related to the odds of reporting zero CLABSI. Our findings support using pattern-based methods for examining safety climate rather than examining the relationships between each narrow dimension of safety climate and broader safety outcomes like CLABSI. PMID:25239711

  13. Safety profile of the intravenous administration of brain-targeted stable nucleic acid lipid particles.

    PubMed

    Conceição, Mariana; Mendonça, Liliana; Nóbrega, Clévio; Gomes, Célia; Costa, Pedro; Hirai, Hirokazu; Moreira, João Nuno; Lima, Maria C; Manjunath, N; de Almeida, Luís Pereira

    2016-03-01

    In a clinical setting, where multiple administrations of the therapeutic agent are usually required to improve the therapeutic outcome, it is crucial to assess the immunogenicity of the administered nanoparticles. In this data work, we investigated the safety profile of the repeated intravenous administration of brain-targeted stable nucleic acid lipid particles (RVG-9r-targeted SNALPs). To evaluate local activation of the immune system, we performed analysis of mouse tissue homogenates and sections from cerebellum. To investigate peripheral activation of the immune system, we used serum of mice that were intravenously injected with RVG-9r-targeted SNALPs. These data are related and were discussed in the accompanying research article entitled "Intravenous administration of brain-targeted stable nucleic acid lipid particles alleviates Machado-Joseph disease neurological phenotype" (Conceição et al., in press) [1]. PMID:26958628

  14. Safety profile of the intravenous administration of brain-targeted stable nucleic acid lipid particles

    PubMed Central

    Conceição, Mariana; Mendonça, Liliana; Nóbrega, Clévio; Gomes, Célia; Costa, Pedro; Hirai, Hirokazu; Moreira, João Nuno; Lima, Maria C.; Manjunath, N.; de Almeida, Luís Pereira

    2016-01-01

    In a clinical setting, where multiple administrations of the therapeutic agent are usually required to improve the therapeutic outcome, it is crucial to assess the immunogenicity of the administered nanoparticles. In this data work, we investigated the safety profile of the repeated intravenous administration of brain-targeted stable nucleic acid lipid particles (RVG-9r-targeted SNALPs). To evaluate local activation of the immune system, we performed analysis of mouse tissue homogenates and sections from cerebellum. To investigate peripheral activation of the immune system, we used serum of mice that were intravenously injected with RVG-9r-targeted SNALPs. These data are related and were discussed in the accompanying research article entitled “Intravenous administration of brain-targeted stable nucleic acid lipid particles alleviates Machado–Joseph disease neurological phenotype” (Conceição et al., in press) [1]. PMID:26958628

  15. Evaluation of Intestinal Phosphate Binding to Improve the Safety Profile of Oral Sodium Phosphate Bowel Cleansing

    PubMed Central

    Robijn, Stef; Vervaet, Benjamin A.; D’Haese, Patrick C.; Verhulst, Anja

    2015-01-01

    Prior to colonoscopy, bowel cleansing is performed for which frequently oral sodium phosphate (OSP) is used. OSP results in significant hyperphosphatemia and cases of acute kidney injury (AKI) referred to as acute phosphate nephropathy (APN; characterized by nephrocalcinosis) are reported after OSP use, which led to a US-FDA warning. To improve the safety profile of OSP, it was evaluated whether the side-effects of OSP could be prevented with intestinal phosphate binders. Hereto a Wistar rat model of APN was developed. OSP administration (2 times 1.2 g phosphate by gavage) with a 12h time interval induced bowel cleansing (severe diarrhea) and significant hyperphosphatemia (21.79 ± 5.07 mg/dl 6h after the second OSP dose versus 8.44 ± 0.97 mg/dl at baseline). Concomitantly, serum PTH levels increased fivefold and FGF-23 levels showed a threefold increase, while serum calcium levels significantly decreased from 11.29 ± 0.53 mg/dl at baseline to 8.68 ± 0.79 mg/dl after OSP. OSP administration induced weaker NaPi-2a staining along the apical proximal tubular membrane. APN was induced: serum creatinine increased (1.5 times baseline) and nephrocalcinosis developed (increased renal calcium and phosphate content and calcium phosphate deposits on Von Kossa stained kidney sections). Intestinal phosphate binding (lanthanum carbonate or aluminum hydroxide) was not able to attenuate the OSP induced side-effects. In conclusion, a clinically relevant rat model of APN was developed. Animals showed increased serum phosphate levels similar to those reported in humans and developed APN. No evidence was found for an improved safety profile of OSP by using intestinal phosphate binders. PMID:25790436

  16. 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.

  17. Efficacy and safety profile of anti-interleukin-1 treatment in Behçet's disease: a multicenter retrospective study.

    PubMed

    Emmi, Giacomo; Talarico, Rosaria; Lopalco, Giuseppe; Cimaz, Rolando; Cantini, Fabrizio; Viapiana, Ombretta; Olivieri, Ignazio; Goldoni, Matteo; Vitale, Antonio; Silvestri, Elena; Prisco, Domenico; Lapadula, Giovanni; Galeazzi, Mauro; Iannone, Florenzo; Cantarini, Luca

    2016-05-01

    Growing data have provided encouraging results on the use of interleukin (IL)-1 inhibitors in Behçet's disease (BD). This study was aimed at reporting the largest experience with anti-IL-1 agents in BD patients. We evaluated 30 BD patients receiving treatment with anti-IL-1 agents. The primary aims of the study were to evaluate the efficacy of anakinra (ANA) and canakinumab (CAN) in a cohort of BD. The secondary aims were to evaluate the overall safety profile of the treatments, explore the timing of response to therapy and any adjustment of dosage and frequency of drugs studied, and investigate predictive factors of response to therapy. The frequency of first line therapy was 90 % with ANA and 10 % with CAN. The overall number of subjects in complete remission after 12 months of therapy with anti-IL-1 drugs was 13: 6 maintained the initial therapy regimen, 1 maintained the same initial anti-IL-1 drug with further therapeutic adjustments, and the remaining 6 shifted from ANA to CAN. Among them, 3 used CAN for at least 12 months without therapeutic adjustments, 1 had therapeutic adjustments, and 3 had an overall history of a 12-month complete remission. Adverse events (AEs) were reported in 15 % patients who received ANA, represented in all cases by local cutaneous reactions, while no AE were observed in patients who received CAN; we did not observe any serious AEs (SAEs) during the follow-up period. Our data have confirmed that the use of anti-IL-1β drugs is efficacious and safe with an overall acceptable retention on treatment. PMID:26156661

  18. Hanford Site Solid Waste Acceptance Criteria

    SciTech Connect

    MCDOWELL, A.K.; TRINER, G.C.

    2002-03-28

    DOE Order 435.1 requires that each treatment, storage, and/or disposal facility (referred to in this document as TSD unit) that manages low-level or transuranic (TRU) 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 waste at TSD units operated by WMP. 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. Revisions to the acceptance criteria document require an Unreviewed Safety Question review to document that the changes are consistent with current applicable safety analysis. 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 (WRAP) Facility; and T-Plant facility. 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 identified TSD pathway. These requirements are communicated in the waste specification records (WSRds) and/or waste stream profile sheet approvals. 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

  19. RMP-02/MTN-006: A Phase 1 Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Tenofovir 1% Gel Compared with Oral Tenofovir Disoproxil Fumarate

    PubMed Central

    Cranston, Ross D.; Kashuba, Angela; Hendrix, Craig W.; Bumpus, Namandjé N.; Richardson-Harman, Nicola; Elliott, Julie; Janocko, Laura; Khanukhova, Elena; Dennis, Robert; Cumberland, William G.; Ju, Chuan; Carballo-Diéguez, Alex; Mauck, Christine; McGowan, Ian

    2012-01-01

    Abstract This study was designed to assess the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic (PD) responses to rectal administration of tenofovir (TFV) 1% vaginally formulated gel and oral tenofovir disoproxil fumarate (TDF). This study was designed as a phase 1, randomized, two-site (United States), double-blind, placebo-controlled study of sexually abstinent men and women. Eighteen participants received a single 300-mg exposure of oral TDF and were then randomized 2:1 to receive a single and then seven daily exposures of rectal TFV or hydroxyethyl cellulose (HEC) placebo gel. Safety endpoints included clinical adverse events (AEs) and mucosal safety parameters. Blood and colonic biopsies were collected for PK analyses and ex vivo HIV-1 challenge. No serious AEs were reported. However, AEs were significantly increased with 7-day TFV gel use, most prominently with gastrointestinal AEs (p=0.002). Only 25% of participants liked the TFV gel. Likelihood of use “if somewhat protective” was ∼75% in both groups. Indices of mucosal damage showed minimal changes. Tissue TFV diphosphate (TFV-DP) Cmax 30 min after single rectal exposure was 6–10 times greater than single oral exposure; tissue TFV-DP was 5.7 times greater following 7-day versus single rectal exposure. In vivo exposure correlated with significant ex vivo tissue infectibility suppression [single-rectal: p=0.12, analysis of covariance (ANCOVA) p=0.006; 7-day rectal: p=0.02, ANCOVA p=0.005]. Tissue PK–PD was significantly correlated (p=0.002). We conclude that rectal dosing with TFV 1% gel resulted in greater TFV-DP tissue detection than oral dosing with reduced ex vivo biopsy infectibility, enabling PK–PD correlations. On the basis of increased gastrointestinal AEs, rectally applied, vaginally formulated TFV was not entirely safe or acceptable, suggesting the need for alternative rectal-specific formulations. PMID:22943559

  20. 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

  1. Efficacy, safety, and patient acceptability of elvitegravir/cobicistat/emtricitabine/tenofovir in the treatment of HIV/AIDS

    PubMed Central

    Prinapori, Roberta; Di Biagio, Antonio

    2015-01-01

    The fixed-dose combination (FDC) elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/c/FTC/TDF) is a once-daily, single-tablet regimen containing an integrase strand transfer inhibitor and a pharmacoenhancer (cobicistat) associated with two nucleos(t)ide reverse transcriptase inhibitors. It is approved as the preferred regimen and as the first-line combined antiretroviral therapy in treatment-naïve patients with HIV infection. Two large trials, 102-Study and 103-Study, demonstrated that EVG/c/FTC/TDF was not inferior to efavirenz/FTC/TDF and ritonavir-boosted atazanavir in association with FTC/TDF, in terms of virological suppression and immunological reconstitution through week 144. Also, simplification arms containing EVG/c/FTC/TDF reached noninferiority in comparison with a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or a raltegravir-based regimen. Furthermore, EVG/c/FTC/TDF exhibited an excellent tolerability profile, with a safer lipid profile, and despite the indication of its use in subjects with an estimated creatinine clearance >70 mL/min, recent data demonstrated that EVG/c/FTC/TDF determined a reduction in estimated glomerular filtration rate (GFR) but not a reduction of actual GFR. Moreover, in a cohort of naïve patients with pretreatment mild-to-moderate renal impairment, GFR decrease was noted as early at week 2, after which it generally stabilized and was nonprogressive through week 48. The FDC’s efficacy and good tolerability enable EVG/c/FTC/TDF to meet the patients’ needs, improving adherence and quality of life, which are among the most important factors affecting the therapeutic efficacy of an antiretroviral regimen. This paper describes the evidence making EVG/c/FTC/TDF a new therapeutic opportunity for different HIV-infected patients. PMID:26345643

  2. Efficacy, safety, and patient acceptability of elvitegravir/cobicistat/emtricitabine/tenofovir in the treatment of HIV/AIDS.

    PubMed

    Prinapori, Roberta; Di Biagio, Antonio

    2015-01-01

    The fixed-dose combination (FDC) elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/c/FTC/TDF) is a once-daily, single-tablet regimen containing an integrase strand transfer inhibitor and a pharmacoenhancer (cobicistat) associated with two nucleos(t)ide reverse transcriptase inhibitors. It is approved as the preferred regimen and as the first-line combined antiretroviral therapy in treatment-naïve patients with HIV infection. Two large trials, 102-Study and 103-Study, demonstrated that EVG/c/FTC/TDF was not inferior to efavirenz/FTC/TDF and ritonavir-boosted atazanavir in association with FTC/TDF, in terms of virological suppression and immunological reconstitution through week 144. Also, simplification arms containing EVG/c/FTC/TDF reached noninferiority in comparison with a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or a raltegravir-based regimen. Furthermore, EVG/c/FTC/TDF exhibited an excellent tolerability profile, with a safer lipid profile, and despite the indication of its use in subjects with an estimated creatinine clearance >70 mL/min, recent data demonstrated that EVG/c/FTC/TDF determined a reduction in estimated glomerular filtration rate (GFR) but not a reduction of actual GFR. Moreover, in a cohort of naïve patients with pretreatment mild-to-moderate renal impairment, GFR decrease was noted as early at week 2, after which it generally stabilized and was nonprogressive through week 48. The FDC's efficacy and good tolerability enable EVG/c/FTC/TDF to meet the patients' needs, improving adherence and quality of life, which are among the most important factors affecting the therapeutic efficacy of an antiretroviral regimen. This paper describes the evidence making EVG/c/FTC/TDF a new therapeutic opportunity for different HIV-infected patients. PMID:26345643

  3. Specific Safety Profile of Bevacizumab in Asian Patients With Advanced NSCLC

    PubMed Central

    Chen, Zhenguang; Zhong, Beilong; Lun, Xueping; Lai, Yingrong; Bella, Amos Ela; Yang, Weilin; Wu, Jiabin

    2015-01-01

    Abstract Randomized studies have obtained varying findings regarding the benefits and toxicities of bevacizumab in the treatment of nonsmall cell lung cancer (NSCLC). It is unclear whether the discrepancies among trials are due to ethnic/racial differences. We therefore performed a meta-analysis of all published, randomized, controlled clinical trials involving bevacizumab in patients with NSCLC to assess its effectiveness and safety in Asian and non-Asian populations. Results from the phase II JO19907 trial, the phase III AVAiL and ECOG 4599 trials, and the phase IV SAiL trials were used to calculate the benefits and toxicities of bevacizumab in Asian and non-Asian patients. Combined statistical estimates, including hazard ratios and odds ratios, were calculated using fixed-effects and random-effects models. A total of 4308 patients were evaluated. Combining bevacizumab with different chemotherapy regimens resulted in similar objective response rates, overall survival, and progression-free survival in Asian and non-Asian populations. Disease control rates, however, were only reported in Asian populations. The rates of severe bleeding (relative risk [RR], 2.17; P = 0.02) and thromboembolism (RR, 3.65; P < 0.0001) were significantly higher, while the rate of severe proteinuria was significantly lower (RR, 0.43; P < 0.0001), in non-Asian than in Asian populations. The rates of severe hypertension (P = 0.71) and hemoptysis (P = 0.66) were similar in Asian and non-Asian populations. Bevacizumab combined with chemotherapy for first-line NSCLC treatment showed similar benefits in Asian and non-Asian populations, but had specific safety profiles in each.

  4. Evaluation of the efficacy, safety, and acceptability of an eyelid warming device for the treatment of meibomian gland dysfunction.

    PubMed

    Benitez Del Castillo, José Manuel; Kaercher, Thomas; Mansour, Khaled; Wylegala, Edward; Dua, Harminder

    2014-01-01

    Meibomian gland dysfunction (MGD) is widespread and has significant impact on patients' quality of life. Eyelid hygiene is the mainstay of treatment but is unstandardized and requires commitment from the patient and encouragement from the ophthalmologist. Blephasteam(®) is an eyelid warming device designed to be an easy-to-use and standardized treatment for MGD. In the present study, 73 patients were treated for 21 days with twice daily Blephasteam(®) sessions. The primary efficacy variable, a symptomatology visual analog scale score, declined from 63.07±21.23 (mean ± standard deviation) on day 0 to 41.90±25.49 on day 21. There were also improvements in a number of secondary efficacy variables including subjective ocular symptoms and clinical signs and symptoms of MGD and dry eye, though tear film breakup time and tear osmolarity were not improved. Global efficacy was assessed as satisfactory or very satisfactory in 83.8% of cases. Patient-reported subjective ocular symptoms declined during the study, and a majority of patients rated the efficacy of Blephasteam(®) as satisfactory or very satisfactory. Most patients found the device comfortable and were able to continue with normal activities (reading, watching TV, using a computer) during the Blephasteam(®) session. No safety or tolerability issues were identified. PMID:25336900

  5. Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile.

    PubMed

    Calderón, M A; Simons, F E R; Malling, H-J; Lockey, R F; Moingeon, P; Demoly, P

    2012-03-01

    Allergen immunotherapy reorients inappropriate immune responses in allergic patients. Sublingual allergen immunotherapy (SLIT) has been approved, notably in the European Union, as an effective alternative to subcutaneous allergen immunotherapy (SCIT) for allergic rhinitis patients. Compared with SCIT, SLIT has a better safety profile. This is possibly because oral antigen-presenting cells (mostly Langerhans and myeloid dendritic cells) exhibit a tolerogenic phenotype, despite constant exposure to danger signals from food and microbes. This reduces the induction of pro-inflammatory immune responses leading to systemic allergic reactions. Oral tissues contain relatively few mast cells and eosinophils (mostly located in submucosal areas) and, in comparison with subcutaneous tissue, are less likely to give rise to anaphylactic reactions. SLIT-associated immune responses include the induction of circulating, allergen-specific Th1 and regulatory CD4+ T cells, leading to clinical tolerance. Although 40-75% of patients receiving SLIT experience mild, transient local reactions in the oral mucosa, these primary reactions rarely necessitate dose reduction or treatment interruption. We discuss 11 published case reports of anaphylaxis (all nonfatal) diagnosed according to the World Allergy Organization criteria and relate this figure to the approximately 1 billion SLIT doses administered worldwide since 2000. Anaphylaxis risk factors associated with SCIT and/or SLIT should be characterized further. PMID:22150126

  6. 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.

  7. Antitussive Efficacy and Safety Profile of Ethyl Acetate Fraction of Terminalia chebula

    PubMed Central

    Wahab, Abdul; Ayub, Khurshed; Sherkheli, M. Azhar; Khan, Rafeeq Alam; Raza, Mohsin

    2013-01-01

    Antitussive effects of ethyl acetate fraction of Terminalia chebula on sulphur dioxide (SO2) gas induced cough have been examined in mice. Safety profile of Terminalia chebula was established by determining LD50 and acute neurotoxicity. The result showed that extract of Terminalia chebula dose dependently suppressed SO2 gas induced cough in mice. Terminalia chebula, after i.p. administration at dose level 500 mg/kg, offered maximum cough suppressive effects; that is, number of coughs at 60 min was 12 ± 1.52 (mean ± SEM) as compared to codeine 10 mg/kg; i.p., dextromethorphan 10 mg/kg; i.p., and saline, having frequency of cough 10.375 ± 0.866, 12.428 ± 0.81, and 46 ± 2.61, respectively. LD50 value of Terminalia chebula was approximately 1265 mg/kg, respectively. No sign of neural impairment was observed at antitussive doses of extract. Antitussive effect of Terminalia chebula was partly reversed with treatment by naloxone (3 mg/kg; s.c.) while rimcazole (3 mg/kg; s.c.) did not antagonize its cough suppression activity. This may suggest that opioid receptors partially contribute in antitussive action of Terminalia chebula. Along with this, the possibility of presence of single or multiple mechanisms activated by several different pharmacological actions (mainly anti-inflammatory, antioxidant, spasmolytic, antibacterial, and antiphlegmatic) could not be eliminated. PMID:24024039

  8. 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

    2016-04-01

    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. PMID:26525350

  9. Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution, Safety, and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides

    PubMed Central

    Leyva, Francisco J.; Bakshi, Rahul P.; Fuchs, Edward J.; Li, Liye; Caffo, Brian S.; Goldsmith, Arthur J.; Ventuneac, Ana; Carballo-Diéguez, Alex; Du, Yong; Leal, Jeffrey P.; Lee, Linda A.; Torbenson, Michael S.

    2013-01-01

    Abstract Rectally applied antiretroviral microbicides for preexposure prophylaxis (PrEP) of HIV infection are currently in development. Since enemas (rectal douches) are commonly used by men who have sex with men prior to receptive anal intercourse, a microbicide enema could enhance PrEP adherence by fitting seamlessly within the usual sexual practices. We assessed the distribution, safety, and acceptability of three enema types—hyperosmolar (Fleet), hypoosmolar (distilled water), and isoosmolar (Normosol-R)—in a crossover design. Nine men received each enema type in random order. Enemas were radiolabeled [99mTc-diethylene triamine pentaacetic acid (DTPA)] to assess enema distribution in the colon using single photon emission computed tomography/computed tomography (SPECT/CT) imaging. Plasma 99mTc-DTPA indicated mucosal permeability. Sigmoidoscopic colon tissue biopsies were taken to assess injury as well as tissue penetration of the 99mTc-DTPA. Acceptability was assessed after each product use and at the end of the study. SPECT/CT imaging showed that the isoosmolar enema had greater proximal colonic distribution (up to the splenic flexure) and greater luminal and colon tissue concentrations of 99mTc-DTPA when compared to the other enemas (p<0.01). Colon biopsies also showed that only the hyperosmolar enema caused sloughing of the colonic epithelium (p<0.05). In permeability testing, the hypoosmolar enema had higher plasma 99mTc-DTPA 24-h area under the concentration-time curve and peak concentration compared to the hyperosmolar and isoosmolar enemas, respectively. Acceptability was generally good with no clear preferences among the three enema types. The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle. PMID:23885722

  10. Perampanel in the management of partial-onset seizures: a review of safety, efficacy, and patient acceptability

    PubMed Central

    Schulze-Bonhage, Andreas; Hintz, Mandy

    2015-01-01

    Perampanel (PER) is a novel antiepileptic drug recently introduced for the adjunctive treatment in epilepsy patients aged 12 years or older with partial-onset seizures with or without secondary generalization in the US and Europe. Its antiepileptic action is based on noncompetitive inhibition of postsynaptic AMPA receptors, decreasing excitatory synaptic transmission. Evaluation of efficacy in three placebo-controlled randomized Phase III studies showed that add-on therapy of PER decreased seizure frequencies significantly compared to placebo at daily doses between 4 mg/day and 12 mg/day. PER’s long half-life of 105 hours allows for once-daily dosing that is favorable for patient compliance with intake. Long-term extension studies showed a 62.5%–69.6% adherence of patients after 1 year of treatment, comparing favorably with other second-generation antiepileptic drugs. Whereas these trials demonstrated an overall favorable tolerability profile of PER, nonspecific central nervous system adverse effects like somnolence, dizziness, headache, and fatigue may occur. In addition, neuropsychiatric disturbances ranging from irritability to suicidality were reported in several case reports; both placebo-controlled and prospective long-term extension trials showed a low incidence of such behavioral and psychiatric complaints. For early recognition of neuropsychiatric symptoms like depression, anxiety, and aggression, slow titration and close monitoring during drug introduction are mandatory. This allows on the one hand to recognize patients particularly susceptible to adverse effects of the drug, and on the other hand to render the drug’s full potential of seizure control available for the vast majority of patient groups tolerating the drug well. PMID:26316718

  11. Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative

    PubMed Central

    2015-01-01

    OBJECTIVE: To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder. BACKGROUND: Our interventional pain management service has been offering trials of SGB therapy to assist with the management of the sympathetically mediated anxiety and hyperarousal symptoms of severe and treatment-refractory combat-related PTSD. There have been multiple case series in the literature describing the potential impact of this procedure for PTSD symptom management as well as the safety of image-guided procedures. We wished to ensure that we were performing this procedure safely and that patients were tolerating and accepting of this adjunctive treatment option. METHODS: We conducted a review of our quality assurance and performance improvement data over the past 18 months during which we performed 250 stellate ganglion blocks for the management of PTSD symptoms to detect any potential complications or unanticipated side effects.  We also analyzed responses from an anonymous patient de-identified survey collected regarding the comfort and satisfaction associated with the procedure. RESULTS: We did not identify any immediate post-procedural complications or delayed complications from any of the 250 procedures performed from November 2013 to April 2015. Of the 110 surveys that were returned and tabulated, 100% of the patients surveyed were overall satisfied with our process and with the procedure, 100% said they would recommend the procedure to a friend, and 95% stated that they would be willing to undergo as many repeat procedures as necessary based on little discomfort and tolerable side effects. CONCLUSION: Our quality assurance assessment suggests that in our center the SGB procedure for PTSD is a safe, well-tolerated, and acceptable

  12. The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

    PubMed Central

    Kigozi, Godfrey; Musoke, Richard; Watya, Stephen; Kighoma, Nehemia; Nkale, James; Nakafeero, Mary; Namuguzi, Dan; Serwada, David; Nalugoda, Fred; Sewankambo, Nelson; Wawer, Maria Joan; Gray, Ronald Henry

    2014-01-01

    Objectives To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. Methods In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing. Results The PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001). Conclusion The PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden. PMID:25144194

  13. 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

  14. Quality of Life, Safety and Efficacy Profile of Thermostable Flolan in Pulmonary Arterial Hypertension

    PubMed Central

    2015-01-01

    Background Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by continuous intravenous infusion and the reconstituted solution may only be administered up to 24 hours when it is maintained between a temperature of 2°C and 8°C. The aim of this single-arm, open label study was to describe the effects of the new thermostable formulation of Flolan on health-related quality of life (HRQoL) and ease of administration in subjects switching from the currently marketed Flolan to the reformulated product. Methods Following a 4-week run-in period and after 4 weeks of treatment with the reformulated product, patients completed the SF-36 HRQoL questionnaire and a study-specific questionnaire evaluating ease of administration, along with World Health Organization (WHO) functional class, six-minute walked distance (6MWD) and N-terminal-pro B-type natriuretic peptide (NT-proBNP) assessment. Results 16 participants completed the study. The SF-36 scores remained unchanged from baseline to Week 4. Conversely, there were small improvements for the majority of the study-specific questionnaire items and 14 (88%) subjects preferred the reformulated product to the currently marketed Flolan. There was no significant change in the dose of reformulated product, 6MWD, Borg dyspnoea index, WHO functional class and mean NT-proBNP levels. No significant changes in haemodynamic parameters were seen from baseline to 2 hours post transition in a subset of patients undergoing catheterization. Conclusion The reformulated product was not associated with significant improvement in HRQoL compared with the currently marketed Flolan as measured by the SF-36. However, most subjects preferred the reformulated product to the currently marketed Flolan. Moreover, the 2 formulations of Flolan had similar safety and efficacy profiles. Trial Registration ClinicalTrials.gov NCT01462565 PMID

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

    PubMed

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

    2015-12-01

    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

  16. 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. PMID:26461922

  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 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

  19. 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. PMID:27536103

  20. Phase 1 Randomized Trial of the Vaginal Safety and Acceptability of SPL7013 Gel (VivaGel®) in Sexually Active Young Women (MTN-004)

    PubMed Central

    MCGOWAN, Ian; GOMEZ, Kailazarid; BRUDER, Karen; FEBO, Irma; CHEN, Beatrice A; RICHARDSON, Barbra A; HUSNIK, Marla; LIVANT, Edward; PRICE, Clare; Jacobson, Cindy

    2011-01-01

    Objectives The study was designed to assess the safety, adherence, acceptability, and effect on vaginal microflora of 3% SPL7013 Gel (VivaGel®), a novel dendrimer topical microbicide that inhibits HIV, HSV-2 and HPV in vitro and in animal models. Design Phase 1, randomized, double-blind, placebo-controlled study in sexually active women. Methods Sixty-one sexually active women aged 18–24 years were recruited from three sites in the United States. Participants were randomized 1:1:1 to receive VivaGel, VivaGel placebo, or a hydroxyethylcellulose (HEC) placebo twice daily for 14 consecutive days. Safety endpoints included genitourinary and/or other adverse events (AE). Changes in vaginal flora were determined from Gram-stained vaginal smears and quantitative vaginal culture. Results No serious AEs or withdrawals due to AEs were reported. Genitourinary symptoms were reported as follows: VivaGel (n=17/22; 77.3%), VivaGel placebo (n=14/21; 66.7%) and HEC (n=8/18; 44.4%) (NS, p=0.1). The incidence of abnormal pelvic exam findings was similar across all gel arms of the study. Using pair-wise comparison, women in the VivaGel arm had a significantly higher incidence of related genitourinary AEs compared with women in the HEC gel arm (0.297 versus 0.111 per 100 person years, respectively; p=0.003). Exposure to VivaGel and VivaGel placebo resulted in minor shifts in the vaginal microflora but there was no overall impact on incidence of bacterial vaginosis as assessed by Nugent score. Conclusions VivaGel was generally well tolerated and comparable with the VivaGel placebo, although there was a higher incidence of low grade related genital AEs compared to the HEC placebo gel. PMID:21505316

  1. 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

  2. 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

  3. Development of a beef flavor lexicon and its application to compare the flavor profile and consumer acceptance of rib steaks from grass- or grain-fed cattle.

    PubMed

    Maughan, Curtis; Tansawat, Rossarin; Cornforth, Daren; Ward, Robert; Martini, Silvana

    2012-01-01

    Ten panelists were selected from the local community to develop a meat lexicon composed of 18 terms that describe flavor attributes found in red meats. This flavor lexicon was used to compare the flavor profile of meat from beef cattle finished on grass or grain. Steaks from grass-fed animals were significantly (P<0.05) higher in barny, bitter, gamey, and grassy flavor, and lower in juicy and umami notes. Gamey, barny, bitter and grassy were some of the attributes inversely correlated to the degree of liking of the meat and therefore can be classified as "negative" attributes. Brothy, umami, roast beef, juicy, browned, fatty and salty are some of the attributes positively correlated to the degree of liking of beef and therefore can be identified as attributes that drive consumers' acceptance. Steaks from grass-fed cattle were rated by consumers as slightly liked (6.08 on a 9-point scale), while steaks from grain-fed animals were rated as moderately liked (7.05 on a 9-point scale). PMID:21703775

  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.

    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. PMID:24015691

  5. 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. PMID:25478734

  6. Optimization of the safety factor profile for high noninductive current fraction discharges in DIII-D

    NASA Astrophysics Data System (ADS)

    Ferron, J. R.; Holcomb, C. T.; Luce, T. C.; Politzer, P. A.; Turco, F.; White, A. E.; DeBoo, J. C.; Doyle, E. J.; Hyatt, A. W.; La Haye, R. J.; Murakami, M.; Petrie, T. W.; Petty, C. C.; Rhodes, T. L.; Zeng, L.

    2011-06-01

    In order to assess the optimum q profile for discharges in DIII-D with 100% of the current driven noninductively (fNI = 1), the self-consistent response of the plasma profiles to changes in the q profile was studied in high fNI, high βN discharges through a scan of qmin and q95 at two values of βN. As expected, both the bootstrap current fraction, fBS, and fNI increased with q95. The temperature and density profiles were found to broaden as either qmin or βN is increased. A consequence is that fBS does not continue to increase at the highest values of qmin. A scaling function that depends on qmin, q95, and the peaking factor for the thermal pressure was found to represent well the fBS/βN inferred from the experimental profiles. The changes in the shapes of the density and temperature profiles as βN is increased modify the bootstrap current density (JBS) profile from peaked close to the axis to relatively flat in the region between the axis and the H-mode pedestal. Therefore, significant externally driven current density in the region inside the H-mode pedestal is required in addition to JBS in order to match the profiles of the noninductive current density (JNI) to the desired total current density (J). In this experiment, the additional current density was provided mostly by neutral beam current drive with the neutral-beam-driven current fraction 40-90% of fBS. The profiles of JNI and J were most similar at qmin ≈ 1.35-1.65, q95 ≈ 6.8, where fBS is also maximum, establishing this q profile as the optimal choice for fNI = 1 operation in DIII-D with the existing set of external current drive sources.

  7. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes

    PubMed Central

    Zulu, Robert; Linyama, David; Long, Sarah; Nonde, Thikazi Jere; Lai, Jaim Jou; Kashitala, Joshua; Veena, Valentine; Kasonde, Prisca

    2016-01-01

    Objectives: To assess the safety, effectiveness, and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia. Methods: We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18–49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40–26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing. Results: Four hundred and ninety-six men comprised the analysis population, with 255 in the Standard Sizing arm and 241 in the Modified Sizing arm. Three men experienced a moderate or severe AEs (0.6%), including 2 in the Standard Sizing arm (0.8%) and 1 in the Modified Sizing arm (0.4%). 73.2% of participants were completely healed at the scheduled day 42 healing check visit, with similar percentages across study arms. Virtually all (99.6%) men, regardless of study arm, stated that they were very satisfied or satisfied with the appearance of their circumcised penis, and 98.6% stated that they would recommend ShangRing circumcision to family/friends. Conclusions: The moderate/severe AE rate was low and similar in the 2 study arms, suggesting that provision of one-half the number of adult device sizes is sufficient for safe service delivery. Effectiveness, time to healing, and acceptability were similar in the study arms. The simplicity of the ShangRing technique, and its relative speed, could facilitate VMMC program goals. In addition, sufficiency of fewer device sizes would simplify logistics

  8. 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)

  9. 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

  10. 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)

  11. 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

  12. 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. PMID:27354959

  13. The reproductive safety profile of mood stabilizers, atypical antipsychotics, and broad-spectrum psychotropics.

    PubMed

    Ernst, Carrie L; Goldberg, Joseph F

    2002-01-01

    There has been growing concern about the potential iatrogenic effects of several newer psychotropic drugs on reproductive health safety in women. Areas of particular concern in this regard include (1) controversies about a potential association between the use of valproate and development of polycystic ovary syndrome (PCOS), (2) the safety of use of newer psychotropic medications during pregnancy, and (3) safety issues with these medications in women while breastfeeding. This review summarizes current information about each of these areas. In particular, existing data suggest that (1) PCOS very likely represents a complex neuroendocrine disorder with multiple determinants; (2) menstrual irregularities may be a frequently seen phenomenon in women with bipolar illness, at least partially independent of psychotropic drug therapy; (3) potential central nervous system teratogenicity remains substantial during first-trimester exposure to valproate or carbamazepine; (4) with newer agents used for bipolar disorder and schizophrenia, safety data during pregnancy, while not definitive, are most abundant with olanzapine and with lamotrigine; relatively less is known about systematic pregnancy outcomes with other atypical antipsychotics or newer anticonvulsants; and (5) risks for neonatal safety during lactation continue to appear substantial with lithium, are of potential concern with lamotrigine and clozapine, are quite likely minimal with valproate or carbamazepine, and are indeterminate with most other new anticonvulsants or atypical antipsychotics. Recommendations are presented for clinical management in each of these instances. PMID:11913676

  14. 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

  15. 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. PMID:17664662

  16. Profile of criticality safety professionals in the Department of Energy contractor system

    SciTech Connect

    Crowell, M.R.; Trice, J.L.

    1986-01-01

    Results are reported from a survey of 178 criticality safety professionals within the DOE contractor system. Data are presented on the group's demographics, work experience, areas of specialization, professional development, and use of ANS/ANSI standards and selected reference documents.

  17. Integration Profile and Safety of an Adenovirus Hybrid-Vector Utilizing Hyperactive Sleeping Beauty Transposase for Somatic Integration

    PubMed Central

    Zhang, Wenli; Muck-Hausl, Martin; Wang, Jichang; Sun, Chuanbo; Gebbing, Maren; Miskey, Csaba; Ivics, Zoltan; Izsvak, Zsuzsanna; Ehrhardt, Anja

    2013-01-01

    We recently developed adenovirus/transposase hybrid-vectors utilizing the previously described hyperactive Sleeping Beauty (SB) transposase HSB5 for somatic integration and we could show stabilized transgene expression in mice and a canine model for hemophilia B. However, the safety profile of these hybrid-vectors with respect to vector dose and genotoxicity remains to be investigated. Herein, we evaluated this hybrid-vector system in C57Bl/6 mice with escalating vector dose settings. We found that in all mice which received the hyperactive SB transposase, transgene expression levels were stabilized in a dose-dependent manner and that the highest vector dose was accompanied by fatalities in mice. To analyze potential genotoxic side-effects due to somatic integration into host chromosomes, we performed a genome-wide integration site analysis using linker-mediated PCR (LM-PCR) and linear amplification-mediated PCR (LAM-PCR). Analysis of genomic DNA samples obtained from HSB5 treated female and male mice revealed a total of 1327 unique transposition events. Overall the chromosomal distribution pattern was close-to-random and we observed a random integration profile with respect to integration into gene and non-gene areas. Notably, when using the LM-PCR protocol, 27 extra-chromosomal integration events were identified, most likely caused by transposon excision and subsequent transposition into the delivered adenoviral vector genome. In total, this study provides a careful evaluation of the safety profile of adenovirus/Sleeping Beauty transposase hybrid-vectors. The obtained information will be useful when designing future preclinical studies utilizing hybrid-vectors in small and large animal models. PMID:24124483

  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. PMID:22514795

  19. The safety profile of vorinostat (suberoylanilide hydroxamic acid) in hematologic malignancies: A review of clinical studies.

    PubMed

    Duvic, Madeleine; Dimopoulos, Meletios

    2016-02-01

    Histone acetyltransferases and histone deacetylases (HDACs) are multifunctional enzymes that posttranslationally modify both histone and nonhistone acetylation sites, affecting a broad range of cellular processes (e.g., cell cycle, apoptosis, and protein folding) often dysregulated in cancer. HDAC inhibitors are small molecules that directly interact with HDAC catalytic sites preventing the removal of acetyl groups, thereby counteracting the effects of HDACs. Since the first HDAC inhibitor, valproic acid, was investigated as a potential antitumor agent, there have been a number of other HDAC inhibitors developed to improve efficacy and safety. Despite significant progress in the management of patients with hematologic malignancies, overall survival is still poor. The discovery that HDACs may play a role in hematologic malignancies and preclinical studies showing promising activity with HDAC inhibitors in various tumor types, led to clinical evaluation of HDAC inhibitors as potential treatment options for patients with advanced hematologic malignancies. The Food and Drug Administration has approved two HDAC inhibitors, vorinostat (2006) and romidepsin (2009), for the treatment of cutaneous T-cell lymphoma. This review highlights the safety of HDAC inhibitors currently approved or being investigated for the treatment of hematologic malignancies, with a specific focus on the safety experience with vorinostat in cutaneous T-cell lymphoma. PMID:26827693

  20. Safety assessment of plant varieties using transcriptomics profiling and a one-class classifier.

    PubMed

    van Dijk, Jeroen P; de Mello, Carla Souza; Voorhuijzen, Marleen M; Hutten, Ronald C B; Arisi, Ana Carolina Maisonnave; Jansen, Jeroen J; Buydens, Lutgarde M C; van der Voet, Hilko; Kok, Esther J

    2014-10-01

    An important part of the current hazard identification of novel plant varieties is comparative targeted analysis of the novel and reference varieties. Comparative analysis will become much more informative with unbiased analytical approaches, e.g. omics profiling. Data analysis estimating the similarity of new varieties to a reference baseline class of known safe varieties would subsequently greatly facilitate hazard identification. Further biological and eventually toxicological analysis would then only be necessary for varieties that fall outside this reference class. For this purpose, a one-class classifier tool was explored to assess and classify transcriptome profiles of potato (Solanum tuberosum) varieties in a model study. Profiles of six different varieties, two locations of growth, two year of harvest and including biological and technical replication were used to build the model. Two scenarios were applied representing evaluation of a 'different' variety and a 'similar' variety. Within the model higher class distances resulted for the 'different' test set compared with the 'similar' test set. The present study may contribute to a more global hazard identification of novel plant varieties. PMID:25046166

  1. Comparison of pharmacokinetic and safety profiles between Bemfola(®) and Gonal-f(®) after subcutaneous application.

    PubMed

    Wolzt, Michael; Gouya, Ghazeleh; Sator, Michael; Hemetsberger, Thomas; Irps, Charlotte; Rettenbacher, Manfred; Vcelar, Brigitta

    2016-06-01

    Recombinant human follicle stimulating hormone (r-hFSH) is effective and safe for controlled ovarian stimulation. Bemfola(®) (Finox AG, Burgdorf, Switzerland), a new biosimilar r-hFSH, has proven comparable non-clinical pharmacological profiles to those of the widely used Gonal-f(®) (Serono Pharma S.p.A., Bari, Italy). The objective of this study was to show that Bemfola(®) yields comparable clinical pharmacokinetic (PK) and safety profiles to Gonal-f(®) in healthy female subjects. In this randomized, Phase I trial conducted in healthy female volunteers (N = 32), a 2-period, balanced 2-treatment crossover design was used. A single subcutaneous dose of 225 IU Bemfola(®) or Gonal-f(®) was administered in each treatment period per sequence. Blood was collected for pharmacokinetic analysis until 10 days after each r-hFSH treatment. For down-regulation of endogenous FSH subjects were given a depot injection with leuprolide acetate prior to the study drug in either sequence. Pharmacokinetic data was available for 23 subjects. No appreciable differences in key PK parameters were detected between the r-hFSH products as per non-compartmental PK analysis [i.e. for Bemfola(®) and Gonal-f(®) respectively AUC0-192 424.90 and 432.75 IU h/L, C max 0.98 and 0.95 IU/L, T max 24.0 h (range 6.0-24.0) and 24.0 h (range 9.0-24.0), t 1/2 43.58 h [standard deviation (SD 14.17)] and 42.58 h (SD 16.47), and K e 0.0075 1/h (SD 0.003) and 0.0077 1/h (SD 0.002)]. Subgroup analysis for estradiol (E2) response was similar for Bemfola(®) and Gonal f(®) (AUC(0--120) p = 0.21 and C max p = 0.82). No major safety issues were identified and no immunogenic reaction to r-hFSH was observed. The results of this study indicate that a single dose of Bemfola(®) exhibits pharmacokinetic and safety profiles comparable to Gonal-f(®) in healthy young women. PMID:25633239

  2. Nonclinical Safety Profile of Etelcalcetide, a Novel Peptide Calcimimetic for the Treatment of Secondary Hyperparathyroidism.

    PubMed

    Fielden, Mark R; Dean, Charles; Black, Kurt; Sawant, Satin G; Subramanian, Raju; Tomlinson, James E; Walter, Sarah; Zimmermann, Cameron; Griggs, Mark W; McKeon, Marie E; Lewis, Elise M; Beevers, Carol; Pyrah, Ian

    2016-05-01

    Etelcalcetide is a novel d-amino acid peptide that functions as an allosteric activator of the calcium-sensing receptor and is being developed as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. To support clinical development and marketing authorization, a comprehensive nonclinical safety package was generated. Primary adverse effects included hypocalcemia, tremoring, and convulsions. Other adverse effects were considered sequelae of stress associated with hypocalcemia. Cardiovascular safety evaluations in the dog revealed an anticipated prolongation of the corrected QT interval that was related to reductions in serum calcium. Etelcalcetide did not affect the human ether-a-go-go gene ion channel current. Etelcalcetide was mutagenic in some strains of Salmonella, however, based on the negative results in 2 in vitro and 2 in vivo mammalian genotoxicity assays, including a 28-day Muta mouse study, etelcalcetide is considered nongenotoxic. Further support for a lack of genotoxicity was provided due to the fact that etelcalcetide was not carcinogenic in a 6-month transgenic rasH2 mouse model or a 2-year study in rats. There were no effects on fertility, embryo-fetal development, and prenatal and postnatal development. All of the adverse effects observed in both rat and dog were considered directly or secondarily related to the pharmacologic activity of etelcalcetide and the expected sequelae associated with dose-related reductions in serum calcium due to suppression of parathyroid hormone secretion. These nonclinical data indicate no safety signal of concern for human risk beyond that associated with hypocalcemia and associated QT prolongation. PMID:26941242

  3. 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. PMID:24158742

  4. Plasma treated with methylene blue and light: clinical efficacy and safety profile.

    PubMed

    Lozano, Miguel; Cid, Joan; Müller, Thomas H

    2013-10-01

    Methylene blue (MB) was the first method developed for pathogen inactivation of a labile blood component that was introduced in 1991. MB and light (MBL) inactivates most lipid-enveloped viruses and those non-enveloped are, in general, resistant. MBL treatment affects several coagulation factors, most noticeably fibrinogen and factor VIII with a loss of approximately 30%. Using endogenous thrombin potential, a global hemostasis evaluation, MBL treatment of plasma resulted in a 7% to 10% of reduction in thrombin potential. Although, originally, the scientific evidence of its efficacy and safety were scarce, the 4.4 million of units transfused have provided a wide body of evidence of its efficacy and safety in most of clinical situations. Nevertheless, some doubts have arisen about the efficacy of MBL plasma when used as a replacement solution for plasma exchange in the treatment of patients suffering from TTP. Probably only randomized controlled trials would provide definite evidence to clarify this point. Reports of severe allergic reactions in a few patients receiving MBL plasma have provoked the recent decision to remove the product from the market in France. Interestingly hemovigilance data in countries such as the same France, Spain, and United Kingdom have not corroborated an increase in severe allergic reaction. Close monitoring of the patients receiving plasma and suffering from allergic reactions and reporting to hemovigilance schemes hopefully will provide the needed data to definitely establish the exact risk of this complication for MBL vs other types of plasma. PMID:24075476

  5. Institutional Profile: Jayne Haines Center for Pharmacogenomics and Drug Safety: educating future generations of healthcare professionals.

    PubMed

    Krynetskiy, Evgeny

    2013-04-01

    The Jayne Haines Center for Pharmacogenomics and Drug Safety operates in the Temple University School of Pharmacy and serves as an educational and research facility for professional pharmacy students, graduate students, residents, postdoctoral fellows and faculties. The Center is involved in educational and investigational projects in a setting that includes an inner city research/teaching hospital and the Temple University Schools of Pharmacy, Medicine, Dentistry and Health Professions. The mission of the Haines Center is to facilitate the basic science approach to the problems of pharmacotherapy, and to provide education for future healthcare professionals in the genetics of drug response. With the expanding role of genetic analysis in preventing adverse effects of pharmacotherapy, we are working towards truly personalized pharmacotherapy that fully exploits the advances of modern biomedical science. PMID:23556444

  6. Safety profiles of gadolinium chelates in juvenile rats differ according to the risk of dissociation.

    PubMed

    Fretellier, Nathalie; Maazouz, Meryam; Luseau, Alexandrine; Baudimont, Fannie; Jestin-Mayer, Gaëlle; Bourgery, Simon; Rasschaert, Marlène; Bruneval, Patrick; Factor, Cécile; Mecieb, Fatiha; Idée, Jean-Marc; Corot, Claire

    2014-12-01

    This study was designed to compare the safety of two gadolinium chelates (GCs), used as contrast agents for magnetic resonance imaging, in juvenile rats. Juvenile rats received five intravenous administrations (between postnatal day [PND] 4 and 18) of gadoteric acid (macrocyclic ionic GC), gadodiamide (linear nonionic GC) or saline, and sacrificed at PND 25. Gadodiamide induced mortality, alopecia and hyperpigmentation of dorsal skin. Two gadodiamide-treated rats presented severe epidermal and dermal lesions. No abnormal signs were detected following administration of gadoteric acid. Higher tissue gadolinium concentrations were found in the gadodiamide group compared to the gadoteric acid group. Dissociation of gadodiamide was observed in skin and liver, with the presence of dissociated and soluble gadolinium. In conclusion, repeated administration of gadoteric acid was well tolerated by juvenile rats. In contrast, gadodiamide induced significant toxicity and more marked tissue gadolinium retention (at least partly in the dissociated and soluble form). PMID:25462783

  7. Safety profile of decellularized, cryopreserved pulmonary allografts when used in the aortic position for neonatal arch reconstruction.

    PubMed

    Knepp, Marc D; Ohye, Richard G; Gajarski, Robert J

    2011-08-01

    Cryopreserved pulmonary allograft is frequently used to reconstruct the hypoplastic aortic arch. A decellularized graft preparation is available as an alternative reconstructive material. This case series profiles our experience using this material for neonatal aortic arch reconstruction. Data from 14 patients who received decellularized pulmonary allograft (DCPA) from 2001 to 2003 included the following: diagnosis; age at implantation; perioperative complications (graft bleeding or dehiscence); intermediate-term results, including infection, recurrent arch gradient (>10 mmHg), graft calcification, or aneurysm; need for graft removal; and cause of death. Eleven (79%) patients survived their initial procedure. Median follow-up was 26 (range: 1-110) months. No early graft dehiscence was reported. No child developed aortic arch obstruction or graft calcification. Twelve patients (86%) underwent postoperative cardiac catheterizations with no measurable arch gradient. No intermediate-term aneurysm, dehiscence, or graft removal occurred. Three early deaths were due to arrhythmia, non-shunt-related hypoxia, and renal failure, and one, intermediate-term death was respiratory syncytial virus related. This series found that DCPA reconstructed arches have a low adverse event profile. No complications occurred. Because this graft material, which may be less immunogenic, has important implications for this subgroup, who are at increased future transplant risk, larger trials evaluating longer-term safety and immunogenicity are warranted. PMID:21479906

  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. Lurasidone: The 2016 update on the pharmacology, efficacy and safety profile.

    PubMed

    Jaeschke, Rafał R; Sowa-Kućma, Magdalena; Pańczyszyn-Trzewik, Patrycja; Misztak, Paulina; Styczeń, Krzysztof; Datka, Wojciech

    2016-08-01

    The aim of this paper was to review the up-to-date evidence base on pharmacology and clinical properties of lurasidone. Lurasidone is an atypical antipsychotic, approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar depression. Lurasidone exhibits both an antipsychotic and antidepressant action. Based on its pharmacodynamics profile, it is believed that the drug's clinical action is mediated mainly through the D2, 5-HT2A and 5-HT7 receptors inhibition. In patients with schizophrenia the recommended dose range is 40-80mg/day. In bipolar depression broader dosage ranges (20-120mg/day) were found to be effective. In terms of side effects, higher rates of akathisia, parkinsonism and hyperprolactinemia were observed in individuals receiving lurasidone (as compared to patients treated with other atypical antipsychotics). On the other hand, treatment with lurasidone yields relatively lower risk for developing sedation or overweight/obesity. PMID:27203278

  10. Improvement of the in vitro safety profile and cytoprotective efficacy of amifostine against chemotherapy by PEGylation strategy.

    PubMed

    Yang, Xiao; Ding, Yanping; Ji, Tianjiao; Zhao, Xiao; Wang, Hai; Zhao, Xiaozheng; Zhao, Ruifang; Wei, Jingyan; Qi, Sheng; Nie, Guangjun

    2016-05-15

    Amifostine, an organic thiophosphate prodrug, has been clinically utilized for selective protection of normal tissues with high expression of alkaline phosphatase from oxidative damage elicited by chemotherapy or radiotherapy. However, the patients receiving amifostine suffer from severe dose-dependent adverse effects. Strategies for improvement of the protective efficacy and toxicity profile of amifostine are urgently required. Here we constructed a PEGylated amifostine (PEG-amifostine) through conjugation of amifostine to the 4-arm PEG (5000Da) by a mild one-step reaction. The relatively large PEG-amifostine molecules clustered into spherical nanoparticles, resulting in distinct hydrolysis properties, cell uptake profile and antioxidative activity compared with the free small molecules. PEGylation prolonged the hydrolysis time of amifostine, providing sustained transformation to its functional metabolites. PEG-amifostine could be internalized into cells and translocated to acidic organelles in a time-dependent manner. The intrinsic cytotoxicity of amifostine, which is related to the reductive reactivity of its metabolites and their ability to diffuse readily, was attenuated after PEGylation. This modification impeded the interaction between free sulfhydryls and functional biomolecules, providing PEG-amifostine with an improved safety profile in vitro. Moreover, PEG-amifostine showed higher efficiency in the elimination of reactive oxygen species and prevention of cisplatin-induced cytotoxicity compared with free amifostine. Overall, our study for the first time developed a PEGylated form of amifostine which significantly improved the efficacy and decreased the adverse effects of this antioxidant in vitro with great promise for clinical translation. In vivo study is urgently needed to confirm and redeem the cytoprotective effects of the PEG-amifostine in chemotherapy. PMID:26944193

  11. Third and fourth generation fluoroquinolone antibacterials: a systematic review of safety and toxicity profiles.

    PubMed

    Sousa, Joana; Alves, Gilberto; Fortuna, Ana; Falcão, Amilcar

    2014-01-01

    In the last decade, several third and fourth generation fluoroquinolones (FQs) have been approved for clinical use. These new agents exhibit a more potent and broader-spectrum antibacterial activity and improved pharmacokinetic properties in comparison to the earlier FQs. Although new FQs are generally safe and well tolerated, moderate-to-severe toxicity events have been reported for some of them, leading to their restriction, suspension or even withdrawal from the market. The most common FQ-related adverse effects (AEs) are usually mild and involve the gastrointestinal tract (e.g. nausea and diarrhea) and the central nervous system (e.g. headache and dizziness). Uncommon, but severe AEs (e.g. arthropathy, QTc interval prolongation, dysglycaemia and phototoxicity) and idiosyncratic reactions (e.g. hepatitis and hemolytic anemia) have also been reported and will be discussed throughout this paper. The evidence currently available suggests that AEs can be inherent to the FQ class or can be associated with a particular chemical moiety of the molecular structure of each FQ, thus varying in frequency, severity and nature. The main goal of this review is to provide a systematic evaluation of safety and tolerability data of the newer FQs with emphasis on those currently marketed. PMID:24410307

  12. Evaluation of the safety and tolerability profile of Sativex: is it reassuring enough?

    PubMed

    Wade, Derick

    2012-04-01

    The adoption of new drug therapies involves an assessment of risk:benefit based upon the best clinical evidence, including clinical trials but also everyday clinical practice data collection. However, in the case of Sativex, a cannabinoid medicine containing the two main active ingredients of cannabis, δ-9-tetrahydrocannabinol and cannabidiol, the picture is somewhat clouded by preconceived views regarding the world's most widely used illicit drug, herbal cannabis. In this review, I aim to look beyond these preconceptions and evaluate the body of published data concerning this medicine currently approved in different countries for the management of one of the most frequent and disabling symptoms associated with multiple sclerosis, spasticity. In particular, data relevant to areas of concern such as tolerability, safety, psychoactivity, effects on withdrawal (including possible drug tolerance) and finally the potential for abuse/dependence are evaluated. Balancing these risk factors, the main positive clinical data published over the years by the Oxford Centre for Enablement, following on from the first pilot study in 2004, are presented. Based upon our experience, the benefits that are seen initially with Sativex when treating multiple sclerosis spasticity patients are generally maintained during long-term treatment. Furthermore, following withdrawal of Sativex, symptoms often return, but, beyond this, sudden cessation is generally safe with no evidence of physiological or psychological dependence. Dose escalation has not usually been observed in clinical trials or clinical practice after the first titration weeks. Adverse effects occur relatively frequently, but they are usually mild to moderate in intensity and rarely require drug discontinuation. Overall, Sativex appears to be well-tolerated and a useful addition for patients who have failed treatment with traditional antispastic agents. PMID:22509986

  13. 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.

  14. 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

  15. 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. PMID:25702071

  16. Safety profile of HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 analysis

    PubMed Central

    Lalezari, Jacob; Latiff, Gulam H; Brinson, Cynthia; Echevarria, Juan; Treviño-Pérez, Sandra; Bogner, Johannes R; Stock, David; Joshi, Samit R; Hanna, George J; Lataillade, Max

    2014-01-01

    Introduction BMS-663068 is a prodrug of BMS-626529, an attachment inhibitor that binds directly to HIV-1 gp120, preventing initial viral attachment and entry into the host CD4+ T-cell. AI438011 is an ongoing, Phase IIb, randomized, active-controlled trial investigating the safety, efficacy and dose–response of BMS-663068 vs. atazanavir/ritonavir (ATV/r) in treatment-experienced (TE), HIV-1-positive subjects. At Week 24, response rates across the BMS-663068 arms were consistent with ATV/r. Materials and Methods Antiretroviral TE subjects (exposure to ≥1 antiretroviral for ≥1 week) with susceptibility to all study drugs (including BMS-626529 IC50 100 nM) were randomized equally to four BMS-663068 arms (400 or 800 mg, BID; 600 or 1200 mg, QD) and a control arm (ATV/r 300/100 mg QD), with tenofovir disoproxil fumarate (TDF) + raltegravir (RAL). The complete safety profile through Week 24 is reported. Results In total, 251 subjects were treated (BMS-663068, 200; ATV/r, 51). No BMS-663068-related adverse events (AEs) led to discontinuation. Grade 2–4 drug-related AEs occurred in 17/200 (8.5%) subjects across the BMS-633068 arms; however, these events were mostly single instances and no dose-relationship was seen. Similarly, no noticeable trend for Grade 3–4 laboratory abnormalities was seen and Grade 3–4 hematologic changes and liver chemistry elevations were uncommon (neutropenia, 2.5%; AST/ALT elevations, 1% (n=196)). In the ATV/r arm, Grade 2–4 drug-related AEs occurred in 14/51 (27.5%) subjects and were mostly secondary to gastrointestinal and/or hepatobiliary disorders. Serious adverse events (SAEs) occurred in 13/200 (6.5%) and 5/51 (9.8%) subjects receiving BMS-663068 and ATV/r, respectively; most were secondary to infections and none were related to study drugs. The most common AE reported for BMS-663068 was headache (28/200, 14%), occurring in 5/51 (10%) subjects in the ATV/r arm; in the BMS-663068 arms, this was not dose-related. There were no

  17. 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

  18. 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.

  19. Intraventricular etoposide safety and toxicity profile in children and young adults with refractory or recurrent malignant brain tumors.

    PubMed

    Pajtler, Kristian W; Tippelt, Stephan; Siegler, Nele; Reichling, Stefanie; Zimmermann, Martina; Mikasch, Ruth; Bode, Udo; Gnekow, Astrid; Pietsch, Torsten; Benesch, Martin; Rutkowski, Stefan; Fleischhack, Gudrun

    2016-07-01

    Systemic administration of etoposide is effective in treating metastatic, recurrent or refractory brain tumors, but penetration into the cerebrospinal fluid is extremely poor. This study was designed to determine the safety and toxicity profile of intraventricular etoposide administration and was affiliated with the prospective, multicenter, nonblinded, nonrandomized, multi-armed HIT-REZ-97 trial. The study enrolled 68 patients, aged 1.1-34.6 (median age 11 years). Adverse events that could possibly be related to intraventricular etoposide therapy were documented and analyzed. Intraventricular etoposide was simultaneously administered with either oral or intravenous chemotherapy in 426 courses according to three major schedules varying in dosing (0.25-1 mg), frequency of administration (bolus injection, every 12 or 24 h), course duration (5-10 days) and length of interval between courses (2-5 weeks). Potential treatment-related adverse effects included transient headache, seizures, infection of the reservoir, nausea and neuropsychological symptoms. Hematological side effects were not observed. One patient, with history of multiple prior therapies, who received long-term intraventricular and oral etoposide treatment developed acute myeloid leukemia as a secondary malignancy. Overall intraventricular etoposide is well tolerated. The results of this study have warranted a phase II trial to determine the effectiveness of this regimen in disease stages with very limited therapeutic options. PMID:27147083

  20. 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. PMID:25428796

  1. Evaluation of in vitro and in vivo safety profile of the Indian traditional medicinal plant Grewia tiliaefolia.

    PubMed

    Dicson, Sheeja Malar; Samuthirapandi, Muniasamy; Govindaraju, Archunan; Kasi, Pandima Devi

    2015-10-01

    Grewia tiliaefolia Vahl., is a subtropical tree used in Ayurvedic formulations and also by tribal communities in India for treatment of wounds, urinary infection and skin diseases. Despite of its medicinal use, the plant has not been previously tested for its safety. This study evaluated the toxicological profile of the methanolic extract of G. tiliaefolia leaves (MEGT) through in vitro (cytotoxic, mutagenic, genotoxic) and in vivo (acute and sub-acute) studies. In vitro assays conclude that there is no significant (p<0.05) level of cytotoxicity and genotoxicity at the tested concentrations (250-2000 μg/ml) in peripheral blood mononuclear cells. Ames assay in the tested Salmonella typhimurium strains revealed no significant (p<0.05) increase in the mutagenic index both in the presence and absence of metabolic activation. Alternatively, no change in mortality, physiological, behavioural, haematological and biochemical parameters were observed under in vivo acute (250, 500, 1000, 2000 mg/kg b.w) and sub-acute (100, 200, 1000 mg/kg b.w) toxicity studies in Wistar rats. Histopathological examinations of the animals did not reveal any treatment related changes and showed normal architecture, even at the highest concentration (1000 mg/kg b.w) following 28 days treatment. Overall, the results show that MEGT is non-toxic at the tested concentrations and is safe to be used as herbal medicine. PMID:26188119

  2. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in...

  3. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Construction acceptance. 193.2303 Section 193.2303 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in...

  4. 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. PMID:24911686

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma

    PubMed Central

    2011-01-01

    Background Interleukin-9 (IL-9)-targeted therapies may offer a novel approach for treating asthmatics. Two randomized placebo-controlled studies were conducted to assess the safety profile and potential efficacy of multiple subcutaneous doses of MEDI-528, a humanized anti-IL-9 monoclonal antibody, in asthmatics. Methods Study 1: adults (18-65 years) with mild asthma received MEDI-528 (0.3, 1, 3 mg/kg) or placebo subcutaneously twice weekly for 4 weeks. Study 2: adults (18-50 years) with stable, mild to moderate asthma and exercise-induced bronchoconstriction received 50 mg MEDI-528 or placebo subcutaneously twice weekly for 4 weeks. Adverse events (AEs), pharmacokinetics (PK), immunogenicity, asthma control (including asthma exacerbations), and exercise challenge test were evaluated in study 1, study 2, or both. Results In study 1 (N = 36), MEDI-528 showed linear serum PK; no anti-MEDI-528 antibodies were detected. Asthma control: 1/27 MEDI-528-treated subjects had 1 asthma exacerbation, and 2/9 placebo-treated subjects had a total of 4 asthma exacerbations (one considered a serious AE). In study 2, MEDI-528 (n = 7) elicited a trend in the reduction in mean maximum decrease in FEV1 post-exercise compared to placebo (n = 2) (-6.49% MEDI-528 vs -12.60% placebo; -1.40% vs -20.10%; -5.04% vs -15.20% at study days 28, 56, and 150, respectively). Study 2 was halted prematurely due to a serious AE in an asymptomatic MEDI-528-treated subject who had an abnormal brain magnetic resonance imaging that was found to be an artifact on further evaluation. Conclusions In these studies, MEDI-528 showed an acceptable safety profile and findings suggestive of clinical activity that support continued study in subjects with mild to moderate asthma. Trial registration ClinicalTrials (NCT): NCT00507130 and ClinicalTrials (NCT): NCT00590720 PMID:21356110

  10. 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

  11. Acceptance speech.

    PubMed

    Carpenter, M

    1994-01-01

    In Bangladesh, the assistant administrator of USAID gave an acceptance speech at an awards ceremony on the occasion of the 25th anniversary of oral rehydration solution (ORS). The ceremony celebrated the key role of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) in the discovery of ORS. Its research activities over the last 25 years have brought ORS to every village in the world, preventing more than a million deaths each year. ORS is the most important medical advance of the 20th century. It is affordable and client-oriented, a true appropriate technology. USAID has provided more than US$ 40 million to ICDDR,B for diarrheal disease and measles research, urban and rural applied family planning and maternal and child health research, and vaccine development. ICDDR,B began as the relatively small Cholera Research Laboratory and has grown into an acclaimed international center for health, family planning, and population research. It leads the world in diarrheal disease research. ICDDR,B is the leading center for applied health research in South Asia. It trains public health specialists from around the world. The government of Bangladesh and the international donor community have actively joined in support of ICDDR,B. The government applies the results of ICDDR,B research to its programs to improve the health and well-being of Bangladeshis. ICDDR,B now also studies acute respiratory diseases and measles. Population and health comprise 1 of USAID's 4 strategic priorities, the others being economic growth, environment, and democracy, USAID promotes people's participation in these 4 areas and in the design and implementation of development projects. USAID is committed to the use and improvement of ORS and to complementary strategies that further reduce diarrhea-related deaths. Continued collaboration with a strong user perspective and integrated services will lead to sustainable development. PMID:12345470

  12. 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. PMID:12345479

  13. 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

  14. 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. PMID:24786551

  15. 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

  16. 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

  17. Review of dutasteride/tamsulosin fixed-dose combination for the treatment of benign prostatic hyperplasia: efficacy, safety, and patient acceptability

    PubMed Central

    Barkin, Jack

    2011-01-01

    Lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) will usually affect older men, of whom 50% over the age 60 years and almost 90% in their nineties will be bothered enough by their symptoms that they request some type of treatment. However, symptomatic bother may also affect men in their forties with a prevalence rate of almost 18%. The International Prostate Symptom Score (IPSS) has become the most widely used and best validated questionnaire to allow the patient to quantify the severity of his LUTS/BPH symptoms. This score has become the cornerstone in demonstrating the “rate of symptom response” for the patient who has been exposed to any type BPH management. Question 8 on the IPSS score is what is defined as the “Quality of Life” question or what is also termed the “Bothersome Index.” The score out of 6 as declared by the patient will reflect the degree of concern that the patient is feeling about his symptoms and the reduction of the score after treatment is a statement of their improved quality of life. There are 2 families of accepted medical therapy to treat the symptoms of BPH and potentially prevent the most worrisome long-term sequelae of progression of BPH: urinary retention or the need for surgery. When defining the impact of the main types of medical therapy, the alpha blockers have been termed the “openers” and the 5 alpha-reductase inhibitors are described as the “shrinkers.” Since they each offer a different mechanism of effect, the concept of combination therapy was raised and trialed many times over recent years. The final aspect of any medical therapy is the patient’s satisfaction with the treatment and the side effects. In the CombAT (Combination of Avodart and Tamsulosin) trial a new assessment was developed and tested called the Patient’s Perception of Study Medication (PPSM) which told the investigators if the patients, given free choice, would choose to take that combination of

  18. Physics-model-based nonlinear actuator trajectory optimization and safety factor profile feedback control for advanced scenario development in DIII-D

    NASA Astrophysics Data System (ADS)

    Barton, J. E.; Boyer, M. D.; Shi, W.; Wehner, W. P.; Schuster, E.; Ferron, J. R.; Walker, M. L.; Humphreys, D. A.; Luce, T. C.; Turco, F.; Penaflor, B. G.; Johnson, R. D.

    2015-09-01

    DIII-D experimental results are reported to demonstrate the potential of physics-model-based safety factor profile control for robust and reproducible sustainment of advanced scenarios. In the absence of feedback control, variability in wall conditions and plasma impurities, as well as drifts due to external disturbances, can limit the reproducibility of discharges with simple pre-programmed scenario trajectories. The control architecture utilized is a feedforward + feedback scheme where the feedforward commands are computed off-line and the feedback commands are computed on-line. In this work, a first-principles-driven (FPD), physics-based model of the q profile and normalized beta ({β\\text{N}} ) dynamics is first embedded into a numerical optimization algorithm to design feedforward actuator trajectories that steer the plasma through the tokamak operating space to reach a desired stationary target state that is characterized by the achieved q profile and {β\\text{N}} . Good agreement between experimental results and simulations demonstrates the accuracy of the models employed for physics-model-based control design. Second, a feedback algorithm for q profile control is designed following an FPD approach, and the ability of the controller to achieve and maintain a target q profile evolution is tested in DIII-D high confinement (H-mode) experiments. The controller is shown to be able to effectively control the q profile when {β\\text{N}} is relatively close to the target, indicating the need for integrated q profile and {β\\text{N}} control to further enhance the ability to achieve robust scenario execution. The ability of an integrated q profile + {β\\text{N}} feedback controller to track a desired target is demonstrated through simulation.

  19. 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. PMID:26752445

  20. 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

  1. 49 CFR 193.2303 - Construction acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: FEDERAL SAFETY STANDARDS Construction § 193.2303 Construction acceptance. No person may place in service... 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...

  2. 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.

  3. 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...

  4. Optimization of physicochemical properties and safety profile of novel bacterial topoisomerase type II inhibitors (NBTIs) with activity against Pseudomonas aeruginosa.

    PubMed

    Reck, Folkert; Ehmann, David E; Dougherty, Thomas J; Newman, Joseph V; Hopkins, Sussie; Stone, Gregory; Agrawal, Nikunj; Ciaccio, Paul; McNulty, John; Barthlow, Herbert; O'Donnell, Jennifer; Goteti, Kosalaram; Breen, John; Comita-Prevoir, Janelle; Cornebise, Mark; Cronin, Mark; Eyermann, Charles J; Geng, Bolin; Carr, Greg R; Pandarinathan, Lakshmipathi; Tang, Xuejun; Cottone, Andrew; Zhao, Liang; Bezdenejnih-Snyder, Natascha

    2014-10-01

    Type II bacterial topoisomerases are well validated targets for antimicrobial chemotherapy. Novel bacterial type II topoisomerase inhibitors (NBTIs) of these targets are of interest for the development of new antibacterial agents that are not impacted by target-mediated cross-resistance with fluoroquinolones. We now disclose the optimization of a class of NBTIs towards Gram-negative pathogens, especially against drug-resistant Pseudomonas aeruginosa. Physicochemical properties (pKa and logD) were optimized for activity against P. aeruginosa and for reduced inhibition of the hERG channel. The optimized analogs 9g and 9i displayed potent antibacterial activity against P. aeruginosa, and a significantly improved hERG profile over previously reported analogs. Compound 9g showed an improved QT profile in in vivo models and lower clearance in rat over earlier compounds. The compounds show promise for the development of new antimicrobial agents against drug-resistant Pseudomonas aeruginosa. PMID:25155913

  5. 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

    2016-01-01

    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

  6. 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…

  7. A chemical tuned strategy to develop novel irreversible EGFR-TK inhibitors with improved safety and pharmacokinetic profiles.

    PubMed

    Xia, Guangxin; Chen, Wenteng; Zhang, Jing; Shao, Jiaan; Zhang, Yong; Huang, Wei; Zhang, Leduo; Qi, Weixing; Sun, Xing; Li, Bojun; Xiang, Zhixiong; Ma, Chen; Xu, Jia; Deng, Hailin; Li, Yufeng; Li, Ping; Miao, Hong; Han, Jiansheng; Liu, Yanjun; Shen, Jingkang; Yu, Yongping

    2014-12-11

    Gatekeeper T790 M mutation in EGFR is the most prevalent factor underlying acquired resistance. Acrylamide-bearing quinazoline derivatives are powerful irreversible inhibitors for overcoming resistance. Nevertheless, concerns about the risk of nonspecific covalent modification have motivated the development of novel cysteine-targeting inhibitors. In this paper, we demonstrate that fluoro-substituted olefins can be tuned to alter Michael addition reactivity. Incorporation of these olefins into the quinazoline templates produced potent EGFR inhibitors with improved safety and pharmacokinetic properties. A lead compound 5a was validated against EGFR(WT), EGFR(T790M) as well as A431 and H1975 cancer cell lines. Additionally, compound 5a displayed a weaker inhibition against the EGFR-independent cancer cell line SW620 when compared with afatinib. Oral administration of 5a at a dose of 30 mg/kg induced tumor regression in a murine-EGFR(L858R/T790M) driven H1975 xenograft model. Also, 5a exhibited improved oral bioavailability and safety as well as favorable tissue distribution properties and enhanced brain uptake. These findings provide the basis of a promising strategy toward the treatment of NSCLC patients with drug resistance. PMID:25409491

  8. 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. PMID:21543160

  9. Transcriptome Profiling of Patient-Specific Human iPSC-Cardiomyocytes Predicts Individual Drug Safety and Efficacy Responses In Vitro.

    PubMed

    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

    2016-09-01

    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

  10. Use of short-term transcriptional profiles to assess the long-term cancer-related safety of environmental and industrial chemicals.

    PubMed

    Thomas, Russell S; Bao, Wenjun; Chu, Tzu-Ming; Bessarabova, Marina; Nikolskaya, Tatiana; Nikolsky, Yuri; Andersen, Melvin E; Wolfinger, Russell D

    2009-12-01

    The process for evaluating chemical safety is inefficient, costly, and animal intensive. There is growing consensus that the current process of safety testing needs to be significantly altered to improve efficiency and reduce the number of untested chemicals. In this study, the use of short-term gene expression profiles was evaluated for predicting the increased incidence of mouse lung tumors. Animals were exposed to a total of 26 diverse chemicals with matched vehicle controls over a period of 3 years. Upon completion, significant batch-related effects were observed. Adjustment for batch effects significantly improved the ability to predict increased lung tumor incidence. For the best statistical model, the estimated predictive accuracy under honest fivefold cross-validation was 79.3% with a sensitivity and specificity of 71.4 and 86.3%, respectively. A learning curve analysis demonstrated that gains in model performance reached a plateau at 25 chemicals, indicating that the size of current data set was sufficient to provide a robust classifier. The classification results showed that a small subset of chemicals contributed disproportionately to the misclassification rate. For these chemicals, the misclassification was more closely associated with genotoxicity status than with efficacy in the original bioassay. Statistical models were also used to predict dose-response increases in tumor incidence for methylene chloride and naphthalene. The average posterior probabilities for the top models matched the results from the bioassay for methylene chloride. For naphthalene, the average posterior probabilities for the top models overpredicted the tumor response, but the variability in predictions was significantly higher. The study provides both a set of gene expression biomarkers for predicting chemically induced mouse lung tumors and a broad assessment of important experimental and analysis criteria for developing microarray-based predictors of safety-related end points

  11. 49 CFR 388.2 - Extent of acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Extent of acceptance. 388.2 Section 388.2 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY... STATES § 388.2 Extent of acceptance. The written acceptance may be in letter form, signed by...

  12. 49 CFR 388.2 - Extent of acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Extent of acceptance. 388.2 Section 388.2 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY... STATES § 388.2 Extent of acceptance. The written acceptance may be in letter form, signed by...

  13. Subthreshold micropulse yellow laser (577 nm) in chronic central serous chorioretinopathy: safety profile and treatment outcome

    PubMed Central

    Yadav, N K; Jayadev, C; Mohan, A; Vijayan, P; Battu, R; Dabir, S; Shetty, B; Shetty, R

    2015-01-01

    Purpose To assess the safety and efficacy of a single session of subthreshold micropulse (SM) yellow laser (577 nm) in the treatment of chronic central serous chorioretinopathy (CSCR). Methods This was a retrospective analysis of 15 eyes of 13 patients with CSCR of >3 months duration who had been treated with SM yellow laser (577 nm). All patients had been treated using multiple spots of laser with a duty cycle of 10% over areas of focal and diffuse leak, as seen on fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA). Reduction in subretinal fluid height on spectral domain optical coherence tomography (SD-OCT) was used to measure the response to treatment. Results The mean follow-up was at 8 weeks (4–19 weeks). All eyes responded to treatment. The mean subretinal fluid height pre and post treatment was 232 and 49 μm, respectively, showing a 79% average reduction (P<0.001) in fluid height. There was no evidence of retinal pigment epithelium or retinal damage on SD-OCT, FFA, or fundus autofluorescence. Median visual improvement was one line on Snellen's visual acuity chart (P=0.015). Microperimetry was performed in eight eyes of which six eyes (75%) showed an improvement in the threshold values post treatment. Conclusion SM yellow laser is an effective treatment option for chronic CSCR. PMID:25613846

  14. 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

  15. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination.

    PubMed

    Boutros, Celine; Tarhini, Ahmad; Routier, Emilie; Lambotte, Olivier; Ladurie, Francois Leroy; Carbonnel, Franck; Izzeddine, Hassane; Marabelle, Aurelien; Champiat, Stephane; Berdelou, Armandine; Lanoy, Emilie; Texier, Matthieu; Libenciuc, Cristina; Eggermont, Alexander M M; Soria, Jean-Charles; Mateus, Christine; Robert, Caroline

    2016-08-01

    Inhibition of immune checkpoints using anti-programmed cell death-1 (PD-1) or anti cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibodies has revolutionized the management of patients with advanced-stage melanoma and is among the most promising treatment approaches for many other cancers. Use of CTLA-4 and PD-1 inhibitors, either as single agents, or in combination, has been approved by the US FDA for the treatment of metastatic melanoma. Treatment with these novel immunotherapies results in a unique and distinct spectrum of adverse events, which are mostly related to activation of the immune system and are, therefore, an unwanted consequence of their mechanisms of action. Adverse effects of CTLA-4 and/or PD-1 inhibition are most commonly observed in the skin, gastrointestinal tract, liver and endocrine systems and include pruritus, rash, nausea, diarrhoea and thyroid disorders. In this Review, the authors describe the adverse event profile of checkpoint inhibitors targeting CTLA-4 and PD-1, used both as monotherapies and in combination and aim to provide some general guidelines, based upon the mechanisms of action of these therapies and on the management of these immune-related adverse events. PMID:27141885

  16. Magnetic safety factor profile before and after sawtooth crashes investigated with toroidicity and ellipticity induced Alfvén eigenmodes

    NASA Astrophysics Data System (ADS)

    Kramer, G. J.; Cheng, C. Z.; Kusama, Y.; Nazikian, R.; Takeji, S.; Tobita, K.

    2001-09-01

    A study of toroidicity and ellipticity induced Alfvén eigenmodes (TAEs and EAEs) that are excited before and after sawtooth crashes during ion cyclotron range of frequency (ICRF) heating in JT-60U is presented. From the TAEs that are observed before sawteeth and that reside inside the q = 1 surface an upper limit has been set for q in the plasma centre at the time of the crash. After the sawtooth crash, EAEs that reside at the q = 1 surface are often observed. In a number of discharges the start of the EAE activity is delayed to up to 150 ms after the crash. In some cases TAE activity was observed between the sawtooth crash and the onset of the EAE activity. These TAEs could be modelled successfully only when it was assumed that the central safety factor (q0) rises above unity after the giant sawtooth crash. The appearance of the TAE activity immediately after the giant sawtooth crash is a strong indication that the fast particle drive remains in the plasma centre. This is consistent with theoretical estimates for the confinement of deeply trapped ICRF ions. The delayed appearance of the EAEs is also consistent with the disappearance of the q = 1 surface from the plasma at the giant sawtooth crash. The only way to obtain agreement between the experimentally measured EAE frequencies and the NOVA-K simulations is to assume that the q = 1 surface reappears in the plasma at the start of the EAE activity. The delayed appearance of the EAE activity seems to be correlated with the electron temperature just before the crash.

  17. 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

  18. A novel sustained-release formulation of recombinant human growth hormone and its pharmacokinetic, pharmacodynamic and safety profiles.

    PubMed

    Wei, Yi; Wang, Yuxia; Kang, Aijun; Wang, Wei; Ho, Sa V; Gao, Junfeng; Ma, Guanghui; Su, Zhiguo

    2012-07-01

    GH-PELA microspheres have the potential to be clinically effective and safe when administered only once every two months, a dose regimen for better patient acceptance and compliance. PMID:22663348

  19. Safety-factor profile tailoring by improved electron cyclotron system for sawtooth control and reverse shear scenarios in ITER

    SciTech Connect

    Zucca, C.; Sauter, O.; Fable, E.; Henderson, M. A.; Polevoi, A.; Saibene, G.

    2008-11-01

    The effect of the predicted local electron cyclotron current driven by the optimized electron cyclotron system on ITER is discussed. A design variant was recently proposed to enlarge the physics program covered by the upper and equatorial launchers. By extending the functionality range of the upper launcher, significant control capabilities of the sawtooth period can be obtained. The upper launcher improvement still allows enough margin to exceed the requirements for neoclassical tearing mode stabilization, for which it was originally designed. The analysis of the sawtooth control is carried on with the ASTRA transport code, coupled with the threshold model by Por-celli, to study the control capabilities of the improved upper launcher on the sawtooth instability. The simulations take into account the significant stabilizing effect of the fusion alpha particles. The sawtooth period can be increased by a factor of 1.5 with co-ECCD outside the q = 1 surface, and decreased by at least 30% with co-ECCD inside q = 1. The present ITER base-line design has the electron cyclotron launchers providing only co-ECCD. The variant for the equatorial launcher proposes the possibility to drive counter-ECCD with 1 of the 3 rows of mirrors: the counter-ECCD can then be balanced with co-ECCD and provide pure ECH with no net driven current. The difference between full co-ECCD off-axis using all 20MW from the equatorial launcher and 20MW co-ECCD driven by 2/3 from the equatorial launcher and 1/3 from the upper launcher is shown to be negligible. Cnt-ECCD also offers greater control of the plasma current density, therefore this analysis addresses the performance of the equatorial launcher to control the central q profile. The equatorial launcher is shown to control very efficiently the value of q{sub 0.2}-q{sub min} in advanced scenarios, if one row provides counter-ECCD.

  20. Anxiolytic-like effects and safety profile of a tryptic hydrolysate from bovine alpha s1-casein in rats.

    PubMed

    Messaoudi, Michaël; Lalonde, Robert; Schroeder, Henri; Desor, Didier

    2009-06-01

    The anxiolytic activity and adverse benzodiazepine-like effects of a bovine alpha s1-casein tryptic hydrolysate (CH) were evaluated. The effects of CH orally administered at doses of 5 and 15 mg/kg were compared with those of diazepam (DZ) at 3 mg/kg in the conditioned defensive burying test. Rats treated either with CH at 15 mg/kg or with DZ showed a decrease in anxiety. A drug-related difference was observed in terms of duration, as the anxiolytic-like action of CH was maintained after 7 days with twice-daily administration, whereas that of DZ was not. CH and DZ were then evaluated for their potential effects on memory in a passive avoidance paradigm. CH-treated rats had significantly longer latencies before entering the dark compartment where they were previously delivered a shock, indicating better retention relative to DZ-treated rats. In the final test, CH and DZ were evaluated for place preference, an index of the possible addictive potential of these substances. DZ-treated rats spent more time in the compartment associated with drug exposure than control rats. This effect was not found in CH-treated rats. Thus, CH did not display side effects associated with DZ, despite its affinity for gamma-aminobutyric acid(A) (GABA(A)) receptors. Specific linking of CH on GABA(A) receptor function involved in anxiolysis, but not on that implied in memory-impairing effects, may be hypothesized to explain its specific activity. This profile might render it advantageous for nutritional purposes. PMID:19453759

  1. Parallel functional activity profiling reveals valvulopathogens are potent 5-hydroxytryptamine(2B) receptor agonists: implications for drug safety assessment.

    PubMed

    Huang, Xi-Ping; Setola, Vincent; Yadav, Prem N; Allen, John A; Rogan, Sarah C; Hanson, Bonnie J; Revankar, Chetana; Robers, Matt; Doucette, Chris; Roth, Bryan L

    2009-10-01

    Drug-induced valvular heart disease (VHD) is a serious side effect of a few medications, including some that are on the market. Pharmacological studies of VHD-associated medications (e.g., fenfluramine, pergolide, methysergide, and cabergoline) have revealed that they and/or their metabolites are potent 5-hydroxytryptamine(2B) (5-HT(2B)) receptor agonists. We have shown that activation of 5-HT(2B) receptors on human heart valve interstitial cells in vitro induces a proliferative response reminiscent of the fibrosis that typifies VHD. To identify current or future drugs that might induce VHD, we screened approximately 2200 U.S. Food and Drug Administration (FDA)-approved or investigational medications to identify 5-HT(2B) receptor agonists, using calcium-based high-throughput screening. Of these 2200 compounds, 27 were 5-HT(2B) receptor agonists (hits); 14 of these had previously been identified as 5-HT(2B) receptor agonists, including seven bona fide valvulopathogens. Six of the hits (guanfacine, quinidine, xylometazoline, oxymetazoline, fenoldopam, and ropinirole) are approved medications. Twenty-three of the hits were then "functionally profiled" (i.e., assayed in parallel for 5-HT(2B) receptor agonism using multiple readouts to test for functional selectivity). In these assays, the known valvulopathogens were efficacious at concentrations as low as 30 nM, whereas the other compounds were less so. Hierarchical clustering analysis of the pEC(50) data revealed that ropinirole (which is not associated with valvulopathy) was clearly segregated from known valvulopathogens. Taken together, our data demonstrate that patterns of 5-HT(2B) receptor functional selectivity might be useful for identifying compounds likely to induce valvular heart disease. PMID:19570945

  2. 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

  3. 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

  4. 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

  5. Gastrointestinal safety, chemotherapeutic potential, and classic pharmacological profile of NOSH-naproxen (AVT-219) a dual NO- and H2S-releasing hybrid.

    PubMed

    Chattopadhyay, Mitali; Kodela, Ravinder; Duvalsaint, Pascale L; Kashfi, Khosrow

    2016-04-01

    Naproxen (NAP) is a potent nonsteroidal anti-inflammatory drug (NSAID) with a favorable cardiovascular profile. However, its long-term use may lead to serious gastrointestinal and renal side effects. NOSH- (nitric oxide and hydrogen sulfide) releasing naproxen (NOSH-NAP, AVT-219) belongs to a new class of anti-inflammatory agents designed to overcome these limitations. We compared the gastrointestinal safety, anti-inflammatory, analgesic, antipyretic, and antiplatelet properties of AVT-219 to that of NAP in preclinical animal models. We also evaluated its anticancer effects in 11 human cancer cell (HCC) lines of six different tissue origins and in a chemotherapeutic xenograft mouse model of colon cancer. AVT-219: (1) was orders of magnitude more potent than NAP in inhibiting the growth of cultured HCC; (2) was safe to the stomach, whereas NAP caused significant ulceration; (3) showed strong anti-inflammatory, analgesic, antipyretic, and antiplatelet properties comparable to NAP; and (4) NAP caused a significant rise in plasma tumor necrosis factor-alpha (TNFα), whereas in the AVT-219-treated rats this rise was significantly less. Mechanistically, AVT-219 was a strong antioxidant, inhibited cyclooxygenase (COX)-1 and -2, thus reducing prostaglandin (PG) E2. In xenografts, AVT-219 significantly reduced tumor growth and tumor mass with no sign of GI toxicity, whereas NAP-treated mice died due to GI bleeding. AVT-219 displayed considerable safety and potency in inhibiting HCC growth; was an effective analgesic, antipyretic, antiplatelet, and anti-inflammatory; and was significantly more efficacious than NAP in reducing the growth of established tumors in a xenograft mouse model. PMID:27069635

  6. Safety and toxicokinetic profiles associated with daily oral administration of grapiprant, a selective antagonist of the prostaglandin E2 EP4 receptor, to cats.

    PubMed

    Rausch-Derra, Lesley C; Rhodes, Linda

    2016-07-01

    OBJECTIVE To evaluate safety and toxicokinetic profiles associated with daily oral administration of grapiprant, a new analgesic that selectively blocks the prostaglandin E2 EP4 receptor, to cats. ANIMALS 24 healthy domestic shorthair cats (12 males and 12 females). PROCEDURES Cats were randomly assigned (3 of each sex/group) to receive a placebo capsule or grapiprant at 3, 9, or 15 mg/kg, administered PO once daily for 28 days, beginning on day 0. Food consumption and behavior were observed daily, body weight was measured weekly, and clinicopathologic tests were performed on blood and urine samples collected on days -7, 14, and 25. Blood samples for toxicokinetic analyses were collected after treatment on days 0 and 27. Cats were euthanized on day 28, and full necropsies and histologic evaluations were performed. RESULTS Grapiprant rapidly reached peak serum concentrations and maintained substantial concentrations throughout the 28-day period. By day 27, maximum serum concentrations ranged from 683 ng/mL to 4,950 ng/mL, which were attained by 1 to 4 hours after administration. Serum half-lives on day 27 ranged from approximately 2 to 14 hours (median, approx 5 to 6 hours). Grapiprant was well tolerated, and no adverse effects were detected at doses ≤ 15 mg/kg. No significant effects of grapiprant were identified on body weight, food consumption, clinicopathologic variables, or gross or histologic necropsy findings. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested the safety of daily oral administration of grapiprant to cats. Additional studies are needed to evaluate the efficacy of grapiprant for treatment of cats with osteoarthritis. PMID:27347820

  7. Evaluation of the Safety and Pharmacokinetic Profile of a New, Pasteurized, Human Tetanus Immunoglobulin Administered as Sham, Postexposure Prophylaxis of Tetanus

    PubMed Central

    Forrat, Rémi; Dumas, Rafaele; Seiberling, Michael; Merz, Michael; Lutsch, Charles; Lang, Jean

    1998-01-01

    In a monocentric, double-blind, randomized trial, we examined the safety and pharmacokinetic profile of a new, pasteurized, human tetanus immunoglobulin (P-HTIG). As part of the purification process, P-HTIG has undergone a heat treatment step (10 h at 60°C) and the removal of Merthiolate. Forty-eight adults with a history of tetanus vaccination were randomized into four groups (n = 12 per group) to receive one of two different batches of this P-HTIG simultaneously with either tetanus-diphtheria (Td) vaccine (sham, postexposure prophylaxis of tetanus) or placebo. Local reactions at the injection site were followed for the first 3 days after injection, and systemic reactions were followed during the entire study period, i.e., up to 42 days posttreatment. Blood samples for tetanus antibody titer determination (enzyme-linked immunosorbent assay method) were drawn prior to treatment on day 0 and on days 1, 2, 3, 7, 14, 21, 28, 35, and 42. A normalization of tetanus antibody titers (subtraction of the day 0 value for each subject at each time period) was performed to assess the additive effect of P-HTIG on tetanus antibody titers. The pharmacokinetic parameters were determined by both a compartmental analysis (modelization) and a noncompartmental analysis. No severe adverse reactions were reported. The rate of local reactions at the P-HTIG injection site was 27%. All local reactions were mild and resolved within 2 days. In contrast, local reactions at the vaccine injection site were seen in 79% of the subjects. The rate of systemic reactions was similar in the P-HTIG plus Td vaccine group (33%) and in the P-HTIG plus placebo group (21%), and all these reactions were mild. In the P-HTIG plus placebo group, tetanus antibody titers rose to a maximum of 0.313 ± 2.49 IU/ml after 4.4 days; in the P-HTIG plus Td vaccine group, a maximum concentration of 15.2 ± 2.42 IU/ml was reached 19 days postinjection. In both groups, 100% of the patients had seroprotective levels of

  8. Novel potent pyridoxine-based inhibitors of AChE and BChE, structural analogs of pyridostigmine, with improved in vivo safety profile.

    PubMed

    Strelnik, Alexey D; Petukhov, Alexey S; Zueva, Irina V; Zobov, Vladimir V; Petrov, Konstantin A; Nikolsky, Evgeny E; Balakin, Konstantin V; Bachurin, Sergey O; Shtyrlin, Yurii G

    2016-08-15

    We report a novel class of carbamate-type ChE inhibitors, structural analogs of pyridostigmine. A small library of congeneric pyridoxine-based compounds was designed, synthesized and evaluated for AChE and BChE enzymes inhibition in vitro. The most active compounds have potent enzyme inhibiting activity with IC50 values in the range of 0.46-2.1μM (for AChE) and 0.59-8.1μM (for BChE), with moderate selectivity for AChE comparable with that of pyridostigmine and neostigmine. Acute toxicity studies using mice models demonstrated excellent safety profile of the obtained compounds with LD50 in the range of 22-326mg/kg, while pyridostigmine and neostigmine are much more toxic (LD50 3.3 and 0.51mg/kg, respectively). The obtained results pave the way to design of novel potent and safe cholinesterase inhibitors for symptomatic treatment of neuromuscular disorders. PMID:27377327

  9. Comparative evaluation of efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients with diabetic nephropathy.

    PubMed

    Khan, Irfan Ahmad; Nasiruddin, Mohammad; Haque, Shahzad F; Khan, Rahat A

    2016-01-01

    To determine the efficacy and safety profile of rhubarb and α-keto analogs of essential amino acids supplementation in patients of diabetic nephropathy (DN), we studied 96 patients of DN attending a tertiary care center of the North India. The patients were randomly divided into three equal interventional groups. Group I (control) that received conservative management along with placebo, Group II (rhubarb) that received conservative management along with rhubarb capsule (350 mg, thrice daily), and Group III [keto amino acid (KAA)] that received conservative management along with α-keto analogs of essential amino acids (600 mg, thrice daily). The treatment was continued for 12 weeks. Clinical and biochemical parameters were assessed at 0, 4, 8, and 12 weeks of treatment. A progressive improvement in clinical features and biochemical parameters was seen in all three groups after 12 weeks of treatment. The KAA group showed more marked improvement in clinical features as well as biochemical parameters compared to the rhubarb group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24 h total urine protein. There was an increase in hemoglobin, 24 h total urine volume, and glomerular filtration rate. There was no statistical difference between the rhubarb and KAA groups with respect to side effects (P > 0.05). Our study suggests that KAA is more effective than rhubarb as add-on therapy with conservative management in patients of DN. PMID:27424687

  10. 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. PMID:25151975

  11. 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

  12. A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression.

    PubMed Central

    Morrell, C Jane; Sutcliffe, Paul; Booth, Andrew; Stevens, John; Scope, Alison; Stevenson, Matt; Harvey, Rebecca; Bessey, Alice; Cantrell, Anna; Dennis, Cindy-Lee; Ren, Shijie; Ragonesi, Margherita; Barkham, Michael; Churchill, Dick; Henshaw, Carol; Newstead, Jo; Slade, Pauline; Spiby, Helen; Stewart-Brown, Sarah

    2016-01-01

    BACKGROUND Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. OBJECTIVES To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. DATA SOURCES We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. REVIEW METHODS Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. RESULTS From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of -1.43 (95% credible interval -4.00 to 1.36)], person-centred approach (PCA)-based and cognitive-behavioural therapy (CBT)-based intervention (universal), interpersonal

  13. 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…

  14. ATLAS ACCEPTANCE TEST

    SciTech Connect

    J.C. COCHRANE; J.V. PARKER; ET AL

    2001-06-01

    The acceptance test program for Atlas, a 23 MJ pulsed power facility for use in the Los Alamos High Energy Density Hydrodynamics program, has been completed. Completion of this program officially releases Atlas from the construction phase and readies it for experiments. Details of the acceptance test program results and of machine capabilities for experiments will be presented.

  15. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  16. Hand Safety

    MedlinePlus

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

  17. 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

  18. 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,...

  19. Preclinical Efficacy and Safety Profile of Allometrically Scaled Doses of Doxycycline Used to Turn "On" Therapeutic Transgene Expression from High-Capacity Adenoviral Vectors in a Glioma Model.

    PubMed

    VanderVeen, Nathan; Raja, Nicholas; Yi, Elizabeth; Appelman, Henry; Ng, Philip; Palmer, Donna; Zamler, Daniel; Dzaman, Marta; Lowenstein, Pedro R; Castro, Maria G

    2016-06-01

    Glioblastoma multiforme (GBM) is the most commonly occurring primary brain cancer in adults, in whom its highly infiltrative cells prevent total surgical resection, often leading to tumor recurrence and patient death. Our group has discovered a gene therapy approach for GBM that utilizes high-capacity "gutless" adenoviral vectors encoding regulatable therapeutic transgenes. The herpes simplex type 1-thymidine kinase (TK) actively kills dividing tumor cells in the brain when in the presence of the prodrug, ganciclovir (GCV), whereas the FMS-like tyrosine kinase 3 ligand (Flt3L) is an immune-stimulatory molecule under tight regulation by a tetracycline-inducible "Tet-On" activation system that induces anti-GBM immunity. As a prelude to a phase I clinical trial, we evaluated the safety and efficacy of Food and Drug Administration (FDA)-approved doses of the tetracycline doxycycline (DOX) allometrically scaled for rats. DOX initiates the expression of Flt3L, which has been shown to recruit dendritic cells to the brain tumor microenvironment-an integral first step in the development of antitumor immunity. The data revealed a highly safe profile surrounding these human-equivalent doses of DOX under an identical therapeutic window as proposed in the clinical trial. This was confirmed through a neuropathological analysis, liver and kidney histopathology, detection of neutralizing antibodies, and systemic toxicities in the blood. Interestingly, we observed a significant survival advantage in rats with GBM receiving the 300 mg/day equivalent dosage of DOX versus the 200 mg/day equivalent. Additionally, rats rejected "recurrent" brain tumor threats implanted 90 days after their primary brain tumors. We also show that DOX detection within the plasma can be an indicator of optimal dosing of DOX to attain therapeutic levels. This work has significant clinical relevance for an ongoing phase I clinical trial in humans with primary GBM and for other therapeutic approaches using

  20. 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

  1. 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. PMID:17986646

  2. Acceptance, values, and probability.

    PubMed

    Steel, Daniel

    2015-10-01

    This essay makes a case for regarding personal probabilities used in Bayesian analyses of confirmation as objects of acceptance and rejection. That in turn entails that personal probabilities are subject to the argument from inductive risk, which aims to show non-epistemic values can legitimately influence scientific decisions about which hypotheses to accept. In a Bayesian context, the argument from inductive risk suggests that value judgments can influence decisions about which probability models to accept for likelihoods and priors. As a consequence, if the argument from inductive risk is sound, then non-epistemic values can affect not only the level of evidence deemed necessary to accept a hypothesis but also degrees of confirmation themselves. PMID:26386533

  3. 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)

  4. Newbery Medal Acceptance.

    ERIC Educational Resources Information Center

    Cleary, Beverly

    1984-01-01

    Reprints the text of Ms. Cleary's Newbery medal acceptance speech in which she gives personal history concerning her development as a writer and her response to the letters she receives from children. (CRH)

  5. Caldecott Medal Acceptance.

    ERIC Educational Resources Information Center

    Provensen, Alice; Provensen, Martin

    1984-01-01

    Reprints the text of the Provensens' Caldecott medal acceptance speech in which they describe their early interest in libraries and literature, the collaborative aspect of their work, and their current interest in aviation. (CRH)

  6. 49 CFR 41.120 - Acceptable model codes.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 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...

  7. 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...

  8. Accept or divert?

    PubMed

    Angelucci, P A

    1999-09-01

    Stretching scarce resources is more than a managerial issue. Should you accept the patient to an understaffed ICU or divert him to another facility? The intense "medical utility" controversy focuses on a situation that critical care nurses now face every day. PMID:10614370

  9. 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.

  10. 1984 Newbery Acceptance Speech.

    ERIC Educational Resources Information Center

    Cleary, Beverly

    1984-01-01

    This acceptance speech for an award honoring "Dear Mr. Henshaw," a book about feelings of a lonely child of divorce intended for eight-, nine-, and ten-year-olds, highlights children's letters to author. Changes in society that affect children, the inception of "Dear Mr. Henshaw," and children's reactions to books are highlighted. (EJS)

  11. 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.

  12. [The acceptability of different oral contraceptive methods].

    PubMed

    Klinger, G; Fritzsche, H; Hempel, E; Carol, W; Böhme, W; Scholz, B; Grass, M; Chemnitius, K H

    1975-05-01

    Results of a survey of contraceptive acceptability are reported. In formation on oral and depot hormonal contraceptives was distributed to 1064 Ovosiston or Nonovlon users, 110 women using depot contraceptives, and 609 women who had never used hormonal contraception. The women's preferences with regard to administration schedule, and their perceptions of effectiveness and safety were noted. Non-users considered daily, weekly, or monthly administration acceptable, while only 2/3 of those taking oral contraceptives thought daily administration convenient. 90.2% of Deposiston patients did not care for daily administration. Deposiston patients also had the greatest confidence in their method. The authors believe on the basis of this survey that weekly administration may be highly acceptable alternative t o conventional oral contraception. PMID:1140078

  13. 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.

  14. 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.

  15. 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

  16. 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)

  17. 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.

  18. 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.

  19. Alternative food safety intervention technologies

    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...

  20. 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. PMID:26704926

  1. 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

  2. 75 FR 1356 - RC2 Corporation, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION RC2 Corporation, 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...

  3. 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,...

  4. Safety, Adherence and Acceptability of Intermittent Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis (PrEP) among HIV-Uninfected Ugandan Volunteers Living in HIV-Serodiscordant Relationships: A Randomized, Clinical Trial

    PubMed Central

    Kibengo, Freddie M.; Ruzagira, Eugene; Katende, David; Bwanika, Agnes N.; Bahemuka, Ubaldo; Haberer, Jessica E.; Bangsberg, David R.; Barin, Burc; Rooney, James F.; Mark, David; Chetty, Paramesh; Fast, Patricia; Kamali, Anatoli; Priddy, Frances H.

    2013-01-01

    Background Efficacy of oral pre-exposure prophylaxis (PrEP) in prevention of HIV acquisition has been evaluated using a daily regimen. However, adherence to long term daily medication is rarely perfect. Intermittent regimen may be a feasible alternative. Preclinical studies have demonstrated effectiveness of intermittent PrEP in SHIV prevention among animals. However, little is known about intermittent PrEP regimens. Design Seventy two HIV-uninfected volunteers in HIV serodiscordant couple relationships in Uganda were randomly assigned to receive daily oral Tenofovir/Emtricitabine (TDF/FTC-Truvada) or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral TDF/FTC or placebo in a 2:1:2:1 ratio. Volunteers and study staff were blinded to drug assignment, but not to regimen assignment. Methods Volunteers were followed for 4 months after randomization, with monthly clinical and laboratory safety assessments and comprehensive HIV risk reduction services. Adherence was monitored using medication event monitoring system (MEMS) and self-report. Sexual activity data were collected via daily short text message (SMS) and self-report. HIV-specific immune responses were assessed by IFN-γ ELISPOT. Results Both daily and intermittent oral TDF/FTC regimens were well tolerated. Median MEMS adherence rates were 98% (IQR: 93-100) for daily PrEP regimen, 91% (IQR: 73-97) for fixed intermittent dosing and 45% (IQR: 20-63) for post-coital dosing. SMS response rate was 74%, but increased to 80% after excluding server outages; results may have been affected by the novelty of this measure. The majority of volunteers expressed willingness with no particular preference for either regimen. Conclusions Both daily and intermittent oral PrEP dosing regimens were safe. Adherence was high for daily and fixed intermittent dosing; post-coital dosing was associated with poor adherence. Fixed intermittent PrEP regimens may be feasible especially if

  5. Electromagnetic induction moisture measurement system acceptance test plan

    SciTech Connect

    Vargo, G.F., Westinghouse Hanford

    1996-08-01

    The purpose of this acceptance test plan (ATP) is to verify that the mechanical, electrical and software features of the ElectroMagnetic Induction (EMI) probe are operating as designed,and that the unit is ready for field service. The accepted EMI and Surface Moisture Measurement Systems (SMMS) will be used primarily in support of Tank Waste Remediation System (TWRS) Safety Programs for moisture measurement of organic and ferrocyanide watch list tanks.

  6. 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,…

  7. Sonic boom acceptability studies

    NASA Astrophysics Data System (ADS)

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

    1992-04-01

    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.

  8. 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.

  9. 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

  10. 76 FR 58784 - Bad Boy Enterprises, LLC, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... 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...

  11. 77 FR 58098 - Haier America Trading, LLC, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... 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...

  12. Dependence of Bootstrap Current, Stability, and Transport on the Safety Factor Profile in DIII-D Steady-state Scenario Discharges

    NASA Astrophysics Data System (ADS)

    Holcomb, C. T.; Ferron, J. R.; Luce, T. C.; Politzer, P. A.; Deboo, J. C.; Petrie, T. W.; Petty, C. C.; La Haye, R. J.; White, A. E.; Turco, F.; Doyle, E. J.; Rhodes, T. L.; Zeng, L.

    2009-11-01

    A high beta, high gain steady state tokamak scenario with large bootstrap current fraction will have strong coupling between the current density and the pressure gradient through turbulent transport and the bootstrap current. To address this coupling experimentally, a scan of the safety factor minimum (qmin, from 1.1 to over 2) and edge value (q95, from 4.5 to 6.5) was performed. The bootstrap current fraction increases with qmin and q95 by virtue of increasing density gradients. Compared to lower qmin, qmin>2 has lower n=1 stability limits, enhanced drift wave growth rates, higher low-k density fluctuations, and lower confinement. At qmin>2 and q95=4.5 the unsustainable condition JBS> JTotal occurs near the axis. These considerations suggest intermediate q is the optimal operating point.

  13. Safety evaluation of the aqueous extract Kothala himbutu (Salacia reticulata) stem in the hepatic gene expression profile of normal mice using DNA microarrays.

    PubMed

    Im, Ryanghyok; Mano, Hiroshi; Nakatani, Sachie; Shimizu, Jun; Wada, Masahiro

    2008-12-01

    Kothala himbutu is a traditional Ayurvedic medicinal plant used to treat diabetes. We aimed to evaluate the safety of an aqueous extract of Kothala himbutu stem (KTE) in normal mice. The mice were divided into two groups: one was administered KTE and the other distilled water for 3 weeks. During the test period, the groups showed no significant differences in body weight gain or plasma parameters, such as fasting blood glucose level, oral glucose tolerance test, or aspartate transaminase (AST) or alanine transaminase (ALT) activity. DNA microarray analysis revealed that expression of genes of known function, such as those for the stress response, ribosomal proteins, transcription, cell function, the inflammatory/immune response, and metabolism (xenobiotic, glutathione, etc.) remained largely unaffected by KTE. However some genes such as catechol-o-methyltransferase and succinyl-CoA synthetase were regulated by KTE, indicating that KTE is not toxic to normal mice and might be effective as a functional food. PMID:19060410

  14. A multicenter, randomized, controlled trial to evaluate the safety profile, tolerability, and efficacy of rofecoxib in advanced elderly patients with osteoarthritis.

    PubMed

    Truitt, K E; Sperling, R S; Ettinger, W H; Greenwald, M; DeTora, L; Zeng, Q; Bolognese, J; Ehrich, E

    2001-04-01

    This 6-week study was conducted to test the efficacy, safety, and tolerability of rofecoxib (a selective COX-2 inhibitor) compared to nabumetone (a non-selective NSAID) and placebo in osteoarthritis (OA) patients aged 80 and older. Three hundred forty-one patients, mean age 83 years, were randomized. Allocations were made in an approximately 1:2:1:2 ratio (placebo: 12.5 mg rofecoxib: 25 mg rofecoxib: 1500 mg nabumetone). Least square mean changes from baseline in the primary efficacy endpoint, Patient Global Assessment of Disease Status, were as follows (with negative numbers indicating improvement): -14.85 mm for placebo; -25.34 mm for 12.5 mg rofecoxib; -25.40 mm for 25 mg of rofecoxib; and -25.95 mm for nabumetone (p<0.001 for all active treatments vs placebo.) Results from secondary endpoints, including the 3 WOMAC sub-scales (pain, stiffness, and disability) and the Investigator Global Assessment of Disease Status, were consistent with those for the primary endpoint. No significant between-group differences were observed in the proportions of patients who discontinued treatment due to either clinical or laboratory adverse experiences. Renal safety (edema and hypertension adverse experiences) was similar for rofecoxib and nabumetone. No gastroduodenal ulcers occurred; however, the demonstration of gastrointestinal risk with rofecoxib or nabumetone was beyond the scope of this trial. We conclude that in patients 80 years and older, rofecoxib, 12.5 mg and 25 mg once daily, demonstrated clinical efficacy for the treatment for OA as did 1500 mg of nabumetone. Rofecoxib and nabumetone were generally well tolerated in this elderly population. PMID:11405384

  15. Safety Profile of PrePex Male Circumcision Device and Client Satisfaction With Adolescent Males Aged 13–17 Years in Zimbabwe

    PubMed Central

    Tshimanga, Mafuta; Mugurungi, Owen; Mangwiro, Tonderayi; Ncube, Getrude; Xaba, Sinokuthemba; Chatikobo, Pesanai; Gundidza, Patricia; Samkange, Christopher; Dhlamini, Roy; Murwira, Munyaradzi; Gwinji, Gerald

    2016-01-01

    Background: The safety and efficacy of the PrePex device for voluntary medical male circumcision (VMMC) has been demonstrated in studies in Rwanda, Uganda, and Zimbabwe, leading to the conditional prequalification of the device for use in adults. Because the majority of VMMC clients in the 14 priority countries are adolescents under 18 years, research to establish the safety and efficacy of the device for males <18 years is required. Methods: One-arm, prospective study included 402 adolescents, aged 13–17 years, using PrePex device between August 2013 and January 2014 at a VMMC centre in Harare. Endpoints are number and grade of adverse events associated with device circumcision, time to complete wound healing, client satisfaction with the procedure, and outcome. Results: The rate of medical ineligibility among adolescent males was high; 237/402 (35.9%) of study participants had to be excluded based on medical reasons. The severe/moderate adverse event rate was low at 2/402 (0.5%). No device displacements/self-removals were observed. Time to complete wound healing was shorter than in adults; 367/398 (92.2%) adolescents had completed wound healing by day 35, whereas 90% of adults had completed wound healing by day 56 as demonstrated in previous studies. Overall, adolescents were highly satisfied with the results of their circumcision. Conclusions: The study demonstrates that the PrePex device can be safely used in adolescents aged 13–17 years. The significant proportion of males opting for surgical circumcision and the high medical ineligibility suggest that surgical circumcision needs to be provided alongside PrePex services in programs targeting young age groups. PMID:27331588

  16. Safety Profile, Feasibility and Early Clinical Outcome of Cotransplantation of Olfactory Mucosa and Bone Marrow Stem Cells in Chronic Spinal Cord Injury Patients

    PubMed Central

    Goni, Vijay G; Chhabra, Rajesh; Gupta, Ashok; Marwaha, Neelam; Dhillon, Mandeep S; Pebam, Sudesh; Gopinathan, Nirmal Raj

    2014-01-01

    Study Design Prospective case series. Purpose To study the safety and feasibility of cotransplantation of bone marrow stem cells and autologous olfactory mucosa in chronic spinal cord injury. Overview of Literature Stem cell therapies are a novel method in the attempt to restitute heavily damaged tissues. We discuss our experience with this modality in postspinal cord injury paraplegics. Methods The study includes 9 dorsal spine injury patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A neurological impairment who underwent de-tethering of the spinal cord followed by cotransplantation with bone marrow stem cells and an olfactory mucosal graft. Participants were evaluated at the baseline and at 6 monthly intervals. Safety and tolerability were evaluated through the monitoring for adverse events and magnetic resonance imaging evaluation. Efficacy assessment was done through neurological and functional outcome measures. Results Surgery was tolerated well by all participants. No significant difference in the ASIA score was observed, although differences in the Functional Independence Measure and Modified Ashworth Scale were statistically significant. No significant complication was observed in any of our patients, except for neurogenic pain in one participant. The follow-up magnetic resonance imaging evaluation revealed an increase in the length of myelomalacia in seven participants. Conclusions The cotransplantation of bone marrow stem cells and olfactory mucosa is a safe, feasible and viable procedure in AIS A participants with thoracic level injuries, as assessed at the 24-month follow-up. No efficacy could be demonstrated. For application, further large-scale multicenter studies are needed. PMID:25187866

  17. 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.

  18. 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.

  19. 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.

  20. 16 CFR 1616.4 - Sampling and acceptance procedures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Sampling and acceptance procedures. 1616.4 Section 1616.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 7 THROUGH 14 (FF 5-74) The Standard §...

  1. 16 CFR 1616.4 - Sampling and acceptance procedures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Sampling and acceptance procedures. 1616.4 Section 1616.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR: SIZES 7 THROUGH 14 (FF 5-74) The Standard §...

  2. 16 CFR 1505.7 - Maximum acceptable surface temperatures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Maximum acceptable surface temperatures. 1505.7 Section 1505.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS REQUIREMENTS FOR ELECTRICALLY OPERATED TOYS OR OTHER ELECTRICALLY OPERATED ARTICLES INTENDED FOR USE BY CHILDREN Regulations...

  3. 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

  4. 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

  5. Accepters and Rejecters of Counseling.

    ERIC Educational Resources Information Center

    Rose, Harriett A.; Elton, Charles F.

    Personality differences between students who accept or reject proffered counseling assistance were investigated by comparing personality traits of 116 male students at the University of Kentucky who accepted or rejected letters of invitation to group counseling. Factor analysis of Omnibus Personality Inventory (OPI) scores to two groups of 60 and…

  6. 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.

  7. Risk of wound infection and safety profile of amoxicillin in healthy patients which required third molar surgery: a systematic review and meta-analysis.

    PubMed

    Isiordia-Espinoza, M A; Aragon-Martinez, O H; Martínez-Morales, J F; Zapata-Morales, J R

    2015-11-01

    The aim of this systematic review and meta-analysis was to assess the risk of surgical wound infection and the adverse effects of amoxicillin in healthy patients who required excision of third molars. We identified eligible reports from searches of PubMed, Medline®, the Cochrane Library, Imbiomed, LILACS, and Google Scholar. Studies that met our minimum requirements were evaluated using inclusion and exclusion criteria and the Oxford Quality Scale. Those with a score of 3 or more on this Scale were included and their data were extracted and analysed. For evaluation of the risk of infection the absolute risk reduction, number needed to treat, and 95% CI were calculated. For evaluation of the risk of an adverse effect the absolute risk increase, number needed to harm, and 95% CI were calculated using the Risk Reduction Calculator. Each meta-analysis was made with the help of the Mantel-Haenszel random effects model, and estimates of risk (OR) and 95% CI were calculated using the Review Manager 5.3, from the Cochrane Library. A significant risk was assumed when the lower limit of the 95% CI was greater than 1. Probabilities of less than 0.05 were accepted as significant. The results showed that there was no reduction in the risk of infection when amoxicillin was given before or after operation compared with an untreated group or placebo. In conclusion, this study suggests that amoxicillin given prophylactically or postoperatively does not reduce the risk of infection in healthy patients having their third molars extracted. PMID:26316017

  8. 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

    2012-08-01

    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. PMID:22779424

  9. 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. PMID:25400213

  10. Conscious Sedation Procedures Using Intravenous Midazolam for Dental Care in Patients with Different Cognitive Profiles: A Prospective Study of Effectiveness and Safety

    PubMed Central

    Collado, Valérie; Faulks, Denise; Nicolas, Emmanuel; Hennequin, Martine

    2013-01-01

    The use of midazolam for dental care in patients with intellectual disability is poorly documented. This study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam in adults and children with intellectual disability (ID) compared to dentally anxious patients (DA). Ninety-eight patients with ID and 44 patients with DA programmed for intravenous midazolam participated in the study over 187 and 133 sessions, respectively. Evaluation criteria were success of dental treatment, cooperation level (modified Venham scale), and occurrence of adverse effects. The mean intravenous dose administered was 8.8±4.9 mg and 9.8±4.1 mg in ID and DA sessions respectively (t-test, NS). 50% N2O/O2 was administered during cannulation in 51% of ID sessions and 61% of DA sessions (NS, Fisher exact test). Oral or rectal midazolam premedication was administered for cannulation in 31% of ID sessions and 3% of DA sessions (p<0,001, Fisher exact test). Dental treatment was successful in 9 out of 10 sessions for both groups. Minor adverse effects occurred in 16.6% and 6.8% of ID and DA sessions respectively (p = 0.01, Fisher exact test). Patients with ID were more often very disturbed during cannulation (25.4% ID vs. 3.9% DA sessions) and were less often relaxed after induction (58.9% ID vs. 90.3% DA) and during dental treatment (39.5% ID vs. 59.7% DA) (p<0.001, Fisher exact test) than patients with DA. When midazolam sedation was repeated, cooperation improved for both groups. Conscious sedation procedures using intravenous midazolam, with or without premedication and/or inhalation sedation (50% N2O/O2), were shown to be safe and effective in patients with intellectual disability when administered by dentists. PMID:23940729

  11. Summertime Safety

    MedlinePlus

    ... Violence & Safety Life Stages & Populations Travelers' Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates ... Submit What's this? Submit Button Past Emails CDC Features Summertime Safety Recommend on Facebook Tweet Share Compartir The feature ...

  12. 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 ...

  13. Safety Education.

    ERIC Educational Resources Information Center

    Daniels, James H.; And Others

    1980-01-01

    Five articles in this issue focus on safety education in agricultural laboratories. Topics discussed include teacher liability; elements of a safety instruction program; state and federal safety standards; ground fault current protection; and eye protection requirements and equipment. (SK)

  14. N Reactor operational safety summary

    SciTech Connect

    Franz, G.R.; Quapp, W.J.; Ogden, D.M.

    1988-08-01

    This report is a safety summary of the N Reactor. Beginning with its conceptual design in the mid-1950`s, and throughout its 23 years of operation, continuous efforts have been made to ensure safe N Reactor operation and protection of the public health and safety. The N Reactor Updated Safety Analysis Report, completed in 1978(UNC1978), and its subsequent amendments document the safety bases of N Reactor. Following the April 1986 Chernobyl accident in the Soviet Union, a major effort to confirm N Reactor safety and further increase its safety margin was initiated. This effort, called the Safety Enhancement Program, reassessed the N Reactor using the latest accepted analysis techniques and commercial light-water reactor guidelines, where applicable. 122 refs., 38 figs., 10 tabs.

  15. 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.

  16. 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.

  17. 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).

  18. 49 CFR 238.603 - Safety planning requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving...

  19. 49 CFR 238.603 - Safety planning requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... acceptable level using a formal safety methodology such as MIL-STD-882; and (4) Impose operational... using a formal safety methodology such as MIL-STD-882; (5) Monitor the progress in resolving...

  20. Accepted scientific research works (abstracts).

    PubMed

    2014-01-01

    These are the 39 accepted abstracts for IAYT's Symposium on Yoga Research (SYR) September 24-24, 2014 at the Kripalu Center for Yoga & Health and published in the Final Program Guide and Abstracts. PMID:25645134

  1. 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

  2. Safety profile of statins alone or combined with ezetimibe: a pooled analysis of 27 studies including over 22,000 patients treated for 6-24 weeks.

    PubMed

    Toth, P P; Morrone, D; Weintraub, W S; Hanson, M E; Lowe, R S; Lin, J; Shah, A K; Tershakovec, A M

    2012-08-01

    Aims:  The aim of this analysis was to assess the overall safety and tolerability profiles of various statins + ezetimibe vs. statin monotherapy and to explore tolerability in sub-populations grouped by age, race, and sex. Methods:  Study-level data were combined from 27 double-blind, placebo-controlled or active-comparator trials that randomized adult hypercholesterolemic patients to statin or statin + ezetimibe for 6-24 weeks. In the full cohort, % patients with AEs within treatment groups (statin: N = 10,517; statin + ezetimibe: N = 11,714) was assessed by logistic regression with terms for first-/second-line therapy (first line = drug-naïve or rendered drug-naïve by washout at study entry; second line = ongoing statin at study entry or statin run-in), trial within first-/second-line therapy, and treatment. The same model was fitted for age (< 65, ≥ 65 years), sex, race (white, black, other) and first-/second-line subgroups with additional terms for subgroup and subgroup-by-treatment interaction. Results:  In the full cohort, the only significant difference between treatments was consecutive AST or ALT elevations ≥ 3 × upper limit of normal (ULN) (statin: 0.35%, statin + ezetimibe: 0.56%; p = 0.017). Significantly more subjects reported ≥ 1 AE; drug-related, hepatitis-related and gastrointestinal-related AEs; and CK elevations ≥ 10 × ULN (all p ≤ 0.008) in first-line vs. second-line therapy studies with both treatments. AEs were generally similar between treatments in subgroups, and similar rates of AEs were reported within age and race subgroups; however, women reported generally higher AE rates. Conclusions:  In conclusion, in second-line studies, ongoing statin treatment at study entry likely screened out participants for previous statin-related AEs and tolerability issues. These results describe the safety profiles of widely used lipid-lowering therapies and encourage their

  3. 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.

  4. 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…

  5. Acceptability of bio-engineered vaccines.

    PubMed

    Danner, K

    1997-01-01

    For hundreds of years bacterial and viral vaccines have been-in a way-bioengineered and were generally well received by the public, the authorities, and the medical profession. Today, additional tools, e.g. molecular biology, enable new approaches to the development of better and safer products. Various vaccines derived from gene technology have now been licensed for commercial use and are acknowledged within the scientific community. Acceptance by the public and the politicians is, however, negatively influenced by the discussions encompassing gene manipulation in man and animals, transgenic plant, and "novel food". Lack of information leads to confusion and fear. Concurrently, the absence of spectacular and life-threatening epidemics limits the perceived value of immune prophylaxis and its benefits. Scientists in institutes and industry are in a position to stimulate acceptability of bio-engineered vaccines by following some simple rule: (1) adherence to the principles of safety; (2) establishment of analytical and control methods; (3) well functioning regulatory and reporting systems; (4) demonstration of usefulness and economic benefits; (5) open communication; and (6) correct and prudent wording. PMID:9023035

  6. 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.

  7. 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.

  8. 24 CFR 51.203 - Safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Conventional Fuels or Chemicals of an Explosive or Flammable Nature § 51.203 Safety standards. The following standards shall be used in determining the acceptable separation distance of a proposed HUD-assisted...

  9. 24 CFR 51.203 - Safety standards.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Conventional Fuels or Chemicals of an Explosive or Flammable Nature § 51.203 Safety standards. The following standards shall be used in determining the acceptable separation distance of a proposed HUD-assisted...

  10. 24 CFR 51.203 - Safety standards.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Conventional Fuels or Chemicals of an Explosive or Flammable Nature § 51.203 Safety standards. The following standards shall be used in determining the acceptable separation distance of a proposed HUD-assisted...

  11. 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…

  12. W-026, acceptance test report fire alarm system (submittal number 1571.1)

    SciTech Connect

    Watson, T.L., Westinghouse Hanford

    1996-12-16

    This Acceptance Test Report was written by 3-D Protection Systems, Inc., and PCL Construction. WRAP I Facility Engineering, Solid Waste Fire Safety, Kaiser Acceptance Inspector and Hanford Fire Department personnel witnessed this test. All exceptions were resolved. The resolutions are attached. Contractor`s Material and Test Certificates are attached. Results from Solid Waste Industrial Hygiene sound level surveys are also included.

  13. 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.

  14. 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

  15. Bicycle safety equipment.

    PubMed

    Ellis, T H; Streight, D; Mellion, M B

    1994-01-01

    It is important for the physician to understand bicycle safety equipment in order to prevent and treat bicycle-related injuries effectively. The physician should understand (1) the basic design and function of bicycles, (2) the relationship of improper bicycle fit to injuries, (3) the potential of the various forms of serious riding and racing for injury, and (4) bicycle safety equipment and the standards involved in its fit, manufacture, and care. A decision to use bicycle safety equipment is a decision to control the risk of injury. Physicians should accept a share of the responsibility for decreasing bicycling-related injuries, because they are viewed by the public as credible sources of information regarding the prevention of accidents and injuries. PMID:8111858

  16. 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.

  17. 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.

  18. Toxicity and safety of topical sodium hypochlorite.

    PubMed

    Bruch, Mary K

    2007-01-01

    The safety and toxicity of sodium hypochlorite is reviewed with particular correlation to topical use. Since sodium hypochlorite is one of the most widely used chemicals in the environment, its safety has been established by long use and toxicity profile. This chapter reviews recent toxicology testing including routine systemic LD50, topical LD50, topical toxicology, irritation and sensitization. The resulting toxicity or safety profile clarifies the safe topical use of electrolytically produced sodium hypochlorite solution (ExSept, Amuchina 10%). PMID:17099299

  19. DIPS Space Exploration Initiative safety

    NASA Astrophysics Data System (ADS)

    Dix, Terry E.

    The Dynamic Isotope Power Subsystem has been identified for potential applications for the Space Exploration Initiative. A qualitative safety assessment has been performed to demonstrate the overall safety adequacy of the Dynamic Isotope Power Subsystem for these applications. Mission profiles were defined for reference lunar and Martian flights. Accident scenarios were qualitatively defined for all mission phases. Safety issue were then identified. The safety issues included radiation exposure, fuel containment, criticality, diversion, toxic materials, heat flux to the extravehicular mobility unit, and disposal. The design was reviewed for areas where safety might be further improved. Safety would be improved by launching the fuel separate from the rest of the subsystem on expendable launch vehicles, using a fuel handling tool during unloading of the hot fuel canister, and constructing a cage-like structure around the reversible heat removal system lithium heat pipes. The results of the safety assessment indicate that the DIPS design with minor modifications will produce a low risk concept.

  20. Indicators of School Crime and Safety, 1998.

    ERIC Educational Resources Information Center

    Kaufman, Phillip; Chen, Xianglei; Choy, Susan P.; Chandler, Kathryn A.; Chapman, Christopher D.; Rand, Michael R.; Ringel, Cheryl

    The string of tragic, violent incidents that occurred during the 1997-98 school year has refocused the American public's attention on school crime and safety. This statistical compilation supports the "Annual Report on School Safety: 1998" by presenting the latest available data on school crime and student safety. The report presents a profile of…

  1. The MAGNEX large acceptance spectrometer

    SciTech Connect

    Cavallaro, M.; Cappuzzello, F.; Cunsolo, A.; Carbone, D.; Foti, A.

    2010-03-01

    The main features of the MAGNEX large acceptance magnetic spectrometer are described. It has a quadrupole + dipole layout and a hybrid detector located at the focal plane. The aberrations due to the large angular (50 msr) and momentum (+- 13%) acceptance are reduced by an accurate hardware design and then compensated by an innovative software ray-reconstruction technique. The obtained resolution in energy, angle and mass are presented in the paper. MAGNEX has been used up to now for different experiments in nuclear physics and astrophysics confirming to be a multipurpose device.

  2. Safety evaluation of rebaudioside A produced by fermentation.

    PubMed

    Rumelhard, Mélina; Hosako, Hiromi; Eurlings, Irene M J; Westerink, Walter M A; Staska, Lauren M; van de Wiel, Jeanine A G; La Marta, James

    2016-03-01

    The safety of rebaudioside A, produced fermentatively by Yarrowia lipolytica encoding the Stevia rebaudiana metabolic pathway (fermentative Reb A), is based on several elements: first, the safety of steviol glycosides has been extensively evaluated and an acceptable daily intake has been defined; second, the use of Y. lipolytica, an avirulent yeast naturally found in foods and used for multiple applications; and third the high purity of fermentative Reb A and its compliance with internationally defined specifications. A bacterial reverse mutation assay and an in vitro micronucleus test conducted with fermentative Reb A provide evidence for its absence of mutagenicity, clastogenicity and aneugenicity. The oral administration of fermentative Reb A to Sprague-Dawley rats for at least 91 days did not lead to any adverse effects at consumption levels up to 2057 mg/kg bw/day for males and 2023 mg/kg bw/day for females, which were concluded to be the No Observed Adverse Effect Levels. The results were consistent with outcomes of previous studies conducted with plant-derived rebaudioside A, suggesting similar safety profiles for fermentative and plant-derived rebaudioside A. The results of the toxicity studies reported here support the safety of rebaudioside A produced fermentatively from Y. lipolytica, as a general purpose sweetener. PMID:26776281

  3. 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...

  4. 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...

  5. 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,...

  6. 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....

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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

  12. 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.

  13. 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)

  14. Acceptability of Treatments for Plagiarism

    ERIC Educational Resources Information Center

    Carter, Stacy L.; Punyanunt-Carter, Narissra Maria

    2007-01-01

    This study focused on various treatments for addressing incidents of plagiarism by college students. College students rated the acceptability of different responses by college faculty to a case description of a college student who engaged in plagiarism. The findings revealed that students found some methods of addressing this problem behavior by…

  15. 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…

  16. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  17. 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.

  18. Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study

    PubMed Central

    Ascher, B; Hoffmann, K; Walker, P; Lippert, S; Wollina, U; Havlickova, B

    2014-01-01

    Background Unwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking. Objective To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study. Methods Patients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm2 or placebo injected into their SMF for up to four treatments ∼28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored. Results Compared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm2 showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm2, P < 0.001 for ATX-101 2 mg/cm2 vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in

  19. A proposed acceptance process for commercial off-the-shelf (COTS) software in reactor applications

    SciTech Connect

    Preckshot, G.G.; Scott, J.A.

    1996-03-01

    This paper proposes a process for acceptance of commercial off-the-shelf (COTS) software products for use in reactor systems important to safety. An initial set of four criteria establishes COTS software product identification and its safety category. Based on safety category, three sets of additional criteria, graded in rigor, are applied to approve/disapprove the product. These criteria fall roughly into three areas: product assurance, verification of safety function and safety impact, and examination of usage experience of the COTS product in circumstances similar to the proposed application. A report addressing the testing of existing software is included as an appendix.

  20. 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…

  1. Evaluation of the safety, immunogenicity, and pharmacokinetic profile of a new, highly purified, heat-treated equine rabies immunoglobulin, administered either alone or in association with a purified, Vero-cell rabies vaccine.

    PubMed

    Lang, J; Attanath, P; Quiambao, B; Singhasivanon, V; Chanthavanich, P; Montalban, C; Lutsch, C; Pepin-Covatta, S; Le Mener, V; Miranda, M; Sabchareon, A

    1998-07-30

    A clinical evaluation of a new, purified, heat-treated equine rabies immunoglobulin (PHT-Erig), F(ab')2 preparation, was carried out in Thailand and in the Philippines-two countries where rabies is endemic. An initial prospective, randomised, controlled trial (Study 1), compared the safety and pharmacokinetics (serum concentrations of rabies antibodies) after administration either of PHT-Erig or of a commercially-available, equine rabies immune globulin (Erig PMC). A second trial (Study 2) simulated post-exposure rabies prophylaxis by using a reference cell culture vaccine, the purified Vero-cell rabies vaccine (PVRV), administered in association with either Erig PMC or PHT-Erig. In Study 1, 27 healthy, Thai adults received a 40 IU kg(-1) dose of either Erig PMC (n = 12) or PHT-Erig (n = 15) via the intramuscular (i.m.) route; half of the dose was injected into the deltoid area and the other half into the buttocks. Serum for rabies antibody determination and F(ab')2 concentration was collected at hours (H) 0, 6 and 12, and on day (D) 2, 3, 4, 6, 8, 10, 12 and 15. Both products were safe, with no serious adverse events, and in particular, no anaphylactic reactions or serum sickness was reported. A statistical comparison of the pharmacokinetic parameters did not demonstrate bioequivalence of the two products. Nonetheless, the relative bioavailability of 93% and the similar absorption rates suggest the pharmacokinetic profiles of Erig and PHT-Erig are similar. The antibody level in either group were low throughout the 15-day study period. The geometric mean titer (GMT) values ranged from group 0.027-0.117 IU ml(-1) in the Erig group and from 0.029 to 0.072 IU ml(-1) in the PHT-Erig. There was no significant difference between the evolution of GMT values for the two groups. In Study 2, 71 healthy volunteers received 40 IU kg(-1) via the intramuscular route of either Erig PMC (n = 36) or PHT-Erig (n = 35) on D0, in association with five doses of PVRV on D0, D3, D7, D14

  2. 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.

  3. Performance-based waste acceptance criteria preliminary baseline assumptions

    SciTech Connect

    Not Available

    1994-10-24

    The Department of Energy`s (DOE`s) strategy for the management of transuranic (TRU) and TRU mixed wastes has focused on the development of the Waste Isolation Pilot Plant (WIPP). The WIPP repository is designated to receive DOE defense wastes that meet the established criteria for acceptance. As a national strategy [DOE, 1993], DOE does not intend to treat candidate wastes unless treatment or processing are necessary to meet the safety, health, and regulatory criteria for transport and disposal at WIPP. The WIPP WAC has evolved over the past 10 years to include criteria and requirements in support of the Waste Characterization program and other related compliance programs. In aggregate, the final health, safety and regulatory criteria for the waste will be documented in the Disposal WAC. This document serves two purposes. First, it familiarizes regulators and stakeholders with the concept of performance based waste acceptance criteria as an augmentation within a final Waste Isolation Pilot Plant (WIPP) Waste Acceptance Criteria. Second, the document preliminarily identifies certain waste characteristics that appear important to the performance assessment process for WIPP; therefore, these could become component characteristics in the Performance Based Waste Acceptance Criteria (PBWAC). Identification of the final PBWAC will be accomplished through iterative runs of the System Prioritization Method (SPM). These iterations will serve to more clearly isolate and identify those waste characteristics that directly and predominately impact on the performance assessment.

  4. Efficacy and safety profile of a novel technique, ThuLEP (Thulium laser enucleation of the prostate) for the treatment of benign prostate hypertrophy. Our experience on 148 patients

    PubMed Central

    2012-01-01

    Background Over the past years laser technology has played a predominant role in prostate surgery, for the treatment of benign prostate hypertrophy (BPH). Various laser devices have been introduced in clinical practice, showing good results in terms of complications and urodynamic outcomes efficacy compared with TURP and Open Prostatectomy. In this study we describe the efficacy and the safety profile of a novel laser technique, ThuLEP (Thulium Laser Enucleation of Prostate) that permits a complete anatomical endoscopic enucleation of prostatic adenoma independently to prostate size. Methods 148 patients with a mean age of 68.2 years were enrolled between September 2009 and March 2012 (36 months), and treated for BPH with ThuLEP. Every patient was evaluated at base line according to: Digital Rectal Examination (DRE), prostate volume, Post-Voided volume (PVR), International Prostate Symptoms Score (I-PSS), International Index of Erectile Function-5 (IIEF-5), Quality of Life (QoL), PSA values, urine analysis and urine culture, uroflowmetry. The same evaluation was conducted after a 12 month follow-up. ThuLEP was performed by 2 expert surgeons. Results Our data showed a better post-operative outcome in terms of catheter removal, blood loss, TURP syndrome, clot retention and residual tissue compared to large series of TURP and OP. Only 1.3% of patients had bladder wall injury during morcellation. I-PSS, Qmax, Prostate Volume, QoL and PVR showed a highly significant improvement at 12 month follow-up in comparison to preoperative assessment. Conclusion ThuLEP represent an innovative option in patients with BPH. It is a size independent surgical endoscopic technique and it can be considered the real alternative, at this time, to TURP and even more to Open Prostatectomy for large prostate, with a complete removal of adenoma and with a low complication rate. PMID:23173611

  5. 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

  6. 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.

  7. 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.

  8. Reactor tank UT acceptance criteria

    SciTech Connect

    Daugherty, W.L.

    1990-01-30

    The SRS reactor tanks are constructed of type 304 stainless steel, with 0.5 inch thick walls. An ultrasonic (UT) in-service inspection program has been developed for examination of these tanks, in accordance with the ISI Plan for the Savannah River Production Reactors Process Water System (DPSTM-88-100-1). Prior to initiation of these inspections, criteria for the disposition of any indications that might be found are required. A working group has been formed to review available information on the SRS reactor tanks and develop acceptance criteria. This working group includes nationally recognized experts in the nuclear industry. The working group has met three times and produced three documents describing the proposed acceptance criteria, the technical basis for the criteria and a proposed initial sampling plan. This report transmits these three documents, which were prepared in accordance with the technical task plan and quality assurance plan for this task, task 88-001-A- 1. In addition, this report summarizes the acceptance criteria and proposed sampling plan, and provides further interpretation of the intent of these three documents where necessary.

  9. 12 CFR 7.1007 - Acceptances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Acceptances. 7.1007 Section 7.1007 Banks and... § 7.1007 Acceptances. A national bank is not limited in the character of acceptances it may make in financing credit transactions. Bankers' acceptances may be used for such purpose, since the making...

  10. 12 CFR 7.1007 - Acceptances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Acceptances. 7.1007 Section 7.1007 Banks and... § 7.1007 Acceptances. A national bank is not limited in the character of acceptances it may make in financing credit transactions. Bankers' acceptances may be used for such purpose, since the making...

  11. 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... QUALITY SYSTEM REGULATION Acceptance Activities § 820.86 Acceptance status. Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or...

  12. 12 CFR 615.5550 - Bankers' acceptances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 6 2011-01-01 2011-01-01 false Bankers' acceptances. 615.5550 Section 615.5550... POLICIES AND OPERATIONS, AND FUNDING OPERATIONS Bankers' Acceptances § 615.5550 Bankers' acceptances. Banks for cooperatives may rediscount with other purchasers the acceptances they have created. The bank...

  13. 48 CFR 245.606-3 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Acceptance. 245.606-3... Contractor Inventory 245.606-3 Acceptance. (a) If the schedules are acceptable, the plant clearance officer shall, within 15 days, complete and send the contractor a DD Form 1637, Notice of Acceptance...

  14. 48 CFR 12.402 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Acceptance. 12.402 Section... Acceptance. (a) The acceptance paragraph in 52.212-4 is based upon the assumption that the Government will rely on the contractor's assurances that the commercial item tendered for acceptance conforms to...

  15. 21 CFR 820.86 - Acceptance status.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Acceptance status. 820.86 Section 820.86 Food and... QUALITY SYSTEM REGULATION Acceptance Activities § 820.86 Acceptance status. Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or...

  16. 12 CFR 615.5550 - Bankers' acceptances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Bankers' acceptances. 615.5550 Section 615.5550... POLICIES AND OPERATIONS, AND FUNDING OPERATIONS Bankers' Acceptances § 615.5550 Bankers' acceptances. Banks for cooperatives may rediscount with other purchasers the acceptances they have created. The bank...

  17. 48 CFR 12.402 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Acceptance. 12.402 Section... Acceptance. (a) The acceptance paragraph in 52.212-4 is based upon the assumption that the Government will rely on the contractor's assurances that the commercial item tendered for acceptance conforms to...

  18. 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…

  19. Central waste complex interim operational safety requirements

    SciTech Connect

    Bendixsen, R.B.; Ames, R.R., Fluor Daniel Hanford

    1997-03-20

    This Interim Operational Safety Requirements document supports the authorization basis for interim operations and identifies restrictions on interim operations for the disposal and storage of solid waste in the Central Waste Complex. The Central Waste Complex Interim Operational Safety Requirements provide the necessary controls on operations in the Central Waste Complex to ensure the radiological and hazardous material exposure will be acceptable from an overall health and safety standpoint to the worker, the onsite personnel, 1327 the public and the environment.

  20. National Safety Council

    MedlinePlus

    ... Introduction Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ... Safety Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ...

  1. 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.

  2. Strain-Based Acceptance Criteria for Energy-Limited Events

    SciTech Connect

    Spencer D. Snow; Dana K. Morton

    2009-07-01

    The American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code was primarily written with stress-based acceptance criteria. These criteria are applicable to force, displacement, and energy-controlled loadings and ensure a factor of safety against failure. However, stress-based acceptance criteria are often quite conservative for one time energy-limited events such as accidental drops and impacts. For several years, the ASME Working Group on Design of Division 3 Containments has been developing the Design Articles for Section III, Division 3, “Containments for Transportation and Storage of Spent Nuclear Fuel and High-Level Radioactive Material and Waste,” and has wanted to establish strain-based acceptance criteria for accidental drops of containments. This Division 3 working group asked the Working Group on Design Methodology (WGDM) to assist in developing these strain-based acceptance criteria. This paper discusses the current proposed strain-based acceptance criteria, associated limitations of use, its background development, and the current status.

  3. 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…

  4. 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.

  5. 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.

  6. 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.

  7. Innovative modeling approaches for risk assessment in food safety

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Food safety involves preventing foodborne illness by describing ways to properly handle, prepare and store food. Regulation of food safety is applied to companies that produce food. Thus, the goal of food safety regulation is to reduce human pathogens to acceptable levels at the processing plant t...

  8. 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…

  9. 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.

  10. 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…

  11. Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers.

    PubMed

    Harding, Keith G; Szczepkowski, Marek; Mikosiński, Jacek; Twardowska-Saucha, Krystyna; Blair, Stephen; Ivins, Nicola M; Saucha, Wojciech; Cains, Jane; Peters, Kim; Parsons, David; Bowler, Philip

    2016-08-01

    The objective of this study was to investigate the safety and performance of AQUACEL™ Ag+ dressing, a wound dressing containing a combination of anti-biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL™ Ag+ dressing, followed by management with AQUACEL™ wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL™ Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non-treatment-related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL™ Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm. PMID:26095122

  12. THE RARITY OF DNA PROFILES1

    PubMed Central

    Weir, Bruce S.

    2008-01-01

    It is now widely accepted that forensic DNA profiles are rare, so it was a surprise to some people that different people represented in offender databases are being found to have the same profile. In the first place this is just an illustration of the birthday problem, but a deeper analysis must take into account dependencies among profiles caused by family or population membership. PMID:19030117

  13. 48 CFR 811.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Market acceptance. 811.103 Section 811.103 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS COMPETITION AND... acceptance....

  14. 48 CFR 811.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Market acceptance. 811.103 Section 811.103 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS COMPETITION AND... acceptance....

  15. Computer acceptance of older adults.

    PubMed

    Nägle, Sibylle; Schmidt, Ludger

    2012-01-01

    Even though computers play a massive role in everyday life of modern societies, older adults, and especially older women, are less likely to use a computer, and they perform fewer activities on it than younger adults. To get a better understanding of the factors affecting older adults' intention towards and usage of computers, the Unified Theory of Acceptance and Usage of Technology (UTAUT) was applied as part of a more extensive study with 52 users and non-users of computers, ranging in age from 50 to 90 years. The model covers various aspects of computer usage in old age via four key constructs, namely performance expectancy, effort expectancy, social influences, and facilitating conditions, as well as the variables gender, age, experience, and voluntariness it. Interestingly, next to performance expectancy, facilitating conditions showed the strongest correlation with use as well as with intention. Effort expectancy showed no significant correlation with the intention of older adults to use a computer. PMID:22317258

  16. 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

  17. 7 CFR 966.29 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 966.29 Section 966.29 Agriculture... Regulating Handling Committee § 966.29 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance with the Secretary within ten days after being notified...

  18. 7 CFR 924.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 924.25 Section 924.25 Agriculture....25 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the committee shall qualify by filing a written acceptance with the Secretary promptly after being notified...

  19. 7 CFR 924.25 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 924.25 Section 924.25 Agriculture....25 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the committee shall qualify by filing a written acceptance with the Secretary promptly after being notified...

  20. 7 CFR 923.25 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 923.25 Section 923.25 Agriculture... COUNTIES IN WASHINGTON Order Regulating Handling Administrative Body § 923.25 Acceptance. Any person prior... written acceptance of willingness to serve on the committee....

  1. 7 CFR 993.31 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 993.31 Section 993.31 Agriculture... Order Regulating Handling Prune Marketing Committee § 993.31 Acceptance. Each person selected as a... with the Secretary a written acceptance within 15 days after receiving notice of his selection....

  2. 7 CFR 1215.23 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Acceptance. 1215.23 Section 1215.23 Agriculture... Acceptance. Each individual nominated for membership of the Board shall qualify by filing a written acceptance with the Secretary at the time of nomination....

  3. 7 CFR 906.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 906.25 Section 906.25 Agriculture... RIO GRANDE VALLEY IN TEXAS Order Regulating Handling Committee § 906.25 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance with the...

  4. 7 CFR 946.26 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 946.26 Section 946.26 Agriculture... Order Regulating Handling Administrative Committee § 946.26 Acceptance. Any person selected by the Secretary as a committee member or as an alternate shall qualify by filing a written acceptance with...

  5. 7 CFR 959.29 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 959.29 Section 959.29 Agriculture... Regulating Handling Committee § 959.29 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance within ten days after being notified of such selection....

  6. 12 CFR 250.164 - Bankers' acceptances.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Bankers' acceptances. 250.164 Section 250.164... MISCELLANEOUS INTERPRETATIONS Interpretations § 250.164 Bankers' acceptances. (a) Section 207 of the Bank Export... bankers' acceptances (“BAs”) that may be created by an individual member bank from 50 per cent (or 100...

  7. 24 CFR 3282.355 - Submission acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Submission acceptance. 3282.355... § 3282.355 Submission acceptance. (a) A party whose submission is determined by the Department to be adequate shall be granted provisional acceptance until December 15, 1976, or for a six month period...

  8. 7 CFR 906.25 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 906.25 Section 906.25 Agriculture... RIO GRANDE VALLEY IN TEXAS Order Regulating Handling Committee § 906.25 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance with the...

  9. 24 CFR 3282.355 - Submission acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Submission acceptance. 3282.355... § 3282.355 Submission acceptance. (a) A party whose submission is determined by the Department to be adequate shall be granted provisional acceptance until December 15, 1976, or for a six month period...

  10. 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...

  11. 7 CFR 1250.330 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Acceptance. 1250.330 Section 1250.330 Agriculture... Research and Promotion Order Egg Board § 1250.330 Acceptance. Any person appointed by the Secretary as a member, or as an alternate member, of the Board shall qualify by filing a written acceptance with...

  12. 7 CFR 923.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 923.25 Section 923.25 Agriculture... COUNTIES IN WASHINGTON Order Regulating Handling Administrative Body § 923.25 Acceptance. Any person prior... written acceptance of willingness to serve on the committee....

  13. 7 CFR 1205.326 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Acceptance. 1205.326 Section 1205.326 Agriculture... Research and Promotion Order Cotton Board § 1205.326 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the Board shall qualify by filing a written acceptance with...

  14. 7 CFR 953.21 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 953.21 Section 953.21 Agriculture... STATES Order Regulating Handling Administrative Committee § 953.21 Acceptance. Any person selected by the... acceptance with the Secretary within the time specified by the Secretary....

  15. 12 CFR 250.164 - Bankers' acceptances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Bankers' acceptances. 250.164 Section 250.164... MISCELLANEOUS INTERPRETATIONS Interpretations § 250.164 Bankers' acceptances. (a) Section 207 of the Bank Export... bankers' acceptances (“BAs”) that may be created by an individual member bank from 50 per cent (or 100...

  16. 7 CFR 966.29 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 966.29 Section 966.29 Agriculture... Regulating Handling Committee § 966.29 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance with the Secretary within ten days after being notified...

  17. 48 CFR 2911.103 - 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. 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...

  18. 7 CFR 1215.23 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Acceptance. 1215.23 Section 1215.23 Agriculture... Acceptance. Each individual nominated for membership of the Board shall qualify by filing a written acceptance with the Secretary at the time of nomination....

  19. 7 CFR 946.26 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 946.26 Section 946.26 Agriculture... Order Regulating Handling Administrative Committee § 946.26 Acceptance. Any person selected by the Secretary as a committee member or as an alternate shall qualify by filing a written acceptance with...

  20. 7 CFR 1205.326 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Acceptance. 1205.326 Section 1205.326 Agriculture... Research and Promotion Order Cotton Board § 1205.326 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the Board shall qualify by filing a written acceptance with...

  1. 7 CFR 953.21 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 953.21 Section 953.21 Agriculture... STATES Order Regulating Handling Administrative Committee § 953.21 Acceptance. Any person selected by the... acceptance with the Secretary within the time specified by the Secretary....

  2. 7 CFR 1250.330 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Acceptance. 1250.330 Section 1250.330 Agriculture... Research and Promotion Order Egg Board § 1250.330 Acceptance. Any person appointed by the Secretary as a member, or as an alternate member, of the Board shall qualify by filing a written acceptance with...

  3. 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...

  4. 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... either— (i) Achieved commercial market acceptance; or (ii) Been satisfactorily supplied to an...

  5. 7 CFR 1210.323 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 10 2011-01-01 2011-01-01 false Acceptance. 1210.323 Section 1210.323 Agriculture... PLAN Watermelon Research and Promotion Plan National Watermelon Promotion Board § 1210.323 Acceptance. Each person nominated for membership on the Board shall qualify by filing a written acceptance with...

  6. 7 CFR 959.29 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 959.29 Section 959.29 Agriculture... Regulating Handling Committee § 959.29 Acceptance. Any person selected as a committee member or alternate shall qualify by filing a written acceptance within ten days after being notified of such selection....

  7. 7 CFR 993.31 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 993.31 Section 993.31 Agriculture... Order Regulating Handling Prune Marketing Committee § 993.31 Acceptance. Each person selected as a... with the Secretary a written acceptance within 15 days after receiving notice of his selection....

  8. 7 CFR 915.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 915.25 Section 915.25 Agriculture... Regulating Handling Administrative Body § 915.25 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the committee shall qualify by filing a written acceptance with...

  9. 7 CFR 1210.323 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Acceptance. 1210.323 Section 1210.323 Agriculture... PLAN Watermelon Research and Promotion Plan National Watermelon Promotion Board § 1210.323 Acceptance. Each person nominated for membership on the Board shall qualify by filing a written acceptance with...

  10. 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...

  11. 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…

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. The Relationship between Treatment Acceptability and Familism

    ERIC Educational Resources Information Center

    Pemberton, Joy R.; Borrego, Joaquin, Jr.

    2005-01-01

    Many studies have examined the acceptability of treatments for children with disruptive behaviors. However, few studies to date have tested the effects of home environment variables such as family support on treatment acceptability. In the current study, parents' level of familism was used to predict their willingness to accept several behavioral…

  19. 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...

  20. 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

  1. 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.

  2. 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.

  3. 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. PMID:25959115

  4. 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.

  5. 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.

  6. Acceptance Test Plan for Fourth-Generation Corrosion Monitoring Cabinet

    SciTech Connect

    NORMAN, E.C.

    2000-10-23

    This Acceptance Test Plan (ATP) will document the satisfactory operation of the third-generation corrosion monitoring cabinet (Hiline Engineering Part No.0004-CHM-072-C01). This ATP will be performed by the manufacturer of the cabinet prior to delivery to the site. The objective of this procedure is to demonstrate and document the acceptance of the corrosion monitoring cabinet. The test will consist of a continuity test of the cabinet wiring from the end of cable to be connected to corrosion probe, through the appropriate intrinsic safety barriers and out to the 15 pin D-shell connectors to be connected to the corrosion monitoring instrument. Additional testing will be performed using a constant current and voltage source provided by the corrosion monitoring hardware manufacturer to verify proper operation of corrosion monitoring instrumentation.

  7. 105 K East isolation barrier acceptance analysis report

    SciTech Connect

    McCracken, K.J.; Irwin, J.J.

    1995-05-31

    The objective of this document is to report and interpret the findings of the isolation barrier acceptance tests performed in 105KE/100K. The tests were performed in accordance with the test plan (McCracken 1995c) and acceptance test procedure (McCracken 1995a). The test report (McCracken 1995b) contains the test data. This document compares the test data (McCracken 1995b) against the criteria (McCracken 1995a, c). A discussion of the leak rate analytical characterization (Irwin 1995) describes how the flow characteristics and the flow rate will be determined using the test data from the test report (McCracken 1995b). The barriers must adequately control the leakage from the main basin to the discharge chute to less than the 1,500 gph (5,680 lph) Safety Analysis Report (SAR 1994) limit.

  8. 76 FR 79656 - E & B Giftware LLC, Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ...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 accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with E & B Giftware LLC, containing a civil penalty of $550,000.00, of which $50,000 shall be suspended, within twenty (20) days......

  9. Safety assessment of drug residues

    SciTech Connect

    Jackson, B.A.

    1980-05-15

    The safety assessment of drug residues is part of the process for defining the conditions for the safe use of drugs in food-producing animals. The information needed to assess the safety of drug residues is provided by chemical and toxicity tests. Toxicity tests are conducted to identify the type of effect produced and to determine the exposure concentrations that would be expected not to produce the effect. These tests include acute, subacute, and chronic toxicity tests, as well as reproduction studies and other special tests. The results are used to find an acceptable daily intake for drug residues that can be used to set a tolerance.

  10. Safety Tips.

    ERIC Educational Resources Information Center

    Nagel, Miriam C., Ed.

    1984-01-01

    Outlines a cooperative effort in Iowa to eliminate dangerous or unwanted chemicals from school science storerooms. Also reviews the Council of State Science Supervisor's safety program and discusses how to prevent cuts and punctures from jagged glass tubing. (JN)

  11. Food Safety

    MedlinePlus

    ... are four basic steps to food safety at home: Clean - always wash your fruits and vegetables, hands, counters, and cooking utensils. Separate - keep raw foods to themselves. Germs can spread from one food ...

  12. Real time patient safety audits: improving safety every day

    PubMed Central

    Ursprung, R; Gray, J; Edwards, W; Horbar, J; Nickerson, J; Plsek, P; Shiono, P; Suresh, G; Goldmann, D

    2005-01-01

    Background: Timely error detection including feedback to clinical staff is a prerequisite for focused improvement in patient safety. Real time auditing, the efficacy of which has been repeatedly demonstrated in industry, has not been used previously to evaluate patient safety. Methods successful at improving quality and safety in industry may provide avenues for improvement in patient safety. Objective: Pilot study to determine the feasibility and utility of real time safety auditing during routine clinical work in an intensive care unit (ICU). Methods: A 36 item patient safety checklist was developed via a modified Delphi technique. The checklist focused on errors associated with delays in care, equipment failure, diagnostic studies, information transfer and non-compliance with hospital policy. Safety audits were performed using the checklist during and after morning work rounds thrice weekly during the 5 week study period from January to March 2003. Results: A total of 338 errors were detected; 27 (75%) of the 36 items on the checklist detected ⩾1 error. Diverse error types were found including unlabeled medication at the bedside (n = 31), ID band missing or in an inappropriate location (n = 70), inappropriate pulse oximeter alarm setting (n = 22), and delay in communication/information transfer that led to a delay in appropriate care (n = 4). Conclusions: Real time safety audits performed during routine work can detect a broad range of errors. Significant safety problems were detected promptly, leading to rapid changes in policy and practice. Staff acceptance was facilitated by fostering a blame free "culture of patient safety" involving clinical personnel in detection of remediable gaps in performance, and limiting the burden of data collection. PMID:16076794

  13. Imprecision profiling.

    PubMed

    Sadler, William A

    2008-08-01

    * Imprecision profiles express precision characteristics of an assay over a range of concentration values. They can convert large quantities of potentially complex data into an easily interpreted graphical summary. * Imprecision profile estimation does not require precisely structured data. This implies that structured method evaluation data can be easily compared with, or merged with, less structured internal quality control (QC) data (or with data from any other source). * Although originally conceived for immunoassays, imprecision profiles could, in principle, be used as a summary method with any measurement system where precision varies with level of measurand. PMID:18852854

  14. 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

  15. Acceptability of GM foods among Pakistani consumers.

    PubMed

    Ali, Akhter; Rahut, Dil Bahadur; Imtiaz, Muhammad

    2016-04-01

    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. PMID:27494790

  16. 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.

  17. Nanodrugs: pharmacokinetics and safety.

    PubMed

    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

  18. 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)

  19. Pioneer Profile.

    ERIC Educational Resources Information Center

    Butcher, Channa Beth

    1987-01-01

    Profiles Herbert A. Sweet, founder and director of Acorn Farms Day Camp (Indiana) for 44 years. Includes reminiscences about the camp's program, staffing, food, World War II, affiliation with the American Camping Association, and camps/directors of today. (NEC)

  20. 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…

  1. Programmable Electronic Safety Systems

    SciTech Connect

    Parry, R.

    1993-05-01

    Traditionally safety systems intended for protecting personnel from electrical and radiation hazards at particle accelerator laboratories have made extensive use of electromechanical relays. These systems have the advantage of high reliability and allow the designer to easily implement failsafe circuits. Relay based systems are also typically simple to design, implement, and test. As systems, such as those presently under development at the Superconducting Super Collider Laboratory (SSCL), increase in size, and the number of monitored points escalates, relay based systems become cumbersome and inadequate. The move toward Programmable Electronic Safety Systems is becoming more widespread and accepted. In developing these systems there are numerous precautions the designer must be concerned with. Designing fail-safe electronic systems with predictable failure states is difficult at best. Redundancy and self-testing are prime examples of features that should be implemented to circumvent and/or detect failures. Programmable systems also require software which is yet another point of failure and a matter of great concern. Therefore the designer must be concerned with both hardware and software failures and build in the means to assure safe operation or shutdown during failures. This paper describes features that should be considered in developing safety systems and describes a system recently installed at the Accelerator Systems String Test (ASST) facility of the SSCL.

  2. 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.

  3. 76 FR 68167 - Spin Master, Inc. and Spin Master, Ltd., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... Order AGENCY: 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... that TMG is harmful if swallowed, and that, upon ingestion, it targets the kidneys and central...

  4. 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...

  5. 76 FR 77981 - Build-A-Bear Workshop, Inc., Provisional Acceptance of a Settlement Agreement and Order

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-15

    ...: 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... time, Build-A-Bear denies that it had sufficient information regarding injuries associated with...

  6. 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.

  7. Laser safety eyewear.

    PubMed

    1993-04-01

    In spite of repeated warnings about laser safety practices, as well as the availability of laser safety eyewear (LSE), eye injuries continue to occur during use of surgical lasers, as discussed in the Clinical Perspective, "Laser Energy and Its Dangers to Eyes," preceding this Evaluation. We evaluated 48 models of LSE, including goggles, spectacles, and wraps, from 11 manufacturers. The evaluated models are designed with absorptive lenses that provide protection from CO2 (carbon dioxide), Nd:YAG (neodymium:yttrium-aluminum-garnet), and 532 (frequency-doubled Nd:YAG) surgical laser wavelengths; several models provide multiwavelength protection. (Refer to ECRI's Product Comparison System report on LSE for specifications of other models.) Although most of the evaluated models can adequately protect users from laser energy--provided that the eyewear is used--many models of LSE, especially goggles, are designed with little regard for the needs of actual use (e.g., adequate labeling, no alteration of color perception, sufficient field of vision [FOV], comfort). Because these factors can discourage people from using LSE, we encourage manufacturers to develop new and improved models that will be worn. We based our ratings primarily on the laser protection provided by the optical density (OD) of the lenses; we acknowledge the contribution of Montana Laser Optics Inc., of Bozeman, Montana, in performing our OD testing. We also considered actual-use factors, such as those mentioned above, to be significant. Among the models rated Acceptable is one whose labeled OD is lower than the level we determined to be adequate for use during most laser surgery; however, this model offers protection under specific conditions of use (e.g., for use by spectators some distance from the surgical site, for use during endoscopic procedures) that should be determined by the laser safety officer (LSO). LSE that would put the wearer at risk are rated Unacceptable (e.g., some models are not

  8. 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...

  9. Fuel Supply Shutdown Facility Interim Operational Safety Requirements

    SciTech Connect

    BENECKE, M.W.

    2000-09-06

    The Interim Operational Safety Requirements for the Fuel Supply Shutdown (FSS) Facility define acceptable conditions, safe boundaries, bases thereof, and management of administrative controls to ensure safe operation of the facility.

  10. 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 ...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  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. PMID:23278470

  20. Alternatives to hazard ratios for comparing efficacy or safety of therapies in noninferiority studies

    PubMed Central

    Uno, Hajime; Wittes, Janet; Fu, Haoda; Solomon, Scott D.; Claggett, Brian; Tian, Lu; Cai, Tianxi; Pfeffer, Marc A.; Evans, Scott R.; Wei, Lee-Jen

    2015-01-01

    A noninferiority study is often used to investigate whether a treatment’s efficacy or safety profile is acceptable compared to an alternative therapy regarding the time to a clinical event. The empirical quantification of the treatment difference for such a study is routinely based on the hazard ratio estimate. The hazard ratio, which is not a relative risk, may be difficult to interpret clinically, especially when the underlying proportional hazards assumption is violated. The precision of the hazard ratio estimate depends primarily on the number of observed events, but not directly on either exposure times or sample size of the study population. If the event rate is low, the study may require an impractically large number of events to ensure that the prespecified noninferiority criterion for the hazard ratio is attainable. This article discusses deficiencies of the current approach for design and analysis of a noninferiority study. We then provide alternative procedures, which do not depend on any model assumption, to compare two treatments. For a noninferiority safety study, the patients’ exposure times are more clinically important than the observed number of events. If the study patients’ exposure times are long enough to evaluate safety reliably, these alternative procedures can effectively provide clinically interpretable evidence on safety, even with relatively few observed events. We illustrate these procedures with data from two studies. One explores the cardiovascular safety of a pain medicine; the second examines the cardiovascular safety of a new treatment for diabetes. These alternative strategies to evaluate safety or efficacy of an intervention lead to more meaningful interpretations of the analysis results than the conventional one via the hazard ratio estimate. PMID:26054047

  1. 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.

  2. Profile video

    NASA Astrophysics Data System (ADS)

    Voglewede, Paul E.; Zampieron, Jeffrey

    2009-05-01

    For unattended persistent surveillance there is a need for a system which provides the following information: target classification, target quantity estimate, cargo presence and characterization, direction of travel, and action. Over highly bandwidth restricted links, such as Iridium, SATCOM or HF, the data rates of common techniques are too high, even after aggressive compression, to deliver the required intelligence in a timely, low power manner. We propose the following solution to this data rate problem: Profile Video. Profile video is a new technique which provides all of the required information in a very low data-rate package.

  3. Playground Safety.

    ERIC Educational Resources Information Center

    Sipes, James L.

    2000-01-01

    Discusses the issues of risk, liability, and fun when landscaping playgrounds with safety in mind. The importance of playground surfaces and several preventive measures landscapers can use to reduce the risk of injury are discussed. Concluding comments address playground design features and liability. (GR)

  4. School Safety.

    ERIC Educational Resources Information Center

    The Newsletter of the Comprehensive Center-Region VI, 1999

    1999-01-01

    The articles in this issue dealing with school safety discusses what rural and small urban settings are doing to prevent violence and to educate young people about prosocial alternatives to violence. The research is quite clear that female, minority, and gay students are the targets of a disproportionate amount of harassment and violence, both in…

  5. 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…

  6. 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 Kilns Safely in the Classroom"…

  7. 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. PMID:22269566

  8. 14 CFR 431.35 - Acceptable reusable launch vehicle mission risk.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... risk. 431.35 Section 431.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... reusable launch vehicle mission risk. (a) To obtain safety approval for an RLV mission, an applicant must demonstrate that the proposed mission does not exceed acceptable risk as defined in this subpart. For...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 49 CFR 551.56 - What information must an Acceptance by Agent contain?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false What information must an Acceptance by Agent contain? 551.56 Section 551.56 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES Service of Process on Foreign Manufacturers and...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Acceptable reentry risk for reentry of a reentry vehicle. 435.35 Section 435.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING REENTRY OF A REENTRY VEHICLE OTHER THAN A REUSABLE LAUNCH VEHICLE (RLV) Safety...

  15. 16 CFR 1631.34 - Small carpets and rugs not meeting acceptance criterion.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Small carpets and rugs not meeting acceptance criterion. 1631.34 Section 1631.34 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE SURFACE FLAMMABILITY OF SMALL CARPETS AND RUGS (FF...

  16. Evaluating the Validity and Social Acceptability of Child Sexual Abuse Prevention Skill Measures

    ERIC Educational Resources Information Center

    Kopp, Brandon; Miltenberger, Raymond G.

    2008-01-01

    In research evaluating sexual abuse prevention programs, knowledge measures are typically used to assess the program's success. In other areas of research on child safety skills, however, skills are typically assessed through behavioral measures such as role-plays. The purpose of this study was to assess the validity and acceptability of a set of…

  17. 49 CFR 180.511 - Acceptable results of inspections and tests.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... structural defect that may initiate cracks or propagate cracks and cause failure of the tank before the next... 49 Transportation 3 2013-10-01 2013-10-01 false Acceptable results of inspections and tests. 180... AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED)...

  18. Long-term safety and efficacy of infliximab for the treatment of ankylosing spondylitis

    PubMed Central

    Elalouf, Ofir; Elkayam, Ori

    2015-01-01

    The introduction of TNFα blockers has revolutionized the treatment of ankylosing spondylitis (AS). The objectives of this review are to summarize the most up-to-date data on long-term efficacy and safety of infliximab in AS, with special emphasis on axial and extra-articular disease, predictors of response, and radiological response. The general consensus of this literature search was that infliximab is highly efficacious in the treatment of AS. Most studies have demonstrated good clinical outcomes after 3 years of treatment, as measured by Spondyloarthritis International Society response in 75%–85% of treated AS patients. Reports on the long-term effects of infliximab as documented by radiological findings, however, are controversial. While some studies reported a similar progression rate as that of the historical OASIS cohort, others have suggested that infliximab may halt new bone formation. The long-term safety of infliximab is well known, mainly from data stored in national registries. While it has been suggested that side effects of infliximab may be fewer in AS compared to rheumatoid arthritis, data on this issue are sparse, with most of the information on long-term safety pertaining to rheumatoid arthritis. It can however be concluded that the long-term efficacy of infliximab is apparently maintained in AS and with an acceptable safety profile. PMID:26640380

  19. Safety of peripheral administration of phenylephrine in a neurologic intensive care unit: A pilot study.

    PubMed

    Delgado, Tim; Wolfe, Brianne; Davis, Gary; Ansari, Safdar

    2016-08-01

    Integral to the management of the neurocritically injured patient are the prevention and treatment of hypotension, maintenance of cerebral perfusion pressure, and occasionally blood pressure augmentation. When adequate volume resuscitation fails to meet perfusion needs, vasopressors are often used to restore end-organ perfusion. This has historically necessitated central venous access given well-documented incidence of extravasation injuries associated with peripheral administration of vasopressors. In this pilot study, we report our 6-month experience with peripheral administration of low-concentration phenylephrine (40 μg/mL) in our neurocritical care unit. We were able to administer peripheral phenylephrine, up to a dose of 2 μg/(kg min), for an average of 14.29hours (1-54.3) in 20 patients with only 1 possible minor complication and no major complications. This was achieved by adding additional safety measures in our computerized physician order entry system and additional nurse-driven safety protocols. Thus, with careful monitoring and safety precautions, peripheral administration of phenylephrine at an optimized concentration appears to have an acceptable safety profile for use in the neurocritical care unit up to a mean infusion time of 14hours. PMID:27288620

  20. 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...

  1. 7 CFR 930.26 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 930.26 Section 930.26 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Body § 930.26 Acceptance. Each person to be appointed by the Secretary as a member or as...

  2. 48 CFR 2811.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Market acceptance. 2811.103 Section 2811.103 Federal Acquisition Regulations System DEPARTMENT OF JUSTICE COMPETITION AND... acceptance. Pursuant to FAR 11.103, the HCA or designee at a level not lower than the BPC has the...

  3. 48 CFR 1311.103 - Market acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Market acceptance. 1311.103 Section 1311.103 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE COMPETITION AND... acceptance. The designee authorized as the head of the agency is set forth in CAM 1301.70....

  4. 36 CFR 251.62 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 2 2011-07-01 2011-07-01 false Acceptance. 251.62 Section 251.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE LAND USES Special Uses § 251.62 Acceptance. Except for an easement, a special use authorization shall become...

  5. 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...

  6. 48 CFR 1011.103 - Market Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Market Acceptance. 1011.103 Section 1011.103 Federal Acquisition Regulations System DEPARTMENT OF THE TREASURY COMPETITION AND... Acceptance. (a) BCPOs can act on behalf of the head of the agency in this subpart only. BCPOs,...

  7. 7 CFR 916.25 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 916.25 Section 916.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Administrative Body § 916.25 Acceptance. Each person to be selected by the Secretary as...

  8. 43 CFR 3452.1-3 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Acceptance. 3452.1-3 Section 3452.1-3 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT..., Cancellation, and Termination § 3452.1-3 Acceptance. The effective date of the lease relinquishment shall,...

  9. 48 CFR 1311.103 - Market acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Market acceptance. 1311.103 Section 1311.103 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE COMPETITION AND... acceptance. The designee authorized as the head of the agency is set forth in CAM 1301.70....

  10. 7 CFR 916.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 916.25 Section 916.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Administrative Body § 916.25 Acceptance. Each person to be selected by the Secretary as...

  11. 7 CFR 920.25 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 920.25 Section 920.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Body § 920.25 Acceptance. Each person to be selected by the Secretary as a member or as...

  12. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CFR 1653.3(c); or (f) The participant has received a taxable loan distribution from the TSP within the... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Loan acceptance. 1655.11 Section 1655.11 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD LOAN PROGRAM § 1655.11 Loan acceptance....

  13. 7 CFR 930.26 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 930.26 Section 930.26 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Body § 930.26 Acceptance. Each person to be appointed by the Secretary as a member or as...

  14. 7 CFR 945.27 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 945.27 Section 945.27 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... § 945.27 Acceptance. Any person nominated to serve on the committee as a member or as an alternate...

  15. 19 CFR 114.21 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Acceptance. 114.21 Section 114.21 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARNETS Processing of Carnets § 114.21 Acceptance. A carnet executed in accordance with § 114.3 shall...

  16. 19 CFR 114.21 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 1 2011-04-01 2011-04-01 false Acceptance. 114.21 Section 114.21 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY CARNETS Processing of Carnets § 114.21 Acceptance. A carnet executed in accordance with § 114.3 shall...

  17. 7 CFR 920.25 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 920.25 Section 920.25 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Body § 920.25 Acceptance. Each person to be selected by the Secretary as a member or as...

  18. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 932.32 Section 932.32 Agriculture... Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the committee shall qualify by filing a written...

  19. 5 CFR 1655.11 - Loan acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CFR 1653.3(c); or (f) The participant has received a taxable loan distribution from the TSP within the... 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....

  20. 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 Section 411.103 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND... acceptance. (a) The head of the contracting activity (HCA) may determine that offerors must demonstrate,...

  1. 7 CFR 989.32 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 989.32 Section 989.32 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... CALIFORNIA Order Regulating Handling Raisin Administrative Committee § 989.32 Acceptance. Each person to...

  2. 7 CFR 932.32 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Acceptance. 932.32 Section 932.32 Agriculture... Regulating Handling Olive Administrative Committee § 932.32 Acceptance. Any person selected by the Secretary as a member or as an alternate member of the committee shall qualify by filing a written...

  3. 7 CFR 945.27 - Acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Acceptance. 945.27 Section 945.27 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... § 945.27 Acceptance. Any person nominated to serve on the committee as a member or as an alternate...

  4. 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 Section 411.103 Federal Acquisition Regulations System DEPARTMENT OF AGRICULTURE COMPETITION AND... acceptance. (a) The head of the contracting activity (HCA) may determine that offerors must demonstrate,...

  5. 36 CFR 251.62 - Acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 2 2010-07-01 2010-07-01 false Acceptance. 251.62 Section 251.62 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE LAND USES Special Uses § 251.62 Acceptance. Except for an easement, a special use authorization shall become...

  6. Why Do Women Accept the Rape Myth?

    ERIC Educational Resources Information Center

    Tabone, Christopher; And Others

    The rape myth, defined as prejudicial, stereotyped, or false beliefs about rape, rape victims, and rapists, is accepted by individuals from varied walks of life, including women. It has been suggested that rape myth acceptance (RMA) among women serves a protective function by enabling women to dissociate themselves from a rape victim's experience.…

  7. 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)

  8. 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.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. Four therapeutic diets: adherence and acceptability.

    PubMed

    Berkow, Susan E; Barnard, Neal; Eckart, Jill; Katcher, Heather

    2010-01-01

    Many health conditions are treated, at least in part, by therapeutic diets. Although the success of any intervention depends on its acceptability to the patient, the acceptability of therapeutic diets and factors that influence it have been largely neglected in nutrition research. A working definition of acceptability is proposed and an examination and summary are provided of available data on the acceptability of common diet regimens used for medical conditions. The goal is to suggest ways to improve the success of therapeutic diets. The proposed working definition of "acceptability" refers to the user's judgment of the advantages and disadvantages of a therapeutic diet-in relation to palatability, costs, and effects on eating behaviour and health-that influence the likelihood of adherence. Very low-calorie, reduced-fat omnivorous, vegetarian and vegan, and low-carbohydrate diets all achieve acceptability among the majority of users in studies of up to one year, in terms of attrition and adherence rates and results of questionnaires assessing eating behaviours. Longer studies are fewer, but they suggest that vegetarian, vegan, and reduced-fat diets are acceptable, as indicated by sustained changes in nutrient intake. Few studies of this length have been published for very low-calorie or low-carbohydrate diets. Long-term studies of adherence and acceptability of these and other therapeutic diets are warranted. PMID:21144137

  16. Improving Acceptance of Automated Counseling Procedures.

    ERIC Educational Resources Information Center

    Johnson, James H.; And Others

    This paper discusses factors that may influence the acceptance of automated counseling procedures by the military. A consensual model of the change process is presented which structures organizational readiness, the change strategy, and acceptance as integrated variables to be considered in a successful installation. A basic introduction to the…

  17. Enzyme Reactions and Acceptability of Plant Foods.

    ERIC Educational Resources Information Center

    Palmer, James K.

    1984-01-01

    Provides an overview of enzyme reactions which contribute to the character and acceptability of plant foods. A detailed discussion of polyphenoloxidase is also provided as an example of an enzyme which can markedly affect the character and acceptability of such foods. (JN)

  18. 34 CFR 668.57 - Acceptable documentation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Acceptable documentation. 668.57 Section 668.57... Application Information § 668.57 Acceptable documentation. (a) Adjusted Gross Income (AGI), income earned from... applicant, the documentation set forth in paragraph (a)(4) of this section if the individual for the...

  19. The acceptability of ending a patient's life

    PubMed Central

    Guedj, M; Gibert, M; Maudet, A; Munoz, S; Mullet, E; Sorum, P

    2005-01-01

    Objectives: To clarify how lay people and health professionals judge the acceptability of ending the life of a terminally ill patient. Design: Participants judged this acceptability in a set of 16 scenarios that combined four factors: the identity of the actor (patient or physician), the patient's statement or not of a desire to have his life ended, the nature of the action as relatively active (injecting a toxin) or passive (disconnecting life support), and the type of suffering (intractable physical pain, complete dependence, or severe psychiatric illness). Participants: 115 lay people and 72 health professionals (22 nurse's aides, 44 nurses, six physicians) in Toulouse, France. Main measurements: Mean acceptability ratings for each scenario for each group. Results: Life ending interventions are more acceptable to lay people than to the health professionals. For both, acceptability is highest for intractable physical suffering; is higher when patients end their own lives than when physicians do so; and, when physicians are the actors, is higher when patients have expressed a desire to die (voluntary euthanasia) than when they have not (involuntary euthanasia). In contrast, when patients perform the action, acceptability for the lay people and nurse's aides does not depend on whether the patient has expressed a desire to die, while for the nurses and physicians unassisted suicide is more acceptable than physician assisted suicide. Conclusions: Lay participants judge the acceptability of life ending actions in largely the same way as do healthcare professionals. PMID:15923476

  20. 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. PMID:22416723