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Sample records for permissible weekly dose

  1. Maximum permissible dose

    International Nuclear Information System (INIS)

    Anon.

    1979-01-01

    This chapter presents a historic overview of the establishment of radiation guidelines by various national and international agencies. The use of maximum permissible dose and maximum permissible body burden limits to derive working standards is discussed

  2. Determination of permissible exposure doses under the provisions of the regulations on installation and operation of marine reactors

    International Nuclear Information System (INIS)

    1979-01-01

    The Ministry of Transportation defines on radioactive doses in the controlled area that exterior radioactive dose shall be 30 mili-rem for a week; concentrations of radioactive materials in the air or under the water shall be permissible concentrations otherwise specified for the employees multiplied by 0.75 in average for a week and that densities of radioactive materials on the surface of the things contaminated by such materials shall be 1/10 of permissible surface densities provided in a table attached. Permissible exposure dose outside the inspected surrounding area is 0.5 rem for a year. Permissible surface densities are included in a list attached. Permissible accumulative dose for the employees is the figure (unit rem) calculated by the formula D = 5(N-18), when D means permissible accumulative dose and N number of the age. Permissible exposure dose is 3 rem for 3 months for the employees, 1.5 rem for a year for persons other than the employees and 12 rem for the urgent work. Permissible densities for the employees, calculation of doses by interior exposure and permissible densities outside the inspected surrounding area are stipulated in detail with attached lists. (Okada, K.)

  3. Determination of permissible doses under the provisions of the regulations on installation and operation of reactors for power generation

    International Nuclear Information System (INIS)

    1979-01-01

    The determination is defined under the regulations on installation and operation of reactors for power generation. In the controlled area exterior radiation dose shall be 30 mili-rem for a week by the Minister of International Trade and Industry. The concentrations of radioactive materials in the air or under the water shall be permissible concentrations specified for the employees multiplied by 0.75 in average for a week. The densities of radioactive materials on the surface of the things contaminated by such materials shall be 1/10 of permissible surface densities stipulated in the table attached. Permissible exposure dose outside the inspected surrounding area is 0.5 rem for a year. Permissible surface densities are included in the table attached. Permissible accumulative dose for the employees is the figure (unit rem) calculated by the formula D = 5(N-18), when D means permissible accumulative dose and N number of the age. Permissible exposure dose is 3 rem for 3 months for the employees, 1.5 rem for a year for persons other than the employees and 12 rem for the urgent work. Permissible concentrations are defined in detail for the employees and outside the inspected surrounding area. Calculation of exposure dose in the case of interior exposure is particularly provided for. (Okada, K.)

  4. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study.

    Science.gov (United States)

    van der Heijde, Désirée; Deodhar, Atul; Wei, James C; Drescher, Edit; Fleishaker, Dona; Hendrikx, Thijs; Li, David; Menon, Sujatha; Kanik, Keith S

    2017-08-01

    To compare efficacy and safety of various doses of tofacitinib, an oral Janus kinase inhibitor, with placebo in patients with active ankylosing spondylitis (AS, radiographic axial spondyloarthritis). In this 16-week (12-week treatment, 4-week washout), phase II, multicentre, dose-ranging trial, adult patients with active AS were randomised (N=51, 52, 52, 52, respectively) to placebo or tofacitinib 2, 5 or 10 mg twice daily. The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. Safety was monitored. Emax model analysis of the primary endpoint predicted a tofacitinib 10 mg twice daily ASAS20 response rate of 67.4%, 27.3% higher than placebo. Supportive normal approximation analysis demonstrated tofacitinib 5 mg twice daily ASAS20 response rate significantly higher than placebo (80.8% vs 41.2%; ptofacitinib 2 and 10 mg twice daily demonstrated greater response rate than placebo (51.9% and 55.8%, respectively; not significant). Secondary endpoints generally demonstrated greater improvements with tofacitinib 5 and 10 mg twice daily than placebo. Objective (including MRI) endpoints demonstrated clear dose response. Adverse events were similar across treatment groups with no unexpected safety findings. Dose-dependent laboratory outcome changes returned close to baseline by week 16. Tofacitinib 5 and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active AS in adult patients with a similar 12-week safety profile as reported in other indications. NCT01786668. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  5. Studies on the establishment of maximum permissible exposure dose for reference Korean

    International Nuclear Information System (INIS)

    Kim, Y.J.; Lee, K.S.; Chun, K.C.; Kim, C.B.; Chung, K.H.; Kim, S.L.; Kim, M.J.

    1981-01-01

    In order to establish the Reference Korean and maximum permissible exposure dose of Reference Korean, for the first year a total of 9,758 males and 7,019 females were surveyed for the height, weight, a body surface area, and a total of 879 individuals of 180 households located in different 30 localities were analyzed for food consumption and a total of radioactive substances (β-ray) contained in food per capita per day. In this report the external and internal exposure dose were also estimated on the basis of data mostly published in other country as well as in Korea in part

  6. Dose Estimation from Daily and Weekly Dosimetry Data

    International Nuclear Information System (INIS)

    Ostrouchov, G.

    2001-01-01

    Statistical analyses of data from epidemiologic studies of workers exposed to radiation have been based on recorded annual radiation doses (yearly dose of record). It is usually assumed that the dose values are known exactly, although it is generally recognized that the data contain uncertainty due to measurement error and bias. In our previous work with weekly data, a probability distribution was used to describe an individual's dose during a specific period of time and statistical methods were developed for estimating it from weekly film dosimetry data. This study showed that the yearly dose of record systematically underestimates doses for Oak Ridge National Laboratory (ORNL) workers. This could result in biased estimates of dose-response coefficients and their standard errors. The results of this evaluation raise serious questions about the suitability of the yearly dose of record for direct use in low-dose studies of nuclear industry workers. Here, we extend our previous work to use full information in Pocket meter data and develop the Data Synthesis for Individual Dose Estimation (DSIDE) methodology. Although the DSIDE methodology in this study is developed in the context of daily and weekly data to produce a cumulative yearly dose estimate, in principle it is completely general and can be extended to other time period and measurement combinations. The new methodology takes into account the ''measurement error'' that is produced by the film and pocket-meter dosimetry systems, the biases introduced by policies that lead to recording left-censored doses as zeros, and other measurement and recording practices. The DSIDE method is applied to a sample of dose histories obtained from hard copy dosimetry records at ORNL for the years 1945 to 1955. First, the rigorous addition of daily pocket-meter information shows that the negative bias is generally more severe than was reported in our work based on weekly film data only, however, the amount of bias also varies

  7. Dose Estimation from Daily and Weekly Dosimetry Data

    Energy Technology Data Exchange (ETDEWEB)

    Ostrouchov, G.

    2001-11-16

    Statistical analyses of data from epidemiologic studies of workers exposed to radiation have been based on recorded annual radiation doses (yearly dose of record). It is usually assumed that the dose values are known exactly, although it is generally recognized that the data contain uncertainty due to measurement error and bias. In our previous work with weekly data, a probability distribution was used to describe an individual's dose during a specific period of time and statistical methods were developed for estimating it from weekly film dosimetry data. This study showed that the yearly dose of record systematically underestimates doses for Oak Ridge National Laboratory (ORNL) workers. This could result in biased estimates of dose-response coefficients and their standard errors. The results of this evaluation raise serious questions about the suitability of the yearly dose of record for direct use in low-dose studies of nuclear industry workers. Here, we extend our previous work to use full information in Pocket meter data and develop the Data Synthesis for Individual Dose Estimation (DSIDE) methodology. Although the DSIDE methodology in this study is developed in the context of daily and weekly data to produce a cumulative yearly dose estimate, in principle it is completely general and can be extended to other time period and measurement combinations. The new methodology takes into account the ''measurement error'' that is produced by the film and pocket-meter dosimetry systems, the biases introduced by policies that lead to recording left-censored doses as zeros, and other measurement and recording practices. The DSIDE method is applied to a sample of dose histories obtained from hard copy dosimetry records at ORNL for the years 1945 to 1955. First, the rigorous addition of daily pocket-meter information shows that the negative bias is generally more severe than was reported in our work based on weekly film data only, however, the

  8. Weekly, low-dose docetaxel combined with estramustine for Japanese castration-resistant prostate cancer: its efficacy and safety profile compared with tri-weekly standard-dose treatment.

    Science.gov (United States)

    Nakai, Yasutomo; Nishimura, Kazuo; Nakayama, Masashi; Uemura, Motohide; Takayama, Hitoshi; Nonomura, Norio; Tsujimura, Akira

    2014-02-01

    We retrospectively investigated the efficacy and safety profile of weekly low-dose docetaxel (DTX) with estramustine in comparison with triweekly standard-dose DTX treatment for Japanese patients with castration-resistant prostate cancer (CRPC). Between April 2002 and January 2011, 75 CRPC patients were treated with triweekly DTX (60-75 mg/m(2) every 3 weeks) (standard-dose group), and 76 CRPC patients were treated with weekly low-dose DTX (20-30 mg/m(2) on days 2 and 9 with estramustine 560 mg on days 1-3 and 8-10) every 3 weeks (low-dose group). Prostate-specific antigen (PSA) response and progression-free and overall survival were analyzed in each group. Median serum PSA level of the standard-dose group and low-dose group was 25.0 and 35.5 ng/ml, respectively. In the standard-dose and low-dose groups, 57.8 and 65.2 % of patients, respectively, achieved a PSA decline ≥ 50 %. There was no significant difference in either median time to progression between the standard-dose group (10.0 months) and low-dose group (7.1 months) or in median duration of survival between the standard-dose group (24.2 months) and low-dose group (30.6 months). Multivariate analysis with a Cox proportional hazards regression model showed that DTX treatment protocol did not influence the risk of death. Incidences of grade 3-4 neutropenia, febrile neutropenia, and thrombocytopenia were significantly higher in the standard-dose versus low-dose group (58.7 vs. 7.9 %, 16.0 vs. 3.9 %, and 8.0 vs. 0 %, respectively). For Japanese CRPC patients, weekly low-dose DTX combined with estramustine has similar efficacy to standard-dose DTX but with fewer adverse events.

  9. Hazards and maximum permissible doses of radiation for man

    International Nuclear Information System (INIS)

    Walinder, G.

    1977-11-01

    Maximum permissible dose levels are primarely based on risks for genetic damage and cancer. The reason for this is the observation that such late effects of radiation seem to arise even after doses that are to low to give rise to acute effects. In contrast to the tumour incidence found in irradiated human populations no genetic effects of radiation have been observed in man. This does not mean that genetic effects have not been induced but that it has been impossible to find an increase or to discern them among all the congenital defects, that can not be ascribed to the irradiation. As a consequence, the radiological risk estimation has been concentrated on the hazard of malignant diseases. Tumour risks are generally expressed as excess rates of incidence and mortality per million persons per rem. These figures are, however, not obtained from direct epidemiological observations but have been calculated from such data under the assumption of a linear relationship between effect and radiation dose. This formal extrapolation of observed data involves an uncertainty which, of course, is proportionately greater for the calculated effects in the millirem range. However, although the calculated tumour risks can not be said to be founded on direct scientific evidence, there are scientific reasons to believe that the figures derived from the formal extrapolations constitute an upper limit of possible ri02050

  10. Is the maximum permissible radiation burden for the population indeed permissible

    International Nuclear Information System (INIS)

    Renesse, R.L. van.

    1975-01-01

    It is argued that legislation based on the ICRP doses will, under economical influences, lead to a situation where the population is exposed to radiation doses near the maximum permissible dose. Due to cumulative radiation effects, this will introduce unacceptable health risks. Therefore, it will be necessary to lower the legal dose limit of 170 millrem per year per person by a factor 10 to 20

  11. Maximum permissible concentration (MPC) values for spontaneously fissioning radionuclides

    International Nuclear Information System (INIS)

    Ford, M.R.; Snyder, W.S.; Dillman, L.T.; Watson, S.B.

    1976-01-01

    The radiation hazards involved in handling certain of the transuranic nuclides that exhibit spontaneous fission as a mode of decay were reaccessed using recent advances in dosimetry and metabolic modeling. Maximum permissible concentration (MPC) values in air and water for occupational exposure (168 hr/week) were calculated for 244 Pu, 246 Cm, 248 Cm, 250 Cf, 252 Cf, 254 Cf, /sup 254m/Es, 255 Es, 254 Fm, and 256 Fm. The half-lives, branching ratios, and principal modes of decay of the parent-daughter members down to a member that makes a negligible contribution to the dose are given, and all daughters that make a significant contribution to the dose to body organs following inhalation or ingestion are included in the calculations. Dose commitments for body organs are also given

  12. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours

    International Nuclear Information System (INIS)

    Fumoleau, Pierre; Trigo, Jose Manuel; Isambert, Nicolas; Sémiond, Dorothée; Gupta, Sunil; Campone, Mario

    2013-01-01

    Cabazitaxel is approved in patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing regimen. This study evaluated a weekly cabazitaxel dosing regimen. Primary objectives were to report dose-limiting toxicities (DLTs) and to determine the maximum tolerated dose (MTD). Efficacy, safety and pharmacokinetics were secondary objectives. Cabazitaxel was administered weekly (1-hour intravenous infusion at 1.5–12 mg/m2 doses) for the first 4 weeks of a 5-week cycle in patients with solid tumours. Monitoring of DLTs was used to determine the MTD and the recommended weekly dose. Thirty-one patients were enrolled. Two of six patients experienced DLTs at 12 mg/m 2 , which was declared the MTD. Gastrointestinal disorders were the most common adverse event. Eight patients developed neutropenia (three ≥ Grade 3); one occurrence of febrile neutropenia was reported. There were two partial responses (in breast cancer) and 13 patients had stable disease (median duration of 3.3 months). Increases in C max and AUC 0–t were dose proportional for the 6–12 mg/m 2 doses. The MTD of weekly cabazitaxel was 12 mg/m 2 and the recommended weekly dose was 10 mg/m 2 . The observed safety profile and antitumour activity of cabazitaxel were consistent with those observed with other taxanes in similar dosing regimens. The study was registered with ClinicalTrials.gov as http://www.clinicaltrials.gov/ct2/show/NCT01755390

  13. Sustained platelet-sparing effect of weekly low dose paclitaxel allows effective, tolerable delivery of extended dose dense weekly carboplatin in platinum resistant/refractory epithelial ovarian cancer

    Directory of Open Access Journals (Sweden)

    Blagden Sarah

    2011-07-01

    Full Text Available Abstract Background Platinum agents have shown demonstrable activity in the treatment of patients with platinum resistant, recurrent ovarian cancer when delivered in a "dose-dense" fashion. However, the development of thrombocytopenia limits the weekly administration of carboplatin to no greater than AUC 2. Paclitaxel has a well-described platelet sparing effect however its use to explicitly provide thromboprotection in the context of dose dense carboplatin has not been explored. Methods We treated seven patients with platinum resistant ovarian cancer who had previously received paclitaxel or who had developed significant peripheral neuropathy precluding the use of further full dose weekly paclitaxel. Results We were able to deliver carboplatin AUC 3 and paclitaxel 20 mg/m2 with no thrombocytopenia or worsening of neuropathic side-effects, and with good activity. Conclusions We conclude that this regimen may be feasible and active, and could be formally developed as a "platinum-focussed dose-dense scaffold" into which targeted therapies that reverse platinum resistance can be incorporated, and merits further evaluation.

  14. Potential Impact of Accelerating the Primary Dose of Rotavirus Vaccine in Infants

    OpenAIRE

    Halvorson, Elizabeth E.; Peters, Timothy R.; Snively, Beverly M.; Poehling, Katherine A.

    2012-01-01

    We estimated the potential impact of administering the first dose of rotavirus vaccine at 6 weeks (42 days of life) instead of 2 months of age, which is permissible for all U.S. vaccines recommended at 2 months of age, on rotavirus hospitalization rates. We used published data for hospitalization rates, vaccine coverage, and vaccine efficacy after one dose and assumed a two-week delay in seroconversion after vaccine administration in the United States. Administering the first dose of rotaviru...

  15. On determination of limit of effective dose for living bodies concerning control areas of nuclear law material mines

    International Nuclear Information System (INIS)

    1977-01-01

    The Notification is based on the prescriptions of the Safety Regulation of Metal Mines. The permissible levels of effective dose for living bodies and others concerning control areas are defined as follows: the effective dose of external radiation for living bodies should be less than 30 millirems in a consecutive week; the concentrations of radioactive substances in the air or in the water possibly drunk by men are specified respectively for Rn 220, Rn 222, Th and U; the densities of such substances on the surfaces of things contaminated by such elements in refineries should be less than 10 micro-micro-curies per centi-meter 2 , etc. Such permissible levels in residential quarters are defined as follows: the effective dose of external radiation for living bodies should be less than 10 millirems in a consecutive week; the concentrations of radioactive substances in the air or in the water possibly drunk by men are specified respectively for Rn 220, Rn 222, Th and U, etc. The permissible exposure dose for miners working regularly in control areas should be less than 3 rems in three consecutive months. The permissible limit of accumulated dose should be less than the figure, in the unit of rem, which is obtained by multiplying the figure of age of the miner concerned minus 18 by 5. (Okada, K.)

  16. Effect of weekly high-dose vitamin D3 supplementation on serum cholecalciferol concentrations in pregnant women.

    Science.gov (United States)

    Dimitris, Michelle C; Perumal, Nandita; Craig-Barnes, Hayley A; Leadley, Michael; Mahmud, Abdullah A; Baqui, Abdullah H; Roth, Daniel E

    2016-04-01

    Vitamin D status is conventionally defined by the serum concentration of 25-hydroxyvitamin D. However, it has been proposed that the serum cholecalciferol concentration (D3) also determines functional vitamin D sufficiency. The objective of this study was to describe the effect of weekly high-dose vitamin D3 supplementation on inter-dose serum D3 in pregnant women. We conducted a sub-study of a completed randomized double-blind placebo-controlled trial of vitamin D3 (35,000 IU/week) supplementation in late pregnancy (AViDD trial) in Dhaka, Bangladesh. This study included pregnant women enrolled at 26-29 weeks gestation who fully adhered to the prenatal supplement intervention for ≥8 consecutive weeks and for whom serum samples were available for D3 analysis (n=65). Serum D3 was uniformly low at enrolment. Mean D3 increased and was maximal at 1 day after vitamin D dose administration (152.09nmol/L, SD 25.11nmol/L) and remained significantly higher in VitD vs. Pl at 7 days (29.59nmol/L vs. 1.92nmol/L, p=0.007). Daily average of the group mean D3 during the week following dosing was 66.97nmol/L in VitD versus 2.13nmol/L in Pl. In conclusion, serum D3 remained significantly elevated throughout the week following ≥8 consecutive weekly doses of 35,000 IU D3 in pregnant women. However, the clinically significant minimum threshold of serum D3 remains to be established. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Five-Week Outcomes From a Dosing Trial of Therapeutic Massage for Chronic Neck Pain

    Science.gov (United States)

    Sherman, Karen J.; Cook, Andrea J.; Wellman, Robert D.; Hawkes, Rene J.; Kahn, Janet R.; Deyo, Richard A.; Cherkin, Daniel C.

    2014-01-01

    PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0–50 points) and pain intensity with a numerical rating scale (range, 0–10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment. PMID:24615306

  18. Radiation therapy and concurrent fixed dose amifostine with escalating doses of twice-weekly gemcitabine in advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Yavuz, A. Aydin; Aydin, Fazil; Yavuz, Melek N.; Ilis, Esra; Ozdemir, Feyyaz

    2001-01-01

    Purpose: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of twice-weekly gemcitabine (TW-G) when administered in conjunction with fixed dose amifostine (A) during external radiotherapy (RT) in patients with advanced pancreatic cancer. Methods and Materials: Ten patients with previously untreated, locally advanced, or asymptomatic-metastatic pancreatic adenocarcinoma were enrolled in this study. RT was delivered by using the standard four-field technique (1.8 Gy daily fractions, 45 Gy followed by a boost of 5.4 Gy, in 5-1/2 weeks). The starting dose of TW-G was 60 mg/m 2 (i.v., 30-min infusion), which is equal to the upper limit of previously reported MTD of TW-G when given without A during RT. A was given just before the TW-G, at a fixed dose of 340 mg/m 2 (i.v., rapid infusion). TW-G doses were escalated by 30-mg/m 2 increments in successive cohorts of 3 to 6 additional patients until DLT was observed. Toxicities were graded using the Radiation Therapy Oncology Group and National Cancer Institute Common Toxicity Criteria, version 2.0. Results: In general, therapy was well tolerated in patients treated at the first two dose levels of 60 mg/m 2 and 90 mg/m 2 . The DLT of TW-G given in conjunction with A during RT were neutropenia, thrombocytopenia, and nausea/vomiting at the dose level of 120 mg/m 2 . Of the 10 patients eligible for a median follow-up of 10 months, 5 remain alive; 1 complete responder, 3 partial responders, and 1 with stable disease. Conclusion: A dose of TW-G at a level of 90 mg/m 2 produced tolerable toxicity and it may possess significant activity when delivered in conjunction with 340 mg/m 2 dose of A during RT of the upper abdomen. Due to the higher MTD of TW-G seen in our study, we consider that the A supplementation may optimize the therapeutic index of TW-G-based chemoradiotherapy protocols in patients with pancreatic carcinoma

  19. Study on a 4-Week Recovery Test of Sweet Bee Venom after a 13-Week, Repeated, Intramuscular Dose Toxicity Test in Sprague-Dawley Rats

    Directory of Open Access Journals (Sweden)

    Chungsan Lim

    2014-06-01

    Full Text Available Objectives:This study was performed to check for reversibility in the changes induced by a 13-week, repeated, dose toxicity test of Sweet Bee Venom (SBV in Sprague-Dawley (SD rats. Methods:Fifteen male and 15 female SD rats were treated with 0.28 mg/kg of SBV (high-dosage group and the same numbers of male and female SD rats were treated with 0.2 mL/kg of normal saline (control group for 13 weeks. We selected five male and five female SD rats from the high-dosage group and the same numbers of male and female SD rats from the control group, and we observed these rats for four weeks. We conducted body-weight measurements, ophthalmic examinations, urinalyses and hematology, biochemistry, histology tests. Results:(1 Hyperemia and movement disorder were observed in the 13-week, repeated, dose toxicity test, but these symptoms were not observed during the recovery period. (2 The rats in the high-dose group showed no significant changes in weight compared to the control group. (3 No significant differences in the ophthalmic parameters, urine analyses, complete blood cell counts (CBCs, and biochemistry were observed among the recovery groups. (4 No changes in organ weights were observed during the recovery period. (5 Histological examination of the thigh muscle indicated cell infiltration, inflammation, degeneration, necrosis of muscle fiber, and fibrosis during the treatment period, but these changes were not observed during the recovery period. The fatty liver change that was observed during the toxicity test was not observed during the recovery period. No other organ abnormalities were observed. Conclusion:The changes that occurred during the 13-week, repeated, dose toxicity test are reversible, and SBV can be safely used as a treatment modality.

  20. Experimental study, in rat wistar, of cadmium distribution and elimination as a function of administration route. Cadmium 109 maximum permissible concentration

    International Nuclear Information System (INIS)

    Valero, Marc.

    1979-01-01

    The absorption and the elimination of cadmium have been investigated in rats wistar after oral administration or after inhalation. Before studying gastro-intestinal absorption, it appeared necessary to precise acute toxicity of orally administred cadmium. The distribution of cadmium within organes was determined following a single or multiple oral doses, and we specially studied retention of a Cd dose ingested after several weeks of treatment with Cd-Acetate. Pulmonary and gastro-intestinal absorption of cadmium after ihalation of Cd-microparticles were studied. Data obtained from these studies on rats and extrapolated to man were used to calculate mximum permissible concentration (M.P.C.) of Cd-109 in water and in air [fr

  1. Single and 2-week repeated intravenous dose toxicity studies of disodium mercaptoundecahydro-closo-dodecaborate in rats

    Energy Technology Data Exchange (ETDEWEB)

    Itoh, Fumio; Yabuuchi, Kazuya; Ohno, Kouji; Muraoka, Yoshihiro [Shionogi and Co. Ltd., Toyonaka, Osaka (Japan). Developmental Research Lab.; Ikeuchi, Isao

    1998-10-01

    Disodium mercaptoundecahydro-closo-dodecaborate (BSH) is a boron compound used in Boron Neutron Capture Therapy for malignant brain tumors. Intravenous single and 2-week repeated dose toxicity studies of BSH were performed in Sprague-Dawley rats. In the single-dose study, BSH was administered at doses of 100, 300 or 600 mg/kg. Death occurred within 10 min (acute type) or from 5 hr to 2 days (delayed type) after dosing in the 600 mg/kg group. No differences in mortality by sex and dosing speed were observed. Major causes of death were considered to be circulatory disorder in acute death and renal injury in delayed death. The renal injury was observed in the 300 and 600 mg/kg groups. In the 2-week repeated dose study, BSH was administered at doses of 30, 100 or 300 mg/kg/day for 14 days. Body weight gain was suppressed in the 100 and 300 mg/kg groups. One male in the 300 mg/kg group died due to renal and pulmonary lesions at day 8. Slight anemia was observed in the 300 mg/kg group. Pathologically, the kidney showed tubular regeneration with increase of weight in the 300 mg/kg. From these results, the NOAEL of BSH is 30 mg/kg/day. (author)

  2. A 4-Week Repeated-Dose Oral Toxicity Study of Bojungikgi-Tang in Crl:CD Sprague Dawley Rats

    Directory of Open Access Journals (Sweden)

    Sae-Rom Yoo

    2017-01-01

    Full Text Available Traditional herbal medicines have been used for centuries in Asian countries. However, recent studies have led to increasing concerns about the safety and toxicity of herbal prescriptions. Bojungikgi-tang (BJIGT, a herbal decoction, has been used in Korea to improve physical strength. To establish the safety information, BJIGT water extract was evaluated in a 4-week repeated-dose oral toxicity test in Crl:CD Sprague Dawley rats. BJIGT was orally administered in daily doses of 0, 500, 1000, and 2000 mg/kg/day for 4 weeks via oral gavage in male and female rats. We examined the mortality, clinical signs, body weight change, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters. No significant changes were observed in mortality, clinical sings, body weight, food intake, organ weights, hematology, serum biochemistry, and urinalysis parameters between the control group and the BJIGT-treated groups in the rats of both sexes. The results indicate that BJIGT did not induce toxic effects at a dose level up to 2000 mg/kg in rats. Thus, this concentration is considered the nonobservable effect dose in rats and is appropriate for a 13-week subchronic toxicity study.

  3. Weekly dose-dense paclitaxel and carboplatin in recurrent ovarian carcinoma: A phase II trial

    International Nuclear Information System (INIS)

    Shawky, H.; Tawfik, H.; Hewidy, M.

    2014-01-01

    Purpose: The aim of this study was to investigate efficacy and toxicity of the dose-dense weekly paclitaxel (T) and carboplatin (C) in the management of platinum-resistant/sensitive recurrent epithelial ovarian cancer (EOC) previously treated with 3 weekly paclitaxel/carboplatin. Methods: Thirty two patients with recurrent EOC who had received 3 weekly TC before were enrolled. Nine patients relapsed within 6 months (platinum-resistant), 13 patients relapsed after 12 months (platinum-sensitive) and in 10 patients recurrence occurred between 6 and 12 months (intermediate platinum-sensitive). Weekly (T) at a dose of 80 mg/m2, followed by weekly (C) AUC 2 on day 1, 8, and 15 of a 28-day cycle for 6 planned cycles were administrated. End-points were overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity. Results: The ORR was 62.5%. For the platinum-resistant, intermediate platinum-sensitive and platinum-sensitive patients the ORR was 44.4% (4/9), 60% (6/10) and 76.9% (10/13), respectively, and 1 (11.1%), 2 (20%) and 5 (38.46%) patients, respectively had CR. PFS was 9.1 months (6.13, 9.1 and 12.17 months, for the 3 groups, respectively) (P < 0.001). OS was 14 months (9.17, 15.2, and 19.23 months, for the 3 groups, respectively) (P < 0.001). Treatment-related adverse events were manageable with only 1 patient (3.1%) suffering from grade 4 neutropenia. Grade 3 hematological and non-hematological toxicities were neutropenia in 8 (25%), and peripheral neuropathy in 4 (12.5%) patients, respectively. Conclusion: Weekly TC is active and well-tolerated in platinum-resistant and platinum-sensitive patients with recurrent EOC previously treated with TC given every 3 weeks

  4. [Toxicity studies of landiolol hydrochloride (ONO-1101) (2). 4-week repeated dose intravenous toxicity study in rats with 4-week recovery test].

    Science.gov (United States)

    Yamaguchi, K; Yanagi, H; Shimizu, K; Sakai, M; Nishibata, K; Oida, H; Shinomiya, K; Suzuki, Y; Yonezawa, H; Fujita, T

    1997-12-01

    4-week repeated dose toxicity study with 4-week recovery test of landiolol hydrochloride (ONO-1101), a novel ultra short acting beta-blocker, was conducted in Sprague-Dawley (SD) rats. ONO-1101 was administered intravenously to rats of both sexes at a dose level of 0 (control), 12.5, 25, 50 or 100 mg/kg/day. In the 100 mg/kg/day group, bradypnea or dyspnea was seen in all animals, pale in ear, eye and foot, tremor, reddish lacrimation and loss of righting reflex were also observed in some animals right after administration, and then those signs disappeared within 1 min after administration. During the treatment period, 3/20 animals of each sex in the 100 mg/kg/day showed clonic convulsion and died within 2 min after administration. No clinical changes were seen in the 50 mg/kg/day group or lower. Histopathological findings showed atrophy of the submaxillary gland in females and vessel-wall thickening and perivascular fibrosis of the injection site (tail) in both sexes at 100 mg/kg/day, however those changes were reversible. ONO-1101 did not effect on body weight, food consumption, ophthalmology, urinalysis, hematology, blood chemistry, organ weights or necropsy at any doses. These results indicate that the no-adverse-effect level of ONO-1101 in rats is 50 mg/kg/day for both sexes in this study.

  5. Double strand break induction and kinetics indicate preserved hypersensitivity in keratinocytes to subtherapeutic doses for 7weeks of radiotherapy.

    Science.gov (United States)

    Qvarnström, Fredrik; Simonsson, Martin; Nyman, Jan; Hermansson, Ingegerd; Book, Majlis; Johansson, Karl-Axel; Turesson, Ingela

    2017-01-01

    Previously we reported that hyper-radiosensitivity (HRS) was evidenced by quantifying DNA double strand break (DSB) foci in epidermis biopsies collected after delivering radiotherapeutic one and five dose fractions. The aim of this study was to determine whether HRS was preserved throughout a 7-week radiotherapy treatment, and also to examine the rate of foci decline and foci persistence between dose fractions. 42 patients with prostate cancer received 7-week fractionated radiotherapy treatment (RT) with daily dose fractions of 0.05-1.10Gy to the skin. Before RT, and at several times throughout treatment, skin biopsies (n=452) were collected at 30min, and 2, 3, 24, and 72h after dose fractions. DSB-foci markers, γH2AX and 53BP1, were labelled in epidermal keratinocytes with immunofluorescence and immunohistochemical staining. Foci were counted both with digital image analysis and manually. HRS in keratinocytes was evidenced by the dose-response relationships of DSB foci, observed throughout the treatment course, independent of sampling time and quantification method. Foci observed at 24h after dose fractions indicated considerable DSB persistence. Accordingly, foci significantly accumulated after 5 consecutive dose fractions. For doses below 0.3Gy, persistent foci could be observed even at 72h after damage induction. A comparison of γH2AX and 53BP1 quantifications in double-stained biopsies showed similar HRS dose-response relationships. These results represented the first evidence of preserved HRS, assessed by γH2AX- and 53BP1-labelled DSB foci, throughout a 7-week treatment course with daily repeated subtherapeutic dose fractions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. SU-E-J-229: Quantitative Assessment for Timely Adaptive Re-Planning Using Weekly Dose Monitoring for Head and Neck Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Shang, Q; Liu, H; Greskovich, J; Koyfman, S; Xia, P [Cleveland Clinic, Cleveland, OH (United States); Li, Z [Cleveland Clinic, Cleveland, OH (United States); the 6th people' s hospital of Shanghai Jiaotong University, Shanghai, Shanghai (China)

    2014-06-01

    Purpose: For patients with head and neck (HN) cancer, mid-course adaptive radiation therapy (ART) is a common practice in our institution to accommodate anatomic changes. The aim of the study is to evaluate whether dose re-calculation on weekly verification images can provide quantitative assessment for timely adaptive re-planning with daily image-guided intensity modulated radiotherapy (IMRT). Methods: We retrospectively selected sixty daily verification images acquired on CT-on-rail/CBCT from ten HN patients. These image sets were typically a week apart. Among these patients, six patients received a mid-course ART. Contours of the tumors and organ-at-risks (OARs) were manually delineated by a physician on each verification CT. After placing the treatment iso-center on the verification CTs according to the recorded clinical shifts, daily dose was re-calculated with the same beam configuration as the original plan. For the purpose of this study, electron densities for both verification CTs and planning CTs were set to 1.0 g/cm3. Results: Two patients had D99 of the CTV < 97% of the planned dose for more than three fractions due to remarkable tumor volume shrinkages. D-max of the spinal cord exceeded a tolerance of 45 Gy for four fractions in additional two patients. D-mean of the parotid increased within 25% of the planned value. D-max of the brainstem and D-mean of the oral cavity did not show significant variation. If the re-planning criteria included D99 of the CTV < 97% of the planned dose and D-max of the spinal cord > 45 Gy, two out ten patients required ART at week 2 and two patients required ART at week 3, respectively. Conclusion: Weekly dose monitoring with re-calculation on verification images can provide quantitative dose guidance for timely adaptive re-planning. Future work will include accumulative dose analysis for the decision of adaptive re-planning. The study is supported in part by Siemens Medical Solutions.

  7. Collaborative work to evaluate toxicity on male reproductive organs by repeated dose studies in rats 22). Effects of 2- and 4-week administration of theobromine on the testis.

    Science.gov (United States)

    Funabashi, H; Fujioka, M; Kohchi, M; Tateishi, Y; Matsuoka, N

    2000-10-01

    The effects of theobromine, a xanthine derivative, on the testis were compared between rats dosed for 2 and 4 weeks to determine whether a 2-week dosing period is long enough to detect toxicity. Theobromine was administered orally to male Sprague-Dawley rats at dose levels of 250 and 500 mg/kg for 2 weeks starting at the age of 6 or 8 weeks, and for 4 weeks from the age of 6 weeks. Histopathological examination of reproductive organs revealed toxic findings in the testis at 500 mg/kg after 2 weeks of dosing at both ages, and at 250 and 500 mg/kg after 4 weeks of dosing. The primary findings were degeneration/necrosis and desquamation of spermatids and spermatocytes, vacuolization of seminiferous tubules, and multinucleated giant cell formation. These findings were present mainly in stages I-VI and XII-XIV. From these results, it is concluded that the toxic effects of theobromine on the testis can be detected by repeated dosing for 2 weeks as well as for 4 weeks.

  8. Regulatory Forum Opinion Piece*: Retrospective Evaluation of Doses in the 26-week Tg.rasH2 Mice Carcinogenicity Studies: Recommendation to Eliminate High Doses at Maximum Tolerated Dose in Future Studies. A Response to the Counterpoints.

    Science.gov (United States)

    Paranjpe, Madhav G; Denton, Melissa D; Vidmar, Tom J; Elbekai, Reem H

    2016-01-01

    We recently conducted a retrospective analysis of data collected from 29 Tg.rasH2 carcinogenicity studies conducted at our facility to determine how successful was the strategy of choosing the high dose of the 26-week studies based on an estimated maximum tolerated dose (MTD). As a result of our publication, 2 counterviews were expressed. Both counterviews illustrate very valid points in their interpretation of our data. In this article, we would like to highlight clarifications based on several points and issues they have raised in their papers, namely, the dose-level selection, determining if MTD was exceeded in 26-week studies, and a discussion on the number of dose groups to be used in the studies. © The Author(s) 2015.

  9. Phase I trial of concurrent chemoradiotherapy for laryngeal and hypopharyngeal cancers with bi-weekly docetaxel

    International Nuclear Information System (INIS)

    Yoshida, Tomoyuki; Nakamura, Kazuhiro; Simizu, Shigetaka

    2005-01-01

    Docetaxel (DOC) has radiation-sensitizing effects because it synchronizes with the most radiation-sensitive G2/M phase of the cell cycle. From the results of concurrent radiotherapy with weekly DOC administrations in a phase I trial, dose-limiting toxicity (DLT) was mucositis and the recommended dose was 10 mg/m 2 , but the administration schedule was a problem. We planned concurrent radiation therapy in a bi-weekly DOC phase I trial to improve the larynx preservation rate and to determine which schedule and dosage of DOC would yield its inherent cytotoxic effects. We decided the maximum tolerated dose (MTD) and DLT to serve as an index of the appearance of adverse events. Patients with stage II or stage III T2N1 hypopharyngeal cancer or stage II or III laryngeal cancer were included in this study. DOC was administered on the days of initiation of bi-weekly radiation (day 1, day 15, day 29). Radiation was given (2 Gy/day: 5 days per week) for a total of 30 Fr, with a total of 60 Gy. The starting dose of DOC was 30 mg/m 2 (level 1) and the dosage was raised by 5 mg/m 2 at each level. DLT was observed due to mucositis and neutropenia at 40 mg/m 2 (level 3), the MTD was 40 mg/m 2 and the recommended dose (RD) was 35 mg/m 2 . Especially in hypopharyngeal cancer of Grade 3 or more, mucositis appeared, with swallowing difficulty in cases with a wide range of irradiation. At dosages of 35 mg/m 2 , the effectiveness was favorable and this was the suitable dosage recommended for the subsequent phase II trial. This clinical study was performed with permission of our IRB (Institutional Review Board). (author)

  10. A short 2 week dose titration regimen reduces the severity of flu-like symptoms with initial interferon gamma-1b treatment.

    Science.gov (United States)

    Devane, John G; Martin, Mary L; Matson, Mark A

    2014-06-01

    Flu-like symptoms (FLS) are commonly experienced by patients receiving interferon gamma-1b which may cause discontinuation or disruption of dosing during initial therapy or on re-initiation following a break in therapy. In contrast to Type I interferons, the impact of dose-titration on FLS has not been reported and is not a practice described or included in the approved prescribing information for interferon gamma-1b.The objective of this study was to assess the effect of a 2 week titration regimen on the severity of FLS during the initial 3 weeks of therapy with three times weekly subcutaneous injections of interferon gamma-1b. Healthy men and women were randomized into a double-blind, two-period, crossover study. Each study period was 3 weeks in duration and there was a minimum 15 day washout between treatment periods. Two treatment regimens were compared: No Titration dosing (full 50 mcg/m(2) subcutaneously [s.c.] three times weekly for 3 weeks) and Titration (15 mcg/m(2) s.c. three times weekly during week 1, 30 mcg/m(2) s.c. three times weekly during week 2 followed by the full dose of 50 mcg/m(2) s.c. three times weekly during week 3). Subjects remained in the clinic for at least 12 hours following each injection. FLS was based on a composite score for fever, chills, tiredness and muscle aches assessed at baseline and 4, 8 and 12 hours following each injection. Acetaminophen was allowed at the discretion of the PI. The primary endpoint was the change from baseline in FLS severity at 8 hours averaged over the 3 weeks of treatment. Additional endpoints included FLS at 4 and 12 hours, individual flu-like symptoms, rates of discontinuation, incidence of FLS and acetaminophen use. NCT 01929382. Of the 40 subjects randomized, there were 15 (37.5%) discontinuations. Titration resulted in a significant reduction in FLS severity at 8 hours (p = 0.023) averaged over the 3 week treatment period. The difference in 3 week FLS severity reflects differences

  11. Dose rate effect from the relationship between ICRU rectal dose and local control rate in intracavitary radiotherapy for carcinoma of the uterine cervix. Six fraction HDR and three-fraction LDR in three weeks

    International Nuclear Information System (INIS)

    Jingu, Kenichi; Akita, Yuzou; Ohmagari, Jyunichi

    2001-01-01

    The dose rate effect, low dose rate radiotherapy (LDR)/high dose rate radiotherapy (HDR), was calculated using the isoeffect ICRU rectal dose by intracavitary radiotherapy (ICRT) for uterine cervix cancer. The subjects analyzed consisted of 78 LDR and 74 HDR patients whose ICRU rectal dose could be calculated and whose local control as stage II/III cases could be evaluated. The point A dose in ICRT was 45-55 Gy/3 fractions/3 weeks for LDR and 30 Gy/6 fractions/3 weeks for HDR. The dose effect relationships associated with local control at each whole pelvis external radiation dose were calculated using the double integration method and Probit analysis, and the 50% and 90% local control ICRU rectal doses were calculated from this relationship. Finally, the dose rate effect LDR/HDR was determined from 50% and 90% local control doses. The dose rate effect calculated from the 50% local control dose was 1.24 and that from the 90% local control dose was 1.14. (author)

  12. Time-Dependent Kinetics of Tretinoin in Chronic Myelogenous Leukaemia during Intermittent Dose Scheduling: 1 Week On/1 Week Off.

    Science.gov (United States)

    Regazzi, M B; Russo, D; Iacona, I; Sacchi, S; Visani, G; Lazzarino, M; Avvisati, G; Pelicci, P G; Dastoli, G; Grandi, C; Spreafico, S; Grattoni, R; Galieni, P; Rupoli, S; Maiolo, A M; Guerra, E; Liberati, A M

    1998-01-01

    This study investigated the pharmacokinetics of tretinoin during alternating cycles of 1 week of tretinoin treatment and 1 week drug-free in patients with Ph1+ chronic myelogenous leukaemia (CML) in the chronic phase. Eighteen patients with CML were treated with tretinoin 80 mg/m(2)/day (in two divided doses) for 7 consecutive days every other week (one cycle = 1 week on/1 week off). Body systemic exposure to tretinoin as determined by the area under the plasma concentration-time curve (AUC) decreased significantly during the first week of drug administration, from (mean +/- SD) 678.3 +/- 498.1 to 258.7 +/- 272.4 microg/L.h. In about 40% of the patients the decline in plasma concentrations was >/=80%, while 17% of the population did not experience any decline. On day 7 of cycle 1, the mean apparent oral clearance (CL/F) was 2.6 times the corresponding value on day 1. After 1 week without tretinoin, the mean AUC on day 1 of cycle 2 was lower (down 15%) but not statistically different from the corresponding value observed on day 1 of cycle 1; 62% of patients showed an increase in the AUC, which was 40% higher than the corresponding value on day 7 of cycle 1. On day 1 of cycle 6, the AUC and CL/F of tretinoin during a dosage interval were not statistically different from those observed on day 1 of cycle 1 and cycle 2. On all occasions the peak plasma concentration (C(max)) was strongly correlated to the corresponding AUC. No significant change in the time to observed C(max) (t(max)) and in the elimination half-life (t((1/2))) was observed during the whole study. These results confirmed that the metabolism of tretinoin is rapidly up-regulated in CML patients, with significant declines in plasma drug exposure during the first week of drug administration. After tretinoin was discontinued, a return to the noninduced state followed a mean time-cycle similar to the induction. The strong decrease in the apparent oral drug clearance and the absence of significant variations

  13. Permissive cytomegalovirus infection of primary villous term and first trimester trophoblasts.

    Science.gov (United States)

    Hemmings, D G; Kilani, R; Nykiforuk, C; Preiksaitis, J; Guilbert, L J

    1998-06-01

    Forty percent of women with primary cytomegalovirus (CMV) infections during pregnancy infect their fetuses with complications for the baby varying from mild to severe. How CMV crosses the syncytiotrophoblast, the barrier between maternal blood and fetal tissue in the villous placenta, is unknown. Virus may cross by infection of maternal cells that pass through physical breaches in the syncytiotrophoblast or by direct infection of the syncytiotrophoblast, with subsequent transmission to underlying fetal placental cells. In this study, we show that pure (>99.99%), long-term and healthy (>3 weeks) cultures of syncytiotrophoblasts are permissively infected with CMV. Greater than 99% of infectious progeny virus remained cell associated throughout culture periods up to 3 weeks. Infection of term trophoblasts required a higher virus inoculum, was less efficient, and progressed more slowly than parallel infections of placental and human embryonic lung fibroblasts. Three laboratory strains (AD169, Towne, and Davis) and a clinical isolate from a congenitally infected infant all permissively infected trophoblasts, although infection efficiencies varied. The infection of first trimester syncytiotrophoblasts with strain AD169 occurred at higher frequency and progressed more rapidly than infection of term cells but less efficiently and rapidly than infection of fibroblasts. These results show that villous syncytiotrophoblasts can be permissively infected by CMV but that the infection requires high virus titers and proceeds slowly and that progeny virus remains predominantly cell associated.

  14. Targeted ultraviolet B phototherapy in vitiligo: A comparison between once-weekly and twice-weekly treatment regimens

    Directory of Open Access Journals (Sweden)

    Imran Majid

    2015-01-01

    Full Text Available Background: Targeted ultraviolet B (T-UVB phototherapy in vitiligo is usually administered twice or thrice a week on non-consecutive days. It is difficult for many patients to adhere to this regimen, forcing them to discontinue treatment. Aim: The study aimed to compare the efficacy of twice-weekly and once-weekly targeted ultraviolet B phototherapy regimens in vitiligo. Methods: Sixty patients with non-segmental vitiligo on the face, neck or trunk were divided into two groups of 30 patients each. The patients in group A received targeted ultraviolet B twice weekly, while those in group B received targeted ultraviolet B once weekly. Repigmentation was monitored and graded as excellent (≥75% repigmentation, good (50−74% repigmentation and poor (<50% repigmentation. The extent of repigmentation at each body site (primary outcome measure, the number of doses required for initiation of pigmentation, and the cumulative dose of targeted ultraviolet B administered was calculated and compared between both groups. Results: A total of 90 lesions (48 in the twice weeklygroup and 42 in the once weekly group were treated on the face, neck and trunk. Excellent results were obtained in 62.5% (30/48 of lesions treated twice weekly, and 64.3% (27/42 in lesions treated once weekly. The mean number of doses required for initiation of pigmentation was 4.69 in the twice weekly group, and 4.35 in the once weekly group. The patients in the twice weekly group received a mean cumulative dose of 8.26 J/cm 2, while the once weekly group received 7.69 J/cm 2. No statistically significant differences were observed between the two groups with respect to the outcome, with respect to the total repigmentation, the number of doses till onset of pigmentation, as well as the cumulative dose of targeted UVB. Conclusion: Once-weekly targeted ultraviolet B phototherapy appears to be as efficacious as the twice-weekly regimen in vitiligo.

  15. Permission Marketing and Privacy Concerns - Why Do Customers (Not) Grant Permissions?

    NARCIS (Netherlands)

    Krafft, Manfred; Arden, Christine M.; Verhoef, Peter C.

    Little is known about the influence of motivators that drive consumers to grant permission to be contacted via personalized communication. In this study, a framework is developed to investigate the effect of select drivers of consumers granting permission to receive personalized messages. The

  16. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Watson Susan B

    2011-02-01

    Full Text Available Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI in schizophrenia (Kane et al., 2010, apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140, "medium" (405 mg/4 weeks; N = 318, or "high" (300 mg/2 weeks; N = 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data, or the Cochran-Armitage test (categorical data. Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose, mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02], high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose, fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose. Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p Conclusions Analyses of several safety and efficacy parameters revealed significant associations with dose of olanzapine LAI, with the highest dose generally showing greater efficacy as well as greater adverse changes in metabolic safety measures. When

  17. Application of ICRP recommendations relevant to internal dose

    International Nuclear Information System (INIS)

    Cowser, K.E.; Snyder, W.S.; Struxness, E.G.

    1969-01-01

    The intent of this paper is to review several of the basic concepts of radiation protection (with emphasis on internal dose) currently recommended by the International Commission on radiological Protection (ICRP), to summarize the assumptions and methods used in the calculation of internal dose, and to illustrate by example the practical application of the pertinent guidelines. Two broad subject areas are considered: (1) standards of radiation protection and (2) bases of internal dose estimation. Topics discussed within the framework of radiation protection standards include maximum permissible dose, categories of radiation exposure, maximum permissible dose commitment, simultaneous internal and external exposure, multiple organ exposure, and size of the exposed group. Discussion of internal dose estimation is limited to selected items that include the body burden of radionuclides and the calculation of absorbed dose, the dose equivalent, the derivation of maximum permissible concentration (MPC), the relationship of stable element intake to the MPC, and short term and chronic exposure situations. (author)

  18. Application of ICRP recommendations relevant to internal dose

    Energy Technology Data Exchange (ETDEWEB)

    Cowser, K E; Snyder, W S; Struxness, E G [Health Physics Division, Oak Ridge National Laboratory, Oak Ridge, TN (United States)

    1969-07-01

    The intent of this paper is to review several of the basic concepts of radiation protection (with emphasis on internal dose) currently recommended by the International Commission on radiological Protection (ICRP), to summarize the assumptions and methods used in the calculation of internal dose, and to illustrate by example the practical application of the pertinent guidelines. Two broad subject areas are considered: (1) standards of radiation protection and (2) bases of internal dose estimation. Topics discussed within the framework of radiation protection standards include maximum permissible dose, categories of radiation exposure, maximum permissible dose commitment, simultaneous internal and external exposure, multiple organ exposure, and size of the exposed group. Discussion of internal dose estimation is limited to selected items that include the body burden of radionuclides and the calculation of absorbed dose, the dose equivalent, the derivation of maximum permissible concentration (MPC), the relationship of stable element intake to the MPC, and short term and chronic exposure situations. (author)

  19. Inter fractional dose variation during intensity-modulated radiation therapy for cervical cancer assessed by weekly CT evaluation

    International Nuclear Information System (INIS)

    Han, Youngyih; Shin, Eun Hyuk; Huh, Seung Jae; Lee, Jung Eun; Park, Won

    2006-01-01

    Purpose: To investigate the inter fractional dose variation of a small-bowel displacement system (SBDS)-assisted intensity-modulated radiation therapy (IMRT) for the treatment of cervical cancer. Methods: Four computed tomography (CT) scans were carried out in 10 patients who received radiotherapy for uterine cervical cancer. The initial CT was taken by use of the SBDS, before the beginning of radiotherapy, and 3 additional CT scans with the SBDS were done in subsequent weeks. IMRT was planned by use of the initial CT, and the subsequent images were fused with the initial CT set. Dose-volume histogram (DVH) changes of the targets (planning target volume [PTV] = clinical target volume [CTV] + 1.5 cm) and of the critical organs were evaluated after obtaining the volumes of each organ on 4 CT sets. Results: No significant differences were found in PTV volumes. Changes on the DVH of the CTVs were not significant, whereas DVH changes of the PTVs at 40% to 100% of the prescription dose level were significant (V 90% ; 2nd week: p = 0.0091, 3rd week: p = 0.0029, 4th week: p = 0.0050). The changes in the small-bowel volume included in the treatment field were significant. These were 119.5 cm 3 (range, 26.9-251.0 cm 3 ), 126 cm 3 (range, 38.3-336 cm 3 ), 161.9 cm 3 (range, 37.7-294.6 cm 3 ), and 149.1 cm 3 (range, 38.6-277.8 cm 3 ) at the 1st, 2nd, 3rd, and 4th weeks, respectively, and were significantly correlated with the DVH change in the small bowel, which were significant at the 3rd (V 80% ; p = 0.0230) and 4th (V 80% ; p = 0.0263) weeks. The bladder-volume change correlated to the large volume change (>20%) of the small-bowel volume. Conclusions: Significant DVH differences for the small bowel can result because of interfractional position variations, whereas the DVH differences of the CTV were not significant. Strict bladder-filling control and an accurate margin for the PTV, as well as image-guided position verification, are important to achieve the goal of IMRT

  20. A 12-week dose-escalating study of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese hemodialysis patients
.

    Science.gov (United States)

    Yokoyama, Keitaro; Fukagawa, Masafumi; Shigematsu, Takashi; Akiba, Takashi; Fujii, Akifumi; Odani, Motoi; Akizawa, Tadao

    2017-08-01

    To evaluate dose-escalation of etelcalcetide (ONO-5163/AMG 416), a novel, intravenous (IV), long-acting calcium-sensing receptor agonist, for treatment of secondary hyperparathyroidism (SHPT) in Japanese hemodialysis patients. In this multicenter study, IV injections of etelcalcetide (3 times a week for 12 weeks) were administered, with dose escalation every 4 weeks depending on changes in serum intact parathyroid hormone (iPTH) and corrected calcium (cCa). A total of 24 patients participated in this study. Serum iPTH was reduced in a time- and dose-dependent manner, with reductions (in pg/mL) at 12 weeks of -226.1 ± 125.3, -362.5 ± 161.5, and -412.4 ± 130.2, respectively, for maximum doses of 5, 10, and 15 mg. At the end of the treatment, 50% of patients had serum iPTH levels within the target range (60 - 240 pg/mL). Serum cCa and phosphorus were reduced in parallel with iPTH. Adverse events (AEs) occurred in 20 patients (83.3%). The most frequently observed AEs (> 10%) were either mild or moderate nasopharyngitis (29.2%), decreased serum calcium (16.7%), and vomiting (12.5%). Dose-escalated triweekly etelcalcetide was effective for SHPT in Japanese hemodialysis patients and was satisfactorily tolerated.
.

  1. Study of four week repeated dose toxic test of Sweet Bee Venom in Beagle Dogs

    Directory of Open Access Journals (Sweden)

    Jae-Seuk Park

    2010-12-01

    Full Text Available Objectives: This study was performed to analyse four week repeated dose toxicity of Sweet Bee Venom(Sweet BV extracted from the bee venom in Beagle dogs. Methods: All experiments were conducted under the regulations of Good Laboratory Practice (GLP at Biotoxtech Company, a non-clinical study authorized institution. Male and female Beagle dogs of 5-6 months old were chosen for the pilot study of four week repeated dose toxicity of Sweet BV which was administered at the level of 0.56㎎/㎏ body weight which is eighty times higher than the clinical application dosage as the high dosage, followed by 0.28 and 0.14㎎/㎏ as midium and low dosage, respectively. Equal amount of excipient(normal saline to the Sweet BV experiment groups was administered as the control group every day for four weeks. Results: 1. No mortality was witnessed in all of the experiment groups. 2. All experiment groups were appealed pain sense in the treating time compared to the control group, and hyperemia and movement disorder were observed around the area of administration in all experiment groups, and higher occurrence in the higher dosage treatment. 3. For weight measurement, Neither male nor female groups showed significant changes. 4. In the urine analysis, CBC and biochemistry didn't show any significant changes in the experiment groups compared with control group. 5. For weight measurement of organs, experiment groups didn't show any significant changes compared with control group. 6. To verify abnormalities of organs and tissues, thigh muscle which treated with Sweet BV, cerebrum, liver, lung, kidney, and spinal cords were removed and conducted histologocal observation with H-E staining. In the histologocal observation of thigh muscle, cell infiltration, inflammatory, degeneration, necrosis of muscle fiber, and fibrosis were found in both thigh tissue. And the changes were depend on the dose of Sweet BV. But another organs were not detected in any abnormalities. 7

  2. Take control of permissions in Leopard

    CERN Document Server

    Tanaka, Brian

    2009-01-01

    Permissions problems got you down? Turn to Unix expert Brian Tanaka's unique guide to the permissions in Mac OS X 10.5 Leopard that control access to your files, folders, and disks. You'll learn how to keep files private, when to set Ignore Permissions, what happens when you repair permissions, how to delete stuck files, and the best ways to solve permissions-related problems. Advanced concepts include the sticky bit, Leopard's more-important access control lists, bit masks, and symbolic versus absolute ways to set permissions. The book covers how to take control of permissions via the Finder

  3. Permissive hypercapnia and risk for brain injury and developmental impairment.

    Science.gov (United States)

    Hagen, Erika W; Sadek-Badawi, Mona; Carlton, David P; Palta, Mari

    2008-09-01

    Permissive hypercapnia is a respiratory-care strategy that is used to reduce the risk for lung injury. The goal of this study was to evaluate whether permissive hypercapnia is associated with higher risk for intraventricular hemorrhage and early childhood behavioral and functional problems than normocapnia among very low birth weight infants. Very low birth weight infants from a statewide cohort were eligible for this study when they were born at <32 weeks' gestational age and survived at least 24 hours. Infants were classified as receiving a permissive hypercapnia, normocapnia, or unclassifiable respiratory strategy during the first 24 hours after birth according to an algorithm based on Pco(2) values and respiratory-treatment decisions that were abstracted from medical charts. Intraventricular hemorrhage diagnosis was also abstracted from the medical chart. Behavioral and functional outcomes were assessed by parent interview at 2 to 3 years. Logistic regression was used to evaluate the relationship between intraventricular hemorrhage and respiratory strategy; ordinary linear regression was used to evaluate differences in behavior and function scores between children by respiratory strategy. Infants who received a permissive hypercapnia strategy were not more likely to have intraventricular hemorrhage than those with normocapnia. There were no differences in any of the behavioral or functional scores among children according to respiratory strategy. There was a significant interaction between care strategy and 1-minute Apgar score, indicating that infants with lower Apgar scores may be at higher risk for intraventricular hemorrhage with permissive hypercapnia. This study suggests that permissive hypercapnia does not increase risk for brain injury and impairment among very low birth weight children. The interaction between respiratory strategy and Apgar score is a potential worrisome exception to this conclusion. Future research should further evaluate the effect

  4. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1): an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study to investigate the effect of once daily nitisinone on 24-h urinary homogentisic acid excretion in patients with alkaptonuria after 4 weeks of treatment.

    Science.gov (United States)

    Ranganath, Lakshminarayan R; Milan, Anna M; Hughes, Andrew T; Dutton, John J; Fitzgerald, Richard; Briggs, Michael C; Bygott, Helen; Psarelli, Eftychia E; Cox, Trevor F; Gallagher, James A; Jarvis, Jonathan C; van Kan, Christa; Hall, Anthony K; Laan, Dinny; Olsson, Birgitta; Szamosi, Johan; Rudebeck, Mattias; Kullenberg, Torbjörn; Cronlund, Arvid; Svensson, Lennart; Junestrand, Carin; Ayoob, Hana; Timmis, Oliver G; Sireau, Nicolas; Le Quan Sang, Kim-Hanh; Genovese, Federica; Braconi, Daniela; Santucci, Annalisa; Nemethova, Martina; Zatkova, Andrea; McCaffrey, Judith; Christensen, Peter; Ross, Gordon; Imrich, Richard; Rovensky, Jozef

    2016-02-01

    Alkaptonuria (AKU) is a serious genetic disease characterised by premature spondyloarthropathy. Homogentisate-lowering therapy is being investigated for AKU. Nitisinone decreases homogentisic acid (HGA) in AKU but the dose-response relationship has not been previously studied. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1) was an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study. The primary objective was to investigate the effect of different doses of nitisinone once daily on 24-h urinary HGA excretion (u-HGA24) in patients with AKU after 4 weeks of treatment. Forty patients were randomised into five groups of eight patients each, with groups receiving no treatment or 1 mg, 2 mg, 4 mg and 8 mg of nitisinone. A clear dose-response relationship was observed between nitisinone and the urinary excretion of HGA. At 4 weeks, the adjusted geometric mean u-HGA24 was 31.53 mmol, 3.26 mmol, 1.44 mmol, 0.57 mmol and 0.15 mmol for the no treatment or 1 mg, 2 mg, 4 mg and 8 mg doses, respectively. For the most efficacious dose, 8 mg daily, this corresponds to a mean reduction of u-HGA24 of 98.8% compared with baseline. An increase in tyrosine levels was seen at all doses but the dose-response relationship was less clear than the effect on HGA. Despite tyrosinaemia, there were no safety concerns and no serious adverse events were reported over the 4 weeks of nitisinone therapy. In this study in patients with AKU, nitisinone therapy decreased urinary HGA excretion to low levels in a dose-dependent manner and was well tolerated within the studied dose range. EudraCT number: 2012-005340-24. Registered at ClinicalTrials.gov: NCTO1828463. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  5. A comparison of twice-weekly MPD-PUVA and three times-weekly skin typing-PUVA regimens for the treatment of psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Buckley, D.A.; Rogers, S. [City of Dublin Skin and Cancer Hospital, Dublin (Ireland); Healy, E. [Royal Victoria Infirmary, Newcastle upon Tyne (United Kingdom)

    1995-09-01

    The most frequent PUVA treatment regimen in current use is three times weekly, using skin typing to estimate the starting dose. Recently, it was suggested that twice-weekly treatment, using the minimal phototoxic dose- (MPD) to calculate suberythmal starting doses of UVA, achieved similar clearance rates with fewer treatments and a lower cumulative UVA dose. We have carried out a trial on 83 patients, comparing twice-weekly MPD-PUVA with three times-weekly skin typing-PUVA, in order to test this hypothesis. Although clearance rates were comparable between the two regimens, there was no overall significant difference in the number of treatments or in the cumulative UVA doses at clearance. However, for patients with skin types I and II the cumulative UVA dose was significantly higher using the twice-weekly MPD regimen (70.OJ/cm{sup 2} vs. 55.8J/cm{sup 2}; P<0.05). Our results do not confirm that there is a reduction in cumulative UVA dosage with twice-weekly MPD-PUVA. (Author).

  6. A 13-week repeated dose study of three 3-monochloropropane-1,2-diol fatty acid esters in F344 rats.

    Science.gov (United States)

    Onami, Saeko; Cho, Young-Man; Toyoda, Takeshi; Mizuta, Yasuko; Yoshida, Midori; Nishikawa, Akiyoshi; Ogawa, Kumiko

    2014-04-01

    3-monochloropropane-1,2-diol (3-MCPD), a rat renal and testicular carcinogen, has been reported to occur in various foods and food ingredients as free or esterified forms. Since reports about toxicity of 3-MCPD esters are limited, we conducted a 13-week rat subchronic toxicity study of 3-MCPD esters (palmitate diester: CDP, palmitate monoester: CMP, oleate diester: CDO). We administered a carcinogenic dose (3.6 × 10(-4) mol/kg B.W./day) of 3-MCPD or these esters at equimolar concentrations and two 1/4 lower doses by gavage with olive oil as a vehicle five times a week for 13 weeks to F344 male and female rats. As a result, five out of ten 3-MCPD-treated females died from acute renal tubular necrosis, but none of the ester-treated rats. Decreased HGB was observed in all high-dose 3-MCPD fatty acid ester-treated rats, except CDO-treated males. The absolute and relative kidney weights were significantly increased in the ester-treated rats at medium and high doses. Relative liver weights were significantly increased in the esters-treated rat at high dose, except for CMP females. Significant increase in apoptotic epithelial cells in the initial segment of the epididymis of high-dose ester-treated males was also observed. The results suggested that although acute renal toxicity was lower than 3-MCPD, these three 3-MCPD fatty acid esters have the potential to exert subchronic toxicity to the rat kidneys and epididymis, to a similar degree as 3-MCPD under the present conditions. NOAELs (no-observed-adverse-effect levels) of CDP, CMP and CDO were suggested to be 14, 8 and 15 mg/kg B.W./day, respectively.

  7. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function

    DEFF Research Database (Denmark)

    Kielgast, Urd; Krarup, Thure; Holst, Jens Juul

    2011-01-01

    OBJECTIVE To investigate the effect of 4 weeks of treatment with liraglutide on insulin dose and glycemic control in type 1 diabetic patients with and without residual ß-cell function. RESEARCH DESIGN AND METHODS Ten type 1 diabetic patients with residual ß-cell function (C-peptide positive) and 19.......1]; P Treatment with liraglutide in type 1 diabetic patients reduces insulin dose with improved or unaltered glycemic control....... activity was performed before (week 0) and during (week 4) treatment. Differences in insulin dose; HbA(1c); time spent with blood glucose 10, and 3.9-9.9 mmol/L; and body weight were evaluated. RESULTS Insulin dose decreased from 0.50 ± 0.06 to 0.31 ± 0.08 units/kg per day (P

  8. Clinical and neural effects of six-week administration of oxytocin on core symptoms of autism.

    Science.gov (United States)

    Watanabe, Takamitsu; Kuroda, Miho; Kuwabara, Hitoshi; Aoki, Yuta; Iwashiro, Norichika; Tatsunobu, Natsubori; Takao, Hidemasa; Nippashi, Yasumasa; Kawakubo, Yuki; Kunimatsu, Akira; Kasai, Kiyoto; Yamasue, Hidenori

    2015-11-01

    Autism spectrum disorder is a prevalent neurodevelopmental disorder with no established pharmacological treatment for its core symptoms. Although previous literature has shown that single-dose administration of oxytocin temporally mitigates autistic social behaviours in experimental settings, it remains in dispute whether such potentially beneficial responses in laboratories can result in clinically positive effects in daily life situations, which are measurable only in long-term observations of individuals with the developmental disorder undergoing continual oxytocin administration. Here, to address this issue, we performed an exploratory, randomized, double-blind, placebo-controlled, crossover trial including 20 high-functional adult males with autism spectrum disorder. Data obtained from 18 participants who completed the trial showed that 6-week intranasal administration of oxytocin significantly reduced autism core symptoms specific to social reciprocity, which was clinically evaluated by Autism Diagnostic Observation Scale (P = 0.034, PFDR intervention were not larger than those seen in our previous single-dose intervention. These findings not only provide the evidence for clinically beneficial effects of continual oxytocin administration on the core social symptoms of autism spectrum disorder with suggesting its underlying biological mechanisms, but also highlight the necessity to seek optimal regimens of continual oxytocin treatment in future studies. © The Author (2015). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. Regulatory Forum Opinion Piece*: Retrospective Evaluation of Doses in the 26-week Tg.rasH2 Mice Carcinogenicity Studies: Recommendation to Eliminate High Doses at Maximum Tolerated Dose (MTD) in Future Studies.

    Science.gov (United States)

    Paranjpe, Madhav G; Denton, Melissa D; Vidmar, Tom J; Elbekai, Reem H

    2015-07-01

    High doses in Tg.rasH2 carcinogenicity studies are usually set at the maximum tolerated dose (MTD), although this dose selection strategy has not been critically evaluated. We analyzed the body weight gains (BWGs), mortality, and tumor response in control and treated groups of 29 Tg.rasH2 studies conducted at BioReliance. Based on our analysis, it is evident that the MTD was exceeded at the high and/or mid-doses in several studies. The incidence of tumors in high doses was lower when compared to the low and mid-doses of both sexes. Thus, we recommend that the high dose in male mice should not exceed one-half of the estimated MTD (EMTD), as it is currently chosen, and the next dose should be one-fourth of the EMTD. Because females were less sensitive to decrements in BWG, the high dose in female mice should not exceed two-third of EMTD and the next dose group should be one-third of EMTD. If needed, a third dose group should be set at one-eighth EMTD in males and one-sixth EMTD in females. In addition, for compounds that do not show toxicity in the range finding studies, a limit dose should be applied for the 26-week carcinogenicity studies. © 2014 by The Author(s).

  10. Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading

    Directory of Open Access Journals (Sweden)

    Hector Garcia-Alcala

    2015-01-01

    Full Text Available Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety of α-lipoic acid (ALA over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid for 4 weeks (phase 1. Subsequently, responders were randomized to receive ALA (600 mg qd; n=16 or to ALA withdrawal (n=17 for 16 weeks (phase 2. During phase 1, the Total Symptom Score (TSS decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p<0.05 and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p<0.05. In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid administration of ALA, subsequent treatment with ALA (600 mg qd over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier: NCT02439879.

  11. A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum.

    Science.gov (United States)

    Hale, Braden R; Owusu-Agyei, Seth; Fryauff, David J; Koram, Kwadwo A; Adjuik, Martin; Oduro, Abraham R; Prescott, W Roy; Baird, J Kevin; Nkrumah, Francis; Ritchie, Thomas L; Franke, Eileen D; Binka, Fred N; Horton, John; Hoffman, Stephen L

    2003-03-01

    Tafenoquine is a promising new 8-aminoquinoline drug that may be useful for malaria prophylaxis in nonpregnant persons with normal glucose-6-phosphate dehydrogenase (G6PD) function. A randomized, double-blind, placebo-controlled chemoprophylaxis trial was conducted with adult residents of northern Ghana to determine the minimum effective weekly dose of tafenoquine for the prevention of infection by Plasmodium falciparum. The primary end point was a positive malaria blood smear result during the 13 weeks of study drug coverage. Relative to the placebo, all 4 tafenoquine dosages demonstrated significant protection against P. falciparum infection: for 25 mg/week, protective efficacy was 32% (95% confidence interval [CI], 20%-43%); for 50 mg/week, 84% (95% CI, 75%-91%); for 100 mg/week, 87% (95% CI, 78%-93%); and for 200 mg/week, 86% (95% CI, 76%-92%). The mefloquine dosage of 250 mg/week also demonstrated significant protection against P. falciparum infection (protective efficacy, 86%; 95% CI, 72%-93%). There was little difference between study groups in the adverse events reported, and there was no evidence of a relationship between tafenoquine dosage and reports of physical complaints or the occurrence of abnormal laboratory parameters. Tafenoquine dosages of 50, 100, and 200 mg/week were safe, well tolerated, and effective against P. falciparum infection in this study population.

  12. Weekly Dose-Volume Parameters of Mucosa and Constrictor Muscles Predict the Use of Percutaneous Endoscopic Gastrostomy During Exclusive Intensity-Modulated Radiotherapy for Oropharyngeal Cancer

    International Nuclear Information System (INIS)

    Sanguineti, Giuseppe; Gunn, G. Brandon; Parker, Brent C.; Endres, Eugene J.; Zeng Jing; Fiorino, Claudio

    2011-01-01

    Purpose: To define predictors of percutaneous endoscopic gastrostomy (PEG) use during intensity-modulated radiotherapy (IMRT) for oropharyngeal cancer. Methods and Materials: Data for 59 consecutive patients treated with exclusive IMRT at a single institution were recovered. Of 59 patients, 25 were treated with hyperfractionation (78 Gy, 1.3 Gy per fraction, twice daily; 'HYPER'); and 34 of 59 were treated with a once-daily fractionation schedule (66 Gy, 2.2 Gy per fraction, or 70 Gy, 2 Gy per fraction; 'no-HYPER'). On the basis of symptoms during treatment, a PEG tube could have been placed as appropriate. A number of clinical/dosimetric factors, including the weekly dose-volume histogram of oral mucosa (OM DVHw) and weekly mean dose to constrictors and larynx, were considered. The OM DVHw of patients with and without PEG were compared to assess the most predictive dose-volume combinations. Results: Of 59 patients, 22 needed a PEG tube during treatment (for 15 of 22, ≥3 months). The best cutoff values for OM DVHw were V9.5 Gy/week 3 and V10 Gy/week 3 . At univariate analysis, fractionation, mean weekly dose to OM and superior and middle constrictors, and OM DVHw were strongly correlated with the risk of PEG use. In a stepwise multivariate logistic analysis, OM V9.5 Gy/week (≥64 vs. 3 ) was the most predictive parameter (odds ratio 30.8, 95% confidence interval 3.7-254.2, p = 0.0015), confirmed even in the no-HYPER subgroup (odds ratio 21, 95% CI 2.1 confidence interval 210.1, p = 0.01). Conclusions: The risk of PEG use is drastically reduced when OM V9.5-V10 Gy/week is 3 . These data warrant prospective validation.

  13. Permissible Delay in Payments

    Directory of Open Access Journals (Sweden)

    Yung-Fu Huang

    2007-01-01

    Full Text Available The main purpose of this paper wants to investigate the optimal retailer's lot-sizing policy with two warehouses under partially permissible delay in payments within the economic order quantity (EOQ framework. In this paper, we want to extend that fully permissible delay in payments to the supplier would offer the retailer partially permissible delay in payments. That is, the retailer must make a partial payment to the supplier when the order is received. Then the retailer must pay off the remaining balance at the end of the permissible delay period. In addition, we want to add the assumption that the retailer's storage space is limited. That is, the retailer will rent the warehouse to store these exceeding items when the order quantity is larger than retailer's storage space. Under these conditions, we model the retailer's inventory system as a cost minimization problem to determine the retailer's optimal cycle time and optimal order quantity. Three theorems are developed to efficiently determine the optimal replenishment policy for the retailer. Finally, numerical examples are given to illustrate these theorems and obtained a lot of managerial insights.

  14. Comparison of 2-Dose and 3-Dose 9-Valent Human Papillomavirus Vaccine Schedules in the United States: A Cost-effectiveness Analysis.

    Science.gov (United States)

    Laprise, Jean-François; Markowitz, Lauri E; Chesson, Harrell W; Drolet, Mélanie; Brisson, Marc

    2016-09-01

    A recent clinical trial using the 9-valent human papillomavirus virus (HPV) vaccine has shown that antibody responses after 2 doses are noninferior to those after 3 doses, suggesting that 2 and 3 doses may have comparable vaccine efficacy. We used an individual-based transmission-dynamic model to compare the population-level effectiveness and cost-effectiveness of 2- and 3-dose schedules of 9-valent HPV vaccine in the United States. Our model predicts that if 2 doses of 9-valent vaccine protect for ≥20 years, the additional benefits of a 3-dose schedule are small as compared to those of 2-dose schedules, and 2-dose schedules are likely much more cost-efficient than 3-dose schedules. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  15. Study of four weeks repeated-dose toxic test of Sweet Bee Venom in rats Original Articles

    Directory of Open Access Journals (Sweden)

    Kwon Hae-Yon

    2011-03-01

    Full Text Available Objectives: This study was performed to analyse four weeks repeated -dose toxicity of Sweet Bee Venom (SBV-pure melittin, the major component of honey bee venom in rats. Methods: All experiments were conducted under the regulations of Good Laboratory Practice (GLPat Biotoxtech Company, a non-clinical study authorized institution. Male and female rats of 5 weeks old were chosen for the pilot study of four weeks repeated-dose toxicity and was injected at the level of 0.56 mg/kg body weight (eighty times higher than the clinical application dosage as the high dosage, followed by 0.28 and 0.14 mg/kg as midium and low dosage, respectively. Equal amount of normal saline was injected as the control group every day for four weeks. Results: 1. No mortality was witnessed in all of the experiment groups. 2. All experiment groups appealed pain sense in the treating time compared to the control group, and side effects such as hyperemia and movement disorder were observed around the area of injection in all experiment groups, and the higher dosage in treatment, the higher occurrence in side effects. 3. Concerning weight measurement, neither male nor female groups showed significant changes compared to the control group. 4. Concerning to the CBC and biochemistry, all experiment groups didn't show any significant changes compared to the control group. 5. Concerning weight measurement of organs, experiment groups didn't show any significant changes compared to the control group. 6. To verify abnormalities of organs and tissues, those such as cerebellum, cerebrum, liver, lung, kidney,and spinal cords were removed and we conducted histologocal observation with H-E staining.Concerning the histologocal observation of liver tissues, some fatty changes were observed around portal vein in 0.56 mg/kg experiment group. But another organs were not detected in any abnormalities. 7. The proper high dosage of SBV for the thirteen weeks repeated test in rats may be 0.28 mg

  16. Reduced lung lesions in pigs challenged 25 weeks after the administration of a single dose of Mycoplasma hyopneumoniae vaccine at approximately 1 week of age.

    Science.gov (United States)

    Reynolds, S C; St Aubin, L B; Sabbadini, L G; Kula, J; Vogelaar, J; Runnels, P; Peters, A R

    2009-09-01

    Two independent studies assessed the duration of immunity of an inactivated adjuvanted Mycoplasma hyopneumoniae vaccine against mycoplasmal pneumonia in seronegative (study A, n=52) and seropositive (study B, n=52) pigs. The pigs were allocated randomly to treatment and were then injected with a single dose of either the vaccine or a placebo at approximately 1 week of age. Twenty-five weeks after treatment administration, the pigs were challenged with a virulent strain (LI 36, Strain 232) of M. hyopneumoniae and the extent of lung lesions consistent with mycoplasmal pneumonia was assessed 4 weeks later. In study A, the geometric mean lung lesion score (expressed as least squares mean percentages of lung lesions) was significantly (P=0.0001) lower in vaccinated (0.3%, n=20) than in control pigs (5.9%, n=24) seronegative to M. hyopneumoniae at enrolment; similarly, in study B, the extent of lung lesions was significantly reduced (P=0.0385) in seropositive vaccinated pigs (2.0%, n=22) compared to controls (4.5%, n=26). At the end of the investigation period, 4 weeks after challenge, mean antibody sample-to-positive (S/P) ratios were significantly higher both in seronegative (P=0.0012) and seropositive (P=0.0001) vaccinated pigs (mean values=0.77 and 0.81, respectively) than in controls (mean values=0.51 and 0.38, respectively).

  17. Phase I dose-escalation study of vinflunine hard capsules administered twice a day for 2 consecutive days every week in patients with advanced/metastatic solid tumors.

    Science.gov (United States)

    Calvo, E; Vermorken, J B; Hiret, S; Rodon, J; Cortes, J; Senellart, H; Van den Brande, J; Dyck, J; Pétain, A; Ferre, P; Bennouna, J

    2012-06-01

    Vinflunine is a new microtubule inhibitor of the vinca-alkaloid family. It is marketed in transitional cell carcinoma of urothelial tract as a 20 min infusion given every 3 weeks in Europe. In this phase I study, vinflunine was administered to patients with advanced malignancies as hard capsules given twice a day on days 1-2 every week, with 3 weeks cycles. Serial blood samples were collected during the first cycle for pharmacokinetic investigations. Thirty-six patients (pts) were treated at 6 dose levels 150 (3 pts), 190 (3 pts), 230 (8 pts), 300 mg/day (6 pts) and then 250 (3 pts) and 270 mg/day (13 pts). The Maximal Tolerated Dose (MTD) was reached at 300 mg/day where 2 patients out of 6 experienced a dose limiting toxicity (febrile neutropenia with diarrhea). The lower dose level of 270 mg/day was the recommended dose (RD), the toxicity profile being mainly anaemia, neutropenia, fatigue and constipation. The pharmacokinetic analysis demonstrated the adequacy of the flat-fixed dosing regimen, as no correlation between clearance of vinflunine and body surface area was evidenced. Blood concentrations and exposure increased with dose, and a pharmacokinetic accumulation was observed, which is consistent with the terminal half-life of the compounds. The inter-individual exposure variability at the RD was 35%. Repeated weekly administration of oral vinflunine is feasible and exhibits a moderate inter-individual PK variability. The MTD was achieved at 300 mg/day given for 2 consecutive days. According to the protocol rules, the RD was established at 270 mg/day.

  18. Android Multi-Level System Permission Management Approach

    OpenAIRE

    Luo, Yang; Zhang, Qixun; Shen, Qingni; Liu, Hongzhi; Wu, Zhonghai

    2017-01-01

    With the expansion of the market share occupied by the Android platform, security issues (especially application security) have become attention focus of researchers. In fact, the existing methods lack the capabilities to manage application permissions without root privilege. This study proposes a dynamic management mechanism of Android application permissions based on security policies. The paper first describes the permissions by security policies, then implementes permission checking code ...

  19. A Randomized controlled trial on safety and efficacy of single intramuscular versus staggered oral dose of 600 000IU Vitamin D in treatment of nutritional rickets.

    Science.gov (United States)

    Mondal, Krishanu; Seth, Anju; Marwaha, Raman K; Dhanwal, Dinesh; Aneja, Satinder; Singh, Ritu; Sonkar, Pitambar

    2014-06-01

    Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets. Children with nutritional rickets (age: 0.5-5 years, n = 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up. No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment. Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia

    Directory of Open Access Journals (Sweden)

    Luke Parkitny

    2017-04-01

    Full Text Available Fibromyalgia (FM is a complex, multi-symptom condition that predominantly affects women. The majority of those affected are unlikely to gain significant symptomatic control from the few treatments that are approved for FM. In this 10-week, single-blind, crossover trial we tested the immune effects of eight weeks of oral administration of low-dose naltrexone (LDN. We enrolled eight women with an average age of 46 years, symptom severity of 62 out of 100, and symptom duration of 14 years. We found that LDN was associated with reduced plasma concentrations of interleukin (IL-1β, IL-1Ra, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12p40, IL-12p70, IL-15, IL-17A, IL-27, interferon (IFN-α, transforming growth factor (TGF-α, TGF-β, tumor necrosis factor (TNF-α, and granulocyte-colony stimulating factor (G-CSF. We also found a 15% reduction of FM-associated pain and an 18% reduction in overall symptoms. The findings of this pilot trial suggest that LDN treatment in fibromyalgia is associated with a reduction of several key pro-inflammatory cytokines and symptoms. The potential role of LDN as an atypical anti-inflammatory medication should be explored further.

  1. Maximum permissible voltage of YBCO coated conductors

    Energy Technology Data Exchange (ETDEWEB)

    Wen, J.; Lin, B.; Sheng, J.; Xu, J.; Jin, Z. [Department of Electrical Engineering, Shanghai Jiao Tong University, Shanghai (China); Hong, Z., E-mail: zhiyong.hong@sjtu.edu.cn [Department of Electrical Engineering, Shanghai Jiao Tong University, Shanghai (China); Wang, D.; Zhou, H.; Shen, X.; Shen, C. [Qingpu Power Supply Company, State Grid Shanghai Municipal Electric Power Company, Shanghai (China)

    2014-06-15

    Highlights: • We examine three kinds of tapes’ maximum permissible voltage. • We examine the relationship between quenching duration and maximum permissible voltage. • Continuous I{sub c} degradations under repetitive quenching where tapes reaching maximum permissible voltage. • The relationship between maximum permissible voltage and resistance, temperature. - Abstract: Superconducting fault current limiter (SFCL) could reduce short circuit currents in electrical power system. One of the most important thing in developing SFCL is to find out the maximum permissible voltage of each limiting element. The maximum permissible voltage is defined as the maximum voltage per unit length at which the YBCO coated conductors (CC) do not suffer from critical current (I{sub c}) degradation or burnout. In this research, the time of quenching process is changed and voltage is raised until the I{sub c} degradation or burnout happens. YBCO coated conductors test in the experiment are from American superconductor (AMSC) and Shanghai Jiao Tong University (SJTU). Along with the quenching duration increasing, the maximum permissible voltage of CC decreases. When quenching duration is 100 ms, the maximum permissible of SJTU CC, 12 mm AMSC CC and 4 mm AMSC CC are 0.72 V/cm, 0.52 V/cm and 1.2 V/cm respectively. Based on the results of samples, the whole length of CCs used in the design of a SFCL can be determined.

  2. Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants.

    Science.gov (United States)

    Koertke, Heinrich; Zittermann, Armin; Wagner, Otto; Secer, Songuel; Sciangula, Alfonso; Saggau, Werner; Sack, Falk-Udo; Ennker, Jürgen; Cremer, Jochen; Musumeci, Francesco; Gummert, Jan F

    2015-06-01

    To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6-2.1 for aortic valve replacement (AVR) and 2.0-2.5 for mitral valve replacement (MVR) or double valve replacement (DVR). In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8-2.8; MVR/DVR: 2.5-3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6-2.1; MVR/DVR: 2.0-2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups. Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively (P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively (P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102-0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070-0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473-5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62-13.60; P = 0.004) for the VLT group. Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  3. Efficacy and tolerability of a high loading dose (25,000 IU weekly) vitamin D3 supplementation in obese children with vitamin D insufficiency/deficiency

    NARCIS (Netherlands)

    Radhakishun, Nalini N E; van Vliet, Mariska; Poland, Dennis C W; Weijer, Olivier; Beijnen, Jos H; Brandjes, Dees P M; Diamant, Michaela; von Rosenstiel, Ines A

    2014-01-01

    BACKGROUND: The recommended dose of vitamin D supplementation of 400 IU/day might be inadequate to treat obese children with vitamin D insufficiency. Therefore, we tested the efficacy and tolerability of a high loading dose vitamin D3 supplementation of 25,000 IU weekly in multiethnic obese

  4. Phase II study of tailored S-1 monotherapy with a 1-week interval after a 2-week dosing period in elderly patients with advanced non-small cell lung cancer.

    Science.gov (United States)

    Goto, Hisatsugu; Okano, Yoshio; Machida, Hisanori; Hatakeyama, Nobuo; Ogushi, Fumitaka; Haku, Takashi; Kanematsu, Takanori; Urata, Tomoyuki; Kakiuchi, Soji; Hanibuchi, Masaki; Sone, Saburo; Nishioka, Yasuhiko

    2018-01-01

    S-1 is an oral fluoropyrimidine that is active in the treatment of non-small cell lung cancer (NSCLC); however, an optimal treatment schedule and appropriate dose adjustments of S-1 in elderly patients have not yet been established. We conducted a phase II trial to evaluate the efficacy and safety of a 2-week S-1 monotherapy treatment followed by a 1-week interval as a first-line treatment of elderly NSCLC patients, by adjusting the dose based on the individual creatinine clearance (Ccr) and body surface area (BSA). The primary endpoint was the disease control rate. Forty patients were enrolled. The disease control and response rates were 89.5% (95% confidence interval [CI] = 79.8-99.2) and 7.9% (95% CI = 0.0-16.4), respectively. The median progression-free survival and overall survival times were 4.4 months (95% CI = 4.2-8.5) and 17.0 months (95% CI = 11.2-18.7), respectively. Neutropenia, anorexia, hyponatremia, hypokalemia, and pneumonia of grade ≥ 3 occurred in 5.0%, 7.5%, 5.0%, 2.5%, and 2.5% of patients, respectively. Among the patient-reported outcomes, most of the individual factors in the patients' quality of life, including upper intestine-related symptoms improved with the treatment, except for dyspnea, which slightly albeit continuously worsened throughout the study. In elderly patients with previously untreated advanced NSCLC, a 2-week S-1 monotherapy treatment, tailored to both the Ccr and BSA, with a 1-week interval was well tolerated and demonstrated promising efficacy. This study was registered at the University Hospital Medical Information Network (UMIN) Center (ID: UMIN000002035), Japan. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  5. Permissive hypotension in the extremely low birthweight infant with signs of good perfusion.

    LENUS (Irish Health Repository)

    Dempsey, E M

    2012-01-31

    INTRODUCTION: Many practitioners routinely treat infants whose mean arterial blood pressure in mm Hg is less than their gestational age in weeks (GA). OBJECTIVE: To assess the effectiveness of utilising a combined approach of clinical signs, metabolic acidosis and absolute blood pressure (BP) values when deciding to treat hypotension in the extremely low birthweight (ELBW) infant. METHODS: Retrospective cohort study of all live born ELBW infants admitted to our neonatal intensive care unit over a 4-year period. Patients were grouped as either normotensive (BP never less than GA), hypotensive and not treated (BPpermissive hypotension) and hypotensive treated (BPweeks). Treated patients had lower birth weight and GA, and significantly lower blood pressure at 6, 12, 18 and 24 h. Normotensive patients and patients designated as having permissive hypotension had similar outcomes. Mean blood pressure in the permissive group increased from 26 mm Hg at 6 h to 31 mm Hg at 24 h. In a logistic regression model, treated hypotension is independently associated with mortality, odds ratio 8.0 (95% CI 2.3 to 28, p<0.001). CONCLUSIONS: Blood pressure spontaneously improves in ELBW infants during the first 24 h. Infants hypotensive on GA criteria but with clinical evidence of good perfusion had as good an outcome as normotensive patients. Treated low blood pressure was associated with adverse outcome.

  6. 30 CFR 62.130 - Permissible exposure level.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Permissible exposure level. 62.130 Section 62... REGULATIONS OCCUPATIONAL NOISE EXPOSURE § 62.130 Permissible exposure level. (a) The mine operator must assure that no miner is exposed during any work shift to noise that exceeds the permissible exposure level. If...

  7. DOSE COEFFICIENTS FOR LIVER CHEMOEMBOLISATION PROCEDURES USING MONTE CARLO CODE.

    Science.gov (United States)

    Karavasilis, E; Dimitriadis, A; Gonis, H; Pappas, P; Georgiou, E; Yakoumakis, E

    2016-12-01

    The aim of the present study is the estimation of radiation burden during liver chemoembolisation procedures. Organ dose and effective dose conversion factors, normalised to dose-area product (DAP), were estimated for chemoembolisation procedures using a Monte Carlo transport code in conjunction with an adult mathematical phantom. Exposure data from 32 patients were used to determine the exposure projections for the simulations. Equivalent organ (H T ) and effective (E) doses were estimated using individual DAP values. The organs receiving the highest amount of doses during these exams were lumbar spine, liver and kidneys. The mean effective dose conversion factor was 1.4 Sv Gy -1 m -2 Dose conversion factors can be useful for patient-specific radiation burden during chemoembolisation procedures. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. Tg.rasH2 Mice and not CByB6F1 Mice Should Be Used for 28-Day Dose Range Finding Studies Prior to 26-Week Tg.rasH2 Carcinogenicity Studies.

    Science.gov (United States)

    Paranjpe, Madhav G; Belich, Jessica; Vidmar, Tom J; Elbekai, Reem H; McKeon, Marie; Brown, Caren

    Our recent retrospective analysis of data, collected from 29 Tg.rasH2 mouse carcinogenicity studies, determined how successful the strategy of choosing the high dose for the 26-week studies was based on the estimated maximum tolerated dose (EMTD) derived from earlier 28-day dose range finding (DRF) studies conducted in CByB6F1 mice. Our analysis demonstrated that the high doses applied at EMTD in the 26-week Tg.rasH2 studies failed to detect carcinogenic effects. To investigate why the dose selection process failed in the 26-week carcinogenicity studies, the initial body weights, terminal body weights, body weight gains, food consumption, and mortality from the first 4 weeks of 26-week studies with Tg.rasH2 mice were compared with 28-day DRF studies conducted with CByB6F1 mice. Both the 26-week and the earlier respective 28-day studies were conducted with the exact same vehicle, test article, and similar dose levels. The analysis of our results further emphasizes that the EMTD and subsequent lower doses, determined on the basis of the 28-day studies in CByB6F1 mice, may not be an accurate strategy for selecting appropriate dose levels for the 26-week carcinogenicity studies in Tg.rasH2 mice. Based on the analysis presented in this article, we propose that the Tg.rasH2 mice and not the CByB6F1 mice should be used in future DRF studies. The Tg.rasH2 mice demonstrate more toxicity than the CByB6F1 mice, possibly because of their smaller size compared to CByB6F1 mice. Also, the Tg.rasH2 males appear to be more sensitive than the female Tg.rasH2 mice.

  9. 12 CFR 703.14 - Permissible investments.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Permissible investments. 703.14 Section 703.14 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS INVESTMENT AND DEPOSIT ACTIVITIES § 703.14 Permissible investments. (a) Variable rate investment. A Federal...

  10. A concept of dynamic permission mechanism on android

    Science.gov (United States)

    Aron, Lukas; Hanacek, Petr

    2016-02-01

    This paper discuss the main security topic in mobile security area and this topic is protect user against the leakage of data. This work primarily contains the proposal of concept of dynamic permission mechanism for Android operating system. This mechanism deals with assignment or enforcement permissions to the application according to files that the application works with. Application has set of permissions that can use, but if the user opens confident files the application permissions should change its permission set and there should not be possible leakage of this secret data. The permissions set should be stricter according to opened confidential file or more open (without restriction) if the file is not secret file. The concept proposes the solution for protecting this data leakage. Idea covers rule that user should be avoided of change this permissions himself, but this behavior should be dynamic, automatic and independent. This proposal is mainly aimed to Android operating system, but the concept can be applied to other mobile platforms with some implementation changes.

  11. Fast neutron dose equivalent rates in heavy ion target areas

    Energy Technology Data Exchange (ETDEWEB)

    Fulmer, C.B.; Butler, H.M.; Ohnesorge, W.F.; Mosko, S.W.

    1978-01-01

    At heavy ion accelerators, personnel access to areas near the target is sometimes important for successful performance of experiments. Radiation levels determine the amount of time that can be spent in these areas without exceeding maximum permissible exposures. Inasmuch as the fast neutrons contribute the major part of the Rem dose rates in these areas, knowledge of the fast neutron levels is important for planning permissive entry to target areas. Fast neutron dose rates were measured near thick medium mass targets bombarded with beams of C, N, O, and Ne ions. beam energies ranged from 3 to 16 MeV/amu. Dose rates (mrem/h) 1 meter from the target 90 degrees from the beam direction range from approx. 0.05 at MeV/amu to approx. 50 at 16 MeV/amu. These data should be helpful in planning permissive entry to heavy ion target areas.

  12. Fast neutron dose equivalent rates in heavy ion target areas

    International Nuclear Information System (INIS)

    Fulmer, C.B.; Butler, H.M.; Ohnesorge, W.F.; Mosko, S.W.

    1978-01-01

    At heavy ion accelerators, personnel access to areas near the target is sometimes important for successful performance of experiments. Radiation levels determine the amount of time that can be spent in these areas without exceeding maximum permissible exposures. Inasmuch as the fast neutrons contribute the major part of the Rem dose rates in these areas, knowledge of the fast neutron levels is important for planning permissive entry to target areas. Fast neutron dose rates were measured near thick medium mass targets bombarded with beams of C, N, O, and Ne ions. beam energies ranged from 3 to 16 MeV/amu. Dose rates (mrem/h) 1 meter from the target 90 degrees from the beam direction range from approx. 0.05 at MeV/amu to approx. 50 at 16 MeV/amu. These data should be helpful in planning permissive entry to heavy ion target areas

  13. Contrasting amino acid profiles among permissive and non-permissive hosts of Candidatus Liberibacter asiaticus, putative causal agent of Huanglongbing.

    Directory of Open Access Journals (Sweden)

    Mamoudou Sétamou

    Full Text Available Huanglongbing is a devastating disease of citrus. In this study, a comprehensive profile of phloem sap amino acids (AA in four permissive host plants of Candidatus Liberibacter asiaticus (CLas and three non-permissive Rutaceae plants was conducted to gain a better understanding of host factors that may promote or suppress the bacterium. The AA profiles of Diaphorina citri nymphs and adults were similarly analyzed. A total of 38 unique AAs were detected in phloem sap of the various plants and D. citri samples, with phloem sap of young shoots containing more AAs and at higher concentrations than their mature counterparts. All AAs detected in phloem sap of non-permissive plants were also present in CLas -permissive hosts plus additional AAs in the latter class of plants. However, the relative composition of 18 commonly shared AAs varied between CLas -permissive hosts and non-permissive plants. Multivariate analysis with a partial least square discriminant methodology revealed a total of 12 AAs as major factors affecting CLas host status, of which seven were positively related to CLas tolerance/resistance and five positively associated with CLas susceptibility. Most of the AAs positively associated with CLas susceptibility were predominantly of the glutamate family, notably stressed-induced AAs such as arginine, GABA and proline. In contrast, AAs positively correlated with CLas tolerance/resistance were mainly of the serine family. Further analysis revealed that whereas the relative proportions of AAs positively associated with CLas susceptibility did not vary with host developmental stages, those associated with CLas tolerance/resistance increased with flush shoot maturity. Significantly, the proline-to-glycine ratio was determined to be an important discriminating factor for CLas permissivity with higher values characteristic of CLas -permissive hosts. This ratio could be exploited as a biomarker in HLB-resistance breeding programs.

  14. Lack of adverse health effects following 30-weeks of dietary exposure to acrylamide at low doses in male F344 rats

    Directory of Open Access Journals (Sweden)

    Jayadev Raju

    Full Text Available Understanding the health hazards following exposure to food-borne acrylamide, especially at low levels typified by human diets, is an ongoing food safety issue. We recently published results from a study that aimed to understand the effects of acrylamide short-term exposure at doses known to cause tumors in rodents, demonstrating that a number of key toxicological end points were altered by acrylamide exposure. Additionally, we reported that at much lower doses for 30 weeks of exposure, dietary acrylamide was ‘not a complete carcinogen’ to the colon in an organ-specific rodent carcinogenesis study but acted as a co-carcinogen along with azoxymethane (AOM, a colon-specific carcinogen. Here, we present toxicological data from a sub-set of this long-term exposure study from animals that received saline (instead of AOM. Briefly, male F344 rats were randomized to receive acrylamide at 0.5, 1.0 and 2.0 mg/kg diet (∼0.02, 0.04, and 0.09 mg/kg BW/day, respectively or no acrylamide (control, for 30 weeks; all rats were then euthanized and their tissues harvested and processed for toxicological evaluation. We report that at the doses tested, acrylamide did not cause any changes in general well-being, body weight or food intake. Similarly, acrylamide did not cause any biologically relevant change in parameters associated with immunophenotyping, serum biochemistry or hematology. Histopathology assessment of tissues showed no changes except in the testis, where non-specific mild lesions were observed in all the groups, inclusive of the controls. No neuropathological effects of acrylamide were observed in the brain and nerve tissues. Together, these results suggest that acrylamide administered to rats through the diet at low doses for 30 weeks did not cause any toxicologically relevant changes. Given that the doses of acrylamide in the current study are low and are comparable to human dietary exposure, this null-effect study provides data that

  15. On the substantion of permissible concentrations of plutonium isotopes in the water of fresh water and sea water NPP cooling reservoirs

    International Nuclear Information System (INIS)

    Grachev, M.I.; Gusev, D.I.; Stepanova, V.D.

    1985-01-01

    Substantiation of maximum permissible concentration (PC) of plutonium isotopes ( 238 Pu, 239 Pu, 240 Pu) in fresh and sea water cooling reservoirs of NPP with fast neutron reactors is given. The main criterion when calculating permissible plutonium content in water of surface reservoirs is the requirement not to exceed the established limits for radiation doses to persons resulted from water use. Data on coefficients of plutonium concentration in sea and fresh water hydrobionts are presented as well as on plutonium PC in water of fresh and sea water cooling reservoirs and bottom sediments of sea water cooling reservoirs. It is shown that doses to critical groups of population doesn't exceed potentially hazardous levels due to plutonium intake through food chains. But the calculation being carried out further should be corrected

  16. Tumor control induced by Boron Neutron Capture Therapy (BNCT) as a function of dose in an experimental model of liver metastases at 5 weeks follow-up

    International Nuclear Information System (INIS)

    Pozzi, E C C; Trivillin, V A; Colombo, L L; Monti Hughes, A; Thorp, S; Cardoso, J E; Garabalino, M A; Molinari, A J; Heber, E M; Curotto, Paula; Miller, M; Itoiz, M E; Aromando, R F; Nigg, D W; Schwint, A E

    2012-01-01

    BNCT has been proposed for the treatment of multifocal, non-resectable, bilobar colorectal liver metastases that do not respond to chemotherapy. We recently reported that BNCT mediated by boronophenylalanine (BPA) induced significant remission of experimental colorectal tumor nodules in rat liver at 3 weeks follow-up with no contributory liver toxicity (Pozzi et al.,2012). The aim of the present study was to evaluate tumor control and potential liver toxicity of BPA-BNCT at 5 weeks follow-up. Prescribed dose was retrospectively evaluated based on blood boron values, allowing for assessment of response over a range of delivered dose values (author)

  17. A CONCEPTUAL FRAMEWORK FOR MANAGING RADIATION DOSE TO PATIENTS IN DIAGNOSTIC RADIOLOGY USING REFERENCE DOSE LEVELS.

    Science.gov (United States)

    Almén, Anja; Båth, Magnus

    2016-06-01

    The overall aim of the present work was to develop a conceptual framework for managing radiation dose in diagnostic radiology with the intention to support optimisation. An optimisation process was first derived. The framework for managing radiation dose, based on the derived optimisation process, was then outlined. The outset of the optimisation process is four stages: providing equipment, establishing methodology, performing examinations and ensuring quality. The optimisation process comprises a series of activities and actions at these stages. The current system of diagnostic reference levels is an activity in the last stage, ensuring quality. The system becomes a reactive activity only to a certain extent engaging the core activity in the radiology department, performing examinations. Three reference dose levels-possible, expected and established-were assigned to the three stages in the optimisation process, excluding ensuring quality. A reasonably achievable dose range is also derived, indicating an acceptable deviation from the established dose level. A reasonable radiation dose for a single patient is within this range. The suggested framework for managing radiation dose should be regarded as one part of the optimisation process. The optimisation process constitutes a variety of complementary activities, where managing radiation dose is only one part. This emphasises the need to take a holistic approach integrating the optimisation process in different clinical activities. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. Effect of Tailored Dose-Dense Chemotherapy vs Standard 3-Weekly Adjuvant Chemotherapy on Recurrence-Free Survival Among Women With High-Risk Early Breast Cancer: A Randomized Clinical Trial.

    Science.gov (United States)

    Foukakis, Theodoros; von Minckwitz, Gunter; Bengtsson, Nils-Olof; Brandberg, Yvonne; Wallberg, Birgitta; Fornander, Tommy; Mlineritsch, Brigitte; Schmatloch, Sabine; Singer, Christian F; Steger, Günther; Egle, Daniel; Karlsson, Eva; Carlsson, Lena; Loibl, Sibylle; Untch, Michael; Hellström, Mats; Johansson, Hemming; Anderson, Harald; Malmström, Per; Gnant, Michael; Greil, Richard; Möbus, Volker; Bergh, Jonas

    2016-11-08

    Standard dosing of chemotherapy based on body surface area results in marked interpatient variation in pharmacokinetics, toxic effects, and efficacy. Whether tailored dosing can improve outcomes is unknown, as is the role of dose-dense adjuvant chemotherapy. To determine whether tailored dose-dense adjuvant chemotherapy improves the outcomes of early breast cancer compared with a standard 3-weekly chemotherapy schedule. A randomized, open-label, phase 3 trial of women aged 65 years and younger who had surgery for nonmetastatic node-positive or high-risk node-negative breast cancer at 86 sites in Sweden, Germany, and Austria between February 20, 2007, and September 14, 2011. Patients were randomized 1:1 either to 4 cycles of leukocyte nadir-based tailored and dose-dense adjuvant epirubicin and cyclophosphamide every 2 weeks followed by 4 cycles of tailored dose-dense docetaxel every 2 weeks, or to standard-interval chemotherapy with 3 cycles of fluorouracil and epirubicin-cyclophosphamide every 3 weeks followed by 3 cycles of docetaxel every 3 weeks. The primary end point was breast cancer recurrence-free survival (BCRFS). Secondary end points included 5-year event-free survival (EFS), distant disease-free survival (DDFS), overall survival (OS), and rates of grade 3 or 4 toxic effects. Among 2017 randomized patients (1006 in the tailored dose-dense group and 1011 in the control group; median [IQR] age, 51 [45-58] years; 80% with hormone receptor-positive tumors; 97% with node-positive disease), 2000 received study treatment (≥1 cycle of chemotherapy; 1001 in the tailored dose-dense group and 999 in the control group). After a median follow-up of 5.3 years (IQR, 4.5-6.1 years), 269 BCRFS events were reported, 118 in the tailored dose-dense group and 151 in the control group (HR, 0.79; 95% CI, 0.61-1.01; log-rank P = .06; 5-year BCRFS, 88.7% vs 85.0%). The tailored dose-dense group had significantly better EFS than the control group (HR, 0.79; 95% CI, 0

  19. Collaborative work on evaluation of ovarian toxicity. 13) Two- or four-week repeated dose studies and fertility study of PPAR alpha/gamma dual agonist in female rats.

    Science.gov (United States)

    Sato, Norihiro; Uchida, Keisuke; Nakajima, Mikio; Watanabe, Atsushi; Kohira, Terutomo

    2009-01-01

    The main focus of this study was to determine the optimal dosing period in a repeated dose toxicity study based on toxic effects as assessed by ovarian morphological changes. To assess morphological and functional changes induced in the ovary by a peroxisome proliferator-activated receptor (PPAR) alpha/gamma dual agonist, the compound was administered to female rats at dose levels of 0, 4, 20, and 100 mg/kg/day in a repeated dose toxicity study for 2 or 4 weeks, and from 2 weeks prior to mating to Day 7 of pregnancy in a female fertility study. In the repeated dose toxicity study, an increase in atresia of large follicles, a decrease in corpora lutea, and an increase in stromal cells were observed in the treated groups. In addition, the granulosa cell exfoliations into antrum of large follicles and corpora lutea with retained oocyte are morphological characteristics induced by this compound, and they might be related with abnormal condition of ovulation. In the female fertility study, the pregnancy rate tended to decrease in the 100 mg/kg/day group. At necropsy, decreases in the number of corpora lutea, implantations and live embryos were noted in the 20 and 100 mg/kg/day group. No changes were observed in animals given 4 mg/kg/day. These findings indicated that histopathological changes in the ovary are important endpoints for evaluation of drugs inducing ovarian damage. In conclusion, a 2-week administration period is sufficient to detect ovarian toxicity of this test compound in the repeated dose toxicity study.

  20. Using equilibrium passive dosing to maintain stable exposure concentrations of triclosan in a 6-week toxicity test

    DEFF Research Database (Denmark)

    Sobek, A.; Ribbenstedt, A.; Mustajärvi, L.

    2015-01-01

    toxicity tests. Yet, the European Commission’s criteria for chemicals’ risk assessments aim at protecting higher levels in the environment. To achieve protection of populations and ecosystems, reliable long-term ecotoxicologial tests are needed. In this study, we used equilibrium passive dosing to maintain...... stable exposure concentrations of triclosan (log Kow 4.8) in a 6-week multigeneration test with the benthic copepod Nitocra spinipes. The tests were performed in 10 mL vials casted with 1000 mg of silicone (DC 1-2577). Based on a previous pilot study, three triclosan concentrations were selected...... and tested (15 μg L-1; 30 μg L-1; 60 μg L-1) as well as a control (no triclosan). At test beginning, each vial contained 12 individuals consisting of 3 individuals from four different life stages. The test includes feeding with phytoplankton three times a week, which can lead to declining freely dissolved...

  1. Collective dose, conceptual basis and practical applications

    International Nuclear Information System (INIS)

    Bonka, H.

    1985-01-01

    In the ICRP Publications no. 22(1973) and no. 26(1977), the ICRP recommends that the maximum permissible whole-body dose by kept below the dose limits corresponding to the sum of all effective dose equivalents of the persons concerned, i.e. the collective dose. The effective dose equivalent is recommended by the ICRP for use as a new quantity for evaluating the stochastic radiation dose for individual persons. Examples are given by the author explaining cost-benefit analyses according to ICRP recommendations, especially discussing the definition of optimum local dose limits with regard to shielding design in nuclear installations. (DG) [de

  2. NEUTRON AND PHOTON DOSE MAPPING OF A DD NEUTRON GENERATOR.

    Science.gov (United States)

    Metwally, Walid A; Taqatqa, Osama A; Ballaith, Mohammed M; Chen, Allan X; Piestrup, Melvin A

    2017-11-01

    Neutron generators are an excellent tool that can be effectively utilized in educational institutions for applications such as neutron activation analysis, neutron radiography, and profiling and irradiation effects. For safety purposes, it is imperative that appropriate measures are taken in order to minimize the radiation dose from such devices to the operators, students and the public. This work presents the simulation and measurement results for the neutron and photon dose rates in the vicinity of the neutron generator installed at the University of Sharjah. A very good agreement is found between the simulated and measured dose rates. All of the public dose constraints were found to be met. The occupational dose constraint was also met after imposing a 200 cm no entry zone around the generator room. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Six fractions per week of external beam radiotherapy and high-dose-rate brachytherapy for carcinoma of the uterine cervix: A phase I/II study

    International Nuclear Information System (INIS)

    Yoon, Sang Min; Huh, Seung Jae; Park, Won; Lee, Jeung Eun; Park, Young Je; Nam, Hee Rim; Lim, Do Hoon; Ahn, Yong Chan

    2006-01-01

    Purpose: This study evaluated the treatment results of external beam radiotherapy administered in six fractions per week and high-dose-rate (HDR) brachytherapy for the treatment of cervical cancer. Methods and Materials: From July 2000 to July 2003, 43 patients were enrolled in this study. The patients received 45 Gy from a 10-MV photon beam using four-field box or anterior-posterior beams. Parametrial regions and the pelvic side walls were boosted with up to 50.4 Gy using a midline block. The daily fraction dose was 1.8 Gy administered in six-weekly fractions, from Monday to Saturday. HDR brachytherapy was also delivered at doses of 24 Gy to point A in six fractions twice a week. The median follow-up time was 37 months (range, 9-60 months). Results: The median overall treatment time was 51 days for all patients (range, 44-62 days). Thirty-four patients (79.1%) achieved complete remission and 8 (18.6%) achieved partial remission after radiotherapy. Locoregional recurrence occurred in 5 patients (11.6%), and a distant metastasis was encountered in 6 patients (13.9%). The 3-year overall survival, locoregional, and distant metastasis-free survival rates were 74.7%, 87.8%, and 84.7%, respectively. Grade 2 and 3 late rectal complications were encountered in 3 (6.5%) and 1 (2.2%), respectively. There were no Grade 3 late bladder complications. Conclusions: Six fractions per week of external beam radiotherapy and HDR brachytherapy is an effective treatment for patients with a carcinoma of the uterine cervix and can be used as a possible alternative to concomitant chemoradiotherapy in elderly patients or in patients with co-morbidity

  4. A Symbolic Approach to Permission Accounting for Concurrent Reasoning

    NARCIS (Netherlands)

    Huisman, Marieke; Mostowski, Wojciech

    2015-01-01

    Permission accounting is fundamental to modular, thread-local reasoning about concurrent programs. This paper presents a new, symbolic system for permission accounting. In existing systems, permissions are numeric value-based and refer to the current thread only. Our system is based on symbolic

  5. Hyperfractionated accelerated radiotherapy with concomitant integrated boost of 70-75 Gy in 5 weeks for advanced head and neck cancer. A phase I dose escalation study

    Energy Technology Data Exchange (ETDEWEB)

    Cvek, J.; Skacelikova, E.; Otahal, B.; Halamka, M.; Feltl, D. [University Hospital Ostrava (Czech Republic). Dept. of Oncology; Kubes, J. [University Hospital Bulovka, Prague (Czech Republic). Dept. of Radiation Oncology; Kominek, P. [University Hospital Ostrava (Czech Republic). Dept. of Otolaryngology

    2012-08-15

    Background and purpose: The present study was performed to evaluate the feasibility of a new, 5-week regimen of 70-75 Gy hyperfractionated accelerated radiotherapy with concomitant integrated boost (HARTCIB) for locally advanced, inoperable head and neck cancer. Methods and materials: A total of 39 patients with very advanced, stage IV nonmetastatic head and neck squamous cell carcinoma (median gross tumor volume 72 ml) were included in this phase I dose escalation study. A total of 50 fractions intensity-modulated radiotherapy (IMRT) were administered twice daily over 5 weeks. Prescribed total dose/dose per fraction for planning target volume (PTV{sub tumor}) were 70 Gy in 1.4 Gy fractions, 72.5 Gy in 1.45 Gy fractions, and 75 Gy in 1.5 Gy fractions for 10, 13, and 16 patients, respectively. Uninvolved lymphatic nodes (PTV{sub uninvolved}) were irradiated with 55 Gy in 1.1 Gy fractions using the concomitant integrated boost. Results: Acute toxicity was evaluated according to the RTOG/EORTC scale; the incidence of grade 3 mucositis was 51% in the oral cavity/pharynx and 0% in skin and the recovery time was {<=} 9 weeks for all patients. Late toxicity was evaluated in patients in complete remission according to the RTOG/EORTC scale. No grade 3/4 late toxicity was observed. The 1-year locoregional progression-free survival was 50% and overall survival was 55%. Conclusion: HARTCIB (75 Gy in 5 weeks) is feasible for patients deemed unsuitable for chemoradiation. Acute toxicity was lower than predicted from radiobiological models; duration of dysphagia and confluent mucositis were particularly short. Better conformity of radiotherapy allows the use of more intensive altered fractionation schedules compared with older studies. These results suggest that further dose escalation might be possible when highly conformal techniques (e.g., stereotactic radiotherapy) are used.

  6. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial

    Directory of Open Access Journals (Sweden)

    Robert B. Saper

    2013-01-01

    Full Text Available Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n=49 versus twice-weekly (n=46 standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale and back-related function (23-point modified Roland-Morris Disability Questionnaire. Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample’s baseline mean pain intensity [6.9 (SD 1.6] and function [13.7 (SD 5.0] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P<0.001. However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3 versus −2.4 (95% CI -3.1, -1.8, P=0.62] or back-related function [-5.1 (95% CI -7.0, -3.2 versus −4.9 (95% CI -6.5, -3.3, P=0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.

  7. 14 CFR 399.35 - Special tariff permission.

    Science.gov (United States)

    2010-01-01

    ... PROCEEDINGS) POLICY STATEMENTS STATEMENTS OF GENERAL POLICY Policies Relating to Rates and Tariffs § 399.35 Special tariff permission. (a) Definition. As used in this section, to grant STP means to approve a... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Special tariff permission. 399.35 Section...

  8. Single, 14-Day, and 13-Week Repeated Dose Toxicity Studies of Daily Oral Gelidium elegans Extract Administration to Rats.

    Science.gov (United States)

    Choi, Jia; Ryu, Su-Jung; Kim, Kui-Jin; Kim, Hyung-Min; Chung, Hee-Chul; Lee, Boo-Yong

    2018-01-20

    Gelidium elegans extract (GEE) is derived from a red alga from the Asia-Pacific region, which has antioxidant, anti-adipogenic, and anti-hyperglycemic effects. However, detailed studies of the toxicology of GEE have not been performed. We evaluated the single oral dose toxicity of GEE in male and female Sprague-Dawley (CD) rats. GEE did not cause deaths or have toxic effects at dosages of 5000 mg/kg/day, although compound-colored stools and diarrhea were observed in both sexes, which lasted 5000 mg/kg. We next evaluated the repeated oral dose toxicity of GEE in CD rats over 14 days and 13 weeks. GEE did not induce any significant toxicological changes in either sex at 2000 mg/kg/day. Repeated oral dose toxicity studies showed no adverse effects, in terms of clinical signs, mortality, body mass, food consumption, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy, organ masses, or histopathology, at dosages of 500, 1000, or 2000 mg/kg/day. The no observed adverse effect level (NOAEL) for GEE is thus likely to be >2000 mg/kg/day, and no pathology was identified in potential target organs. Therefore, this study indicates that repeated oral dosing with GEE is safe in CD rats.

  9. EFFECTIVE DOSE TO PATIENTS FROM THORACIC SPINE EXAMINATIONS WITH TOMOSYNTHESIS.

    Science.gov (United States)

    Svalkvist, Angelica; Söderman, Christina; Båth, Magnus

    2016-06-01

    The purposes of the present work were to calculate the average effective dose to patients from lateral tomosynthesis examinations of the thoracic spine, compare the results with the corresponding conventional examination and to determine a conversion factor between dose-area product (DAP) and effective dose for the tomosynthesis examination. Thoracic spine examinations from 17 patients were included in the study. The registered DAP and information about the field size for each projection radiograph were, together with patient height and mass, used to calculate the effective dose for each projection radiograph. The total effective doses for the tomosynthesis examinations were obtained by adding the effective doses from the 60 projection radiographs included in the examination. The mean effective dose was 0.47 mSv (range 0.24-0.81 mSv) for the tomosynthesis examinations and 0.20 mSv (range 0.07-0.29 mSv) for the corresponding conventional examinations (anteroposterior + left lateral projection). For the tomosynthesis examinations, a conversion factor between total DAP and effective dose of 0.092 mSv Gycm(-2) was obtained. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

    Science.gov (United States)

    Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

    2018-02-02

    The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

  11. Exploring Permission-Induced Risk in Android Applications for Malicious Application Detection

    KAUST Repository

    Wang, Wei

    2014-10-07

    Android has been a major target of malicious applications (malapps). How to detect and keep the malapps out of the app markets is an ongoing challenge. One of the central design points of Android security mechanism is permission control that restricts the access of apps to core facilities of devices. However, it imparts a significant responsibility to the app developers with regard to accurately specifying the requested permissions and to the users with regard to fully understanding the risk of granting certain combinations of permissions. Android permissions requested by an app depict the app\\'s behavioral patterns. In order to help understanding Android permissions, in this paper, we explore the permission-induced risk in Android apps on three levels in a systematic manner. First, we thoroughly analyze the risk of an individual permission and the risk of a group of collaborative permissions. We employ three feature ranking methods, namely, mutual information, correlation coefficient, and T-test to rank Android individual permissions with respect to their risk. We then use sequential forward selection as well as principal component analysis to identify risky permission subsets. Second, we evaluate the usefulness of risky permissions for malapp detection with support vector machine, decision trees, as well as random forest. Third, we in depth analyze the detection results and discuss the feasibility as well as the limitations of malapp detection based on permission requests. We evaluate our methods on a very large official app set consisting of 310 926 benign apps and 4868 real-world malapps and on a third-party app sets. The empirical results show that our malapp detectors built on risky permissions give satisfied performance (a detection rate as 94.62% with a false positive rate as 0.6%), catch the malapps\\' essential patterns on violating permission access regulations, and are universally applicable to unknown malapps (detection rate as 74.03%).

  12. A 12-week DBPC dose-finding study with sublingual monomeric allergoid tablets in house dust mite-allergic patients.

    Science.gov (United States)

    Hüser, C; Dieterich, P; Singh, J; Shah-Hosseini, K; Allekotte, S; Lehmacher, W; Compalati, E; Mösges, R

    2017-01-01

    In sublingual immunotherapy, optimal doses are a key factor for therapeutic outcomes. The aim of this study with tablets containing carbamylated monomeric house dust mite allergoids was to determine the most effective and safe dose. In this double-blind, placebo-controlled dose-finding study, 131 patients with house dust mite-induced allergic rhinoconjunctivitis were randomized to 12-week treatments with 300 UA/day, 1000 UA/day, 2000 UA/day, 3000 UA/day or placebo. Conjunctival provocation tests (CPT) were performed before, during and after treatment. The change in mean allergic severity (primary endpoint), calculated from the severity of the CPT reaction, and the proportion of patients with an improved CPT threshold (secondary endpoint) determined the treatment effect. The mean allergic severity decreased in all groups, including the placebo group. It was lower in all active treatment groups (300 UA/day: 0.14, 1000 UA/day: 0.15, 2000 UA/day: 0.10, 3000 UA/day: 0.15) than in the placebo group (0.30). However, this difference was not statistically significant (P allergoid sublingual tablets is well tolerated and reduces the CPT reaction in house dust mite-allergic patients. © 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.

  13. Rethinking Permissioned Blockchains

    OpenAIRE

    Vukolic, Marko

    2017-01-01

    Current blockchain platforms, especially the recent permissioned systems, have architectural limitations: smart contracts run sequentially, all node executes all smart contracts, consensus protocols are hard-coded, the trust model is static and not exible, and non-determinism in smart-contract execution poses serious problems. Overcoming these limitations is critical for improving both functional properties of blockchains, such as con dentiality and consistency, as well as their non-functiona...

  14. A Phase I-II dose escalation study of fixed-dose rate gemcitabine, oxaliplatin and capecitabine every two weeks in advanced cholangiocarcinomas

    DEFF Research Database (Denmark)

    Lassen, Ulrik V; Jensen, Lars Henrik; Sorensen, Morten

    2011-01-01

    (O) and capecitabine (C), and evaluate the safety and efficacy of this regimen in patients with advanced cholangiocarcinoma (CC). Methods. In the Phase I part of the study a dose-escalation schedule of FDR G, O and C, administered every two weeks, was performed in patients with solid tumours...... and no other treatments or advanced CC. In the Phase II part response rate, toxicity, progression-free survival (PFS) and overall survival was evaluated in patients with newly diagnosed advanced CC. Results. Thirty-six patients entered the Phase I part and G 1 000 mg/m(2) day 1 and 15, O 60 mg/m(2) day 1...... and 15, and C 1 000 mg/m(2) BID day 1-7 and day 15-21 were established as MTD. In the Phase II part, 41 patients with advanced CC were included. Overall response rate was 34% and 51% had stable disease, resulting in a clinical benefit rate of 85%. Grade III and IV adverse events were rare. Median...

  15. Single, 14-Day, and 13-Week Repeated Dose Toxicity Studies of Daily Oral Gelidium elegans Extract Administration to Rats

    Directory of Open Access Journals (Sweden)

    Jia Choi

    2018-01-01

    Full Text Available Gelidium elegans extract (GEE is derived from a red alga from the Asia–Pacific region, which has antioxidant, anti-adipogenic, and anti-hyperglycemic effects. However, detailed studies of the toxicology of GEE have not been performed. We evaluated the single oral dose toxicity of GEE in male and female Sprague-Dawley (CD rats. GEE did not cause deaths or have toxic effects at dosages of 5000 mg/kg/day, although compound-colored stools and diarrhea were observed in both sexes, which lasted <2 days. Therefore, the LD50 of GEE is likely to be >5000 mg/kg. We next evaluated the repeated oral dose toxicity of GEE in CD rats over 14 days and 13 weeks. GEE did not induce any significant toxicological changes in either sex at 2000 mg/kg/day. Repeated oral dose toxicity studies showed no adverse effects, in terms of clinical signs, mortality, body mass, food consumption, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy, organ masses, or histopathology, at dosages of 500, 1000, or 2000 mg/kg/day. The no observed adverse effect level (NOAEL for GEE is thus likely to be >2000 mg/kg/day, and no pathology was identified in potential target organs. Therefore, this study indicates that repeated oral dosing with GEE is safe in CD rats.

  16. NEUTRON GENERATOR FACILITY AT SFU: GEANT4 DOSE RATE PREDICTION AND VERIFICATION.

    Science.gov (United States)

    Williams, J; Chester, A; Domingo, T; Rizwan, U; Starosta, K; Voss, P

    2016-11-01

    Detailed dose rate maps for a neutron generator facility at Simon Fraser University were produced via the GEANT4 Monte Carlo framework. Predicted neutron dose rates throughout the facility were compared with radiation survey measurements made during the facility commissioning process. When accounting for thermal neutrons, the prediction and measurement agree within a factor of 2 or better in most survey locations, and within 10 % inside the vault housing the neutron generator. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. Software Development for Estimating the Conversion Factor (K-Factor) at Suitable Scan Areas, Relating the Dose Length Product to the Effective Dose.

    Science.gov (United States)

    Kobayashi, Masanao; Asada, Yasuki; Matsubara, Kosuke; Suzuki, Syouichi; Koshida, Kichiro; Matsunaga, Yuta; Kawaguchi, Ai; Haba, Tomonobu; Toyama, Hiroshi; Kato, Ryouichi

    2017-05-01

    We developed a k-factor-creator software (kFC) that provides the k-factor for CT examination in an arbitrary scan area. It provides the k-factor from the effective dose and dose-length product by Imaging Performance Assessment of CT scanners and CT-EXPO. To assess the reliability, we compared the kFC-evaluated k-factors with those of the International Commission on Radiological Protection (ICRP) publication 102. To confirm the utility, the effective dose determined by coronary computed tomographic angiography (CCTA) was evaluated by a phantom study and k-factor studies. In the CCTA, the effective doses were 5.28 mSv in the phantom study, 2.57 mSv (51%) in the k-factor of ICRP, and 5.26 mSv (1%) in the k-factor of the kFC. Effective doses can be determined from the kFC-evaluated k-factors in suitable scan areas. Therefore, we speculate that the flexible k-factor is useful in clinical practice, because CT examinations are performed in various scan regions. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. Study on the determination of permissible concentration in sea food

    International Nuclear Information System (INIS)

    Lee, C.M.; Lee, K.J.; Lee, W.K.

    2002-01-01

    Radioactive permissible concentration limit using the data which is suitable for Koreans is not established. In this paper, concentration limit is determined by using Korean food intake. Ministry of science of technology will adopt the new recommendation soon, so at this paper, dose limit of new value in ICRP 60 is used. Experts who have studied on this area worry about over-exposure by estimation of the case that intake contaminated a food by one radionuclide, therefore, complex intake limit is determined about all kinds of fishery products to solve this problem. Derived Food Concentration in single food divided by S(number of samples) and N(number of radionuclides) gives Complex intake limit (Derived Food Concentration in plural food). The value of N and S in this study is 3 and 12 respectively

  19. [Weekly low-dose methotrexate in rheumatoid arthritis. Review of the literature].

    Science.gov (United States)

    Manganelli, P; Troise Rioda, W

    1993-10-01

    Methotrexate (MTX) is an antifolic drug that in recent years has been largely employed in the treatment of Rheumatoid Arthritis (RA). Both short and long term clinical trials have demonstrated its efficacy and good tolerability. It induces a significant improvement of all clinical variables and a decrease in the erythrocyte sedimentation rate and other acute phase reactants with a steroid sparing effect. The probability of continuing MTX therapy for up to 5 years is 46-55% whereas that of continuing gold, hydroxychloroquine, sulfasalazine or D-penicillamine therapy is less than 20%. MTX is a rapidly acting drug with a clinical response within 4 weeks and a plateau phase after 6 months of therapy. Discontinuation of long-term MTX therapy induces a flare-up of the disease so that patients receiving long-term MTX must continue the drug to maintain clinical benefits. In spite of its clinical efficacy, MTX does not seem to have a significant effect on disease progression as determined radiographically. In this respect, MTX appears to have some superiority when compared to azathioprine, but not when compared to gold salts. MTX has been employed in patients with RA unresponsive to other Disease-Modifying Antirheumatic Drugs (DMARDs), but according to some recent views on the therapeutic strategy of RA, it could be used in early RA as a first choice drug. Toxic effects are the main reason in limiting long-term MTX treatment. Hepatic toxicity is one of the more common side-effects of MTX, but the recognition of its "risk factors" such as alcohol abuse, may reduce it. Acute pneumonitis is one of the more severe complications of MTX therapy and may be life-threatening. In RA patients treated with MTX are also reported complications of immunosuppression, such as Pneumocystis carinii pneumonia whose clinical-radiological picture may be similar to that of acute pneumonitis. The mechanism of action of low-dose weekly MTX in RA is still unclear, but it might be more

  20. 42 CFR 433.66 - Permissible provider-related donations.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Permissible provider-related donations. 433.66... Requirements State Financial Participation § 433.66 Permissible provider-related donations. (a) General rule... provider-related donations without a reduction in FFP, only in accordance with the requirements of this...

  1. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial.

    Science.gov (United States)

    Goldberg, Ivan; Gil Pina, Rafael; Lanzagorta-Aresti, Aitor; Schiffman, Rhett M; Liu, Charlie; Bejanian, Marina

    2014-07-01

    To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity. Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. NCT01177098. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Can ‘Mobile Platform’ and ‘Permission Marketing’ dance a tango to the consumers' tune? Modeling adoption of ‘SMS based Permission Advertising’

    OpenAIRE

    Prerna Bamoriya

    2015-01-01

    Many a times situation of advertising clutter is further aggrieved by the markers’ intrusive practices i.e. not asking for consumer’s explicit permission. It results in consumers’ alienation and reduced advertising effectiveness. Solution could be integration of Permission Marketing with an innovative advertising platform like Mobile. This study aimed to develop and validate a comprehensive model for understanding consumers’ adoption behavior towards SMS Based Permission Advertising (SBPA). F...

  3. Quantitative Security Risk Assessment of Android Permissions and Applications

    OpenAIRE

    Wang , Yang; Zheng , Jun; Sun , Chen; Mukkamala , Srinivas

    2013-01-01

    Part 6: Mobile Computing; International audience; The booming of the Android platform in recent years has attracted the attention of malware developers. However, the permissions-based model used in Android system to prevent the spread of malware, has shown to be ineffective. In this paper, we propose DroidRisk, a framework for quantitative security risk assessment of both Android permissions and applications (apps) based on permission request patterns from benign apps and malware, which aims ...

  4. Open-label, randomized study of individualized, pharmacokinetically (PK)-guided dosing of paclitaxel combined with carboplatin or cisplatin in patients with advanced non-small-cell lung cancer (NSCLC).

    Science.gov (United States)

    Joerger, M; von Pawel, J; Kraff, S; Fischer, J R; Eberhardt, W; Gauler, T C; Mueller, L; Reinmuth, N; Reck, M; Kimmich, M; Mayer, F; Kopp, H-G; Behringer, D M; Ko, Y-D; Hilger, R A; Roessler, M; Kloft, C; Henrich, A; Moritz, B; Miller, M C; Salamone, S J; Jaehde, U

    2016-10-01

    Variable chemotherapy exposure may cause toxicity or lack of efficacy. This study was initiated to validate pharmacokinetically (PK)-guided paclitaxel dosing in patients with advanced non-small-cell lung cancer (NSCLC) to avoid supra- or subtherapeutic exposure. Patients with newly diagnosed, advanced NSCLC were randomly assigned to receive up to 6 cycles of 3-weekly carboplatin AUC 6 or cisplatin 80 mg/m(2) either with standard paclitaxel at 200 mg/m(2) (arm A) or PK-guided dosing of paclitaxel (arm B). In arm B, initial paclitaxel dose was adjusted to body surface area, age, sex, and subsequent doses were guided by neutropenia and previous-cycle paclitaxel exposure [time above a plasma concentration of 0.05 µM (Tc>0.05)] determined from a single blood sample on day 2. The primary end point was grade 4 neutropenia; secondary end points included neuropathy, radiological response, progression-free survival (PFS) and overall survival (OS). Among 365 patients randomly assigned, grade 4 neutropenia was similar in both arms (19% versus 16%; P = 0.10). Neuropathy grade ≥2 (38% versus 23%, P PK-guided dosing of paclitaxel does not improve severe neutropenia, but reduces paclitaxel-associated neuropathy and thereby improves the benefit-risk profile in patients with advanced NSCLC. NCT01326767 (https://clinicaltrials.gov/ct2/show/NCT01326767). © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  5. Efficacy and safety of once-weekly intravenous epoetin alfa in maintaining hemoglobin levels in hemodialysis patients.

    Science.gov (United States)

    Locatelli, Francesco; Villa, Giuseppe; Messa, Piergiorgio; Filippini, Armando; Cannella, Giuseppe; De Ferrari, Giacomo; Naso, Agostino; Rossi, Egidio; Formica, Marco; Lombardi, Luigi; Rotolo, Ugo; Conte, Feruccio

    2008-01-01

    Although an erythropoiesis-stimulating agent (ESA) is most frequently administered intravenously for treatment of anemia in patients with chronic kidney disease who are on dialysis, few studies have compared the efficacy of different intravenous (i.v.) dosing schedules. This multicenter, phase IIIb, open-label, controlled study randomized 289 stable hemodialysis patients to continue with conventional dosing of i.v. epoetin alfa or darbepoetin, or to switch to once-weekly i.v. epoetin alfa at the same cumulative weekly starting dose, to maintain hemoglobin levels at 11.0-13.0 g/dL, and within 1.0 g/dL of the baseline value. Hemoglobin levels and ESA doses were recorded every 4 weeks for 28 weeks. Hemoglobin levels fell significantly and ESA doses increased significantly between baseline and week 28 (mean of week 16-28 values) in the once-weekly epoetin alfa group, compared with the conventional treatment group (phemoglobin levels between the groups was 0.73 g/dL (greater than the threshold for therapeutic equivalence of 0.5 g/dL). The changes between groups from baseline was significant at all time points for hemoglobin levels (0.36, 0.46, 0.81, 0.87, 0.78, 0.62 and 0.49 g/dL) and from week 12 for ESA dose (718.5, 1,326.5, 1,732.0, 1,839.7 and 1,959.1 IU/week; p=0.005). Hemoglobin was maintained at the target level in 78% and 84% of patients on conventional dosing, and 67% and 64% of those on once-weekly epoetin alfa in the intention-to-treat (p=0.1) and per protocol (p=0.016) populations, respectively. This study did not show therapeutic equivalence of once-weekly i.v. epoetin alfa with conventional dosing regimens.

  6. Escitalopram in obsessive-compulsive disorder: a randomized, placebo-controlled, paroxetine-referenced, fixed-dose, 24-week study

    DEFF Research Database (Denmark)

    Stein, Dan J; Andersen, Elisabeth Anne Wreford; Tonnoir, Brigitte

    2007-01-01

    OBJECTIVE: A randomized, placebo controlled fixed-dose trial was undertaken to determine the efficacy and tolerability of escitalopram in obsessive-compulsive disorder (OCD), using paroxetine as the active reference. RESEARCH DESIGN AND METHODS: A total of 466 adults with OCD from specialized...... clinical centres, psychiatric hospital departments, psychiatric practices, or general practice were randomized to one of four treatment groups: escitalopram 10 mg/day (n = 116), escitalopram 20 mg/day (n = 116), paroxetine 40 mg/day (n = 119), or placebo (n = 115) for 24 weeks. The primary efficacy...... of adverse events, and on changes in vital signs (blood pressure and pulse). Main outcome measures; RESULTS: Escitalopram 20 mg/day was superior to placebo on the primary and all secondary outcome endpoints, including remission. Escitalopram 10 mg/day and paroxetine 40 mg/day were also effective...

  7. Single Dose Versus 3 Doses of Intramuscular Benzathine Penicillin for Early Syphilis in HIV: A Randomized Clinical Trial.

    Science.gov (United States)

    Andrade, Roberto; Rodriguez-Barradas, Maria C; Yasukawa, Kosuke; Villarreal, Erick; Ross, Michael; Serpa, Jose A

    2017-03-15

    Patients coinfected with syphilis and human immunodeficiency virus (HIV) may have a slower decrease in rapid plasma reagin (RPR) titers. Currently a single dose of 2.4 million units of intramuscular benzathine penicillin G (BPG) is recommended for the treatment of early syphilis. Some observational studies have suggested that this regimen may lead to high failure rates in coinfected patients. We conducted an open-label randomized clinical trial to compare the efficacy of single-dose and 3-dose regimens of BPG for the treatment of early syphilis in HIV-infected individuals. RPR titers were monitored every 3 months. Treatment success was defined as a decrease in RPR titers of ≥2 dilutions (4-fold) during a 12-month follow-up period. Sixty-four patients were included. In the intention-to-treat analysis, treatment success rates were 80% (28 of 35 subjects) and 93% (27 of 29 subjects) in the single-dose and 3-dose regimens, respectively (absolute difference, 13% [95% confidence interval {CI}, -5% to 30%; P = .17). In the per-protocol analysis, success rates were 93% (27 of 29) and 100% in the single-dose and 3-dose regimens, respectively (absolute difference, 7% [95% CI, -7% to 22%]; P = .49). CD4 T-cell count, RPR titer and syphilis stage did not affect treatment results. When compared with a single dose of BPG, a 3-dose regimen did not improve syphilis serological outcomes. Our results support the Centers for Disease Control and Prevention recommendation of a single dose of BPG in HIV-infected patients with early syphilis. NCT02611765. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  8. Absence of in vivo genotoxicity of 3-monochloropropane-1,2-diol and associated fatty acid esters in a 4-week comprehensive toxicity study using F344 gpt delta rats.

    Science.gov (United States)

    Onami, Saeko; Cho, Young-Man; Toyoda, Takeshi; Horibata, Katsuyoshi; Ishii, Yuji; Umemura, Takashi; Honma, Masamitsu; Nohmi, Takehiko; Nishikawa, Akiyoshi; Ogawa, Kumiko

    2014-07-01

    3-Monochloropropane-1,2-diol (3-MCPD) is regarded as a rat renal and testicular carcinogen and has been classified as a possible human carcinogen (group 2B) by International Agency for Research on Cancer. This is potentially of great importance given that esters of this compound have recently found to be generated in many foods and food ingredients as a result of food processing. There have been a few reports about their toxicity, although we have recently found that the toxicity profile of 3-MCPD esters was similar to that of 3-MCPD in a rat 13-week repeated dose study, except for the acute renal toxicity seen in 3-MCPD-treated females. In the present study, to examine in vivo genotoxicity we administered equimolar doses of 3-MCPD or 3-MCPD fatty acid esters (palmitate diester, palmitate monoester and oleate diester) to 6-week-old male F344 gpt delta rats carrying a reporter transgene for 4 weeks by intragastric administration. In vivo micronucleus, Pig-a mutation and gpt assays were performed, as well as investigations of major toxicological parameters including histopathological features. As one result, the relative kidney weights of the 3-MCPD and all three ester groups were significantly increased compared with the vehicle control group. However, the frequency of micronucleated reticulocytes and Pig-a mutant red blood cells did not differ among groups. Moreover, no changes were observed in mutant frequencies of gpt and red/gam (Spi(-)) genes in the kidney and the testis of 3-MCPD and 3-MCPD-fatty-acid-esters-treated rats. In histopathological analyses, no treatment related changes were observed, except for decrease of eosinophilic bodies in the kidneys of all treated groups. These results suggest that 3-MCPD and its fatty acid esters are not in vivo genotoxins, although they may exert renal toxicity. © The Author 2014. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e

  9. Android Permission Model

    OpenAIRE

    Birendra, Chalise

    2016-01-01

    The recent evolution on the smart phone technology has made its application market huge and less secure. Every single day large number of apps introduced in the android market (mostly on google play store) without any particular inspections which creates a lot of security issues and they remain unresolved. There are a lot of recent and increasing security issues which are mostly caused by the android apps. Mainly, the access of user data through the apps relied on the users given permission t...

  10. Determination of the maximum individual dose exposure resulting from a hypothetical LEU plate-melt accident

    International Nuclear Information System (INIS)

    Abdelhady, Amr

    2013-01-01

    Highlights: ► Studying the radioactive release results from hypothetical plate-melt accident. ► Hotspot code was used to study the dose distributions around the reactor. ► A 90% decrease in the received dose in proper operation of filtration. ► The received dose is lower than the annual permissible dose after filtration. - Abstract: The objective of this study was to provide an estimate of the potential impact of accidental radioactive release from the testing cell of the Egyptian second research reactor ETRR-2 on the dose level of public around the reactor. The assessment was performed for two cases: an evaluation of the impact that accidental release has on the dose that would be received by public around the reactor in case of proper operation of testing cell filtration system; and an assessment of the potential dose in case of loss of testing cell filtration system. The results show that the filtration system has a great role in decreasing the dose received by an individual located outside the reactor to a dose level lower than the annual permissible dose

  11. Control over Permissible Short Emergency Overloads in Power Transformers

    Directory of Open Access Journals (Sweden)

    V. A. Anischenko

    2010-01-01

    Full Text Available The paper proposes a method for determination a permissible duration of short intermittent overloads of power transformers that permits to avoid non-permissible over-heating of winding insulation and fully utilize overloading transformer ability.

  12. Clinical responses after total body irradiation by over permissible dose of γ-rays in one time

    International Nuclear Information System (INIS)

    Jiang Benrong; Wang Guilin; Liu Huilan; Tang Xingsheng; Ai Huisheng

    1990-01-01

    The clinical responses of patients after total body over permissilbe dose γ-ray irradiation were observed and analysed. The results showed: when the dose was above 5 cGy, there was some immunological depression, but no significant change in hematopoietic functions. 5 cases showed some transient changes of ECG, perhaps due to vagotonia caused by psychological imbalance, One case vomitted 3-4 times after 28 cGy irradiation, this suggested that a few times of vomitting had no significance in the estimation of the irradiated dose and the whole clinical manifestations must be concretely analysed

  13. A radiotherapeutic clinical trial of twice per week vs. five times per week in oral cancer

    International Nuclear Information System (INIS)

    Handa, K.; Edoliya, T.N.; Pandey, R.P.; Agarwal, Y.C.; Sinha, N.

    1980-01-01

    135 cases of oral cancer have been treated by two fractions per week, and the results are compared with 115 approximately identical cases treated by conventional five days a week schedule with other parameters being identical. Radical irradiation was done by 6000 to 6500 rd in 6-6 1/2 weeks (NSD 1800-1900 ret) and palliative dose was 4500 R4 weeks (NSD 1532 ret). Tumour regression was found markedly superior by conventional regime in radically irradiated cases but much less superior for palliative treatment. Acute and late reaction as well as tumour control at 1 year was better with daily treatment, more so in cases treated for radical cure, while in palliative treatment, the superiority of daily regime was less marked. Our study provides evidence that only for palliation in advanced cases, radiation therapy by 2 fractions a week can be alternatively used. (orig.) [de

  14. Relative efficacy of weekly and two differing doses of daily iron-folate supplementation in improving hemoglobin in mild and moderately anemic children between 3 and 5 years of age: a cluster randomized trial.

    Science.gov (United States)

    Kapil, U; Sachdev, H P S; Dwivedi, S N; Pandey, R M; Upadhyay, A D; Sareen, N

    2013-04-01

    In India, 75% of children hemoglobin response with two dosages of daily (20 mg iron and 100 μg folic acid, or 40 mg iron and 200 μg folic acid) and weekly (40 mg iron and 200 μg folic acid) IFA supplementation in children of 3-5 years of age with mild or moderate anemia (hemoglobin 7-10 g/dl). Community-based cluster randomized control trial in nine adjoining Anganwadi Centers. Four hundred twenty six enrolled participants received directly supervised IFA tablet supplementation as per the above three groups. After 100 days, the number of available subjects in the NNACP daily dose (A), daily dose doubled (B) and weekly dose (C) groups were 112, 114 and 110, respectively. Hemoglobin was estimated at baseline, 50 and 100 days by the Cynmeth hemoglobin method. At 50 days, there were no differences between the three groups, but at 100 days, adjusted hemoglobin was lowered with weekly supplementation. The mean (95% confidence interval) hemoglobin (g/dl) differences were: (i) A-B: -0.05 (-0.17, 0.05), (ii) A-C: -0.38 (-0.50, -0.27) and (iii) B-C: -0.33, (-0.45, -0.21). Anemia reduction was 18.8%, 18.4% and 10.9%, respectively, in the three groups. Directly supervised IFA supplementation at the NNACP or double dose is equally efficacious but superior to weekly regimen.

  15. Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

    Science.gov (United States)

    Johannsson, Gudmundur; Feldt-Rasmussen, Ulla; Håkonsson, Ida Holme; Biering, Henrik; Rodien, Patrice; Tahara, Shigeyuki; Toogood, Andrew; Rasmussen, Michael Højby

    2018-05-01

    Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin ® . Local tolerability and treatment satisfaction were also assessed. 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939). Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan ( n  = 61) or once-daily Norditropin ( n  = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin ( P  = 0.0171). In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin. © 2018 The authors.

  16. High dose teriparatide (rPTH1-34) therapy increases callus volume and enhances radiographic healing at 8-weeks in a massive canine femoral allograft model.

    Science.gov (United States)

    Nishitani, Kohei; Mietus, Zachary; Beck, Christopher A; Ito, Hiromu; Matsuda, Shuichi; Awad, Hani A; Ehrhart, Nicole; Schwarz, Edward M

    2017-01-01

    Small animal studies have demonstrated significant high-dose recombinant parathyroid hormone1-34 (rPTH1-34) effects on intercalary allograft healing. Towards a human adjuvant therapy to decrease non-unions, we evaluated rPTH1-34 safety and efficacy in a clinically relevant canine femoral allograft model. Adult female mongrel hounds (n = 20) received a 5cm mid-diaphyseal osteotomy reconstructed with a plated allograft, and were randomized to: 1) Placebo (n = 5; daily saline), 2) Continuous rPTH1-34 (n = 7; 5 μg/kg/day s.c. from day 1-55 post-op), or 3) Delayed rPTH1-34 (n = 8; 5 μg/kg/day s.c. from day 14-28 post-op). Safety was assessed by physical behavior and blood calcium monitoring. Cone beam CT (CB-CT) was performed on days 14, 28 and 56 post-op to assess 2D cortical healing, 3D bone volume, and Union Ratio. Biomechanical testing and dynamic histomorphometry were also performed. The high drug dose was poorly tolerated, as most dogs receiving rPTH1-34 had to be given intravenous saline, and one dog died from hypercalcemia. Continuous rPTH1-34 significantly increased 2D healing and callus volumes at 4-weeks versus Placebo, and sustained the significant increase in cortical union at 8-week (p<0.05). These rPTH1-34 effects were confirmed by histomorphometry, revealing significant increases in mineral apposition rates (MAR) on host bone and graft-host junctions (p<0.05). Delayed rPTH1-34 significantly increased callus volume and MAR at 8 weeks (p<0.05). Although no biomechanical differences were observed, as expected for early healing, the results demonstrated that 2D RUST scoring significantly correlated with torsional biomechanics (p<0.01). In conclusion, 8-weeks of intermittent high-dose rPTH1-34 treatment significantly increases callus formation and accelerates bony union of intercalary massive allografts in a clinically relevant canine model, but with serious side-effects from hypercalcemia.

  17. High dose teriparatide (rPTH1-34 therapy increases callus volume and enhances radiographic healing at 8-weeks in a massive canine femoral allograft model.

    Directory of Open Access Journals (Sweden)

    Kohei Nishitani

    Full Text Available Small animal studies have demonstrated significant high-dose recombinant parathyroid hormone1-34 (rPTH1-34 effects on intercalary allograft healing. Towards a human adjuvant therapy to decrease non-unions, we evaluated rPTH1-34 safety and efficacy in a clinically relevant canine femoral allograft model. Adult female mongrel hounds (n = 20 received a 5cm mid-diaphyseal osteotomy reconstructed with a plated allograft, and were randomized to: 1 Placebo (n = 5; daily saline, 2 Continuous rPTH1-34 (n = 7; 5 μg/kg/day s.c. from day 1-55 post-op, or 3 Delayed rPTH1-34 (n = 8; 5 μg/kg/day s.c. from day 14-28 post-op. Safety was assessed by physical behavior and blood calcium monitoring. Cone beam CT (CB-CT was performed on days 14, 28 and 56 post-op to assess 2D cortical healing, 3D bone volume, and Union Ratio. Biomechanical testing and dynamic histomorphometry were also performed. The high drug dose was poorly tolerated, as most dogs receiving rPTH1-34 had to be given intravenous saline, and one dog died from hypercalcemia. Continuous rPTH1-34 significantly increased 2D healing and callus volumes at 4-weeks versus Placebo, and sustained the significant increase in cortical union at 8-week (p<0.05. These rPTH1-34 effects were confirmed by histomorphometry, revealing significant increases in mineral apposition rates (MAR on host bone and graft-host junctions (p<0.05. Delayed rPTH1-34 significantly increased callus volume and MAR at 8 weeks (p<0.05. Although no biomechanical differences were observed, as expected for early healing, the results demonstrated that 2D RUST scoring significantly correlated with torsional biomechanics (p<0.01. In conclusion, 8-weeks of intermittent high-dose rPTH1-34 treatment significantly increases callus formation and accelerates bony union of intercalary massive allografts in a clinically relevant canine model, but with serious side-effects from hypercalcemia.

  18. Is the publication of exit poll results morally permissible?

    DEFF Research Database (Denmark)

    Sønderholm, Jørn

    2016-01-01

    This article is about exit polls. It addresses the question of whether or not it is morally permissible to publish exit poll results. The conclusion of the article is that an affirmative answer should be given to this question. In section 2, the master argument in favor of the moral permissibility...... of the publication of exit poll results is introduced. This is a strong argument. It is, however, argued that it might be the case that the conclusion of this argument should be rejected if there are other, and weightier, arguments against the idea that the publication of exit poll results is morally permissible....... In section 3, the strongest arguments against the moral permissibility of the publication of exit poll results are outlined and discussed. The conclusion of this section is that all these arguments fail in their intended purpose. The conclusion of the article is therefore justified....

  19. COMPUTED TOMOGRAPHY DOSE INDEX MEASUREMENT FOR Hi-ART MEGAVOLTAGE HELICAL CT.

    Science.gov (United States)

    Liu, Minglu; Wang, Yunlai; Liao, Xiongfei

    2016-11-01

    On-line megavoltage computed tomography (MVCT) images are used to verify patient daily set-up in Hi-ART helical TomoTherapy unit. To evaluate the patient dose from MVCT scanning in image guidance, weighted computed tomography (CT) dose index (CTDI w ) was measured with PTW TM30009 CT pencil chamber in head and body phantoms for slice thicknesses of 2, 4 and 6 mm with different scan lengths. Dose length products (DLPs) were subsequently calculated. The CTDI w and DLP were compared with XVI kV CBCT and Brilliance simulator CT for routine clinical protocols. It was shown that CTDI and DLP had close relationship with the slice thickness and the scan length. The dose distribution in the transversal plane was very inhomogeneous due to the attenuation of the couch. Patient dose from MVCT was lower than XVI CBCT for the head scan, while larger for body scan. CTDI w , which is measured easily and reproducibly, can be used to assess the patient dose in MVCT. Regular measurement should be performed in QA & QC programmes. Appropriate slice thickness and scan range should be chosen to reduce the patient dose. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes.

    Science.gov (United States)

    Matfin, Glenn; Van Brunt, Kate; Zimmermann, Alan G; Threlkeld, Rebecca; Ignaut, Debra A

    2015-04-21

    This 4-week, phase 3b, multicenter, open-label, single-arm, outpatient study demonstrated the safe and effective use of the dulaglutide single-dose pen containing 0.5 mL of placebo for subcutaneous injection in injection-naïve adult patients with type 2 diabetes (T2D), with A1C ≤ 8.5% (69 mmol/mol), BMI ≥ 23 kg/m2 and ≤ 45 kg/m(2). Patients completed a modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire (mD-FISQ) and were trained to self-inject with the single-dose pen. Patients completed the initial self-injection at the site, injected at home for 2 subsequent weeks, and returned to the site for the final injection. The initial and final self-injections were evaluated for success; the final (initial) self-injection success rate was the primary (secondary) outcome measure, and the primary (secondary) objective was to demonstrate this success rate as being significantly greater than 80%. Patients recorded their level of pain after each injection. After the final injection, patients completed the mD-FISQ and the Medication Delivery Device Assessment Battery (MDDAB) to assess their perceptions of the single-dose pen, including ease of use and experience with the device. Among 211 patients (mean age: 61 years), the primary objective was met, with a final injection success rate of 99.1% (95% CI: 96.6% to 99.7%). Among 214 patients, the initial injection success rate was 97.2% (95% CI: 94.0% to 98.7%), meeting the key secondary objective. Overall, most patients (>96%) found the device easy to use, were satisfied with the device, and would be willing to continue to use the single-dose pen after the study. There was a significant reduction (P injecting, as measured by the mD-FISQ. The dulaglutide single-dose pen was found to be a safe and effective device for use by patients with T2D who were injection-naïve. A positive injection experience is an important factor for patients and providers when initiating injectable

  1. Inhalation toxicity of methanol/gasoline in rats: effects of 13-week exposure.

    Science.gov (United States)

    Poon, R; Park, G; Viau, C; Chu, I; Potvin, M; Vincent, R; Valli, V

    1998-01-01

    The subchronic inhalation toxicity of a methanol/gasoline blend (85% methanol, 15% gasoline, v/v) was studied in rats. Sprague Dawley rats (10 animals per group) of both sexes were exposed to vapours of methanol/gasoline at 50/3, 500/30 and 5000/300ppm for 6 hours per day, 5 days per week, for 13 weeks. Control animals inhaled filtered room air only. Control recovery and high dose recovery groups were also included which inhaled room air for an extra 4 weeks following the treatment period. No clinical signs of toxicity were observed in the treatment group and their growth curves were not significantly different from the control. Except for decreased forelimb grip strength in high dose females, no treatment-related neurobehavioural effects (4-6 hours post inhalation) were observed using screening tests which included cage-side observations, righting reflex, open field activities, and forelimb and hindlimb grip strength. At necropsy, the organ to body weight ratios for the liver, spleen, testes, thymus and lungs were not significantly different from the control group. There were no treatment-related effects in the hematological endpoints and no elevation in serum formate levels. Minimal serum biochemical changes were observed with the only treatment-related change being the decreased creatinine in the females. A dose-related increase in urinary ascorbic acid was detected in males after 2, 4 and 8 weeks of exposure, but not after the 12th week, and in females only at week-2. Increased urinary albumin was observed in treated males starting at the lowest dose and at all exposure periods, but not in females. A treatment-related increase in urinary beta 2-microglobulin was detected in males at week-2 only. Except for mild to moderate mucous cell metaplasia in nasal septum B, which occurred more often and with a slightly higher degree of severity in the low dose groups of both sexes, and presence of a minimal degree of interstitial lymphocyte infiltration in the prostate

  2. 45 CFR 1639.4 - Permissible representation of eligible clients.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Permissible representation of eligible clients... CORPORATION WELFARE REFORM § 1639.4 Permissible representation of eligible clients. Recipients may represent an individual eligible client who is seeking specific relief from a welfare agency. [62 FR 30766...

  3. Resident alveolar macrophages are susceptible to and permissive of Coxiella burnetii infection.

    Directory of Open Access Journals (Sweden)

    Matthew Calverley

    Full Text Available Coxiella burnetii, the causative agent of Q fever, is a zoonotic disease with potentially life-threatening complications in humans. Inhalation of low doses of Coxiella bacteria can result in infection of the host alveolar macrophage (AM. However, it is not known whether a subset of AMs within the heterogeneous population of macrophages in the infected lung is particularly susceptible to infection. We have found that lower doses of both phase I and phase II Nine Mile C. burnetii multiply and are less readily cleared from the lungs of mice compared to higher infectious doses. We have additionally identified AM resident within the lung prior to and shortly following infection, opposed to newly recruited monocytes entering the lung during infection, as being most susceptible to infection. These resident cells remain infected up to twelve days after the onset of infection, serving as a permissive niche for the maintenance of bacterial infection. A subset of infected resident AMs undergo a distinguishing phenotypic change during the progression of infection exhibiting an increase in surface integrin CD11b expression and continued expression of the surface integrin CD11c. The low rate of phase I and II Nine Mile C. burnetii growth in murine lungs may be a direct result of the limited size of the susceptible resident AM cell population.

  4. Adjuvant chemotherapy with 5-fluorouracil, L-folinic acid and levamisole for patients with colorectal cancer: non-randomised comparison of weekly versus four-weekly schedules--less pain, same gain. QUASAR Colorectal Cancer Study Group.

    Science.gov (United States)

    Kerr, D J; Gray, R; McConkey, C; Barnwell, J

    2000-08-01

    QUASAR is a large trial of adjuvant chemotherapy for colorectal cancer in which clinicians could choose to deliver a standard adjuvant cytotoxic chemotherapy regimen, 5-fluorouracil (5-FU) and L-folinic acid (L-FA), in either a once-weekly or a four-weekly schedule. We report results of a non-randomised comparison between these schedules with respect to survival, recurrence and differential toxicity. In a factorial (2 x 2) trial design, QUASAR compared high-dose (175 mg) versus low-dose (25 mg) L-FA and levamisole versus placebo. The dose of 5-FU was fixed at 370 mg/m2 and although the recommended schedule was i.v. bolus delivery, daily for 5 days repeated four-weekly for 6 months, a significant proportion of randomising clinicians were constrained to deliver once-weekly 5-FU-L-FA for 30 weeks. Four thousand nine hundred twenty-seven patients were entered into QUASAR between May 1994 and October 1997, eighteen hundred twenty-nine of whom have recurred and sixteen hundred eighty-nine died. Similar numbers 2370 vs. 2559 were treated with the once-weekly and four-weekly schedules and the demographic features of the 2 groups were well balanced: stage C, 73.3% once-weekly vs. 71.0% four-weekly; colon, 68.0% vs. 68.3%; high-dose FA, 50.1% vs. 49.9%; levamisole, 49.3% vs. 49.3%; females, 40.2% vs. 41.7%; median age (years) 62 vs. 61. The risk of recurrence and survival were similar regardless of schedule: three-year survival was 70.6% once-weekly vs. 71.0% four-weekly; three-year recurrence risk was 35.6% once-weekly vs. 35.5% four-weekly; But, the once-weekly regimen was much less toxic: number of patients for whom toxicity was reported (once-weekly: four-weekly), stomatitis, 37 vs. 337; diarrhoea, 260 vs. 440; neutropenia, 20 vs. 153. The once-weekly regimen is much less toxic than and, apparently, about as effective as the four-weekly schedule. This suggests that the toxicity of 5-FU-L-FA adjuvant chemotherapy could be reduced substantially by weekly scheduling without

  5. The concept of the effective dose

    International Nuclear Information System (INIS)

    Jacobi, W.

    1975-01-01

    Irradiation of the human body by external or internal sources leads mostly to a simultaneous exposure of several organs. However, so far no clear and consistent recommendations for the combination of organ doses and the assessment of an exposure limit under such irradiation conditions are available. Following a proposal described in ICRP-publication 14 one possible concept for the combination of organ doses is discussed in this paper. This concept is based on the assumption that at low doses the total radiation detriment to the exposed person is given by the sum of radiation detriments to the single organs. Taking into account a linear dose-risk relationship, the sum of weighted organ doses leads to the definition of an 'Effective Dose'. The applicability and consequences of this 'Effective Dose Concept' are discussed especially with regard to the assessment of the maximum permissible intake of radionuclides into the human body and the combination of external and internal exposure. (orig.) [de

  6. 46 CFR 115.700 - Permission for repairs and alterations.

    Science.gov (United States)

    2010-10-01

    ... replacement in kind, of electrical wiring, fuel lines, tanks, boilers and other pressure vessels, and steering... 46 Shipping 4 2010-10-01 2010-10-01 false Permission for repairs and alterations. 115.700 Section... AND CERTIFICATION Repairs and Alterations § 115.700 Permission for repairs and alterations. (a...

  7. 46 CFR 176.700 - Permission for repairs and alterations.

    Science.gov (United States)

    2010-10-01

    ... repair or replacement, other than replacement in kind, of electrical wiring, fuel lines, tanks, boilers... 46 Shipping 7 2010-10-01 2010-10-01 false Permission for repairs and alterations. 176.700 Section... (UNDER 100 GROSS TONS) INSPECTION AND CERTIFICATION Repairs and Alterations § 176.700 Permission for...

  8. Summary of personnel doses and discharge of radioactivity at Swedish nuclear power plants 1971-1975

    International Nuclear Information System (INIS)

    Malmqvist, L.; Persson, Aa.

    1977-01-01

    The report is a summary of personnel doses and activity discharges from Swedish nuclear power plants during the first five years of electric power production by nuclear plants. The personnel doses for the Sweedish plants are lower than the corresponding values for American plants. The highest Swedish value is o,13 manrem per MWE and year. The discharge of radioactivity to the atmosphere from the Swedish plants has been for below the maximum permissible limits. The discharge of radioactivity to the water recipients was less than 1 % of what is permissible

  9. User-centric android flexible permissions

    NARCIS (Netherlands)

    Scoccia, Gian Luca; Malavolta, Ivano; Autili, Marco; Di Salle, Amleto; Inverardi, Paola

    2017-01-01

    Privacy in mobile apps is a fundamental aspect to be considered, particularly with regard to meeting end user expectations. Due to the rigidities of the Android permission model, desirable trade-offs are not allowed. End users are confined into a secondary role, having the only option of choosing

  10. COMPARISON OF THE PERIPHERAL DOSES FROM DIFFERENT IMRT TECHNIQUES FOR PEDIATRIC HEAD AND NECK RADIATION THERAPY.

    Science.gov (United States)

    Toyota, Masahiko; Saigo, Yasumasa; Higuchi, Kenta; Fujimura, Takuya; Koriyama, Chihaya; Yoshiura, Takashi; Akiba, Suminori

    2017-11-01

    Intensity-modulated radiation therapy (IMRT) can deliver high and homogeneous doses to the target area while limiting doses to organs at risk. We used a pediatric phantom to simulate the treatment of a head and neck tumor in a child. The peripheral doses were examined for three different IMRT techniques [dynamic multileaf collimator (DMLC), segmental multileaf collimator (SMLC) and volumetric modulated arc therapy (VMAT)]. Peripheral doses were evaluated taking thyroid, breast, ovary and testis as the points of interest. Doses were determined using a radio-photoluminescence glass dosemeter, and the COMPASS system was used for three-dimensional dose evaluation. VMAT achieved the lowest peripheral doses because it had the highest monitor unit efficiency. However, doses in the vicinity of the irradiated field, i.e. the thyroid, could be relatively high, depending on the VMAT collimator angle. DMLC and SMLC had a large area of relatively high peripheral doses in the breast region. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Weekly Low-Dose Docetaxel-Based Chemoradiotherapy for Locally Advanced Oropharyngeal or Hypopharyngeal Carcinoma: A Retrospective, Single-Institution Study

    International Nuclear Information System (INIS)

    Fukada, Junichi; Shigematsu, Naoyuki; Takeda, Atsuya; Ohashi, Toshio; Tomita, Toshiki; Shiotani, Akihiro; Kunieda, Etsuo; Kawaguchi, Osamu; Fujii, Masato; Kubo, Atsushi

    2010-01-01

    Purpose: To retrospectively assess the efficacy, toxicity, and prognostic factors of weekly low-dose docetaxel-based chemoradiotherapy for Stage III/IV oropharyngeal or hypopharyngeal carcinoma. Methods and Materials: Between 2001 and 2005, 72 consecutive patients with locally advanced oropharyngeal or hypopharyngeal carcinoma were treated with concurrent chemoradiotherapy (CCR; radiation at 60 Gy plus weekly docetaxel [10 mg/m 2 ]). Thirty of these patients also received neoadjuvant chemotherapy (NAC; docetaxel, cisplatin, and 5-fluorouracil) before concurrent chemoradiotherapy. Survival was calculated according to the Kaplan-Meier method. The prognostic factors were evaluated by univariate and multivariate analyses. Results: The median follow-up was 33 months, with overall survival, disease-free survival, and locoregional control rates at 3 years of 59%, 45%, and 52%, respectively. Thirty-six patients (50%) experienced more than one Grade 3 to 4 acute toxicity. Grade 3 mucositis occurred in 32 patients (44%), Grade 4 laryngeal edema in 1 (1%). Grade ≥3 severe hematologic toxicity was observed in only 2 patients (3%). Grade 3 dysphagia occurred as a late complication in 2 patients (3%). Multivariate analyses identified age, T stage, hemoglobin level, and completion of weekly docetaxel, but not NAC, as significant factors determining disease-free survival. Conclusions: Docetaxel is an active agent used in both concurrent and sequential chemoradiotherapy regimens. Mucositis was the major acute toxicity, but this was well tolerated in most subjects. Anemia was the most significant prognostic factor determining survival. Further studies are warranted to investigate the optimal protocol for integrating docetaxel into first-line chemoradiotherapy regimens, as well as the potential additive impact of NAC.

  12. Increased Tumor Oxygenation and Drug Uptake During Anti-Angiogenic Weekly Low Dose Cyclophosphamide Enhances the Anti-Tumor Effect of Weekly Tirapazamine

    Science.gov (United States)

    Doloff, J.C.; Khan, N.; Ma, J.; Demidenko, E.; Swartz, H.M.; Jounaidi, Y.

    2010-01-01

    Metronomic cyclophosphamide treatment is associated with anti-angiogenic activity and is anticipated to generate exploitable hypoxia using hypoxia-activated prodrugs. Weekly administration of tirapazamine (TPZ; 5 mg/kg body weight i.p.) failed to inhibit the growth of 9L gliosarcoma tumors grown s.c. in scid mice. However, the anti-tumor effect of weekly cyclophosphamide (CPA) treatment (140 mg/kg BW i.p.) was substantially enhanced by weekly TPZ administration. An extended tumor free period and increased frequency of tumor eradication without overt toxicity were observed when TPZ was given 3, 4 or 5 days after each weekly CPA treatment. Following the 2nd CPA injection, Electron Paramagnetic Resonance (EPR) Oximetry indicated significant increases in tumor pO2, starting at 48 hr, which further increased after the 3rd CPA injection. pO2 levels were, however, stable in growing untreated tumors. A strong negative correlation (−0.81) between tumor pO2 and tumor volume during 21 days of weekly CPA chemotherapy was observed, indicating increasing tumor pO2 with decreasing tumor volume. Furthermore, CPA treatment resulted in increased tumor uptake of activated CPA. CPA induced increases in VEGF RNA, which reached a maximum on day 1, and in PLGF RNA which was sustained throughout the treatment, while anti-angiogenic host thrombospondin-1 increased dramatically through day 7 post-CPA treatment. Weekly cyclophosphamide treatment was anticipated to generate exploitable hypoxia. However, our findings suggest that weekly CPA treatment induces a functional improvement of tumor vasculature, which is characterized by increased tumor oxygenation and drug uptake in tumors, thus counter-intuitively, benefiting intratumoral activation of TPZ and perhaps other bioreductive drugs. PMID:19754361

  13. Efficacy and Safety of Single and Double Doses of Ivermectin versus 7-Day High Dose Albendazole for Chronic Strongyloidiasis

    Science.gov (United States)

    Suputtamongkol, Yupin; Premasathian, Nalinee; Bhumimuang, Kid; Waywa, Duangdao; Nilganuwong, Surasak; Karuphong, Ekkapun; Anekthananon, Thanomsak; Wanachiwanawin, Darawan; Silpasakorn, Saowaluk

    2011-01-01

    Background Strongyloidiasis, caused by an intestinal helminth Strongyloides stercoralis, is common throughout the tropics. It remains an important health problem due to autoinfection, which may result in hyperinfection and disseminated infection in immunosuppressed patients, especially patients receiving chemotherapy or corticosteroid treatment. Ivermectin and albendazole are effective against strongyloidiasis. However, the efficacy and the most effective dosing regimen are to be determined. Methods A prospective, randomized, open study was conducted in which a 7-day course of oral albendazole 800 mg daily was compared with a single dose (200 microgram/kilogram body weight), or double doses, given 2 weeks apart, of ivermectin in Thai patients with chronic strongyloidiasis. Patients were followed-up with 2 weeks after initiation of treatment, then 1 month, 3 months, 6 months, 9 months, and 1 year after treatment. Combination of direct microscopic examination of fecal smear, formol-ether concentration method, and modified Koga agar plate culture were used to detect strongyloides larvae in two consecutive fecal samples in each follow-up visit. The primary endpoint was clearance of strongyloides larvae from feces after treatment and at one year follow-up. Results Ninety patients were included in the analysis (30, 31 and 29 patients in albendazole, single dose, and double doses ivermectin group, respectively). All except one patient in this study had at least one concomitant disease. Diabetes mellitus, systemic lupus erythrematosus, nephrotic syndrome, hematologic malignancy, solid tumor and human immunodeficiency virus infection were common concomitant diseases in these patients. The median (range) duration of follow-up were 19 (2–76) weeks in albendazole group, 39 (2–74) weeks in single dose ivermectin group, and 26 (2–74) weeks in double doses ivermectin group. Parasitological cure rate were 63.3%, 96.8% and 93.1% in albendazole, single dose oral ivermectin

  14. Efficacy and tolerability of concurrent weekly low dose cisplatin during radiation treatment of localised muscle invasive bladder transitional cell carcinoma: A report of two sequential Phase II studies from the Trans Tasman Radiation Oncology Group

    International Nuclear Information System (INIS)

    Gogna, Nirdosh Kumar; Matthews, John H.L.; Turner, Sandra L.; Mameghan, Heidi; Duchesne, Gillian M.; Spry, Nigel; Berry, Martin P.; Keller, Jacqui; Tripcony, Lee

    2006-01-01

    Background and purpose: To determine the feasibility, toxicity, and clinical effectiveness of concurrent weekly cisplatin chemotherapy in conjunction with definitive radiation in the treatment of localised muscle invasive bladder cancer. Patients and methods: In January 1997 the Trans Tasman Radiation Oncology Group embarked on a Phase II study (TROG 97.01) of weekly cisplatin (35 mg/m 2 x 7 doses) plus radiation to a dose of 63 Gy over 7 weeks. Following an interim toxicity analysis, the dose intensity of cisplatin was reduced to 6 cycles and the radiation schedule changed to 64 Gy over 6.5 weeks leading to the second study (TROG 99.06). A total of 113 patients were enrolled. Results: Acute grade 3 urinary toxicity occurred in 23% of the patients. Acute grade 4 pelvic toxicity was not seen. Thirty-eight patients (33%) experienced grade 3 or 4 cisplatin related toxicities with 15 patients (12%) requiring significant dose modification. The reduced dose intensity in Study 99.06 improved tolerability. Incidence of significant late morbidity was low (6%). Seventy-nine patients (70%) achieved complete remission at the 6 month cystoscopic assessment. Local invasive recurrence was seen in 11 of the 79 patients (14%). In 18 patients (16%) isolated superficial TCC/CIS were detected (6 months and beyond).The local control rate was 45% with a functional bladder being retained in 69 of the 113 patients (61%). RFS and DSS at 5 years were 33% and 50%, respectively. Conclusion: Our two sequential Phase II studies have shown that concurrent chemoradiation using weekly cisplatin in the management of localised invasive bladder TCC is feasible and reasonably well tolerated. This approach is currently being investigated further in a randomised study

  15. Permissive hypercapnia for the prevention of morbidity and mortality in mechanically ventilated newborn infants.

    Science.gov (United States)

    Woodgate, P G; Davies, M W

    2001-01-01

    combined data was possible for three outcomes. There was no evidence that permissive hypercapnia reduced the incidence of death or chronic lung disease at 36 weeks (RR 0.94, 95% CI 0.78, 1.15), intraventricular haemorrhage grade 3 or 4 (RR 0.84, 95% CI 0.54, 1.31) or periventricular leukomalacia (RR 1.02, 95% CI 0.49, 2.12). There were no differences in any other reported outcomes when the strategy of permissive hypercapnia/minimal ventilation was compared to routine ventilation in newborn infants. Long term neurodevelopmental outcomes were not reported. One trial reported that permissive hypercapnia reduced the incidence of chronic lung disease in the 501 to 750 gram subgroup. This review does not demonstrate any significant overall benefit of a permissive hypercapnia/minimal ventilation strategy compared to a routine ventilation strategy. At present, therefore, these ventilation strategies cannot be recommended to reduce mortality, or pulmonary and neurodevelopmental morbidity. Ventilatory strategies which target high levels of PCO2 (> 55 mmHg) should only be undertaken in the context of well-designed controlled clinical trials. These trials should aim to establish the safe, or ideal, range for CO2 in ventilated newborns, and examine the role of protective ventilatory techniques in achieving this target.

  16. The Effects of 6 Weeks of Endurance Training and Consumption of Different Doses of Boldenone on Hematological Factors and Spleen Structure Changes in Male Wistar Rats

    Directory of Open Access Journals (Sweden)

    Asieh Abbassi Daloii

    2017-06-01

    Full Text Available Background and Objectives: Regardless of how many periods and how long the androgenic-anabolic steroids have been used, they can cause side effects. The objective of this study was to investigate the effect a 6-week endurance training and using different doses of anabolic steroid boldenone on hematological factors and changes in spleen structure in male Wistar rats. Methods: In this experimental study, 47 male Wistar rats aged 12 weeks, were randomly divided into 7 groups (control, sham, boldenone-1, boldenone-2, endurance training, endurance training+boldenone-1, endurance training+boldenone-2. Increasing endurance training program was performed at the speed of 10-30m/min (Vo2max, 75-80% for 6 weeks and 5 days/week. The drug was injected deeply into the quadriceps and hamstring muscles once a week, on an appointed day. After anesthesia and dissection, the spleen was removed. Finally, the selected microscopic sections, were studied using a light microscope after staining with hematoxylin and eosin. Data were analyzed by dependent t-, one-way ANOVA, and post-hoc LSD tests at α<0.05 level. Results: In this study, boldenone supplementation at different doses led to weight gain, non-significant decrease in spleen weight (p=0.297, increase in white blood cells (p=0.041, and increase in hematocrit level (p=0.017. Also, there was a significant difference between the effect of exercise and boldenone consumption on the extent of damage to white pulp, red pulp, and the spleen sinusoidal space (p=0.001. Conclusion: The findings of this study showed it is likely that short-term consumption of boldenone have negative effects on the spleen structure, followed by negative changes in hematological factors.

  17. Entyvio lengthen dose-interval study: lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease.

    Science.gov (United States)

    Chan, Webber; Lynch, Nicole; Bampton, Peter; Chang, Jeff; Chung, Alvin; Florin, Timothy; Hetzel, David J; Jakobovits, Simon; Moore, Gregory; Pavli, Paul; Radford-Smith, Graham; Thin, Lena; Baraty, Brandon; Haifer, Craig; Yau, Yunki; Leong, Rupert W L

    2018-07-01

    Vedolizumab (VDZ), an α4β7 anti-integrin antibody, is efficacious in the induction and maintenance of remission in ulcerative colitis (UC) and Crohn's disease (CD). In the GEMINI long-term safety study, enrolled patients received 4-weekly VDZ. Upon completion, patients were switched to 8-weekly VDZ in Australia. The clinical success rate of treatment de-escalation for patients in remission on VDZ has not been described previously. To determine the proportion of patients who relapsed after switching from 4 to 8-weekly VDZ, the mean time to relapse, and the recapture rate when switching back to 8-weekly dosing. This was a retrospective, observational, multicenter study of patients previously recruited into GEMINI long-term safety in Australia. Data on the demographics and biochemical findings were collected. There were 34 patients [23 men, mean age 49.1 (±13.1) years] and their mean disease duration was 17.6 (±8.5) years. The mean 4-weekly VDZ infusion duration was 286.5 (±48.8) weeks. A total of five (15%) patients relapsed on dose-interval increase (4/17 UC, 1/17 CD) at a median duration from dose interval lengthening to flare of 14 weeks (interquartile range=6-25). Eighty percent (4/5) of patients re-entered remission following dose-interval decrease back to 4-weekly. No clinical predictors of relapse could be determined because of the small cohort size. The risk of patients relapsing when switching from 4 to 8-weekly VDZ ∼15% and is similar between CD and UC. Dose-interval decrease recaptures 80% of patients who relapsed. Therapeutic drug monitoring of VDZ may be of clinical relevance.

  18. Maximum permissible dietary contamination after the accidental release of radioactive materials from a nuclear reactor

    Energy Technology Data Exchange (ETDEWEB)

    Pochin, E E; Rock Carling, Ernest; Court Brown, W M [Medical Research Council, Committee on Protection against Ionizing Radiations, London (United Kingdom); and others

    1960-12-01

    After the accident to No. 1 pile at Windscale on October 10, 1957 (Atomic Energy Office, 1957), the Atomic Energy Authority asked the Medical Research Council for advice on the maximum intake of certain radioactive isotopes that should be regarded as permissible, under emergency conditions, for members of the general population living in, or deriving food from, an area contaminated owing to an accident to a reactor. The Council's Committee on Protection against Ionizing Radiations, together with its Subcommittees on Internal and External Radiations, has considered this problem, and concludes that the intake of radioactive materials by ingestion of contaminated food would generally be the limiting source of hazard after any such accident. Intake by inhalation, or radiation from the exterior, would become of importance only in rather special circumstances. In the following report, therefore, the Committee proposes maximum permissible levels of dietary contamination for the relevant isotopes in the emergency conditions envisaged. In proposing these levels, the Protection Committee has used the fullest information available on the radiation doses that would be delivered to different body tissues and at different ages by the isotopes concerned, and on the ways in which these materials would enter the body.

  19. Maximum permissible dietary contamination after the accidental release of radioactive materials from a nuclear reactor

    International Nuclear Information System (INIS)

    Pochin, E.E.; Rock Carling, Ernest; Court Brown, W.M.

    1960-01-01

    After the accident to No. 1 pile at Windscale on October 10, 1957 (Atomic Energy Office, 1957), the Atomic Energy Authority asked the Medical Research Council for advice on the maximum intake of certain radioactive isotopes that should be regarded as permissible, under emergency conditions, for members of the general population living in, or deriving food from, an area contaminated owing to an accident to a reactor. The Council's Committee on Protection against Ionizing Radiations, together with its Subcommittees on Internal and External Radiations, has considered this problem, and concludes that the intake of radioactive materials by ingestion of contaminated food would generally be the limiting source of hazard after any such accident. Intake by inhalation, or radiation from the exterior, would become of importance only in rather special circumstances. In the following report, therefore, the Committee proposes maximum permissible levels of dietary contamination for the relevant isotopes in the emergency conditions envisaged. In proposing these levels, the Protection Committee has used the fullest information available on the radiation doses that would be delivered to different body tissues and at different ages by the isotopes concerned, and on the ways in which these materials would enter the body

  20. Treatment of local recurrent breast cancer by divided dose electron beam radiation twice a week

    International Nuclear Information System (INIS)

    Ito, Ichiro; Suzuki, Yoshihiko; Miyaishi, Kazuo; Mitsuhashi, Norio; Kimura, Makoto

    1978-01-01

    The objectives of this study were to investigate the effects of divided dose electron beam radiation twice a week (with a focal dose of 600 rads at a time) on local recurrent tumors of postoperative breast cancer and to compare it with the conventional photon radiation in the hope that it might be better tolerated by the patients, with less damage to normal skin and lung tissues. Out of 261 patients with breast cancer who came to the Department of Radiology, at Gunma Univ. Hospital, Maebashi, during the period Jan., 1970, through Jun., 1976, 41 patients who received electron beam radiation for local recurrence (in 81 sites) and 31 who received prophylactic radiation over the chest wall postoperatively. Tumors completely disappeared from 73 out of 81 sites irradiated for local recurrence (accounting 90% of the 81 sites). The local recurrent lesions were classified to the ''disseminated'' and the ''focal'' type to compare the effects of the radiation, and it was found that the radiation eliminated the tumors from all (100%) of the 63 sites of the former type, while the radiation was capable of eliminating the tumors from only 10 out of the 18 sites of the latter type (56%). When the focal type tumors were classified by histopathologic typing to compare the effects of the radiation, the radiation was assessed effective in papillotubular carcinoma, medullary tubular carcinoma and scirrhous carcinoma in the decreasing sequence of significance. Pulmonary disorders occurred in 12% of all the observed sites. However, it is possible to further reduce this incidence by the adequate use of the tissue compensating filter, Mix-R. A skin disorder (erosion) was observed in 59% of all the sites observed. However, it may be anticipated that the topical application of a suitable corticoid (Beta-methasone-17-valerate cream) preparation will by prophylactically effective. (auth.)

  1. NASA Space Radiation Protection Strategies: Risk Assessment and Permissible Exposure Limits

    Science.gov (United States)

    Huff, J. L.; Patel, Z. S.; Simonsen, L. C.

    2017-01-01

    Permissible exposure limits (PELs) for short-term and career astronaut exposures to space radiation have been set and approved by NASA with the goal of protecting astronauts against health risks associated with ionizing radiation exposure. Short term PELs are intended to prevent clinically significant deterministic health effects, including performance decrements, which could threaten astronaut health and jeopardize mission success. Career PELs are implemented to control late occurring health effects, including a 3% risk of exposure induced death (REID) from cancer, and dose limits are used to prevent cardiovascular and central nervous system diseases. For radiation protection, meeting the cancer PEL is currently the design driver for galactic cosmic ray and solar particle event shielding, mission duration, and crew certification (e.g., 1-year ISS missions). The risk of cancer development is the largest known long-term health consequence following radiation exposure, and current estimates for long-term health risks due to cardiovascular diseases are approximately 30% to 40% of the cancer risk for exposures above an estimated threshold (Deep Space one-year and Mars missions). Large uncertainties currently exist in estimating the health risks of space radiation exposure. Improved understanding through radiobiology and physics research allows increased accuracy in risk estimation and is essential for ensuring astronaut health as well as for controlling mission costs, optimization of mission operations, vehicle design, and countermeasure assessment. We will review the Space Radiation Program Element's research strategies to increase accuracy in risk models and to inform development and validation of the permissible exposure limits.

  2. Peripheral photon and neutron doses from prostate cancer external beam irradiation.

    Science.gov (United States)

    Bezak, Eva; Takam, Rundgham; Marcu, Loredana G

    2015-12-01

    Peripheral photon and neutron doses from external beam radiotherapy (EBRT) are associated with increased risk of carcinogenesis in the out-of-field organs; thus, dose estimations of secondary radiation are imperative. Peripheral photon and neutron doses from EBRT of prostate carcinoma were measured in Rando phantom. (6)LiF:Mg,Cu,P and (7)LiF:Mg,Cu,P glass-rod thermoluminescence dosemeters (TLDs) were inserted in slices of a Rando phantom followed by exposure to 80 Gy with 18-MV photon four-field 3D-CRT technique. The TLDs were calibrated using 6- and 18-MV X-ray beam. Neutron dose equivalents measured with CR-39 etch-track detectors were used to derive readout-to-neutron dose conversion factor for (6)LiF:Mg,Cu,P TLDs. Average neutron dose equivalents per 1 Gy of isocentre dose were 3.8±0.9 mSv Gy(-1) for thyroid and 7.0±5.4 mSv Gy(-1) for colon. For photons, the average dose equivalents per 1 Gy of isocentre dose were 0.2±0.1 mSv Gy(-1) for thyroid and 8.1±9.7 mSv Gy(-1) for colon. Paired (6)LiF:Mg,Cu,P and (7)LiF:Mg,Cu,P TLDs can be used to measure photon and neutron doses simultaneously. Organs in close proximity to target received larger doses from photons than those from neutrons whereas distally located organs received higher neutron versus photon dose. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Corticosteroid administration within 2 weeks after renal transplantation affects the incidence of femoral head osteonecrosis

    Science.gov (United States)

    Saito, Masazumi; Ueshima, Keiichiro; Fujioka, Mikihiro; Ishida, Masashi; Goto, Tsuyoshi; Arai, Yuji; Ikoma, Kazuya; Fujiwara, Hiroyoshi; Fukushima, Wakaba; Kubo, Toshikazu

    2014-01-01

    Background and purpose It has been suggested that avascular osteonecrosis (AVN) of the femoral head occurs early after systemic steroid administration. The purpose of this study was to investigate the risks regarding development of AVN at a very early stage after renal transplantation. Methods The presence or absence of AVN was determined by MRI at 4 weeks, at 6–12 weeks, at 24 weeks, and at 12 months after renal transplantation in 286 patients (183 males) with a mean age of 39 (16–65) years. The relationship between AVN and age, sex, absence or presence of acute rejection (AR), type of transplanted kidney (living or cadaveric), type of immune suppressor, and total dose of orally administered steroids given in the 2-week period after transplantation was investigated. Results There were no statistically significant correlations between the development of AVN and age, sex, absence or presence of AR, type of transplanted kidney, or type of immune suppressor. A significant dose-response relationship was found between development of AVN and the total dose of steroid administered in the first 2 weeks after surgery. Interpretation We found a relationship between AVN development and steroid dose in the early postoperative period, and we also showed a dose-response relationship. PMID:24786907

  4. The ecological determination of the permissible concentrations for radioactive contamination

    International Nuclear Information System (INIS)

    Kononovich, A.L.

    1996-01-01

    It is supposed that all inhabitants of the ecosystem are enjoying equal rights. The report describes the approximate method of ecology normalizing of the permissible radionuclide concentrations. Definition of the permissible concentration is made by an indirect way, since the defining criterion is unknown

  5. Can ‘Mobile Platform’ and ‘Permission Marketing’ dance a tango to the consumers' tune? Modeling adoption of ‘SMS based Permission Advertising’

    Directory of Open Access Journals (Sweden)

    Prerna Bamoriya

    2015-12-01

    Full Text Available Many a times situation of advertising clutter is further aggrieved by the markers’ intrusive practices i.e. not asking for consumer’s explicit permission. It results in consumers’ alienation and reduced advertising effectiveness. Solution could be integration of Permission Marketing with an innovative advertising platform like Mobile. This study aimed to develop and validate a comprehensive model for understanding consumers’ adoption behavior towards SMS Based Permission Advertising (SBPA. For this, data was collected using systematic random sampling from 524 respondents and was analyzed using Structural Equation Modeling. Study revealed some critical variables along with complex relationships among such variables, in form of an empirically validated model. At last, study made some important implications for practitioners and researchers.

  6. The link between maternal sleep and permissive parenting during late adolescence.

    Science.gov (United States)

    Tu, Kelly M; Elmore-Staton, Lori; Buckhalt, Joseph A; El-Sheikh, Mona

    2018-03-05

    Utilizing a multi-method design, the present study examined the association between maternal sleep, assessed via actigraphy and self-reports, and permissive parenting (e.g. lax, inconsistent discipline) during adolescence, as well as the extent to which this association differed by mothers' race/ethnicity and socioeconomic status. The sample was comprised of 234 mothers (M age = 41.76 years, SD = 6.25; 67% European-American, 31% African-American, 2% other race/ethnicities) and 237 adolescents (113 boys, 124 girls; M age = 15.80 years, SD = 0.80; 66% European-American, 34% African-American). Mothers' sleep duration (actual sleep minutes) and quality (sleep efficiency, latency, long wake episodes) were assessed using actigraphy. Mothers also reported on their sleep problems and adolescents reported on mothers' permissive parenting behaviours. Results revealed that actigraphy-based longer sleep duration and shorter sleep latency were associated with lower levels of permissive parenting. Further, mothers' race/ethnicity and socioeconomic status moderated the association between actigraphy-based sleep quality (i.e. sleep efficiency, long wake episodes) and permissive parenting. Specifically, a negative association between sleep efficiency and permissive parenting was evident only for African-American mothers. In addition, a positive association between more frequent night wakings and permissive parenting was evident only for mothers from lower socioeconomic status households. The findings highlight the benefits of longer and higher-quality sleep for reducing the risk of permissive parenting, especially among ethnic minority mothers and mothers from lower socioeconomic status households. © 2018 European Sleep Research Society.

  7. A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

    International Nuclear Information System (INIS)

    Geara, Fady B; Shamseddine, Ali; Khalil, Ali; Abboud, Mirna; Charafeddine, Maya; Seoud, Muhieddine

    2010-01-01

    This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m 2 Cisplatin (group I; 16 patients) or 50 mg/m 2 paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months. Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively. This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix

  8. Administration of cetuximab every 2 weeks in the treatment of metastatic colorectal cancer

    DEFF Research Database (Denmark)

    Tabernero, Josep; Pfeiffer, Per; Cervantes, Andrés

    2008-01-01

    The primary purpose of this paper is to present the available evidence for the administration of cetuximab on an every-2-weeks basis in combination with irinotecan in metastatic colorectal cancer (mCRC). Cetuximab is an epidermal growth factor receptor-targeted IgG(1) monoclonal antibody...... that is approved for use in combination with irinotecan or as monotherapy in the treatment of mCRC. The currently approved dosing regimen for cetuximab is a 400-mg/m(2) initial dose followed by 250 mg/m(2) weekly. Many commonly used chemotherapy agents for mCRC (including irinotecan alone or in combination with 5......-fluorouracil [5-FU]/folinic acid [FA] and oxaliplatin plus 5-FU/FA) are administered on an every-2-weeks basis. The ability to synchronize the administration of cetuximab and concomitant chemotherapy is desirable for both patients and health care workers. A cetuximab dose of 500 mg/m(2) every 2 weeks exhibited...

  9. May I sleep in your bed? Getting permission to book

    NARCIS (Netherlands)

    Karlsson, L.; Kemperman, A.D.A.M.; Dolnicar, S.

    2017-01-01

    Demand for tourist accommodation offered on peer-to-peer networks is skyrocketing. In such networks tourists can only book if the accommodation provider (host) gives their permission. Needing permission to book accommodation is radically new in tourism. No hotel, motel or B&B assesses a tourist

  10. Rationalizing the Permissibility of Mosque Decoration

    Directory of Open Access Journals (Sweden)

    Spahic Omer

    2016-06-01

    Full Text Available This paper discusses the subject of mosque decoration and some of the criteria which determine its permissibility or otherwise. Some aspects of the matter are somewhat sensitive and double-edged. Thus, the paper presents an objective, balanced and scientific account of the theme, steering clear of the sentimental aspects of the evidences often put forth by both the proponents and opponents of mosque decoration. The main thrusts of the paper are the issues pertaining to the legitimacy of decoration in general, the subject of the function of mosques vis-à-vis their decoration, as well as the broad guidelines that regulate mosque decoration emphasizing the decoration of the mihrab (praying niche area and the qiblah wall. The paper concludes that in principle mosque decoration is permissible so long as it conforms to the requirements of the Islamic spirituality and the quintessence of genuine Islamic art and architecture.

  11. Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids

    DEFF Research Database (Denmark)

    Weinstein, Steven F; Corren, Jonathan; Murphy, Kevin

    2010-01-01

    A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 microg versus MF 400 microg administered twice-daily (b.i.d.) via metered-dose inhaler in patients...... with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (>or=12 years of age) were randomized to MF/F 200/10 microg, MF/F 400/10 microg, or MF 400 microg, b.i.d. after a 2- to 3-week open-label run in with MF 400...... microg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV(1) AUC(0-12h)) from baseline to week 12 for MF/F 400/10 microg versus MF 400 microg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events...

  12. Substantiation of the permissible radioactive contamination of working clothes

    International Nuclear Information System (INIS)

    Shcherbakov, V.L.; Korostin, A.S.

    1977-01-01

    A permissible level of working clothes contamination was determined on the base of the main migration routes of radioactive contaminants: permeation directly through the clothes into subclothes space on skin surface, emission into the air with amount of contaminants subsequently got by the organism of a working person through inhalation as well as transfer in the process of contacting of contaminated working clothes and surfaces of premises equipment, working person hands with amount of contaminants posteriorly got by the organism by alimentary or inhalation ways. Using the experimental and literature data available the permissible levels of working clothes contamination for the mentioned migration routes of radioactive materials have been calculated. According to the data obtained the permissible levels of working clothes contamination must not exceed 4 alpha-part/(cm 2 xmin) for contamination with high-tonic isotopes, 20 alpha-part./(cm 2 xmin) with other alpha-detine isotopes, 1000 beta-part./(cm 2 xmin) with beta-active ones. The permissible level of contamination of additional materials of the individual protection in the case of their contamination with high-tonic alpha-actine isotopes must not exceed 50 alpha-part./(cm 2 xmin), 200 alpha-part./(cm 2 xmin) for contamination th other alpha-active isotopes and 400 beta-part./(cm 2 xmin) with beta-active isotopes

  13. Pegylated Long-Acting Human Growth Hormone Possesses a Promising Once-Weekly Treatment Profile, and Multiple Dosing Is Well Tolerated in Adult Patients with Growth Hormone Deficiency

    DEFF Research Database (Denmark)

    Søndergaard, Esben; Klose, Marianne Christina; Hansen, Mette

    2011-01-01

    Background: Recombinant human GH (rhGH) replacement therapy in children and adults currently requires daily sc injections for several years or lifelong, which may be both inconvenient and distressing for patients. NNC126-0083 is a pegylated rhGH developed for once-weekly administration. Objectives......: Our objective was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of NNC126-0083 in adult patients with GH deficiency (GHD). Subjects and Methods: Thirty-three adult patients with GHD, age 20-65 yr, body mass index 18.5-35.0 kg/m(2), and glycated...... to 240 h after the third dosing. Physical examination, antibodies, and local tolerability were assessed. Results: NNC126-0083 was well tolerated with no difference in local tolerability compared with placebo and with no signs of lipoatrophy. A more than dose-proportional exposure was observed...

  14. Permissive Subsorted Partial Logic in CASL

    DEFF Research Database (Denmark)

    Cerioli, Maura; Haxthausen, Anne Elisabeth; Krieg-Brückner, Bernd

    1997-01-01

    This paper presents a permissive subsorted partial logic used in the CoFI Algebraic Specification Language. In contrast to other order-sorted logics, subsorting is not modeled by set inclusions, but by injective embeddings allowing for more general models in which subtypes can have different data...

  15. Dose from radiological examinations

    International Nuclear Information System (INIS)

    Imamura, Keiko; Uji, Teruyuki; Sakuyama, Keiko; Fujikawa, Mitsuhiro; Fujii, Masamichi

    1976-01-01

    Relatively high gonad doses, several hundred to one thousand mR, have been observed in case of pelvis, hip-joint, coccyx, lower abdomen and lumber examination. Dose to the ovary is especially high in barium enema and I.V.P. examinations. About 12 per cent of the 4-ray examination are high-dose. The gonad dose is relatively high in examination of abdomen and lower extremities, in infants. The dose to the eyes is especially high, 1.0 to 2.5R per exposure, in temporal bone and nasal sinuses tomography. X-ray doses have been compared with dose limits recommended by ICRP and with the gonad dose from natural radiations. The gonad dose in lumbar examination, barium enema, I.V.P. etc. is as high as the maximum permissible dose per year recommended by ICRP. Several devices have been made for dose reduction in the daily examinations: (1) separating the radiation field from the gonad by one centimeter decreases the gonad dose about one-half. (2) using sensitive screens and films. In pelvimetry and in infant hip-joint examination, the most sensitive screen and film are used. In the I.V.P. examination of adult, use of MS screen in place of FS screen decreases the dose to one-third, in combination with careful setting of radiation field, (3) use of grid increases the dose about 50 percent and the lead rubber protection (0.1mm lead equivalent) decreases the gonad dose to one-thirtieth in the spinal column examination of infant, (4) A lead protector, 1mm thickness and 2.5cm in diameter, on the eyes decreases the dose to about one-eighth in the face and nead examinations. These simple and effective methods for dose reduction. Should be carried out in as many examinations as possible in addition to observing dose limits recommended by ICRP. (Evans, J.)

  16. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile.

    Science.gov (United States)

    Rasmussen, Michael Højby; Olsen, Minna W Brændholt; Alifrangis, Lene; Klim, Søren; Suntum, Mette

    2014-10-01

    Human growth hormone (hGH) replacement therapy currently requires daily sc injections for years/lifetime, which may be both inconvenient and distressing for patients. NNC0195-0092 is a novel hGH derivative intended for once-weekly treatment of GH deficiency. A noncovalent albumin binding moiety is attached to the hGH backbone. Clearance is reduced as a consequence of a reversible binding to circulating serum albumin, which prolongs the pharmacodynamic (PD) effect. To evaluate safety, local tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose (SD) and multiple doses (MD) of NNC0195-0092. Randomized, single-center, placebo-controlled, double-blind, SD/MD, dose-escalation trial of 105 healthy male subjects. NNC0195-0092 sc administration: Five cohorts of eight subjects received one dose of NNC0195-0092 (0.01-0.32 mg/kg) (n = 6) or placebo (n = 2). Sixteen subjects (equal numbers of Japanese and non-Asian) received once-weekly doses of NNC0195-0092 (0.02-0.24 mg/kg; n=12) or placebo (n=4) for 4 weeks. Blood samples were drawn for assessment of safety, PK, IGF-1, and IGF binding protein 3 profiles and anti-drug antibodies. SD and MD of NNC0195-0092 were well tolerated at all dose levels. No safety concerns or local tolerability issues were identified. A dose-dependent IGF-1 response was observed. IGF-1 profiles suggest that NNC0195-0092 may be suitable for once-weekly dosing, with a clinically relevant dose ≤0.08 mg/kg/week. No differences in PK and PD were observed between Japanese and non-Asian subjects. SD and MD of NNC0195-0092 administered to healthy Japanese and non-Asian male subjects were well tolerated at all doses. The present trial suggests that NNC0195-0092 has the potential for an efficacious, well-tolerated, once-weekly GH treatment.

  17. Fetal dose evaluation during breast cancer radiotherapy

    International Nuclear Information System (INIS)

    Antypas, Christos; Sandilos, Panagiotis; Kouvaris, John; Balafouta, Ersi; Karinou, Eleftheria; Kollaros, Nikos; Vlahos, Lambros

    1998-01-01

    Purpose: The aim of the work was to estimate the radiation dose delivered to the fetus in a pregnant patient irradiated for breast cancer. Methods and Materials: A 45-year woman was treated for left breast cancer using a 6 MV photon beam with two isocentric opposing tangential unwedged fields. Daily dose was 2.3 Gy at 95% isodose line given by two fields/day, 5 days/week. A total dose of 46 Gy was given in 20 fractions over a 4-week period. Pregnancy confirmed during the second therapeutic week. Treatment lasted between the second and sixth gestation week. Radiation dose to fetus was estimated from in vivo and phantom measurements using thermoluminescence dosimeters and an ionization chamber. In vivo measurements were performed by inserting either a catheter with TL dosimeters or ionization chamber into the patient's rectum. Phantom measurements were performed by simulating the treatment conditions on an anthropomorphic phantom. Results: TLD measurements (in vivo and phantom) revealed fetal dose to be 0.085% of the tumor dose, corresponding to a cumulative fetal dose of 3.9 cGy for the entire treatment of 46 Gy. Chamber measurements (in vivo and phantom) revealed a fetal dose less than the TLD result: 0.079 and 0.083% of the tumor dose corresponding to cumulative fetal dose of 3.6 cGy and 3.8 cGy for in vivo and phantom measurement, respectively. Conclusions: It was concluded that the cumulative dose delivered to the unshielded fetus was 3.9 cGy for a 46 Gy total tumor dose. The estimated fetal dose is low compared to the total tumor dose given due to the early stage of pregnancy, the large distance between fundus-radiation field, and the fact that no wedges and/or lead blocks were used. No deterministic biological effects of radiation on the live-born embryo are expected. The lifetime risk for radiation-induced fatal cancer is higher than the normal incidence, but is considered as inconsequential

  18. Radiation exposure doses of employees in reactor facilities for test and research and under research and development stages, and in facilities for nuclear fuel refining, fabrication, reprocessing and usage

    International Nuclear Information System (INIS)

    1980-01-01

    (1) Radiation exposure doses in reactor facilities. The owners of reactor facilities are obliged by law to control the radiation exposure doses of the employees below the permissible levels. The data based on the reports made in this connection are given in tables for the fiscal year 1978 (from April 1978 to March 1979). It was revealed that the radiation exposure doses of the employees were far below the permissible levels. The distributions of exposure doses in Japan Atomic Energy Research Institute, Power Reactor and Nuclear Fuel Development Corporation and so on are presented for the whole year and the respective quarters. (2) Radiation exposure doses in facilities for nuclear fuel. The owners are similarly obliged to control radiation exposure. The data in this connection are given, and the doses were far below the permissible levels. The distributions in the private enterprises and so on are presented for the whole year. (J.P.N.)

  19. Effect of an Early Dose of Measles Vaccine on Morbidity Between 18 Weeks and 9 Months of Age: A Randomized, Controlled Trial in Guinea-Bissau

    DEFF Research Database (Denmark)

    Do, Vu An; Biering-Sorensen, Sofie; Fisker, Ane Bærent

    2017-01-01

    with a higher risk of the well-known adverse events of fever, rash, and convulsions within the first 14 days. From 15 days after randomization to age 9 months, early measles vaccination was associated with reductions in maternally reported diarrhea (hazard ratio [HR], 0.89; 95% confidence interval [CI],.82-. 97......Background: Children in Guinea-Bissau receive measles vaccine (MV) at 9 months of age, but studies have shown that an additional dose before 9 months of age might have beneficial nonspecific effects. Within a randomized trial designed to examine nonspecific effects of early MV receipt on mortality......, we conducted a substudy to investigate the effect of early MV receipt on morbidity. Methods: Children were randomly assigned at a ratio of 2: 1 to receive 2 doses of MVat 18 weeks and age 9 months (intervention group) or 1 dose of MV at age 9 months, in accordance with current practice (control group...

  20. Automated dose estimation for lost or damaged dosimeters

    International Nuclear Information System (INIS)

    Thompson, W.L.; Deininger, R.J.

    1988-01-01

    This paper reports that some dosimetry vendors will compute doses for their customers' lost/damaged dosimeters based upon an average of recent dosimeter readings. However, the vendors usually require authorization from the customer for each such occurrence. Therefore, the tedious task of keeping track of the overdue status of each missing dosimeter and constantly notifying the vendor is still present. Also, depending on the monthly variability of a given person's doses, it may be more valid to use the employee's average dose, his/her highest dose over a recent period, an average dose of other employees with similar job duties for that period, or the maximum permissible dose. Thus, the task of estimating doses for lost/damaged dosimeters cannot be delegated to dosimetry vendor. Instead, the radiation safety department must sue the data supplied by the vendor as input for performing estimates. The process is performed automatically at the Medical Center Hospital of Vermont using a personal computer and a relational database

  1. A METHOD TO IMPROVE DOSE ASSESSMENT BY RECONSTRUCTION OF THE COMPLETE ISOTOPES INVENTORY.

    Science.gov (United States)

    Bonin, Alice; Tsilanizara, Aimé

    2017-06-01

    Radiation shielding assessments may underestimate the expected dose if some isotopes at trace level are not considered in the isotopes inventory of the shielded radioactive materials. Indeed, information about traces is not often available. Nevertheless, the activation of some minor isotopic traces may significantly contribute to the dose build-up. This paper presents a new method (Isotopes Inventory Reconstruction-IIR) estimating the concentration of the minor isotopes in the irradiated material at the beginning of the cooling period. The method requires the solution of the inverse problem describing the irradiated material's decay. In a mixture of an irradiated uranium-plutonium oxide shielded by a set-up made of stainless-steel, porous polyethylene plaster and lead methyl methacrylate, the comparison between different methods proves that the IIR-method allows better assessment of the dose than other approximate methods. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Validation of a MOSFET dosemeter system for determining the absorbed and effective radiation doses in diagnostic radiology.

    Science.gov (United States)

    Manninen, A-L; Kotiaho, A; Nikkinen, J; Nieminen, M T

    2015-04-01

    This study aimed to validate a MOSFET dosemeter system for determining absorbed and effective doses (EDs) in the dose and energy range used in diagnostic radiology. Energy dependence, dose linearity and repeatability of the dosemeter were examined. The absorbed doses (ADs) were compared at anterior-posterior projection and the EDs were determined at posterior-anterior, anterior-posterior and lateral projections of thoracic imaging using an anthropomorphic phantom. The radiation exposures were made using digital radiography systems. This study revealed that the MOSFET system with high sensitivity bias supply set-up is sufficiently accurate for AD and ED determination. The dosemeter is recommended to be calibrated for energies 80 kVp. The entrance skin dose level should be at least 5 mGy to minimise the deviation of the individual dosemeter dose. For ED determination, dosemeters should be implanted perpendicular to the surface of the phantom to prevent the angular dependence error. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Estimation of staff lens doses during interventional procedures. Comparing cardiology, neuroradiology and interventional radiology.

    Science.gov (United States)

    Vano, E; Sanchez, R M; Fernandez, J M

    2015-07-01

    The purpose of this article is to estimate lens doses using over apron active personal dosemeters in interventional catheterisation laboratories (cardiology IC, neuroradiology IN and radiology IR) and to investigate correlations between occupational lens doses and patient doses. Active electronic personal dosemeters placed over the lead apron were used on a sample of 204 IC procedures, 274 IN and 220 IR (all performed at the same university hospital). Patient dose values (kerma area product) were also recorded to evaluate correlations with occupational doses. Operators used the ceiling-suspended screen in most cases. The median and third quartile values of equivalent dose Hp(10) per procedure measured over the apron for IC, IN and IR resulted, respectively, in 21/67, 19/44 and 24/54 µSv. Patient dose values (median/third quartile) were 75/128, 83/176 and 61/159 Gy cm(2), respectively. The median ratios for dosemeters worn over the apron by operators (protected by the ceiling-suspended screen) and patient doses were 0.36; 0.21 and 0.46 µSv Gy(-1) cm(-2), respectively. With the conservative approach used (lens doses estimated from the over apron chest dosemeter) we came to the conclusion that more than 800 procedures y(-1) and per operator were necessary to reach the new lens dose limit for the three interventional specialties. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Studies on chronic effects of lower dose level irradiation

    International Nuclear Information System (INIS)

    Yun, T.G.; Yun, Y.S.; Yun, M.S.

    1980-01-01

    This experiment is being carried out to elucidate the chronic effects of Co 60 (γ-ray) - low doses irradiation on JCR mice at 3rd week, 6th week, and 5th month after their birth. Experimental mice at 3rd week of age have been irradiated with Co 60 - 60mR weekly, Co 60 - 500mR weekly and Co 60 - 61R biweekly at the dose rate of 60mR per second for 23 weeks until now. Co 60 - 61R irradiated mice were subdivided into Co 60 - alone group and Co 60 combined with red ginseng extracts group. In their survivor's rate and their body weight etc., no significant differences between control groups and test groups in these experimental mice. Experimented mice at 6 weeks and 5 months of age are also being irradiated with Co 60 in the same doses as the above for 14 weeks and 8 weeks until present. In these experimental groups, there are also no significant differences between control groups and experimental groups in their survivor's rate and their body weight

  5. Effect of kefir and low-dose aspirin on arterial blood pressure measurements and renal apoptosis in unhypertensive rats with 4 weeks salt diet.

    Science.gov (United States)

    Kanbak, Güngör; Uzuner, Kubilay; Kuşat Ol, Kevser; Oğlakçı, Ayşegül; Kartkaya, Kazım; Şentürk, Hakan

    2014-01-01

    Abstract We aim to study the effect of low-dose aspirin and kefir on arterial blood pressure measurements and renal apoptosis in unhypertensive rats with 4 weeks salt diet. Forty adult male Sprague-Dawley rats were divided into five groups: control, high-salt (HS) (8.0% NaCl), HS+aspirin (10 mg/kg), HS+kefir (10.0%w/v), HS+aspirin +kefir. We measured sistolic blood pressure (SBP), mean arterial pressure (MAP), diastolic pressure, pulse pressure in the rats. Cathepsin B, L, DNA fragmentation and caspase-3 activities were determined from rat kidney tissues and rats clearance of creatinine calculated. Although HS diet increased significantly SBP, MAP, diastolic pressure, pulse pressure parameters compared the control values. They were not as high as accepted hypertension levels. When compared to HS groups, kefir groups significantly decrease Cathepsin B and DNA fragmentation levels. Caspase levels were elevated slightly in other groups according to control group. While, we also found that creatinine clearance was higher in HS+kefir and HS+low-dose aspirin than HS group. Thus, using low-dose aspirin had been approximately decreased of renal function damage. Kefir decreased renal function damage playing as Angiotensin-converting enzyme inhibitor. But, low-dose aspirin together with kefir worsened rat renal function damage. Cathepsin B might play role both apoptosis and prorenin-processing enzyme. But not caspase pathway may be involved in the present HS diet induced apoptosis. In conclusion, kefir and low-dose aspirin used independently protect renal function and renal damage induced by HS diet in rats.

  6. Optimizing Radiation Doses for Computed Tomography Across Institutions: Dose Auditing and Best Practices.

    Science.gov (United States)

    Demb, Joshua; Chu, Philip; Nelson, Thomas; Hall, David; Seibert, Anthony; Lamba, Ramit; Boone, John; Krishnam, Mayil; Cagnon, Christopher; Bostani, Maryam; Gould, Robert; Miglioretti, Diana; Smith-Bindman, Rebecca

    2017-06-01

    Radiation doses for computed tomography (CT) vary substantially across institutions. To assess the impact of institutional-level audit and collaborative efforts to share best practices on CT radiation doses across 5 University of California (UC) medical centers. In this before/after interventional study, we prospectively collected radiation dose metrics on all diagnostic CT examinations performed between October 1, 2013, and December 31, 2014, at 5 medical centers. Using data from January to March (baseline), we created audit reports detailing the distribution of radiation dose metrics for chest, abdomen, and head CT scans. In April, we shared reports with the medical centers and invited radiology professionals from the centers to a 1.5-day in-person meeting to review reports and share best practices. We calculated changes in mean effective dose 12 weeks before and after the audits and meeting, excluding a 12-week implementation period when medical centers could make changes. We compared proportions of examinations exceeding previously published benchmarks at baseline and following the audit and meeting, and calculated changes in proportion of examinations exceeding benchmarks. Of 158 274 diagnostic CT scans performed in the study period, 29 594 CT scans were performed in the 3 months before and 32 839 CT scans were performed 12 to 24 weeks after the audit and meeting. Reductions in mean effective dose were considerable for chest and abdomen. Mean effective dose for chest CT decreased from 13.2 to 10.7 mSv (18.9% reduction; 95% CI, 18.0%-19.8%). Reductions at individual medical centers ranged from 3.8% to 23.5%. The mean effective dose for abdominal CT decreased from 20.0 to 15.0 mSv (25.0% reduction; 95% CI, 24.3%-25.8%). Reductions at individual medical centers ranged from 10.8% to 34.7%. The number of CT scans that had an effective dose measurement that exceeded benchmarks was reduced considerably by 48% and 54% for chest and abdomen, respectively. After

  7. Immortalized sheep microglial cells are permissive to a diverse range of ruminant viruses.

    Science.gov (United States)

    Stanton, James B; Swanson, Beryl; Orozco, Edith; Muñoz-Gutiérrez, Juan F; Evermann, James F; Ridpath, Julia F

    2017-12-01

    Ruminants, including sheep and goats (small ruminants), are key agricultural animals in many parts of the world. Infectious diseases, including many viral diseases, are significant problems to efficient production of ruminants. Unfortunately, reagents tailored to viruses of ruminants, and especially small ruminants, are lacking compared to other animals more typically used for biomedical research. The purpose of this study was to determine the permissibility of a stably immortalized, sheep microglial cell line to viruses that are reported to infect ruminants: bovine viral diarrhea virus (BVDV), bovine herpesvirus 1 (BoHV-1), small ruminant lentiviruses (SRLV), and bovine respiratory syncytial virus (BRSV). Sublines A and H of previously isolated, immortalized, and characterized (CD14-positive) ovine microglial cells were used. Bovine turbinate cells and goat synovial membrane cells were used for comparison. Cytopathic changes were used to confirm infection of individual wells, which were then counted and used to calculate the 50% tissue culture infectious dose. Uninoculated cells served as negative controls and confirmed that the cells were not previously infected with these viruses using polymerase chain reaction (PCR). Inoculation of the two microglial cell sublines with laboratory and field isolates of BVDV, BoHV-1, and BRSV resulted in viral infection in a manner similar to bovine turbinate cells. Immortalized microglia cells are also permissive to SRLV, similar to goat synovial membrane cells. These immortalized sheep microglial cells provide a new tool for the study of ruminant viruses in ruminant microglial cell line.

  8. Permissible annual depositions and radionuclide concentrations in air

    International Nuclear Information System (INIS)

    Belyaev, V.A.; Golovko, M.Yu.

    1993-01-01

    It is established that it necessary to take into account the other ways of radionuclide intake apart from the inhalation one when determining the standards for radionuclide contamination of the atmospheric air. Whereby it is proposed to standardize annual depositions rather than permissible concentration in the atmospheric air for the ways related to radionuclide releases on the ground surface, which is explained by ambiguity of their dry deposition rate from the air. Formulae and results of calculation of standard characteristics are presented. The permissible radionuclide depositions, related to the intake through food chains are calculated with account for diet diversity, agroclimatic and phenological parameters in different regions of the country

  9. Follow My Recommendations: A Personalized Privacy Assistant for Mobile App Permissions

    DEFF Research Database (Denmark)

    Andersen, Mads Schaarup; Liu, Bin; Schaub, Florian

    2016-01-01

    Modern smartphone platforms have millions of apps, many of which request permissions to access private data and resources, like user accounts or location. While these smartphone platforms provide varying degrees of control over these permissions, the sheer number of decisions that users are expec...

  10. An Ethics of Permission: A Response to the California End of Life Option Act.

    Science.gov (United States)

    Nelson, Craig

    2016-01-01

    An ethics of permission can be helpful in framing a response to the ethical differences surrounding the California End of Life Option Act. Law does not define morality, and reaching a moral understanding demands thorough reflection. An ethics of permission examines the ethical demands of a permissive law for both clinician and patient. Serving the good of the patient, respecting professional conscience, and following the law are three ethical elements. Although developing an ethics of permission includes these three elements, these elements do not exhaust all the moral implications involved. An ethics of permission also includes the importance of exercising professional tolerance in the honoring of clinicians who choose to participate or refuse to participate. In addition, an ethics of permission also provides insight in implementing just and fair behavior among medical professionals.

  11. Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life

    Directory of Open Access Journals (Sweden)

    Williams Angela E

    2007-07-01

    Full Text Available Abstract Background Improving patients' health-related quality of life (HRQoL is recognized as a fundamental part of asthma management. The aims of this study were to evaluate the long-term efficacy (including symptom-free days and exacerbations and impact on HRQoL of a stable-dose regimen of salmeterol/fluticasone propionate (SAL/FP and an adjustable maintenance dosing (AMD regimen of formoterol/budesonide (FOR/BUD where treatment is adjusted based on symptoms [SAM40056]. Methods A total of 688 outpatients with asthma receiving regular low-dose inhaled corticosteroids (ICS plus a long-acting β2-agonist, or medium dose ICS alone participated in this randomized, double-blind, double-dummy, parallel-group, 1-year trial, which was conducted in 91 centers in 15 countries. Patients were randomized to receive 1 inhalation of SAL/FP 50/250 μg BID or 2 inhalations of FOR/BUD 6/200 μg BID during Weeks 1–4. For Weeks 5–52, patients meeting strict continuation criteria for stable asthma at Week 4 received AMD with FOR/BUD or stable-dose SAL/FP. Results The percentage of symptom-free days was significantly greater (58.8% vs 52.1%; p = 0.034 and the annual exacerbation rate was significantly lower (47%; p = 0.008 with stable-dose SAL/FP compared with FOR/BUD AMD. A total of 568 patients completed the Asthma Quality of Life Questionnaire (AQLQ at least once during the study. The mean change from baseline in AQLQ overall score was numerically greater with SAL/FP than FOR/BUD at week 28 and week 52, but did not reach statistical significance (p = 0.121 at Week 52. However, in a post hoc logistic regression analyses for any AQLQ improvement, significant benefits with SAL/FP were seen at both time points (p = 0.038 and p = 0.009, respectively. The minimally important difference of ≥ 0.5-point improvement in AQLQ overall score was achieved by a significantly greater number of patients receiving SAL/FP at Week 28 (68% vs 60%; p = 0.049; a trend for this

  12. Model of organ dose combination

    International Nuclear Information System (INIS)

    Valley, J.-F.; Lerch, P.

    1977-01-01

    The ICRP recommendations are based on the limitation of the dose to each organ. In the application and for a unique source the critical organ concept allows to limit the calculation and represents the irradiation status of an individuum. When several sources of radiation are involved the derivation of the dose contribution of each source to each organ is necessary. In order to represent the irradiation status a new parameter is to be defined. Propositions have been made by some authors, in particular by Jacobi introducing at this level biological parameters like the incidence rate of detriment and its severity. The new concept is certainly richer than a simple dose notion. However, in the actual situation of knowledge about radiation effects an intermediate parameter, using only physical concepts and the maximum permissible doses to the organs, seems more appropriate. The model, which is a generalization of the critical organ concept and shall be extended in the future to take the biological effects into account, will be presented [fr

  13. The influence of dose per fraction on the pathogenesis of radiation nephropathy

    Energy Technology Data Exchange (ETDEWEB)

    Yildiz, F.; Atahan, I.L.; Tuncel, M.; Konan, A. [Hacettepe University, Faculty of Medicine, Ankara (Turkey). Departments of Radiation Oncology and Anatomy

    1998-11-01

    Both kidneys of male Wistar rats were irradiated with either a 1 0-Gy single dose or 26 Gy at a rate of 2 Gy per fraction per day. Serum blood urea nitrogen (BUN), creatinine and blood haematocrit levels were assessed prior to radiotherapy and at intervals of 8 weeks thereafter. A subset of animals from each dose group were killed at 4, 8,16 and 24 weeks and both kidneys of each animal were examined by electron microscopy. In both dose groups a significant increase in BUN and creatinine levels, together with a decrease in haematocrit level, was observed at 16 weeks, and this was followed by an apparent improvement at 24 weeks. There was no statistical difference in these responses between the two groups. The morphological changes in both dose groups were essentially similar, but differed in severity. At 4 weeks after irradiation glomerular and proximal tubular injury were observed in both groups. A marked increase of glomerular and tubular injury in the 10-Gy dose group, without any apparent progression in the 26-Gy dose group, was detected at 8 weeks. By 16 weeks a noticeable improvement in both tubular and glomerular lesions (especially in the 10-Gy dose group) was observed. No apparent difference from the 16th week of evaluation was found at 24 weeks. These findings indicate that there is some recovery in kidney after irradiation, but the extent of the recovery process is somewhat limited. Copyright (1998) Blackwell Science Pty Ltd 38 refs., 1 tab., 4 figs.

  14. Maximum permissible body burdens and maximum permissible concentrations of radionuclides in air and in water for occupational exposure. Recommendations of the National Committee on Radiation Protection. Handbook 69

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1959-06-05

    The present Handbook and its predecessors stem from the Second International Congress of Radiology, held in Stockholm in 1928. At that time, under the auspices of the Congress, the International Commission on Radiological Protection (ICRP) was organized to deal initially with problems of X-ray protection and later with radioactivity protection. At that time 'permissible' doses of X-rays were estimated primarily in terms of exposures which produced erythema, the amount of exposure which would produce a defined reddening of the skin. Obviously a critical problem in establishing criteria for radiation protection was one of developing useful standards and techniques of physical measurement. For this reason two of the organizations in this country with a major concern for X-ray protection, the American Roentgen Ray Society and the Radiology Society of North America, suggested that the National Bureau of Standards assume responsibility for organizing representative experts to deal with the problem. Accordingly, early in 1929, an Advisory Committee on X-ray and Radium Protection was organized to develop recommendations on the protection problem within the United States and to formulate United States points of view for presentation to the International Commission on Radiological Protection. The organization of the U.S. Advisory Committee included experts from both the medical and physical science fields. The recommendations of this Handbook take into consideration the NCRP statement entitled 'Maximum Permissible Radiation Exposures to Man', published as an addendum to Handbook 59 on April 15, 1958. As noted above this study was carried out jointly by the ICRP and the NCRP, and the complete report is more extensive than the material contained in this Handbook.

  15. Maximum permissible body burdens and maximum permissible concentrations of radionuclides in air and in water for occupational exposure. Recommendations of the National Committee on Radiation Protection. Handbook 69

    International Nuclear Information System (INIS)

    1959-01-01

    The present Handbook and its predecessors stem from the Second International Congress of Radiology, held in Stockholm in 1928. At that time, under the auspices of the Congress, the International Commission on Radiological Protection (ICRP) was organized to deal initially with problems of X-ray protection and later with radioactivity protection. At that time 'permissible' doses of X-rays were estimated primarily in terms of exposures which produced erythema, the amount of exposure which would produce a defined reddening of the skin. Obviously a critical problem in establishing criteria for radiation protection was one of developing useful standards and techniques of physical measurement. For this reason two of the organizations in this country with a major concern for X-ray protection, the American Roentgen Ray Society and the Radiology Society of North America, suggested that the National Bureau of Standards assume responsibility for organizing representative experts to deal with the problem. Accordingly, early in 1929, an Advisory Committee on X-ray and Radium Protection was organized to develop recommendations on the protection problem within the United States and to formulate United States points of view for presentation to the International Commission on Radiological Protection. The organization of the U.S. Advisory Committee included experts from both the medical and physical science fields. The recommendations of this Handbook take into consideration the NCRP statement entitled 'Maximum Permissible Radiation Exposures to Man', published as an addendum to Handbook 59 on April 15, 1958. As noted above this study was carried out jointly by the ICRP and the NCRP, and the complete report is more extensive than the material contained in this Handbook

  16. Study of a 13-weeks, Repeated, Intramuscular Dose, Toxicity Test of Sweet Bee Venom in Sprague-Dawley Rats

    Directory of Open Access Journals (Sweden)

    Hyunmin Kang

    2014-06-01

    Full Text Available Objectives:This study was performed to analyze a 13-week repeated dose toxicity test of Sweet Bee Venom (SBV extracted from bee venom and administered in Sprague-Dawley (SD rats. Methods:Male and female 5-week-old SD rats were treated once daily with SBV (high-dosage group: 0.28 mg/kg; medium-dosage group: 0.14 mg/kg; or low-dosage group: 0.07 mg/kg for 13 weeks. Normal saline was administered to the control group in a similar manner (0.2 mL/kg. We conducted clinical observations, body weight measurements, ophthalmic examinations, urinalyses, hematology and biochemistry tests, and histological observations using hematoxylin and eosin (H&E staining to identify any abnormalities caused by the SBV treatment. Results:During this study, no mortality was observed in any of the experimental groups. Hyperemia and a movement disorder were observed around the area of in all groups that received SBV treatment, with a higher occurrence in rats treated with a higher dosage. Male rats receiving in the high-dosage group showed a significant decrease in weight during the treatment period. Compared to the control group, no significant changes in the ophthalmic parameters, the urine analyses, the complete blood cell count (CBC, and the biochemistry in the groups treated with SBV. Compared to the control group, some changes in organ weights were observed in the medium-and the high-dosage groups, but the low-dosage group showed no significant changes. Histological examination of thigh muscle indicated cell infiltration, inflammation, degeneration, and necrosis of muscle fiber, as well as fibrosis, in both the medium- and the high-dosage groups. Fatty liver change was observed in the periportal area of rats receiving medium and high dosages of SBV. No other organ abnormalities were observed. Conclusion:Our findings suggest that the No Observed Adverse Effect Level (NOAEL of SBV is approximately 0.07 mg/kg in male and female SD rats.

  17. ICRP-recommendations on dose limits for workers

    International Nuclear Information System (INIS)

    Beninson, D.J.

    1976-01-01

    Dose limits proposed by the ICRP have been incorporated in most national and international standards and their respect has caused a distribution of doses with a average not exceeding 1/10 of the maximum permissible dose. This distribution corresponds to a risk which is well within the risks in 'safe industries'. There are at present some inconsistancies in the current system of recommended limits, for example having the same limit of 5 rem for the whole-body and also for some organs. Hopefully, this incosistancy will be removed in the next recommendation of the ICRP. But the whole-body limit of 5 rem in a year has been safe and there is little ground to reduce this limit on the basis of comparisons with 'safe industries'. (orig./HP) [de

  18. Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis.

    Science.gov (United States)

    Chataway, Jeremy; Martin, Keith; Barrell, Kevin; Sharrack, Basil; Stolt, Pelle; Wraith, David C

    2018-03-13

    To assess safety, tolerability, and efficacy of the antigen-specific immunotherapy ATX-MS-1467 in participants with relapsing multiple sclerosis using different treatment protocols to induce tolerance. Two open-label trials in adult participants with relapsing multiple sclerosis were conducted. Study 1 was a multicenter, phase 1b safety evaluation comparing intradermal (i.d.) (cohort 1) with subcutaneous (cohort 2) administration in 43 participants. Both cohorts received ATX-MS-1467 dosed at 25, 50, 100, 400, and 800 μg at 14-day intervals over 8 weeks, followed by 8 weeks with 4 additional 800-μg doses at 14-day intervals and 32 weeks off study medication. Study 2 was a phase 2a, multicenter, single-arm trial enrolling 37 participants. ATX-MS-1467 was titrated from 50 μg i.d. on day 1 to 200 μg on day 15 and 800 μg on day 29 followed by biweekly administration of 800 μg for 16 weeks and 16 weeks off study medication. Efficacy was evaluated on MRI parameters and clinical variables. Safety endpoints included treatment-emergent adverse events and injection-site reactions. In study 1, there was a significant decrease in new/persisting T1 gadolinium-enhanced (GdE) lesions in cohort 1 from baseline to week 16, returning to baseline values at week 48. In study 2, the number of T1 GdE lesions were significantly reduced on treatment and remained reduced at study completion. Safety results were unremarkable in both studies. Relatively slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions and a sustained effect post treatment. Further trials of ATX-MS-1467 are warranted. This work provides Class IV evidence that for patients with relapsing multiple sclerosis, slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions. © 2018 American Academy of Neurology.

  19. Caffeine Citrate Dosing Adjustments to Assure Stable Caffeine Concentrations in Preterm Neonates.

    Science.gov (United States)

    Koch, Gilbert; Datta, Alexandre N; Jost, Kerstin; Schulzke, Sven M; van den Anker, John; Pfister, Marc

    2017-12-01

    To identify dosing strategies that will assure stable caffeine concentrations in preterm neonates despite changing caffeine clearance during the first 8 weeks of life. A 3-step simulation approach was used to compute caffeine doses that would achieve stable caffeine concentrations in the first 8 weeks after birth: (1) a mathematical weight change model was developed based on published weight distribution data; (2) a pharmacokinetic model was developed based on published models that accounts for individual body weight, postnatal, and gestational age on caffeine clearance and volume of distribution; and (3) caffeine concentrations were simulated for different dosing regimens. A standard dosing regimen of caffeine citrate (using a 20 mg/kg loading dose and 5 mg/kg/day maintenance dose) is associated with a maximal trough caffeine concentration of 15 mg/L after 1 week of treatment. However, trough concentrations subsequently exhibit a clinically relevant decrease because of increasing clearance. Model-based simulations indicate that an adjusted maintenance dose of 6 mg/kg/day in the second week, 7 mg/kg/day in the third to fourth week and 8 mg/kg/day in the fifth to eighth week assures stable caffeine concentrations with a target trough concentration of 15 mg/L. To assure stable caffeine concentrations during the first 8 weeks of life, the caffeine citrate maintenance dose needs to be increased by 1 mg/kg every 1-2 weeks. These simple adjustments are expected to maintain exposure to stable caffeine concentrations throughout this important developmental period and might enhance both the short- and long-term beneficial effects of caffeine treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. [Behavior of Orf virus in permissive and nonpermissive systems].

    Science.gov (United States)

    Büttner, M; Czerny, C P; Schumm, M

    1995-04-01

    Dogs were immunized i.m. with attenuated poxvirus vaccines (vaccinia virus, Orf-virus) and a bovine herpesvirus-1 (BHV-1) vaccine. After intradermal (i.d.) application of the vaccine viruses a specific delayed type hypersensitivity (DTH) reaction of the skin occurred only with vaccinia virus. The i.d. application of Orf-virus caused a short-term, non-specific inflammatory reaction of the skin, even in dogs not immunized with Orf-virus. Out of 30 sera from Orf-virus immunized beagles (n = 4) only eight were found reactive to Orf-virus in a competition ELISA. Three sera from dogs not Orf-virus immunized but skin-tested with the virus contained low antibody titers. Using indirect immunofluorescence (IIF) in flow cytometry, the existence of Orf-virus antigens was examined on the surface and in the cytoplasm of permissive (BFK and Vero)- and questionable permissive MDCK cells. The canine kidney MDCK cell line was found to be non-permissive for Orf-virus replication; the occurrence of an Orf-(ecthyma contagiosum) like disease in dogs is unlikely.

  1. On permission of waste-burying business in Tokai Research Establishment, Japan Atomic Energy Research Institute (Answer)

    International Nuclear Information System (INIS)

    1995-01-01

    As to this case written in the title which was inquired on July 19, 1994, from the prime minister, and changed partly on November 21, 1994, the Nuclear Safety Commission answered to the prime minister as follows after the prudent deliberation. As for the application of the criteria for permission, the technical capability is adequate, and the results of the examination of safety by the expert committee for examining nuclear fuel safety is adequate. It was judged that the safety after the permission of this waste-burying business can be secured. The expert committee reported on the policy of the investigation and deliberation, and the contents of the investigation and deliberation, such as the basic location conditions, namely, site, weather, ground, hydraulics, earthquakes and social environment, the radioactive wastes to be buried, the method of determining radioactivity concentration, the expected time of changing the measures to be taken for security, the safety design for the waste-burying facility related to radiation control, environment safety, earthquakes, fires and explosion, the loss of electric power and the standards and criteria to be conformed, and the assessment of dose equivalent in normal state, after finishing the period of control and safety evaluation, and the course of the investigation and deliberation. (K.I.)

  2. Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial.

    Science.gov (United States)

    Colgate, E Ross; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Mychaleckyj, Josyf C; Nayak, Uma; Qadri, Firdausi; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Zaman, K; Petri, William A; Kirkpatrick, Beth D

    2016-09-01

    Rotavirus is the world's leading cause of childhood diarrheal death. Despite successes, oral rotavirus vaccines are less effective in developing countries. In an urban slum of Dhaka, we performed active diarrhea surveillance to evaluate monovalent G1P[8] rotavirus vaccine (RV1) efficacy and understand variables contributing to risk of rotavirus diarrhea (RVD). We performed a randomized controlled trial of monovalent oral rotavirus vaccine (RV1). Seven hundred healthy infants received RV1 or no RV1 (1:1) using delayed dosing (10 and 17 weeks) and were followed for 1 year. Intensive diarrhea surveillance was performed. The primary outcome was ≥1 episode of RVD. Nutritional, socioeconomic, and immunologic factors were assessed by logistic regression best-subsets analysis for association with risk of RVD and interactions with vaccine arm. Incidence of all RVD was 38.3 cases per 100 person-years. Per-protocol RV1 efficacy was 73.5% (95% confidence interval [CI], 45.8%-87.0%) against severe RVD and 51% (95% CI, 33.8%-63.7%) against all RVD. Serum zinc level (odds ratio [OR], 0.77; P = .002) and lack of rotavirus immunoglobulin A (IgA) seroconversion (OR, 1.95; P = .018) were associated with risk of RVD, independent of vaccination status. Water treatment and exclusive breastfeeding were of borderline significance. Factors not associated with RVD included height for age at 10 weeks, vitamin D, retinol binding protein, maternal education, household income, and sex. In an urban slum with high incidence of RVD, the efficacy of RV1 against severe RVD was higher than anticipated in the setting of delayed dosing. Lower serum zinc level and lack of IgA seroconversion were associated with increased risk of RVD independent of vaccination. NCT01375647. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  3. On the calibration of photon dosemeters in the equivalent dose units

    International Nuclear Information System (INIS)

    Bregadze, Yu.I.; Isaev, B.M.; Maslyaev, P.F.

    1980-01-01

    General aspects of transition from exposure dose of photo radiation to equivalent one are considered. By determination the equivalent dose is a function of point location in an irradiated object, that is why it is necessary to know equivalent dose distribution in the human body for uniform description of the risk degree. The international electrotechnical comission recommends to measure equivalent doses at 7 and 800 mg/cm 2 depths in a tissue-equivalent ball with 30 cm diameter, calling them skin equivalent dose and depth equivalent dose, respectively, and to compare them with the permissible 500 mZ and 50 mZ a year, respectively. Practical transition to using equivalent dose for evaluation of radiation danger of being in photon radiation field of low energy should include measures on regraduating already produced dose meters, graduating the dose meters under production and developing the system of their metrologic supply [ru

  4. Time and dose-related changes in the thickness of pig skin after irradiation with single doses of 90Sr/90Y β-rays

    International Nuclear Information System (INIS)

    Rezvani, M.; Hamlet, R.; Hopewell, J.W.; Sieber, V.K.

    1994-01-01

    Time-related changes in pig skin thickness have been evaluated using a non-invasive ultrasound technique after exposure to a range of single doses of 90 Sr/ 90 Yr β-rays. The reduction in relative skin thickness developed in two distinct phases: the first was between 12 and 20 weeks postirradiation. No further changes were then seen until 52 weeks postirradiation when a second phase of skin thinning was observed. This was complete after 76 weeks and no further changes in relative skin thickness were seen in the maximum follow up period of 129 weeks. The timings of these phases of damage were independent of the radiation dose, however, the severity of both phases of radiation-induced skin thinning were dose related. (Author)

  5. Natural penetrating radiation inside silicate dwellings in Chengdu and recommendation on permissible limits for radioactivity of building material made of silicate cinders

    International Nuclear Information System (INIS)

    Li Guangzao

    1984-01-01

    This paper reports the results of external exposure rate of penetrating radiation inside silicate dwellings in Chengdu. The average exposure rate was 24.3+-3.5 R/h. It was evidently higher than of red brick dwellings. The average effective equivalent of the population in silicate dwellings was 123.4+-10.4 mrem/y and the average additional dose was 29.5+-12.5 mrem/y. The permissible limits recommended for silicate building material would be 6 pCi/g, 7 pCi/g and 102 pCi/g for 226 Ra, 232 Th and 40 K, respectively. The total activity must fulfill the formula of Csub(Ra)/6 + Csub(Th)/7 + Csub(k)/102 1. Under ordinary condition the exposure rate (10+background) R/h of penetrating radiation from the surface of dry building material might be taken as the permissible limit for dwellings and other public buildings

  6. The importance of triggering dose and conditions of split dose incubation to the development of thermotolerance

    International Nuclear Information System (INIS)

    Chang, P.Y.; Blakely, E.A.

    1987-01-01

    We have observed a lack of development of thermotolerance in CHO-TSH1, a protein synthetic mutant hamster cell line, under continuous heat stress treatments of 41.5 0 C, 42 0 C, and 42.5 0 C. The parental CHO-SC1 line develops thermotolerance under similar conditions. During the past year we have further examined this phenomenon in the mutant by studying the role of the level of the triggering heat dose and the time of administration to the ultimate development of thermotolerance. By increasing the temperature of the triggering dose for a brief interval, followed by the time at the permissive temperature, we were able to induce the development of thermotolerance in the protein-synthetic mutant cell. 4 refs., 2 figs

  7. Religiosity and Premarital Sexual Permissiveness: A Response to the Reiss-Heltsley and Broderick Debate

    Science.gov (United States)

    Ruppel, Howard J., Jr.

    1970-01-01

    When religiosity among college students was measured by Faulkner and DeJong's 5-D Scale of Religiosity" and the Reiss scale was used to measure permissiveness, the expected stronger relationship between religiosity and permissiveness in groups with traditions of low sexual permissiveness than in groups with traditions of high sexual…

  8. Radiation research contracts: Biological effects of small radiation doses

    Energy Technology Data Exchange (ETDEWEB)

    Hug, O [International Atomic Energy Agency, Division of Health, Safety and Waste Disposal, Vienna (Austria)

    1959-04-15

    To establish the maximum permissible radiation doses for occupational and other kinds of radiation exposure, it is necessary to know those biological effects which can be produced by very small radiation doses. This particular field of radiation biology has not yet been sufficiently explored. This holds true for possible delayed damage after occupational radiation exposure over a period of many years as well as for acute reactions of the organism to single low level exposures. We know that irradiation of less than 25 Roentgen units (r) is unlikely to produce symptoms of radiation sickness. We have, however, found indications that even smaller doses may produce certain instantaneous reactions which must not be neglected

  9. IDACstar: A MCNP Application to Perform Realistic Dose Estimations from Internal or External Contamination of Radiopharmaceuticals.

    Science.gov (United States)

    Ören, Ünal; Hiller, Mauritius; Andersson, M

    2017-04-28

    A Monte Carlo-based stand-alone program, IDACstar (Internal Dose Assessment by Computer), was developed, dedicated to perform radiation dose calculations using complex voxel simulations. To test the program, two irradiation situations were simulated, one hypothetical contamination case with 600 MBq of 99mTc and one extravasation case involving 370 MBq of 18F-FDG. The effective dose was estimated to be 0.042 mSv for the contamination case and 4.5 mSv for the extravasation case. IDACstar has demonstrated that dosimetry results from contamination or extravasation cases can be acquired with great ease. An effective tool for radiation protection applications is provided with IDACstar allowing physicists at nuclear medicine departments to easily quantify the radiation risk of stochastic effects when a radiation accident has occurred. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Gender Differences In Premarital Sexual Permissiveness Among ...

    African Journals Online (AJOL)

    This paper examined the concept of premariatal sexual permissiveness among selected University undergraduates in a state owned university in Nigeria, believing that the policy of non-residential status of the University will facilitate premarital sexual activity among the students. Using a total of 400 purposively selected ...

  11. Dose response of continuous subcutaneous infusion of recombinant glucagon-like peptide-1 in combination with metformin and sulphonylurea over 12 weeks in patients with type 2 diabetes mellitus

    DEFF Research Database (Denmark)

    Torekov, Signe Sørensen; Holst, J J; Ehlers, M R

    2014-01-01

    (7-36) amide (rGLP-1) administered by continuous subcutaneous infusion (CSCI) in subjects with type 2 diabetes. METHODS: We compared the efficacy and safety of three doses of recombinant GLP-1, ranging from 1.25 to 5.0 pmol/kg/min (pkm) and placebo, given by continuous subcutaneous infusion over 3...... months in combination with metformin and sulphonylurea (SU), to lower haemoglobin A1c (HbA1c), fasting plasma glucose and weight in 95 type 2 diabetes patients with inadequate glycaemic control. RESULTS: The mean decreases in HbA1c at endpoint (week 12) were significantly greater for all three rGLP-1...... dose groups when each was compared with the placebo group, with the greatest decrease occurring in the 5.0 pkm dose group (-1.3%, s.d. ± 0.18, p fasting plasma glucose from baseline to endpoint were significantly greater for all three rGLP-1 dose groups than...

  12. Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment.

    Science.gov (United States)

    Derman, Richard; Kohles, Joseph D; Babbitt, Ann

    2009-01-01

    Data from two open-label trials (PRIOR and CURRENT) of women with postmenopausal osteoporosis or osteopenia were evaluated to assess whether monthly oral and quarterly intravenous (IV) ibandronate dosing improved self-reported gastrointestinal (GI) tolerability for patients who had previously experienced GI irritation with bisphosphonate (BP) use. In PRIOR, women who had discontinued daily or weekly BP treatment due to GI intolerance received monthly oral or quarterly IV ibandronate for 12 months. The CURRENT subanalysis included women receiving weekly BP treatment who switched to monthly oral ibandronate for six months. GI symptom severity and frequency were assessed using the Osteoporosis Patient Satisfaction Questionnaire. In PRIOR, mean GI tolerability scores increased significantly at month 1 from screening for both treatment groups (oral: 79.3 versus 54.1; IV: 84.4 versus 51.0; p 90% at Month 10). In the CURRENT subanalysis >60% of patients reported improvements in heartburn or acid reflux and >70% indicated improvement in other stomach upset at month 6. Postmenopausal women with GI irritability with daily or weekly BPs experienced improvement in symptoms with extended dosing monthly or quarterly ibandronate compared with baseline.

  13. Induction by X-rays of chromosome aberrations in male guinea-pigs and golden hamsters. 4. Dose-response for spermatogonia treated with fractionated doses

    Energy Technology Data Exchange (ETDEWEB)

    Lyon, M F; Cox, B D [Medical Research Council, Harwell (UK). Radiobiological Research Unit

    1975-10-01

    The effect of dose fractionation on the induction of translocations by 400 and 600 rad X-rays in spermatogonia of guinea-pigs and hamsters was investigated cytologically. Three types of fractionation were used, dividing the dose into (a) two equal fractions 24h apart, (b) two equal fractions 8 weeks apart, and (c) eight or twelve equal fractions of 50 rad, at intervals of one week. The two species responded similarly throughout, but gave lower translocation yields than the mouse. The effects of the first and third types of fractionation were similar to those described previously in the mouse, and suggested that a first radiation dose modifies the spermatogonial population so that its sensitivity to a dose 24h later is altered, and that repeated radiation doses result in development of resistance to translocation induction. After 8-week fractionation, the results suggested that in guinea-pigs and hamsters, the spermatogonial population had not returned to normal by 8 weeks after the first dose, whereas in the mouse, normal sensitivity had returned by this time. The results, reported previously, of single doses of X-rays suggest that the spermatogonial population consists of sub-populations differing in sensitivity to cell killing and genetic effects. The effects of fractionated doses in the mouse suggest that the sensitive and resistant types represent different phases of the samecell type rather than two distinct types of cell. In the guinea-pig and hamster, this question remains open.

  14. Axiomatizations of Banzhaf Permisson Values for Games with a Hierarchical Permission Structure.

    NARCIS (Netherlands)

    van den Brink, J.R.

    2010-01-01

    In games with a permission structure it is assumed that players in a cooperative transferable utility game are hierarchically ordered in the sense that there are players that need permission from other players before they are allowed to cooperate. We provide axiomatic characterizations of Banzhaf

  15. Warfarin maintenance dose in older patients: higher average dose and wider dose frequency distribution in patients of African ancestry than those of European ancestry.

    Science.gov (United States)

    Garwood, Candice L; Clemente, Jennifer L; Ibe, George N; Kandula, Vijay A; Curtis, Kristy D; Whittaker, Peter

    2010-06-15

    Studies report that warfarin doses required to maintain therapeutic anticoagulation decrease with age; however, these studies almost exclusively enrolled patients of European ancestry. Consequently, universal application of dosing paradigms based on such evidence may be confounded because ethnicity also influences dose. Therefore, we determined if warfarin dose decreased with age in Americans of African ancestry, if older African and European ancestry patients required different doses, and if their daily dose frequency distributions differed. Our chart review examined 170 patients of African ancestry and 49 patients of European ancestry cared for in our anticoagulation clinic. We calculated the average weekly dose required for each stable, anticoagulated patient to maintain an international normalized ratio of 2.0 to 3.0, determined dose averages for groups 80 years of age and plotted dose as a function of age. The maintenance dose in patients of African ancestry decreased with age (PAfrican ancestry required higher average weekly doses than patients of European ancestry: 33% higher in the 70- to 79-year-old group (38.2+/-1.9 vs. 28.8+/-1.7 mg; P=0.006) and 52% in the >80-year-old group (33.2+/-1.7 vs. 21.8+/-3.8 mg; P=0.011). Therefore, 43% of older patients of African ancestry required daily doses >5mg and hence would have been under-dosed using current starting-dose guidelines. The dose frequency distribution was wider for older patients of African ancestry compared to those of European ancestry (PAfrican ancestry indicate that strategies for initiating warfarin therapy based on studies of patients of European ancestry could result in insufficient anticoagulation and thereby potentially increase their thromboembolism risk. Copyright 2010 Elsevier Inc. All rights reserved.

  16. Accelerated repopulation of mouse tongue epithelium during fractionated irradiations or following single doses

    International Nuclear Information System (INIS)

    Doerr, W.; Kummermehr, J.

    1990-01-01

    Mouse tongue mucosa was established as an animal model to study repopulation after large single doses or during continuous irradiation. A top-up irradiation technique was used employing priming doses or fractionated treatment to the whole snout (300 kV X-rays) followed by local test doses (25 kV X-rays) to elicit denudation in a confined field of the inferior tongue surface. Clearcut quantal dose-response curves of ulcer incidence were obtained to all protocols; animal morbidity, i.e. body weight loss was minimal. Repopulation following priming doses of 10 and 13 Gy started with a delay of at least 3 days and then progressed rapidly to nearly restore original tissue tolerance by day 11. During continuous fractionation over 1 to 3 weeks with 5 fractions/week and doses per fraction of 2.5, 3 and 3.5 Gy, repopulation was small in week one but subsequently increased to fully compensate the weekly dose at all dose levels. Additional measurements of cell density during a 4 weeks course of 5 x 3 Gy or 5 x 4 Gy per week showed only moderate depletion to 67% of the control figures. The fact that rapid repopulation is achieved at relatively moderate damage levels should be taken into account when the timing of a treatment split is considered. (author). 18 refs.; 7 figs.; 1 tab

  17. Dose-Response for Multiple Biomarkers of Exposure and Genotoxic Effect Following Repeated Treatment of Rats with the Alkylating Agents, MMS and MNU.

    Science.gov (United States)

    Ji, Zhiying; LeBaron, Matthew J; Schisler, Melissa R; Zhang, Fagen; Bartels, Michael J; Gollapudi, B Bhaskar; Pottenger, Lynn H

    2016-05-01

    The nature of the dose-response relationship for various in vivo endpoints of exposure and effect were investigated using the alkylating agents, methyl methanesulfonate (MMS) and methylnitrosourea (MNU). Six male F344 rats/group were dosed orally with 0, 0.5, 1, 5, 25 or 50mg/kg bw/day (mkd) of MMS, or 0, 0.01, 0.1, 1, 5, 10, 25 or 50 mkd of MNU, for 4 consecutive days and sacrificed 24h after the last dose. The dose-responses for multiple biomarkers of exposure and genotoxic effect were investigated. In MMS-treated rats, the hemoglobin adduct level, a systemic exposure biomarker, increased linearly with dose (r (2) = 0.9990, P agents. © The Author 2015. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Permissivity of the NCI-60 cancer cell lines to oncolytic Vaccinia Virus GLV-1h68

    International Nuclear Information System (INIS)

    Ascierto, Maria Libera; Bedognetti, Davide; Uccellini, Lorenzo; Rossano, Fabio; Ascierto, Paolo A; Stroncek, David F; Restifo, Nicholas P; Wang, Ena; Szalay, Aladar A; Marincola, Francesco M; Worschech, Andrea; Yu, Zhiya; Adams, Sharon; Reinboth, Jennifer; Chen, Nanhai G; Pos, Zoltan; Roychoudhuri, Rahul; Di Pasquale, Giovanni

    2011-01-01

    Oncolytic viral therapy represents an alternative therapeutic strategy for the treatment of cancer. We previously described GLV-1h68, a modified Vaccinia Virus with exclusive tropism for tumor cells, and we observed a cell line-specific relationship between the ability of GLV-1h68 to replicate in vitro and its ability to colonize and eliminate tumor in vivo. In the current study we surveyed the in vitro permissivity to GLV-1h68 replication of the NCI-60 panel of cell lines. Selected cell lines were also tested for permissivity to another Vaccinia Virus and a vesicular stomatitis virus (VSV) strain. In order to identify correlates of permissity to viral infection, we measured transcriptional profiles of the cell lines prior infection. We observed highly heterogeneous permissivity to VACV infection amongst the cell lines. The heterogeneity of permissivity was independent of tissue with the exception of B cell derivation. Cell lines were also tested for permissivity to another Vaccinia Virus and a vesicular stomatitis virus (VSV) strain and a significant correlation was found suggesting a common permissive phenotype. While no clear transcriptional pattern could be identified as predictor of permissivity to infection, some associations were observed suggesting multifactorial basis permissivity to viral infection. Our findings have implications for the design of oncolytic therapies for cancer and offer insights into the nature of permissivity of tumor cells to viral infection

  19. Dose reduction of risperidone and olanzapine can improve cognitive function and negative symptoms in stable schizophrenic patients: A single-blinded, 52-week, randomized controlled study.

    Science.gov (United States)

    Zhou, Yanling; Li, Guannan; Li, Dan; Cui, Hongmei; Ning, Yuping

    2018-05-01

    The long-term effects of dose reduction of atypical antipsychotics on cognitive function and symptomatology in stable patients with schizophrenia remain unclear. We sought to determine the change in cognitive function and symptomatology after reducing risperidone or olanzapine dosage in stable schizophrenic patients. Seventy-five stabilized schizophrenic patients prescribed risperidone (≥4 mg/day) or olanzapine (≥10 mg/day) were randomly divided into a dose-reduction group ( n=37) and a maintenance group ( n=38). For the dose-reduction group, the dose of antipsychotics was reduced by 50%; for the maintenance group, the dose remained unchanged throughout the whole study. The Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, and Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery were measured at baseline, 12, 28, and 52 weeks. Linear mixed models were performed to compare the Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects and MATRICS Consensus Cognitive Battery scores between groups. The linear mixed model showed significant time by group interactions on the Positive and Negative Syndrome Scale negative symptoms, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, attention/vigilance, working memory and total score of MATRICS Consensus Cognitive Battery (all pNegative Syndrome Scale negative subscale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, working memory and total score of MATRICS Consensus Cognitive Battery for the dose reduction group compared with those for the maintenance group (all pnegative symptoms in patients with stabilized schizophrenia.

  20. Optimizing bevacizumab dosing in glioblastoma: less is more.

    Science.gov (United States)

    Ajlan, Abdulrazag; Thomas, Piia; Albakr, Abdulrahman; Nagpal, Seema; Recht, Lawrence

    2017-10-01

    Compared to traditional chemotherapies, where dose limiting toxicities represent the maximum possible dose, monoclonal antibody therapies are used at doses well below maximum tolerated dose. However, there has been little effort to ascertain whether there is a submaximal dose at which the efficacy/complication ratio is maximized. Thus, despite the general practice of using Bevacizumab (BEV) at dosages of 10 mg/kg every other week for glioma patients, there has not been much prior work examining whether the relatively high complication rates reported with this agent can be decreased by lowering the dose without impairing efficacy. We assessed charts from 80 patients who received BEV for glioblastoma to survey the incidence of complications relative to BEV dose. All patients were treated with standard upfront chemoradiation. The toxicity was graded based on the NCI CTCAE, version 4.03. The rate of BEV serious related adverse events was 12.5% (n = 10/80). There were no serious adverse events (≥grade 3) when the administered dose was (<3 mg/kg/week), compared to a 21% incidence in those who received higher doses (≥3 mg/kg/week) (P < 0.01). Importantly, the three patient deaths attributable to BEV administration occurred in patients receiving higher doses. Patients who received lower doses also had a better survival rate, although this did not reach statistical significance [median OS 39 for low dose group vs. 17.3 for high dose group (P = 0.07)]. Lower rates of serious BEV related toxicities are noted when lower dosages are used without diminishing positive clinical impact. Further work aimed at optimizing BEV dosage is justified.

  1. Breakout Session: Fight for Your Right to Copy: How One Library Acquired the Copyright Permissions Service and Reduced Students’ Costs. Presented by Emily Riha, Copyright Permissions Coordinator, University of Minnesota.

    Directory of Open Access Journals (Sweden)

    Connie Strittmatter

    2018-02-01

    Full Text Available Emily Riha, Copyright Permissions Coordinator at the University of Minnesota, presented at the 2017 Kraemer Copyright Conference her experience when the process of securing copyright permissions moved from Printing Services to the University Libraries.

  2. 26 CFR 1.422-5 - Permissible provisions.

    Science.gov (United States)

    2010-04-01

    ... of the incentive stock option are subject to a substantial risk of forfeiture and not transferable...) INCOME TAXES Certain Stock Options § 1.422-5 Permissible provisions. (a) General rule. An option that otherwise qualifies as an incentive stock option does not fail to be an incentive stock option merely...

  3. Comparison of Dosage Requirement of Erythropoietin Stimulating Agent (ESA in Maintenance of Hemoglobin Concentration in patients undergoing twice weekly versus thrice weekly Hemodialysis in Pakistani Population

    Directory of Open Access Journals (Sweden)

    Osama Kunwer Naveed

    2018-03-01

    Full Text Available Anemia is one of the major complications of patients with chronic kidney disease (CKD undergoing hemodialysis (HD and is associated with left ventricular hypertrophy and also increases morbidity and mortality. Anemia in patients with CKD can be due to two major reasons; iron deficiency or erythropoietin insufficiency. Erythropoietin Stimulating Agent (ESAs administration is the mainstay in treating anemia if the patient is iron sufficient. However, higher doses of ESAs have been associated with increased cerebrovascular and cardiovascular events. We conducted this study to see how much erythropoietin is required in our setting in iron sufficient patients to maintain hemoglobin(Hb  level and the effect of dialysis frequency on ESA doses.  Methods and Findings: A cross-sectional study was conducted at the Department of Nephrology at Ziauddin University Hospital. Patients’ charts were reviewed for Hb levels and doses of ESA to maintain Hb between 10-12 mg/dl. Patients were excluded if they had iron deficiency, malignancy, were on immunosuppressive agents, had renal transplant, and with Hb >12 mg/dl or <10 mg/dl and their ferritin levels, transferrin saturation, hemoglobin concentration, frequency of hemodialysis and ESA dosage were monitored. We also compared these variables between patients undergoing hemodialysis thrice weekly with those undergoing hemodialysis twice a week. A total of 105 patients were analyzed. 24 were excluded as they did not match the inclusion criteria. 81 patients were included in the study. 36 (44.4% were males and 45 (55.6% were females. Mean age of the patient was 56.47 ± 11.72 years. The average dose of ESA was 106.91 ± 61.47 for patients undergoing hemodialysis thrice weekly and 183.94 ± 116.71 for patients undergoing hemodialysis twice a week. Significant difference was found to exist between dosage of patients undergoing thrice weekly dialysis versus twice weekly dialysis(p=<0.001.  Our study has limitations

  4. 17 CFR 230.433 - Conditions to permissible post-filing free writing prospectuses.

    Science.gov (United States)

    2010-04-01

    ... writing prospectus used at the same time as a communication in a business combination transaction subject... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Conditions to permissible post... Prospectuses § 230.433 Conditions to permissible post-filing free writing prospectuses. (a) Scope of section...

  5. Maternal risk factors in fetal alcohol syndrome: provocative and permissive influences.

    Science.gov (United States)

    Abel, E L; Hannigan, J H

    1995-01-01

    We present an hypothesis integrating epidemiological, clinical case, and basic biomedical research to explain why only relatively few women who drink alcohol during pregnancy give birth to children with alcohol-related birth defects (ARBDs), in particular, Fetal Alcohol Syndrome (FAS). We argue that specific sociobehavioral risk factors, e.g., low socioeconomic status, are permissive for FAS in that they provide the context for increased vulnerability. We illustrate how these permissive factors are related to biological factors, e.g., decreased antioxidant status, which in conjunction with alcohol, provoke FAS/ARBDs in vulnerable fetuses. We propose an integrative heuristic model hypothesizing that these permissive and provocative factors increase the likelihood of FAS/ARBDs because they potentiate two related mechanisms of alcohol-induced teratogenesis, specifically, maternal/fetal hypoxia and free radical formation.

  6. Releasable activity and maximum permissible leakage rate within a transport cask of Tehran Research Reactor fuel samples

    Directory of Open Access Journals (Sweden)

    Rezaeian Mahdi

    2015-01-01

    Full Text Available Containment of a transport cask during both normal and accident conditions is important to the health and safety of the public and of the operators. Based on IAEA regulations, releasable activity and maximum permissible volumetric leakage rate within the cask containing fuel samples of Tehran Research Reactor enclosed in an irradiated capsule are calculated. The contributions to the total activity from the four sources of gas, volatile, fines, and corrosion products are treated separately. These calculations are necessary to identify an appropriate leak test that must be performed on the cask and the results can be utilized as the source term for dose evaluation in the safety assessment of the cask.

  7. Time and dose-related changes in the thickness of pig skin after irradiation with single doses of [sup 90]Sr/[sup 90]Y [beta]-rays

    Energy Technology Data Exchange (ETDEWEB)

    Rezvani, M.; Hamlet, R.; Hopewell, J.W.; Sieber, V.K. (Churchill Hospital, Oxford (United Kingdom))

    1994-04-01

    Time-related changes in pig skin thickness have been evaluated using a non-invasive ultrasound technique after exposure to a range of single doses of [sup 90]Sr/[sup 90]Yr [beta]-rays. The reduction in relative skin thickness developed in two distinct phases: the first was between 12 and 20 weeks postirradiation. No further changes were then seen until 52 weeks postirradiation when a second phase of skin thinning was observed. This was complete after 76 weeks and no further changes in relative skin thickness were seen in the maximum follow up period of 129 weeks. The timings of these phases of damage were independent of the radiation dose, however, the severity of both phases of radiation-induced skin thinning were dose related. (Author).

  8. Dose Recalculation and the Dose-Guided Radiation Therapy (DGRT) Process Using Megavoltage Cone-Beam CT

    International Nuclear Information System (INIS)

    Cheung, Joey; Aubry, Jean-Francois; Yom, Sue S.; Gottschalk, Alexander R.; Celi, Juan Carlos; Pouliot, Jean

    2009-01-01

    Purpose: At University of California San Francisco, daily or weekly three-dimensional images of patients in treatment position are acquired for image-guided radiation therapy. These images can be used for calculating the actual dose delivered to the patient during treatment. In this article, we present the process of performing dose recalculation on megavoltage cone-beam computed tomography images and discuss possible strategies for dose-guided radiation therapy (DGRT). Materials and Methods: A dedicated workstation has been developed to incorporate the necessary elements of DGRT. Patient image correction (cupping, missing data artifacts), calibration, completion, recontouring, and dose recalculation are all implemented in the workstation. Tools for dose comparison are also included. Examples of image correction and dose analysis using 6 head-and-neck and 2 prostate patient datasets are presented to show possible tracking of interfraction dosimetric endpoint variation over the course of treatment. Results: Analysis of the head-and-neck datasets shows that interfraction treatment doses vary compared with the planning dose for the organs at risk, with the mean parotid dose and spinal cord D 1 increasing by as much as 52% and 10%, respectively. Variation of the coverage to the target volumes was small, with an average D 5 dose difference of 1%. The prostate patient datasets revealed accurate dose coverage to the targeted prostate and varying interfraction dose distributions to the organs at risk. Conclusions: An effective workflow for the clinical implementation of DGRT has been established. With these techniques in place, future clinical developments in adaptive radiation therapy through daily or weekly dosimetric measurements of treatment day images are possible.

  9. CALCULATION OF FLUENCE-TO-EFFECTIVE DOSE CONVERSION COEFFICIENTS FOR THE OPERATIONAL QUANTITY PROPOSED BY ICRU RC26.

    Science.gov (United States)

    Endo, Akira

    2017-07-01

    Fluence-to-effective dose conversion coefficients have been calculated for photons, neutrons, electrons, positrons, protons, muons, pions and helium ions for various incident angles of radiations. The aim of this calculation is to provide a set of conversion coefficients to the Report Committee 26 (RC26) of the International Commission on Radiation Units and Measurements (ICRU) for use in defining personal dose equivalent for individual monitoring. The data sets comprise effective dose conversion coefficients for incident angles of radiations from 0° to ±90° in steps of 15° and at ±180°. Conversion coefficients for rotational, isotropic, superior hemisphere semi-isotropic and inferior hemisphere semi-isotropic irradiations are also included. Numerical data of the conversion coefficients are presented as supplementary data. The conversion coefficients are used to define the personal dose equivalent, which is being considered by the ICRU RC26, as the operational quantity for individual monitoring. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. High dose radiotherapy for pituitary tumours

    International Nuclear Information System (INIS)

    Mead, K.W.

    1981-01-01

    The results of treatment of 120 pituitary tumours are presented. Based on this experience operable chromophobe adenomas are now treated with 5,000 rads in 4 weeks and inoperable ones receive an additional central dose to 7,500 rads. Pituitary Cushing's tumours are given 10,000 rads in 5 weeks using small fields and acromegalics 5,000 rads to the whole sella and 7,500 to its lower half. The absence of complications at these dose levels is attributed to the use of small fields and the precise application of treatment

  11. High dose radiotherapy for pituitary tumours

    Energy Technology Data Exchange (ETDEWEB)

    Mead, K.W. (Queensland Radium Inst., Herston (Australia))

    1981-11-01

    The results of treatment of 120 pituitary tumours are presented. Based on this experience operable chromophobe adenomas are now treated with 5,000 rads in 4 weeks and inoperable ones receive an additional central dose to 7,500 rads. Pituitary Cushing's tumours are given 10,000 rads in 5 weeks using small fields and acromegalics 5,000 rads to the whole sella and 7,500 to its lower half. The absence of complications at these dose levels is attributed to the use of small fields and the precise application of treatment.

  12. Treatment Compliance with Fixed-Dose Combination of Vildagliptin/Metformin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Monotherapy: A 24-Week Observational Study

    Directory of Open Access Journals (Sweden)

    Grigorios Rombopoulos

    2015-01-01

    Full Text Available Objective. To evaluate the differences in treatment compliance with vildagliptin/metformin fixed-dose versus free-dose combination therapy in patients with type 2 diabetes mellitus (T2DM in Greece. Design. Adult patients with T2DM, inadequately controlled with metformin monotherapy, (850 mg bid, participated in this 24-week, multicenter, observational study. Patients were enrolled in two cohorts: vildagliptin/metformin fixed-dose combination (group A and vildagliptin metformin free-dose combination (group B. Results. 659 patients were enrolled, 360 were male, with mean BMI 30.1, mean T2DM duration 59.6 months, and mean HbA1c at baseline 8%; 366 patients were assigned to group A and 293 to group B; data for 3 patients was missing. In group A, 98.9% of patients were compliant with their treatment compared to 84.6% of group B. The odds ratio for compliance in group A versus B was (OR 18.9 (95% CI: 6.2, 57.7; P<0.001. In group A mean HbA1c decreased from 8.1% at baseline to 6.9% (P<0.001 at the study end and from 7.9% to 6.8% (P<0.001 in group B. Conclusions. Patients in group A were more compliant than patients in group B. These results are in accordance with international literature suggesting that fixed-dose combination therapies lead to increased compliance to treatment.

  13. Endometrial safety of ultra-low-dose estradiol vaginal tablets

    DEFF Research Database (Denmark)

    Simon, James; Nachtigall, Lila; Ulrich, Lian G

    2010-01-01

    To evaluate the endometrial hyperplasia and carcinoma rate after 52-week treatment with ultra-low-dose 10-microgram 17ß-estradiol vaginal tablets in postmenopausal women with vaginal atrophy.......To evaluate the endometrial hyperplasia and carcinoma rate after 52-week treatment with ultra-low-dose 10-microgram 17ß-estradiol vaginal tablets in postmenopausal women with vaginal atrophy....

  14. Endometrial safety of ultra-low-dose estradiol vaginal tablets

    DEFF Research Database (Denmark)

    Simon, James; Nachtigall, Lila; Ulrich, Lian G

    2010-01-01

    To evaluate the endometrial hyperplasia and carcinoma rate after 52-week treatment with ultra-low-dose 10-microgram 17β-estradiol vaginal tablets in postmenopausal women with vaginal atrophy.......To evaluate the endometrial hyperplasia and carcinoma rate after 52-week treatment with ultra-low-dose 10-microgram 17β-estradiol vaginal tablets in postmenopausal women with vaginal atrophy....

  15. A Dynamic Operation Permission Technique Based on an MFM Model and Numerical Simulation

    International Nuclear Information System (INIS)

    Akio, Gofuku; Masahiro, Yonemura

    2011-01-01

    It is important to support operator activities to an abnormal plant situation where many counter actions are taken in relatively short time. The authors proposed a technique called dynamic operation permission to decrease human errors without eliminating creative idea of operators to cope with an abnormal plant situation by checking if the counter action taken is consistent with emergency operation procedure. If the counter action is inconsistent, a dynamic operation permission system warns it to operators. It also explains how and why the counter action is inconsistent and what influence will appear on the future plant behavior by a qualitative influence inference technique based on a model by the Mf (Multilevel Flow Modeling). However, the previous dynamic operation permission is not able to explain quantitative effects on plant future behavior. Moreover, many possible influence paths are derived because a qualitative reasoning does not give a solution when positive and negative influences are propagated to the same node. This study extends the dynamic operation permission by combining the qualitative reasoning and the numerical simulation technique. The qualitative reasoning based on an Mf model of plant derives all possible influence propagation paths. Then, a numerical simulation gives a prediction of plant future behavior in the case of taking a counter action. The influence propagation that does not coincide with the simulation results is excluded from possible influence paths. The extended technique is implemented in a dynamic operation permission system for an oil refinery plant. An MFM model and a static numerical simulator are developed. The results of dynamic operation permission for some abnormal plant situations show the improvement of the accuracy of dynamic operation permission and the quality of explanation for the effects of the counter action taken

  16. Procedures for permission under atomic energy laws in the Federal Republic of Germany

    International Nuclear Information System (INIS)

    Kuhnt, D.

    1980-01-01

    The selection of proper locations by the enterprisers responsible for projects is usually accompanied in recent years by the active location policy of the state. The application for the permission of locations and projects shall be filed to one or more ministries of the province where the facilities are to be installed. The papers describing the projects, especially safety reports and summaries shall be attached to the applications. The applications shall be published on a bulletin of the government office or daily newspapers, and every person has access to the applications, the safety reports and the summaries for two months. When objections are lodged within the period, closed hearings are held to examine the protests with attendance of the objector, the enterpriser of the project and the government office which has joined the decision. Following the phase of public participation and after the confirmation of facts highly important to the decision, fact examination is carried out with cooperation of specialists by the government office authorized for permission. As a special feature of the procedures under Atomgesetz, the government office is not necessarily obliged to give permission considering the safety policy, even when the pre-requisites of permission are all fulfilled. In other respects, permission may be offered for each partial installation of the facilities and various stages of operation by particular administrative measures (partial permission). The experiences of past 20 years indicate the virtual defects of the laws applied, and the amendment is urgently required. (Okada, K.)

  17. Primary treatment of acromegaly with high-dose lanreotide: a case series

    Directory of Open Access Journals (Sweden)

    Cordes Uwe

    2010-03-01

    Full Text Available Abstract Introduction The first-line treatment for acromegaly is transsphenoidal surgery. In approximately 50% of patients, however, a cure is not possible with surgery and alternatives are needed. Somatostatin analog therapy is the recommended first-line treatment in patients with such cases. Here we provide the first report of a high-dose lanreotide primary therapy in patients with acromegaly. Case presentation Six patients who were not suitable for surgery were given 60 mg of lanreotide (Autogel® every four weeks. All patients were German nationals and Caucasian. When the response of our patients was unsatisfactory, the dose was increased sequentially to 90 mg every four weeks, 120 mg every four weeks, 120 mg every three weeks and 180 mg every three weeks. Treatment duration was 12 to 24 months. In all cases, the lanreotide dose was 120 mg every 4 weeks or higher. In five of our patients, growth hormone (GH levels were successfully reduced (in three patients GH Tumor shrinkage or degeneration was observed in the five responding patients. No drug-related adverse events were noted. Conclusions These results suggest that lanreotide at high doses of 120 mg every four weeks or more is an effective first-line therapy for patients with acromegaly that surgery alone cannot treat.

  18. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  19. Parental permissiveness, control, and affect and drug use among adolescents.

    Science.gov (United States)

    Becoña, Elisardo; Martínez, Úrsula; Calafat, Amador; Fernández-Hermida, José Ramón; Juan, Montse; Sumnall, Harry; Mendes, Fernando; Gabrhelík, Roman

    2013-01-01

    Parents play an important role in determining the risk of children's drug use. The aim of this study was to analyse how certain family-related variables (permissiveness toward drug use, and parental control and affect) were linked to the use of alcohol, tobacco and cannabis, based on young people's self-report of such variables. The sample was composed of 1,428 school children (51.8% males) aged between 11 and 19 from Mallorca (Spain). We found that the young people who perceived their parents as permissive and those who perceived less maternal control and higher levels of both paternal and maternal affect were more likely to use alcohol, tobacco and cannabis. Sex differences were found within this pattern. Variables of maternal affect and control were not influential among males, whereas the general pattern was maintained among females. This study highlights the importance of perceived permissiveness and the need of considering parent's and children's gender when providing control and affect, as fathers will influence male children whereas mothers will influence female children.

  20. PATIENT RADIATION DOSE FROM CHEST X-RAY EXAMINATIONS IN THE WEST BANK-PALESTINE.

    Science.gov (United States)

    Lahham, Adnan; Issa, Ahlam; ALMasri, Hussein

    2018-02-01

    Radiation doses to patients resulting from chest X-ray examinations were evaluated in four medical centers in the West Bank and East Jerusalem-Palestine. Absorbed organ and effective doses were calculated for a total of 428 adult male and female patients by using commercially available Monte Carlo based softwares; CALDOSE-X5 and PCXMC-2.0, and hermaphrodite mathematical adult phantoms. Patients were selected randomly from medical records in the time period from November 2014 to February 2015. A database of surveyed patients and exposure factors has been established and includes: patient's height, weight, age, gender, X-ray tube voltage, electric current (mAs), examination projection (anterior posterior (AP), posterior anterior (PA), lateral), X-ray tube filtration thickness in each X-ray equipment, anode angle, focus to skin distance and X-ray beam size. The average absorbed doses in the whole body from different projections were: 0.06, 0.07 and 0.11 mGy from AP, PA and lateral projections, respectively. The average effective dose for all surveyed patients was 0.14 mSv for all chest X-ray examinations and projections in the four investigated medical centers. The effect of projection geometry was also investigated. The average effective doses for AP, PA and lateral projections were 0.14, 0.07 and 0.22 mSv, respectively. The collective effective dose estimated for the exposed population was ~60 man-mSv. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Permissive parenting and mental health in college students: Mediating effects of academic entitlement.

    Science.gov (United States)

    Barton, Alison L; Hirsch, Jameson K

    2016-01-01

    Student mental health may suffer due to unreasonable expectations associated with academic entitlement; permissive parenting may be one source of these expectations. The authors examined the role of academic entitlement as a mediator of the relationship between permissive parenting and psychological functioning. Participants were 524 undergraduate students at a single institution (52% female; age range = 18-22). Data collection was completed in May 2011. Cross-sectional design. Participants completed online self-report measures of parenting styles, academic entitlement, stress, depressive symptoms, and well-being. Permissive parenting was associated with greater academic entitlement and, in turn, to more perceived stress and poorer mental health. Mother/father differences were found in some cases. Academic entitlement may partially explain why permissive parenting is detrimentally related to mental health for college students. Implications for academic affairs and counseling include helping students develop an appreciation of the role of self-regulation in college success.

  2. Parkinson’s Disease: Low-Dose Haloperidol Increases Dopamine Receptor Sensitivity and Clinical Response

    Directory of Open Access Journals (Sweden)

    Craig J. Hudson

    2014-01-01

    Full Text Available Background. It is known that ultra-low doses of haloperidol can cause dopamine supersensitivity of dopamine D2 receptors and related behaviour in animals. Objective. The objective was to determine whether a daily ultra-low dose of 40 micrograms of haloperidol could enhance the clinical action of levodopa in Parkinson’s disease patients. Method. While continuing their daily treatment with levodopa, 16 patients with Parkinson’s disease were followed weekly for six weeks. They received an add-on daily dose of 40 micrograms of haloperidol for the first two weeks only. The SPES/SCOPA scale (short scale for assessment of motor impairments and disabilities in Parkinson’s disease was administered before treatment and weekly throughout the trial. Results. The results showed a mean decrease in SPES/SCOPA scores after one week of the add-on treatment. Conclusion. SCOPA scores decreased after the addition of low-dose haloperidol to the standard daily levodopa dose. This finding is consistent with an increase in sensitivity of dopamine D2 receptors induced by haloperidol. Such treatment for Parkinson’s disease may possibly permit the levodopa dose to be reduced and, thus, delay the onset of levodopa side effects.

  3. An Internal Dose Assessment Associated with Personal Food Intake

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Joeun; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of); Hwang, Wontae [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2015-10-15

    ICRP (International Commission on Radiological Protection), Therefore, had recommended the concept of 'Critical Group'. Recently the ICRP has recommended the use of 'Representative Person' on the new basic recommendation 103. On the other hand the U.S. NRC (Nuclear Regulatory Commission) has adopted more conservative concept, 'Maximum Exposed Individuals (MEI)' of critical Group. The dose assessment in Korea is based on MEI. Although dose assessment based on MEI is easy to receive the permission of the regulatory authority, it is not efficient. Meanwhile, the internal dose by food consumption takes an important part. Therefore, in this study, the internal dose assessment was performed in accordance with ICRP's new recommendations. The internal dose assessment was performed in accordance with ICRP's new recommendations. It showed 13.2% decreased of the annual internal dose due to gaseous effluents by replacing MEI to the concept of representative person. Also, this calculation based on new ICRP's recommendation has to be extended to all areas of individual dose assessment. Then, more accurate and efficient values might be obtained for dose assessment.

  4. Personalized Feedback on Staff Dose in Fluoroscopy-Guided Interventions: A New Era in Radiation Dose Monitoring.

    Science.gov (United States)

    Sailer, Anna M; Vergoossen, Laura; Paulis, Leonie; van Zwam, Willem H; Das, Marco; Wildberger, Joachim E; Jeukens, Cécile R L P N

    2017-11-01

    Radiation safety and protection are a key component of fluoroscopy-guided interventions. We hypothesize that providing weekly personal dose feedback will increase radiation awareness and ultimately will lead to optimized behavior. Therefore, we designed and implemented a personalized feedback of procedure and personal doses for medical staff involved in fluoroscopy-guided interventions. Medical staff (physicians and technicians, n = 27) involved in fluoroscopy-guided interventions were equipped with electronic personal dose meters (PDMs). Procedure dose data including the dose area product and effective doses from PDMs were prospectively monitored for each consecutive procedure over an 8-month period (n = 1082). A personalized feedback form was designed displaying for each staff individually the personal dose per procedure, as well as relative and cumulative doses. This study consisted of two phases: (1) 1-5th months: Staff did not receive feedback (n = 701) and (2) 6-8th months: Staff received weekly individual dose feedback (n = 381). An anonymous evaluation was performed on the feedback and occupational dose. Personalized feedback was scored valuable by 76% of the staff and increased radiation dose awareness for 71%. 57 and 52% reported an increased feeling of occupational safety and changing their behavior because of personalized feedback, respectively. For technicians, the normalized dose was significantly lower in the feedback phase compared to the prefeedback phase: [median (IQR) normalized dose (phase 1) 0.12 (0.04-0.50) µSv/Gy cm 2 versus (phase 2) 0.08 (0.02-0.24) µSv/Gy cm 2 , p = 0.002]. Personalized dose feedback increases radiation awareness and safety and can be provided to staff involved in fluoroscopy-guided interventions.

  5. Permissive Parenting and Mental Health in College Students: Mediating Effects of Academic Entitlement

    Science.gov (United States)

    Barton, Alison L.; Hirsch, Jameson K.

    2016-01-01

    Objective: Student mental health may suffer due to unreasonable expectations associated with academic entitlement; permissive parenting may be one source of these expectations. The authors examined the role of academic entitlement as a mediator of the relationship between permissive parenting and psychological functioning. Participants:…

  6. Maximum Permissible Concentrations and Negligible Concentrations for pesticides

    NARCIS (Netherlands)

    Crommentuijn T; Kalf DF; Polder MD; Posthumus R; Plassche EJ van de; CSR

    1997-01-01

    Maximum Permissible Concentrations (MPCs) and Negligible Concentrations (NCs) derived for a series of pesticides are presented in this report. These MPCs and NCs are used by the Ministry of Housing, Spatial Planning and the Environment (VROM) to set Environmental Quality Objectives. For some of the

  7. 50 CFR 216.252 - Permissible methods of taking.

    Science.gov (United States)

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF COMMERCE MARINE MAMMALS REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS Taking Marine Mammals Incidental to Conducting Precision Strike Weapon Missions in the Gulf of Mexico § 216.252 Permissible methods of taking. (a) Under Letters of Authorization issued pursuant to...

  8. Pregnancy Calendar: A Week-by-Week Guide

    Science.gov (United States)

    ... Fitness Diseases & Conditions Infections Drugs & Alcohol School & Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español A Week-by-Week Pregnancy Calendar KidsHealth / For Parents / A Week-by-Week ...

  9. 50 CFR 216.213 - Permissible methods of taking.

    Science.gov (United States)

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF COMMERCE MARINE MAMMALS REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS Taking of Marine Mammals Incidental to Explosive Severance Activities Conducted During Offshore Structure Removal Operations on the Outer Continental Shelf in the U.S. Gulf of Mexico § 216.213 Permissible...

  10. Concurrent weekly cisplatin plus external beam radiotherapy and high-dose rate brachytherapy for advanced cervical cancer: A control cohort comparison with radiation alone on treatment outcome and complications

    International Nuclear Information System (INIS)

    Chen, S.-W.; Liang, J.-A.; Hung, Y.-C.; Yeh, L.-S.; Chang, W.-C.; Lin, W.-C.; Yang, S.-N.; Lin, F.-J.

    2006-01-01

    Purpose: To test, though a control-cohort study, the hypothesis that concurrent chemoradiotherapy (CCRT) using weekly cisplatin, plus high-dose rate intracavitary brachytherapy (HDRICB) is superior to radiation (RT) alone in patients with advanced cervical cancer. Methods and Materials: A total of 171 patients with Stage IIB-III cervical cancer were enrolled in this study. Seventy patients were treated with CCRT and the results were compared with those of 101 patients who had been treated with RT using the same protocol at an early period. RT consisted of 45 Gy in 25 fractions to the whole pelvis, followed by a 12.6-Gy boost to the parametrium. Four courses of HDRICB using 6.0 Gy to Point A were performed. Chemotherapy consisted of weekly cisplatin at a dose of 40 mg/m 2 for 5-6 cycles. Results: The 4-year actuarial survival was 74% for the CCRT group and 68% for the RT group (p = 0.60). The 4-year pelvic relapse-free survival was 87% for the CCRT group and 85% for the RT group (p = 0.37). The 4-year distant metastases-free survival was 75% for the CCRT group and 76% for the RT group (p = 0.44). The cumulative incidence of gastrointestinal and genitourinary injuries of grade 3 or above was 14.3% for the CCRT group and 7.9% for the RT group (p = 0.19). Conclusion: This study did not show a survival benefit of CCRT with weekly cisplatin and HDRICB for Stage II-III cervical cancer, nor did it demonstrate a significant increase of late complications when comparing with RT alone

  11. Time of administration important? Morning versus evening dosing of valsartan.

    Science.gov (United States)

    Zappe, Dion H; Crikelair, Nora; Kandra, Albert; Palatini, Paolo

    2015-02-01

    Studies suggest that bedtime dosing of an angiotensin-converting enzyme (ACE)-inhibitor or angiotensin receptor blocker shows a more sustained and consistent 24-h antihypertensive profile, including greater night-time blood pressure (BP) reduction. We compared the antihypertensive effects of morning (a.m.) and evening (p.m.) dosing of valsartan on 24-h BP. This 26-week, multicentre, randomized, double-blind study evaluated the efficacy and safety of valsartan 320 mg, dosed a.m. or p.m., versus lisinopril 40 mg (a.m.), a long-acting ACE-inhibitor, in patients with grade 1-2 hypertension and at least one additional cardiovascular risk factor. Patients (n = 1093; BP = 156 ± 11/91 ± 8 mmHg; 62 years, 56% male, 99% white) received (1 : 1 : 1) valsartan 160 mg a.m. or p.m. or lisinopril 20 mg a.m. for 4 weeks, then force-titrated to double the initial dose for 8 weeks. At Week 12, hydrochlorothiazide (HCTZ) 12.5 mg was added for 14 weeks if office BP was more than 140/90 mmHg and/or ambulatory BP more than 130/80 mmHg. Mean 24-h ambulatory SBP change from baseline to Weeks 12 and 26 was comparable between valsartan a.m. (-10.6 and -13.3 mmHg) and p.m. (-9.8 and -12.3 mmHg) and lisinopril (-10.7 and -13.7 mmHg). There was no benefit of valsartan p.m. versus a.m. on night-time BP, early morning BP and morning BP surge. Evening dosing also did not improve BP lowering in patients requiring add-on HCTZ or in nondippers at baseline. All treatments were well tolerated. Once-daily dosing of valsartan 320 mg results in equally effective 24-h BP efficacy, regardless of dosing time. ClinicalTrials.gov Identifier: NCT00241124.

  12. 36 CFR 223.12 - Permission to cut, damage, or destroy trees without advertisement.

    Science.gov (United States)

    2010-07-01

    ... destroy trees without advertisement. 223.12 Section 223.12 Parks, Forests, and Public Property FOREST... § 223.12 Permission to cut, damage, or destroy trees without advertisement. Permission may be granted to cut, damage, or destroy trees, portions of trees, or other forest products on National Forest System...

  13. 47 CFR 74.790 - Permissible service of digital TV translator and LPTV stations.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Permissible service of digital TV translator... DISTRIBUTIONAL SERVICES Low Power TV, TV Translator, and TV Booster Stations § 74.790 Permissible service of digital TV translator and LPTV stations. (a) Digital TV translator stations provide a means whereby the...

  14. Radiation exposure of radiologists during angiography: Dose measurements outside the lead apron

    International Nuclear Information System (INIS)

    Fischer, H.; Przetak, C.; Teubert, G.; Ewen, K.; Moedder, U.

    1995-01-01

    The aim of this study was to provide practical information to angiographers concerning radiation exposure to body parts not covered by lead aprons. Individual doses to the neck and hands of radiologists measured in micro-Sieverts were obtained during the course of 80 angiographies of various types. The number of diagnostic and interventional procedures, which might lead to exceeding permissible doses, have been calculated. Possibilities of estimating doses during angiography by means of parameters such as screening times were examined statistically. Especially with regard to the hands, estimations of the doses are insufficient (correlation r=0.21). Radiologists who undertake much angiographic and particularly interventional work may reach exposure levels requiring protective measures in addition to lead aprons. (orig.) [de

  15. Permissiveness toward tobacco sponsorship undermines tobacco control support in Africa.

    Science.gov (United States)

    Ayo-Yusuf, Olalekan A; Olutola, Bukola G; Agaku, Israel T

    2016-06-01

    School personnel, who are respected members of the community, may exert significant influence on policy adoption. This study assessed the impact of school personnel's permissiveness toward tobacco industry sponsorship activities on their support for complete bans on tobacco advertisements, comprehensive smoke-free laws and increased tobacco prices. Representative data were obtained from the Global School Personnel Survey for 29 African countries (n = 17 929). Adjusted prevalence ratios (aPR) were calculated using multi-variable Poisson regression models to assess the impact of permissiveness toward tobacco sponsorship activities on support for tobacco control policies (p industry should be allowed to sponsor school events were significantly less likely to support complete bans on tobacco advertisements [aPR = 0.89; 95% confidence interval (CI) 0.84-0.95] and comprehensive smoke-free laws (aPR = 0.95; 95% CI 0.92-0.98). In contrast, support for complete tobacco advertisement bans was more likely among those who believed that the tobacco industry encourages youths to smoke (aPR = 1.27; 95% CI 1.17-1.37), and among those who taught about health sometimes (aPR = 1.06; 95% CI 1.01-1.11) or a lot (aPR = 1.05; 95% CI 1.01-1.10) compared with those who did not teach about health at all. These findings underscore the need to educate school personnel on tobacco industry's strategies to undermine tobacco control policies. This may help to build school personnel support for laws intended to reduce youth susceptibility, experimentation and established use of tobacco products. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Legitimate Permissions And Specifity Of Their Enforceability In Modern Russia

    Directory of Open Access Journals (Sweden)

    Vitaly Subochev

    2014-01-01

    Full Text Available Northern Caucasus Institute of Advanced Training (branch of Krasnodar University of Ministry of Internal Affairs of Russia, 123, Malbahova Street, Nalshik, 360016, Russia. Abstract: The article investigates the basic legal permissions in Russian law - legal rights, freedoms and legitimate interests. Potential of these means of legal regulation is examined as well as their common features and essential differences. Authors argue that the effectiveness of the mechanism of legal regulation largely depends on the proper use of legal permissions. Particular attention is paid to such kind of legal mean as a legitimate interest. The article draws attention to the fact that if a legal right or freedom are such kind of permissions which are guaranteed by the law in order to sustain certain demands of subjects of law, the legitimate interest is qualitatively different mean of regulation. The authors suggest considering a legitimate interest as reflected in the objective law legal possibility of subjects of law to enjoy certain social benefits and to seek protection from the state authorities in order to meet their interests which are not contradictory to provisions of law. Qualitative difference between legitimate interest and legal right and freedom is that the legitimate interest is an opportunity, guaranteed to a lesser extent than the permitted behavior within a legal right or freedom. Legitimate interest is a mere permission, admitted by the state and to some extent supported by it. But legal right and freedom - are those means of regulation, which are directly approved and sanctioned by the state which presuppose duty of a person to a particular behavior. The author's vision of the specifity of legal enforcement of legitimate admissions is presented.

  17. LEGITIMATE PERMISSIONS AND SPECIFITY OF THEIR ENFORCEABILITY IN MODERN RUSSIA

    Directory of Open Access Journals (Sweden)

    Vitaly Subochev

    2014-01-01

    Full Text Available Northern Caucasus Institute of Advanced Training (branch of Krasnodar University of Ministry of Internal Affairs of Russia, 123, Malbahova Street, Nalshik, 360016, Russia. Abstract: The article investigates the basic legal permissions in Russian law - legal rights, freedoms and legitimate interests. Potential of these means of legal regulation is examined as well as their common features and essential differences. Authors argue that the effectiveness of the mechanism of legal regulation largely depends on the proper use of legal permissions. Particular attention is paid to such kind of legal mean as a legitimate interest. The article draws attention to the fact that if a legal right or freedom are such kind of permissions which are guaranteed by the law in order to sustain certain demands of subjects of law, the legitimate interest is qualitatively different mean of regulation. The authors suggest considering a legitimate interest as reflected in the objective law legal possibility of subjects of law to enjoy certain social benefits and to seek protection from the state authorities in order to meet their interests which are not contradictory to provisions of law. Qualitative difference between legitimate interest and legal right and freedom is that the legitimate interest is an opportunity, guaranteed to a lesser extent than the permitted behavior within a legal right or freedom. Legitimate interest is a mere permission, admitted by the state and to some extent supported by it. But legal right and freedom - are those means of regulation, which are directly approved and sanctioned by the state which presuppose duty of a person to a particular behavior. The author's vision of the specifity of legal enforcement of legitimate admissions is presented.

  18. Once-Weekly, High-Dose Stereotactic Body Radiotherapy for Lung Cancer: 6-Year Analysis of 60 Early-Stage, 42 Locally Advanced, and 7 Metastatic Lung Cancers

    International Nuclear Information System (INIS)

    Salazar, Omar M.; Sandhu, Taljit S.; Lattin, Paul B.; Chang, Jung H.; Lee, Choon K.; Groshko, Gayle A.; Lattin, Cheryl J.

    2008-01-01

    Purpose: To explore once-weekly stereotactic body radiotherapy (SBRT) in nonoperable patients with localized, locally advanced, or metastatic lung cancer. Methods and Materials: A total of 102 primary (89 untreated plus 13 recurrent) and 7 metastatic tumors were studied. The median follow-up was 38 months, the average patient age was 75 years. Of the 109 tumors studied, 60 were Stage I (45 IA and 15 IB), 9 were Stage II, 30 were Stage III, 3 were Stage IV, and 7 were metastases. SBRT only was given in 73% (40 Gy in four fractions to the planning target volume to a total dose of 53 Gy to the isocenter for a biologically effective dose of 120 Gy 10 ). SBRT was given as a boost in 27% (22.5 Gy in three fractions once weekly for a dose of 32 Gy at the isocenter) after 45 Gy in 25 fractions to the primary plus the mediastinum. The total biologically effective dose was 120 Gy 10 . Respiration gating was used in 46%. Results: The overall response rate was 75%; 33% had a complete response. The overall response rate was 89% for Stage IA patients (40% had a complete response). The local control rate was 82%; it was 100% and 93% for Stage IA and IB patients, respectively. The failure rate was 37%, with 17% within the planning target volume. No Grade 3-4 acute toxicities developed in any patient; 12% and 7% of patients developed Grade 1 and 2 toxicities, respectively. Late toxicity, all Grade 2, developed in 3% of patients. The 5-year cause-specific survival rate for Stage I was 70% and was 74% and 64% for Stage IA and IB patients, respectively. The 3-year Stage III cause-specific survival rate was 30%. The patients with metastatic lung cancer had a 57% response rate, a 27% complete response rate, an 86% local control rate, a median survival time of 19 months, and 23% 3-year survival rate. Conclusions: SBRT is noninvasive, convenient, fast, and economically attractive; it achieves results similar to surgery for early or metastatic lung cancer patients who are older

  19. A new model for deteriorating items with inflation under permissible delay in payments

    Directory of Open Access Journals (Sweden)

    R.P. Tripathi

    2014-05-01

    Full Text Available Inflation is an important factor influencing traditional economic order quality models. Marketing strategy depends on inflation due to public demand and availability of the materials. This paper presents an optimal inventory policy for deteriorating items using exponential demand rate under permissible delay in payments. Mathematical model has been derived under two cases: case I: cycle time is greater than or equal to permissible delay period, case II: cycle time is less than permissible delay period by considering holding cost as a function of time. Numerical examples and sensitivity analysis are given to reflect the numerical results. Mathematica software is used for finding optimal solutions.

  20. Phase I study of twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas

    International Nuclear Information System (INIS)

    Pipas, J. Marc; Mitchell, Sandra E.; Barth, Richard J.; Vera-Gimon, Raul; Rathmann, Joerg; Meyer, Louise P.; Wagman, Richard S.; Lewis, Lionel D.; McDonnell, Carol; Colacchio, Thomas A.; Perez, Raymond P.

    2001-01-01

    Purpose: To determine the maximum tolerated dose and dose-limiting toxicity associated with twice-weekly gemcitabine and concomitant external-beam radiotherapy in patients with adenocarcinoma of the pancreas. Methods and Materials: Twenty-one patients with biopsy-proven adenocarcinoma of the pancreas were treated with external-beam radiotherapy to a dose of 50.4 Gy in 28 fractions, concurrent with gemcitabine, infused over 30 min before irradiation on a Monday and Thursday schedule. The dose of gemcitabine was escalated in 5 cohorts of 3-6 patients each. Initial gemcitabine dose was 10 mg/m 2 , with dose escalation until dose-limiting toxicity was observed. Results: The maximum tolerated dose of gemcitabine was 50 mg/m 2 , when given in a twice-weekly schedule with radiation. Dose-limiting toxicity was seen in 2 patients at 60 mg/m 2 , and consisted of severe upper gastrointestinal bleeding approximately 1 month after completion of treatment. Six patients had radiographic evidence of response to treatment, and 5 of these underwent complete surgical resection. Three patients who underwent complete resection had been deemed to have unresectable tumors before enrollment on trial. Four patients are alive, including 2 without evidence of disease more than 1 year after resection. Conclusion: The combination of external-beam radiation and twice-weekly gemcitabine at a dose of 50 mg/m 2 is well tolerated and shows promising activity for the treatment of pancreatic cancer. Our data suggest a higher maximum tolerated dose and different dose-limiting toxicity than previously reported. Further investigation of this regimen is warranted

  1. Outdoor solar UVA dose assessment with EBT2 radiochromic film using spectrophotometer and densitometer measurements.

    Science.gov (United States)

    Abukassem, I; Bero, M A

    2015-04-01

    Direct measurements of solar ultraviolet radiations (UVRs) have an important role in the protection of humans against UVR hazard. This work presents simple technique based on the application of EBT2 GAFCHROMIC(®) film for direct solar UVA dose assessment. It demonstrates the effects of different parts of the solar spectrum (UVB, visible and infrared) on performed UVA field measurements and presents the measurement uncertainty budget. The gradient of sunlight exposure level permitted the authors to establish the mathematical relationships between the measured solar UVA dose and two measured quantities: the first was the changes in spectral absorbance at the wavelength 633 nm (A633) and the second was the optical density (OD). The established standard relations were also applied to calculate the solar UVA dose variations during the whole day; 15 min of exposure each hour between 8:00 and 17:00 was recorded. Results show that both applied experimental methods, spectrophotometer absorbance and densitometer OD, deliver comparable figures for EBT2 solar UVA dose assessment with relative uncertainty of 11% for spectral absorbance measurements and 15% for OD measurements. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Blood-pressure-independent wall thickening of intramyocardial arterioles in experimental uraemia: evidence for a permissive action of PTH.

    Science.gov (United States)

    Amann, K; Törnig, J; Flechtenmacher, C; Nabokov, A; Mall, G; Ritz, E

    1995-11-01

    Abnormalities in cardiovascular structures, e.g. LV hypertrophy and thickening of vessels (arteries, arterioles, veins) are hallmarks of renal failure. They are in part independent of elevated blood pressure. Parathyroid hormone (PTH) has been shown to affect cardiac function and has also been identified as a permissive factor in the genesis of cardiac fibrosis. The present study in rats with experimental renal failure was designed to examine whether PTH was permissive for wall thickening of intramyocardial arterioles as well. Male SD rats were sham operated or subtotally nephrectomized and maintained for 2 weeks. Subgroups of subtotally nephrectomized (SNX) rats were parathyroidectomized (PTX). Saline or rat 1, 34 PTH was administered by osmotic minipump. Eucalcaemia was maintained in PTX animals by a high-calcium diet (3%). Serum calcium was not statistically different between the groups. After perfusion fixation, intramyocardial arterioles were assessed using stereological techniques (wall thickness; wall/lumen ratio; minimal lumen diameter; length density). In random samples of the left ventricle, wall thickness of arterioles was 2.2 +/- 0.25 microns in sham-op controls and 2.76 +/- 0.41 in SNX (n = at least 8 animals per group). SNX-PTX animals+solvent did not differ significantly from sham-op controls (2.08 +/- 0.42 microns), while SNX-PTX animals+PTH had values not significantly different from SNX (2.59 +/- 0.54 microns). Differences in wall thickness were not paralleled by differences in systolic blood pressure (sham-op 110 +/- 13.3 mmHg; SNX 138 +/- 8.4 mmHg, SNX-PTX+solvent 142 +/- 5.2 mmHg; SNX-PTX+PTH 148 +/- 5.7 mmHg). PTH treated animals showed signs of marked vascular smooth-muscle cell and endothelial-cell activation. The data suggest that wall thickening of intramyocardial arterioles in short-term experimental uraemia is dependent upon the presence of PTH (permissive effect).

  3. Studies on the chronic effect of lower dose level irradiation

    International Nuclear Information System (INIS)

    Yun, T.G.; Yun, E.S.; Chung, I.Y.; Yun, M.S.; Chae, H.S.; Lee, J.Y.

    1982-01-01

    This experiment was carried out to evaluate the chronic hazard of Co-60 low dose radiation on ICR mice. There is now considerable evidence from human studies that age, both at exposure to radiation and at observation for risk, can be major determinant of radiation induced cancer risk. For this reason, ICR mice at different ages such as below were exposed to 60m rads/week, 500m rads/week and 60 rads/biweek whole body Co-60 radiation at a dose rate of 3.6 rads/min. ICR mice were irradiated during pregnant period, from 1st week to 3rd week, from 3rd week to 52nd week, from 6th week to 52nd week, and from 22nd week to 52nd week after the birth. All experimental mice were autopsied immediately after being sacrificed at 52nd week. All major organs were examined grossly and weighed. After fixation histo-pathological preparations were made for microscopical study. Blood cells W.B.C., R.B.C., Hb-from eye's vein were counted by hemocytometer and hemometer. (Author)

  4. Genotoxicity of Silver Nanoparticles in Lung Cells of Sprague Dawley Rats after 12 Weeks of Inhalation Exposure

    Directory of Open Access Journals (Sweden)

    Hyun Sun Cho

    2013-11-01

    Full Text Available Due to the widespread use of silver nanoparticles in consumer products, the toxicity of silver nanoparticles has also been studied in relation to their application. However, most genotoxicity studies of silver nanoparticles have been performed in vitro. Therefore, this study evaluated the DNA damage to lung cells caused by repeated inhalation of silver nanoparticles. Male Sprague Dawley rats were exposed to silver nanoparticles for 12 weeks in a whole-body inhalation chamber. The animals were divided into one control group and three dose groups that were exposed to silver nanoparticles (14–15 nm diameter at concentrations of 0.66 × 106 particles/cm3 (49 μg/m3, low dose, 1.41 × 106 particles/cm3 (117 μg/m3, middle dose, and 3.24 × 106 particles /cm3 (381 μg/m3, high dose, respectively, for six hours/day over 12 weeks. The rats were sacrificed after the 12-week exposure period and the DNA damage assessed using a Comet assay of cells obtained from the right lungs. The olive tail moment values were 2.93 ± 0.19, 3.81 ± 0.23, 3.40 ± 0.22, and 5.16 ± 0.32 for the control, low-, middle-, and high-dose groups, respectively. Although no dose-dependent results were observed, a significant increase in the level of DNA damage was noted for the high-dose group.

  5. Calculate the maximum expected dose for technical radio physicists a cobalt machine

    International Nuclear Information System (INIS)

    Avila Avila, Rafael; Perez Velasquez, Reytel; Gonzalez Lapez, Nadia

    2009-01-01

    Considering the daily operations carried out by technicians Radiophysics Medical Service Department of Radiation Oncology Hospital V. General Teaching I. Lenin in the city of Holguin, during a working week (Between Monday and Friday) as an important element in calculating the maximum expected dose (MDE). From the exponential decay law which is subject the source activity, we propose corrections to the cumulative doses in the weekly period, leading to obtaining a formula which takes into a cumulative dose during working days and sees no dose accumulation of rest days (Saturday and Sunday). The estimate factor correction is made from a power series expansion convergent is truncated at the n-th term coincides with the week period for which you want to calculate the dose. As initial condition is adopted ambient dose equivalent rate as a given, which allows estimate MDE in the moments after or before this. Calculations were proposed use of an Excel spreadsheet that allows simple and accessible processing the formula obtained. (author)

  6. Method of simulating dose reduction for digital radiographic systems

    International Nuclear Information System (INIS)

    Baath, M.; Haakansson, M.; Tingberg, A.; Maansson, L. G.

    2005-01-01

    The optimisation of image quality vs. radiation dose is an important task in medical imaging. To obtain maximum validity of the optimisation, it must be based on clinical images. Images at different dose levels can then either be obtained by collecting patient images at the different dose levels sought to investigate - including additional exposures and permission from an ethical committee - or by manipulating images to simulate different dose levels. The aim of the present work was to develop a method of simulating dose reduction for digital radiographic systems. The method uses information about the detective quantum efficiency and noise power spectrum at the original and simulated dose levels to create an image containing filtered noise. When added to the original image this results in an image with noise which, in terms of frequency content, agrees with the noise present in an image collected at the simulated dose level. To increase the validity, the method takes local dose variations in the original image into account. The method was tested on a computed radiography system and was shown to produce images with noise behaviour similar to that of images actually collected at the simulated dose levels. The method can, therefore, be used to modify an image collected at one dose level so that it simulates an image of the same object collected at any lower dose level. (authors)

  7. Phase I trial of cetuximab in combination with capecitabine, weekly irinotecan, and radiotherapy as neoadjuvant therapy for rectal cancer

    International Nuclear Information System (INIS)

    Hofheinz, Ralf-Dieter; Horisberger, Karoline; Woernle, Christoph; Wenz, Frederik; Kraus-Tiefenbacher, Uta; Kaehler, Georg; Dinter, Dietmar; Grobholz, Rainer; Heeger, Steffen; Post, Stefan; Hochhaus, Andreas; Willeke, Frank

    2006-01-01

    Purpose: To establish the feasibility and efficacy of chemotherapy with capecitabine, weekly irinotecan, cetuximab, and pelvic radiotherapy for patients with locally advanced rectal cancer. Methods and materials: Twenty patients with rectal cancer (clinical Stage uT3-T4 or N+) received a standard dosing regimen of cetuximab (400 mg/m 2 on Day 1 and 250 mg/m 2 on Days 8, 15, 22, and 29) and escalating doses of irinotecan and capecitabine according to phase I methods: dose level I, irinotecan 40 mg/m 2 on Days 1, 8, 15, 22, and 29 and capecitabine 800 mg/m 2 on Days 1-38; dose level II, irinotecan 40 mg/m 2 and capecitabine 1000 mg/m 2 ; and dose level III, irinotecan 50 mg/m 2 and capecitabine 1000 mg/m 2 . Radiotherapy was given to a dose of 50.4 Gy (45 Gy plus 5.4 Gy). Resection was scheduled 4-5 weeks after termination of chemoradiotherapy. Results: On dose level I, no dose-limiting toxicities occurred; however, Grade 3 diarrhea affected 1 of 6 patients on dose level II. Of 5 patients treated at dose level III, 2 exhibited dose-limiting toxicity (diarrhea in 2 and nausea/vomiting in 1). Therefore, dose level II was determined as the recommended dose for future studies. A total of 10 patients were treated on dose level II and received a mean relative dose intensity of 100% of cetuximab, 94% of irinotecan, and 95% of capecitabine. All patients underwent surgery. Five patients had a pathologically complete remission and six had microfoci of residual tumor only. Conclusion: Preoperative chemoradiotherapy with cetuximab, capecitabine, and weekly irinotecan is feasible and well tolerated. The preliminary efficacy is very promising. Larger phase II trials are ongoing

  8. Influence of Permissive Parenting on Youth Farm Risk Behaviors.

    Science.gov (United States)

    Jinnah, Hamida A; Stoneman, Zolinda

    2016-01-01

    Farm youth continue to experience high rates of injuries and premature deaths as a result of agricultural activities. Increased parental permissiveness is positively associated with many different types of high-risk behaviors in youth. This study explored whether permissive parenting (fathering and mothering) predicts youth unsafe behaviors on the farm. Data were analyzed for 67 youth and their parents. Families were recruited from a statewide farm publication, through youth organizations (i.e., FFA [Future Farmers of America]), local newspapers, farmer referrals, and through the Cooperative Extension Network. Hierarchical multiple regression was completed. Results revealed that fathers and mothers who practiced lax-inconsistent disciplining were more likely to have youth who indulged in unsafe farm behaviors. Key hypotheses confirmed that permissive parenting (lax-inconsistent disciplining) by parents continued to predict youth unsafe farm behaviors, even after youth age, youth gender, youth personality factor of risk-taking, and father's unsafe behaviors (a measure associated with modeling) were all taken into account. A key implication is that parents may play an important role in influencing youth farm safety behaviors. Parents (especially fathers) need to devote time to discuss farm safety with their youth. Farm safety interventions need to involve parents as well as address and respect the culture and values of families. Interventions need to focus not only on safe farm practices, but also promote positive parenting practices, including increased parent-youth communication about safety, consistent disciplining strategies, and increased monitoring and modeling of safe farm behaviors by parents.

  9. A randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (abraxane) in patients with extensive-stage small cell lung cancer.

    Science.gov (United States)

    Grilley-Olson, Juneko E; Keedy, Vicki L; Sandler, Alan; Moore, Dominic T; Socinski, Mark A; Stinchcombe, Thomas E

    2015-02-01

    Platinum plus etoposide is the standard therapy for extensive-stage small cell lung cancer (ES-SCLC) and is associated with significant myelosuppression. We hypothesized that the combination of carboplatin and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) would be better tolerated. We investigated carboplatin with nab-paclitaxel on every-3-week and weekly schedules. This noncomparative randomized phase II trial used a two-stage design. The primary objective was objective response rate, and secondary objectives were progression-free survival, overall survival, and toxicity. Patients with ES-SCLC and an Eastern Cooperative Oncology Group performance status ≤2 and no prior chemotherapy were randomized in a 1:1 ratio to arm A (carboplatin area under the curve [AUC] of 6 on day 1 and nab-paclitaxel of 300 mg/m(2) on day 1 every 3 weeks) or arm B (carboplatin AUC of 6 on day 1 and nab-paclitaxel 100 mg/m(2) on days 1, 8, and 15 every 21 days). Response was assessed after every two cycles. Patients required frequent dose reductions, treatment delays, and omission of the weekly therapy. The trial was closed because of slow accrual. Carboplatin and nab-paclitaxel demonstrated activity in ES-SCLC but required frequent dose adjustments. ©AlphaMed Press; the data published online to support this summary is the property of the authors.

  10. Low Radiation Dose and Low Cell Dose Increase the Risk of Graft Rejection in a Canine Hematopoietic Stem Cell Transplantation Model.

    Science.gov (United States)

    Lange, Sandra; Steder, Anne; Glass, Änne; Killian, Doreen; Wittmann, Susanne; Machka, Christoph; Werner, Juliane; Schäfer, Stephanie; Roolf, Catrin; Junghanss, Christian

    2016-04-01

    The canine hematopoietic stem cell transplantation (HSCT) model has become accepted in recent decades as a good preclinical model for the development of new transplantation strategies. Information on factors associated with outcome after allogeneic HSCT are a prerequisite for designing new risk-adapted transplantation protocols. Here we report a retrospective analysis aimed at identifying risk factors for allograft rejection in the canine HSCT model. A total of 75 dog leukocyte antigen-identical sibling HSCTs were performed since 2003 on 10 different protocols. Conditioning consisted of total body irradiation at 1.0 Gy (n = 20), 2.0 Gy (n = 40), or 4.5 Gy (n = 15). Bone marrow was infused either intravenously (n = 54) or intraosseously (n = 21). Cyclosporin A alone or different combinations of cyclosporine A, mycophenolate mofetil, and everolimus were used for immunosuppression. A median cell dose of 3.5 (range, 1.0 to 11.8) total nucleated cells (TNCs)/kg was infused. Cox analyses were used to assess the influence of age, weight, radiation dose, donor/recipient sex, type of immunosuppression, and cell dose (TNCs, CD34(+) cells) on allograft rejection. Initial engraftment occurred in all dogs. Forty-two dogs (56%) experienced graft rejection at median of 11 weeks (range, 6 to 56 weeks) after HSCT. Univariate analyses revealed radiation dose, type of immunosuppression, TNC dose, recipient weight, and recipient age as factors influencing long-term engraftment. In multivariate analysis, low radiation dose (P rejection. Peripheral blood mononuclear cell chimerism ≥30% (P = .008) and granulocyte chimerism ≥70% (P = .023) at 4 weeks after HSCT were independent predictors of stable engraftment. In summary, these data indicate that even in low-dose total body irradiation-based regimens, the irradiation dose is important for engraftment. The level of blood chimerism at 4 weeks post-HSCT was predictive of long-term engraftment in the canine HSCT

  11. 20 CFR 416.1321 - Suspension for not giving us permission to contact financial institutions.

    Science.gov (United States)

    2010-04-01

    ... contact financial institutions. 416.1321 Section 416.1321 Employees' Benefits SOCIAL SECURITY....1321 Suspension for not giving us permission to contact financial institutions. (a) If you don't give us permission to contact any financial institution and request any financial records about you when...

  12. A single 2 g oral dose of extended-release azithromycin for treatment of gonococcal urethritis.

    Science.gov (United States)

    Yasuda, Mitsuru; Ito, Shin; Kido, Akira; Hamano, Kiminari; Uchijima, Yutaka; Uwatoko, Noriyasu; Kusuyama, Hiroyuki; Watanabe, Akiko; Miyamura, Ryuzou; Miyata, Kazutoyo; Deguchi, Takashi

    2014-11-01

    We treated gonococcal urethritis in men with a single 2 g dose of azithromycin extended-release formulation (azithromycin-SR) to determine its microbiological outcomes and tolerability. We enrolled 189 Japanese men with gonococcal urethritis between April 2009 and December 2013. The patients were given a single 2 g dose of azithromycin-SR. Microbiological efficacy was evaluated by the results of the post-treatment molecular testing of Neisseria gonorrhoeae. MIC testing was performed only for pretreatment isolates of N. gonorrhoeae collected from the patients. We evaluated 130 patients for microbiological outcomes. Of these patients, 122 (93.8%) were judged to be microbiologically cured on the basis of negative test results. All isolates for which the azithromycin MICs were ≤0.25 mg/L were eradicated, whereas 5 of 12 isolates for which the MICs were 1 mg/L persisted after the treatment. Forty-six adverse events occurred in 41 patients. However, all adverse events were classified as mild. The eradication rate of N. gonorrhoeae was 93.8% in men with gonococcal urethritis treated with a single 2 g dose of azithromycin-SR. The breakpoint MIC of a 2 g dose of azithromycin-SR for gonococcal urethritis associated with clinical treatment failures appeared to be 1 mg/L. With regard to side effects of higher doses of azithromycin, the 2 g dose of azithromycin-SR appeared to improve tolerability. However, the widespread use of a high-dose regimen of azithromycin might lead to the development of further resistance to azithromycin. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  13. Low and high dose rate heavy ion radiation-induced intestinal and colonic tumorigenesis in APC1638N/+ mice

    Science.gov (United States)

    Suman, Shubhankar; Kumar, Santosh; Moon, Bo-Hyun; Fornace, Albert J.; Datta, Kamal

    2017-05-01

    Ionizing radiation (IR) is a recognized risk factor for colorectal cancer (CRC) and astronauts undertaking long duration space missions are expected to receive IR doses in excess of permissible limits with implications for colorectal carcinogenesis. Exposure to IR in outer space occurs at low doses and dose rates, and energetic heavy ions due to their high linear energy transfer (high-LET) characteristics remain a major concern for CRC risk in astronauts. Previously, we have demonstrated that intestinal tumorigenesis in a mouse model (APC1638N/+) of human colorectal cancer was significantly higher after exposure to high dose rate energetic heavy ions relative to low-LET γ radiation. The purpose of the current study was to compare intestinal tumorigenesis in APC1638N/+ mice after exposure to energetic heavy ions at high (50 cGy/min) and relatively low (0.33 cGy/min) dose rate. Male and female mice (6-8 weeks old) were exposed to either 10 or 50 cGy of 28Si (energy: 300 MeV/n; LET: 70 keV/μm) or 56Fe (energy: 1000 MeV/n; LET: 148 keV/μm) ions at NASA Space Radiation Laboratory in Brookhaven National Laboratory. Mice (n = 20 mice/group) were euthanized and intestinal and colon tumor frequency and size were counted 150 days after radiation exposure. Intestinal tumorigenesis in male mice exposed to 56Fe was similar for high and low dose rate exposures. Although male mice showed a decreasing trend at low dose rate relative to high dose rate exposures, the differences in tumor frequency between the two types of exposures were not statistically significant after 28Si radiation. In female mice, intestinal tumor frequency was similar for both radiation type and dose rates tested. In both male and female mice intestinal tumor size was not different after high and low dose rate radiation exposures. Colon tumor frequency in male and female mice after high and low dose rate energetic heavy ions was also not significantly different. In conclusion, intestinal and colonic tumor

  14. Fetal doses from plutonium-239 and polonium-210

    International Nuclear Information System (INIS)

    Harrison, J.D.; Morgan, A.; Stather, J.W.

    1992-01-01

    The transfer of 239 Pu and 210 Po from the maternal circulation to the developing embryo and fetus was studied in rodents. The highest concentrations of both isotopes were measured in the yolk sac. In utero doses to haemopoietic tissue have been calculated taking account of transfer to the blastocyst/egg cylinder, yolk sac, liver and bone marrow. From animal data, the concentration ratios relative to maternal liver for these tissues were taken to be 0.1, 2, 0.01 and o.02, respectively for 239 Pu; and 1, 2, 0.1 and 0.1, respectively, for 210 Po. These concentration ratios were applied to periods of human gestation of 0-2.5 weeks, 2.5-6 weeks, 6-12 weeks and 12-38 weeks, and used to calculate fetal tissue doses for chronic maternal intake by ingestion of 1 kBq 239 Pu or 2 kBq 210 Po in the year of pregnancy (1 ALI for a member of the public). On this basis, the total in utero dose to haemopoietic tissue was about 1 μSv from 239 Pu and 60 μSv from 210 Po compared with red bone marrow doses to the mother in the year of 19 μSv from 239 Pu and 160 μSv from 210 Po. The yolk sac and bone marrow dominated in utero doses from both nuclides. For 239 Pu, because of its long half life, an important consideration was activity present in the offspring at birth and committed dose equivalents to red bone marrow in the child and mother. The total dose to haemopoietic tissue in the offspring to age 70 years, including in utero doses, was calculated as 13 μSv compared with a maternal dose to red bone marrow of 1400 μSv. For both isotopes the risk of leukaemia in the year of pregnancy was estimated to be of the same order for mother and fetus. For 239 Pu, the overall risk to 70 years of age was two orders of magnitude higher for the mother than her offspring. For 239 Pu, an acute intake of 1 kBq by ingestion during the period of yolk sac haemopoiesis would result in the highest in utero dose, estimated at about 20 μSv. However, activity at birth would be lower and the overall

  15. Doses to nurses by the technetium-99m, in private and public sector

    International Nuclear Information System (INIS)

    Bied, J.Ch.; Philippon, B.

    1999-01-01

    The global body dose due to the technetium is 1.2 and 1.9 mSv for the two nurses of the private sector. In the public sector, the level reached by the personnel is 0.75 mSv for the global body dose, and the only technetium (global body dose 1.4 and 2.1 mSv for the private sector, 0.95 for the public sector and for the whole of radiations measured by the O.P.R.I. film dosemeter. The doses received at the fingers level present higher levels in the private sector. But these values, 15.2 and 10.7 mSv by month, that is to say 180 mSv by year are the 2/5 of the maximum permissible value. The two persons of the private sector received whole body doses, higher that the doses of the public sector. These doses are about 1.2 to 1.9 these ones received in the public sector. (N.C.)

  16. Radiation dose distributions due to sudden ejection of cobalt device

    International Nuclear Information System (INIS)

    Abdelhady, Amr

    2016-01-01

    The evaluation of the radiation dose during accident in a nuclear reactor is of great concern from the viewpoint of safety. One of important accident must be analyzed and may be occurred in open pool type reactor is the rejection of cobalt device. The study is evaluating the dose rate levels resulting from upset withdrawal of co device especially the radiation dose received by the operator in the control room. Study of indirect radiation exposure to the environment due to skyshine effect is also taken into consideration in order to evaluate the radiation dose levels around the reactor during the ejection trip. Microshield, SHLDUTIL, and MCSky codes were used in this study to calculate the radiation dose profiles during cobalt device ejection trip inside and outside the reactor building. - Highlights: • This study aims to calculate the dose rate profiles after cobalt device ejection from open-pool-type reactor core. • MicroShield code was used to evaluate the dose rates inside the reactor control room. • McSKY code was used to evaluate the dose rates outside the reactor building. • The calculated dose rates for workers are higher than the permissible limits after 18 s from device ejection.

  17. Early alcohol use with parental permission: Psychosocial characteristics and drinking in late adolescence.

    Science.gov (United States)

    Colder, Craig R; Shyhalla, Kathleen; Frndak, Seth E

    2018-01-01

    The earliest experiences with alcohol for many children occur in the family context with parental supervision. The current study examined individual and sociocultural characteristics associated with early (prior to age 13years) sipping and tasting alcohol with parental permission in two longitudinal community samples. Early sipping/tasting was also tested as a predictor of frequency and quantity of alcohol use, and alcohol-related problems seven years later in late adolescence. Early sipping/tasting with parental permission was associated with a sociocultural context supportive of alcohol use (e.g., parental alcohol use, permissive rules about alcohol use in the home, parental attitudes about underage drinking, perceived peer norms), adolescent sensation seeking and disinhibition (e.g., surgency, externalizing behavior) and appraisals of alcohol (negative outcome expectancies and negative implicit alcohol associations). Early sipping/tasting predicted increased frequency and quantity of alcohol consumption, and increased alcohol-related problems in late adolescence, even after controlling sociocultural and individual difference variables. Findings suggest that early sipping/tasting with parental permission is not benign and is a viable target for preventive interventions. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Point Organ Radiation Dose in Abdominal CT: Effect of Patient Off-Centering in an Experimental Human Cadaver Study.

    Science.gov (United States)

    Ali Khawaja, Ranish Deedar; Singh, Sarabjeet; Padole, Atul; Otrakji, Alexi; Lira, Diego; Zhang, Da; Liu, Bob; Primak, Andrew; Xu, George; Kalra, Mannudeep K

    2017-08-01

    To determine the effect of patient off-centering on point organ radiation dose measurements in a human cadaver scanned with routine abdominal CT protocol. A human cadaver (88 years, body-mass-index 20 kg/m2) was scanned with routine abdominal CT protocol on 128-slice dual source MDCT (Definition Flash, Siemens). A total of 18 scans were performed using two scan protocols (a) 120 kV-200 mAs fixed-mA (CTDIvol 14 mGy) (b) 120 kV-125 ref mAs (7 mGy) with automatic exposure control (AEC, CareDose 4D) at three different positions (a) gantry isocenter, (b) upward off-centering and (c) downward off-centering. Scanning was repeated three times at each position. Six thimble (in liver, stomach, kidney, pancreas, colon and urinary bladder) and four MOSFET dosimeters (on cornea, thyroid, testicle and breast) were placed for calculation of measured point organ doses. Organ dose estimations were retrieved from dose-tracking software (eXposure, Radimetrics). Statistical analysis was performed using analysis of variance. There was a significant difference between the trends of point organ doses with AEC and fixed-mA at all three positions (p 92% for both protocols; p < 0.0001). For both protocols, the highest mean difference in point doses was found for stomach and lowest for colon. Measured absorbed point doses in abdominal CT vary with patient-centering in the gantry isocenter. Due to lack of consideration of patient positioning in the dose estimation on automatic software-over estimation of the doses up to 92% was reported. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  19. Quantitative assessment of changes in the dermal fibroblast population of pig skin after single doses of X-rays

    Energy Technology Data Exchange (ETDEWEB)

    Hamlet, R.; Hopewell, J.W.

    1988-10-01

    Changes in the density of fibroblast nuclei in reticular dermis of pigs was studied from 6 to 104 weeks after a single dose of 15.4 Gy of X-rays. The largest decrease in fibroblasts occurred between 12 and 26 weeks after irradiation; after this there was only a slight fall in fibroblast number until 104 weeks when observations ceased. At 26 weeks and later times after irradiation reduction in the density of fibroblast nuclei in the reticular dermis was dose-dependent for single doses in the range 8.0-20.7 Gy. The dose-response curve had an initial shoulder, after which the fall in the fibroblast nuclear density was linearly related to dose. Data obtained between 26 weeks and 104 weeks after irradiation, could be fitted by the same dose-response curve. The fall in the counts of fibroblast nuclei was compared with earlier studies. The loss of fibroblasts occurred after an initial reduction in blood flow in the pig skin but was concomitant with general reduction in dermal thickness.

  20. Fundamental study on the characteristics of a radiophotoluminescence glass dosemeter with no energy compensation filter for measuring patient entrance doses in cardiac interventional procedures.

    Science.gov (United States)

    Kato, Mamoru; Chida, Koichi; Moritake, Takashi; Koguchi, Yasuhiro; Sato, Tadaya; Oosaka, Hajime; Tosa, Tetsuo; Kadowaki, Ken

    2014-12-01

    Cardiac interventional procedures have been increasing year by year. However, radiation skin injuries have been still reported. There is a necessity to measure the patient entrance skin dose (ESD), but an accurate dose measurement method has not been established. To measure the ESD, a lot of radiophotoluminescence dosemeters (RPLDs) provide an accurate measurement of the direct actual ESD at the points they are arrayed. The purpose of this study was to examine the characteristics of RPLD to measure the ESD. As a result, X-ray permeable RPLD (with no tin filter) did not interfere with the percutaneous coronary intervention procedure. The RPLD also had good fundamental performance characteristics. Although the RPLD had a little energy dependence, it showed excellent dose and dose-rate linearity, and good angular dependence. In conclusion, by calibrating the energy dependence, RPLDs are useful dosemeter to measure the ESD in cardiac intervention. © The Author 2013. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Drug evaluation and the permissive principle: continuities and contradictions between standards and practices in antidepressant regulation.

    Science.gov (United States)

    Abraham, John; Davis, Courtney

    2009-08-01

    Pharmaceuticals are not permitted on to the market unless they are granted regulatory approval. The regulatory process is, therefore, crucial in whether or not a drug is widely prescribed. Regulatory agencies have developed standards of performance that pharmaceuticals are supposed to meet before entering the market. Regulation of technologies is often discussed by reference to the precautionary principle. In contrast, this paper develops the concept of the 'permissive principle' as a way of understanding the departure of regulators' practices from standards of drug efficacy to which regulatory agencies themselves subscribe. By taking a case study of antidepressant regulation in the UK and the USA, the mechanisms of permissive regulatory practices are examined. An STS methodology of both spatial (international) and temporal comparisons of regulatory practices with regulatory standards is employed to identify the nature and extent of the permissive regulation. It is found that the permissive principle was adopted by drug regulators in the UK and the USA, but more so by the former than the latter. Evidently, permissive regulation, which favours the commercial interests of the drug manufacturer, but is contrary to the interests of patients, may penetrate to the heart of regulatory science. On the other hand, permissive regulation of specific drugs should not be regarded as an inevitable result of marketing strategies and concomitant networks deployed by powerful pharmaceutical companies, because the extent of permissive regulation may vary according to the intra-institutional normative commitments of regulators to uphold their technical standards against the commercial interests of the manufacturer. Likely sociological factors that can account for such permissive regulatory practices are 'corporate bias', secrecy and excessive regulatory trust in the pharmaceutical industry in the UK, political expediency and ideological capture in the USA, combined in both countries

  2. A single-blinded randomised clinical trial of permissive underfeeding in patients requiring parenteral nutrition.

    Science.gov (United States)

    Owais, Anwar Elias; Kabir, Syed Irfan; Mcnaught, Clare; Gatt, Marcel; MacFie, John

    2014-12-01

    The importance of adequate nutritional support is well established, but characterising what 'adequate nutrition' represents remains contentious. In recent years there has been increasing interest in the concept of 'permissive underfeeding' where patients are intentionally prescribed less nutrition than their calculated requirements. The aim of this study was to evaluate the effect of permissive underfeeding on septic and nutrition related morbidity in patients requiring short term parenteral nutrition (PN). This was a single-blinded randomised clinical trial of 50 consecutive patients requiring parenteral nutritional support. Patients were randomized to receive either normocaloric or hypocaloric feeding (respectively 100% vs. 60% of estimated requirements). The primary end point was septic complications. Secondary end points included the metabolic, physiological and clinical outcomes to the two feeding protocols. Permissive underfeeding was associated with fewer septic complications (3 vs. 12 patients; p = 0.003), and a lower incidence of the systemic inflammatory response syndrome (9 vs. 16 patients; p = 0.017). Permissively underfed patients had fewer feed related complications (2 vs. 9 patients; p = 0.016). Permissive underfeeding in patients requiring short term PN appears to be safe and may results in reduced septic and feed-related complications. NCT01154179 TRIAL REGISTRY: http://clinicaltrials.gov/ct2/show/NCT01154179. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  3. On possible risks of low-dose irradiation

    International Nuclear Information System (INIS)

    Hug, O.; Gesellschaft fuer Strahlen- und Umweltforschung m.b.H., Neuherberg/Muenchen

    1974-01-01

    The survey on more recent experimental and epidemiological data and newer concepts for a realistic estimation of the radiation risk leads to the conclusion that for radiation late damages and possibly also for genetic damages with a chronical radiation exposure in the order of magnitude of the natural radiation exposure and probably also in the order of magnitude of the maximum permissible radiation dose, the risk is very probably lower than is to be expected based on the findings after relatively high doses and dose rates. A few less direct comparative studies have detected a time factor of 3 to 5. Considering the analysis of the RBW demely ionizing radiation which at high doses is not greater than 3, increases with decreasing dose and according to biophysical considerations, can possibly reach a value of 30, an effectiveness reduced by a factor of 10 of small doses and dose rates of loosely ionizing radiation would be even to be expected. All radiobiological knowledge on the effect of ionizing radiation allows one to expect that even smallest radiation doses can cause cellular damages due to the linear irreversable components of the radiation effect and probably that these damages can even be the starting point of a malignant tumour. Regarding this cancer-initiating effect however, the effectiveness of loosely ionizing radiation per rad in the region of natural radiation exposure lie considerably below that existing at high doses and dose rates. Whether however this initial carcinogenic effect of very small doses is at all noticeable during the average life duration in an increase of the spontaneous age-specific tumour rate is questionable if the assumption is confirmed that with decreasing dose, the time manifestation of the radiation induced tumours is delayed. (orig./LH) [de

  4. Adaptation of mechano-graphy to the measurement of integrated doses (1962); Adaptation de la mecanographie pour la comptabilisation des doses integrees (1962)

    Energy Technology Data Exchange (ETDEWEB)

    Tabardel-Brian, R; Dulau, J [Commissariat a l' Energie Atomique, Centre de Production de Plutonium, Marcoule (France). Centre d' Etudes Nucleaires

    1962-07-01

    Because of the increasing number of workers exposed to nuclear radiation, and with a view to avoiding doses above the maximum permissible dose for these workers, it was necessary to find a system whereby the total irradiation assimilated during periods of 3 and 12 consecutive months could be known and circulated rapidly, within 48 hours. The method chosen for this requires the services of the Mechano-graphic service of the Marcoule Centre. The present article describes the mechanical data processing solution to this problem. (authors) [French] Devant le nombre croissant de travailleurs appeles a etre exposes a une irradiation d'origine nucleaire et avec le souci constant d'eviter les depassements de Dose Maximum Admissible a ces agents, il convenait de trouver un systeme de diffusion de doses integrees capable de nous renseigner, dans un delai de 48 h, sur le capital irradiation integre au cours des periodes 3 mois et 12 mois consecutifs. Le mode de diffusion retenu fait appel aux services de l'Atelier Mecanographie du Centre de Marcoule. Le present rapport expose la solution mecanographique apportee a ce probleme. (auteurs)

  5. Development of a 30-week-pregnant female tomographic model from computed tomography (CT) images for Monte Carlo organ dose calculations

    International Nuclear Information System (INIS)

    Shi Chengyu; Xu, X. George

    2004-01-01

    Assessment of radiation dose and risk to a pregnant woman and her fetus is an important task in radiation protection. Although tomographic models for male and female patients of different ages have been developed using medical images, such models for pregnant women had not been developed to date. This paper reports the construction of a partial-body model of a pregnant woman from a set of computed tomography (CT) images. The patient was 30 weeks into pregnancy, and the CT scan covered the portion of the body from above liver to below pubic symphysis in 70 slices. The thickness for each slice is 7 mm, and the image resolution is 512x512 pixels in a 48 cmx48 cm field; thus, the voxel size is 6.15 mm 3 . The images were segmented to identify 34 major internal organs and tissues considered sensitive to radiation. Even though the masses are noticeably different from other models, the three-dimensional visualization verified the segmentation and its suitability for Monte Carlo calculations. The model has been implemented into a Monte Carlo code, EGS4-VLSI (very large segmented images), for the calculations of radiation dose to a pregnant woman. The specific absorbed fraction (SAF) results for internal photons were compared with those from a stylized model. Small and large differences were found, and the differences can be explained by mass differences and by the relative geometry differences between the source and the target organs. The research provides the radiation dosimetry community with the first voxelized tomographic model of a pregnant woman, opening the door to future dosimetry studies

  6. WifiLeaks: Underestimated Privacy Implications of the ACCESS_WIFI_STATE Android Permission

    OpenAIRE

    Achara , Jagdish Prasad; Cunche , Mathieu; Roca , Vincent; Francillon , Aurélien

    2014-01-01

    A short version has been accepted for publication in: 7th ACM Conference on Security and Privacy in Wireless and Mobile Networks (WISEC'14) Oxford, United Kingdom, July 23rd -- 25th 2014; On Android, users can choose to install an application, or not, based on the permissions it requests. These permissions are later enforced on the application by the system, e.g., when accessing sensitive user data. In this work, we focus on the access to Wi-Fi related information, which is protected by the A...

  7. Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission.

    Science.gov (United States)

    Goodman, David W; Starr, H Lynn; Ma, Yi-Wen; Rostain, Anthony L; Ascher, Steve; Armstrong, Robert B

    2017-01-01

    To evaluate the efficacy and safety of individualized dosing within the approved dose range for osmotic-release oral system (OROS) methylphenidate hydrochloride in adults with attention-deficit/hyperactivity disorder (ADHD). A double-blind, 6-week trial was conducted between July 2009 and February 2010 at 35 US sites. Adults with ADHD (DSM-IV diagnostic criteria) and a screening ADHD Investigator Symptom Rating Scale (AISRS) score > 24 were randomly assigned to OROS methylphenidate 18 mg or matching placebo. Treatment dose could be increased at 18 mg increments, up to 72 mg/d, until an optimal dose was achieved. AISRS score changes from baseline to end point (primary outcome) were analyzed using analysis of covariance. At baseline, the intent-to-treat population of 169 OROS methylphenidate and 172 placebo subjects (mean age = 35.8 years) had mean (standard deviation [SD]) AISRS scores of 37.8 (6.94) and 37.0 (7.51), respectively. OROS methylphenidate-treated subjects exhibited a significantly greater mean (SD) AISRS score improvement than placebo subjects (-17.1 [12.44] vs -11.7 [13.30]; P ADHD. OROS methylphenidate treatment with individualized doses titrated to achieve symptom remission demonstrated greater ADHD symptom reduction than placebo treatment. These data support the overall efficacy of OROS methylphenidate treatment in the management of adults with ADHD and provide new possibilities for additional intervention. ClinicalTrials.gov identifier: NCT00937040. © Copyright 2017 Physicians Postgraduate Press, Inc.

  8. A permissive graphical patcher for supercollider synths

    OpenAIRE

    Dufeu, Frédéric

    2016-01-01

    This article presents the first version of a permissive graphical patcher (referred to in the text as SCPGP) dedicated to fluid interconnection and control of SuperCollider Synths. With SCPGP, the user programs her/his SynthDefs normally as code in the SuperCollider environment, along with a minimal amount of additional information on these SynthDefs, and programs Patterns according to a simple SuperCollider-compliant syntax.\\ud From the execution of this SuperCollider session, the SCPGP inte...

  9. Radiation dose to Sri Lankan infants from Caesium-137 in contaminated milk

    International Nuclear Information System (INIS)

    Hewamanna, R.; Dias, M.P.

    1999-01-01

    The radiation dose to infants due to ingestion of milk containing the maximum limit of radioactivity in milk powder imported to Sri Lanka has been calculated. The radioactivity of Cs-137 was used as an index of fission products for setting radioactivity limits. The computation for milk powder was based on an average daily intake of 125 g by infants, (a critical group of population) during the first year after birth. The recommended dose commitment to the general public is 1 mSv/y. The maximum permissible limit of 20 Bq/kg of Cs-137 in milk powder as stipulated by the Atomic Energy Authority for milk powder imported to Sri Lanka would yield a dose equivalent of 12.6 micro seivert/y from Cs-137

  10. Methotrexate osteopathy in long-term, low-dose methotrexate treatment for psoriasis and rheumatoid arthritis

    NARCIS (Netherlands)

    Zonneveld, I. M.; Bakker, W. K.; Dijkstra, P. F.; Bos, J. D.; van Soesbergen, R. M.; Dinant, H. J.

    1996-01-01

    In dermatology and rheumatology, methotrexate is frequently prescribed in low dosages per week; in oncology, high dosages per week are prescribed. Methotrexate osteopathy was first reported in children with leukemia treated with high doses of methotrexate. In animal studies, low doses of

  11. Verification of Snapshotable Trees using Access Permissions and Typestate

    DEFF Research Database (Denmark)

    Mehnert, Hannes; Aldrich, Jonathan

    2012-01-01

    We use access permissions and typestate to specify and ver- ify a Java library that implements snapshotable search trees, as well as some client code. We formalize our approach in the Plural tool, a sound modular typestate checking tool. We describe the challenges to verify- ing snapshotable tree...

  12. A quantitative assessment of changes in the dermal fibroblast population of pig skin after single doses of X-rays

    International Nuclear Information System (INIS)

    Hamlet, R.; Hopewell, J.W.

    1988-01-01

    Changes in the density of fibroblast nuclei in reticular dermis of pigs was studied from 6 to 104 weeks after a single dose of 15.4 Gy of X-rays. The largest decrease in fibroblasts occurred between 12 and 26 weeks after irradiation; after this there was only a slight fall in fibroblast number until 104 weeks when observations ceased. At 26 weeks and later times after irradiation reduction in the density of fibroblast nuclei in the reticular dermis was dose-dependent for single doses in the range 8.0-20.7 Gy. The dose-response curve had an initial shoulder, after which the fall in the fibroblast nuclear density was linearly related to dose. Data obtained between 26 weeks and 104 weeks after irradiation, could be fitted by the same dose-response curve. The fall in the counts of fibroblast nuclei was compared with earlier studies. The loss of fibroblasts occurred after an initial reduction in blood flow in the pig skin but was concomitant with general reduction in dermal thickness. (author)

  13. Determination of organ doses in radiographic imaging and diagnostic radiology

    International Nuclear Information System (INIS)

    Rathjen, M.

    1981-01-01

    Earlier publications on diagnostic radiation exposure commonly presented data on the gonadal dose. This emphasis on the genetic radiation risk is no longer valid in view of recent radiobiological findings; equal attention should be paid to the somatic radiation risk which is manifested by the induction of malignant neoplasms, e.g. in the lungs, red bone marrow, thyroid and female breast (ICRP 26). The permissible radiation doses for these organs and the gonals for routine diagnostic radiology are determined. A formula is established on the basis of terms from relevant publications (e.g. open-air dose, backscattering factor) and from the author's own measurements in an Alderson-Rando phantom (depth dose curves, dose decrements). The measurements were carried out using CaP 2 thermoluminescence dosemeters, and the organ doses for the various techniques of X-ray examination were calculated by computer. Calculations of this type will enable the radiologist to determine the patient exposure quickly and easily from the records kept according to Sect. 29 of the X-ray Ordinance. Experimental value from relevant publications are compared with the author's own results. (orig./HP) [de

  14. What Is the Most Effective Way of Increasing the Bioavailability of Dietary Long Chain Omega-3 Fatty Acids—Daily vs. Weekly Administration of Fish Oil?

    Directory of Open Access Journals (Sweden)

    Samaneh Ghasemifard

    2015-07-01

    Full Text Available The recommendations on the intake of long chain omega-3 polyunsaturated fatty acids (n-3 LC-PUFA vary from eating oily fish (“once to twice per week” to consuming specified daily amounts of eicosapentaenoic acid (EPA and docosahexaenoic acid (DHA (“250–500 mg per day”. It is not known if there is a difference in the uptake/bioavailability between regular daily consumption of supplementsvs. consuming fish once or twice per week. In this study, the bioavailability of a daily dose of n-3 LC-PUFA (Constant treatment, representing supplements, vs. a large weekly dose of n-3 LC-PUFA (Spike treatment, representing consuming once or twice per week, was assessed. Six-week old healthy male Sprague-Dawley rats were fed either a Constant treatment, a Spike treatment or Control treatment (no n-3 LC-PUFA, for six weeks. The whole body, tissues and faeces were analysed for fatty acid content. The results showed that the major metabolic fate of the n-3 LC-PUFA (EPA+docosapentaenoic acid (DPA + DHA was towards catabolism (β-oxidation accounting for over 70% of total dietary intake, whereas deposition accounted less than 25% of total dietary intake. It was found that significantly more n-3 LC-PUFA were β-oxidised when originating from the Constant treatment (84% of dose, compared with the Spike treatment (75% of dose. Conversely, it was found that significantly more n-3 LC-PUFA were deposited when originating from the Spike treatment (23% of dose, than from the Constant treatment (15% of dose. These unexpected findings show that a large dose of n-3 LC-PUFA once per week is more effective in increasing whole body n-3 LC-PUFA content in rats compared with a smaller dose delivered daily.

  15. Radiation dose to technologists per nuclear medicine examination and estimation of annual dose.

    Science.gov (United States)

    Bayram, Tuncay; Yilmaz, A Hakan; Demir, Mustafa; Sonmez, Bircan

    2011-03-01

    Conventional diagnostic nuclear medicine applications have been continuously increasing in most nuclear medicine departments in Turkey, but to our knowledge no one has studied the doses to technologists who perform nuclear medicine procedures. Most nuclear medicine laboratories do not have separate control rooms for technologists, who are quite close to the patient during data acquisition. Technologists must therefore stay behind lead shields while performing their task if they are to reduce the radiation dose received. The aim of this study was to determine external radiation doses to technologists during nuclear medicine procedures with and without a lead shield. Another aim was to investigate the occupational annual external radiation doses to Turkish technologists. This study used a Geiger-Müller detector to measure dose rates to technologists at various distances from patients (0.25, 0.50, 1, and 2 m and behind a lead shield) and determined the average time spent by technologists at these distances. Deep-dose equivalents to technologists were obtained. The following conventional nuclear medicine procedures were considered: thyroid scintigraphy performed using (99m)Tc pertechnetate, whole-body bone scanning performed using (99m)Tc-methylene diphosphonate, myocardial perfusion scanning performed using (99m)Tc-methoxyisobutyl isonitrile, and (201)Tl (thallous chloride) and renal scanning performed using (99m)Tc-dimercaptosuccinic acid. The measured deep-dose equivalent to technologists per procedure was within the range of 0.13 ± 0.05 to 0.43 ± 0.17 μSv using a lead shield and 0.21 ± 0.07 to 1.01 ± 0.46 μSv without a lead shield. Also, the annual individual dose to a technologist performing only a particular scintigraphic procedure throughout a year was estimated. For a total of 95 clinical cases (71 patients), effective external radiation doses to technologists were found to be within the permissible levels. This study showed that a 2-mm lead shield

  16. Individual radiation doses. Annual report 1995

    International Nuclear Information System (INIS)

    Bergman, L.

    1995-05-01

    During the year we measured whole body doses on 10226 bearers, distributed as follows: 0-0,5 mSv on 8816 persons, 0,6-1,0 mSv on 693 persons, 1,1-5,0 on 678 persons, >5 mSv on 39 persons. At higher dose than 4 mSv/4 weeks, the reason to the irradiation will be investigated. 2 figs, 2 tabs

  17. Left-turn phase: permissive, protected, or both? A quasi-experimental design in New York City.

    Science.gov (United States)

    Chen, Li; Chen, Cynthia; Ewing, Reid

    2015-03-01

    The practice of left-turn phasing selection (permissive, protected-only, or both) varies from one locality to another. The literature evidence on this issue is equally mixed and insufficient. In this study, we evaluate the safety impacts of changing left-turn signal phasing from permissive to protected/permissive or protected-only at 68 intersections in New York City using a rigorous quasi-experimental design accompanied with regression modeling. Changes in police reported crashes including total crashes, multiple-vehicle crashes, left-turn crashes, pedestrian crashes and bicyclist crashes were compared between before period and after period for the treatment group and comparison group by means of negative binomial regression using a Generalized Estimating Equations (GEE) technique. Confounding factors such as the built environment characteristics that were not controlled in comparison group selection are accounted for by this approach. The results show that the change of permissive left-turn signal phasing to protected/permissive or protected-only signal phasing does not result in a significant reduction in intersection crashes. Though the protected-only signal phasing does reduce the left-turn crashes and pedestrian crashes, this reduction was offset by a possible increase in over-taking crashes. These results suggest that left-turn phasing should not be treated as a universal solution that is always better than the permissive control for left-turn vehicles. The selection and implementation of left-turn signal phasing needs to be done carefully, considering potential trade-offs between safety and delay, and many other factors such as geometry, traffic flows and operations. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Gastrointestinal tolerability with ibandronate after previous weekly bisphosphonate treatment

    Directory of Open Access Journals (Sweden)

    Richard Derman

    2009-09-01

    Full Text Available Richard Derman1, Joseph D Kohles2, Ann Babbitt31Department of Obstetrics and Gynecology, Christiana Hospital, Newark, DE, USA; 2Roche, Nutley, NJ, USA; 3Greater Portland Bone and Joint Specialists, Portland, ME, USAAbstract: Data from two open-label trials (PRIOR and CURRENT of women with postmenopausal osteoporosis or osteopenia were evaluated to assess whether monthly oral and quarterly intravenous (IV ibandronate dosing improved self-reported gastrointestinal (GI tolerability for patients who had previously experienced GI irritation with bisphosphonate (BP use. In PRIOR, women who had discontinued daily or weekly BP treatment due to GI intolerance received monthly oral or quarterly IV ibandronate for 12 months. The CURRENT subanalysis included women receiving weekly BP treatment who switched to monthly oral ibandronate for six months. GI symptom severity and frequency were assessed using the Osteoporosis Patient Satisfaction Questionnaire™. In PRIOR, mean GI tolerability scores increased significantly at month 1 from screening for both treatment groups (oral: 79.3 versus 54.1; IV: 84.4 versus 51.0; p < 0.001 for both. Most patients reported improvement in GI symptom severity and frequency from baseline at all post-screening assessments (>90% at Month 10. In the CURRENT subanalysis >60% of patients reported improvements in heartburn or acid reflux and >70% indicated improvement in other stomach upset at month 6. Postmenopausal women with GI irritability with daily or weekly BPs experienced improvement in symptoms with extended dosing monthly or quarterly ibandronate compared with baseline.Keywords: ibandronate, osteoporosis, bisphosphonate, gastrointestinal

  19. Pooled analysis of phase II trials evaluating weekly or conventional cisplatin as first-line therapy for advanced urothelial carcinoma

    DEFF Research Database (Denmark)

    Maughan, Benjamin L; Agarwal, Neeraj; Hussain, Syed A

    2013-01-01

    Weekly gemcitabine with GC every 3-4 weeks is considered conventional first-line chemotherapy for advanced urothelial carcinoma (UC). Weekly split-dose cisplatin with wGC might be less toxic and have similar activity, but has not been compared with GC. We pooled published phase II trials of GC an...

  20. Effects of irradiation at different dose rates on the onset of type I diabetes in model mice

    International Nuclear Information System (INIS)

    Nomura, Takashi; Sakai, Kazuo

    2003-01-01

    We previously demonstrated that low-dose irradiation (0.5 Gy) increased the level of antioxidants and decreased the level of lipid peroxide in normal mice. We also found that 0.5 Gy-irradiation of NOD mice suppressed the onset of type I diabetes. These results were obtained by the irradiation at high dose rate. The aim of the present study is to examine the effects at the low dose rate. The mice were acutely irradiated with 0.5 Gy of X-rays (300 kVp) at 94.2 Gy/hr at 10, 11, 12, 13 or 14 weeks of age, or chronically irradiated with 0.5 Gy of 137 Cs γ-rays at 0.95 mGy/hr starting at 10,11,12,13 or 14 weeks of age. When irradiated at 12th week with the high dose rate X-rays, the onset of diabetes suppressed, and the increase in the specific activity of superoxide dismutase (SOD) in pancreas was observed. On the other hand, the low dose rate γ-rays delivered from 12th week of age to 14th was less effective in the suppression of the incidence of diabetes than the high dose rate X-rays at the 12-14 weeks of age. Furthermore, the significant increase in pancreatic SOD activity was not observed after the low dose irradiation. Splenic macrophage activities of superoxide generation were not affected by the high dose rate irradiation nor the low dose rate irradiation. (author)

  1. Resuscitation of neonates at 23 weeks' gestational age: a cost-effectiveness analysis.

    Science.gov (United States)

    Partridge, J Colin; Robertson, Kathryn R; Rogers, Elizabeth E; Landman, Geri Ottaviano; Allen, Allison J; Caughey, Aaron B

    2015-01-01

    Resuscitation of infants at 23 weeks' gestation remains controversial; clinical practices vary. We sought to investigate the cost effectiveness of resuscitation of infants born 23 0/7-23 6/7 weeks' gestation. Decision-analytic modeling comparing universal and selective resuscitation to non-resuscitation for 5176 live births at 23 weeks in a theoretic U.S. cohort. Estimates of death (77%) and disability (64-86%) were taken from the literature. Maternal and combined maternal-neonatal utilities were applied to discounted life expectancy to generate QALYs. Incremental cost-effectiveness ratios were calculated, discounting costs and QALYs. Main outcomes included number of survivors, their outcome status and incremental cost-effectiveness ratios for the three strategies. A cost-effectiveness threshold of $100 000/QALY was utilized. Universal resuscitation would save 1059 infants: 138 severely disabled, 413 moderately impaired and 508 without significant sequelae. Selective resuscitation would save 717 infants: 93 severely disabled, 279 moderately impaired and 343 without significant sequelae. For mothers, non-resuscitation is less expensive ($19.9 million) and more effective (127 844 mQALYs) than universal resuscitation ($1.2 billion; 126 574 mQALYs) or selective resuscitation ($845 million; 125 966 mQALYs). For neonates, both universal and selective resuscitation were cost-effective, resulting in 22 256 and 15 134 nQALYS, respectively, versus 247 nQALYs for non-resuscitation. In sensitivity analyses, universal resuscitation was cost-effective from a maternal perspective only at utilities for neonatal death permissive response to parental requests for aggressive intervention at 23 weeks' gestation.

  2. Small Animal Models for Human Metapneumovirus: Cotton Rat is More Permissive than Hamster and Mouse

    Science.gov (United States)

    Zhang, Yu; Niewiesk, Stefan; Li, Jianrong

    2014-01-01

    Human metapneumovirus (hMPV) is the second most prevalent causative agent of pediatric respiratory infections worldwide. Currently, there are no vaccines or antiviral drugs against this virus. One of the major hurdles in hMPV research is the difficulty to identify a robust small animal model to accurately evaluate the efficacy and safety of vaccines and therapeutics. In this study, we compared the replication and pathogenesis of hMPV in BALB/c mice, Syrian golden hamsters, and cotton rats. It was found that BALB/c mice are not permissive for hMPV infection despite the use of a high dose (6.5 log10 PFU) of virus for intranasal inoculation. In hamsters, hMPV replicated efficiently in nasal turbinates but demonstrated only limited replication in lungs. In cotton rats, hMPV replicated efficiently in both nasal turbinate and lung when intranasally administered with three different doses (4, 5, and 6 log10 PFU) of hMPV. Lungs of cotton rats infected by hMPV developed interstitial pneumonia with mononuclear cells infiltrates and increased lumen exudation. By immunohistochemistry, viral antigens were detected at the luminal surfaces of the bronchial epithelial cells in lungs. Vaccination of cotton rats with hMPV completely protected upper and lower respiratory tract from wildtype challenge. The immunization also elicited elevated serum neutralizing antibody. Collectively, these results demonstrated that cotton rat is a robust small animal model for hMPV infection. PMID:25438015

  3. Corruption and the Other(s): Scope of Superordinate Identity Matters for Corruption Permissibility.

    Science.gov (United States)

    Pisor, Anne C; Gurven, Michael

    2015-01-01

    The decision to engage in corruption-public and private corruption, nepotism, and embezzlement-is often attributed to rational actors maximizing benefits to themselves. However, the importance of reciprocal relationships in humans suggests that an actor may weigh the costs of harms of her corrupt behavior to individuals who may generate future benefits for her. We hypothesize that actors who have a larger circle of actual and potential social partners will have more individuals to consider when generating harms and will thus be less likely to find corrupt acts permissible than actors with smaller circles of valued others. Using data from the World Values Survey and European Values Study (WVS), we explore whether participants with a larger geographic identity or a greater number of group memberships (i.e. a larger scope of actual and potential social partners) are less likely to find accepting bribes permissible. We find mixed support for our hypotheses, but consistently find that WVS participants with local, country, continent, or world geographic identities are less likely to find accepting a bribe permissible than those with regional identities-that is, actors whose primary identities that encompass more than their region find corruption less permissible. We discuss the importance of considering an actor's valuation of others when modeling corruption persistence, noting that establishing scopes of positive valuation is a precursor to predicting where actors will target benefits and shunt costs.

  4. A thirteen week ad libitum administration toxicity study of tartrazine ...

    African Journals Online (AJOL)

    Tartrazine is a colorant widely used in food products, drugs and cosmetics. The current study evaluates the effect of sub-chronic ingestion of tartrazine in drinking water at doses of 0, 0.1, 0.45, 1 and 2.5% for 13 weeks in mice. Our results show that female body weight gain and food consumption decreased in all treated ...

  5. Late effects of various dose-fractionation regimens

    International Nuclear Information System (INIS)

    Turesson, I.; Notter, G.

    1983-01-01

    These clinical investigations of various dose-fractionation regimens on human skin show that: The late reactions cannot be predicted from the early reactions; The dose-response curves for late reactions are much steeper than for early reactions; Equivalent doses for various fractionation schedules concerning late effects can be calculated by means of a corrected CRE (NSD) formula; the correction must be considered preliminary because further follow-up is needed. A clinical fractionation study of this type requires: Extremely careful dosimetry; Study of the same anatomical region; Very long follow-up; Studies at different effect levels; Skin reaction is the only end point we have studied systematically for different fractionation regimens. Experience with the CRE formula as a model for calculating isoeffect doses for different fractionation schedules in routine clinical use can be summarized as follows: The CRE formula has been used prospectively since 1972 in all patients; CRE-equivalent weekly doses to 5 x 2.0 Gy per week has been used. (Although the fractionation schedule is changed, the overall treatment time is still the same); The CRE range was 18 to 21 for curative radiotherapy on carcinomas; No irradiation was applied during pronounced acute reactions. No unexpected complications have been observed under these conditions

  6. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks

    Directory of Open Access Journals (Sweden)

    Elliott Jackie

    2012-11-01

    Full Text Available Abstract Background Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days. Methods/design We aim to compare DAFNE delivered over five consecutive days (1 week course with DAFNE delivered one day a week over five weeks (5 week course in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course include HbA1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA1c Discussion This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other

  7. SU-E-J-68: Adaptive Radiotherapy of Head and Neck Cancer: Re-Planning Based On Prior Dose

    Energy Technology Data Exchange (ETDEWEB)

    Dogan, N; Padgett, K [University of Miami Miller School of Medicine, Miami, FL (United States); Evans, J; Sleeman, W; Song, S [Virginia Commonwealth University, Richmond, VA (United States); Fatyga, M [Mayo Clinic Arizona, Phoenix, AZ (United States)

    2015-06-15

    Purpose: Adaptive Radiotherapy (ART) with frequent CT imaging has been used to improve dosimetric accuracy by accounting for anatomical variations, such as primary tumor shrinkage and/or body weight loss, in Head and Neck (H&N) patients. In most ART strategies, the difference between the planned and the delivered dose is estimated by generating new plans on repeated CT scans using dose-volume constraints used with the initial planning CT without considering already delivered dose. The aim of this study was to assess the dosimetric gains achieved by re-planning based on prior dose by comparing them to re-planning not based-on prior dose for H&N patients. Methods: Ten locally-advanced H&N cancer patients were selected for this study. For each patient, six weekly CT imaging were acquired during the course of radiotherapy. PTVs, parotids, cord, brainstem, and esophagus were contoured on both planning and six weekly CT images. ART with weekly re-plans were done by two strategies: 1) Generating a new optimized IMRT plan without including prior dose from previous fractions (NoPriorDose) and 2) Generating a new optimized IMRT plan based on the prior dose given from previous fractions (PriorDose). Deformable image registration was used to accumulate the dose distributions between planning and six weekly CT scans. The differences in accumulated doses for both strategies were evaluated using the DVH constraints for all structures. Results: On average, the differences in accumulated doses for PTV1, PTV2 and PTV3 for NoPriorDose and PriorDose strategies were <2%. The differences in Dmean to the cord and brainstem were within 3%. The esophagus Dmean was reduced by 2% using PriorDose. PriorDose strategy, however, reduced the left parotid D50 and Dmean by 15% and 14% respectively. Conclusion: This study demonstrated significant parotid sparing, potentially reducing xerostomia, by using ART with IMRT optimization based on prior dose for weekly re-planning of H&N cancer patients.

  8. Salivary gland doses from dental radiographic exposures

    International Nuclear Information System (INIS)

    Hoshi, Masaharu; Kato, Kazuo; Wada, Takuro; Antoku, Shigetoshi; Russell, W.J.

    1989-01-01

    Salivary gland doses incurred during dental radiography were measured by phantom dosimetry, and these dose data and data obtained during a two-week survey of Hiroshima and Nagasaki dental hospitals and clinics were used to estimate the respective doses to members of the populations of the two cities. The results obtained were used to supplement previously determined doses to the thyroid gland, lens, and pituitary gland from dental radiography. No significant differences in doses were observed by age, sex or city. Doses to the salivary glands during dental radiography are probably not sufficiently large to cause bias in assessments of atomic bomb survivors for late radiation effects. However, the steadily increasing use of dental radiography underscores the need for continued monitoring of dental radiography doses in the interests of these assessments. (author)

  9. Phase I and pharmacokinetic study of the combination of topotecan and ifosfamide administered intravenously every 3 weeks

    NARCIS (Netherlands)

    Kerbusch, T.; Groenewegen, G.; Mathôt, R. A. A.; Herben, V. M. M.; ten Bokkel Huinink, W. W.; Swart, M.; Ambaum, B.; Rosing, H.; Jansen, S.; Voest, E. E.; Beijnen, J. H.; Schellens, J. H. M.

    2004-01-01

    To determine the maximum-tolerated dose (MTD), dose-limiting toxicities, and pharmacokinetics of topotecan administered as a 30-min intravenous (i.v.) infusion over 5 days in combination with a 1-h i.v. infusion of ifosfamide (IF) for 3 consecutive days every 3 weeks. Patients with advanced

  10. Determination the lethal dose of ascaris lumbricoides ova by gamma irradiation

    International Nuclear Information System (INIS)

    Shamma, M.; Al-Adawi, M.; Sharabi, N.

    2002-11-01

    The lethal gamma irradiation dose of ascaris lumbricoides which collected from Damascus Sewage water Plant was determined. Ascaris lumbricoides ova were treated with several gamma irradiation doses with (0.1, 0.2, 0.3, 0.4,...and 1.5 KGy). No morphological changes were observed on the eggs when directly examined microscopically after irradiation. However after two weeks of incubation at 37 degree centigrade the cell contents of the eggs which irradiated with 0.5 KGy and beyond were fragmented and scattered in the whole eggs and no larvae were observed after eight weeks of incubation. It is concluded that the dose 0.5 my be considered as the dose of choice if sewage water is to be treated by gamma rays. (author)

  11. Determination the lethal dose of ascaris lumbricoides ova by gamma irradiation

    CERN Document Server

    Shamma, M A; Sharabi, N

    2002-01-01

    The lethal gamma irradiation dose of ascaris lumbricoides which collected from Damascus Sewage water Plant was determined. Ascaris lumbricoides ova were treated with several gamma irradiation doses with (0.1, 0.2, 0.3, 0.4,...and 1.5 KGy). No morphological changes were observed on the eggs when directly examined microscopically after irradiation. However after two weeks of incubation at 37 degree centigrade the cell contents of the eggs which irradiated with 0.5 KGy and beyond were fragmented and scattered in the whole eggs and no larvae were observed after eight weeks of incubation. It is concluded that the dose 0.5 my be considered as the dose of choice if sewage water is to be treated by gamma rays.

  12. Comparison of early treatment with low doses of nilotinib, imatinib and a clinically relevant dose of silymarin in thioacetamide-induced liver fibrosis.

    Science.gov (United States)

    Shaker, Mohamed E; Shiha, Gamal E; Ibrahim, Tarek M

    2011-11-30

    Our previous study has already confirmed a promising anti-fibrotic activity especially for nilotinib; when given at a daily dose of 10 mg/kg during the last 4 weeks of thioacetamide (TAA)-induced liver fibrosis for 12 weeks in rats. Therefore, this study was carried out to compare the prophylactic potential of low dose of nilotinib to that of its predecessor, imatinib, and a clinically relevant dose of the standard hepatoprotective treatment, silymarin, in TAA-intoxication. Male Wistar rats received intraperitoneal injections of TAA (150 mg/kg, twice weekly) for 8 weeks, as well as oral treatments with imatinib (5 mg/kg/day), nilotinib (5 mg/kg/day) and silymarin (50 mg/kg/day) from the first day of TAA-intoxication. At the end of the study, chronic hepatic injury was evaluated by analysis of liver function tests in serum. Hepatic oxidative stress was assessed by measuring malondialdehyde, 4-hydroxynonenal, total nitrate/nitrite and reduced glutathione contents, as well as myeloperoxidase and superoxide dismutase activities. Hepatic fibrosis was evaluated by histopathology and collagen content. Our results suggest that the prophylactic potential of nilotinib (5 mg/kg/day), imatinib (5mg/kg/day) and silymarin (50 mg/kg/day) in TAA-intoxication for 8 weeks is lower than the late treatments of nilotinib (10 mg/kg/day), imatinib (10mg/kg/day) and silymarin (100 mg/kg/day) during the last 4 weeks of TAA-intoxication for 12 weeks in rats. Taken together, this study suggests that nilotinib may have higher anti-fibrotic activity when administered at a significant stage of fibrosis as a result of impairment of its metabolism in the fibrotic livers. Copyright © 2011 Elsevier B.V. All rights reserved.

  13. Oral keratinocytes support non-replicative infection and transfer of harbored HIV-1 to permissive cells.

    Science.gov (United States)

    Vacharaksa, Anjalee; Asrani, Anil C; Gebhard, Kristin H; Fasching, Claudine E; Giacaman, Rodrigo A; Janoff, Edward N; Ross, Karen F; Herzberg, Mark C

    2008-07-17

    Oral keratinocytes on the mucosal surface are frequently exposed to HIV-1 through contact with infected sexual partners or nursing mothers. To determine the plausibility that oral keratinocytes are primary targets of HIV-1, we tested the hypothesis that HIV-1 infects oral keratinocytes in a restricted manner. To study the fate of HIV-1, immortalized oral keratinocytes (OKF6/TERT-2; TERT-2 cells) were characterized for the fate of HIV-specific RNA and DNA. At 6 h post inoculation with X4 or R5-tropic HIV-1, HIV-1gag RNA was detected maximally within TERT-2 cells. Reverse transcriptase activity in TERT-2 cells was confirmed by VSV-G-mediated infection with HIV-NL4-3Deltaenv-EGFP. AZT inhibited EGFP expression in a dose-dependent manner, suggesting that viral replication can be supported if receptors are bypassed. Within 3 h post inoculation, integrated HIV-1 DNA was detected in TERT-2 cell nuclei and persisted after subculture. Multiply spliced and unspliced HIV-1 mRNAs were not detectable up to 72 h post inoculation, suggesting that HIV replication may abort and that infection is non-productive. Within 48 h post inoculation, however, virus harbored by CD4 negative TERT-2 cells trans infected co-cultured peripheral blood mononuclear cells (PBMCs) or MOLT4 cells (CD4+ CCR5+) by direct cell-to-cell transfer or by releasing low levels of infectious virions. Primary tonsil epithelial cells also trans infected HIV-1 to permissive cells in a donor-specific manner. Oral keratinocytes appear, therefore, to support stable non-replicative integration, while harboring and transmitting infectious X4- or R5-tropic HIV-1 to permissive cells for up to 48 h.

  14. Oral keratinocytes support non-replicative infection and transfer of harbored HIV-1 to permissive cells

    Directory of Open Access Journals (Sweden)

    Giacaman Rodrigo A

    2008-07-01

    Full Text Available Abstract Background Oral keratinocytes on the mucosal surface are frequently exposed to HIV-1 through contact with infected sexual partners or nursing mothers. To determine the plausibility that oral keratinocytes are primary targets of HIV-1, we tested the hypothesis that HIV-1 infects oral keratinocytes in a restricted manner. Results To study the fate of HIV-1, immortalized oral keratinocytes (OKF6/TERT-2; TERT-2 cells were characterized for the fate of HIV-specific RNA and DNA. At 6 h post inoculation with X4 or R5-tropic HIV-1, HIV-1gag RNA was detected maximally within TERT-2 cells. Reverse transcriptase activity in TERT-2 cells was confirmed by VSV-G-mediated infection with HIV-NL4-3Δenv-EGFP. AZT inhibited EGFP expression in a dose-dependent manner, suggesting that viral replication can be supported if receptors are bypassed. Within 3 h post inoculation, integrated HIV-1 DNA was detected in TERT-2 cell nuclei and persisted after subculture. Multiply spliced and unspliced HIV-1 mRNAs were not detectable up to 72 h post inoculation, suggesting that HIV replication may abort and that infection is non-productive. Within 48 h post inoculation, however, virus harbored by CD4 negative TERT-2 cells trans infected co-cultured peripheral blood mononuclear cells (PBMCs or MOLT4 cells (CD4+ CCR5+ by direct cell-to-cell transfer or by releasing low levels of infectious virions. Primary tonsil epithelial cells also trans infected HIV-1 to permissive cells in a donor-specific manner. Conclusion Oral keratinocytes appear, therefore, to support stable non-replicative integration, while harboring and transmitting infectious X4- or R5-tropic HIV-1 to permissive cells for up to 48 h.

  15. Permission of the alteration in nuclear fuel material processing business in the Kumatori Works of Nuclear Fuel Industries, Ltd. (report)

    International Nuclear Information System (INIS)

    1982-01-01

    A report by the Nuclear Safety Commission to the Prime Minister concerning the permission of the alteration in nuclear fuel material processing business in the Kumatori Works, Nuclear Fuel Industries Ltd., was presented. The technical capability of NFI and the safety of the business alteration were confirmed. The items of the safety examination concerning the alteration, made by the Committee on Examination of Nuclear Fuel Safety of NSC, are as follows: the aseismic design and fire prevention measures of the No.2 processing building and the No.3 waste storage building to be newly installed; criticality control concerning the No.2 processing building; the release control of gaseous and liquid wastes; the management of solid wastes; radiation control; the exposure dose of general public. (J.P.N.)

  16. STOSS THERAPY AND WEEKLY VITAMIN D THERAPY IN THE MANAGEMENT OF NUTRITIONAL RICKETS IN CHILDREN- A COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Madhava Vijayakumar

    2017-01-01

    Full Text Available BACKGROUND The Aim of the study is to study the risk factors of nutritional rickets in children of age 1-5 years and to compare the effectiveness of classical single mega dose vitamin D administration (stoss therapy and weekly cholecalciferol administration. METHODS 50 children of age group 1-5 year with clinical, biochemical and radiological features of nutritional rickets and an equal number of age and gender matched control were included in the study. Their risk factors were compared. Those children with rickets were divided randomly into two groups of equal numbers. For one group, single oral dose of 6,00,000 IU of vitamin D and for the other group, weekly oral dose of 60,000 IU of vitamin D was administered for 8 weeks. All children were given calcium supplementation. Regular follow up was done at 1, 2, 6, 9 and 12 months and the improvement was assessed clinically, radiologically and as per the laboratory results. RESULTS Major risk factors for the development of nutritional rickets were prematurity, low birth weight, high birth order, consumption of complementary feeds poor in calcium, lack of adequate sunlight exposure and prolonged exclusive breast feeding. Response to treatment was comparable both clinically and as per the investigation results among those who received single massive dose and those on weekly vitamin D therapy. CONCLUSION Increased birth order, prematurity and low birth weight were important risk factors for rickets. Inadequate dietary calcium and inadequate sunlight exposure increased chance of getting rickets. Supplementation of vitamin D and calcium were protective. Inadequate maternal sunlight exposure, lack of antenatal and post-natal calcium and vitamin D supplementation showed a significant association with rickets. The most common clinical feature of rickets was bow legs. Both massive single dose therapy and weekly vitamin D administration were equally effective and revealed no significant difference in clinical

  17. 29 CFR 3.6 - Payroll deductions permissible with the approval of the Secretary of Labor.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Payroll deductions permissible with the approval of the Secretary of Labor. 3.6 Section 3.6 Labor Office of the Secretary of Labor CONTRACTORS AND SUBCONTRACTORS ON....6 Payroll deductions permissible with the approval of the Secretary of Labor. Any contractor or...

  18. Assessment of eye, hand and male gonadal skin dose in radiotherapy

    International Nuclear Information System (INIS)

    Pushap, M.P.S.

    1979-01-01

    An attempt has been made to gauge the dose to (1) the eye, (2) the skin of the hands and (3) the gonads from radiotherapy of other parts of the body. The study has been done on actual male patients at the Jorjani Medical Centre, Tehran. The study, indicated high dose to the eye lid i.e. about 3% of the tumour dose in the case of head irradiation. The eyes and gonads lie at unequal distances from thorax, so are their doses. It is further emphasised that a minimum dose of 400 rad in three weeks to one month has been reported to be cataractogenic in man. A 50% incidence of progressive loss of vision with a dose of 750 rad to 1000 rad in three weeks to three months time has been observed. If appropriate techniques are not employed to shield the eye, even from stray radiation, such limits may easily be reached. (K.B.)

  19. Android Apps and Permissions: Security and Privacy Risks

    OpenAIRE

    Boksasp, Trond; Utnes, Eivind

    2012-01-01

    This thesis investigates the permissions requested by Android applications, and the possibility of identifying suspicious applications based only on information presented to the user before an application is downloaded. During the course of this project, a large data set consisting of applications published on Google Play and three different third-party Android application markets was collected over a two-month period. These applications are analysed using manual pattern recognition and k-mea...

  20. Sexual and Gender Minority Adolescents' Views On HIV Research Participation and Parental Permission: A Mixed-Methods Study.

    Science.gov (United States)

    Mustanski, Brian; Coventry, Ryan; Macapagal, Kathryn; Arbeit, Miriam R; Fisher, Celia B

    2017-06-01

    Sexual and gender minority adolescents are underrepresented in HIV research, partly because institutional review boards (IRBs) are reluctant to waive parental permission requirements for these studies. Understanding teenagers' perspectives on parental permission and the risks and benefits of participating in HIV research is critical to informing evidence-based IRB decisions. Data from 74 sexual and gender minority adolescents aged 14-17 who participated in an online focus group in 2015 were used to examine perspectives on the risks and benefits of participation in a hypothetical HIV surveillance study and the need for parental permission and adequate protections. Data were analyzed thematically; mixed methods analyses examined whether concerns about parental permission differed by whether teenagers were out to their parents. Most adolescents, especially those who were not out to their parents, would be unwilling to participate in an HIV study if parental permission were required. Perceived benefits of participation included overcoming barriers to HIV testing and contributing to the health of sexual and gender minority youth. Few risks of participation were identified. Adolescents suggested steps that researchers could take to facilitate informed decision making about research participation and ensure minors' safety in the absence of parental permission; these included incorporating multimedia presentations into the consent process and explaining researchers' motivations for conducting the study. Respondents believed that the benefits of HIV surveillance research outweighed the risks. Requiring parental permission may exclude many sexual and gender minority teenagers from taking part in HIV research, especially if they are not out. Copyright © 2017 by the Guttmacher Institute.

  1. LD-aminopterin in the canine homologue of human atopic dermatitis: a randomized, controlled trial reveals dosing factors affecting optimal therapy.

    Science.gov (United States)

    Zebala, John A; Mundell, Alan; Messinger, Linda; Griffin, Craig E; Schuler, Aaron D; Kahn, Stuart J

    2014-01-01

    Options are limited for patients with atopic dermatitis (AD) who do not respond to topical treatments. Antifolate therapy with systemic methotrexate improves the disease, but is associated with adverse effects. The investigational antifolate LD-aminopterin may offer improved safety. It is not known how antifolate dose and dosing frequency affect efficacy in AD, but a primary mechanism is thought to involve the antifolate-mediated accumulation of 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR). However, recent in vitro studies indicate that AICAR increases then decreases as a function of antifolate concentration. To address this issue and understand how dosing affects antifolate efficacy in AD, we examined the efficacy and safety of different oral doses and schedules of LD-aminopterin in the canine model of AD. This was a multi-center, double-blind trial involving 75 subjects with canine AD randomized to receive up to 12 weeks of placebo, once-weekly (0.007, 0.014, 0.021 mg/kg) or twice-weekly (0.007 mg/kg) LD-aminopterin. The primary efficacy outcome was the Global Score (GS), a composite of validated measures of disease severity and itch. GS improved in all once-weekly cohorts, with 0.014 mg/kg being optimal and significant (43%, P<0.01). The majority of improvement was seen by 8 weeks. In contrast, GS in the twice-weekly cohort was similar to placebo and worse than all once-weekly cohorts. Adverse events were similar across all treated cohorts and placebo. Once-weekly LD-aminopterin was safe and efficacious in canine AD. Twice-weekly dosing negated efficacy despite having the same daily and weekly dose as effective once-weekly regimens. Optimal dosing in this homologue of human AD correlated with the concentration-selective accumulation of AICAR in vitro, consistent with AICAR mediating LD-aminopterin efficacy in AD.

  2. LD-aminopterin in the canine homologue of human atopic dermatitis: a randomized, controlled trial reveals dosing factors affecting optimal therapy.

    Directory of Open Access Journals (Sweden)

    John A Zebala

    Full Text Available Options are limited for patients with atopic dermatitis (AD who do not respond to topical treatments. Antifolate therapy with systemic methotrexate improves the disease, but is associated with adverse effects. The investigational antifolate LD-aminopterin may offer improved safety. It is not known how antifolate dose and dosing frequency affect efficacy in AD, but a primary mechanism is thought to involve the antifolate-mediated accumulation of 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR. However, recent in vitro studies indicate that AICAR increases then decreases as a function of antifolate concentration. To address this issue and understand how dosing affects antifolate efficacy in AD, we examined the efficacy and safety of different oral doses and schedules of LD-aminopterin in the canine model of AD.This was a multi-center, double-blind trial involving 75 subjects with canine AD randomized to receive up to 12 weeks of placebo, once-weekly (0.007, 0.014, 0.021 mg/kg or twice-weekly (0.007 mg/kg LD-aminopterin. The primary efficacy outcome was the Global Score (GS, a composite of validated measures of disease severity and itch. GS improved in all once-weekly cohorts, with 0.014 mg/kg being optimal and significant (43%, P<0.01. The majority of improvement was seen by 8 weeks. In contrast, GS in the twice-weekly cohort was similar to placebo and worse than all once-weekly cohorts. Adverse events were similar across all treated cohorts and placebo.Once-weekly LD-aminopterin was safe and efficacious in canine AD. Twice-weekly dosing negated efficacy despite having the same daily and weekly dose as effective once-weekly regimens. Optimal dosing in this homologue of human AD correlated with the concentration-selective accumulation of AICAR in vitro, consistent with AICAR mediating LD-aminopterin efficacy in AD.

  3. Delivery of adjuvant sequential dose-dense FEC-Doc to patients with breast cancer is feasible, but dose reductions and toxicity are dependent on treatment sequence.

    Science.gov (United States)

    Wildiers, H; Dirix, L; Neven, P; Prové, A; Clement, P; Squifflet, P; Amant, F; Skacel, T; Paridaens, R

    2009-03-01

    This study prospectively investigates the impact of dose densification and altering sequence of fluorouracil, epirubicin and cyclophosphamide [FEC(100)] and docetaxel [Doc] on dose delivery and tolerability of adjuvant chemotherapy in breast cancer patients. 117 patients with high-risk primary operable breast cancer were randomized (1:1:2:2) to conventional (three cycles of 3-weekly FEC(100) then three cycles of 3-weekly Doc 100 mg/m(2) or reverse sequence) or dose-dense (dd) treatment (four 10- to 11-day cycles of FEC(75) then four 2-weekly cycles of Doc 75 mg/m(2), or the reverse). In the dd arms, pegfilgrastim was given on day 2 of each cycle, but only as secondary prophylaxis in conventional arms. The primary endpoint was the proportion of patients completing intended cycles at relative dose intensity >or=85% and this was achieved by 95% of patients in each group except for the ddDoc-->FEC group (90%). Dose intensity in the dd arms increased by 48% for FEC and 11% for docetaxel, compared with the conventional arms (both P Doc dose reductions were more frequent with dd treatment and when Doc was given after FEC. Grade 3-4 neutropenia was significantly more frequent with conventional treatment, while fatigue and hand-foot syndrome were numerically more common with dd treatment, particularly when Doc was given after FEC. Discussion Delivery of adjuvant sequential ddFEC and Doc is feasible with growth factor support, and chemotherapy sequence appeared to affect delivery of target doses and toxicity.

  4. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults.

    Science.gov (United States)

    Troy, Stephanie B; Kouiavskaia, Diana; Siik, Julia; Kochba, Efrat; Beydoun, Hind; Mirochnitchenko, Olga; Levin, Yotam; Khardori, Nancy; Chumakov, Konstantin; Maldonado, Yvonne

    2015-06-15

    Inactivated polio vaccine (IPV) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations. However, IPV is unaffordable for many developing countries. Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV, but prior studies, all using 20% of the standard dose used in intramuscular IPV, resulted in inferior antibody titers. We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40% of the standard dose of IPV intradermally, 20% of the standard dose intradermally, the full standard dose intramuscularly, or 40% of the standard dose intramuscularly. Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device. Baseline immunity was 87%, 90%, and 66% against poliovirus serotypes 1, 2, and 3, respectively. After vaccination, antibody titers increased a median of 64-fold. Vaccine response to 40% of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher (although not significantly) antibody titers. Intradermal administration had higher a incidence of local side effects (redness and itching) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration. A 60% reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  5. Corruption and the Other(s: Scope of Superordinate Identity Matters for Corruption Permissibility.

    Directory of Open Access Journals (Sweden)

    Anne C Pisor

    Full Text Available The decision to engage in corruption-public and private corruption, nepotism, and embezzlement-is often attributed to rational actors maximizing benefits to themselves. However, the importance of reciprocal relationships in humans suggests that an actor may weigh the costs of harms of her corrupt behavior to individuals who may generate future benefits for her. We hypothesize that actors who have a larger circle of actual and potential social partners will have more individuals to consider when generating harms and will thus be less likely to find corrupt acts permissible than actors with smaller circles of valued others. Using data from the World Values Survey and European Values Study (WVS, we explore whether participants with a larger geographic identity or a greater number of group memberships (i.e. a larger scope of actual and potential social partners are less likely to find accepting bribes permissible. We find mixed support for our hypotheses, but consistently find that WVS participants with local, country, continent, or world geographic identities are less likely to find accepting a bribe permissible than those with regional identities-that is, actors whose primary identities that encompass more than their region find corruption less permissible. We discuss the importance of considering an actor's valuation of others when modeling corruption persistence, noting that establishing scopes of positive valuation is a precursor to predicting where actors will target benefits and shunt costs.

  6. Perceived realism moderates the relation between sexualized media consumption and permissive sexual attitudes in Dutch adolescents.

    Science.gov (United States)

    Baams, Laura; Overbeek, Geertjan; Dubas, Judith Semon; Doornwaard, Suzan M; Rommes, Els; van Aken, Marcel A G

    2015-04-01

    This study examined whether the development of sexualized media consumption and permissive sexual attitudes would be more strongly interrelated when adolescents perceived sexualized media images as highly realistic. We used data from a three-wave longitudinal sample of 444 Dutch adolescents aged 13-16 years at baseline. Results from parallel process latent growth modeling multigroup analyses showed that higher initial levels of sexualized media consumption were associated with higher initial level of permissive sexual attitudes. Moreover, increases of sexualized media consumption over time were associated with increases of permissive sexual attitudes over time. Considering the moderation by perceived realism, we found these effects only for those who perceived sexualized media as more realistic. Findings for male and female adolescents were similar except for the relations between initial levels and subsequent development. Among male adolescents who perceived sexualized media images to be realistic, higher initial levels of permissive sexual attitudes were related to subsequent less rapid development of sexualized media consumption. For male adolescents who perceived sexualized media to be less realistic, higher initial levels of sexualized media consumption were related to a subsequent less rapid development of permissive sexual attitudes. These relations were not found for female adolescents. Overall, our results suggest that, in male and female adolescents, those with a high level of perceived realism showed a correlated development of sexualized media consumption and permissive sexual attitudes. These findings point to a need for extended information on how to guide adolescents in interpreting and handling sexualized media in everyday life.

  7. Exposure dose in recent treatment of nuclear medicine and countermeasures

    International Nuclear Information System (INIS)

    Iio, Masahiro

    1974-01-01

    Radioactive pharmaceuticals widely used for the diagnosis in nuclear medicine utilize radiation as tracer for dynamic behavior measurement and locality diagnosis, and the exposure due to their use has very little chance to attain the maximum permissible dose of ICRP. The MIRD (Medical Internal Radiation Dose) method tends to be adopted for the measurement of internally absorbed dose due to radio-pharmaceuticals in future. The feature of the MIRD method is that the targeted object is not a critical organ but the region of interest, and the source organ and target organ are fully taken into consideration. Recently, the exposure of patients has been significantly lowered by applying sup(99m)Tc and the like. Though the contribution to national dose is small, it is required to perform immediate conversion from the older nuclear medicine typified with conventional 131 I, 198 Au and 203 Hg to modern one centering around sup(99m)Tc. The problems in calculating the absorbed dose due to nuclear medicine diagnosis are very low accuracy of biological data though the high accuracy of data in physics has been achieved, and the difficulty to obtain data for calculating patients' absorbed dose in routine inspection. (Wakatsuki, Y.)

  8. Steep Dose-Response Relationship for Stage I Non-Small-Cell Lung Cancer Using Hypofractionated High-Dose Irradiation by Real-Time Tumor-Tracking Radiotherapy

    International Nuclear Information System (INIS)

    Onimaru, Rikiya; Fujino, Masaharu; Yamazaki, Koichi; Onodera, Yuya; Taguchi, Hiroshi; Katoh, Norio; Hommura, Fumihiro; Oizumi, Satoshi; Nishimura, Masaharu; Shirato, Hiroki

    2008-01-01

    Purpose: To investigate the clinical outcomes of patients with pathologically proven, peripherally located, Stage I non-small-cell lung cancer who had undergone stereotactic body radiotherapy using real-time tumor tracking radiotherapy during the developmental period. Methods and Materials: A total of 41 patients (25 with Stage T1 and 16 with Stage T2) were admitted to the study between February 2000 and June 2005. A 5-mm planning target volume margin was added to the clinical target volume determined with computed tomography at the end of the expiratory phase. The gating window ranged from ±2 to 3 mm. The dose fractionation schedule was 40 or 48 Gy in four fractions within 1 week. The dose was prescribed at the center of the planning target volume, giving more than an 80% dose at the planning target volume periphery. Results: For 28 patients treated with 48 Gy in four fractions, the overall actuarial survival rate at 3 years was 82% for those with Stage IA and 32% for those with Stage IB. For patients treated with 40 Gy in four fractions within 1 week, the overall actuarial survival rate at 3 years was 50% for those with Stage IA and 0% for those with Stage IB. A significant difference was found in local control between those with Stage IB who received 40 Gy vs. 48 Gy (p = 0.0015) but not in those with Stage IA (p = 0.5811). No serious radiation morbidity was observed with either dose schedule. Conclusion: The results of our study have shown that 48 Gy in four fractions within 1 week is a safe and effective treatment for peripherally located, Stage IA non-small-cell lung cancer. A steep dose-response curve between 40 and 48 Gy using a daily dose of 12 Gy delivered within 1 week was identified for Stage IB non-small-cell lung cancer in stereotactic body radiotherapy using real-time tumor tracking radiotherapy

  9. Weldon Spring dose calculations

    International Nuclear Information System (INIS)

    Dickson, H.W.; Hill, G.S.; Perdue, P.T.

    1978-09-01

    In response to a request by the Oak Ridge Operations (ORO) Office of the Department of Energy (DOE) for assistance to the Department of the Army (DA) on the decommissioning of the Weldon Spring Chemical Plant, the Health and Safety Research Division of the Oak Ridge National Laboratory (ORNL) performed limited dose assessment calculations for that site. Based upon radiological measurements from a number of soil samples analyzed by ORNL and from previously acquired radiological data for the Weldon Spring site, source terms were derived to calculate radiation doses for three specific site scenarios. These three hypothetical scenarios are: a wildlife refuge for hunting, fishing, and general outdoor recreation; a school with 40 hr per week occupancy by students and a custodian; and a truck farm producing fruits, vegetables, meat, and dairy products which may be consumed on site. Radiation doses are reported for each of these scenarios both for measured uranium daughter equilibrium ratios and for assumed secular equilibrium. Doses are lower for the nonequilibrium case

  10. A multicentre cohort study assessing day of week effect and outcome from emergency appendicectomy.

    Science.gov (United States)

    Ferguson, Henry J M; Hall, Nigel J; Bhangu, Aneel

    2014-09-01

    There is evidence to suggest that patients undergoing treatment at weekends may be subject to different care processes and outcomes compared with weekdays. This study aimed to determine whether clinical outcomes from weekend appendicectomy are different from those performed on weekdays. Multicentre cohort study during May-June 2012 from 95 centres (89 within the UK). The primary outcome was the 30-day adverse event rate. Multilevel modelling was used to account for clustering within hospitals while adjusting for case mix to produce adjusted ORs and 95% CIs. When compared with Monday, there were no significant differences for other days of the week considering 30-day adverse events in adjusted models. On Sunday, rates of simple appendicitis were highest, and rates of normal (OR 0.62, 95% CI 0.42 to 0.90) and complex appendicitis (OR 0.65, 95% CI 0.46 to 0.93) lowest. This was accompanied by a 43% lower likelihood in use of laparoscopy on Sunday (OR 0.47, 95% CI 0.32 to 0.69), accompanied by the lowest level of consultant presence for the week. When pooling weekends and weekdays, laparoscopy use remained less likely at the weekend (OR 0.68, 95% CI 0.55 to 0.83), with no significant difference for 30-day adverse event rate (OR 1.01, 95% CI 0.80 to 1.29). This study found that weekend appendicectomy was not associated with increased 30-day adverse events. It cannot rule out smaller increases that may be shown by larger studies. It further illustrated that patients operated on at weekends were subject to different care processes, which may expose them to risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Hand Dose in Nuclear Medicine Staff Members

    International Nuclear Information System (INIS)

    Taha, T.M.; Shahein, A.Y.; Hassan, R.

    2009-01-01

    Measurement of the hand dose during preparation and injection of radiopharmaceuticals is useful in the assessment of the extremity doses received by nuclear medicine personnel. Hand radiation doses to the occupational workers that handling 99m Tc-labeled compounds, 131 I for diagnostic in nuclear medicine were measured by thermoluminescence dosimetry. A convenient method is to use a TLD ring dosimeter for measuring doses of the diagnostic units of different nuclear medicine facilities . Their doses were reported in millisieverts that accumulated in 4 weeks. The radiation doses to the hands of nuclear medicine staff at the hospitals under study were measured. The maximum expected annual dose to the extremities appeared to be less than the annual limit (500 mSv/y) because all of these workers are on rotation and do not constantly handle radioactivity throughout the year

  12. Individually dosed omalizumab: an effective treatment for severe peanut allergy.

    Science.gov (United States)

    Brandström, J; Vetander, M; Lilja, G; Johansson, S G O; Sundqvist, A-C; Kalm, F; Nilsson, C; Nopp, A

    2017-04-01

    Treatment with omalizumab has shown a positive effect on food allergies, but no dosages are established. Basophil allergen threshold sensitivity (CD-sens) can be used to objectively measure omalizumab treatment efficacy and correlates with the outcome of double-blind placebo-controlled food challenge to peanut. To evaluate whether individualized omalizumab treatment monitored by CD-sens could be an effective intervention for suppression of allergic reactions to peanut. Severely peanut allergic adolescents (n = 23) were treated with omalizumab for 8 weeks, and CD-sens was analysed before and after. Based on whether CD-sens was suppressed after 8 weeks, the patients either were subject to a peanut challenge or received eight more weeks with increased dose of omalizumab, followed by peanut challenge or another 8-week cycle of omalizumab. IgE and IgE-antibodies to peanut and its components were analysed before treatment. After individualized omalizumab treatment (8-24 weeks), all patients continued with an open peanut challenge with no (n = 18) or mild (n = 5) objective allergic symptoms. Patients (n = 15) needing an elevated omalizumab dose (ED) to suppress CD-sens had significantly higher CD-sens values at baseline 1.49 (0.44-20.5) compared to those (n = 8) who managed with normal dose (ND) 0.32 (0.24-5.5) (P omalizumab, monitored by CD-sens, is an effective and safe treatment for severe peanut allergy. The ratio of IgE-ab to storage protein Ara h 2/IgE as well as CD-sens to peanut may predict the need of a higher omalizumab dose. Clinical trials numbers: EudraCT; 2012-005625-78, ClinicalTrials.gov; NCT02402231. © 2016 John Wiley & Sons Ltd.

  13. EFFECTIVE DOSE IN TWO DIFFERENT DENTAL CBCT SYSTEMS: NEWTOM VGi AND PLANMECA 3D MID.

    Science.gov (United States)

    Ghaedizirgar, Mohammad; Faghihi, Reza; Paydar, Reza; Sina, Sedigheh

    2017-11-01

    Cone beam computed tomography, CBCT, is a kind of CT scanner producing conical diverging X-rays, in which a large area of a two-dimensional detector is irradiated in each rotation. Different investigations have been performed on dosimetry of dental CBCT. As there is no special protocol for dental CBCT, CT scan protocols are used for dosimetry. The purpose of this study is measurement of dose to head and neck organs in two CBCT systems, i.e. Planmeca 3D Mid (PM) and NewTom VGi (NT), using thermoluminescence dosimetry and Rando phantom. The thermoluminescent dosimetry (TLD)-100 chips were put at the position of different organs of the head and neck. Two TLD-100 chips were inserted at each position, the dose values were measured for several different field sizes, i.e. 8 × 8, 12 × 8 and 15 × 15 cm2 for NewTom, and 10 × 10 and 20 × 17 cm2 for Planmeca systems. According to the results, the average effective dose in PM is much more than the NT system in the same field size, because of the greater mAs values. For routine imaging protocols used for NT, the effective dose values are 70, 73 and 121 µSv for 8 × 8, 12 × 8 and 15 × 15 cm2 field sizes, respectively. In PM, the effective dose in 10 × 10 cm2 and 17 × 20 cm2 is 259 and 341 µSv, respectively. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Gender Differences in Adolescent Premarital Sexual Permissiveness in Three Asian Cities: Effects of Gender-Role Attitudes

    Science.gov (United States)

    Xiayun, Zuo; Chaohua, Lou; Ersheng, Gao; Yan, Cheng; Hongfeng, Niu; Zabin, Laurie S.

    2014-01-01

    Purpose Gender is an important factor in understanding premarital sexual attitudes and behaviors. Many studies indicate that males are more likely to initiate sexual intercourse and have more permissive perceptions about sex than females. Yet few studies have explored possible reasons for these gender differences. With samples of unmarried adolescents in three Asian cities influenced by Confucian cultures, this paper investigates the relationship between underlying gender norms and these differences in adolescents’ premarital sexual permissiveness. Methods 16,554 unmarried participants aged 15–24 were recruited in the Three-City Asian Study of Adolescents and Youth, a collaborative survey conducted in 2006–2007 in urban and rural areas of Hanoi, Shanghai and Taipei, with 6204, 6023 and 4327 from each city respectively. All of the adolescents were administered face-to-face interviews, coupled with Computer Assisted Self Interview (CASI) for sensitive questions. Scales on gender-role attitudes and on premarital sexual permissiveness for both male and female respondents were developed and applied to our analysis of the data. Multi-linear regression was used to analyze the relationship between gender-role attitudes and sexual permissiveness. Results Male respondents in each city held more permissive attitudes towards premarital sex than did females with both boys and girls expressing greater permissiveness to male premarital sexual behaviors. Boys also expressed more traditional attitudes to gender roles (condoning greater inequality) than did girls in each city. Adolescents’ gender-role attitudes and permissiveness to premarital sex varied considerably across the three cities, with the Vietnamese the most traditional, the Taiwanese the least traditional, and the adolescents in Shanghai in the middle. A negative association between traditional gender roles and premarital sexual permissiveness was only found among girls in Shanghai and Taipei. In Shanghai

  15. Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial

    Directory of Open Access Journals (Sweden)

    Tashkin DP

    2012-02-01

    Full Text Available Donald P Tashkin1, Dennis E Doherty2, Edward Kerwin3, Carlos E Matiz-Bueno4, Barbara Knorr5, Tulin Shekar5, Sibabrata Banerjee5, Heribert Staudinger51David Geffen School of Medicine at UCLA, Los Angeles, CA, 2Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY, 3Clinical Research Institute of Southern Oregon, Medford, OR USA; 4Fundación Salud Bosque, Bogota, Colombia; 5Merck Sharp & Dohme Corp, Whitehouse Station, NJ USABackground: A clinical trial of mometasone furoate/formoterol fumarate (MF/F administered via a metered-dose inhaler in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD investigated the efficacy and safety of a fixed-dose combination of MF/F.Methods: This multicenter, double-blind, placebo-controlled trial had a 26-week treatment period and a 26-week safety extension. Subjects (n = 1055; ≥40 years were current or ex-smokers randomized to twice-daily treatment with inhaled MF/F 400/10 µg, MF/F 200/10 µg, MF 400 µg, F 10 µg, or placebo. The coprimary endpoints of the trial were mean changes from baseline in forced expiratory volume in 1 second (FEV1 over 0–12 hours (AUC0–12 FEV1 with MF/F versus MF, and in morning predose FEV1 with MF/F versus F. Key secondary endpoints were quality of life (Saint George’s Respiratory Questionnaire [SGRQ], symptom-free nights, and partly stable COPD at 26 weeks, as well as time to first COPD exacerbation.Results: Significant improvements in FEV1 AUC0–12 occurred at endpoint with MF/F 400/10 and MF/F 200/10 versus MF 400 (P ≤ 0.007. Significant bronchodilation occurred in 5 minutes with MF/F, and serial spirometry demonstrated sustained FEV1 improvements with MF/F over the treatment period. Significant improvements in morning predose FEV1 occurred with both MF/F doses, and these effects were further investigated by excluding results for subjects whose morning FEV1 data were collected >2 days after the last

  16. Bioavailability of higher dose methotrexate comparing oral and subcutaneous administration in patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Hoekstra, Monique; Haagsma, C.; Neef, C; Proost, Johannes H; Knuif, A.; van der Laar, M.

    Objective. To determine the bioavailability of higher oral doses of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA). Methods. A pharmacokinetic analysis was performed in 15 patients with RA taking a stable dose of MTX (greater than or equal to25 mg weekly). Separated by 2 weeks,

  17. A Rational Threshold Signature Model and Protocol Based on Different Permissions

    Directory of Open Access Journals (Sweden)

    Bojun Wang

    2014-01-01

    Full Text Available This paper develops a novel model and protocol used in some specific scenarios, in which the participants of multiple groups with different permissions can finish the signature together. We apply the secret sharing scheme based on difference equation to the private key distribution phase and secret reconstruction phrase of our threshold signature scheme. In addition, our scheme can achieve the signature success because of the punishment strategy of the repeated rational secret sharing. Besides, the bit commitment and verification method used to detect players’ cheating behavior acts as a contributing factor to prevent the internal fraud. Using bit commitments, verifiable parameters, and time sequences, this paper constructs a dynamic game model, which has the features of threshold signature management with different permissions, cheat proof, and forward security.

  18. Weekly Carboplatin Reduces Toxicity During Synchronous Chemoradiotherapy for Merkel Cell Carcinoma of Skin

    International Nuclear Information System (INIS)

    Poulsen, Michael; Walpole, Euan; Harvey, Jennifer; Dickie, Graeme; O'Brien, Peter; Keller, Jacqui; Tpcony, Lee; Rischin, Danny

    2008-01-01

    Purpose: The toxicity of radiotherapy (RT) combined with weekly carboplatin and adjuvant carboplatin and etoposide was prospectively assessed in a group of patients with high-risk Stage I and II Merkel cell carcinoma of the skin. This regimen was compared with the Trans-Tasman Radiation Oncology Group 96:07 study, which used identical eligibility criteria but carboplatin and etoposide every 3 weeks during RT. Patients and Methods: Patients were eligible if they had disease localized to the primary site and lymph nodes, with high-risk features. RT was delivered to the primary site and lymph nodes to a dose of 50 Gy and weekly carboplatin (area under the curve of 2) was given during RT. This was followed by three cycles of carboplatin and etoposide. A total of 18 patients were entered into the study, and their data were compared with the data from 53 patients entered into the Trans-Tasman Radiation Oncology Group 96:07 study. Results: Involved lymph nodes (Stage II) were present in 14 patients (77%). Treatment was completed as planned in 16 patients. The weekly carboplatin dose was delivered in 17 patients, and 15 were able to complete all three cycles of adjuvant carboplatin and etoposide. Grade 3 and 4 neutrophil toxicity occurred in 7 patients, but no cases of febrile neutropenia developed. Compared with the Trans-Tasman Radiation Oncology Group 96:07 protocol (19 of 53 cases of febrile neutropenia), the reduction in the febrile neutropenia rate (p = 0.003) and decrease in Grade 3 skin toxicity (p = 0.006) were highly statistically significant. Conclusion: The results of our study have shown that weekly carboplatin at this dosage is a safe way to deliver synchronous chemotherapy during RT for MCC and results in a marked reduction of febrile neutropenia and Grade 3 skin toxicity compared with the three weekly regimen

  19. Radiation-induced signaling results in mitochondrial impairment in mouse heart at 4 weeks after exposure to X-rays.

    Science.gov (United States)

    Barjaktarovic, Zarko; Schmaltz, Dominik; Shyla, Alena; Azimzadeh, Omid; Schulz, Sabine; Haagen, Julia; Dörr, Wolfgang; Sarioglu, Hakan; Schäfer, Alexander; Atkinson, Michael J; Zischka, Hans; Tapio, Soile

    2011-01-01

    Radiation therapy treatment of breast cancer, Hodgkin's disease or childhood cancers expose the heart to high local radiation doses, causing an increased risk of cardiovascular disease in the survivors decades after the treatment. The mechanisms that underlie the radiation damage remain poorly understood so far. Previous data show that impairment of mitochondrial oxidative metabolism is directly linked to the development of cardiovascular disease. In this study, the radiation-induced in vivo effects on cardiac mitochondrial proteome and function were investigated. C57BL/6N mice were exposed to local irradiation of the heart with doses of 0.2 Gy or 2 Gy (X-ray, 200 kV) at the age of eight weeks, the control mice were sham-irradiated. After four weeks the cardiac mitochondria were isolated and tested for proteomic and functional alterations. Two complementary proteomics approaches using both peptide and protein quantification strategies showed radiation-induced deregulation of 25 proteins in total. Three main biological categories were affected: the oxidative phophorylation, the pyruvate metabolism, and the cytoskeletal structure. The mitochondria exposed to high-dose irradiation showed functional impairment reflected as partial deactivation of Complex I (32%) and Complex III (11%), decreased succinate-driven respiratory capacity (13%), increased level of reactive oxygen species and enhanced oxidation of mitochondrial proteins. The changes in the pyruvate metabolism and structural proteins were seen with both low and high radiation doses. This is the first study showing the biological alterations in the murine heart mitochondria several weeks after the exposure to low- and high-dose of ionizing radiation. Our results show that doses, equivalent to a single dose in radiotherapy, cause long-lasting changes in mitochondrial oxidative metabolism and mitochondria-associated cytoskeleton. This prompts us to propose that these first pathological changes lead to an increased

  20. Influence of lead apron shielding on absorbed doses from cone-beam computed tomography.

    Science.gov (United States)

    Rottke, Dennis; Andersson, Jonas; Ejima, Ken-Ichiro; Sawada, Kunihiko; Schulze, Dirk

    2017-06-01

    The aim of the present work was to investigate absorbed and to calculate effective doses (EDs) in cone-beam computed tomography (CBCT). The study was conducted using examination protocols with and without lead apron shielding. A full-body male RANDO® phantom was loaded with 110 GR200A thermoluminescence dosemeter chips at 55 different sites and set up in two different CBCT systems (CS 9500®, ProMax® 3D). Two different protocols were performed: the phantom was set up (1) with and (2) without a lead apron. No statistically significant differences in organ and absorbed doses from regions outside the primary beam could be found when comparing results from exposures with and without lead apron shielding. Consequently, calculating the ED showed no significant differences between the examination protocols with and without lead apron shielding. For the ProMax® 3D with shielding, the ED was 149 µSv, and for the examination protocol without shielding 148 µSv (SD = 0.31 µSv). For the CS 9500®, the ED was 88 and 86 µSv (SD = 0.95 µSv), respectively, with and without lead apron shielding. The results revealed no statistically significant differences in the absorbed doses between examination with and without lead apron shielding, especially in organs outside the primary beam. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. 11 CFR 114.15 - Permissible use of corporate and labor organization funds for certain electioneering communications.

    Science.gov (United States)

    2010-01-01

    ... 11 Federal Elections 1 2010-01-01 2010-01-01 false Permissible use of corporate and labor organization funds for certain electioneering communications. 114.15 Section 114.15 Federal Elections FEDERAL ELECTION COMMISSION GENERAL CORPORATE AND LABOR ORGANIZATION ACTIVITY § 114.15 Permissible use of corporate...

  2. THE CHALLENGE OF CIEMAT INTERNAL DOSIMETRY SERVICE FOR ACCREDITATION ACCORDING TO ISO/IEC 17025 STANDARD, FOR IN VIVO AND IN VITRO MONITORING AND DOSE ASSESSMENT OF INTERNAL EXPOSURES.

    Science.gov (United States)

    Lopez, M A; Martin, R; Hernandez, C; Navarro, J F; Navarro, T; Perez, B; Sierra, I

    2016-09-01

    The accreditation of an Internal Dosimetry Service (IDS) according to ISO/IEC 17025 Standard is a challenge. The aim of this process is to guarantee the technical competence for the monitoring of radionuclides incorporated in the body and for the evaluation of the associated committed effective dose E(50). This publication describes the main accreditation issues addressed by CIEMAT IDS regarding all the procedures involving good practice in internal dosimetry, focussing in the difficulties to ensure the traceability in the whole process, the appropriate calculation of detection limit of measurement techniques, the validation of methods (monitoring and dose assessments), the description of all the uncertainty sources and the interpretation of monitoring data to evaluate the intake and the committed effective dose. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Low dose vitamin C, vitamin E or L-arginine supplementation and ...

    African Journals Online (AJOL)

    The effect of chronic low-dose supplementation with vitamin C (300mg/day for 6 weeks in adults or 100mg/day for 6 weeks in children) or vitamin E (100 IU/day for 6 weeks in adults) or L-Arginine (1g/day for 6 weeks in adults) in ameliorating the pathophysiology and combating the deleterious effects of sickle cell disease in ...

  4. WE-D-BRE-06: Quantification of Dose-Response for High Grade Esophagtis Patients Using a Novel Voxel-To-Voxel Method

    International Nuclear Information System (INIS)

    Niedzielski, J; Martel, M; Tucker, S; Gomez, D; Court, L; Yang, J; Briere, T

    2014-01-01

    Purpose: Radiation induces an inflammatory response in the esophagus, discernible on CT studies. This work objectively quantifies the voxel esophageal radiation-response for patients with acute esophagitis. This knowledge is an important first-step towards predicting the effect of complex dose distributions on patient esophagitis symptoms. Methods: A previously validated voxel-based methodology of quantifying radiation esophagitis severity was used to identify the voxel dose-response for 18 NSCLC patients with severe esophagitis (CTCAE grading criteria, grade2 or higher). The response is quantified as percent voxel volume change for a given dose. During treatment (6–8 weeks), patients had weekly 4DCT studies and esophagitis scoring. Planning CT esophageal contours were deformed to each weekly CT using a demons DIR algorithm. An algorithm using the Jacobian Map from the DIR of the planning CT to all weekly CTs was used to quantify voxel-volume change, along with corresponding delivered voxel dose, to the planning voxel. Dose for each voxel for each time-point was calculated on each previous weekly CT image, and accumulated using DIR. Thus, for each voxel, the volume-change and delivered dose was calculated for each time-point. The data was binned according to when the volume-change first increased by a threshold volume (10%–100%, in 10% increments), and the average delivered dose calculated for each bin. Results: The average dose resulting in a voxel volume increase of 10–100% was 21.6 to 45.9Gy, respectively. The mean population dose to give a 50% volume increase was 36.3±4.4Gy, (range:29.8 to 43.5Gy). The average week of 50% response was 4.1 (range:4.9 to 2.8 weeks). All 18 patients showed similar dose to first response curves, showing a common trend in the initial inflammatoryresponse. Conclusion: We extracted the dose-response curve of the esophagus on a voxel-to-voxel level. This may be useful for estimating the esophagus response (and patient symptoms

  5. Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

    Science.gov (United States)

    Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

    2014-09-30

    Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before

  6. Thirteen-week oral toxicity study of L-arginine in rats.

    Science.gov (United States)

    Tsubuku, Shoji; Hatayama, Kazuhisa; Mawatari, Kazunori; Smriga, Miro; Kimura, Takeshi

    2004-01-01

    The amino acid L-arginine (Arg) has been used extensively in dietary and pharmacological products. This study evaluated toxicological and behavioral effects of Arg produced by Ajinomoto Co. (Tokyo, Japan) during a dosing study with male and female Sprague-Dawley rats. The amino acid was incorporated into a standard diet at doses equal to 1.25%, 2.5%, and 5.0% (w/w). A control group of rats received only a standard diet. All diets were administered ad libitum for 13 continuous weeks. To examine recoverability of any potential effects, the administration period was followed by a 5-week-long recovery, during which only a standard diet was provided. In male and female rats in each concentration group, treatment-related changes were not observed for clinical signs, body weights, diet consumption, ophthalmology, gross pathology, organ weight, or histopathology. An elevated level of plasma glucose was detected in some male rats (5.0%, w/w) during the analysis conducted in the fifth week of administration; however, the degree of the change was within the physiological range, and no changes were observed at the end of the administration period. In the same group, an increase in hemoglobin, together with a tendency toward an increase in the red blood cell counts, was found, but the change was considered toxicologically insignificant. The no-observed-adverse-effect level (NOAEL) for Arg was estimated at 5.0% (w/w) for both genders (males, 3.3 +/- 0.1 g/kg/day; females, 3.9 +/- 0.2 g/kg/day).

  7. Biological changes in experimental animals after irradiation with sublethal doses

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Dae Seong; Park, Yong Dae; Jin, Chang Hyun; Byun, Myung Woo; Jeong, Il Yun [Advanced Radiation Technology Institute, Korea Atomic Energy Research Institute, Jeongeup (Korea, Republic of)

    2008-05-15

    The objective of the present study was to investigate general clinical aspects such as weekly body weight and blood changes, and weekly food intake in gamma-irradiated C57BL/6j male mice fed AIN-76A purified rodent diet for 14 weeks. The mice were whole-body irradiated with 0, 2, 4 and 6 Gy of gamma-rays (Gammacell 40 Exactor, {sup 137}Cs, MDS Nordion) at a dose rate of 1.8 {sub c}Gy per second. The mean body weight change of 6 Gy-irradiated mice significantly decreased when compared to that of the non-irradiated control mice. Moreover, high dose of radiation resulted in decreased levels of AST, ALT, but in increased levels of total cholersterol, triglyceride, HDL-C in mice.

  8. 12 CFR 714.2 - What are the permissible leasing arrangements?

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false What are the permissible leasing arrangements? 714.2 Section 714.2 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING... leasing. In direct leasing, you purchase personal property from a vendor, becoming the owner of the...

  9. Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational, Multicenter, Prospective Open-Label Study.

    Science.gov (United States)

    Kim, Hyo-Won; Park, Eun-Jin; Kim, Ji-Hoon; Boon-Yasidhi, Vitharon; Tarugsa, Jariya; Reyes, Alexis; Manalo, Stella; Joung, Yoo-Sook

    2018-04-24

    We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study. Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole for 12 weeks (mean dose, 5.1 ± 2.5 mg; range 2-15 mg). Aripiprazole significantly reduced the mean caregiver-rated scores for the Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate Speech subscales of the Aberrant Behavior Checklist from baseline to week 12 (p autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.

  10. Vitamin D supplementation in nursing home patients: randomized controlled trial of standard daily dose versus individualized loading dose regimen.

    Science.gov (United States)

    Wijnen, Hugo; Salemink, Dayenne; Roovers, Lian; Taekema, Diana; de Boer, Hans

    2015-05-01

    Supplementation of cholecalciferol 800 IU daily appears to be insufficient to raise vitamin D levels to >75 nmol/l in nursing home (NH) patients. Our objective was to compare the efficacy of an individualized cholecalciferol loading dose (LD) regimen and a daily dose (DD) regimen of cholecalciferol 800 IU in reaching 25-OH vitamin D (25OHD) levels >75 nmol/l. A total of 30 NH patients with 25OHD levels 50 nmol/l were included. Patients were randomized using the minimization method in the LD or DD group. The cholecalciferol LD, calculated with an algorithm based on serum 25OHD level and body weight, was administered in divided doses of 50,000 IU twice a week, followed by a monthly maintenance dose of either 50,000 or 25,000 IU. The DD regimen consisted of cholecalciferol 800 IU daily for 26 weeks. Serum 25OHD, calcium, creatinine, phosphate, and parathyroid hormone were measured, and 2-minute walking test, handgrip strength, and timed get up and go test were assessed at baseline (T 0), after 5 weeks (T 5), 12 weeks (T 12), and 26 weeks (T 26). The primary endpoint was the percentage of patients with 25OHD levels >75 nmol/l at T 5. Secondary endpoints were the proportion of patients with 25OHD levels >75 nmol/l at T 26, safety of LD regimen, and improvement of performance tests with normalization of vitamin D levels. Median baseline 25OHD levels (interquartile range) were comparable between the 14 DD and 16 LD patients: 20.9 (15.9-29.6) and 21.7 (16.4-32.8) nmol/l, respectively. Levels of 25OHD >75 nmol/l at T 5 were reached in 79 % of the 14 LD patients, but in none of the 13 DD patients (p 75 nmol/l were reached in 83 % of the 12 LD patients and in 30 % of the ten DD patients (p tests was observed. In NH patients with severe 25OHD deficiency, an individualized calculated cholecalciferol LD is likely to be superior to a DD of cholecalciferol 800 IU in terms of the ability to rapidly normalize vitamin D levels.

  11. Measurement of the Dose to the Family Members Taking Care of Thyroid Cancer Patients Undergoing I-131 Therapy in Nuclear Medicine Using TLD-100.

    Science.gov (United States)

    Zehtabian, M; Dehghan, N; Danaei Ghazanfarkhani, M; Haghighatafshar, M; Sina, S

    2017-05-01

    The family members or friends of the patients undergoing treatment using radioiodine in nuclear medicine are inevitably exposed to ionization radiation. The purpose of this study is measurement of the dose received by the people taking care of the thyroid cancer patients treated by 131I. For this purpose, the dose amounts received by 29 people accompanying patients were measured using thermoluminescence dosimeters. A badge containing three TLD-100 chips was given to each caregiver. The people were asked to wear the badges for 24 days, when they are taking care of the patients. Finally the dose to each person was estimated by averaging the readings of the three TLDs. The measured dose amounts to the people were compared with the recommendations of international commitions. According to the results obtained in this study, the amounts of dose received by the caregivers were between 0.03 and 0.38 mSv, with the average of 0.12 mSv. By comparison of the results of this study with the recommendations of International Commission on Radiological Protection (ICRP), it can be observed that the dose to family members of the patients is less than the dose constraints. However, it is recommended that the caregivers be aware of the radiation protection principles in order to reduce their dose. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Parental feeding practices predict authoritative, authoritarian, and permissive parenting styles.

    Science.gov (United States)

    Hubbs-Tait, Laura; Kennedy, Tay Seacord; Page, Melanie C; Topham, Glade L; Harrist, Amanda W

    2008-07-01

    Our goal was to identify how parental feeding practices from the nutrition literature link to general parenting styles from the child development literature to understand how to target parenting practices to increase effectiveness of interventions. Stand-alone parental feeding practices could be targeted independently. However, parental feeding practices linked to parenting styles require interventions treating underlying family dynamics as a whole. To predict parenting styles from feeding practices and to test three hypotheses: restriction and pressure to eat are positively related whereas responsibility, monitoring, modeling, and encouraging are negatively related to an authoritarian parenting style; responsibility, monitoring, modeling, and encouraging are positively related whereas restriction and pressure to eat are negatively related to an authoritative parenting style; a permissive parenting style is negatively linked with all six feeding practices. Baseline data of a randomized-controlled intervention study. Two hundred thirty-nine parents (93.5% mothers) of first-grade children (134 boys, 105 girls) enrolled in rural public schools. Parental responses to encouraging and modeling questionnaires and the Child Feeding Questionnaire, as well as parenting styles measured by the Parenting Styles and Dimensions Questionnaire. Correlation and regression analyses. Feeding practices explained 21%, 15%, and 8% of the variance in authoritative, authoritarian, and permissive parenting, respectively. Restriction, pressure to eat, and monitoring (negative) significantly predicted an authoritarian style (Hypothesis 1); responsibility, restriction (negative), monitoring, and modeling predicted an authoritative style (Hypothesis 2); and modeling (negative) and restriction significantly predicted a permissive style (Hypothesis 3). Parental feeding practices with young children predict general parenting styles. Interventions that fail to address underlying parenting styles

  13. Pharmacokinetics of marbofloxacin in pigs after intravenous and intramuscular administration of a single dose of 8 mg/kg: dose proportionality, influence of the age of the animals and urinary elimination.

    Science.gov (United States)

    Schneider, M; Paulin, A; Dron, F; Woehrlé, F

    2014-12-01

    The pharmacokinetics of marbofloxacin in pigs were evaluated as a function of dose and animal age following intravenous and intramuscular administration of a 16% solution (Forcyl(®) ). The absolute bioavailability of marbofloxacin as well as the dose proportionality was evaluated in 27-week-old fattening pigs. Blood PK and urinary excretion of marbofloxacin were evaluated after a single intramuscular dose of 8 mg/kg in 16-week-old male pigs. An additional group of 12-week-old weaned piglets was used for the evaluation of age-related kinetics. The plasma and urine concentration of marbofloxacin was determined using a HPLC method. Pharmacokinetic parameters were calculated using noncompartmental methods. After intravenous administration in 27-week-old fattening pigs, the total body clearance was 0.065 L/h·kg. After intramuscular administration to the same animals, the mean observed Cmax was 6.30 μg/mL, and the AUCINF was 115 μg·h/mL. The absolute bioavailability was 91.5%, and dose proportionality was shown within the dose range of 4-16 mg/kg. The renal clearance was about half of the value of the total clearance. The total systemic clearance values significantly decreased as a function of age, being 0.092 L/h·kg and 0.079 L/h·kg in pigs aged 12 and 16 weeks, respectively. © 2014 The Authors. Journal of Veterinary Pharmacology and Therapeutics Published by John Wiley & Sons Ltd.

  14. Results of the Phase I Dose-Escalating Study of Motexafin Gadolinium With Standard Radiotherapy in Patients With Glioblastoma Multiforme

    International Nuclear Information System (INIS)

    Ford, Judith M.; Seiferheld, Wendy; Alger, Jeffrey R.; Wu, Genevieve; Endicott, Thyra J.; Mehta, Minesh; Curran, Walter; Phan, See-Chun

    2007-01-01

    Purpose: Motexafin gadolinium (MGd) is a putative radiation enhancer initially evaluated in patients with brain metastases. This Phase I trial studied the safety and tolerability of a 2-6-week course (10-22 doses) of MGd with radiotherapy for glioblastoma multiforme. Methods and Materials: A total of 33 glioblastoma multiforme patients received one of seven MGd regimens starting at 10 doses of 4 mg/kg/d MGd and escalating to 22 doses of 5.3 mg/kg/d MGd (5 or 10 daily doses then three times per week). The National Cancer Institute Cancer Therapy Evaluation Program toxicity and stopping rules were applied. Results: The maximal tolerated dose was 5.0 mg/kg/d MGd (5 d/wk for 2 weeks, then three times per week) for 22 doses. The dose-limiting toxicity was reversible transaminase elevation. Adverse reactions included rash/pruritus (45%), chills/fever (30%), and self-limiting vesiculobullous rash of the thumb and fingers (42%). The median survival of 17.6 months prompted a case-matched analysis. In the case-matched analysis, the MGd patients had a median survival of 16.1 months (n = 31) compared with the matched Radiation Therapy Oncology Group database patients with a median survival of 11.8 months (hazard ratio, 0.43; 95% confidence interval, 0.20-0.94). Conclusion: The maximal tolerated dose of MGd with radiotherapy for glioblastoma multiforme in this study was 5 mg/kg/d for 22 doses (daily for 2 weeks, then three times weekly). The baseline survival calculations suggest progression to Phase II trials is appropriate, with the addition of MGd to radiotherapy with concurrent and adjuvant temozolomide

  15. Assessment of dose using TLD during activity handling at RPhL, BRIT

    International Nuclear Information System (INIS)

    Choughule, Nitin V.; Bairwa, S.M.; Murali, S.; Rakesh, R.B.; Madhumita, B.; Adtani, M.M.; Mehra, Kiran; Padmanabhan, D.; Borkute, S.D.; Pal, N.; Sachdev, S.S.

    2012-01-01

    Radiopharmaceutical Lab (RPhL), BRIT undertakes production, supply of radiopharmaceuticals. At RPhL short lived isotopes 131 I, 99 Mo, 99m Tc, 125 I, 153 Sm, 32 P and 51 Cr, are handled with total activity handled per week ranging from MBq to TBq (mCiCi). Radiological survey provides idea on radiation level helps to ensure safe working condition. In order to improve the working condition and to estimate the integrated dose over a period of week with uniform pattern of activity handling in the period, a study was carried out using TLD badges. Specifically prepared TLD badges containing CaSO 4 :Dy phosphor were placed at various locations at RPhL It is used for personnel monitoring. One set of TLD was exposed for a week long period while the other set was exposed only during activity handling, kept in the lead pot during the rest of the period. Dose measured by TLDs were compared with the dose estimated using the survey data for the respective locations as well as with the dose estimated using the activity handled by taking into account the time, distance and shielding. The maximum radiation level recorded during lab survey was used to estimate the TLD exposure during the period. It was observed that results on TLD dose measurement and estimated doses using survey results were of same order. The cumulative TLD dose recorded for week duration (168 h) was significantly higher than doses recorded by exposed TLD only during activity handling (8 h). It was expected that the TLD dose would not be more than dose estimated using radiation survey data, while in 3 among 8 experimental TLDs, the dose was ∼ 25% higher. This could be due to the movement of active material or open handling of activity do not get reflected during normal radiation survey and contribution from background radiation at the lab where those TLDs were placed. The individual dose of all the personnel working in different labs were well within the relevant dose limits indicating the safe working condition

  16. Evaluation of doses to staff involved in interventional cardiology in two Khartoum hospitals

    International Nuclear Information System (INIS)

    Bashir, M. K. A.

    2009-11-01

    In interventional cardiac procedures, staff operates near the patient in a non-uniformly scattered radiation field. Consequently, workers may receive, over a period of time, relatively high radiation doses. The measurement of individual doses to personnel becomes critical due to the use of protective devices and, as a consequence of the large number of methods proposed to assess the effective dose, In this study, staff doses were measured in two cardiac centers: Ahmed Gasim Hospital and Cardiac Center, Khartoum. The objective was to measure personal dose equivalent and accordingly estimate the effective dose which is received by staff in interventional cardiology. Measurements were performed using electronic personal dosimeters (EPDs) worn over lead apron during the examination and were read immediately following each examination. A total number of 40 radiation worker were monitored for a period of two weeks. The highest doses received by the cardiologist followed by nurses and then X-ray technicians. Staff received mean effective doses that ranged from 24 to 110 μSv estimated for four weeks. Recommendations on how to reduce staff doses in interventional cardiology are presented. (Author)

  17. Serum level modifications of female sex hormones after radiocastration with different total doses

    International Nuclear Information System (INIS)

    Naujokat, B.; Rohloff, R.; Willich, N.; Eiermann, W.

    1988-01-01

    We determined serum level of estradiol, FSH and LH over a period of six to eight weeks after ovarian irradiation for castration with different doses (2x2.5 Gy/3x2.5 Gy/4x2.5 Gy) in 15 patients with metastatic breast cancer as compared to changes after ovarectomy in five patients. The time course of the changing estradiol-, FSH and LH-serum levels sigificantly depends on the ovarian dose. After radiological castration with a dose of 4x2.5 Gy = 10 Gy in four days the estrogen levels decrease within two to three weeks, and the FSH- and LH-levels increase after three to four weeks into the postmenopausal range. Therefore, the time course is not very different from changes after ovarectomy. (orig.) [de

  18. Exploring Permission-Induced Risk in Android Applications for Malicious Application Detection

    KAUST Repository

    Wang, Wei; Wang, Xing; Feng, Dawei; Liu, Jiqiang; Han, Zhen; Zhang, Xiangliang

    2014-01-01

    Android has been a major target of malicious applications (malapps). How to detect and keep the malapps out of the app markets is an ongoing challenge. One of the central design points of Android security mechanism is permission control

  19. Tackle-related injury rates and nature of injuries in South African Youth Week tournament rugby union players (under-13 to under-18): an observational cohort study.

    Science.gov (United States)

    Burger, Nicholas; Lambert, Mike I; Viljoen, Wayne; Brown, James C; Readhead, Clint; Hendricks, Sharief

    2014-08-12

    The tackle situation is most often associated with the high injury rates in rugby union. Tackle injury epidemiology in rugby union has previously been focused on senior cohorts but less is known about younger cohorts. The aim of this study was to report on the nature and rates of tackle-related injuries in South African youth rugby union players representing their provinces at national tournaments. Observational cohort study. Four South African Youth Week tournaments (under-13 Craven Week, under-16 Grant Khomo Week, under-18 Academy Week, under-18 Craven Week). Injury data were collected from 3652 youth rugby union players (population at risk) in 2011 and 2012. Tackle-related injury severity ('time-loss' and 'medical attention'), type and location, injury rate per 1000 h (including 95% CIs). Injury rate ratios (IRR) were calculated and modelled using a Poisson regression. A χ(2) analysis was used to detect linear trends between injuries and increasing match quarters. The 2012 under-13 Craven Week had a significantly greater 'time-loss' injury rate when compared with the 2012 under-18 Academy Week (IRR=4.43; 95% CI 2.13 to 9.21, p<0.05) and under-18 Craven Week (IRR=3.52; 95% CI 1.54 to 8.00, p<0.05). The Poisson regression also revealed a higher probability of 'overall' ('time-loss' and 'medical attention' combined) and 'time-loss' tackle-related injuries occurring at the under-13 Craven Week. The proportion of 'overall' and 'time-loss' injuries increased significantly with each quarter of the match when all four tournaments were combined (p<0.05). There was a difference in the tackle-related injury rate between the under-13 tournament and the two under-18 tournaments, and the tackle-related injury rate was higher in the final quarter of matches. Ongoing injury surveillance is required to better interpret these findings. Injury prevention strategies targeting the tackle may only be effective once the rate and nature of injuries have been accurately determined

  20. Suppression of carcinogenesis in mice by adaptive responses to low dose rate irradiation

    Energy Technology Data Exchange (ETDEWEB)

    Sakai, Kazuo; Iwasaki, Toshiyasu; Hoshi, Yuko; Nomura, Takaharu; Ina, Yasuhiro; Tanooka, Hiroshi [Central Research Institute of Electric Power Industry, Low Dose Radiation Research Center, Komae, Tokyo (Japan)

    2003-07-01

    Effects of prolonged low-dose-rate irradiation on the process of carcinogenesis were examined in mice treated with chemical carcinogen or irradiated with high doses of X-rays. Female ICR mice, 5 week-old, 35 in each group, were exposed to gamma-rays from a {sup 137}Cs source in the long-term low dose rate irradiation facility at CRIEPI. The dose rate was 2.6 mGy/hr (A), 0.96 mGy/hr (B), or 0.30 mGy/hr (C). Thirty-five days later, the mice were injected into the groin with 0.5 mg of methylcholanthrene (MC) dissolved in olive oil and irradiation was continued. Cumulative tumor incidences after 216 days following MC injection were 89% in group A, 76% in group B, and 94% in group C. That in non-irradiated control group was 94%. The difference in the tumor incidence between the control and position B was statistically significant, indicating the suppressive effect of the low dose rate irradiation on the process of MC-induced carcinogenesis with an optimum dose rate around 1 mGy/hr. In B6C3F1 mice, although the suppression of tumor incidence was not observed, there was a significant delay in tumor appearance in the irradiated mice between 100-150 days after MC injection. A group of 20 female C57BL/6N mice, 5 weeks old, were exposed to gamma-rays at 0.95 mGy/hr for 5 weeks. Then, they were exposed weekly to 1.8 Gy whole body X-irradiation (300 kVp) for consecutive 4 weeks to induce thymic lymphoma. Another group received only the fractionated irradiation. The first mouse died from thymic lymphoma appeared 89 days after the last irradiation in the group received only the fractionated irradiation, while 110 days in the group combined with the low dose rate irradiation. (author)

  1. Background radiation dose of dumpsites in Ota and Environs

    Science.gov (United States)

    Usikalu, M. R.; Ola, O. O.; Achuka, J. A.; Babarimisa, I. O.; Ayara, W. A.

    2017-05-01

    In-situ measurement of background radiation dose from selected dumpsites in Ota and its environs was done using Radialert Nuclear Radiation Monitor (Digilert 200). Ten measurements were taken from each dumpsite. The measured background radiation range between 0.015 mRhr-1 for AOD and 0.028 mRhr-1 for SUS dumpsites. The calculated annual equivalent doses vary between 1.31 mSvyr-1 for AOD and 2.28 mSv/yr for SUS dumpsites. The air absorbed dose calculated ranged from 150 nGyhr-1 to 280 nGy/hr for AOD and SUS dumpsites respectively with an average value of 217 nGyhr-1 for all the locations. All the estimated parameters were higher than permissible limit set for background radiation for the general public. Conclusively, the associated challenge and radiation burden posed by the wastes on the studied locations and scavengers is high. Therefore, there is need by the regulatory authorities to look into the way and how waste can be properly managed so as to alleviate the effects on the populace leaving and working in the dumpsites vicinity.

  2. 34 CFR 222.194 - Are “in-kind” contributions permissible?

    Science.gov (United States)

    2010-07-01

    .... (b) Third party in-kind contributions mean property or services that benefit this grant program and... indirect costs, the provisions of 34 CFR 80.24 govern the allowability and valuation of in-kind contributions, except that it is permissible for a third party to contribute real property to a grantee for a...

  3. ESTABLISHMENT OF DETAILED EYE MODEL OF ADULT CHINESE MALE AND DOSE CONVERSION COEFFICIENTS CALCULATION UNDER NEUTRON EXPOSURE.

    Science.gov (United States)

    Zhu, Hongyu; Qiu, Rui; Wu, Zhen; Ren, Li; Li, Chunyan; Zhang, Hui; Li, Junli

    2017-12-01

    The human eye lens is sensitive to radiation. ICRP-118 publication recommended a reduction of the occupational annual equivalent dose limit from 150 to 20 mSv, averaged over defined periods of 5 y. Therefore, it is very important to build a detailed eye model for the accurate dose assessment and radiation risk evaluation of eye lens. In this work, a detailed eye model was build based on the characteristic anatomic parameters of the Chinese adult male. This eye model includes seven main structures, which are scleral, choroid, lens, iris, cornea, vitreous body and aqueous humor. The lens was divided into sensitive volume and insensitive volume based on different cell populations. The detailed eye model was incorporated into the converted polygon-mesh version of the Chinese reference adult male whole-body surface model. After the incorporation, dose conversion coefficients for the eye lens were calculated for neutron exposure at AP, PA and LAT geometries with Geant4, the neutron energies were from 0.001 eV to 10 MeV. The calculated lens dose coefficients were compared with those of ICRP-116 publication. Significant differences up to 97.47% were found at PA geometry. This could mainly be attributed to the different geometry characteristic of eye model and parameters of head in different phantom between the present work and ICRP-116 publication. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes.

    Science.gov (United States)

    Cook, Andrea J; Wellman, Robert D; Cherkin, Daniel C; Kahn, Janet R; Sherman, Karen J

    2015-10-01

    This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. The aim was to determine the optimal dose of massage for neck pain. Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain

  5. Sustained Antibody Responses 6 Years Following 1, 2, or 3 Doses of Quadrivalent Human Papillomavirus (HPV) Vaccine in Adolescent Fijian Girls, and Subsequent Responses to a Single Dose of Bivalent HPV Vaccine: A Prospective Cohort Study.

    Science.gov (United States)

    Toh, Zheng Quan; Russell, Fiona M; Reyburn, Rita; Fong, James; Tuivaga, Evelyn; Ratu, Tupou; Nguyen, Cattram D; Devi, Rachel; Kama, Mike; Matanitobua, Silivia; Tabrizi, Sepehr N; Garland, Suzanne M; Sinha, Rohit; Frazer, Ian; Tikoduadua, Lisi; Kado, Joseph; Rafai, Eric; Mulholland, Edward K; Licciardi, Paul V

    2017-04-01

    The duration of antibody response following reduced human papillomavirus (HPV) vaccine doses has not been determined. We compared the antibody responses in girls previously vaccinated with zero, 1, 2, or 3 doses of quadrivalent HPV vaccine (4vHPV; Gardasil, Merck) 6 years previously. A prospective cohort study was undertaken in 200 Fijian girls 15-19 years of age. Approximately equal numbers of girls from 2 main ethnic groups (Fijians of Indian descent [FID] and Indigenous Fijians [iTaukei]) in Fiji were recruited for each dosage groups. Blood was drawn before and 28 days following a single dose of bivalent HPV vaccine (2vHPV; Cervarix, GlaxoSmithKline). We measured neutralizing antibodies (NAb) against HPV-6, -11, -16, and -18 using the pseudovirion-based neutralization assay. After 6 years (before a dose of 2vHPV was given), the geometric mean NAb titers for all 4 HPV types were not statistically different between 2-dose (2D) and 3-dose (3D) recipients: HPV-6 (3D: 2216 [95% confidence interval {CI},1695-2896]; 2D: 1476 [95% CI, 1019-2137]; P = .07), HPV-11 (3D: 4431 [95% CI, 3396-5783]; 2D: 2951 [95% CI, 1984-4390]; P = .09), HPV-16 (3D: 3373 [95% CI, 2511-4530]; 2D: 3275 [95% CI, 2452-4373]; P = .89); HPV-18 (3D: 628 [95% CI: 445-888]; 2D: 606 [95% CI, 462-862]; P = .89), and were higher in FID than iTaukei girls. Although 1-dose recipients had significantly lower NAb titers than 2-/3-dose recipients, their NAb titers were 5- to 30-fold higher than unvaccinated girls. Post-2vHPV NAb titers against HPV-16 and -18 were not statistically different between girls who received 1, 2, or 3 doses of 4vHPV previously. Two doses of 4vHPV provide similar NAb titers as 3 doses for 6 years, although the clinical significance is unknown. A single dose of 4vHPV elicits antibodies that persisted for at least 6 years, and induced immune memory, suggesting possible protection against HPV vaccine types after a single dose of 4vHPV. © The Author 2016. Published by Oxford University

  6. Weekly Volume and Dosimetric Changes During Chemoradiotherapy With Intensity-Modulated Radiation Therapy for Head and Neck Cancer: A Prospective Observational Study

    Energy Technology Data Exchange (ETDEWEB)

    Bhide, Shreerang A [Institute of Cancer Research, 237 Fulham Road, London SW6 6JB (United Kingdom); Head and Neck Unit, Royal Marsden NHS Foundation Trust Hospital, London SW3 6JJ (United Kingdom); Davies, Mark; Burke, Kevin; McNair, Helen A; Hansen, Vibeke [Department of Radiation Oncology, Royal Marsden NHS Foundation Trust Hospital, London and Sutton (United Kingdom); Barbachano, Y [Department of Statistics, Royal Marsden NHS Foundation Trust Hospital, London and Sutton (United Kingdom); El-Hariry, I A [Head and Neck Unit, Royal Marsden NHS Foundation Trust Hospital, London SW3 6JJ (United Kingdom); Newbold, Kate [Department of Radiation Oncology, Royal Marsden NHS Foundation Trust Hospital, London and Sutton (United Kingdom); Harrington, Kevin J [Institute of Cancer Research, 237 Fulham Road, London SW6 6JB (United Kingdom); Head and Neck Unit, Royal Marsden NHS Foundation Trust Hospital, London SW3 6JJ (United Kingdom); Nutting, Christopher M., E-mail: chris.nutting@rmh.nhs.u [Head and Neck Unit, Royal Marsden NHS Foundation Trust Hospital, London SW3 6JJ (United Kingdom)

    2010-04-15

    Purpose: The aim of this study was to investigate prospectively the weekly volume changes in the target volumes and organs at risk and the resulting dosimetric changes during induction chemotherapy followed by chemoradiotherapy with intensity-modulated radiation therapy (C-IMRT) for head-and-neck cancer patients. Methods and Materials: Patients receiving C-IMRT for head-and-neck cancer had repeat CT scans at weeks 2, 3, 4, and 5 during radiotherapy. The volume changes of clinical target volume 1 (CTV1) and CTV2 and the resulting dosimetric changes to planning target volume 1 (PTV1) and PTV2 and the organs at risk were measured. Results: The most significant volume differences were seen at week 2 for CTV1 and CTV2. The reductions in the volumes of CTV1 and CTV2 at week 2 were 3.2% and 10%, respectively (p = 0.003 and p < 0.001). The volume changes resulted in a significant reduction in the minimum dose to PTV1 and PTV2 (2 Gy, p = 0.002, and 3.9 Gy, p = 0.03, respectively) and an increased dose range across PTV1 and PTV2 (2.5 Gy, p < 0.001, and 5.1 Gy, p = 0.008, respectively). There was a 15% reduction in the parotid volumes by week 2 (p < 0.001) and 31% by week 4 (p < 0.001). There was a statistically significant increase in the mean dose to the ipsilateral parotid only at week 4 (2.7 Gy, p = 0.006). The parotid glands shifted medially by an average of 2.3 mm (p < 0.001) by week 4. Conclusion: The most significant volumetric changes and dosimetric alterations in the tumor volumes and organs at risk during a course of C-IMRT occur by week 2 of radiotherapy. Further adaptive radiotherapy with replanning, if appropriate, is recommended.

  7. Evaluation of secondary exposure doses to transportation and medical personnel in the radiation emergency medicine

    International Nuclear Information System (INIS)

    Kato, Hideki; Suzuki, Shoichi; Koga, Sukehiko; Mukoyama, Takashi; Tomatsu, Hirotaka; Suzuki, Yusuke

    2009-01-01

    Radionuclide contamination is one of the accidents that might occur while carrying out a periodical inspection of nuclear power stations during normal reactor operation. When such an accident occurs, rescue and medical personnel, involved in transporting and treating affected workers run the risk of exposure to secondary radiation. In this study, the ambient dose equivalent rate at a certain distance from the surface of the human body contaminated with typical radioactive corrosion products was calculated. Further, the relationships among the adhesion area, contamination density, and secondary exposure dose were clarified. The secondary exposure dose and permissible working hours in a radiation emergency medicine were estimated by presenting these relationships in the form of a chart and by specifying the contamination levels. (author)

  8. Thirteen week toxicity study of dietary l-tryptophan in rats with a recovery period of 5 weeks.

    Science.gov (United States)

    Shibui, Yusuke; Matsumoto, Hideki; Masuzawa, Yoko; Ohishi, Takumi; Fukuwatari, Tsutomu; Shibata, Katsumi; Sakai, Ryosei

    2018-04-01

    Although l-tryptophan is nutritionally important and widely used in medical applications, toxicity data for its oral administration are limited. The purpose of this study was to evaluate the potential toxicity of an experimental diet containing added l-tryptophan at doses of 0 (basal diet), 1.25%, 2.5% and 5.0% when administered to Sprague-Dawley rats for 13 weeks. There were no toxicological changes in clinical signs, ophthalmology, urinalysis, hematology, necropsy, organ weight and histopathology between control rats and those fed additional l-tryptophan. Body weight gain and food consumption significantly decreased throughout the administration period in males in the 2.5% group and in both sexes in the 5.0% group. At the end of the dosing period, decreases in water intake in males in the 5.0% group and in serum glucose in females in the 5.0% group were observed. The changes described above were considered toxicologically significant; however, they were not observed after a 5 week recovery period, suggesting reversibility. Consequently, the no-observed-adverse-effect level of l-tryptophan in the present study was 1.25% for males and 2.5% for females (mean intake of l-tryptophan: 779 mg kg -1 body weight day -1 [males] and 1765 mg kg -1 body weight day -1 [females]). As the basal diet used in this study contained 0.27% of proteinaceous l-tryptophan, the no-observed-adverse-effect level of overall l-tryptophan was 1.52% for males and 2.77% for females (mean intake of overall l-tryptophan: 948 mg kg -1 body weight day -1 (males) and 1956 mg kg -1 body weight day -1 (females)). We conclude that l-tryptophan has a low toxicity profile in terms of human use. Copyright © 2017 John Wiley & Sons, Ltd.

  9. ESTABLISHMENT OF THE PERMISSIBLE TRAIN SPEED ON THE CURVED TURNOUTS

    Directory of Open Access Journals (Sweden)

    O. M. Patlasov

    2016-04-01

    Full Text Available Purpose. Turnouts play a key role in the railway transportation process. One-sided and many-sided curved turnouts were railed over the last 20 years in difficult conditions (curved sections, yard necks. They have a number of geometric features, unlike the conventional one-sided turnouts. Today the normative documents prohibit laying such turnouts in curved track sections and only partially regulate the assessment procedure of their real condition. The question of establishment the permissible train speed within the curved turnouts is still open. In this regard, authors propose to set the train speed according to the driving comfort criterion using the results of field measurements of ordinates from the baseline for the particular curved turnout. Methodology. The article considers the criteria using which one can set the permissible speed on the turnouts. It defines the complexity of their application, advantages and disadvantages. Findings. The work analyzes the speed distribution along the length of the real curved turnout for the forward and lateral directions. It establishes the change rate values of unbalanced accelerations for the existing norms of the curved track sections maintenance according to the difference in the adjacent bend versine at speeds up to 160 km/h. Originality. A method for establishing the trains’ speed limit within the curved turnouts was developed. It takes into account the actual geometric position in the plan of forward and lateral turnout directions. This approach makes it possible to establish a barrier places in plan on the turnouts limiting the train speed. Practical value. The proposed method makes it possible to objectively assess and set the trains’ permissible speed on the basis of the ordinate measurement of the forward and lateral directions of the curved turnouts from the baseline using the driving comfort criteria. The method was tested using real turnouts, which are located within the Pridneprovsk

  10. Swedish or American heterosexual college youth: who is more permissive?

    Science.gov (United States)

    Weinberg, M S; Lottes, I L; Shaver, F M

    1995-08-01

    Theories of human sexuality have proposed that two factors reduce the double standard of sexuality and lead to a convergence of male and female sexual behavior: the degree of social benefits and amount of power women have in basic societal institutions and the extent to which a society accepts permissive sexual norms. As these factors increase, the strength of the double standard will decrease and the convergence between male and female behaviors will increase. Compared to the United States, Sweden has instituted more policies to promote gender equality and has been thought to accept more permissive premarital sexual attitudes. The focus of the research reported here is to examine country and gender differences in sexual attitudes and sexual behavior for a sample of university students in the United States (N = 407) and Sweden (N = 570). Results indicate that Swedish students endorsed more similar sexual standards for women and men and reported more accepting attitudes than did American students. For sexual behavior, American men reported the most sexual experience, Swedish men the least, with the women of both countries generally in the middle category. Notwithstanding this more permissive behavior on the part of American men, gender convergence with respect to sexual behavior is stronger in Sweden on several of the dimensions examined: age of first engaging in partner-related sexual activities for those who were sexually experienced, relationship with first partner, number of partners both in the last year and in their lifetime, and affective reactions to first coitus. Gender convergence, however, is weaker in Sweden than in the United States with respect to the incidence and frequency of various sexual activities and the degree of satisfaction with current sex life. Findings are discussed with respect to the questions they raise about the current theories that framed this research and the differential amount of sex education provided in the two countries.

  11. Once-daily dose regimen of ribavirin is interchangeable with a twice-daily dose regimen: randomized open clinical trial

    Directory of Open Access Journals (Sweden)

    Balk JM

    2015-08-01

    Full Text Available Jiska M Balk,1 Guido RMM Haenen,1 Özgür M Koc,2 Ron Peters,3 Aalt Bast,1 Wim JF van der Vijgh,1 Ger H Koek,4 1Department of Toxicology, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Centre, 2Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, 3DSM Resolve, Geleen, 4Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, the Netherlands Background: The combination of ribavirin (RBV and pegylated interferon (PEG-IFN is effective in the treatment of chronic hepatitis C infection. Reducing the frequency of RBV intake from twice to once a day will improve compliance and opens up the opportunity to combine RBV with new and more specific direct-acting agents in one pill. Therefore, the purpose of this study was to evaluate the pharmacokinetic profile of RBV in a once-daily to twice-daily regimen. The secondary aim was to determine tolerability as well as the severity and differences in side effects of both treatment regimens. Methods: In this randomized open-label crossover study, twelve patients with chronic type 1 hepatitis C infection and weighing more than 75 kg were treated with 180 µg of PEG-IFN weekly and 1,200 mg RBV daily for 24 weeks. The patients received RBV dosed as 1,200 mg once-daily for 12 weeks followed by RBV dosed as 600 mg twice-daily for 12 weeks, or vice versa. In addition to the pharmacokinetic profile, the hematological profile and side effects were recorded. The RBV concentrations in plasma were determined using liquid chromatography-tandem mass spectrometry. Results: Eight of twelve patients completed the study. Neither the time taken for RBV to reach peak plasma concentration nor the AUC0-last (adjusted for difference in dose was significantly different between the two groups (P>0.05. Furthermore, the once-daily regimen did not give more side effects than the twice-daily regimen (P>0

  12. 3'-deoxy-3'-[18F]fluorothymidine PET Quantification of Bone Marrow Response to Radiation Dose

    International Nuclear Information System (INIS)

    McGuire, Sarah M.; Menda, Yusuf; Boles Ponto, Laura L.; Gross, Brandie; Buatti, John; Bayouth, John E.

    2011-01-01

    Purpose: The purpose of this study was to quantify the relationship of bone marrow response to radiation dose, using 3'-deoxy-3'-[ 18 F]fluorothymidine ([ 18 F]FLT)-labeled uptake quantified in positron-emission tomography (PET) scans. Methods and Materials: Pre- and post-Week 1 treatment [ 18 F]FLT PET images were registered to the CT images used to create the radiation treatment plan. Changes in [ 18 F]FLT uptake values were measured using profile data of standardized uptake values (SUVs) and doses along the vertebral bodies located at a field border where a range of radiation doses were present for 10 patients. Data from the profile measurements were grouped into 1 Gy dose bins from 1 to 9 Gy to compare SUV changes for all patients. Additionally, the maximum pretreatment, the post-Week 1 treatment, and the dose values located within the C6-T7 vertebrae that straddled the field edge were measured for all patients. Results: Both the profile and the individual vertebral data showed a strong correlation between SUV change and radiation dose. Relative differences in SUVs between bins >1 Gy and 18 F]FLT PET images for identifying active bone marrow and monitoring changes due to radiation dose. Additionally, the change in [ 18 F]FLT uptake observed in bone marrow for different weekly doses suggests potential dose thresholds for reducing bone marrow toxicity.

  13. Development and application of a complex numerical model and software for the computation of dose conversion factors for radon progenies.

    Science.gov (United States)

    Farkas, Árpád; Balásházy, Imre

    2015-04-01

    A more exact determination of dose conversion factors associated with radon progeny inhalation was possible due to the advancements in epidemiological health risk estimates in the last years. The enhancement of computational power and the development of numerical techniques allow computing dose conversion factors with increasing reliability. The objective of this study was to develop an integrated model and software based on a self-developed airway deposition code, an own bronchial dosimetry model and the computational methods accepted by International Commission on Radiological Protection (ICRP) to calculate dose conversion coefficients for different exposure conditions. The model was tested by its application for exposure and breathing conditions characteristic of mines and homes. The dose conversion factors were 8 and 16 mSv WLM(-1) for homes and mines when applying a stochastic deposition model combined with the ICRP dosimetry model (named PM-A model), and 9 and 17 mSv WLM(-1) when applying the same deposition model combined with authors' bronchial dosimetry model and the ICRP bronchiolar and alveolar-interstitial dosimetry model (called PM-B model). User friendly software for the computation of dose conversion factors has also been developed. The software allows one to compute conversion factors for a large range of exposure and breathing parameters and to perform sensitivity analyses. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Evaluation of the Occupational Doses of Interventional Radiologists

    International Nuclear Information System (INIS)

    Kuipers, Gerritjan; Velders, Xandra L.; Winter, Robbert J. de; Reekers, Jim A.; Piek, Jan J.

    2008-01-01

    The aim of the present study was to determine whether there is a linear relation between the doses measured above and those measured under the lead apron of the radiologists performing interventional procedures. To monitor radiation exposure the International Commission of Radiological Protection (ICRP) recommends the use of a single dosimeter under the protective apron. To determine the exposure more accurately an additional dosimeter is recommended above the protective apron. The exposure of eight radiologists was monitored with two personal dosimeters during 3 consecutive years. To measure the doses uniformly the two dosimeters were worn in a special holder attached to the lead apron. The two personal dosimeters were replaced every 4 weeks on the same day. The doses above and under the protective aprons of seven radiologists did not differ significantly. A significant lower dose above and under the protective apron was measured for one of the radiologists. During a 4-week period the average dose measured above the lead apron was 3.44 mSv (median, 3.05 mSv), while that under the 0.25-mm lead apron was 0.12 mSv (median, 0.1 mSv). The coefficients of the regression line result in the equation Y = 0.036X - 0.004, with Y as the dose under the lead apron and X as the dose above the lead apron. The statistical analysis of the data established a linear relation between the doses above and those under the lead apron (R 2 = 0.59). Before the special holder was introduced it was not possible to derive a relation between the doses above and those under the lead apron, as the doses were measured at varying places above and under the lead apron. There is no evidence that the effective dose can be estimated more accurately when an additional dosimeter is used. The present study revealed a threshold before doses under the lead apron were measured. Due to the threshold it can be concluded that the doses under the lead apron will not be underestimated easily when doses above the

  15. Ameliorative effects of low dose/low dose-rate irradiation on reactive oxygen species-related diseases model mice

    International Nuclear Information System (INIS)

    Nomura, Takaharu

    2008-01-01

    Living organisms have developed complex biological system which protects themselves against environmental radiation, and irradiation with proper dose, dose-rate and irradiation time can stimulate their biological responses against oxidative stress evoked by the irradiation. Because reactive oxygen species are involved in various human diseases, non-toxic low dose/low dose-rate radiation can be utilized for the amelioration of such diseases. In this study, we used mouse experimental models for fatty liver, nephritis, diabetes, and ageing to elucidate the ameliorative effect of low dose/low dose-rate radiation in relation to endogenous antioxidant activity. Single irradiation at 0.5 Gy ameliorates carbon tetrachloride-induced fatty liver. The irradiation increases hepatic anti-oxidative system involving glutathione and glutathione peroxidase, suggesting that endogenous radical scavenger is essential for the ameliorative effect of low dose radiation on carbon tetrachloride-induced fatty liver. Single irradiation at 0.5 Gy ameliorates ferric nitrilotriacetate-induced nephritis. The irradiation increases catalase and decreases superoxide dismutase in kidney. The result suggests that low dose radiation reduced generation of hydroxide radical generation by reducing cellular hydroperoxide level. Single irradiation at 0.5 Gy at 12 week of age ameliorates incidence of type I diabetes in non-obese diabetic (NOD) mice through the suppression of inflammatory activity of splenocytes, and resultant apoptosis of β-cells in pancreas. The irradiation activities of superoxide dismutase and catalase, which coordinately diminish intracellular reactive oxygen species. Continuous irradiation at 0.70 mGy/hr from 10 week of age elongates life span, and suppresses alopecia in type II diabetesmice. The irradiation improved glucose clearance without affecting insulin-resistance, and increased pancreatic catalase activity. The results suggest that continuous low dose-rate irradiation protect

  16. High dose rate versus low dose rate interstitial radiotherapy for carcinoma of the floor of mouth

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Yamazaki, Hideya; Koizumi, Masahiko; Kagawa, Kazufumi; Yoshida, Ken; Shiomi, Hiroya; Imai, Atsushi; Shimizutani, Kimishige; Tanaka, Eichii; Nose, Takayuki; Teshima, Teruki; Furukawa, Souhei; Fuchihata, Hajime

    1998-01-01

    Purpose: Patients with cancer of the floor of mouth are treated with radiation because of functional and cosmetic reasons. We evaluate the treatment results of high dose rate (HDR) and low dose rate (LDR) interstitial radiation for cancer of the floor of mouth. Methods and Materials: From January 1980 through March 1996, 41 patients with cancer of the floor of mouth were treated with LDR interstitial radiation using 198 Au grains, and from April 1992 through March 1996 16 patients with HDR interstitial radiation. There were 26 T1 tumors, 30 T2 tumors, and 1 T3 tumor. For 21 patients treated with interstitial radiation alone, a total radiation dose of interstitial therapy was 60 Gy/10 fractions/6-7 days in HDR and 85 Gy within 1 week in LDR. For 36 patients treated with a combination therapy, a total dose of 30 to 40 Gy of external radiation and a total dose of 48 Gy/8 fractions/5-6 days in HDR or 65 Gy within 1 week in LDR were delivered. Results: Two- and 5-year local control rates of patients treated with HDR interstitial radiation were 94% and 94%, and those with LDR were 75% and 69%, respectively. Local control rate of patients treated with HDR brachytherapy was slightly higher than that with 198 Au grains (p = 0.113). For late complication, bone exposure or ulcer occurred in 6 of 16 (38%) patients treated with HDR and 13 of 41 (32%) patients treated with LDR. Conclusion: HDR fractionated interstitial brachytherapy can be an alternative to LDR brachytherapy for cancer of the floor of mouth and eliminate radiation exposure for the medical staff

  17. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses.

    Science.gov (United States)

    Bozkurt, Ozlem; Uras, Nurdan; Sari, Fatma Nur; Atay, Funda Yavanoglu; Sahin, Suzan; Alkan, Ayse Dogan; Canpolat, Fuat Emre; Oguz, Serife Suna

    2017-09-01

    Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants. To assess the effect of three different doses of vitamin D supplementation (400, 800 and 1000IU/d) in preterm infants ≤32weeks gestation on the prevalence of vitamin D deficiency and 25(OH) D levels at 36weeks postmenstrual age (PMA). Prospective randomized trial. 121 preterm infants with gestational age of 24-32weeks were randomly allocated to receive 400, 800 or 1000IU/d vitamin D. Serum concentration of 25(OH) D and the prevalence of vitamin D deficiency at 36weeks PMA. Vitamin D deficiency was defined as serum 25(OH) D concentrations vitamin D levels before supplementation. The average 25(OH) vitamin D concentrations at 36weeks PMA were significantly higher in 800IU (40±21.4ng/ml) and 1000IU group (43±18.9ng/ml) when compared to 400IU group (29.4±13ng/ml). The prevalence of vitamin D deficiency (2.5 vs 22.5; RR: 0.09; CI:0.01-0.74) and insufficiency (30 vs 57.5; RR:0.32; CI:0.13-0.80) was significantly lower in 1000IU group when compared to 400IU group at 36weeks PMA. 1000IU/d of vitamin D supplementation in preterm infants ≤32weeks gestation age effectively decreases the prevalence of vitamin D deficiency and leads to higher concentrations of 25(OH) vitamin D at 36weeks PMA TRIAL REGISTRATION: Clinical Trials.gov: NCT02941185. Copyright © 2017. Published by Elsevier B.V.

  18. Effect of an Early Dose of Measles Vaccine on Morbidity Between 18 Weeks and 9 Months of Age: A Randomized, Controlled Trial in Guinea-Bissau

    DEFF Research Database (Denmark)

    Do, Vu An; Biering-Sorensen, Sofie; Fisker, Ane Bærent

    2017-01-01

    Background: Children in Guinea-Bissau receive measles vaccine (MV) at 9 months of age, but studies have shown that an additional dose before 9 months of age might have beneficial nonspecific effects. Within a randomized trial designed to examine nonspecific effects of early MV receipt on mortality......). Children were visited weekly from enrollment to age 9 months; the mother reported morbidity, and the field assistants examined the children. Using Cox and binomial regression models, we compared the 2 randomization groups. Results: Among the 1592 children, early measles vaccination was not associated...... with a higher risk of the well-known adverse events of fever, rash, and convulsions within the first 14 days. From 15 days after randomization to age 9 months, early measles vaccination was associated with reductions in maternally reported diarrhea (hazard ratio [HR], 0.89; 95% confidence interval [CI],.82-. 97...

  19. Vaxchora: A Single-Dose Oral Cholera Vaccine.

    Science.gov (United States)

    Cabrera, Adriana; Lepage, Jayne E; Sullivan, Karyn M; Seed, Sheila M

    2017-07-01

    To review trials evaluating the efficacy and safety of Vaxchora, a reformulated, single-dose, oral, lyophilized Vibrio cholerae CVD 103-HgR vaccine for the prevention of travel-related cholera caused by V cholerae serogroup O1. A literature search was conducted using MEDLINE (1946 to January week 3, 2017) and EMBASE (1996 to 2017 week 3). Keywords included oral cholera vaccine, single-dose, Vaxchora, and CVD 103-HgR. Limits included human, clinical trials published in English since 2010. ClinicalTrials.gov was used as a source for unpublished data. Additional data sources were obtained through bibliographic review of selected articles. Studies that addressed the safety and efficacy of Vaxchora, the reformulated, single-dose oral CVD 103-HgR cholera vaccine, were selected for analysis. Approval of Vaxchora, was based on efficacy of the vaccine in human trials demonstrating 90.3% protection among those challenged with V cholerae 10 days after vaccination and in immunogenicity studies with 90% systemic vibriocidal antibody conversion at 6 months after a single-dose of vaccine. Tolerability was acceptable, with the most common adverse effects reported to be fatigue, headache, and abdominal pain. Vaxchora is the only FDA-approved, single-dose oral vaccine for the prevention of cholera caused by V cholerae serogroup O1 in adult travelers from the United States going to cholera-affected areas. Safety and efficacy has not been established in children, immunocompromised persons, and pregnant or breastfeeding women or those living in cholera-endemic areas.

  20. A Retrospective Study Evaluating the Effect of Low Doses of Perineural Dexamethasone on Ropivacaine Brachial Plexus Peripheral Nerve Block Analgesic Duration.

    Science.gov (United States)

    Schnepper, Gregory D; Kightlinger, Benjamin I; Jiang, Yunyun; Wolf, Bethany J; Bolin, Eric D; Wilson, Sylvia H

    2017-09-23

    Examination of the effectiveness of perineural dexamethasone administered in very low and low doses on ropivacaine brachial plexus block duration. Retrospective evaluation of brachial plexus block duration in a large cohort of patients receiving peripheral nerve blocks with and without perineural dexamethasone in a prospectively collected quality assurance database. A single academic medical center. A total of 1,942 brachial plexus blocks placed over a 16-month period were reviewed. Demographics, nerve block location, and perineural dexamethasone utilization and dose were examined in relation to block duration. Perineural dexamethasone was examined as none (0 mg), very low dose (2 mg or less), and low dose (greater than 2 mg to 4 mg). Continuous catheter techniques, local anesthetics other than ropivacaine, and block locations with fewer than 15 subjects were excluded. Associations between block duration and predictors of interest were examined using multivariable regression models. A subgroup analysis of the impact of receiving dexamethasone on block duration within each block type was also conducted using a univariate linear regression approach. A total of 1,027 subjects were evaluated. More than 90% of brachial plexus blocks contained perineural dexamethasone (≤4 mg), with a median dose of 2 mg. Increased block duration was associated with receiving any dose of perineural dexamethasone (P block duration did not differ with very low- or low-dose perineural dexamethasone after controlling for other factors (P = 0.420). Perineural dexamethasone prolonged block duration compared with ropivacaine alone; however, duration was not greater with low-dose compared with very low-dose perineural dexamethasone. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  1. Bioavailibility of higher dose methotrexate comparing oral and subcutaneous route of administration in patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Hoekstra, Monique; Hoekstra, M.; Haagsma, Cees; Neef, Cees; Proost, Johannes; van de Laar, Mart A F J; Knuif, Antonius

    2004-01-01

    OBJECTIVE: To determine the bioavailability of higher oral doses of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA). METHODS: A pharmacokinetic analysis was performed in 15 patients with RA taking a stable dose of MTX (> or = 25 mg weekly). Separated by 2 weeks, a pharmacokinetic

  2. Phase I Study of Conformal Radiotherapy and Concurrent Full-Dose Gemcitabine With Erlotinib for Unresected Pancreatic Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Robertson, John M., E-mail: jrobertson@beaumont.edu [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Margolis, Jeffrey [Division of Medical Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Jury, Robert P. [Department of Surgery, William Beaumont Hospital, Royal Oak, MI (United States); Balaraman, Savitha; Cotant, Matthew B.; Ballouz, Samer; Boxwala, Iqbal G.; Jaiyesimi, Ishmael A.; Nadeau, Laura [Division of Medical Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Hardy-Carlson, Maria [Division of Radiation Oncology, M. D. Anderson Cancer Center, Houston, TX (United States); Marvin, Kimberly S.; Wallace, Michelle; Ye Hong [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States)

    2012-02-01

    Purpose: To determine the recommended dose of radiotherapy when combined with full-dose gemcitabine and erlotinib for unresected pancreas cancer. Methods and Materials: Patients with unresected pancreatic cancer (Zubrod performance status 0-2) were eligible for the present study. Gemcitabine was given weekly for 7 weeks (1,000 mg/m{sup 2}) with erlotinib daily for 8 weeks (100 mg). A final toxicity assessment was performed in Week 9. Radiotherapy (starting at 30 Gy in 2-Gy fractions, 5 d/wk) was given to the gross tumor plus a 1-cm margin starting with the first dose of gemcitabine. A standard 3 plus 3 dose escalation (an additional 4 Gy within 2 days for each dose level) was used, except for the starting dose level, which was scheduled to contain 6 patients. In general, Grade 3 or greater gastrointestinal toxicity was considered a dose-limiting toxicity, except for Grade 3 anorexia or Grade 3 fatigue alone. Results: A total of 20 patients were treated (10 men and 10 women). Nausea, vomiting, and infection were significantly associated with the radiation dose (p = .01, p = .03, and p = .03, respectively). Of the 20 patients, 5 did not complete treatment and were not evaluable for dose-escalation purposes (3 who developed progressive disease during treatment and 2 who electively discontinued it). Dose-limiting toxicity occurred in none of 6 patients at 30 Gy, 2 of 6 at 34 Gy, and 1 of 3 patients at 38 Gy. Conclusion: The results of the present study have indicated that the recommended Phase II dose is 30 Gy in 15 fractions.

  3. Phase I Study of Conformal Radiotherapy and Concurrent Full-Dose Gemcitabine With Erlotinib for Unresected Pancreatic Cancer

    International Nuclear Information System (INIS)

    Robertson, John M.; Margolis, Jeffrey; Jury, Robert P.; Balaraman, Savitha; Cotant, Matthew B.; Ballouz, Samer; Boxwala, Iqbal G.; Jaiyesimi, Ishmael A.; Nadeau, Laura; Hardy-Carlson, Maria; Marvin, Kimberly S.; Wallace, Michelle; Ye Hong

    2012-01-01

    Purpose: To determine the recommended dose of radiotherapy when combined with full-dose gemcitabine and erlotinib for unresected pancreas cancer. Methods and Materials: Patients with unresected pancreatic cancer (Zubrod performance status 0–2) were eligible for the present study. Gemcitabine was given weekly for 7 weeks (1,000 mg/m 2 ) with erlotinib daily for 8 weeks (100 mg). A final toxicity assessment was performed in Week 9. Radiotherapy (starting at 30 Gy in 2-Gy fractions, 5 d/wk) was given to the gross tumor plus a 1-cm margin starting with the first dose of gemcitabine. A standard 3 plus 3 dose escalation (an additional 4 Gy within 2 days for each dose level) was used, except for the starting dose level, which was scheduled to contain 6 patients. In general, Grade 3 or greater gastrointestinal toxicity was considered a dose-limiting toxicity, except for Grade 3 anorexia or Grade 3 fatigue alone. Results: A total of 20 patients were treated (10 men and 10 women). Nausea, vomiting, and infection were significantly associated with the radiation dose (p = .01, p = .03, and p = .03, respectively). Of the 20 patients, 5 did not complete treatment and were not evaluable for dose-escalation purposes (3 who developed progressive disease during treatment and 2 who electively discontinued it). Dose-limiting toxicity occurred in none of 6 patients at 30 Gy, 2 of 6 at 34 Gy, and 1 of 3 patients at 38 Gy. Conclusion: The results of the present study have indicated that the recommended Phase II dose is 30 Gy in 15 fractions.

  4. Effect of repeated oral therapeutic doses of methylphenidate on food intake and growth rate in rats.

    Science.gov (United States)

    Alam, Nausheen; Najam, Rahila

    2015-01-01

    Central nervous system stimulants are known to produce anorexia. Previous data suggest that methylphenidate can have variable effects on caloric intake and growth rate. A dose-response study was performed to monitor caloric intake, liquid intake and growth rate in rats following repeated administration of human oral therapeutic doses 2 mg/kg/day, 5mg/kg/day and 8mg/kg/day of methylphenidate. We found that food intake and water intake, increased in all weeks and at all doses used in the study. Growth rate increased more at higher dose (8mg/kg/day) and at low dose (2mg/kg/day) of methylphenidate in 1(st) and 2(nd) week whereas more decreased by the above doses in 3(rd) week, suggesting that food stimulation leads to initial increase in growth rate but long term administration of methylphenidate attenuate growth rate that is not due to modulation of appetite but may be due to anxiety and increased activity produce by stimulants. A possible role of DA, 5HT receptors in modulation of appetite and anxiety is discussed.

  5. High-Dose Vitamin C Injection to Cancer Patients May Promote Thrombosis Through Procoagulant Activation of Erythrocytes.

    Science.gov (United States)

    Kim, Keunyoung; Bae, Ok-Nam; Koh, Sung-Hee; Kang, Seojin; Lim, Kyung-Min; Noh, Ji-Yoon; Shin, Sue; Kim, Inho; Chung, Jin-Ho

    2015-10-01

    Potential risk of high-dose vitamin C consumption is often ignored. Recently, gram-dose vitamin C is being intravenously injected for the treatment of cancer, which can expose circulating blood cells to extremely high concentrations of vitamin C. As well as platelets, red blood cells (RBCs) can actively participate in thrombosis through procoagulant activation. Here, we examined the procoagulant and prothrombotic risks associated with the intravenous injection of gram-dose vitamin C. Vitamin C (0.5-5 mM) increased procoagulant activity of freshly isolated human RBCs via the externalization of phosphatidylserine (PS) to outer cellular membrane and the formation of PS-bearing microvesicles. PS exposure was induced by the dysregulation of key enzymes for the maintenance of membrane phospholipid asymmetry, which was from vitamin C-induced oxidative stress, and resultant disruption of calcium and thiol homeostasis. Indeed, the intravenous injection of vitamin C (0.5-1.0 g/kg) in rats in vivo significantly increased thrombosis. Notably, the prothrombotic effects of vitamin C were more prominent in RBCs isolated from cancer patients, who are at increased risks of thrombotic events. Vitamin C-induced procoagulant and prothrombotic activation of RBCs, and increased thrombosis in vivo. RBCs from cancer patients exhibited increased sensitivity to the prothrombotic effects of vitamin C, reflecting that intravenous gram-dose vitamin C therapy needs to be carefully revisited. © The Author 2015. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  6. Treatment dose-response in amblyopia therapy: the Monitored Occlusion Treatment of Amblyopia Study (MOTAS).

    Science.gov (United States)

    Stewart, Catherine E; Moseley, Merrick J; Stephens, David A; Fielder, Alistair R

    2004-09-01

    Amblyopia is the commonest visual disorder of childhood. Yet the contributions of the two principal treatments (spectacle wear and occlusion) to outcome are unknown. This study was undertaken to investigate the dose-response relationship of amblyopia therapy. The study comprised three distinct phases: baseline, in which repeat measures of visual function were undertaken to confirm the initial visual deficit; refractive adaptation: an 18-week period of spectacle wear with six weekly measurements of logarithm of the minimum angle of resolution (logMAR) visual acuity; occlusion: in which participants were prescribed 6 hours of "patching" per day. In the latter phase, occlusion was objectively monitored and logMAR visual acuity recorded at 2-week intervals until any observed gains had ceased. Data were obtained from 94 participants (mean age, 5.1 +/- 1.4 years) with amblyopia associated with strabismus (n = 34), anisometropia (n = 23), and both anisometropia and strabismus (n = 37). Eighty-six underwent refractive adaptation. Average concordance with patching was 48%. The relationship between logMAR visual acuity gain and total occlusion dose was monotonic and linear. Increasing dose rate beyond 2 h/d hastened the response but did not improve outcome. More than 80% of the improvement during occlusion occurred within 6 weeks. Treatment outcome was significantly better for children younger than 4 years (n = 17) than in those older than 6 years (n = 24; P = 0.0014). Continuous objective monitoring of the amount of patching therapy received has provided insight into the dose-response relationship of occlusion therapy for amblyopia. Patching is most effective within the first few weeks of treatment, even for those in receipt of a relatively small dose. Further studies are needed to elucidate the neural basis for the dose-response functions. Copyright Association for Research in Vision and Ophthalmology

  7. Weekly Gemcitabine and Cisplatin in Combination With Radiotherapy in Patients With Locally Advanced Head-and-Neck Cancer: Phase I Study

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Radiation Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Afonso, Sergio Luis [Clinical Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Cardoso Tavares, Vivian [Head and Neck Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil); Bernardes Godoi da Silva, Lucas; Stefano, Eduardo Jose [Radiation Oncology Department, Faculty of Medicine of Marilia, Sao Paulo (Brazil)

    2011-11-15

    Purpose: To define the maximum tolerated dose by describing the dose-limiting toxicity (DLT) of weekly gemcitabine and cisplatin in patients with locally advanced head-and-neck (LAHN) cancer concomitant to irradiation. Methods and Materials: Patients with LAHN cancer were enrolled in a prospective, dose-escalation Phase I study. Toxicity was graded according to the Common Toxicity Criteria score. Maximum tolerated dose was defined when DLT developed in 2 of 6 patients. The starting dose of cisplatin was 20 mg/m{sup 2} and that of gemcitabine was 10 mg/m{sup 2} in 3 patients, with a subsequent dose escalation of 10 mg/m{sup 2} of cisplatin only for 3 new patients. In the next levels, only a dose escalation of gemcitabine with 10 mg/m{sup 2} for each new cohort was used (Level 1, 10 mg/m{sup 2} of gemcitabine and 20 mg/m{sup 2} of cisplatin; Level 2, 10 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin; and Level 3, 20 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin). Radiation therapy was administered by use of a conformal technique over a period of 6 to 7 weeks in 2.0-Gy daily fractions for 5 consecutive days per week to a total dose of 70 Gy. Results: From 2008 to 2009, 12 patients completing 3 dose levels were included in the study. At Dose Level 3, 1 of 3 patients had DLT with Grade 3 mucositis. Of the next 3 required patients, 2 showed DLT with Grade 3 dermatitis. At a follow-up of 3 months, 10 of 12 evaluable patients (83.3%) obtained a complete response and 1 patient (8.3%) obtained a partial response. Among the complete responders, at a median follow-up of 10 months (range, 6-14 months), 9 patients are alive and disease free. Conclusion: Gemcitabine at low doses combined with cisplatin is a potent radiosensitizer effective in patients with LAHN cancer. The recommended Phase II dose is 10 mg/m{sup 2} of gemcitabine and 30 mg/m{sup 2} of cisplatin with an acceptable tolerability profile.

  8. Dose equivalent distribution during occupational exposure in oncology

    International Nuclear Information System (INIS)

    Marco H, J.

    1996-01-01

    In this work are presented the results of the radiological surveillance of occupationally exposed workers at the National Institute of Oncology and Radiology during 26 years. The incidence of the equivalent dose in the personal working with radiant sources and radioactive substances in areas of x rays diagnostic, teletherapy, brachytherapy, nuclear medicine and biomedical research was showed. The employed dosimetric system makes use of ORWO RD3/RD4 monitoring film with copper and lead filters inside a plastic cassette manufactured in Cuba. The experimental method is supported by the optical densitometric analysis of films together with a set of standard film calibrated in standard X and gamma photon beams by means of a secondary standard dosimeter, type NPL. Statistics show that except those workings with radium-226, manual brachytherapy or Mo-99/Tc-99 generator elution, the equivalent dose distribution in our workers has been kept in regions well down the annual permissible limit. (authors). 6 refs., 3 tabs

  9. Assessment of permissible low-level releases of radionuclides into the marine environment

    International Nuclear Information System (INIS)

    Kryshev, I.I.; Sazykina, T.G.

    2002-01-01

    The subject of this paper is radio-ecological assessment of permissible low-level releases of radionuclides in sea waters ensuring the radiological protection of the human population, as well as marine biota. (author)

  10. Capecitabine based postoperative accelerated chemoradiation of pancreatic carcinoma. A dose-escalation study

    International Nuclear Information System (INIS)

    Morganti, Alessio G.; Picardi, Vincenzo; Ippolito, Edy; Massaccesi, Mariangela; Macchia, Gabriella; Deodato, Francesco; Caravatta, Luciana; Tambaro, Rosa; Mignogna, Samantha; Cellini, Numa; Valentini, Vincenzo; Mattiucci, Gian Carlo; Di Lullo, Liberato; Giglio, Gianfranco; Caprino, Paola; Sofo, Luigi; Ingrosso, Marcello

    2010-01-01

    The objective of this study was to evaluate the safety of escalating up to 55 Gy within five weeks, the dose of external beam radiotherapy to the previous tumor site concurrently with a fixed daily dose of capecitabine, in patients with resected pancreatic cancer. Material and methods. Patients with resected pancreatic carcinoma were eligible for this study. Capecitabine was administered at a daily dose of 1600 mg/m 2 . Regional lymph nodes received a total radiation dose of 45 Gy with 1.8 Gy per fractions. The starting radiation dose to the tumor bed was 50.0 Gy (2.0 Gy/fraction, 25 fractions). Escalation was achieved up to a total dose of 55.0 Gy by increasing the fraction size by 0.2 Gy (2.2 Gy/fraction), while keeping the duration of radiotherapy to five weeks (25 fractions). A concomitant boost technique was used. Dose limiting toxicity (DLT) was defined as any grade>3 hematologic toxicity, grade>2 liver, renal, neurologic, gastrointestinal, or skin toxicity, by RTOG criteria, or any toxicity producing prolonged (> 10 days) radiotherapy interruption. Results and discussion. Twelve patients entered the study (median age: 64 years). In the first cohort (six patients), no patient experienced DLT. Similarly in the second cohort, no DLT occurred. All 12 patients completed the planned regimen of therapy. Nine patients experienced grade 1-2 nausea and/or vomiting. Grade 2 hematological toxicity occurred in four patients. The results of our study indicate that a total radiation dose up to 55.0 Gy/5 weeks can be safely administered to the tumor bed, concurrently with capecitabine (1600 mg/m 2 ) in patients with resected pancreatic carcinoma.

  11. The Effect of Realtime Monitoring on Dose Exposure to Staff Within an Interventional Radiology Setting

    Energy Technology Data Exchange (ETDEWEB)

    Baumann, Frederic, E-mail: fredericbaumann@hotmail.com; Katzen, Barry T. [Baptist Hospital of Miami, Miami Cardiac & Vascular Institute (MCVI) (United States); Carelsen, Bart [Philips HealthCare, Clinical Science Interventional X-ray (Netherlands); Diehm, Nicolas [Kantonsspital Aarau, Clinical and Interventional Angiology (Switzerland); Benenati, James F.; Peña, Constantino S. [Baptist Hospital of Miami, Miami Cardiac & Vascular Institute (MCVI) (United States)

    2015-10-15

    PurposeThe purpose of this study is to evaluate a new device providing real-time monitoring on radiation exposure during fluoroscopy procedures intending to reduce radiation in an interventional radiology setting.Materials and MethodsIn one interventional suite, a new system providing a real-time radiation dose display and five individual wireless dosimeters were installed. The five dosimeters were worn by the attending, fellow, nurse, technician, and anesthesiologist for every procedure taking place in that suite. During the first 6-week interval the dose display was off (closed phase) and activated thereafter, for a 6-week learning phase (learning phase) and a 10-week open phase (open phase). During these phases, the staff dose and the individual dose for each procedure were recorded from the wireless dosimeter and correlated with the fluoroscopy time. Further subanalysis for dose exposure included diagnostic versus interventional as well as short (<10 min) versus long (>10 min) procedures.ResultsA total of 252 procedures were performed (n = 88 closed phase, n = 50 learning phase, n = 114 open phase). The overall mean staff dose per fluoroscopic minute was 42.79 versus 19.81 µSv/min (p < 0.05) comparing the closed and open phase. Thereby, anesthesiologists were the only individuals attaining a significant dose reduction during open phase 16.9 versus 8.86 µSv/min (p < 0.05). Furthermore, a significant reduction of total staff dose was observed for short 51 % and interventional procedures 45 % (p < 0.05, for both).ConclusionA real-time qualitative display of radiation exposure may reduce team radiation dose. The process may take a few weeks during the learning phase but appears sustained, thereafter.

  12. The Effect of Realtime Monitoring on Dose Exposure to Staff Within an Interventional Radiology Setting

    International Nuclear Information System (INIS)

    Baumann, Frederic; Katzen, Barry T.; Carelsen, Bart; Diehm, Nicolas; Benenati, James F.; Peña, Constantino S.

    2015-01-01

    PurposeThe purpose of this study is to evaluate a new device providing real-time monitoring on radiation exposure during fluoroscopy procedures intending to reduce radiation in an interventional radiology setting.Materials and MethodsIn one interventional suite, a new system providing a real-time radiation dose display and five individual wireless dosimeters were installed. The five dosimeters were worn by the attending, fellow, nurse, technician, and anesthesiologist for every procedure taking place in that suite. During the first 6-week interval the dose display was off (closed phase) and activated thereafter, for a 6-week learning phase (learning phase) and a 10-week open phase (open phase). During these phases, the staff dose and the individual dose for each procedure were recorded from the wireless dosimeter and correlated with the fluoroscopy time. Further subanalysis for dose exposure included diagnostic versus interventional as well as short (<10 min) versus long (>10 min) procedures.ResultsA total of 252 procedures were performed (n = 88 closed phase, n = 50 learning phase, n = 114 open phase). The overall mean staff dose per fluoroscopic minute was 42.79 versus 19.81 µSv/min (p < 0.05) comparing the closed and open phase. Thereby, anesthesiologists were the only individuals attaining a significant dose reduction during open phase 16.9 versus 8.86 µSv/min (p < 0.05). Furthermore, a significant reduction of total staff dose was observed for short 51 % and interventional procedures 45 % (p < 0.05, for both).ConclusionA real-time qualitative display of radiation exposure may reduce team radiation dose. The process may take a few weeks during the learning phase but appears sustained, thereafter

  13. A randomised controlled trial of the efficacy and safety of allopurinol dose escalation to achieve target serum urate in people with gout.

    Science.gov (United States)

    Stamp, Lisa K; Chapman, Peter T; Barclay, Murray L; Horne, Anne; Frampton, Christopher; Tan, Paul; Drake, Jill; Dalbeth, Nicola

    2017-09-01

    To determine the efficacy and safety of allopurinol dose escalation using a treat-to-target serum urate (SU) approach. A randomised, controlled, parallel-group, comparative clinical trial was undertaken. People with gout receiving at least creatinine clearance (CrCL)-based allopurinol dose for ≥1 month and SU ≥6 mg/dL were recruited. Participants were randomised to continue current dose (control) or allopurinol dose escalation for 12 months. In the dose escalation group, allopurinol was increased monthly until SU was gout. Allopurinol dose escalation is well tolerated. ANZCTR12611000845932; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Is Dose Deformation–Invariance Hypothesis Verified in Prostate IGRT?

    Energy Technology Data Exchange (ETDEWEB)

    Simon, Antoine, E-mail: antoine.simon@univ-rennes1.fr [INSERM, U1099, 35000 Rennes (France); Laboratoire Traitement du Signal et de l' Image, Université de Rennes 1, 35000 Rennes (France); Le Maitre, Amandine; Nassef, Mohamed; Rigaud, Bastien [INSERM, U1099, 35000 Rennes (France); Laboratoire Traitement du Signal et de l' Image, Université de Rennes 1, 35000 Rennes (France); Castelli, Joël [INSERM, U1099, 35000 Rennes (France); Laboratoire Traitement du Signal et de l' Image, Université de Rennes 1, 35000 Rennes (France); Department of Radiotherapy, Centre Eugène Marquis, 35000 Rennes (France); Acosta, Oscar; Haigron, Pascal [INSERM, U1099, 35000 Rennes (France); Laboratoire Traitement du Signal et de l' Image, Université de Rennes 1, 35000 Rennes (France); Lafond, Caroline; Crevoisier, Renaud de [INSERM, U1099, 35000 Rennes (France); Laboratoire Traitement du Signal et de l' Image, Université de Rennes 1, 35000 Rennes (France); Department of Radiotherapy, Centre Eugène Marquis, 35000 Rennes (France)

    2017-03-15

    Purpose: To assess dose uncertainties resulting from the dose deformation–invariance hypothesis in prostate cone beam computed tomography (CT)–based image guided radiation therapy (IGRT), namely to evaluate whether rigidly propagated planned dose distribution enables good estimation of fraction dose distributions. Methods and Materials: Twenty patients underwent a CT scan for planning intensity modulated radiation therapy–IGRT delivering 80 Gy to the prostate, followed by weekly CT scans. Two methods were used to obtain the dose distributions on the weekly CT scans: (1) recalculating the dose using the original treatment plan; and (2) rigidly propagating the planned dose distribution. The cumulative doses were then estimated in the organs at risk for each dose distribution by deformable image registration. The differences between recalculated and propagated doses were finally calculated for the fraction and the cumulative dose distributions, by use of per-voxel and dose-volume histogram (DVH) metrics. Results: For the fraction dose, the mean per-voxel absolute dose difference was <1 Gy for 98% and 95% of the fractions for the rectum and bladder, respectively. The maximum dose difference within 1 voxel reached, however, 7.4 Gy in the bladder and 8.0 Gy in the rectum. The mean dose differences were correlated with gas volume for the rectum and patient external contour variations for the bladder. The mean absolute differences for the considered volume receiving greater than or equal to dose x (V{sub x}) of the DVH were between 0.37% and 0.70% for the rectum and between 0.53% and 1.22% for the bladder. For the cumulative dose, the mean differences in the DVH were between 0.23% and 1.11% for the rectum and between 0.55% and 1.66% for the bladder. The largest dose difference was 6.86%, for bladder V{sub 80Gy}. The mean dose differences were <1.1 Gy for the rectum and <1 Gy for the bladder. Conclusions: The deformation–invariance hypothesis was

  15. SU-G-206-16: Investigation of Dosimetric Consequence Via Cone-Beam CT Based Dose Reconstruction in Hepatocellular Carcinoma Radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Huang, P; Gang, Y; Qin, S; Li, D [Shandong Province Key Laboratory of Medical Physics and Image Processing Technology, School of Physics and Electronics, Shandong Normal University (China); Li, H; Chen, J; Ma, C; Yin, Y [Department of Radiation Oncology, Shandong Cancer Hospital and Institute (China)

    2016-06-15

    Purpose: Many patients with technically unresectable or medically inoperable hepatocellular carcinoma (HCC) had hepatic dosimetric variations as a result of inter-fraction anatomical deformation. This study was conducted to assess the hepatic dosimetric consequences via reconstructing weekly dose in HCC patients receiving three dimensional conformal radiation therapy. Methods: Twenty-one HCC patients with 21 planning CT (pCT) scans and 63 weekly Cone-beam CT (CBCT) scans were enrolled in this investigation. Among them, six patients had been diagnosed of radiation induced liver disease (RILD) and the other fifteen patients had good prognosis after treatment. And each patient had three weekly CBCT before re-planning. In reconstructing CBCT-based weekly dose, we registered pCT to CBCT to provide the correct Hounsfield units for the CBCT using gradient-based deformable image registration (DIR), and this modified CBCT (mCBCT) were introduced to enable dose calculation.To obtain the weekly dosimetric consequences, the initial plan beam configurations and dose constraints were re-applied to mCBCT for performing dose calculation, and the mCBCT were extrapolated to 25 fractions. Besides, the manually delineated contour was propagated automatically onto the mCBCT of the new patient by exploiting the deformation vectors field, and the reconstructed weekly dose was mapped back to pCT to understand the dose distribution difference. Also, weekly dosimetric variations were compared with the hepatic radiation tolerance in terms of D50 and Dmean. Results: Among the twenty-one patients, the three weekly D50 increased by 0.7Gy, 5.1Gy and 6.1Gy, respectively, and Dmean increased by 0.9%, 4.7% and 5.5%, respectively. For patients with RILD, the average values of the third weekly D50 and Dmean were both high than hepatic radiation tolerance, while the values of patients without RILD were below. Conclusion: The planned dose on pCT was not a real dose to the liver, and the liver overdose

  16. Elimination of ascorbic acid after high-dose infusion in prostate cancer patients

    DEFF Research Database (Denmark)

    Nielsen, Torben Kjær; Højgaard, Martin; Andersen, Jon Thor Trærup

    2015-01-01

    IV AA. The purpose of the present study was to assess the basic kinetic variables in human beings over a relevant AA dosing interval for proper design of future clinical trials. Ten patients with metastatic prostate cancer were treated for four weeks with fixed AA doses of 5, 30 and 60 g. AA...... was measured consecutively in plasma and indicated first-order elimination kinetics throughout the dosing range with supra-physiological concentrations. The target dose of 60g AA IV produced a peak plasma AA concentration of 20.3 mM. Elimination half-life was 1.87 hr (mean, SD ± 0.40), volume of distribution 0.......19 L/kg (SD ±0.05) and clearance rate 6.02 L/hr (100mL/min). No differences in pharmacokinetic parameters were observed between weeks/doses. A relatively fast first-order elimination with half-life of about 2 hr makes it impossible to maintain AA concentrations in the potential cytotoxic range after...

  17. Dose to radiation therapists from activation at high-energy accelerators used for conventional and intensity-modulated radiation therapy

    International Nuclear Information System (INIS)

    Rawlinson, J. Alan; Islam, Mohammad K.; Galbraith, Duncan M.

    2002-01-01

    The increased beam-on times which characterize intensity-modulated radiation therapy (IMRT) could lead to an increase in the dose received by radiation therapists due to induced activity. To examine this, gamma ray spectrometry was used to identify the major isotopes responsible for activation at a representative location in the treatment room of an 18 MV accelerator (Varian Clinac 21EX). These were found to be 28 Al, 56 Mn, and 24 Na. The decay of the dose rate measured at this location following irradiation was analyzed in terms of the known half-lives to yield saturation dose rates of 9.6, 12.4, and 6.2 μSv/h, respectively. A formalism was developed to estimate activation dose (μSv/week) due to successive patient irradiation cycles, characterized by the number of 18 MV fractions per week, F, the number of MU per fraction, M, the in-room time between fractions, t d (min), and the treatment delivery time t r ' (min). The results are represented by the sum of two formulas, one for the dose from 28 Al≅1.8x10 -3 F M (1-e -0.3t r ' )/t r ' and one for the dose from the other isotopes ≅1.1x10 -6 F 1.7 Mt d . For conventional therapy doses are about 60 μ Sv/week for an 18 MV workload of 60 000 MU/week. Irradiation for QA purposes can significantly increase the dose. For IMRT as currently practiced, lengthy treatment delivery times limit the number of fractions that can be delivered per week and hence limit the dose to values similar to those in conventional therapy. However for an IMRT regime designed to maximize patient throughput, doses up to 330 μSv/week could be expected. To reduce dose it is recommended that IMRT treatments should be delivered at energies lower than 18 MV, that in multienergy IMRT, high-energy treatments should be scheduled in the latter part of the day, and that equipment manufacturers should strive to minimize activation in the design of high-energy accelerators

  18. Missed doses of oral antihyperglycemic medications in US adults with type 2 diabetes mellitus: prevalence and self-reported reasons.

    Science.gov (United States)

    Vietri, Jeffrey T; Wlodarczyk, Catherine S; Lorenzo, Rose; Rajpathak, Swapnil

    2016-09-01

    Adherence to antihyperglycemic medication is thought to be suboptimal, but the proportion of patients missing doses, the number of doses missed, and reasons for missing are not well described. This survey was conducted to estimate the prevalence of and reasons for missed doses of oral antihyperglycemic medications among US adults with type 2 diabetes mellitus, and to explore associations between missed doses and health outcomes. The study was a cross-sectional patient survey. Respondents were contacted via a commercial survey panel and completed an on-line questionnaire via the Internet. Respondents provided information about their use of oral antihyperglycemic medications including doses missed in the prior 4 weeks, personal characteristics, and health outcomes. Weights were calculated to project the prevalence to the US adult population with type 2 diabetes mellitus. Outcomes were compared according to number of doses missed in the past 4 weeks using bivariate statistics and generalized linear models. Approximately 30% of adult patients with type 2 diabetes mellitus reported missing or reducing ≥1 dose of oral antihyperglycemic medication in the prior 4 weeks. Accidental missing was more commonly reported than purposeful skipping, with forgetting the most commonly reported reason. The timing of missed doses suggested respondents had also forgotten about doses missed, so the prevalence of missed doses is likely higher than reported. Outcomes were poorer among those who reported missing three or more doses in the prior 4 weeks. A substantial number of US adults with type 2 diabetes mellitus miss doses of their oral antihyperglycemic medications.

  19. Industry experience in promoting weekly iron-folic acid supplementation in the Philippines.

    Science.gov (United States)

    Garcia, Josel; Datol-Barrett, Eva; Dizon, Maynilad

    2005-12-01

    After participating in a pilot project under a government-industry partnership to promote the adoption of weekly iron-folic acid supplementation among women of reproductive age in the Philippines in 1998, United Laboratories (UNILAB), the Philippines' largest private pharmaceutical company, decided in April 2002 to launch a weekly iron-folic acid supplement for pregnant and non-pregnant women under the brand name Femina. The business objective set for the Femina brand was to build the category of preventive iron-folic acid supplements in line with the Philippine Department of Health's advocacy on weekly supplementation as an alternate to daily dosing to reduce the prevalence of anemia in the country. The brand was supported with an integrated mix of traditional advertising media with complementary direct-to-consumer educational programs that aimed to create awareness of iron-deficiency anemia, its causes and effects, and the role of weekly intake of iron-folic acid in preventing the condition. Aggressive marketing support for 1 year was successful in creating awareness among the target women. Significant lessons derived from consumers identified opportunity areas that can be further addressed in developing advocacy programs on weekly iron supplementation implemented on a nationwide scale in the future.

  20. Split-dose recovery in epithelial and vascular-connective tissue of pig skin

    International Nuclear Information System (INIS)

    Peel, D.M.; Hopewell, J.W.; Simmonds, R.H.; Dodd, P.; Meistrich, M.L.

    1984-01-01

    In the first 16 weeks after irradiation, two distinct waves of reaction can be observed in pig skin; the first wave (3-9 weeks) represents the expression of damage to the epithelium while the second is indicative of primary damage to the dermis, mediated through vascular injury. Following β-irradiation with a strontium-90 applicator, a severe epithelial reaction was seen with little subsequent dermal effects. X-rays (250 kV) on the other hand, produced a minimal epithelial response at doses which led to the development of dermal necrosis after 10-16 weeks. Comparison of single doses with two equal doses separated by 24 h produced a D 2 -D 1 value of 7.0 Gy at the doses which produced moist desquamation in 50% of fields (ED 50 ) after strontium-90 irradiation. After X-irradiation comparison of ED 50 doses for the later dermal reaction suggested a D 2 -D 1 value of 4.5 Gy. Over this same dose range of X-rays the D 2 -D 1 value for the first wave epithelial reaction was 3.5 Gy. These values of D 2 -D 1 for epithelial and dermal reactions in pig skin were compared with published data and were examined in relation to the theoretical predictions of a linear quadratic model for tissue target cell survival. The results were broadly in keeping with the productions of such a model. (Auth.)

  1. Permissive Attitude Towards Drug Use, Life Satisfaction, and Continuous Drug Use Among Psychoactive Drug Users in Hong Kong.

    Science.gov (United States)

    Cheung, N Wt; Cheung, Y W; Chen, X

    2016-06-01

    To examine the effects of a permissive attitude towards regular and occasional drug use, life satisfaction, self-esteem, depression, and other psychosocial variables in the drug use of psychoactive drug users. Psychosocial factors that might affect a permissive attitude towards regular / occasional drug use and life satisfaction were further explored. We analysed data of a sample of psychoactive drug users from a longitudinal survey of psychoactive drug abusers in Hong Kong who were interviewed at 6 time points at 6-month intervals between January 2009 and December 2011. Data of the second to the sixth time points were stacked into an individual time point structure. Random-effects probit regression analysis was performed to estimate the relative contribution of the independent variables to the binary dependent variable of drug use in the last 30 days. A permissive attitude towards drug use, life satisfaction, and depression at the concurrent time point, and self-esteem at the previous time point had direct effects on drug use in the last 30 days. Interestingly, permissiveness to occasional drug use was a stronger predictor of drug use than permissiveness to regular drug use. These 2 permissive attitude variables were affected by the belief that doing extreme things shows the vitality of young people (at concurrent time point), life satisfaction (at concurrent time point), and self-esteem (at concurrent and previous time points). Life satisfaction was affected by sense of uncertainty about the future (at concurrent time point), self-esteem (at concurrent time point), depression (at both concurrent and previous time points), and being stricken by stressful events (at previous time point). A number of psychosocial factors could affect the continuation or discontinuation of drug use, as well as the permissive attitude towards regular and occasional drug use, and life satisfaction. Implications of the findings for prevention and intervention work targeted at

  2. Weekly 24-hour continuous infusion interleukin-2 for metastatic melanoma and renal cell carcinoma: a phase I study.

    Science.gov (United States)

    Perez, E A; Scudder, S A; Meyers, F A; Tanaka, M S; Paradise, C; Gandara, D R

    1991-02-01

    Twenty-nine patients with biopsy-confirmed metastatic melanoma (17) or metastatic renal cell carcinoma (12) were treated with escalating doses or recombinant human interleukin-2 (IL-2) administered as weekly 24-h intravenous infusions. Patients received from 3 to 12 x 10(6) C.U./m2 (18-72 x 10(6) I.U./m2) weekly over a treatment period of 1 to 16 weeks, with a median of eight weekly cycles administered. Patients in all treatment groups experienced non-life-threatening systemic side effects consisting of fever, nausea, vomiting, fluid retention, and diarrhea. Grade III hypotension was seen in four of six patients (67%) at 12 x 10(6) C.U./m2, and represented the dose-limiting toxicity. Grade IV hypotension occurred in 1 of 14 patients at 6 x 10(6) C.U./m2; no other grade IV toxicities were observed. Grade III fever occurred in 3 of 11 patients (27%) treated at 3 x 10(6) C.U./m2, 3 of 14 patients (21%) at 6 x 10(6) C.U./m2, and 3 of 6 patients (50%) at 9 x 10(6) C.U./m2. An objective response was observed in 3 of 28 evaluable patients (10%): 1 complete response and 1 partial response in renal cell cancer, and 1 partial response in a melanoma patient. We conclude that for future studies, the recommended dose of IL-2 given as a weekly 24-h infusion is 9 x 10(6) C.U./m2 and that a low rate of objective tumor response can be obtained in patients with melanoma and renal cell carcinoma using this regimen.

  3. 75 FR 66050 - Permissible Sharing of Client Records by Customs Brokers

    Science.gov (United States)

    2010-10-27

    .... USCBP-2010-0038] RIN 1651-AA80 Permissible Sharing of Client Records by Customs Brokers AGENCIES... the Code of Federal Regulations (CFR) pertaining to the obligations of customs brokers to keep clients' information confidential. The proposed amendment would allow brokers, upon the client's consent in a written...

  4. Concerning permission of change in nuclear fuel processing business of Japan Nuclear Fuel Co. , Ltd

    Energy Technology Data Exchange (ETDEWEB)

    1988-12-01

    In response to an inquiry on the title issue received on Jun. 17, 1988, the Nuclear Safety Commission made a study and submitted the findings to the Prime Minister on Jul. 21, 1988. The study was intended to determine the conformity of the permission to the applicable criteria specified in laws relating to control of nuclear material, nuclear fuel and nuclear reactor. The proposed modification plan included changes in the facilities in the No.1 processing building and changes in processing methods which were required to perform processing of blanket fuel assemblies for fast breeder reactor. It also included changes in the facilities in the No.2 building which were required to improve the processes. The safety study covered the anti-earthquake performance, fire/explosion prevention, criticality control, containment performance, radioactive waste disposal, and other major safety issues. Other investigations included exposure dose evaluation and accident analysis. Study results were examined on the basis of the Basic Guidelines for Nuclear Fuel Facilities Safety Review and the Uranium Processing Safety Review Guidelines. It was concluded that the modifications would not have adverse effect on the safety of the facilities. (Nogami, K.).

  5. Concerning permission of change in nuclear fuel processing business of Japan Nuclear Fuel Co., Ltd

    International Nuclear Information System (INIS)

    1988-01-01

    In response to an inquiry on the title issue received on Jun. 17, 1988, the Nuclear Safety Commission made a study and submitted the findings to the Prime Minister on Jul. 21, 1988. The study was intended to determine the conformity of the permission to the applicable criteria specified in laws relating to control of nuclear material, nuclear fuel and nuclear reactor. The proposed modification plan included changes in the facilities in the No.1 processing building and changes in processing methods which were required to perform processing of blanket fuel assemblies for fast breeder reactor. It also included changes in the facilities in the No.2 building which were required to improve the processes. The safety study covered the anti-earthquake performance, fire/explosion prevention, criticality control, containment performance, radioactive waste disposal, and other major safety issues. Other investigations included exposure dose evaluation and accident analysis. Study results were examined on the basis of the Basic Guidelines for Nuclear Fuel Facilities Safety Review and the Uranium Processing Safety Review Guidelines. It was concluded that the modifications would not have adverse effect on the safety of the facilities. (Nogami, K.)

  6. Nonclinical safety and pharmacokinetics of Miglyol 812: A medium chain triglyceride in exenatide once weekly suspension.

    Science.gov (United States)

    Buss, Nicholas; Ryan, Patricia; Baughman, Todd; Roy, Denis; Patterson, Claire; Gordon, Carolyn; Dixit, Rakesh

    2018-05-28

    Exenatide, a glucagon-like peptide-1 receptor agonist was originally developed as either a twice daily or once weekly injectable therapeutic for patients with type 2 diabetes. Exenatide QW suspension was developed for use with an autoinjector device, in which the microspheres are suspended in Miglyol 812, a mixture of medium chain triglycerides (MCTs). MCTs are a class of lipids whose fatty acid chains contain from six to 12 carbon atoms (medium chain fatty acids or MCFAs). While MCTs are edible oils present in many foods, including foodstuffs containing coconut and palm kernel oils, limited information is available regarding the oral and subcutaneous bioavailability of MCTs as well as safety following subcutaneous injection. These studies were designed to investigate the non-clinical pharmacokinetics and safety of MCTs. In a single dose pharmacokinetic study, MCFAs were rapidly detected in the plasma of rats following oral administration of either Miglyol 812 or tricaprylin at doses of 10 or 9.48 g kg -1 , respectively. Following subcutaneous dosing with Miglyol 812, MCFAs were rapidly absorbed with a similar profile to that following oral dosing. Furthermore, the toxicity of Miglyol 812 alone was evaluated in a 3 month repeat dose toxicology studies in cynomolgus monkeys. In this study, weekly subcutaneous doses of 0.15 g kg -1 did not elicit any treatment-related effects in cynomolgus monkeys. In conclusion, these studies alongside the available literature data show that Miglyol 812 is a safe excipient for use in subcutaneously administered therapeutics. Copyright © 2018 John Wiley & Sons, Ltd.

  7. Infliximab Dose Reduction Sustains the Clinical Treatment Effect in Active HLAB27 Positive Ankylosing Spondylitis: A Two-Year Pilot Study

    Directory of Open Access Journals (Sweden)

    Boel Mörck

    2013-01-01

    Full Text Available The rationale of the study was to evaluate the efficacy of infliximab (IFX treatment in patients with ankylosing spondylitis (AS and to determine whether IFX dose reduction and interval extension sustains the treatment effect. Nineteen patients were included and treated with IFX 5 mg/kg every 6 weeks for 56 weeks. All patients concomitantly received MTX with median dose 7.5 mg/weekly. During the second year, the IFX dose was reduced to 3 mg/kg every 8 weeks. Eighteen patients completed the 1-year and 15 patients the 2-year trial. The ≥50% improvement at week 16 from baseline of BASDAI was achieved in 16/19 (84% patients. Significant reductions in BASDAI, BASFI, and BASMI scores, decrease in ESR and CRP, and improvement in SF-36 were observed at weeks 16 and 56. The MRI-defined inflammatory changes in the sacroiliac joints disappeared in 10/15 patients (67% already at 16 weeks. IFX treatment effect was sustained throughout the second year after IFX dose reduction and interval extension. We conclude that IFX treatment is effective in well-established active AS and a dose reduction sustains the treatment effect. These observations are of clinical importance and open the opportunity to reduce the drug costs. This trial is registered with ClinicalTrials.gov NCT01850121.

  8. Gut microbiota and tacrolimus dosing in kidney transplantation.

    Directory of Open Access Journals (Sweden)

    John R Lee

    Full Text Available Tacrolimus dosing to establish therapeutic levels in recipients of organ transplants is a challenging task because of much interpatient and intrapatient variability in drug absorption, metabolism, and disposition. In view of the reported impact of gut microbial species on drug metabolism, we investigated the relationship between the gut microbiota and tacrolimus dosing requirements in this pilot study of adult kidney transplant recipients. Serial fecal specimens were collected during the first month of transplantation from 19 kidney transplant recipients who either required a 50% increase from initial tacrolimus dosing during the first month of transplantation (Dose Escalation Group, n=5 or did not require such an increase (Dose Stable Group, n=14. We characterized bacterial composition in the fecal specimens by deep sequencing of the PCR amplified 16S rRNA V4-V5 region and we investigated the hypothesis that gut microbial composition is associated with tacrolimus dosing requirements. Initial tacrolimus dosing was similar in the Dose Escalation Group and in the Stable Group (4.2 ± 1.1 mg/day vs. 3.8 ± 0.8 mg/day, respectively, P=0.61, two-way between-group ANOVA using contrasts but became higher in the Dose Escalation Group than in the Dose Stable Group by the end of the first transplantation month (9.6 ± 2.4 mg/day vs. 3.3 ± 1.5 mg/day, respectively, P<0.001. Our systematic characterization of the gut microbial composition identified that fecal Faecalibacterium prausnitzii abundance in the first week of transplantation was 11.8% in the Dose Escalation Group and 0.8% in the Dose Stable Group (P=0.002, Wilcoxon Rank Sum test, P<0.05 after Benjamini-Hochberg correction for multiple hypotheses. Fecal Faecalibacterium prausnitzii abundance in the first week of transplantation was positively correlated with future tacrolimus dosing at 1 month (R=0.57, P=0.01 and had a coefficient ± standard error of 1.0 ± 0.6 (P=0.08 after multivariable linear

  9. Radiation exposure for 'caregivers' during high-dose outpatient radioiodine therapy

    International Nuclear Information System (INIS)

    Marriott, C. J.; Webber, C. E.; Gulenchyn, K. Y.

    2007-01-01

    On 27 occasions, radiation doses were measured for a family member designated as the 'caregiver' for a patient receiving high-dose radioiodine outpatient therapy for differentiated thyroid carcinoma. For 25 of the administrations, patients received 3.7 GBq of 131 I. Radiation doses for the designated caregivers were monitored on an hourly basis for 1 week using electronic personal dosemeters. The average penetrating dose was 98±64 μSv. The maximum penetrating dose was 283 μSv. Measured dose rate profiles showed that, on average, one-third of the caregiver dose was received during the journey home from hospital. The mean dose rate profile showed rapid clearance of 131 I with three distinct phases. The corresponding clearance half-times were 131 I contaminating the home. (authors)

  10. PROBABILISTIC APPROACH FOR THE DETERMINATION OF CUTS PERMISSIBLE BRAKING MODES ON THE GRAVITY HUMPS

    Directory of Open Access Journals (Sweden)

    Volodymyr BOBROVSKYI

    2016-03-01

    Full Text Available The paper presents the research results of cuts braking modes on the gravity humps. The objective of this paper is developing the methods for assessment of braking modes of cuts under conditions of fuzziness of their rolling properties, as well as selecting the permissible starting speed range of cuts from retardant positions. As a criterion for assessing the modes of target control of cut rolling speed, it was proposed to use an average gap size on a classification track at the established norms of probable exceeding of permissible speed of cars collision and their stop in retarders. As a criterion for evaluating the modes of interval control of cuts rolling speed, using the risk of their non-separation on the switches was proposed. Using the simulation modeling and mathematical statistics, the configuration of the range of permissible speed of cuts coming out from retardant positions has been set. The conducted researches allow simplifying the choice of cut braking modes in systems of automatic control of cut rolling speed.

  11. Effects of multiple low dose radiation on spleen T lymphocyte subgroups in eight-week diabetic rats

    International Nuclear Information System (INIS)

    Guan Feng; Li Yanbo; Zhao Hongguang; Guo Wei; Wang Zhicheng; Gong Shouliang; Guo Caixia

    2008-01-01

    Objective: To explore the changes of spleen lymphocyte subgroups in diabetic rats after multiple low dose radiation (LDR). Methods: The experiment was divided into normal control group, pure diabetes mellitus (DM) group, and DM plus different doses of irradiation groups (the irradiation doses were 0.025, 0.050 and 0.075 Gy, respectively). The diabetic rat model was induced by intraperitoneal injection of streptozotocin. After the diabetic rats were irradiated 15 times, the percentages of spleen CD4 + and CD8 + T cells and ratio of CD4 + /CD8 + T cells were detected with flow cytometry on the fourth weekend. Results: The diabetic rats manifested obvious polydipsia, polyphagia, polyuria and weight loss. On the fourth weekend after irradiation, as compared with normal control group, the percentage of spleen CD4 + T cells increased significantly (P + T cells decreased significantly (P + /CD8 + T cells was increased significantly (P + T cells were declined markedly in both 0.050 and 0.075 Gy plus DM groups (P + T cells increased significantly in LDR plus DM groups (P + /CD8 + T cells was declined obviously (P<0.01). Conclusion: The multiple LDR could regulate the immune function in diabetic rats, and rectificate the immunological imbalance in order to protect body. (authors)

  12. Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine

    Directory of Open Access Journals (Sweden)

    Bianca Scolaro

    2018-05-01

    Full Text Available Objective: Statin intolerance, whether real or perceived, is a growing issue in clinical practice. Our aim was to evaluate the effects of reduced-dose statin therapy complemented with nutraceuticals. Methods: First phase: Initially, 53 type 2 diabetic statin-treated patients received a supplementation with fish oil (1.7 g EPA + DHA/day, chocolate containing plant sterols (2.2 g/day, and green tea (two sachets/day for 6 weeks. Second phase: “Good responders” to supplementation were identified after multivariate analysis (n = 10, and recruited for a pilot protocol of statin dose reduction. “Good responders” were then provided with supplementation for 12 weeks: standard statin therapy was kept during the first 6 weeks and reduced by 50% from weeks 6–12. Results: First phase: After 6 weeks of supplementation, plasma LDL-C (−13.7% ± 3.7, P = .002 and C-reactive protein (−35.5% ± 5.9, P = .03 were reduced. Analysis of lathosterol and campesterol in plasma suggested that intensity of LDL-C reduction was influenced by cholesterol absorption rate rather than its synthesis. Second phase: no difference was observed for plasma lipids, inflammation, cholesterol efflux capacity, or HDL particles after statin dose reduction when compared to standard therapy. Conclusions: Although limited by the small sample size, our study demonstrates the potential for a new therapeutic approach combining lower statin dose and specific dietary compounds. Further studies should elucidate “good responders” profile as a tool for personalized medicine. This may be particularly helpful in the many patients with or at risk for CVD who cannot tolerate high dose statin therapy. Trial registration: ClinicalTrials.gov, NCT02732223. Keywords: Atherosclerosis, Omega-3 fatty acids, Plant sterols, Polyphenols, Responders

  13. In vivo assessment of the tolerance dose of small liver volumes after single-fraction HDR irradiation

    International Nuclear Information System (INIS)

    Ricke, Jens; Seidensticker, Max; Luedemann, Lutz; Pech, Maciej; Wieners, Gero; Hengst, Susanne; Mohnike, Konrad; Cho, Chie Hee; Lopez Haenninen, Enrique; Al-Abadi, Hussain; Felix, Roland; Wust, Peter

    2005-01-01

    Purpose: To prospectively assess a dose-response relationship for small volumes of liver parenchyma after single-fraction irradiation. Methods and Materials: Twenty-five liver metastases were treated by computed tomography (CT)-guided interstitial brachytherapy. Magnetic resonance imaging was performed 1 day before and 3 days and 6, 12, and 24 weeks after therapy. MR sequences included T1-w gradient echo (GRE) enhanced by hepatocyte-targeted gadobenate dimeglumine. All MRI data sets were merged with 3D dosimetry data and evaluated by two radiologists. The reviewers indicated the border of hyperintensity on T2-w images (edema) or hypointensity on T1-w images (loss of hepatocyte function). Based on the total 3D data, a dose-volume histogram was calculated. We estimated the threshold dose for either edema or function loss as the D 90 , i.e., the dose achieved in at least 90% of the pseudolesion volume. Results: Between 3 days and 6 weeks, the extension of the edema increased significantly from the 12.9 Gy isosurface to 9.9 Gy (standard deviation [SD], 3.3 and 2.6). No significant change was detected between 6 and 12 weeks. After 24 weeks, the edematous tissue had shrunk significantly to 14.7 Gy (SD, 4.2). Three days postbrachytherapy, the D 90 for hepatocyte function loss reached the 14.9 Gy isosurface (SD, 3.9). At 6 weeks, the respective zone had increased significantly to 9.9 Gy (SD, 2.3). After 12 and 24 weeks, the dysfunction volume had decreased significantly to the 11.9 Gy and 15.2 Gy isosurface, respectively (SD, 3 and 4.1). Conclusions: The 95% interval from 7.6 to 12.2 Gy found as the minimal hepatocyte tolerance after 6 weeks accounts for the radiobiologic variations found in CT-guided brachytherapy, including heterogeneous dose rates by variable catheter arrays

  14. Low dose diagnostic radiation does not increase cancer risk in cancer prone mice

    Energy Technology Data Exchange (ETDEWEB)

    Boreham, D., E-mail: dboreham@nosm.ca [Northern Ontario School of Medicine, ON (Canada); Phan, N., E-mail: nghiphan13@yahoo.com [Univ. of Ottawa, Ottawa, ON (Canada); Lemon, J., E-mail: lemonja@mcmaster.ca [McMaster Univ., Hamilton, ON (Canada)

    2014-07-01

    The increased exposure of patients to low dose diagnostic ionizing radiation has created concern that these procedures will result in greater risk of carcinogenesis. However, there is substantial evidence that shows in many cases that low dose exposure has the opposite effect. We have investigated whether CT scans can modify mechanisms associated with carcinogenesis in cancer-prone mice. Cancer was induced in Trp53+/- mice with an acute high dose whole-body 4 Gy γ-radiation exposure. Four weeks following the cancer-inducing dose, weekly whole-body CT scans (10 mGy/scan, 75 kVp X-rays) were given for ten consecutive weeks adding an additional radiation burden of 0.1 Gy. Short-term biological responses and subsequent lifetime cancer risk were investigated. Five days following the last CT scan, there were no detectable differences in the spontaneous levels of DNA damage in blood cells (reticulocytes). In fact, CT scanned mice had significantly lower constitutive levels of oxidative DNA damage and cell death (apoptosis), compared to non-CT scanned mice. This shows that multiple low dose radiation exposures modified the radio response and indicates protective processes were induced in mice. In mice treated with the multiple CT scans following the high cancer-inducing 4 Gy dose, tumour latency was increased, significantly prolonging lifespan. We conclude that repeated CT scans can reduce the cancer risk of a prior high-dose radiation exposure, and delay the progression of specific types of radiation-induced cancers in Trp53+/-mice. This research shows for the first time that low dose exposure long after cancer initiation events alter risk and reduce cancer morbidity. Cancer induction following low doses does not follow a linear non-threshold model of risk and this model should not be used to extrapolate risk to humans following low dose exposure to ionizing radiation. (author)

  15. State-of-the-art literature review on permissive/protected left-turn control.

    Science.gov (United States)

    2013-06-01

    In spring 2010, the Illinois Department of Transportation initiated an areawide implementation to integrate the : flashing yellow arrow as the display for the left-turn permissive interval at more than 100 intersections operating : with protected/per...

  16. Maximum permissible concentration of radon {sup 222}Rn in air; La concentration maximale admissible du radon 222 dans l'air

    Energy Technology Data Exchange (ETDEWEB)

    Hamard, J; Beau, P G; Ergas, A [Commissariat a l' Energie Atomique, Fontenay-aux-Roses (France). Centre d' Etudes Nucleaires, departement de la protection sanitaire, service d' hygiene atomique

    1968-09-01

    In order to verify the validity of the values proposed for the maximum permissible concentration of {sup 222}Rn in air, one can either approach the problem: - by epidemiological studies tending to determine the relation dose-effect both quantitatively and qualitatively; - or by choosing a lung model and clearance constants allowing a more accurate determination of the delivered dose and the localisation of the more severely irradiated portions of the bronchial tree. The radon MPC have been calculated using the model and the respiration constants set up by the I.C.R.P. Task Group on Lung dynamics. Two cases have been considered, i.e. when the radon daughter products behave as soluble materials and as insoluble ones. The values which have been found have been compared with those given up to now by several national and international bodies. (authors) [French] Deux voies d'approche peuvent etre empruntees pour verifier la validite des valeurs proposees pour la concentration maximale admissible du radon 222 dans l'air: - etudes epidemiologiques tendant a preciser qualitativement et quantitativement la relation dose-effet; - choix d'un modele pulmonaire et de constantes d'epuration permettant une determination plus precise de la dose delivree et la localisation des segments de l'arbre pulmonaire les plus irradies. Les auteurs ont utilise pour le calcul de la CMA du radon le modele et les constantes respiratoires proposees par le Task Group on Lungs dynamics de la C.I.P.R. On a pris en consideration le cas ou les descendants du radon se comportent comme des substances solubles et celui ou ils se comportent comme des substances insolubles. Les valeurs trouvees sont comparees a celles proposees jusqu'alors par divers organismes nationaux et internationaux. (auteurs)

  17. The Study of External Radiation Dose for Radiation Worker at PRSG-BATAN Serpong

    International Nuclear Information System (INIS)

    Sunarningsih; Mashudi; A Lilik W; Yosep S

    2012-01-01

    The study of External radiation dose for radiation worker at PRSG-BATAN Serpong has been carried out. The sample is taken from the System Reactor division (BSR), Operation Reactor division, (BOR) Safety division UPN, UJM and head of PRSG by setting Thermoluminescence Dosemeter (TLD) on the chest, then is detected by a tool TLD reader model 6600. The aim of this study is to evaluate the occupational exposure dose that has been accepted by the radiation worker for the last five years. The result in average doses at BSR is 0,99 mSv, BOR is 3,27 mSv, at BK is 0,69 mSv and UPN + UJM + head of PRSG is 0,03 mSv. The result highest doses at BSR is 6,58 mSv, BOR is 28,94 mSv, BK is 4,24 mSv, and UPN UJM Head of PRSG is 0,52 mSv. Dose interval radiation worker at PRSG BATAN ttd - 28,98 mSv. To overall the external personal dose acceptant for radiation worker at PRSG BATAN one below maximum permissible dose acceptant that allowed by BAPETEN, that is 20 mSv in average every year during five years. (author)

  18. Small dose multi-fractionation therapy, its radiobiological aspects and clinics

    International Nuclear Information System (INIS)

    Iwai, Hiroshi; Katagiri, Shiro; Furuhata, Akihiko; Fukusi, Itsuhisa

    1979-01-01

    Recent radiobiological data reveal that cell killings by small dose fractionation are almost due to nonrepairable damage with low oxygen enhancement ratio. Then, Small dose multi-fractionation method suggests a higher therapeutic-ratio than that in conventional high dose fractionated irradiation. Using these data of radiobiology, intermittent irradiations three times a day, four hours interval, with 60 - 80 rads for multi-fractionation, with high total doses of 7,200 - 7,500 rads/6.5 - 7 weeks mainly on bladder, laryngeal and esophageal tumour are applied. The results obtained are slightly improved. (author)

  19. Absorbed dose to mice in prolonged irradiation by low-dose rate ionizing radiation

    Energy Technology Data Exchange (ETDEWEB)

    Shiragai, Akihiro [National Inst. of Radiological Sciences, Chiba (Japan); Saitou, Mikio; Kudo, Iwao [and others

    2000-07-01

    In this paper, the dose absorbed by mice was evaluated as a preliminary study of the late effects of prolonged continuous irradiation of mice with low-dose rate ionizing radiation. Eight-week-old male and female SPF C3H/HeN mice in three irradiation rooms were exposed to irradiation at 8000, 400, and 20 mGy, respectively, using a {sup 137}Cs {gamma}-source. Nine racks were arranged in a circle approximately 2.5 m from the source in each room, and 10 cages were arranged on the 4 shelves of each rack. Dose distributions, such as in air at the source level, in the three rooms were estimated by using ionization chambers, and the absorbed dose distributions in the room and relative dose distributions in the cages in relation to the distance of the cage center were examined. The mean abdomen doses of the mice measured by TLD were compared with the absorbed doses in the cages. The absorbed dose distributions showed not only inverse-inverse-square-law behavior with distance from the source, but geometric symmetry in every room. The inherent scattering and absorption in each room are responsible for such behavior and asymmetry. Comparison of relative dose distributions revealed cage positions that are not suitable for experiments with high precision doses, but all positions can be used for prolonged continuous irradiation experiments if the position of the cages is rotated regularly. The mean abdomen doses of the mice were similar in each cage. The mean abdomen doses of the mice and the absorbed doses in a cage were almost the same in all cages. Except for errors concerning the positions of the racks and cages, the uncertainties in the exposure doses were estimated to be about {+-}12% for 8000 mGy group, 17% for 400 mGy group, and 35% for 20 mGy group. (K.H.)

  20. 29 CFR 3.5 - Payroll deductions permissible without application to or approval of the Secretary of Labor.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true Payroll deductions permissible without application to or approval of the Secretary of Labor. 3.5 Section 3.5 Labor Office of the Secretary of Labor CONTRACTORS AND... STATES § 3.5 Payroll deductions permissible without application to or approval of the Secretary of Labor...

  1. Weekly working hours for Norwegian hospital doctors since 1994 with special attention to postgraduate training, work-home balance and the European working time directive: a panel study.

    Science.gov (United States)

    Rosta, Judith; Aasland, Olaf G

    2014-10-13

    To examine the weekly working hours of Norwegian hospital doctors from 1994 to 2012 with special emphasis on the quality of postgraduate training and work-home balance, and in relation to the requirements of the European Working Time Directive (EWTD). Panel study based on postal questionnaires. Norway. Unbalanced cohort of 1300-1600 doctors in 1994, 1995, 1996, 1997, 2000, 2002, 2004, 2006, 2008, 2010 and 2012. Self-reported total weekly working hours and whether 45 weekly working hours are too short, sufficient, or too long to meet the quality requirements of obligatory postgraduate training for junior doctors. From 1994 to 2012, the number of weekly working hours was stable for senior (46-47 h) and junior (45-46 h) hospital doctors. In 2012, significantly more senior (27-35%) than junior (11-20%) doctors reported suboptimal work-home balance, defined as working more than 48 h a week. The majority perceived the present situation with an average of 45 h per week for juniors as sufficient for obligatory postgraduate specialist training, but doctors of higher age (OR 1.04, 95% CI 1.01 to 1.08), senior doctors (1.07, 1.04 to 1.11) and doctors working in surgical specialties (OR 1 vs laboratory medicine 0.03, 0.01 to 0.25, internal medicine 0.31, 0.17 to 0.58, psychiatry 0.12, 0.04 to 0.36, paediatrics 0.36, 0.12 to 1.07, anaesthesiology 0.08, 0.02 to 0.39, gynaecology 0.07, 0.01 to 0.56 and others 0.39, 0.04 to 3.56) were more likely to want the work-week to be longer. The weekly working hours of Norwegian hospital doctors were always below the EWTD requirements. A significant growth of hospital doctor density over the past two decades, national regulations and cultural values might be important factors. Specialty differences in perception of sufficient training time may call for more flexibility in working time regulations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Procedures for permission of installation of nuclear power stations

    International Nuclear Information System (INIS)

    Narita, Yoriaki

    1980-01-01

    The locations of atomic power stations are first selected by electric power enterprises in consultation with the Ministry of International Trade and Industry or under the guidance of authorities concerned. The surveys of the climate, topography, water and plants in the planned sites and the influences of nuclear power generation to the surrounding areas are made by the enterprisers under the administrative guidance of the MITI. Secondly, the basic project shall be submitted to and decided by the Power Resource Development Council headed by the Prime Minister (Article 10, the Power Resource Development Law). The Council shall, if necessary, call for the attendance of the governors of prefectures concerned and hear their opinions (Article 11, the Law). As the third and most complicated phase, various procedures include; (a) permission of the changes of electrical facilities under the Electricity Enterprises Act; (b) authorization of the installation of reactors under the Nuclear Reactor Regulation Law; (c) permission or authorization under other regulations including the Agricultural Land Act, etc.; (d) additional procedures related to the indemnification to fishery and so forth. Finally the reactors are to be operated after receiving the certificates of the Minister of ITI on the inspections of construction works, nuclear fuel materials used for the reactors and welding processes of reactor containment vessels, boilers, turbines, etc. (Okada, K.)

  3. High dose rate versus medium dose rate intraluminal brachytherapy in inoperable esophageal carcinoma

    International Nuclear Information System (INIS)

    Langendijk, J.; Jager, J.; Jong, J. de; Rijken, J.; Pannebakker, M.

    1996-01-01

    Introduction: The purpose of this study was to compare the results of medium dose rate (MDR) intraluminal brachytherapy (ILBT) and high dose rate (HDR) ILBT in patients with inoperable esophageal carcinoma, with regard to dysphagia, complication rate and survival. Material and methods: Included were 114 patients with inoperable esophageal cancer who were treated with a single session of ILBT. In all cases a single dose of 15 Gy was administered, calculated at a 1 cm radius. Forty-eight patients were treated with MDR ( 137 Cs)ILBT. In June 1990 MDR was replaced by HDR and from then 66 patients were treated with HDR ( 192 Ir). Dysphagia was prospectively scored using a 5-point scale at 6 weeks, 3, 6, 9 and 12 months. Results: No significant differences were noted between the two groups with regard to pretreatment variables. In patients treated with MDR-ILBT improvement of swallowing ability was noted in 30 out of 42 evaluable patients (71%), no change in 9 (21%) and progression of dysphagia in 3 patients (8%), as compared to 34 out of 59 evaluable patients (58%), 16 (27%) and 6 (15%) resp. in de HDR-ILBT group. In the latter category, progression of dysphagia was caused by fistulae in 2 patients. The differences were not significant (ns). Additional treatment in case of recurrent or persistent dysphagia was needed in 50% of the cases in the MDR-ILBT group as compared to 41% in the HDR-ILBT group (ns). The median survival of the MDR-ILBT group was 3.9 months as compared to 4.3 months in the HDR-ILBT group (ns). In 2 patients (4%) treated with MDR-ILBT bronchio-oesphageal fistulae developed at 6 weeks and 2 months. In the HDR-ILBT group fistulae were noted in 7 cases (11%) at 2 weeks, 4 weeks, 2, 3, 3, 4 and 9 months (ns). In all of these cases persistent of recurrent tumour was present. Conclusions: No significant differences were noted with regard to palliation of dysphagia, survival and complication rate between MDR-ILBT and HDR-ILBT in the management of esophageal

  4. 77 FR 17367 - Permissible Sharing of Client Records by Customs Brokers

    Science.gov (United States)

    2012-03-26

    ...-0038] RIN 1651-AA80 Permissible Sharing of Client Records by Customs Brokers AGENCY: U.S. Customs and... would allow brokers, upon the client's consent in a written authorization, to share client information... services to the broker's clients. Although the proposed rule was prepared in response to a request from a...

  5. A cash flow oriented EOQ model under permissible delay in payments

    African Journals Online (AJOL)

    A cash flow oriented EOQ model under permissible delay in payments. RP Tripathi, SS Misra, HS Shukla. Abstract. This study presents an inventory model to determine an optimal ordering policy for non-deteriorating items and timedependent demand rate with delay in payments permitted by the supplier under inflation and ...

  6. Estimating permissible /sup 129/I-emission rates

    Energy Technology Data Exchange (ETDEWEB)

    Huebschmann, W G

    1976-06-01

    A mathematical method of iodine release limitation is presented which, in assessing the radiological effectiveness of /sup 129/I, takes advantage of the fact that the chemical behaviour of /sup 129/I resembles that of /sup 131/I and relies on the already extensive knowledge of the chemical and biological behaviour of /sup 131/I. If this method is used for calculating permissible /sup 129/I emission rates it is stated that no unnecessary restrictions need be imposed on a fuel reprocessing plant and that the grazing season for the pasture-cow-milk pathway can be taken into account. The concept is currently in use at the Karlsruhe Nuclear Research Center and seems to be appropriate for licensing of nuclear fuel reprocessing plants.

  7. Optimal timing and frequency of bone marrow soup therapy for functional restoration of salivary glands injured by single-dose or fractionated irradiation.

    Science.gov (United States)

    Fang, Dongdong; Shang, Sixia; Liu, Younan; Bakkar, Mohammed; Sumita, Yoshinori; Seuntjens, Jan; Tran, Simon D

    2018-02-01

    Injections of bone marrow (BM) cell extract, known as 'BM soup', were previously reported to mitigate ionizing radiation (IR) injury to salivary glands (SGs). However, the optimal starting time and frequency to maintain BM soup therapeutic efficacy remains unknown. This study tested the optimal starting time and frequency of BM soup injections in mice radiated with either a single dose or a fractionated dose. First, BM soup treatment was started at 1, 3 or 7 weeks post-IR; positive (non-IR) and negative (IR) control mice received injections of saline (vehicle control). Second, BM soup-treated mice received injections at different frequencies (1, 2, 3 and 5 weekly injections). Third, a 'fractionated-dose radiation' model to injure mouse SGs was developed (5 Gy × 5 days) and compared with the single high dose radiation model. All mice (n = 65) were followed for 16 weeks post-IR. The results showed that starting injections of BM soup between 1 and 3 weeks mitigated the effect of IR-induced injury to SGs and improved the restoration of salivary function. Although the therapeutic effect of BM soup lessens after 8 weeks, it can be sustained by increasing the frequency of weekly injections. Moreover, both single-dose and fractionated-dose radiation models are efficient and comparable in inducing SG injury and BM soup treatments are effective in restoring salivary function in both radiation models. In conclusion, starting injections of BM soup within 3 weeks post-radiation, with 5 weekly injections, maintains 90-100% of saliva flow in radiated mice. Copyright © 2017 John Wiley & Sons, Ltd.

  8. The calculation of maximum permissible exposure levels for laser radiation

    International Nuclear Information System (INIS)

    Tozer, B.A.

    1979-01-01

    The maximum permissible exposure data of the revised standard BS 4803 are presented as a set of decision charts which ensure that the user automatically takes into account such details as pulse length and pulse pattern, limiting angular subtense, combinations of multiple wavelength and/or multiple pulse lengths, etc. The two decision charts given are for the calculation of radiation hazards to skin and eye respectively. (author)

  9. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  10. Efficacy of an Eight Week Trial of Imipramine and Citalopram in Patients with Mixed Anxiety-Depressive Disorder

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Abbasi-Asl

    2008-12-01

    Full Text Available "n "nObjective: Mixed anxiety-depressive disorder (MADD is a condition in which patients have both anxiety and depressive symptoms but do not meet the diagnostic criteria for either an anxiety disorder or a mood disorder. "nThe aim of this study was to compare the efficacy of imipramine and citalopram in the treatment of MADD. "n "nMethods: Fifty one outpatients aged 18 to 55 who were diagnosed with MADD were randomly assigned to receive citalopram or imipramine for 8 weeks. Patients were assessed using Hamilton Depression Rating Scale (HDRS and Hamilton Anxiety Rating Scale (HARS at baseline, weeks 4 and "n8 of the study. The mean differences in Hamilton scores from the baseline  were used as the main outcome measures of response to treatment. "n "nResults: Thirty six patients completed the study. Patients in the citalopram group (n=20 received a mean dosage of 22 mg per day during the first 4 weeks and a mean dosage of 33 mg per day during weeks 4 to 8. Subjects in the Imipramine group (n= 16 received a mean dosage of 77 mg per day during the first 4 weeks and a mean dosage of 89 mg per day during weeks 4 "nto 8. It was noted that the both treatments were effective on depression and anxiety at the end of the fourth and eighth weeks. However, the mean differences of HDRS and HARS scores between citalopram and imipramine groups were not significantly different at the end of weeks 4 and 8. "n "nConclusion: The results of this study suggest that the efficacy of regular doses of citalopram is comparable with lower range of therapeutic doses of imipramine in the treatment of MADD. A more comprehensive study is warranted to confirm the results of this study.

  11. TFH cells accumulate in mucosal tissues of humanized-DRAG mice and are highly permissive to HIV-1

    Science.gov (United States)

    Allam, Atef; Majji, Sai; Peachman, Kristina; Jagodzinski, Linda; Kim, Jiae; Ratto-Kim, Silvia; Wijayalath, Wathsala; Merbah, Melanie; Kim, Jerome H.; Michael, Nelson L.; Alving, Carl R.; Casares, Sofia; Rao, Mangala

    2015-01-01

    CD4+ T follicular helper cells (TFH) in germinal centers are required for maturation of B-cells. While the role of TFH-cells has been studied in blood and lymph nodes of HIV-1 infected individuals, its role in the mucosal tissues has not been investigated. We show that the gut and female reproductive tract (FRT) of humanized DRAG mice have a high level of human lymphocytes and a high frequency of TFH (CXCR5+PD-1++) and precursor-TFH (CXCR5+PD-1+) cells. The majority of TFH-cells expressed CCR5 and CXCR3 and are the most permissive to HIV-1 infection. A single low-dose intravaginal HIV-1 challenge of humanized DRAG mice results in 100% infectivity with accumulation of TFH-cells mainly in the Peyer’s patches and FRT. The novel finding of TFH-cells in the FRT may contribute to the high susceptibility of DRAG mice to HIV-1 infection. This mouse model thus provides new opportunities to study TFH-cells and to evaluate HIV-1 vaccines. PMID:26034905

  12. Safety and efficacy of fixed-dose 10 mg daily isotretinoin treatment for acne vulgaris in Malaysia.

    Science.gov (United States)

    Yap, Felix Boon-Bin

    2017-09-01

    Low-dose isotretinoin is used to reduce side effects albeit higher relapse. This study aimed to determine the efficacy and safety of fixed-dose 10 mg daily isotretinoin for the treatment of acne. This prospective study was performed between 2011 and 2015. All 150 patients were given 10 mg daily isotretinoin until a cumulative dose of 90-110 mg/kg. The mean age was 26.6 years with 64.7% moderate acne, 29.3% severe, and 6% very severe. The mean cumulative dose was 98.8 ± 6.05 mg/kg. All 150 patients had total clearance with a mean time to clearance of 24.0 weeks. Patients with severe/very severe acne had higher cumulative dosage (102.1 vs. 97.0, P < 0.001) and longer duration to clearance (32.9 weeks vs. 19.1 weeks, P < 0.001). Mild relapse was seen in 4%. The mean time to relapse was 32.3 weeks. Lip dryness was the commonest side effects (100%). Mild transient elevation of liver enzymes was detected in 3.3% and a slight increase of serum lipid in 2.7% with no treatment discontinuation. Fixed-dose 10 mg daily treatment with isotretinoin until a cumulative dose of 90-110 mg/kg is safe with low relapse rate. © 2016 Wiley Periodicals, Inc.

  13. Single i.v. ketamine augmentation of newly initiated escitalopram for major depression: results from a randomized, placebo-controlled 4-week study.

    Science.gov (United States)

    Hu, Y-D; Xiang, Y-T; Fang, J-X; Zu, S; Sha, S; Shi, H; Ungvari, G S; Correll, C U; Chiu, H F K; Xue, Y; Tian, T-F; Wu, A-S; Ma, X; Wang, G

    2016-02-01

    While oral antidepressants reach efficacy after weeks, single-dose intravenous (i.v.) ketamine has rapid, yet time-limited antidepressant effects. We aimed to determine the efficacy and safety of single-dose i.v. ketamine augmentation of escitalopram in major depressive disorder (MDD). Thirty outpatients with severe MDD (17-item Hamilton Rating Scale for Depression total score ⩾ 24) were randomized to 4 weeks double-blind treatment with escitalopram 10 mg/day+single-dose i.v. ketamine (0.5 mg/kg over 40 min) or escitalopram 10 mg/day + placebo (0.9% i.v. saline). Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR). Suicidal ideation was evaluated with the QIDS-SR item 12. Adverse psychopathological effects were measured with the Brief Psychiatric Rating Scale (BPRS)-positive symptoms, Young Mania Rating Scale (YMRS) and Clinician Administered Dissociative States Scale (CADSS). Patients were assessed at baseline, 1, 2, 4, 24 and 72 h and 7, 14, 21 and 28 days. Time to response (⩾ 50% MADRS score reduction) was the primary outcome. By 4 weeks, more escitalopram + ketamine-treated than escitalopram + placebo-treated patients responded (92.3% v. 57.1%, p = 0.04) and remitted (76.9% v. 14.3%, p = 0.001), with significantly shorter time to response [hazard ratio (HR) 0.04, 95% confidence interval (CI) 0.01-0.22, p escitalopram + placebo, escitalopram + ketamine was associated with significantly lower MADRS scores from 2 h to 2 weeks [(peak = 3 days-2 weeks; effect size (ES) = 1.08-1.18)], QIDS-SR scores from 2 h to 2 weeks (maximum ES = 1.27), and QIDS-SR suicidality from 2 to 72 h (maximum ES = 2.24). Only YMRS scores increased significantly with ketamine augmentation (1 and 2 h), without significant BPRS or CADSS elevation. Single-dose i.v. ketamine augmentation of escitalopram was safe and effective in severe MDD, holding promise for speeding up

  14. Incorporating detrital conditioning in outdoor microcosms dosed with JP-8 jet fuel

    International Nuclear Information System (INIS)

    Matthews, R.A.; Markiewicz, A.; Harter, V.; Landis, W.G.

    1995-01-01

    The authors have developed an outdoor microcosm system that incorporates detrital conditioning to test the hypothesis that microbiota play a critical role in altering the community response to hydrocarbon toxicants. The microcosms were constructed using 568 L tanks, arranged in 6 units of 4 tanks, with each unit equidistant from a central conditions tank (CT). During pre-treatment, the microcosms and CT were filled with nutrient-amended well water, artificial sediment, leaf packs containing dried maple leaves, elodea fragment, and unglazed tiles for periphyton growth. Water circulation was maintained at the rate of 24 exchanges per day. After four weeks, invertebrates from local ponds were added to the CT. Leafpacks were added to the CT and microcosms every two weeks; eight week old packs were discarded after returning invertebrates to the CT. On a weekly basis, 25% of the sediments, leaf packs, tiles, and elodea from each microcosms were transferred to another microcosm; the CT walls and tiles were scraped; an the water quality was monitored. Circulation was discontinued one week prior to dosing. On 4/12/96, the microcosms were dosed to contain 0--0.25 microg/L of JP-8 jet fuel. Within two weeks the GC/MS hydrocarbon concentrations were very low in the water column of the highest treatment group. There has been little acute toxicity, despite selecting doses that caused severe, acute toxicity in laboratory microcosm studies. The presence of a complex, detritus-based microbial community appears to mitigate the influences of the toxicant on the microcosms

  15. Phase i study of 'dose-dense' pemetrexed plus carboplatin/radiotherapy for locally advanced non-small cell lung carcinoma

    Directory of Open Access Journals (Sweden)

    Treat Joseph

    2011-02-01

    Full Text Available Abstract Background This phase I study investigates the feasibility of carboplatin plus dose-dense (q2-week pemetrexed given concurrently with radiotherapy (XRT for locally advanced and oligometastatic non-small cell lung cancer (NSCLC. Methods Eligible patients had Stage III or IV (oligometastatic NSCLC. Patients received XRT to 63 Gy in standard fractionation. Patients received concurrent carboplatin (AUC = 6 during weeks 1 and 5 of XRT, and pemetrexed during weeks 1, 3, 5, and 7 of XRT. The starting dose level (level 1 of pemetrexed was 300 mg/m2. Following the finding of dose limiting toxicity (DLT in dose level 1, an amended dose level (level 1A continued pemetrexed at 300 mg/m2, but with involved field radiation instead of extended nodal irradiation. Consolidation consisted of carboplatin (AUC = 6 and pemetrexed (500 mg/m2 q3 weeks × 2 -3 cycles. Results Eighteen patients were enrolled. Fourteen patients are evaluable for toxicity analysis. Of the initial 6 patients treated on dose level 1, two experienced DLTs (one grade 4 sepsis, one prolonged grade 3 esophagitis. There was one DLT (grade 5 pneumonitis in the 8 patients treated on dose level 1A. In 16 patients evaluable for response (4 with oligometastatic stage IV disease and 12 with stage III disease, the median follow-up time is 17.8 months. Thirteen of 16 patients had in field local regional response. The actuarial median survival time was 28.6 months in all patients and 34.7 months (estimated in stage III patients. Conclusions Concurrent carboplatin with dose-dense (q2week pemetrexed at 300 mg/m2 with involved field XRT is feasible and encouraging in patients with locally advanced and oligometastatic NSCLC. Trial Registration ClinicalTrials.gov NCT00330044

  16. Vaccination of piglets up to 1 week of age with a single-dose Mycoplasma hyopneumoniae vaccine induces protective immunity within 2 weeks against virulent challenge in the presence of maternally derived antibodies.

    Science.gov (United States)

    Wilson, Stephen; Van Brussel, Leen; Saunders, Gillian; Runnels, Paul; Taylor, Lucas; Fredrickson, Dan; Salt, Jeremy

    2013-05-01

    Enzootic pneumonia, resulting from infection with Mycoplasma hyopneumoniae, is of considerable economic importance to the pig industry and normally is controlled through active vaccination of piglets. We have demonstrated that administration of an inactivated Mycoplasma hyopneumoniae vaccine to piglets less than 1 week old is efficacious under field conditions and reduces the level of lung lesions observed in comparison to that in control pigs. Here, the results of two separate studies, one in piglets with and the second one in piglets without maternal antibodies, conducted to satisfy the requirements of the European Pharmacopoeia (monograph no. 07/2009:2448), are reported. Piglets received either minimal titer Suvaxyn MH-One or saline at less than 1 week of age and were challenged with Mycoplasma hyopneumoniae 2 weeks later. The number of lung lesions was recorded 4 weeks after challenge, and bronchial swab and lung tissue specimens were analyzed for quantification of Mycoplasma hyopneumoniae DNA. In the presence and absence of maternal antibodies, vaccination of piglets at less than 1 week of age was efficacious, with vaccinated piglets having significantly lower percentages of lung with lesions and lower Mycoplasma hyopneumoniae counts detected in bronchial swab and lung tissue specimens at necropsy. In conclusion, the vaccination of piglets at 1 week of age with Suvaxyn MH-One is efficacious in the presence of high levels of maternal antibodies.

  17. An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients

    Directory of Open Access Journals (Sweden)

    Besarab Anatole

    2012-08-01

    Full Text Available Abstract Background Peginesatide is a peptide-based erythropoiesis-stimulating agent that was designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. The primary objective of this phase 2 dose-finding study was to determine the once-monthly peginesatide dosing strategy that would maintain hemoglobin within ±1.0 g/dL of baseline values after conversion from epoetin alfa; the safety of peginesatide was evaluated concurrently. Methods Chronic hemodialysis patients on stable regimens of epoetin alfa were sequentially assigned to cohorts that differed on (1 how the peginesatide starting dose was determined (using a single epoetin alfa–to-peginesatide dose conversion ratio or a tiered, weight-based or absolute-dose conversion table and on (2 whether or not a 1-week erythropoiesis-stimulating agent-free interval was used. Peginesatide doses were titrated to maintain hemoglobin levels within ±1.0 g/dL from baseline. Results A total of 164 patients were enrolled and received intravenous peginesatide every 4 weeks for up to 6 doses; the duration of the study including follow-up was ≤29 weeks. Overall, the proportion of patients with hemoglobin levels within ±1.0 g/dL of baseline increased over the course of the study from 39% (Weeks 2–13 to 54% (Weeks 18–25. Cohorts that used tiered dose conversion tables trended towards having more stable peginesatide doses than did those cohorts that used a single dose conversion ratio. Moreover, cohorts that used an erythropoiesis-stimulating agent-free interval did not have the substantial initial increase in hemoglobin levels that was seen in those cohorts that did not use such an interval. In this study, the safety profile of peginesatide was consistent with those of marketed erythropoiesis-stimulating agents. Conclusions The results of this study were used to guide the dosing regimens used subsequently in phase 3 studies. Once

  18. Dose escalation using conformal high-dose-rate brachytherapy improves outcome in unfavorable prostate cancer.

    Science.gov (United States)

    Martinez, Alvaro A; Gustafson, Gary; Gonzalez, José; Armour, Elwood; Mitchell, Chris; Edmundson, Gregory; Spencer, William; Stromberg, Jannifer; Huang, Raywin; Vicini, Frank

    2002-06-01

    To overcome radioresistance for patients with unfavorable prostate cancer, a prospective trial of pelvic external beam irradiation (EBRT) interdigitated with dose-escalating conformal high-dose-rate (HDR) prostate brachytherapy was performed. Between November 1991 and August 2000, 207 patients were treated with 46 Gy pelvic EBRT and increasing HDR brachytherapy boost doses (5.50-11.5 Gy/fraction) during 5 weeks. The eligibility criteria were pretreatment prostate-specific antigen level >or=10.0 ng/mL, Gleason score >or=7, or clinical Stage T2b or higher. Patients were divided into 2 dose levels, low-dose biologically effective dose 93 Gy (149 patients). No patient received hormones. We used the American Society for Therapeutic Radiology and Oncology definition for biochemical failure. The median age was 69 years. The mean follow-up for the group was 4.4 years, and for the low and high-dose levels, it was 7.0 and 3.4 years, respectively. The actuarial 5-year biochemical control rate was 74%, and the overall, cause-specific, and disease-free survival rate was 92%, 98%, and 68%, respectively. The 5-year biochemical control rate for the low-dose group was 52%; the rate for the high-dose group was 87% (p failure. The Radiation Therapy Oncology Group Grade 3 gastrointestinal/genitourinary complications ranged from 0.5% to 9%. The actuarial 5-year impotency rate was 51%. Pelvic EBRT interdigitated with transrectal ultrasound-guided real-time conformal HDR prostate brachytherapy boost is both a precise dose delivery system and a very effective treatment for unfavorable prostate cancer. We demonstrated an incremental beneficial effect on biochemical control and cause-specific survival with higher doses. These results, coupled with the low risk of complications, the advantage of not being radioactive after implantation, and the real-time interactive planning, define a new standard for treatment.

  19. Maternal methadone dosing schedule and fetal neurobehavior

    Science.gov (United States)

    Jansson, Lauren M.; DiPietro, Janet A.; Velez, Martha; Elko, Andrea; Knauer, Heather; Kivlighan, Katie T.

    2008-01-01

    Objective Daily methadone maintenance is the standard of care for opiate dependency during pregnancy. Previous research has indicated that single-dose maternal methadone administration significantly suppresses fetal neurobehaviors. The purpose of this study was to determine if split-dosing would have less impact on fetal neurobehavior than single-dose administration. Methods Forty methadone-maintained women were evaluated at peak and trough maternal methadone levels on single- and split-dosing schedules. Monitoring sessions occurred at 36 and 37 weeks gestation in a counterbalanced study design. Fetal measures included heart rate, variability, accelerations, motor activity and fetal movement-heart rate coupling (FM-FHR). Maternal measures included heart period, variability, skin conductance, respiration and vagal tone. Repeated measure analysis of variance was used to evaluate within-subject changes between split- and single-dosing regimens. Results All fetal neurobehavioral parameters were suppressed by maternal methadone administration, regardless of dosing regimen. Fetal parameters at peak were significantly lower during single vs. split methadone administration. FM-FHR coupling was less suppressed from trough to peak during split-dosing vs. single-dosing. Maternal physiologic parameters were generally unaffected by dosing condition. Conclusion Split- dosed fetuses displayed less neurobehavioral suppression from trough to peak maternal methadone levels as compared to single-dosed fetuses. Split-dosing may be beneficial for methadone-maintained pregnant women. PMID:19085624

  20. Combination With Low-dose Dextromethorphan Improves the Effect of Amlodipine Monotherapy in Clinical Hypertension

    Science.gov (United States)

    Yin, Wei-Hsian; Chen, Pei; Yeh, Hung-I; Wang, Kuo-Yang; Hung, Yi-Jen; Tseng, Wei-Kung; Wen, Ming-Shien; Wu, Tao-Cheng; Wu, Chau-Chung; Cheng, Shu-Meng; Chen, Jaw-Wen

    2016-01-01

    Abstract The combination of low rather than high dose of dextromethorphan (DXM) with amlodipine (AM) could improve blood pressure (BP) reduction in hypertensive animals. The study aimed to evaluate the feasibility of different doses of DXM combined with standard AM treatment in clinical hypertension. This was a prospective, 14-week, dose-escalation, multicenter study. After 2-week run-in period with AM 5 mg/day, hypertensive patients who got the BP goal of 140/90 mmHg kept receiving AM monotherapy for another 12 weeks. The nonresponders, while kept on AM 5 mg/day, received additional DXM treatment for 3 sequential dose-titrated periods with initially 2.5 mg/day, followed by 7.5 mg/day, and finally 30 mg/day. Each period was for 4 weeks. The patients at BP goal after each treatment period were defined as the responders and kept on the same combination till the end of the study. The responder rate of each treatment period was recorded. The changes of BP and serum antioxidant/endothelial markers between week 14 and week 2 were evaluated. Of the 103 patients initially enrolled, 89 entered the treatment period. In the 78 patients completing the study, 31 (40%) at BP goal after 2-week AM run-in kept on AM monotherapy (DXM0). The addition of 2.5 (DXM2.5) and 7.5 mg/day (DXM7.5) of DXM enabled BP goal achievement in 22 (47%) nonresponders to AM monotherapy including 16 (29%) with DXM2.5 and 6 (18%) with DXM7.5. Only 4 patients (16%) reached BP goal with the combination of DXM 30 mg/day (DXM30). Overall, 73% of the 78 patients reached BP goal at the end of the 14-week study. Mean systolic BP was reduced by 7.9% ± 7.0% with DXM2.5 (P < 0.001) and by 5.4% ± 2.4% with DXM7.5 (P = 0.003) respectively at week 14 from that at week 2, which was unchanged in either DXM0 or DXM30 group. Besides, the effects of combination treatment were particularly significant in the patients with impaired endothelial function suggested by reduced serum NOx level

  1. Account of low temperature hardening in calculation of permissible stresses

    International Nuclear Information System (INIS)

    Novikov, N.V.; Ul'yanenko, A.P.; Gorodyskij, N.I.

    1980-01-01

    Suggested is a calculation scheme of permissible stresses with the account of temperature hardening for steels and alloys, the dependences of strength, plasticity and rupture work of which on cooling temperature do not have threshold changes in a wide range of low temperatures (from 300 to 4.2 K). Application of the suggested scheme is considered on the example of 12Kh18N10T austenitic chromium-nickel steel

  2. Mycobacteria exploit nitric oxide-induced transformation of macrophages into permissive giant cells.

    Science.gov (United States)

    Gharun, Kourosh; Senges, Julia; Seidl, Maximilian; Lösslein, Anne; Kolter, Julia; Lohrmann, Florens; Fliegauf, Manfred; Elgizouli, Magdeldin; Vavra, Martina; Schachtrup, Kristina; Illert, Anna L; Gilleron, Martine; Kirschning, Carsten J; Triantafyllopoulou, Antigoni; Henneke, Philipp

    2017-12-01

    Immunity to mycobacteria involves the formation of granulomas, characterized by a unique macrophage (MΦ) species, so-called multinucleated giant cells (MGC). It remains unresolved whether MGC are beneficial to the host, that is, by prevention of bacterial spread, or whether they promote mycobacterial persistence. Here, we show that the prototypical antimycobacterial molecule nitric oxide (NO), which is produced by MGC in excessive amounts, is a double-edged sword. Next to its antibacterial capacity, NO propagates the transformation of MΦ into MGC, which are relatively permissive for mycobacterial persistence. The mechanism underlying MGC formation involves NO-induced DNA damage and impairment of p53 function. Moreover, MGC have an unsurpassed potential to engulf mycobacteria-infected apoptotic cells, which adds a further burden to their antimycobacterial capacity. Accordingly, mycobacteria take paradoxical advantage of antimicrobial cellular efforts by driving effector MΦ into a permissive MGC state. © 2017 The Authors.

  3. A long-acting integrase inhibitor protects female macaques from repeated high-dose intravaginal SHIV challenge.

    Science.gov (United States)

    Andrews, Chasity D; Yueh, Yun Lan; Spreen, William R; St Bernard, Leslie; Boente-Carrera, Mar; Rodriguez, Kristina; Gettie, Agegnehu; Russell-Lodrigue, Kasi; Blanchard, James; Ford, Susan; Mohri, Hiroshi; Cheng-Mayer, Cecilia; Hong, Zhi; Ho, David D; Markowitz, Martin

    2015-01-14

    Long-acting GSK1265744 (GSK744 LA) is a strand transfer inhibitor of the HIV/SIV (simian immunodeficiency virus) integrase and was shown to be an effective preexposure prophylaxis (PrEP) agent in a low-dose intrarectal SHIV (simian-human immunodeficiency virus) rhesus macaque challenge model. We examined the pharmacokinetics and efficacy of GSK744 LA as PrEP against repeat high-dose intravaginal SHIV challenge in female rhesus macaques treated with Depo-Provera (depot medroxyprogesterone acetate), which promotes viral transmission vaginally. When Depo-Provera-treated female rhesus macaques were dosed with GSK744 LA (50 mg/kg) monthly, systemic and tissue drug concentrations were lower than previously observed in male rhesus macaques. GSK744 concentrations were fivefold lower on average in cervical tissues than in rectal tissues. Eight female rhesus macaques were treated with GSK744 LA at week 0, and four female rhesus macaques served as controls. All animals received a high-dose challenge of SHIV162P3 at week 1. No infection was detected in GSK744 LA-treated rhesus macaques, whereas viremia was detected 1 to 2 weeks after SHIV challenge in all control animals. The GSK744 LA-treated rhesus macaques were given a second administration of drug at week 4 and further challenged at weeks 5 and 7. GSK744 LA treatment protected six of eight female rhesus macaques against three high-dose SHIV challenges, whereas all control animals became infected after the first challenge (P = 0.0003, log-rank test). These results support further clinical development of GSK744 LA for PrEP. Copyright © 2015, American Association for the Advancement of Science.

  4. Comparison of two doses of intravenous temsirolimus in patients with relapsed/refractory mantle cell lymphoma.

    Science.gov (United States)

    Jurczak, Wojciech; Ramanathan, Sundra; Giri, Pratyush; Romano, Alessandra; Mocikova, Heidi; Clancy, Jill; Lechuga, Mariajose; Casey, Michelle; Boni, Joseph; Giza, Agnieszka; Hess, Georg

    2018-03-01

    Temsirolimus 175 mg once-weekly for 3 weeks, followed by 75 mg once-weekly intravenously dosed (175/75 mg) is approved in the European Union for treatment of relapsed/refractory mantle cell lymphoma (MCL). A phase IV study explored whether similar efficacy, but improved safety could be achieved with 75 mg without 175 mg loading doses (ClinicaTrials.gov: NCT01180049). Patients with relapsed/refractory MCL were randomized to once-weekly temsirolimus 175/75 mg (n = 47) or 75 mg (n = 42). Treatment continued until objective disease progression. Primary endpoint: progression-free survival (PFS). Secondary endpoints included overall survival (OS) and adverse events (AEs). Median PFS was 4.3 versus 4.5 months (hazard ratio [HR] 0.731; 80% confidence interval [CI], 0.520-1.027), and median OS 18.7 versus 11.0 months (HR 0.681; 80% CI, 0.472-0.982) with 175/75 mg versus 75 mg. There were fewer patients with serious AEs, dose reduction, or death with 175/75 mg (57.4%, 48.9%, and 48.9%) versus 75 mg (73.8%, 64.3%, and 65.1%). Temsirolimus 175/75 mg remains the preferred dosing regimen for relapsed/refractory MCL.

  5. A lower dose threshold for the in vivo protective adaptive response to radiation. Tumorigenesis in chronically exposed normal and Trp53 heterozygous C57BL/6 mice

    International Nuclear Information System (INIS)

    Mitchel, R.E.J.; Burchart, P.; Wyatt, H.

    2008-01-01

    Low doses of ionizing radiation to cells and animals may induce adaptive responses that reduce the risk of cancer. However, there are upper dose thresholds above which these protective adaptive responses do not occur. We have now tested the hypothesis that there are similar lower dose thresholds that must be exceeded in order to induce protective effects in vivo. We examined the effects of low dose/low dose rate fractionated exposures on cancer formation in Trp53 normal or cancer-prone Trp53 heterozygous female C57BL/6 mice. Beginning at 6 weeks of age, mice were exposed 5 days/week to single daily doses (0.33 mGy, 0.7 mGy/h) totaling 48, 97 or 146 mGy over 30, 60 or 90 weeks. The exposures for shorter times (up to 60 weeks) appeared to be below the level necessary to induce overall protective adaptive responses in Trp53 normal mice, and detrimental effects (shortened lifespan, increased frequency) evident for only specific tumor types (B- and T-cell lymphomas), were produced. Only when the exposures were continued for 90 weeks did the dose become sufficient to induce protective adaptive responses, balancing the detrimental effects for these specific cancers, and reducing the risk level back to that of the unexposed animals. Detrimental effects were not seen for other tumor types, and a protective effect was seen for sarcomas after 60 weeks of exposure, which was then lost when the exposure continued for 90 weeks. As previously shown for the upper dose threshold for protection by low doses, the lower dose boundary between protection and harm was influenced by Trp53 functionality. Neither protection nor harm was observed in exposed Trp53 heterozygous mice, indicating that reduced Trp53 function raises the lower dose/dose rate threshold for both detrimental and protective tumorigenic effects. (author)

  6. Intravenous immunoglobulin for maintenance treatment of multifocal motor neuropathy: A multi-center, open-label, 52-week phase 3 trial.

    Science.gov (United States)

    Kuwabara, Satoshi; Misawa, Sonoko; Mori, Masahiro; Iwai, Yuta; Ochi, Kazuhide; Suzuki, Hidekazu; Nodera, Hiroyuki; Tamaoka, Akira; Iijima, Masahiro; Toda, Tatsushi; Yoshikawa, Hiroo; Kanda, Takashi; Sakamoto, Ko; Kusunoki, Susumu; Sobue, Gen; Kaji, Ryuji

    2018-04-10

    Intravenous immunoglobulin (IVIg) therapy is currently the only established treatment in patients with multifocal motor neuropathy (MMN), and many patients have an IVIg-dependent fluctuation. We aimed to investigate the efficacy and safety of every 3 week IVIg (1.0 g/kg) for 52 weeks. This study was an open-label phase 3 clinical trial, enrolling 13 MMN patients. After an induction IVIg therapy (0.4 g/kg/d for 5 consecutive days), maintenance dose (1.0 g/kg) was given every 3 weeks for 52 weeks. The major outcome measures were the Medical Research Council (MRC) sum score and hand-grip strength at week 52. This trial is registered with ClinicalTrials.gov, number NCT01827072. At week 52, 11 of the 13 patients completed the study, and all 11 had a sustained improvement. The mean (SD) MRC sum score was 85.6 (8.7) at the baseline, and 90.6 (12.8) at week 52. The mean grip strength was 39.2 (30.0) kPa at the baseline and 45.2 (32.8) kPa at week 52. Two patients dropped out because of adverse event (dysphagia) and decision of an investigator, respectively. Three patients developed coronary spasm, dysphagia, or inguinal herniation, reported as the serious adverse events, but considered not related with the study drug. The other adverse effects were mild and resolved by the end of the study period. Our results show that maintenance treatment with 1.0 g/kg IVIg every 3 week is safe and efficacious for MMN patients up to 52 weeks. Further studies are required to investigate optimal dose and duration of maintenance IVIg for MMN. © 2018 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.

  7. Physiological and immunological changes following exposure to low versus high-dose ionizing irradiation; comparative analysis with dose rate and cumulative dose

    International Nuclear Information System (INIS)

    Heesun, Kim; Heewon, Jang; Soungyeon, Song; Shinhye, Oh; Cukcheul, Shin; Meeseon, Jeong; Chasoon, Kim; Kwnaghee, Yang; Seonyoung, Nam; Jiyoung, Kim; Youngwoo, Jin; Changyoung, Cha

    2008-01-01

    Full text: While high-dose of ionizing radiation is generally harmful and causes damage to living organisms some reports suggest low-dose of radiation may not be as damaging as previously thought. Despite increasing evidence regarding the protective effect of low-dose radiation, no studies have directly compared the exact dose-response pattern by high- and low-dose of radiation exposed at high-and low-dose rate. This study aims to explore the cellular and molecular changes in mice exposed to low- and high-dose of radiation exposed at low- and high-dose rate. When C57BL/6 mice (Female, 6 weeks) were exposed at high-dose rate, 0.8 Gy/min, no significant change on the level of WBC, RBC, or platelets was observed up to total dose of 0.5 Gy. However, 2 Gy of radiation caused dramatic reduction in the level of white blood cells (WBC) and platelets. This reduction was accompanied by increased DNA damage in hematopoietic environments. The reduction of WBC was mainly due to the reduction in the number of CD4+ T cells and CD19+ B cells. CD8+ T cells and NK cells appeared to be relatively resistant to high-dose of radiation. This change was also accompanied by the reduction of T- and B- progenitor cells in the bone marrow. In contrast, no significant changes of the number of CD4+ T, CD8+ T, NK, and B cells were observed in the spleen of mice exposed at low-dose-rate (0.7 m Gy/h or 3.95 mGy/h) for up to 2 Gy, suggesting that low-dose radiation does not alter cellular distribution in the spleen. Nevertheless, mice exposed to low-dose radiation exhibited elevation of VEGF, MCP-1, IL-4, Leptin, IL-3, and Tpo in the peripheral blood and slight increases in MIP-2, RANTES, and IL-2 in the spleen. This suggests that chronic γ-radiation can stimulate immune function without causing damage to the immune components of the body. Taken together, these data indicate hormesis of low-dose radiation, which could be attributed to the stimulation of immune function. Dose rate rather than total

  8. Dose escalation to rash for erlotinib plus gemcitabine for metastatic pancreatic cancer: the phase II RACHEL study.

    Science.gov (United States)

    Van Cutsem, E; Li, C-P; Nowara, E; Aprile, G; Moore, M; Federowicz, I; Van Laethem, J-L; Hsu, C; Tham, C K; Stemmer, S M; Lipp, R; Zeaiter, A; Fittipaldo, A; Csutor, Z; Klughammer, B; Meng, X; Ciuleanu, T

    2014-11-25

    This phase II, open-label, randomised study evaluated whether patients with metastatic pancreatic cancer receiving erlotinib/gemcitabine derived survival benefits from increasing the erlotinib dose. After a 4-week run-in period (gemcitabine 1000 mg m(-2) once weekly plus erlotinib 100 mg per day), patients with metastatic pancreatic cancer who developed grade 0/1 rash were randomised to receive gemcitabine plus erlotinib dose escalation (150 mg, increasing by 50 mg every 2 weeks (maximum 250 mg); n=71) or gemcitabine plus standard-dose erlotinib (100 mg per day; n=75). The primary end point was to determine whether overall survival (OS) was improved by increasing the erlotinib dose. Secondary end points included progression-free survival (PFS), incidence of grade ⩾2 rash, and safety. Erlotinib dose escalation induced grade ⩾2 rash in 29 out of 71 (41.4%) patients compared with 7 out of 75 (9.3%) patients on standard dose. Efficacy was not significantly different in the dose-escalation arm compared with the standard-dose arm (OS: median 7.0 vs 8.4 months, respectively, hazard ratio (HR), 1.26, 95% confidence interval (CI): 0.88-1.80; P=0.2026; PFS: median 3.5 vs 4.5 months, respectively, HR, 1.09, 95% CI: 0.77-1.54; P=0.6298). Incidence of adverse events was comparable between randomised arms. The erlotinib dose-escalation strategy induced rash in some patients; there was no evidence that the higher dose translated into increased benefit.

  9. Elective caesarean section at 38 weeks versus 39 weeks

    DEFF Research Database (Denmark)

    Glavind, Julie; Kindberg, S F; Uldbjerg, N

    2013-01-01

    To investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes.......To investigate whether elective caesarean section before 39 completed weeks of gestation increases the risk of adverse neonatal or maternal outcomes....

  10. Time-dose modifications

    International Nuclear Information System (INIS)

    Kian Ang, K.

    1987-01-01

    Changes in fractionation schedule can be made by various approaches. However, from the first principle, it is anticipated that strategies of hyperfractionation and/or accelerated fractionation offer the most promised in improving the therapeutic ratio. Hyperfractionation is defined as a treatment schedule in which a large number of significantly reduced dose fractions (--1.2 Gy/fraction) is used to give a greater total dose in a conventional overall time period. The results of the pilot studies testing the efficacy of hyperfractionation have been encouraging. The most valid clinical trial of pure hyperfractionation, however, is that conducted by the EORTC. This study compared 70 Gy in 35 fractions or 80.5 Gy in 70 fractions over 7 weeks in the treatment of patients with oropharyngeal carcinomas. The local tumor control was significantly improved in the hyperfractionated arm without increasing the morbidity. Accelerated fractionation is defined as a schedule in which the overall time of treatment is reduced without significant changes in the total dose and fraction size. The strategy has been used to treat patients with malignant gliomas, melanomas and Head and Neck cancers. The data in Head and Neck Cancers seem to be promising

  11. Permissiveness toward divorce : The influence of divorce experiences in three social contexts

    NARCIS (Netherlands)

    Sieben, I.J.P.; Verbakel, C.M.C.

    2013-01-01

    In this study, we assess whether divorce experiences in three social contexts shape individual’s permissiveness toward divorce. Using European Values Study data from 44 countries, we find that—net of personal divorce experience—parental divorce before the age of 18 (socialization context); parental

  12. Permissiveness toward divorce: The influence of divorce experiences in three social contexts

    NARCIS (Netherlands)

    Sieben, I.J.P.; Verbakel, C.M.C.

    2013-01-01

    In this study, we assess whether divorce experiences in three social contexts shape individual’s permissiveness toward divorce. Using European Values Study data from 44 countries, we find that—net of personal divorce experience—parental divorce before the age of 18 (socialization context); parental

  13. Low dose in nuclear cardiology: state of the art in the era of new cadmium-zinc-telluride cameras.

    Science.gov (United States)

    Acampa, Wanda; Buechel, Ronny R; Gimelli, Alessia

    2016-06-01

    The use of myocardial perfusion imaging has seen a tremendous growth during the last decade and has become the most commonly used non-invasive imaging tool for risk stratification in patients with suspected and known coronary artery disease. Adherence to radiation safety best practices varied significantly between laboratories but the possibility to use the new cameras in nuclear cardiology can reduce dramatically the radiation dose without losing accuracy. Moreover, the physical characteristics of ultrafast technology could be able to open new doors for the evaluation of old parameters, changing the impact of nuclear cardiology in the diagnostic strategies. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  14. Larval diet affects mosquito development and permissiveness to Plasmodium infection.

    Science.gov (United States)

    Linenberg, Inbar; Christophides, George K; Gendrin, Mathilde

    2016-12-02

    The larval stages of malaria vector mosquitoes develop in water pools, feeding mostly on microorganisms and environmental detritus. Richness in the nutrient supply to larvae influences the development and metabolism of larvae and adults. Here, we investigated the effects of larval diet on the development, microbiota content and permissiveness to Plasmodium of Anopheles coluzzii. We tested three fish diets often used to rear mosquitoes in the laboratory, including two pelleted diets, Dr. Clarke's Pool Pellets and Nishikoi Fish Pellets, and one flaked diet, Tetramin Fish-Flakes. Larvae grow and develop faster and produce bigger adults when feeding on both types of pellets compared with flakes. This correlates with a higher microbiota load in pellet-fed larvae, in agreement with the known positive effect of the microbiota on mosquito development. Larval diet also significantly influences the prevalence and intensity of Plasmodium berghei infection in adults, whereby Nishikoi Fish Pellets-fed larvae develop into adults that are highly permissive to parasites and survive longer after infection. This correlates with a lower amount of Enterobacteriaceae in the midgut microbiota. Together, our results shed light on the influence of larval feeding on mosquito development, microbiota and vector competence; they also provide useful data for mosquito rearing.

  15. Patterns of prednisone use during pregnancy in women with rheumatoid arthritis: Daily and cumulative dose.

    Science.gov (United States)

    Palmsten, Kristin; Rolland, Matthieu; Hebert, Mary F; Clowse, Megan E B; Schatz, Michael; Xu, Ronghui; Chambers, Christina D

    2018-04-01

    To characterize prednisone use in pregnant women with rheumatoid arthritis using individual-level heat-maps and clustering individual trajectories of prednisone dose, and to evaluate the association between prednisone dose trajectory groups and gestational length. This study included pregnant women with rheumatoid arthritis who enrolled in the MotherToBaby Autoimmune Diseases in Pregnancy Study (2003-2014) before gestational week 20 and reported prednisone use without another oral glucocorticoid during pregnancy (n = 254). Information on medication use and pregnancy outcomes was collected by telephone interview plus by medical record review. Prednisone daily dose and cumulative dose were plotted by gestational day using a heat map for each individual. K-means clustering was used to cluster individual trajectories of prednisone dose into groups. The associations between trajectory group and demographics, disease severity measured by the Health Assessment Questionnaire at enrollment, and gestational length were evaluated. Women used prednisone 3 to 292 days during pregnancy, with daily doses ranging from <1 to 60 mg. Total cumulative dose ranged from 8 to 6225 mg. Disease severity, non-biologic disease modifying anti-rheumatic drug use, and gestational length varied significantly by trajectory group. After adjusting for disease severity, non-biologic disease modifying anti-rheumatic drug use, and other covariates, the highest vs lowest daily dose trajectory group was associated with reduced gestational age at delivery (β: -2.3 weeks (95%: -3.4, -1.3)), as was the highest vs lowest cumulative dose trajectory group (β: -2.6 weeks (95%: -3.6, -1.5)). In pregnant women with rheumatoid arthritis, patterns of higher prednisone dose were associated with shorter gestational length compared with lower dose. Copyright © 2018 John Wiley & Sons, Ltd.

  16. Supra-aortic low-dose contrast-enhanced time-resolved magnetic resonance (MR) angiography at 3 T: comparison with time-of-flight MR angiography and high-resolution contrast-enhanced MR angiography.

    Science.gov (United States)

    Lee, Youn-Joo; Kim, Bum-soo; Koo, Ja-Sung; Kim, Bom-Yi; Jang, Jinhee; Choi, Hyun Seok; Jung, So-Lyung; Ahn, Kook-Jin

    2015-06-01

    Low-dose, time-resolved, contrast-enhanced, magnetic resonance angiography (TR-CEMRA) has been described previously; however, a comparative study between low dose TR-CEMRA and time-of-flight MRA (TOF-MRA) in the diagnosis of supra-aortic arterial stenosis has not yet been published. To demonstrate the feasibility and effectiveness of low-dose TR-CEMRA compared with TOF-MRA, using high-resolution contrast-enhanced MRA (HR-CEMRA) as the reference standard. This prospective study consisted of 30 consecutive patients. All patients underwent TOF-MRA of the neck and circle of Willis and supra-aortic HR-CEMRA, followed by supra-aortic low-dose TR-CEMRA. Gadoterate meglumine (Gd-DOTA, Dotarem(®), Guerbet, Roissy CdG Cedex, France) was injected at a dose of 0.1 mmol/kg for HR-CEMRA, followed by a 0.03 mmol/kg bolus for low-dose TR-CEMRA. Three readers evaluated the assessibility and image quality, and then two readers classified each stenosis into the following categories: normal (0-30%), mild stenosis (31-50%), moderate (51-70%), severe (71-99%), and occlusion. TR-CEMRA and HR-CEMRA showed a greater number of assessable arterial segments than TOF-MRA (P supra-aortic arterial stenosis, and could be more useful option than TOF-MRA. © The Foundation Acta Radiologica 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  17. Effect of low-dose radiation on ocular circulation

    International Nuclear Information System (INIS)

    Baba, Keiko; Hiroishi, Goro; Honda, Masae; Yoshikawa, Hiroshi; Fujisawa, Kimihiko; Ishibashi, Tatsuro

    1999-01-01

    We treated 6 eyes of unilateral age-related macular degeneration by low-dose radiation. Each eye received daily dose of 2 Gy by 4MV lineac totalling 20 Gy over 2 weeks. Color doppler flowmetry was used to determine the mean blood flow velocity (Vmean) and vascular resistive index (RI) in the short posterior ciliary artery, central retinal artery and ophthalmic artery in the treated and fellow eyes before and up to 6 months of treatment. There were no significant differences in Vmean and RI before and after treatment. The findings show the absence of apparent influence of low-dose radiation on the ocular circulation in age-related macular degeneration. (author)

  18. Effect of low-dose radiation on ocular circulation

    Energy Technology Data Exchange (ETDEWEB)

    Baba, Keiko; Hiroishi, Goro; Honda, Masae; Yoshikawa, Hiroshi; Fujisawa, Kimihiko; Ishibashi, Tatsuro [Kyushu Univ., Fukuoka (Japan). Faculty of Medicine

    1999-05-01

    We treated 6 eyes of unilateral age-related macular degeneration by low-dose radiation. Each eye received daily dose of 2 Gy by 4MV lineac totalling 20 Gy over 2 weeks. Color doppler flowmetry was used to determine the mean blood flow velocity (Vmean) and vascular resistive index (RI) in the short posterior ciliary artery, central retinal artery and ophthalmic artery in the treated and fellow eyes before and up to 6 months of treatment. There were no significant differences in Vmean and RI before and after treatment. The findings show the absence of apparent influence of low-dose radiation on the ocular circulation in age-related macular degeneration. (author)

  19. Serological response of pigs to a standard and increased dose of foot-and-mouth disease vaccine

    International Nuclear Information System (INIS)

    Sims, L.D.; Dyrting, K.C.; Wong, K.W.

    2000-01-01

    Two randomly allocated age-matched groups of 17 conventionally reared pigs derived from vaccinated sows were vaccinated at 10 and 14 weeks of age with a commercially available foot-and-mouth disease vaccine, using either a 1 mL dose or a 3 mL dose. A control group of four pigs was left unvaccinated. Pigs were monitored at regular intervals from birth to 26 weeks of age for antibodies to FMD Type O virus using a liquid phase blocking ELISA. At 12 weeks post vaccination, significantly more pigs vaccinated twice with 3 mL of vaccine had developed antibodies against Type O foot-and-mouth disease virus (at an ELISA titre of 90 or greater) than those vaccinated twice with 1 mL of vaccine (chi-squared test, p = 0.006). Overall, the response to vaccination was poor in both groups of pigs. Four weeks after the first dose of vaccine only four pigs had detectable antibody against the virus. Twelve weeks after the second dose of vaccine only 60% of pigs given the 3 mL dose and 15% of pigs given the 1 mL dose had ELISA titres of 90 or greater. Maternal antibody is considered to have played a role in this poor response, as it was present in 27 of the 34 vaccinated pigs at the time of first vaccination. Two pigs in the unvaccinated control group developed a low level antibody response (antibody titre <90). Infection with field virus was considered a highly unlikely cause of this. These results show, that under field conditions using a widely adopted protocol not all pigs vaccinated develop antibody to foot-and-mouth disease. This, in part, may explain why vaccination programmes against this disease in Hong Kong seem to have a limited impact. The results also suggest, that an increased dose of vaccine has a positive effect on the humoral immune response against FMD virus and may improve protection against this disease. Timing of vaccination needs to be re-evaluated to reduce the impact of maternally derived antibodies. (author)

  20. Larval diet affects mosquito development and permissiveness to Plasmodium infection

    OpenAIRE

    Gendrin, MEM; Christophides; Linenberg, Inbar

    2016-01-01

    The larval stages of malaria vector mosquitoes develop in water pools, feeding mostly on microorganisms and environmental detritus. Richness in the nutrient supply to larvae influences the development and metabolism of larvae and adults. Here, we investigated the effects of larval diet on the development, microbiota content and permissiveness to Plasmodium of Anopheles coluzzii . We tested three fish diets often used to rear mosquitoes in the laboratory, including two pelleted diets, Dr. Clar...

  1. Treatment of chronic spontaneous urticaria with a single dose of omalizumab: A study of four cases

    Directory of Open Access Journals (Sweden)

    Radhakrishnan Subramaniyan

    2016-01-01

    Full Text Available Background: Chronic spontaneous urticaria (CSU has a detrimental effect on patients′ emotional and physical quality of life. Omalizumab, an anti-immunoglobulin E humanized monoclonal antibody, has been shown to be very effective in the treatment of refractory chronic urticaria patients but may not be an economically viable option for all CSU patients. However, we present a case series where a single dose of omalizumab gave sustained relief of symptoms in patients with CSU, which may be an economical option. Aims: The aim of this study is to assess the efficacy of a single dose of omalizumab in the treatment of CSU. Materials and Methods: Four patients of CSU whose disease was not controlled with four times the licensed dose of tablet fexofenadine 180 mg were exhibited one subcutaneous injection of omalizumab and were followed up at 4 weekly intervals for 24 weeks for Weekly Urticaria Activity Score 7 (UAS7 and Dermatology Life Quality Index (DLQI. Results: A sharp decline in UAS7 and DLQI was documented in 7-10 days. The decline was maintained up to 16 weeks in one case and 20 weeks in the other three cases. Both the scores at the end of the follow-up period of 24 weeks were better than the pre-omalizumab scores. Conclusion: The results of this case series indicate the efficacy of a single-dose omalizumab in treating moderate to severe refractory CSU. Further studies are required to identify the minimum frequency of administering omalizumab to effectively control CSU. This would greatly reduce the cost of this novel therapy.

  2. Differences in HCV viral decline between low and standard-dose pegylated-interferon-alpha-2a with ribavirin in HIV/HCV genotype 3 patients.

    Directory of Open Access Journals (Sweden)

    Antonio Rivero-Juárez

    Full Text Available BACKGROUND: The aim of the study was to analyze the different impact of standard and low-dose Peg-IFN-α2a/RBV therapies on HCV viral decline in HIV/HCV genotype 3 co-infected patients during the first weeks of treatment. METHODS: Plasma HCV viral decline was analyzed between baseline and weeks 1, 2 and 4 in two groups of treatment-naïve HCV genotype 3 patients with HIV co-infection. The Standard Dose Group (SDG included patients who received Peg-IFN at 180 µg/per week with a weight-adjusted dose of ribavirin; Low-Dose Group (LDG patients received Peg-IFN at 135 µg/per week with 800 mg/day ribavirin. The effect of IL28B genotype on HCV viral decline was evaluated in both groups. HCV viral decline was analyzed using a multivariate linear regression model. RESULTS: One hundred and six patients were included: 48 patients in the SDG and 58 in the LDG. HCV viral decline for patients in the LDG was less than for those in the SDG (week 1:1.72±0.74 log(10 IU/mL versus 1.78±0.67 log(10 IU/mL, p = 0.827; week 2:2.3±0.89 log(10 IU/mL versus 3.01±1.02 log(10 IU/mL, p = 0.013; week 4:3.52±1.2 log(10 IU/mL versus 4.09±1.1 log(10 IU/mL, p = 0.005. The linear regression model identified the Peg-IFN/RBV dose as an independent factor for HCV viral decline at week 4. CONCLUSIONS: Our results showed that HCV viral decline was less for patients in the low-dose group compared to those receiving the standard dose. Until a randomized clinical trial is conducted, clinicians should be cautious about using lower doses of Peg-IFN/RBV in HIV/HCV genotype 3 co-infected patients.

  3. Role of signal dose preoperative antibiotic in acute nonperforated appendicitics

    International Nuclear Information System (INIS)

    Malik, S.A.; Rasheed, M.; Abbasi, A.S.; Iqbal, R.A.; Mian, M.A.

    2013-01-01

    Objective: To determine the efficacy of a single dose of preoperative antibiotic in preventing post operative infective complications in patients undergoing appendicectomy for non perforated acute appendicitis. Study Design: Randomized controlled trials. Place and Duration of Study: Surgical unit I and II, department of General Surgery, Combined Military Hospital (CMH) Lahore from 1st June to 31st October 2010. Patients and Methods: Seventy patients with acute appendicitis scheduled for appendicectomy were included in the study and randomly divided into two groups of 35 each using random numbers table. Group A received single dose preoperative antibiotic and group B received three-dose regimens of cefuroxime. Postoperative infective complications were the primary endpoint. Results: The rate of postoperative wound infection was not statistically insignificantly different among the groups; (8.57%) group A and (5.71%) group B at 1st post operative week and (5.71%) group A and (5.71%) group B at 2nd post operative week. None of the patients from either group showed any signs of intra abdominal abscess formation. Conclusion: Single dose of preoperative antibiotics is adequate for prevention of postoperative infective complications in patients with non-perforated appendicitis undergoing open appendicectomy. (author)

  4. A guide for the calculation of the maximum permissible costs for shelters

    International Nuclear Information System (INIS)

    Schwarzlose, H.

    1981-01-01

    Among other things, this paper has the aim to define the scope which is reasonable for shelter costs as well as to inform about their real amount. Various assumptions have been made and examples have been given which seldom coincide with the specific facts. Thus, the possibility of how to find solutions which are precisely appropriate for persons is shown in a formula. The less the income, life expectancy and the number of persons to be considered the less are the maximum permissible costs for shelters. Under certain conditions the permissible costs are lower than the real costs. Thus, taking those assumptions into account, the shelter is not profitable any more. This case, for example, really applies to a couple, 57 years old, without children, with an income of 40,000 DM/year who intend to build an interior shelter. For a family with children who are under age, however, it is always profitable to build an interior basic shelter. (orig.) [de

  5. Permissive and instructive anterior patterning rely on mRNA localization in the wasp embryo.

    Science.gov (United States)

    Brent, Ava E; Yucel, Gozde; Small, Stephen; Desplan, Claude

    2007-03-30

    The long-germ mode of embryogenesis, in which segments arise simultaneously along the anteriorposterior axis, has evolved several times in different lineages of the holometabolous, or fully metamorphosing, insects. Drosophila's long-germ fate map is established largely by the activity of the dipteran-specific Bicoid (Bcd) morphogen gradient, which operates both instructively and permissively to accomplish anterior patterning. By contrast, all nondipteran long-germ insects must achieve anterior patterning independently of bcd. We show that bcd's permissive function is mimicked in the wasp by a maternal repression system in which anterior localization of the wasp ortholog of giant represses anterior expression of the trunk gap genes so that head and thorax can properly form.

  6. Efficacy and Safety of Daikenchuto for Constipation and Dose-Dependent Differences in Clinical Effects

    Directory of Open Access Journals (Sweden)

    Tatsuya Hirose

    2018-01-01

    Full Text Available Background. Daikenchuto (DKT is a Kampo medicine used for the treatment of constipation. In this study, we evaluated the effectiveness of DKT against constipation. Patients and Methods. Thirty-three patients administered DKT for constipation were selected and divided into low-dose (7.5 g DKT; n=22 and high-dose (15 g DKT; n=11 groups. We retrospectively evaluated weekly defaecation frequency, side effects, and clinical laboratory data. Results. Median defaecation frequencies after DKT administration (5, 5.5, 5, and 8 for the first, second, third, and fourth weeks, resp. were significantly higher than that before DKT administration (2 in all 33 cases (P<0.01. One case (3% of watery stool, one case of loose stools (3%, and no cases of abdominal pain (0% were observed. Median defaecation frequencies in the high-dose group (7 and 9 were significantly higher than those in the low-dose group (4 and 3 in the first (P=0.0133 and second (P=0.0101 weeks, respectively. There was no significant change in clinical laboratory values. Conclusion. We suggest that DKT increases defaecation frequency and is safe for treating constipation.

  7. Pharmacokinetics, Safety, and 48-Week Efficacy of Oral Raltegravir in HIV-1–Infected Children Aged 2 Through 18 Years

    Science.gov (United States)

    Nachman, Sharon; Zheng, Nan; Acosta, Edward P.; Teppler, Hedy; Homony, Brenda; Graham, Bobbie; Fenton, Terence; Xu, Xia; Wenning, Larissa; Spector, Stephen A.; Frenkel, Lisa M.; Alvero, Carmelita; Worrell, Carol; Handelsman, Edward; Wiznia, Andrew; Moultrie, Harry; Kindra, Gurpreet; Sanders, Margaret Ann; Williams, Ruth; Jensen, Jennifer; Acevedo, Midnela; Fabregas, Lizbeth; Jurgrau, Andrea; Foca, Marc; Higgins, Alice; Deville, Jaime G.; Nielsen-Saines, Karin; Carter, Michele F.; Swetnam, John; Wilson, Joan; Donnelly, Margaret; Akleh, Siham; Rigaud, Mona; Kaul, Aditya; Patel, Nehali; Gaur, Aditya; Utech, L. Jill; Cardoso, Edmundo; Moreira, Ana Maria; Santos, Breno; Bobat, Raziya; Mngqibisa, Rosie; Burey, Marlene; Abadi, Jacob; Rosenberg, Michael; Luzuriaga, Katherine; Picard, Donna; Pagano-Therrien, Jessica; Dittmer, Sylvia; Ndiweni, Hilda Ntatule; Patel, Amisha; DelRey, Michelle; McMullen-Jackson, Chivon; Paul, Mary E.; Melvin, Ann; Venema-Weiss, Corry; Lane, Jenna; Beneri, Christy; Ferraro, Denise; Infanzon, Erin; McAuley, James B; Aziz, Mariam; McNichols, Maureen; Pelton, Stephen; McLaud, Deb; Clarke, Diana; Zeichner, Steven; Akar, Arezou; Thompson, Deidre; Douglas, Steven D.; Rutstein, Richard M.; Vincent, Carol A.; Vachon, Mary Elizabeth; Cavallo, Martha; Purswani, Murli Udharam; Masheto, Gaerolwe; Ogwu, Anthony; Kakhu, Tebogo; Viani, Rolando M.; Darcey, Anita,; Norris, Kimberly; Burchett, Sandra K.; Kneut, Catherine; Karthas, Nancy; Casey, Denise; Emmanuel, Patricia; Lujan-Zilbermann, Jorge; Rana, Sohail; Houston, Patricia; Mengistab, Mulu; Rathore, Mobeen; Mirza, Ayesha; Gayton, Tabetha; Barr, Emily; Dunn, Jennifer; Hahn, Kerry; Eysallenne, Zulma; Howard, F. Sholar; Graham, Kathleen; Negra, Marinella Della; Queiroz, Wladimir; Lian, Yu Ching; Wara, Diane; Ruel, Ted; VanDyke, Russell; Reilly, Patricia; Bradford, Sheila; van Rensburg, Anita Janse; Dobbels, Els; Bester, Marietjie; Bamji, Mahrukh; Paul, Santa; Sarza, Mirala; Kovacs, Andrea; Homans, James; Spencer, LaShonda; Hofer, Cristna; Abreu, Thalita; Oliveira, Ricardo; Joao, Esau C.; Pinto, Jorge; Ferreira, Flavia; Kakehasi, Fabiana; Cervi, Maria Celia; Isaac, Marcia De Lima; Losso, Marcelo H.; Stankievich, Erica; Foradori, Irene; Tucker, Diane; Church, Joseph; Belzer, Marvin; Hopkins, Johns; Ellen, Jonathan; Agwu, Allison; Laurel, Borkovic

    2014-01-01

    Background. IMPAACT P1066 is a phase I/II open-label multicenter trial to evaluate pharmacokinetics, safety, tolerability, and efficacy of multiple raltegravir formulations in human immunodeficiency virus (HIV)–infected youth. Methods. Dose selection for each cohort (I: 12 to <19 years; II: 6 to <12 years; and III: 2 to <6 years) was based on review of short-term safety (4 weeks) and intensive pharmacokinetic evaluation. Safety data through weeks 24 and 48, and grade ≥3 or serious adverse events (AEs) were assessed. The primary virologic endpoint was achieving HIV RNA <400 copies/mL or ≥1 log10 reduction between baseline and week 24. Results. The targeted pharmacokinetic parameters (AUC0-12h and C12h) were achieved for each cohort, allowing dose selection for 2 formulations. Of 96 final dose subjects, there were 15 subjects with grade 3 or higher clinical AEs (1 subject with drug-related [DR] psychomotor hyperactivity and insomnia); 16 subjects with grade 3 or higher laboratory AEs (1 with DR transaminase elevation); 14 subjects with serious clinical AEs (1 with DR rash); and 1 subjects with serious laboratory AEs (1 with DR transaminase increased). There were no discontinuations due to AEs and no DR deaths. Favorable virologic responses at week 48 were observed in 79.1% of patients, with a mean CD4 increase of 156 cells/µL (4.6%). Conclusions. Raltegravir as a film-coated tablet 400 mg twice daily (6 to <19 years, and ≥25 kg) and chewable tablet 6 mg/kg (maximum dose 300 mg) twice daily (2 to <12 years) was well tolerated and showed favorable virologic and immunologic responses. Clinical Trials Registration NCT00485264. PMID:24145879

  8. Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study.

    Science.gov (United States)

    Ou, Jian-Jun; Xun, Guang-Lei; Wu, Ren-Rong; Li, Le-Hua; Fang, Mao-Sheng; Zhang, Hong-Geng; Xie, Shi-Ping; Shi, Jian-Guo; Du, Bo; Yuan, Xue-Qin; Zhao, Jing-Ping

    2011-02-01

    S-citalopram (escitalopram) is the very active moiety of citalopram. It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder (MDD). The aim of our study was to compare the efficacy and safety of escitalopram vs citalopram in Chinese MDD patients. In the double-blind study, 240 MDD patients were randomly assigned to treatment for 6 weeks either with escitalopram (10-20 mg/d) or citalopram (20-40 mg/d). The primary efficacy measurement was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the end of study. The secondary efficacy measurements were response and remission rates. The adverse events (AEs) were recorded by the investigator. Two hundred and three (85%) patients completed the trial. The average dose was 13.9 mg/d in the escitalopram group and 27.6 mg/d in the citalopram group. No significant differences were found between the two groups in the change in HAMD-17 total score, response, and remission rate. These results were similar in severe MDD patients. No significant differences were found between the two groups in AEs. No serious AEs were observed in this study. The study suggests that escitalopram 10-20 mg/d are as effective and safe as citalopram 20-40 mg/d in the short-term treatment for Chinese MDD patients.

  9. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial.

    Science.gov (United States)

    Behrens, Frank; Tak, Paul P; Østergaard, Mikkel; Stoilov, Rumen; Wiland, Piotr; Huizinga, Thomas W; Berenfus, Vadym Y; Vladeva, Stoyanka; Rech, Juergen; Rubbert-Roth, Andrea; Korkosz, Mariusz; Rekalov, Dmitriy; Zupanets, Igor A; Ejbjerg, Bo J; Geiseler, Jens; Fresenius, Julia; Korolkiewicz, Roman P; Schottelius, Arndt J; Burkhardt, Harald

    2015-06-01

    To determine the safety, tolerability and signs of efficacy of MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with rheumatoid arthritis (RA). Patients with active, moderate RA were enrolled in a randomised, multicentre, double-blind, placebo-controlled, dose-escalation trial of intravenous MOR103 (0.3, 1.0 or 1.5 mg/kg) once a week for 4 weeks, with follow-up to 16 weeks. The primary outcome was safety. Of the 96 randomised and treated subjects, 85 completed the trial (n=27, 24, 22 and 23 for pooled placebo and MOR103 0.3, 1.0 and 1.5 mg/kg, respectively). Treatment emergent adverse events (AEs) in the MOR103 groups were mild or moderate in intensity and generally reported at frequencies similar to those in the placebo group. The most common AE was nasopharyngitis. In two cases, AEs were classified as serious because of hospitalisation: paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject. Both patients recovered fully. In exploratory efficacy analyses, subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo. MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters. MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA. The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases. NCT01023256. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects

    DEFF Research Database (Denmark)

    Carlsen, J E; Køber, L; Torp-Pedersen, C

    1990-01-01

    OBJECTIVE--To determine the relevant dose of bendrofluazide for treating mild to moderate hypertension. DESIGN--Double blind parallel group trial of patients who were given placebo for six weeks and then randomly allocated to various doses of bendrofluazide (1.25, 2.5, 5, or 10 mg daily) or place...... of bendrofluazide to treat mild to moderate hypertension is 1.25-2.5 mg a day. Higher doses caused more pronounced adverse biochemical effects including adverse lipid effects. Previous trials with bendrofluazide have used too high doses....... relations between dose and effect were shown for potassium, urate, glucose, total cholesterol, and apolipoprotein B concentrations. The 1.25 mg dose increased only urate concentrations, whereas the 10 mg dose affected all the above biochemical variables. CONCLUSION--The relevant range of doses...

  11. Pharmacokinetics and bioavailability of plant lignan 7-hydroxymatairesinol and effects on serum enterolactone and clinical symptoms in postmenopausal women: a single-blinded, parallel, dose-comparison study.

    Science.gov (United States)

    Udani, Jay K; Brown, Donald J; Tan, Maria Olivia C; Hardy, Mary

    2013-01-01

    7-Hydroxymaitairesinol (7-HMR) is a naturally occurring plant lignan found in whole grains and the Norway spruce (Piciea abies). The purpose of this study was to evaluate the bioavailability of a proprietary 7-HMR product (HMRlignan, Linnea SA, Locarno, Switzerland) through measurement of lignan metabolites and metabolic precursors. A single-blind, parallel, pharmacokinetic and dose-comparison study was conducted on 22 postmenopausal females not receiving hormone replacement therapy. Subjects were enrolled in either a 36 mg/d (low-dose) or 72 mg/d dose (high-dose) regimen for 8 weeks. Primary measured outcomes included plasma levels of 7-HMR and enterolactone (ENL), and single-dose pharmacokinetic analysis was performed on a subset of subjects in the low-dose group. Safety data and adverse event reports were collected as well as data on hot flash frequency and severity. Pharmacokinetic studies demonstrated 7-HMR C max = 757.08 ng/ml at 1 hour and ENL C max = 4.8 ng/ml at 24 hours. From baseline to week 8, plasma 7-HMR levels increased by 191% in the low-dose group (p < 0.01) and by 1238% in the high-dose group (p < 0.05). Plasma ENL levels consistently increased as much as 157% from baseline in the low-dose group and 137% in the high-dose group. Additionally, the mean number of weekly hot flashes decreased by 50%, from 28.0/week to 14.3/week (p < 0.05) in the high-dose group. No significant safety issues were identified in this study. The results demonstrate that HMRlignan is quickly absorbed into the plasma and is metabolized to ENL in healthy postmenopausal women. Clinically, the data demonstrate a statistically significant improvement in hot flash frequency. Doses up to 72 mg/d HMRlignan for 8 weeks were safe and well tolerated in this population.

  12. Quantitative in vivo assessment of radiation injury of the liver using Gd-EOB-DTPA enhanced MRI: tolerance dose of small liver volumes

    Directory of Open Access Journals (Sweden)

    Pech Maciej

    2011-04-01

    Full Text Available Abstract Backround Hepatic radiation toxicity restricts irradiation of liver malignancies. Better knowledge of hepatic tolerance dose is favourable to gain higher safety and to optimize radiation regimes in radiotherapy of the liver. In this study we sought to determine the hepatic tolerance dose to small volume single fraction high dose rate irradiation. Materials and methods 23 liver metastases were treated by CT-guided interstitial brachytherapy. MRI was performed 3 days, 6, 12 and 24 weeks after therapy. MR-sequences were conducted with T1-w GRE enhanced by hepatocyte-targeted Gd-EOB-DTPA. All MRI data sets were merged with 3D-dosimetry data. The reviewer indicated the border of hypointensity on T1-w images (loss of hepatocyte function or hyperintensity on T2-w images (edema. Based on the volume data, a dose-volume-histogram was calculated. We estimated the threshold dose for edema or function loss as the D90, i.e. the dose achieved in at least 90% of the pseudolesion volume. Results At six weeks post brachytherapy, the hepatocyte function loss reached its maximum extending to the former 9.4Gy isosurface in median (i.e., ≥9.4Gy dose exposure led to hepatocyte dysfunction. After 12 and 24 weeks, the dysfunctional volume had decreased significantly to a median of 11.4Gy and 14Gy isosurface, respectively, as a result of repair mechanisms. Development of edema was maximal at six weeks post brachytherapy (9.2Gy isosurface in median, and regeneration led to a decrease of the isosurface to a median of 11.3Gy between 6 and 12 weeks. The dose exposure leading to hepatocyte dysfunction was not significantly different from the dose provoking edema. Conclusion Hepatic injury peaked 6 weeks after small volume irradiation. Ongoing repair was observed up to 6 months. Individual dose sensitivity may differ as demonstrated by a relatively high standard deviation of threshold values in our own as well as all other published data.

  13. Rat skin carcinogenesis as a basis for estimating risks at low doses and dose rates of various types of radiation

    International Nuclear Information System (INIS)

    Burns, F.J.; Vanderlaan, M.; Strickland, P.; Albert, R.E.

    1976-01-01

    The recovery rate, age dependence and latent period for tumor induction in rat skin were measured for single and split doses of radiation, and the data were analyzed in terms of a general model in an attempt to estimate the expected tumor response for various types of radiation given at low dose rates for long periods of time. The dorsal skin of male rats was exposed to electrons, x rays, or protons in either single or split doses for several doses and the tumor responses were compared during 80 weeks of observation. A two stage model incorporating a reversible or recoverable mode was developed and various parameters in the model, including recovery rate, dose-response coefficients, and indices of age sensitivity, were evaluated experimentally. The measured parameters were then utilized to calculate expected tumor responses for exposure periods extending for duration of life. The calculations indicated that low dose rates could be markedly ( 1 / 100 to 1 / 1000 ) less effective in producing tumors than the same dose given in a short or acute exposure, although the magnitude of the reduction in effectiveness declines as the dose declines

  14. Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck.

    Science.gov (United States)

    Trieu, Vanessa; Pinto, Harlan; Riess, Jonathan W; Lira, Ruth; Luciano, Richard; Coty, Jessie; Boothroyd, Derek; Colevas, A Dimitrios

    2018-03-14

    Chemotherapy for recurrent, metastatic squamous cell carcinoma of the head and neck need not be known for extreme toxicity.The weekly regimen studied here has been demonstrated to be tolerable and effective. The objective of this study was to establish the response rate, progression-free survival (PFS) and overall survival (OS), and safety profile of weekly docetaxel, platinum, and cetuximab (TPC) in patients with relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN). Twenty-nine patients with metastatic or recurrent SCCHN with an Eastern Cooperative Oncology Group (ECOG) performance status <3 were enrolled in an institutional review board-approved phase II trial. This study permitted prior chemoradiation, radiation, and/or surgery, provided that 3 months had elapsed since the end of the potentially curative treatment. Patients received cisplatin 30 mg/m 2 or carboplatin area under the curve (AUC) 2, docetaxel 30 mg/m 2 , and cetuximab 250 mg/m 2 weekly for 3 weeks, followed by a break during the fourth week, for a 28-day cycle. Planned intrapatient dose modifications were based on individual toxicity. Twenty-seven patients received TPC and were evaluable for response and toxicity. Rates of complete response (CR), partial response (PR), and confirmed PR were 3%, 52%, and 30%, respectively. The overall objective response rate was 56%. Estimated median PFS and OS were 4.8 and 14.7 months, respectively. The rates of grade 3 and 4 worst-grade adverse events (AEs) per patient were 85% and 7%, respectively. Dose density through cycle 4 was preserved for all patients; however, treatment beyond cycle 6 with the TPC regimen proved unfeasible. Weekly docetaxel, cisplatin, and cetuximab is an effective regimen for patients with metastatic or recurrent SCCHN. Response rates, PFS, and OS compare favorably with other combination chemotherapy treatments. Grade 4 toxicity rates observed in this study were substantially lower than those described with regimens

  15. Effects of clinically relevant doses of methyphenidate on spatial memory, behavioral sensitization and open field habituation: a time related study.

    Science.gov (United States)

    Haleem, Darakhshan Jabeen; Inam, Qurrat-ul-Aen; Haleem, Muhammad Abdul

    2015-03-15

    The psychostimulant methylphenidate (MPD) is a first-line drug for the treatment of attention deficit hyperactivity disorder (ADHD). Despite acceptable therapeutic efficacy, there is limited data regarding the long-term consequences of MPD exposure over extended periods. The present study concerns effects of clinically relevant doses of MPD, administered orally to rats for an extended period, on spatial memory, behavioral sensitization and habituation to an open field. Water maze test was used to monitor memory acquisition (2 h after training), retention (day next to training), extinction (1 week after training) and reconsolidation (weekly for 4 weeks). Administration of MPD at doses of 0.25-1.0 mg/kg improved memory acquisition, retention, reconsolidation and impaired memory extinction. Treatment with 0.25 and 0.5 mg/kg MPD for 6 weeks produced a sustained increase in motor activity but higher dose (1.0 mg/kg) elicited behavioral sensitization. High as well as low doses MPD impaired open field habituation. We conclude that clinically relevant doses of MPD enhance memory even if used for extended period. It is suggested that higher (1.0 mg/kg) clinically relevant doses of MPD, if used for extended period, may exacerbate hyperactivity and impulsivity associated with the disease. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Phase II Radiation therapy oncology group trial of weekly paclitaxel and conventional external beam radiation therapy for supratentorial glioblastoma multiforme

    International Nuclear Information System (INIS)

    Langer, Corey J.; Ruffer, James; Rhodes, Harker; Paulus, Rebecca; Murray, Kevin; Movsas, Benjamin; Curran, Walter

    2001-01-01

    Purpose: Fractionated external beam radiotherapy (EBRT) ± carmustine (BCNU) is the standard of care for patients with glioblastoma multiforme (GBM), but survival results remain poor. Preclinical studies indicate synergy between RT and paclitaxel (TAX) in astrocytoma cell lines. Phase I studies in GBM have demonstrated a maximum tolerated dose for TAX of 225 mg/m 2 /3 h/week x 6, during EBRT, with no exacerbation of typical RT-induced toxicities. The Radiation Therapy Oncology Group (RTOG) therefore mounted a Phase II study to determine the feasibility and efficacy of conventional EBRT and concurrent weekly TAX at its MTD. Patients and Methods: Sixty-two patients with histologic diagnosis of GBM were enrolled from 8/16/96 through 3/21/97 in a multi-institutional Phase II trial of EBRT and TAX 225 mg/m 2 /3 h (1-3 h before EBRT), administered the first treatment day of each RT week. Total EBRT dose was 60 Gy (200 cGy/fraction), 5 days per week. A smaller treatment field, to include gross disease plus a margin only, was used after 46 Gy. Results: Sixty-one patients (98%) were evaluable. Median age was 55 years (range, 28-78). Seventy-four percent were ≥50 years. Recursive partitioning analysis (RPA) Classes III, IV, V, VI included 10 (17%), 21 (34%), 25 (41%), and 5 (8%) patients, respectively. Gross total resection was performed in only 16%. There was no Grade 3 or 4 neutropenia or thrombocytopenia. Hypersensitivity reactions precluding further use of TAX occurred in 4 patients. There were 2 instances of late neurotoxicity (4% Grade 3 or 4). Ninety-one percent of patients received treatment per protocol. Seventy-seven percent completed prescribed treatment (6 weeks). Of 35 patients with measurable disease, CR/PR was observed in 23%, MR in 17%, and SD in 43%. Seventeen percent demonstrated progression at first follow-up. Median potential follow-up time is 20 months. Median survival is 9.7 months, with median survivals for RPA classes III, IV, V, and VI of 16.3, 10

  17. Radiation doses due to the natural radioactivity in Pakistan marble

    International Nuclear Information System (INIS)

    Tufail, M.; Iqbal, M.; Mirza, S.M.

    2000-01-01

    In view of its high potential for containing large amounts of radioactive materials and due to its wide-spread use as construction and facing material worldwide, radiation doses received from the marble used in dwellings have been determined. As a first step, specific activity measurements were made using a NaI(TI) gamma ray spectrometer using the spectrum stripping technique. For the samples studied, the average values of specific activities for 226 Ra, 232 Th and 40 K have been found to be 27, 26 and 58 Bg kg -1 respectively. The mesh-adaptive, volume-integral method based code INGRE (Mirza et al. 1991) gave calculated values of the dose equivalent rates inside the standard room (Tufail et al.,1994) due to 226 Ra, 232 Th and 40 K; these were found to lie between 5-77,12-52 and 1-11 nGy h -1 respectively. The values of whole body dose equivalent rates have been found to lie in the 27-108 nGy h -1 range. As these values are below internationally accepted maximum permissible values, therefore marble available in Pakistan can safely be used in dwellings as a construction material. (author)

  18. Handball load and shoulder injury rate: a 31-week cohort study of 679 elite youth handball players.

    Science.gov (United States)

    Møller, M; Nielsen, R O; Attermann, J; Wedderkopp, N; Lind, M; Sørensen, H; Myklebust, G

    2017-02-01

    Knowledge of injury patterns, an essential step towards injury prevention, is lacking in youth handball. To investigate if an increase in handball load is associated with increased shoulder injury rates compared with a minor increase or decrease, and if an association is influenced by scapular control, isometric shoulder strength or glenohumeral range of motion (ROM). 679 players (14-18 years) provided weekly reports on shoulder injury and handball load (training and competition hours) over 31 weeks using the SMS, phone and medical examination system. Handball load in a given week was categorised into (1) 60% relative to the weekly average amount of handball load the preceding 4 weeks. Assessment of shoulder isometric rotational and abduction strength, ROM and scapular control was performed at baseline and midseason. An increase in handball load by >60% was associated with greater shoulder injury rate (HR 1.91; 95% CI 1.00 to 3.70, p=0.05) compared with the reference group. The effect of an increase in handball load between 20% and 60% was exacerbated among players with reduced external rotational strength (HR 4.0; 95% CI 1.1 to 15.2, p=0.04) or scapular dyskinesis (HR 4.8; 95% CI 1.3 to 18.3, p=0.02). Reduced external rotational strength exacerbated the effect of an increase above 60% (HR 4.2; 95% CI 1.4 to 12.8, p=0.01). A large increase in weekly handball load increases the shoulder injury rate in elite youth handball players; particularly, in the presence of reduced external rotational strength or scapular dyskinesis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  19. Coffee consumption and mortality from all causes, cardiovascular disease, and cancer: a dose-response meta-analysis.

    Science.gov (United States)

    Crippa, Alessio; Discacciati, Andrea; Larsson, Susanna C; Wolk, Alicja; Orsini, Nicola

    2014-10-15

    Several studies have analyzed the relationship between coffee consumption and mortality, but the shape of the association remains unclear. We conducted a dose-response meta-analysis of prospective studies to examine the dose-response associations between coffee consumption and mortality from all causes, cardiovascular disease (CVD), and all cancers. Pertinent studies, published between 1966 and 2013, were identified by searching PubMed and by reviewing the reference lists of the selected articles. Prospective studies in which investigators reported relative risks of mortality from all causes, CVD, and all cancers for 3 or more categories of coffee consumption were eligible. Results from individual studies were pooled using a random-effects model. Twenty-one prospective studies, with 121,915 deaths and 997,464 participants, met the inclusion criteria. There was strong evidence of nonlinear associations between coffee consumption and mortality for all causes and CVD (P for nonlinearity Coffee consumption was not associated with cancer mortality. Findings from this meta-analysis indicate that coffee consumption is inversely associated with all-cause and CVD mortality. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. Measurements Of Fingers Doses Of Staff Members In Nuclear Medicine Department

    International Nuclear Information System (INIS)

    AL LEHYANI, S.H.; SHOUSHA, H.A.; HASSAN, R.A.

    2009-01-01

    For some occupationally radiation exposed groups, the hands are more heavily exposed to ionizing radiation than the rest of the body. The Egyptian Atomic Energy Authority runs an extensive personal dosimetry service in Egypt, but finger doses have not been measured to a wide extent. In this study, the finger doses were measured for five different nuclear medicine staff occupational groups for which heavy irradiation of the hands was suspected. Finger doses were measured for nuclear medicine physicians, technologists, nurses and physicists. The nuclear medicine staff working with the radioactive materials wears two TLD dosimeters during the whole period, which lasted from 1 to 4 weeks. The staff performs their work on a regular basis throughout the month, and means annual doses were calculated for these groups. The doses to the fingers for the 99m Tc technologists and nurses of groups (2) and (3) were observed to be 30.24 ± 14.5 μSv/GBq (mean ± SD) and 30.37 ± 17.5 μSv/GBq, respectively. Similarly, the dose to the fingers for the 131 I technologists in group (5) was estimated to be 126.13 ± 38.2μSv/GBq. Finger doses for the physicians could not be calculated per unit of activity because they did not handle the radiopharmaceuticals directly but their doses were reported in millisieverts that accumulated in 1 week. The doses to the fingers of the physicist were 16.3±7.7 μSv/GBq. The maximum average finger dose in this study was found to be 2.8 mSv for the technologists handled therapeutic 131 I (group 5). It could be concluded that the maximum expected annual dose to the extremities appeared to be less than the annual limit (500 mSv/y).

  1. Low-Dose versus Standard-Dose Intravenous Immunoglobulin to Prevent Fetal Intracranial Hemorrhage in Fetal and Neonatal Alloimmune Thrombocytopenia: A Randomized Trial.

    Science.gov (United States)

    Paridaans, Noortje P; Kamphuis, Marije M; Taune Wikman, Agneta; Tiblad, Eleonor; Van den Akker, Eline S; Lopriore, Enrico; Challis, Daniel; Westgren, Magnus; Oepkes, Dick

    2015-01-01

    Pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT) are commonly treated using weekly intravenous immunoglobulin (IVIG) at 1 g/kg maternal weight. IVIG is an expensive multidonor human blood product with dose-related side effects. Our aim was to evaluate the effectiveness of IVIG at a lower dose, i.e., 0.5 g/kg. This was a randomized controlled multicenter trial conducted in Sweden, the Netherlands and Australia. Pregnant women with human platelet antigen alloantibodies and an affected previous child without intracranial hemorrhage (ICH) were enrolled. The participants were randomized to IVIG at 0.5 or 1 g/kg per week. The analyses were per intention to treat. The primary outcome was fetal or neonatal ICH. Secondary outcomes were platelet count at birth, maternal and neonatal IgG levels, neonatal treatment and bleeding other than ICH. A total of 23 women were randomized into two groups (low dose: n = 12; standard dose: n = 11). The trial was stopped early due to poor recruitment. No ICH occurred. The median newborn platelet count was 81 × 10(9)/l (range 8-269) in the 0.5 g/kg group versus 110 × 10(9)/l (range 11-279) in the 1 g/kg group (p = 0.644). The risk of adverse outcomes in FNAIT pregnancies treated with IVIG at 0.5 g/kg is very low, similar to that using 1 g/kg, although our uncompleted trial lacked the power to conclusively prove the noninferiority of using the low dose.

  2. A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: No advantage of loading doses over daily supplementation

    Directory of Open Access Journals (Sweden)

    Farrauto Leonardo

    2011-06-01

    Full Text Available Abstract Background There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients. The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels. Methods In this randomized controlled study, patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario, Canada. Participants were randomized to one of three loading dose groups: placebo; 50,000 IU vitamin D2; or 100,000 IU D2. Following a placebo/loading dose, all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days. Serum 25-hydroxy vitamin D (25-OHD was measured at baseline, discharge from acute care (approximately 4-weeks, and 3-months. Results Sixty-five patients were enrolled in the study (44% male. An immediate rise in 25-OHD occurred in the 100,000 group, however there were no significant differences in 25-OHD between the placebo, 50,000 and 100,000 loading dose groups after 4-weeks (69.3, 84.5, 75.6 nmol/L, p = 0.15 and 3-months (86.7, 84.2, 73.3 nmol/L, p = 0.09, respectively. At the end of the study, approximately 75% of the placebo and 50,000 groups had reached the target therapeutic range (75 nmol/L, and 44% of the 100,000 group. Conclusions In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture, our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2. At the end of the study, all three groups were equally effective in attaining improvement in 25-OHD levels. Given that a daily dose of 1,000 IU vitamin D3 (with or without a loading dose resulted in at least 25% of patients having suboptimal vitamin D status, patients with acute hip fracture may benefit from a higher daily dose of vitamin D. Trial registration Clinical

  3. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: a randomized trial.

    Science.gov (United States)

    Jacobson, Ira M; Brown, Robert S; Freilich, Bradley; Afdhal, Nezam; Kwo, Paul Y; Santoro, John; Becker, Scott; Wakil, Adil E; Pound, David; Godofsky, Eliot; Strauss, Robert; Bernstein, David; Flamm, Steven; Pauly, Mary Pat; Mukhopadhyay, Pabak; Griffel, Louis H; Brass, Clifford A

    2007-10-01

    This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 microg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [<125 IU/mL] serum hepatitis C virus RNA at 24-week follow-up). Sustained virologic response, but not end-of-treatment, rates were significantly higher with weight-based than with flat-dose RBV (44.2% versus 40.5%; P = 0.008). Sustained virologic response rates by intention-to-treat analysis were 34.0% and 28.9%, respectively, in genotype 1 patients (P = 0.005) and 31.2% and 26.7%, respectively, in genotype 1 patients with high baseline viral load (P = 0.056). In genotype 2/3 patients, rates were not significantly different (61.8% and 59.5%, respectively) regardless of treatment duration. Besides greater hemoglobin reductions with weight-based RBV, safety profiles were similar across RBV dosing groups, including the 1400-mg/day group. PEG-IFN alfa-2b plus weight-based RBV is more effective than flat-dose RBV, particularly in genotype 1 patients, providing equivalent efficacy across all weight groups. RBV 1400 mg/day is appropriate for patients 105 to 125 kg. For genotype 2/3 patients, 24 weeks of treatment with flat-dose RBV is adequate; no evidence of additional benefit of extending treatment to 48 weeks was demonstrated.

  4. Effects of single doses of X-rays on renal function in the pig after the irradiation of both kidneys

    International Nuclear Information System (INIS)

    Robbins, M.E.C.; Hopewell, J.W.

    1988-01-01

    Irradiation of a single kidney in the pig with relatively low doses of X-rays, in the order of 8 Gy, produces a pronounced reduction in both glomerular filtration rate (GFR) and effective renal plasma flow (ERPF). This apparent high radiosensitivity may be due, in part, to the compensatory hypertrophy displayed by the contralateral unirradiated kidney. This could suppress any potential for recovery by the irradiated kidney. To test this hypothesis, both kidneys of 14-week-old Large White pigs were sequentially irradiated with single doses of 250 kV X-rays, in the range 8.8 to 12.6 Gy. Two weeks after irradiation, GFR and ERPF increased markedly in all irradiated kidneys; levels then declined in a dose-dependent manner. Following a dose of 8.8 Gy renal haemodynamics returned to control values within 4 weeks of irradiation. After higher doses, GFR and ERPF decreased markedly and remained below control values up to 24 weeks after irradiation. At all doses the mean functional status of irradiated kidneys in animals in which both kidneys were irradiated was significantly greater than that previously observed in the irradiated kidney of pigs in which only one kidney was irradiated. The findings support the above hypothesis, and indicate that individual kidneys in the same animal may differ in their response to a similar nephrotoxic insult. 35 refs.; 6 figs.; 2 tabs

  5. Randomized study comparing full dose monotherapy (S-1 followed by irinotecan) and reduced dose combination therapy (S-1/oxaliplatin followed by S-1/irinotecan) as initial therapy for older patients with metastatic colorectal cancer

    DEFF Research Database (Denmark)

    Winther, Stine Braendegaard; Österlund, Pia; Berglund, Åke

    2017-01-01

    to select which older patients should receive therapy. Methods: The NORDIC 9 trial is a Nordic multicenter randomized phase II study comparing full dose monotherapy (S-1 30 mg/m2 twice daily days 1-14 every 3 weeks, followed by second line irinotecan 250-350 mg/m2 iv day 1 every 3 weeks or 180-250 mg/m2 iv...... day 1 every 2 weeks) with reduced dose combination therapy (S-1 20 mg/m2 days 1-14 + oxaliplatin 100 mg/m2 iv day 1 every 3 weeks, followed by second line S-1 20 mg/m2 days 1-14 + irinotecan 180 mg/m2 day 1 every 3 week) for older patients (≥70 years) with mCRC who are not candidates for full...... chance for tailored treatment strategies in these patients. Trial registration: EU Clinical Trial Register, EudraCT no. 2014-000394-39. Registered 05 May 2014....

  6. Phase i study of 'dose-dense' pemetrexed plus carboplatin/radiotherapy for locally advanced non-small cell lung carcinoma

    International Nuclear Information System (INIS)

    Shen, Xinglei; DeNittis, Albert; Werner-Wasik, Maria; Axelrod, Rita; Gilman, Paul; Meyer, Thomas; Treat, Joseph; Curran, Walter J; Machtay, Mitchell

    2011-01-01

    This phase I study investigates the feasibility of carboplatin plus dose-dense (q2-week) pemetrexed given concurrently with radiotherapy (XRT) for locally advanced and oligometastatic non-small cell lung cancer (NSCLC). Eligible patients had Stage III or IV (oligometastatic) NSCLC. Patients received XRT to 63 Gy in standard fractionation. Patients received concurrent carboplatin (AUC = 6) during weeks 1 and 5 of XRT, and pemetrexed during weeks 1, 3, 5, and 7 of XRT. The starting dose level (level 1) of pemetrexed was 300 mg/m 2 . Following the finding of dose limiting toxicity (DLT) in dose level 1, an amended dose level (level 1A) continued pemetrexed at 300 mg/m 2 , but with involved field radiation instead of extended nodal irradiation. Consolidation consisted of carboplatin (AUC = 6) and pemetrexed (500 mg/m 2 ) q3 weeks × 2 -3 cycles. Eighteen patients were enrolled. Fourteen patients are evaluable for toxicity analysis. Of the initial 6 patients treated on dose level 1, two experienced DLTs (one grade 4 sepsis, one prolonged grade 3 esophagitis). There was one DLT (grade 5 pneumonitis) in the 8 patients treated on dose level 1A. In 16 patients evaluable for response (4 with oligometastatic stage IV disease and 12 with stage III disease), the median follow-up time is 17.8 months. Thirteen of 16 patients had in field local regional response. The actuarial median survival time was 28.6 months in all patients and 34.7 months (estimated) in stage III patients. Concurrent carboplatin with dose-dense (q2week) pemetrexed at 300 mg/m 2 with involved field XRT is feasible and encouraging in patients with locally advanced and oligometastatic NSCLC.

  7. Three-Week Bright-Light Intervention Has Dose-Related Effects on Threat-Related Corticolimbic Reactivity and Functional Coupling

    DEFF Research Database (Denmark)

    Fisher, Patrick M; Madsen, Martin K; Mc Mahon, Brenda

    2014-01-01

    environmental stimuli (e.g., threat) and may underlie these effects. Serotonin signaling modulates this circuit and is implicated in the pathophysiology of seasonal and other affective disorders. METHODS: We evaluated the effects of a bright-light intervention protocol on threat-related corticolimbic reactivity......-related amygdala and prefrontal reactivity in a dose-dependent manner. Conversely, amygdala-prefrontal and intraprefrontal functional coupling increased significantly in a dose-dependent manner. Genotype status significantly moderated bright-light intervention effects on intraprefrontal functional coupling....... CONCLUSIONS: This is the first study to evaluate the effects of clinically relevant bright-light intervention on threat-related brain function. We show that amygdala-prefrontal reactivity and communication are significantly affected by bright-light intervention, an effect partly moderated by genotype...

  8. Primary Human Placental Trophoblasts are Permissive for Zika Virus (ZIKV) Replication.

    Science.gov (United States)

    Aagaard, Kjersti M; Lahon, Anismrita; Suter, Melissa A; Arya, Ravi P; Seferovic, Maxim D; Vogt, Megan B; Hu, Min; Stossi, Fabio; Mancini, Michael A; Harris, R Alan; Kahr, Maike; Eppes, Catherine; Rac, Martha; Belfort, Michael A; Park, Chun Shik; Lacorazza, Daniel; Rico-Hesse, Rebecca

    2017-01-27

    Zika virus (ZIKV) is an emerging mosquito-borne (Aedes genus) arbovirus of the Flaviviridae family. Although ZIKV has been predominately associated with a mild or asymptomatic dengue-like disease, its appearance in the Americas has been accompanied by a multi-fold increase in reported incidence of fetal microcephaly and brain malformations. The source and mode of vertical transmission from mother to fetus is presumptively transplacental, although a causal link explaining the interval delay between maternal symptoms and observed fetal malformations following infection has been missing. In this study, we show that primary human placental trophoblasts from non-exposed donors (n = 20) can be infected by primary passage ZIKV-FLR isolate, and uniquely allowed for ZIKV viral RNA replication when compared to dengue virus (DENV). Consistent with their being permissive for ZIKV infection, primary trophoblasts expressed multiple putative ZIKV cell entry receptors, and cellular function and differentiation were preserved. These findings suggest that ZIKV-FLR strain can replicate in human placental trophoblasts without host cell destruction, thereby serving as a likely permissive reservoir and portal of fetal transmission with risk of latent microcephaly and malformations.

  9. Effectiveness and tolerance of long-term malaria prophylaxis with mefloquine. Need for a better dosing regimen.

    Science.gov (United States)

    Lobel, H O; Bernard, K W; Williams, S L; Hightower, A W; Patchen, L C; Campbell, C C

    1991-01-16

    To measure the effectiveness and tolerance of long-term malaria prophylaxis with mefloquine, the incidence of Plasmodium falciparum malaria and of adverse reactions was compared in Peace Corps volunteers in West Africa who took mefloquine every 2 weeks and in volunteers who took chloroquine phosphate weekly. Mefloquine was only 63% more effective than chloroquine; the monthly incidence of P falciparum infections was one case per 100 volunteers who took mefloquine and 2.7 cases per 100 volunteers who took chloroquine. Using daily proguanil (chloroguanide) hydrochloride in addition to chloroquine did not provide additional protection. All mefloquine prophylaxis failures occurred during the second week of the every-2-weeks dosing regimen in volunteers who had used mefloquine for more than 2 months. Blood concentrations of mefloquine were lower during the second week of the alternate-week regimen than during the first week, suggesting that blood levels are too low during the second week to suppress parasitemia. No serious adverse reactions were observed. The results indicate that a dosing regimen of 250 mg of mefloquine weekly should be considered for travelers to areas with chloroquine-resistant P falciparum malaria.

  10. Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomised, double blind, placebo controlled trial (Aspirin4VLU).

    Science.gov (United States)

    Jull, Andrew; Wadham, Angela; Bullen, Chris; Parag, Varsha; Kerse, Ngaire; Waters, Jill

    2017-11-24

    Objective  To determine the effect of low dose aspirin on ulcer healing in patients with venous leg ulcers. Design  Pragmatic, community based, parallel group, double blind, randomised controlled trial. Setting  Five community nursing centres in New Zealand. Participants  251 adults with venous leg ulcers who could safely be treated with aspirin or placebo: 125 were randomised to aspirin and 126 to placebo. Interventions  150 mg oral aspirin daily or matching placebo for up to 24 weeks treatment, with compression therapy as standard background treatment. Main outcome measures  The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one ulcer was present). Secondary outcomes included proportion of participants healed, change in ulcer area, change in health related quality of life, and adverse events. Analysis was by intention to treat. Results  The median number of days to healing of the reference ulcer was 77 in the aspirin group and 69 in the placebo group (hazard ratio 0.85, 95% confidence interval 0.64 to 1.13, P=0.25). The number of participants healed at the endpoint was 88 (70%) in the aspirin group and 101 (80%) in the placebo group (risk difference -9.8%, 95% confidence interval -20.4% to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm 2 in the aspirin group and 4.8 cm 2 in the placebo group (mean difference -0.7 cm 2 , 95% confidence interval -1.9 to 0.5 cm 2 , P=0.25). 40 adverse events occurred among 29 participants in the aspirin group and 37 adverse events among 27 participants in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7, P=0.71). Conclusion  Our findings do not support the use of low dose aspirin as adjuvant treatment for venous leg ulcers. Trial registration  ClinicalTrials.gov NCT02158806. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. Single visit rabies pre-exposure priming induces a robust anamnestic antibody response after simulated post-exposure vaccination: results of a dose-finding study.

    Science.gov (United States)

    Jonker, Emile F F; Visser, Leonardus G

    2017-09-01

    The current standard 3-dose intramuscular rabies PrEP schedule suffers from a number of disadvantages that severely limit accessibility and availability. The cost of is often prohibitive, it requires 3 visits to the clinic, and there are regular vaccine shortages. Volunteers ( N  = 30) were randomly assigned to 4 study arms: 1 standard dose intramuscular (IM) dose of PVRV (purified Vero cell rabies vaccine, Verorab), and 1/5th, 2/5th or 3/5th- fractional intradermal (ID) dose of PVRV in a single visit. All subjects received a simulated rabies post-exposure prophylaxis (D0, D3) 1 year later. Rabies virus neutralizing antibodies (RVNA) were determined by virus neutralization microtest (FAVN) on D0, D7, D28, Y1 and Y1 + D7. 28 out of 30 subjects (93%) seroconverted 1 month after primary vaccination; 1 subject in the 1-dose IM arm and 1 in the 1/5th-fractional dose ID arm did not. After 1 year, 22 out of 30 subjects (73%) no longer had RVNA above 0.5 IU/ml, with no discernible difference between study groups. After 1 year, all 30 subjects mounted a booster response within 7 days after simulated PEP, with the highest titers found in the single dose IM group ( P  rabies vaccine was sufficient to induce an adequate anamnestic antibody response to rabies PEP in all subjects 1 year later, even in those in whom the RVNA threshold of 0.5 IU/ml was not reached after priming. © International Society of Travel Medicine, 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

  12. The Impact of Different Permissible Exposure Limits on Hearing Threshold Levels Beyond 25 dBA.

    Science.gov (United States)

    Sayapathi, Balachandar S; Su, Anselm Ting; Koh, David

    2014-10-01

    Development of noise-induced hearing loss is reliant on a few factors such as frequency, intensity, and duration of noise exposure. The occurrence of this occupational malady has doubled from 120 million to 250 million in a decade. Countries such as Malaysia, India, and the US have adopted 90 dBA as the permissible exposure limit. According to the US Occupational Safety and Health Administration (OSHA), the exposure limit for noise is 90 dBA, while that of the US National Institute of Occupational Safety and Health (NIOSH) is 85 dBA for 8 hours of noise exposure. This study aimed to assess the development of hearing threshold levels beyond 25 dBA on adoption of 85 dBA as the permissible exposure limit compared to 90 dBA. This is an intervention study done on two automobile factories. There were 203 employees exposed to noise levels beyond the action level. Hearing protection devices were distributed to reduce noise levels to a level between the permissible exposure limit and action level. The permissible exposure limits were 90 and 85 dBA in factories 1 and 2, respectively, while the action levels were 85 and 80 dBA, respectively. The hearing threshold levels of participants were measured at baseline and at first month of postshift exposure of noise. The outcome was measured by a manual audiometer. McNemar and chi-square tests were used in the statistical analysis. We found that hearing threshold levels of more than 25 dBA has changed significantly from pre-intervention to post-intervention among participants from both factories (3000 Hz for the right ear and 2000 Hz for the left ear). There was a statistically significant association between participants at 3000 Hz on the right ear at 'deteriorated' level ( χ² (1) = 4.08, φ = - 0.142, P = 0.043), whereas there was worsening of hearing threshold beyond 25 dBA among those embraced 90 dBA. The adoption of 85 dBA as the permissible exposure limit has preserved hearing threshold level among participants at 3000 Hz

  13. Review of NCRP radiation dose limit for embryo and fetus in occupationally-exposed women

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

    On the basis of the current review, the NCRP has decided to make no change in the current recommendation of its radiation dose limit to the unborn. The NCRP recommendation is restated here as follows: During the entire gestation period, the maximum permissible dose equivalent to the embryo-fetus from occupational exposure of the expectant mother should be 0.5 rem. Since the preparation of the 1971 report there has been no new evidence concerning teratogenic or carcinogenic effects of irradiation of the embryo-fetus that would justify a change in the limit in either direction. It is implicit in this position and recommendation that women who can reasonably be expected to be pregnant should not, in certain instances, be exposed to the same radiation environment as women who are not considered fertile or as men. This applies particularly to conditions where radiation workers can receive dose equivalents of 0.5 rem or more in short periods

  14. Effect of low-dose versus higher-dose antenatal iron supplementation on child health outcomes at 36 months of age in Viet Nam: longitudinal follow-up of a cluster randomised controlled trial.

    Science.gov (United States)

    Hanieh, Sarah; Ha, Tran T; Simpson, Julie A; Braat, Sabine; Thuy, Tran T; Tran, Thach D; King, Janet; Tuan, Tran; Fisher, Jane; Biggs, Beverley-Ann

    2017-01-01

    Intermittent iron-folic acid supplementation (IFA) is currently recommended for pregnant women in populations where anaemia prevalence among pregnant women is Viet Nam among children of 36 months of age, born to women previously enrolled in a cluster randomised controlled trial of antenatal micronutrient supplementation (daily IFA (60 mg elemental iron) vs twice-weekly IFA (60 mg elemental iron) vs twice-weekly multiple micronutrient (MMN) supplementation (60 mg elemental iron)). Primary outcomes were height-for-age z-scores (HAZ), according to WHO growth standards and cognitive composite scores (Bayley Scales of Infant and Toddler Development, third edition) at 36 months of age. A total of 1017 children born to mothers enrolled in the cluster randomised trial were assessed at 36 months of age. Adjusted mean differences (MDs) in HAZ were -0.14 (95% CI -0.28 to -0.01) and -0.15 (95% CI -0.29 to -0.01) in children born to mothers who received twice-weekly IFA or MMN compared with those who received daily IFA. Children born to mothers who received twice-weekly MMN had lower composite motor scores compared with those who received daily IFA (MD -2.07, 95% CI -4.11 to -0.03). There were no differences in composite cognitive scores in the twice-weekly compared with daily regimens. Low-dose antenatal IFA supplementation (120 mg elemental iron per week) resulted in lower HAZ and motor composite scores in children compared with higher-dose antenatal IFA supplementation (420 mg elemental iron per week). This highlights the importance of adequate iron stores during pregnancy and the need for careful monitoring when lower-dose antenatal iron regimens are used. Australia New Zealand Clinical Trials Registry: 12610000944033.

  15. Age-specific doses of lormetazepam as a night sedative in cases of chronic sleep disturbance.

    Science.gov (United States)

    Jovanović, U J; Ott, H; Heidrich, H; Stephan, K; Schratzer, M

    1980-01-01

    Lormetazepam, a new benzodiazepine derivative, was tested under double blind conditions in order to find the optimal dosage for different age groups of out-patients. 120 patients suffering from chronic sleep disturbance were included in the study: a younger group (age 20 to 55) and an older group (age 56 to 85 years). Four different doses were given to each age group: 0.5, 1.0, 2.0, and 3.0 mg to the younger group and 0.5, 1.0, 1.5, and 2.0 mg to the older group. A pre-placebo week (i.e. when all patients received placebo) in which baseline data were recorded preceded the two verum weeks, and these were followed by a post-placebo or withdrawal week (again all patients receiving placebo). The level of significance accepted for statistical decisions was alpha = 0.05. No differences in effects between the different doses were observed with regard to sleep pattern variables (sleep latency, sleep duration, frequency of awakenings, sleep quality, occurrence of 'bad' dreams) with the exception of sleep quality which was better in the older group than in the younger group after 0.5 mg in week 2. Considerable differences with regard to hangover feelings the next morning and during the next day (morning feelings, tranquility, alertness, and concentration), comparison of the effects of discontinuing therapy upon the above-mentioned sleep pattern variables and small differences in side effects--which were few--led to the following conclusion: --0.5 mg stood out as the best dose for the older group. --None of the dosages given to the younger group emerged clearly as superior. However, it would seem that the 1 mg dose should be the dose recommended, since fewer unfavourable scores and side effects appeared after this dose.

  16. A study on the effect of low doses gamma radiation on mushroom spawn

    International Nuclear Information System (INIS)

    Ajlouni, Said

    1993-03-01

    Mushroom spawn (Hybrid-521) was irradiated at room temperature using low doses of gamma radiation (50-600 rad). The spawn was then planted at two stages; first, after 24 hours of irradiation, and second after storage for three weeks at refrigeration temperature. Results of this study showed that the applied doses of gamma radiation did not have any stimulatory effect on mushroom growth or productivity. It was also noticed that mushroom production rate decreased when irradiated spawn was stored for three weeks prior to planting, as compared with spawn planted 24 hours after irradiation. (author). 18 refs., 2 figs., 2 tabs

  17. Student Learning with Permissive and Restrictive Cell Phone Policies: A Classroom Experiment

    Science.gov (United States)

    Lancaster, Alexander L.

    2018-01-01

    Based on Finn and Ledbetter's (2013; 2014) work regarding classroom technology policies, this experimental study examined the implementation of a permissive and a restrictive cellular phone policy and the effect of these policies on students' cognitive and affective learning in two sections of a public speaking course. College students (N = 31)…

  18. Randomized Clinical Trial of Weekly vs. Triweekly Cisplatin-Based Chemotherapy Concurrent With Radiotherapy in the Treatment of Locally Advanced Cervical Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Ryu, Sang-Young, E-mail: ryu@kcch.re.kr [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Lee, Won-Moo; Kim, Kidong [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Park, Sang-Il [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of); Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol [Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Cho, Chul-Koo [Department of Radiation Oncology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of); Nam, Byung-Ho [Cancer Biostatistics Branch, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Lee, Eui-Don [Department of Gynecologic Oncology, Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of)

    2011-11-15

    Purpose: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. Methods and Materials: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m{sup 2}, six cycles) and triweekly (cisplatin 75 mg/m{sup 2} every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years. Results: All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03). Conclusions: Triweekly cisplatin 75-mg/m{sup 2} chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m{sup 2} regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.

  19. Minimal doses of hydroxyurea for sickle cell disease

    Directory of Open Access Journals (Sweden)

    C.S.P. Lima

    1997-08-01

    Full Text Available The use of hydroxyurea (HU can improve the clinical course of sickle cell disease. However, several features of HU treatment remain unclear, including the predictability of drug response and determination of adequate doses, considering positive responses and minimal side effects. In order to identify adequate doses of HU for treatment of sickle cell disease, 10 patients, 8 with sickle cell anemia and 2 with Sß thalassemia (8SS, 2Sß, were studied for a period of 6 to 19 months in an open label dose escalation trial (10 to 20 mg kg-1 day-1. Hemoglobin (Hb, fetal hemoglobin (Hb F and mean corpuscular volume (MCV values and reticulocyte, neutrophil and platelet counts were performed every two weeks during the increase of the HU dose and every 4 weeks when the maximum HU dose was established. Reduction in the number of vasoocclusive episodes was also considered in order to evaluate the efficiency of the treatment. The final Hb and Hb F concentrations, and MCV values were significantly higher than the initial values, while the final reticulocyte and neutrophil counts were significantly lower. There was an improvement in the concentration of Hb (range: 0.7-2.0 g/dl at 15 mg HU kg-1 day-1, but this concentration did not increase significantly when the HU dose was raised to 20 mg kg-1 day-1. The concentration of Hb F increased significantly (range: 1.0-18.1% when 15 mg HU was used, and continued to increase when the dose was raised to 20 mg kg-1 day-1. The final MCV values increased 11-28 fl (femtoliters. However, reticulocyte (range: 51-205 x 109/l and neutrophil counts (range: 9.5-1.3 x 109/l obtained at this dose were significantly lower than those obtained with 15 mg kg-1 day-1. All patients reported a decrease in frequency or severity of vasoocclusive episodes. These results suggest that a hydroxyurea dose of 15 mg kg-1 day-1 seems to be adequate for treatment of sickle cell disease in view of the minimal side effects observed and the improvement

  20. Dose: Comparison of 6 and 12 Nutrition and Physical Activity Sessions Targeting Middle School Adolescents

    Directory of Open Access Journals (Sweden)

    Mical Kay Shilts

    2009-12-01

    Full Text Available Determining optimal intervention dose to meet time constraints of the teacher while maximizing behavioral impact for students has proven challenging. This study investigated the influence of intervention dose on 7th & 8th grade participants’ dietary and physical activity (PA behaviors. Participants were assigned randomly to a: 1 6 week-12 session nutrition intervention [treatment#1], or 2 3 week-6 session nutrition intervention [treatment#2] with data collected pre/post intervention. Using ANCOVA, measures assessed dietary and PA self-efficacy and behaviors. Ethnically diverse participants (n=107 were included in the analyses (46% male. All students set two goals: one dietary and one PA regardless of dose. Treatment#1 resulted in similar outcomes compared to treatment#2 with no significant differences between groups. As a result, we recommend that teachers using the 12 week intervention give students the option of setting new goals after the 6th lesson to maintain motivation.

  1. Weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Hu Wei; Ding Weijun; Yang Haihua; Shao Minghai; Wang Biyun; Wang Jianhua; Wu Sufang; Wu Shixiu; Jin Lihui; Ma, Charlie C.-M.

    2009-01-01

    Purpose: To evaluate the efficacy and toxicity of weekly paclitaxel with concurrent radiotherapy followed by adjuvant chemotherapy (AC) in patients with locally advanced nasopharyngeal carcinoma (NPC). Methods and materials: Between 2004 and 2007, 54 patients with locally advanced NPC were included in this protocol. Patient characteristics: median age 48; 69% male; 52% World Health Organization (WHO) III; 50% stage III, 50% stage IV. The patients underwent a course of definitive conventional radiotherapy (70 Gy in 7 weeks with 2 Gy/fraction), with concurrent weekly paclitaxel 35 mg/m 2 from the first to the sixth week of radiation. AC was started 4 weeks after the end of the radiotherapy (RT), paclitaxel 135 mg/m 2 on day 1 and cisplatin 30 mg/m 2 on days 1-3 were administered every 4 weeks for two cycles. Results: Median follow-up was 32 months. Eighty-five percentage of complete response and 15% partial response were achieved at the time of one month after AC. The 3-year actuarial rate of local regional control was 86%; distant metastases-free survival, progression-free survival and overall survival at 3 years were 81%, 69% and 76%, respectively. Forty-nine (91%) patients completed six courses of concurrent chemotherapy with weekly paclitaxel, and 4 (7%) patients delayed at the second cycle of AC. No patient developed severe acute toxicities. Conclusions: Weekly paclitaxel with concurrent RT followed by AC is a potentially effective and toxicity tolerable method for locally advanced NPC. Further studies are needed to identify the optimal dose of weekly paclitaxel in this strategy.

  2. Effects of split-dose irradiation of the rabbit's eye - a histopathological study

    International Nuclear Information System (INIS)

    Grabenbauer, G.G.

    1987-01-01

    Thirty-six rabbits were included in a study investigating into the effects of split-dose 300 KV X-irradiation on the cornea, ciliary body, nictitating membrane and lacrimal gland. In each animal, soly the right the eye was irradiated using total doses of 21 Gy, 30 Gy, 36 Gy and 45 Gy that were administered according to a fixed schedule in fractions of 3 Gy five times per week. After latency periods of six weeks, three months and six months the animals receiving 21 Gy, 30 Gy and 36 Gy showed no changes of the bulbi, eye lids and lacrimal glands that could be ascertained by histopathological evaluation. In the animals exposed to the 45 Gy dose, changes of the cornea and conjunctiva caused by radiation injuries to the lacrimal glands and conjunctival goblet cells started to appear after a minimum period of 3 months. This dose level was also the threshold for the occurrence of corneal damage or even ulceration as a result of secondary reduction or qualitative change of lacrimal secretions. (ECB) [de

  3. Primary experiment aimed at selecting the suitable dose to mutation induction in two soybean cultivars

    International Nuclear Information System (INIS)

    Nabulsi, I.; Mir Ali, N

    1991-07-01

    Seeds from two soybean [Glycine Max L. (Merrill)] cultivars K-25 and K-38 were irradiated with the following doses of gamma rays: 100, 150, 200, 250, 300, 350, 400 and 500 Gy. The dose rate was 9.25 Gy/minute. A week after irradiation 25 seeds were sown from each variety in pots (26.5 x 26.5 cm) with 4 replicates in a randomized complete block design under greenhouse conditions. The distance between the cotyledon and the first leaf was measured 4 weeks after sowing and the results showed stimualtion effect in the 100 and 150 Gy doses in comparison to the control whereas in the higher doses, a gradual reduction was realized in addition to the appearance of the necrotic spots on the leaves which was increased in percentages along with the dose. The results indicated that doses between 100 and 200 Gy achieved the highest rate of mutations with minimal rate of lethality hence achieving the aim of this preliminary experiment. (author). 5 refs., 2 tabs., 2 figs

  4. Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Fujii, Masato; Tsukuda, Mamoru; Kubota, Akira; Kida, Akinori; Okami, Kenji

    2003-01-01

    Docetaxel (DOC) is one of the most promising drugs for head and neck cancer (HNSCC). A phase I/II trial of concurrent DOC and radiation for HNSCC was conducted to estimate the recommended dose schedule of DOC, and then to evaluate the therapeutic benefit based on the response and toxicity of the recommended dose schedule. Patients with squamous cell carcinomas of the head and neck were entered. All the patients received radiation with 2.0 Gy single daily fractions up to 60 Gy. DOC was administered weekly for 6 consecutive weeks during radiotherapy. Dose-limiting toxicities, grade 3/4 mucositis and grade 3 pain, manifested in four patients in level 2, and that dose of DOC, 15 mg/m 2 , was considered the maximum tolerated dose (MTD). The recommended dose was decided as 10 mg/m 2 . The phase II study was conducted using DOC at 10 mg/m 2 . Thirty-nine patients with stage II, III or IV were registered, and 35 patients were eligible, 32 patients were evaluable for the response and 34 patients for the toxicity. The overall response rate was 96.9%. The prognoses of the complete response (CR) patients were statistically better than for the partial response (PR) patients. Grade 3 or 4 adverse events consisted of lymphopenia in 64.7%, mucositis in 41.2% and anorexia in 20.6% of the patients. Thirty-two of the 35 eligible patients showed high compliance of over 90%, and their toxicities were manageable. Even low-dose DOC shows a strong effect on HNSCC in combination with radiation, with high survival rates in CR patients. The effect on survival will be assessed by further follow-up. (author)

  5. Clinical Factors Associated With Dose Escalation of Solifenacin for the Treatment of Overactive Bladder in Real Life Practice

    Directory of Open Access Journals (Sweden)

    Ji-Youn Chun

    2014-03-01

    Full Text Available PurposeTo determine the baseline clinical characteristics associated with dose escalation of solifenacin in patients with overactive bladder (OAB.MethodsWe analyzed the data of patients with OAB (micturition frequency ≥8/day and urgency ≥1/day who were treated with solifenacin and followed up for 24 weeks. According to our department protocol, all the patients kept voiding diaries, and OAB symptom scores (OABSS were monitored at baseline and after 4, 12, and 24 weeks of solifenacin treatment.ResultsIn total, 68 patients (mean age, 60.8±10.0 years were recruited. The dose escalation rate by the end of the study was 41.2%, from 23.5% at 4 weeks and 17.6% at 12 weeks. At baseline, the dose escalator group had significantly more OAB wet patients (53.6% vs. 20.0% and higher total OABSS (10.2±2.4 vs. 7.9±3.5, P=0.032 than the nonescalator group. OAB wet (odds ratio [OR], 4.615; 95% confidence interval [CI], 1.578-13.499; P<0.05 and total OABSS (OR, 1.398; 95% CI, 1.046-1.869; P<0.05 were found to be independently associated with dose escalation.ConclusionsPatients who have urgency urinary incontinence and high total OABSS have a tendency for dose escalation of solifenacin.

  6. Dose escalation using conformal high-dose-rate brachytherapy improves outcome in unfavorable prostate cancer

    International Nuclear Information System (INIS)

    Martinez, Alvaro A.; Gustafson, Gary; Gonzalez, Jose; Armour, Elwood; Mitchell, Chris; Edmundson, Gregory; Spencer, William; Stromberg, Jannifer; Huang, Raywin; Vicini, Frank

    2002-01-01

    Purpose: To overcome radioresistance for patients with unfavorable prostate cancer, a prospective trial of pelvic external beam irradiation (EBRT) interdigitated with dose-escalating conformal high-dose-rate (HDR) prostate brachytherapy was performed. Methods and Materials: Between November 1991 and August 2000, 207 patients were treated with 46 Gy pelvic EBRT and increasing HDR brachytherapy boost doses (5.50-11.5 Gy/fraction) during 5 weeks. The eligibility criteria were pretreatment prostate-specific antigen level ≥10.0 ng/mL, Gleason score ≥7, or clinical Stage T2b or higher. Patients were divided into 2 dose levels, low-dose biologically effective dose 93 Gy (149 patients). No patient received hormones. We used the American Society for Therapeutic Radiology and Oncology definition for biochemical failure. Results: The median age was 69 years. The mean follow-up for the group was 4.4 years, and for the low and high-dose levels, it was 7.0 and 3.4 years, respectively. The actuarial 5-year biochemical control rate was 74%, and the overall, cause-specific, and disease-free survival rate was 92%, 98%, and 68%, respectively. The 5-year biochemical control rate for the low-dose group was 52%; the rate for the high-dose group was 87% (p<0.001). Improvement occurred in the cause-specific survival in favor of the brachytherapy high-dose level (p=0.014). On multivariate analysis, a low-dose level, higher Gleason score, and higher nadir value were associated with increased biochemical failure. The Radiation Therapy Oncology Group Grade 3 gastrointestinal/genitourinary complications ranged from 0.5% to 9%. The actuarial 5-year impotency rate was 51%. Conclusion: Pelvic EBRT interdigitated with transrectal ultrasound-guided real-time conformal HDR prostate brachytherapy boost is both a precise dose delivery system and a very effective treatment for unfavorable prostate cancer. We demonstrated an incremental beneficial effect on biochemical control and cause

  7. Efficacy of fix dose combination (atorvastatin and amlodipine) in treatment of uncontrolled hypertension and dyslipidemia

    International Nuclear Information System (INIS)

    Bashir, S.; Sherwani, M.U.K.; Batool, A.

    2012-01-01

    The fixed-dose combination containing the antihypertensive agent amlodipine and the statin, atorvastatin, is the first combination of its kind designed to treat two risk factors for cardiovascular disease (CVD), i.e., hypertension and dyslipidemia. in this study, blood pressure and lipid lowering effects of combination of amlodipine and atorvastatin were evaluated in uncontrolled hypertensive patients. Methods: Thirty patients both male and female in the age group 35-60 years attending the hypertensive clinic of PMRC FJMC suffering from uncontrolled hypertension were selected. baseline blood pressure was checked after half hour rest in sitting and standing position using mercury sphygmomanometer. Blood sample was collected from all patients after overnight fasting for assessment of serum cholesterol, triglycerides, LDL and HDL cholesterol levels. they were prescribed with fixed dose combination of 5 mg amlodipine and 10 mg atorvastatin. Patients were followed for their blood pressure measurement after every 4 weeks up to 12 weeks. At the end of 12 weeks their fasting blood sample was taken again for determination of serum cholesterol, triglyceride, IDL and HDL cholesterol levels. Results: Systolic blood pressure after 4, 8 and 12 weeks was significantly lower at all intervals from baseline. when systolic blood pressure after 8 and 12 weeks was compared with 4 weeks, the effect was again significant (p=0.024, p=0.002 respectively). There was no significant reduction seen in 8 versus 12 weeks (p=0.493). Diastolic blood pressure at 4, 8 and 12 weeks was significantly lower from baseline. Diastolic blood pressure after 4 and 8 weeks when compared with 8 and 12 weeks was not significantly low (p=0.99 and 0.91 respectively). Lipid profile of the patients was significantly reduced from baseline after twelve weeks of fixed dose combination of treatment (p<0.000). Conclusion: Combination therapy proved to be effective in controlling hypertension and dyslipidemia than single

  8. Efficacy of fix dose combination (atorvastatin and amlodipine) in treatment of uncontrolled hypertension and dyslipidemia

    Energy Technology Data Exchange (ETDEWEB)

    Bashir, S; Sherwani, M U.K.; Batool, A [Fatima Jinnah Medical College, Lahore (Pakistan)

    2012-07-15

    The fixed-dose combination containing the antihypertensive agent amlodipine and the statin, atorvastatin, is the first combination of its kind designed to treat two risk factors for cardiovascular disease (CVD), i.e., hypertension and dyslipidemia. in this study, blood pressure and lipid lowering effects of combination of amlodipine and atorvastatin were evaluated in uncontrolled hypertensive patients. Methods: Thirty patients both male and female in the age group 35-60 years attending the hypertensive clinic of PMRC FJMC suffering from uncontrolled hypertension were selected. baseline blood pressure was checked after half hour rest in sitting and standing position using mercury sphygmomanometer. Blood sample was collected from all patients after overnight fasting for assessment of serum cholesterol, triglycerides, LDL and HDL cholesterol levels. they were prescribed with fixed dose combination of 5 mg amlodipine and 10 mg atorvastatin. Patients were followed for their blood pressure measurement after every 4 weeks up to 12 weeks. At the end of 12 weeks their fasting blood sample was taken again for determination of serum cholesterol, triglyceride, IDL and HDL cholesterol levels. Results: Systolic blood pressure after 4, 8 and 12 weeks was significantly lower at all intervals from baseline. when systolic blood pressure after 8 and 12 weeks was compared with 4 weeks, the effect was again significant (p=0.024, p=0.002 respectively). There was no significant reduction seen in 8 versus 12 weeks (p=0.493). Diastolic blood pressure at 4, 8 and 12 weeks was significantly lower from baseline. Diastolic blood pressure after 4 and 8 weeks when compared with 8 and 12 weeks was not significantly low (p=0.99 and 0.91 respectively). Lipid profile of the patients was significantly reduced from baseline after twelve weeks of fixed dose combination of treatment (p<0.000). Conclusion: Combination therapy proved to be effective in controlling hypertension and dyslipidemia than single

  9. Implications of the quadratic cell survival curve and human skin radiation ''tolerance doses'' on fractionation and superfractionation dose selection

    International Nuclear Information System (INIS)

    Douglas, B.G.

    1982-01-01

    An analysis of early published multifraction orthovoltage human acute skin irradiation tolerance isoeffect doses is presented. It indicates that human acute skin radiation reactions may result from the repetition, with each dose fraction, of a cell survival curve of the form: S = e/sup -(αD + βD 2 )/). The analysis also shows no need for an independent proliferation related time factor for skin, for daily treatments of six weeks or less in duration. The value obtained for the constant β/α for orthovoltage irradiation from these data is 2.9 x 10 -3 rad -1 for the cell line determining acute skin tolerance. A radiation isoeffect relationship, based on the quadratic cell survival curve, is introduced for human skin. This relationship has some advantages over the nominal standard dose (NSD). First, its use is not restricted to tolerance level reactions. Second, a modification of the relationship, which is also introduced, may be employed in the selection of doses per treatment when irradiation dose fractions are administered at short intervals where repair of sublethal injury is incomplete

  10. A Phase 1 Study of Everolimus + Weekly Cisplatin + Intensity Modulated Radiation Therapy in Head-and-Neck Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Fury, Matthew G. [Department of Medicine, Head and Neck Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Department of Medicine, Weill Cornell Medical College, New York, New York (United States); Lee, Nancy Y. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Sherman, Eric; Ho, Alan L. [Department of Medicine, Head and Neck Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Department of Medicine, Weill Cornell Medical College, New York, New York (United States); Rao, Shyam [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Heguy, Adriana [Department of Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Shen, Ronglai [Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Korte, Susan; Lisa, Donna [Department of Medicine, Head and Neck Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Ganly, Ian; Patel, Snehal; Wong, Richard J.; Shaha, Ashok; Shah, Jatin [Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Haque, Sofia [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Katabi, Nora [Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Pfister, David G. [Department of Medicine, Head and Neck Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Department of Medicine, Weill Cornell Medical College, New York, New York (United States)

    2013-11-01

    Purpose: Elevated expression of eukaryotic protein synthesis initiation factor 4E (eIF4E) in histologically cancer-free margins of resected head and neck squamous cell carcinomas (HNSCCs) is mediated by mammalian target of rapamycin complex 1 (mTORC1) and has been associated with increased risk of disease recurrence. Preclinically, inhibition of mTORC1 with everolimus sensitizes cancer cells to cisplatin and radiation. Methods and Materials: This was single-institution phase 1 study to establish the maximum tolerated dose of daily everolimus given with fixed dose cisplatin (30 mg/m{sup 2} weekly × 6) and concurrent intensity modulated radiation therapy for patients with locally and/or regionally advanced head-and-neck cancer. The study had a standard 3 + 3 dose-escalation design. Results: Tumor primary sites were oral cavity (4), salivary gland (4), oropharynx (2), nasopharynx (1), scalp (1), and neck node with occult primary (1). In 4 of 4 cases in which resected HNSCC surgical pathology specimens were available for immunohistochemistry, elevated expression of eIF4E was observed in the cancer-free margins. The most common grade ≥3 treatment-related adverse event was lymphopenia (92%), and dose-limiting toxicities (DLTs) were mucositis (n=2) and failure to thrive (n=1). With a median follow up of 19.4 months, 2 patients have experienced recurrent disease. The maximum tolerated dose was everolimus 5 mg/day. Conclusions: Head-and-neck cancer patients tolerated everolimus at therapeutic doses (5 mg/day) given with weekly cisplatin and intensity modulated radiation therapy. The regimen merits further evaluation, especially among patients who are status post resection of HNSCCs that harbor mTORC1-mediated activation of eIF4E in histologically negative surgical margins.

  11. A Phase 1 Study of Everolimus + Weekly Cisplatin + Intensity Modulated Radiation Therapy in Head-and-Neck Cancer

    International Nuclear Information System (INIS)

    Fury, Matthew G.; Lee, Nancy Y.; Sherman, Eric; Ho, Alan L.; Rao, Shyam; Heguy, Adriana; Shen, Ronglai; Korte, Susan; Lisa, Donna; Ganly, Ian; Patel, Snehal; Wong, Richard J.; Shaha, Ashok; Shah, Jatin; Haque, Sofia; Katabi, Nora; Pfister, David G.

    2013-01-01

    Purpose: Elevated expression of eukaryotic protein synthesis initiation factor 4E (eIF4E) in histologically cancer-free margins of resected head and neck squamous cell carcinomas (HNSCCs) is mediated by mammalian target of rapamycin complex 1 (mTORC1) and has been associated with increased risk of disease recurrence. Preclinically, inhibition of mTORC1 with everolimus sensitizes cancer cells to cisplatin and radiation. Methods and Materials: This was single-institution phase 1 study to establish the maximum tolerated dose of daily everolimus given with fixed dose cisplatin (30 mg/m 2 weekly × 6) and concurrent intensity modulated radiation therapy for patients with locally and/or regionally advanced head-and-neck cancer. The study had a standard 3 + 3 dose-escalation design. Results: Tumor primary sites were oral cavity (4), salivary gland (4), oropharynx (2), nasopharynx (1), scalp (1), and neck node with occult primary (1). In 4 of 4 cases in which resected HNSCC surgical pathology specimens were available for immunohistochemistry, elevated expression of eIF4E was observed in the cancer-free margins. The most common grade ≥3 treatment-related adverse event was lymphopenia (92%), and dose-limiting toxicities (DLTs) were mucositis (n=2) and failure to thrive (n=1). With a median follow up of 19.4 months, 2 patients have experienced recurrent disease. The maximum tolerated dose was everolimus 5 mg/day. Conclusions: Head-and-neck cancer patients tolerated everolimus at therapeutic doses (5 mg/day) given with weekly cisplatin and intensity modulated radiation therapy. The regimen merits further evaluation, especially among patients who are status post resection of HNSCCs that harbor mTORC1-mediated activation of eIF4E in histologically negative surgical margins

  12. Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

    International Nuclear Information System (INIS)

    Holtmann, Henrik; Niewald, Marcus; Prokein, Benjamin; Graeber, Stefan; Ruebe, Christian

    2015-01-01

    An actual clinical trial showed the effect of low dose radiotherapy in painful heel spur (plantar fasciitis) with single doses of 1.0 Gy and total doses of 6.0 Gy applied twice weekly. Furthermore, a lot of animal experimental and in vitro data reveals the effect of lower single doses of 0.5 Gy which may be superior in order to ease pain and reduce inflammation in patients with painful heel spur. Our goal is therefore to transfer this experimentally found effect into a randomized multicenter trial. This was a controlled, prospective, two-arm phase III-multicenter trial. The standard arm consisted of single fractions of 1.0 Gy applied two times a week, for a total dose of 6.0 Gy (total therapy time: 3 weeks). The experimental arm consisted of single fractions of 0.5 Gy applied 3 times a week, for a total dose of 6.0 Gy (total therapy time: 4 weeks). Following a statistical power calculation, there were 120 patients for each investigation arm. The main inclusion criteria were: age > = 40 years, clinical and radiologically diagnosed painful heel spur (plantar fasciitis), and current symptoms for at least 6 months. The main exclusion criteria were: former local trauma, surgery or radiotherapy of the heel; pregnant or breastfeeding women; and a pre-existing severe psychiatric or psychosomatic disorder. After approving a written informed consent the patients are randomized by a statistician into one of the trial arms. After radiotherapy, the patients are seen after six weeks, after twelve weeks and then every twelve weeks up to 48 weeks. Additionally, they receive a questionnaire every six weeks after the follow-up examinations up to 48 weeks. The effect is measured using the visual analogue scale of pain (VAS), the calcaneodynia score according to Rowe and the SF-12 score. The primary endpoint is the pain relief three months after therapy. Patients of both therapy arms with an insufficient result are offered a second radiotherapy series applying the standard dose

  13. Correlation between dose and tumor response in the radiotherapy of lung cancer of various histological types

    International Nuclear Information System (INIS)

    Koga, Kenji; Kusuhara, Toshiyuki; Nishikawa, Kiyoshi; Asada, Keiko; Watanabe, Katsushi

    1984-01-01

    Correlation between dose and tumor response by cell types was determined in 50 patients with lung cancer in order to predict the possibility of further tumor regression. The TDF (time-dose-fractionation) concept was used as dose factor. The radiation source was a cobalt-60 γ-ray or linear accelerator 10 MV X-ray. As a routine regime a fraction dose of 2 Gy five times per week was given to 39 of the 50 patients, but a dose of 2 Gy three times per week or of 1.5 Gy five times per week was given to seven and four patients, respectively. Radiation response was the best in small cell carcinoma and better in adenocarcinoma than in squamous cell carcinoma, showing a tumor regression rate of 50% or more in 90%, 80% and 58% of the patients, respectively. The correlation between tumor regression rate and TDF values was good in squamous cell carcinoma (r = 0.73) and small cell carcinoma (r = - 0.72), but poor in adenocarcinoma (r = - 0.10). These results suggest that in squamous cell carcinoma improvement of tumor regression can be expected by increasing TDF values, and in adenocarcinoma and small cell carcinoma the optimal TDF values are about 100 and 60 to 80, respectively. (author)

  14. Dose and time dependent ototoxicity of aspartame in rats.

    Science.gov (United States)

    Ozturan, Orhan; Dogan, Remzi; Tugrul, Selahattin; Gedik, Ozge; Sjostrand, Alev Pektas; Yildirim, Yavuz Selim

    2017-04-01

    Low-dose administration of Aspartame (Ap) did not produce a significant ototoxic effect at the end of the 6th month. However, duration of the ototoxic effect is shortened and severity of the effect is increased as dose and duration of Ap administration is increased. While Ap toxicity has been studied in short- and long-term studies, its effects on hearing have not been investigated. This study was conducted to evaluate the effects of long-term consumption of Ap administered in various doses on hearing status of rats. The study included 54 female Wistar Albino rats. Ap was given for 6 months to the rats. The groups were assigned according to levels of Ap dosage. DPOAE and ABR tests were utilized for serial hearing evaluations. Serial hearing measurement times were designed as baseline, 1st week, 2nd week, 1st, 2nd, 3rd, and 6th months. While audiological parameters deteriorated with 100 mg/kg/day dose after the 3rd month, ABR thresholds were elevated and DPOAE values were significantly decreased in 500 mg/kg/day and 1000 mg/kg/day applications after the 2nd month. In 2000 mg/kg/day and 4000 mg/kg/day applications, deteriorations in audiological parameters were detected as early as the first and second months; respectively.

  15. Expected treatment dose construction and adaptive inverse planning optimization: Implementation for offline head and neck cancer adaptive radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Yan Di; Liang Jian [Department of Radiation Oncology, Beaumont Health System, Royal Oak, Michigan 48073 (United States)

    2013-02-15

    Purpose: To construct expected treatment dose for adaptive inverse planning optimization, and evaluate it on head and neck (h and n) cancer adaptive treatment modification. Methods: Adaptive inverse planning engine was developed and integrated in our in-house adaptive treatment control system. The adaptive inverse planning engine includes an expected treatment dose constructed using the daily cone beam (CB) CT images in its objective and constrains. Feasibility of the adaptive inverse planning optimization was evaluated retrospectively using daily CBCT images obtained from the image guided IMRT treatment of 19 h and n cancer patients. Adaptive treatment modification strategies with respect to the time and the number of adaptive inverse planning optimization during the treatment course were evaluated using the cumulative treatment dose in organs of interest constructed using all daily CBCT images. Results: Expected treatment dose was constructed to include both the delivered dose, to date, and the estimated dose for the remaining treatment during the adaptive treatment course. It was used in treatment evaluation, as well as in constructing the objective and constraints for adaptive inverse planning optimization. The optimization engine is feasible to perform planning optimization based on preassigned treatment modification schedule. Compared to the conventional IMRT, the adaptive treatment for h and n cancer illustrated clear dose-volume improvement for all critical normal organs. The dose-volume reductions of right and left parotid glands, spine cord, brain stem and mandible were (17 {+-} 6)%, (14 {+-} 6)%, (11 {+-} 6)%, (12 {+-} 8)%, and (5 {+-} 3)% respectively with the single adaptive modification performed after the second treatment week; (24 {+-} 6)%, (22 {+-} 8)%, (21 {+-} 5)%, (19 {+-} 8)%, and (10 {+-} 6)% with three weekly modifications; and (28 {+-} 5)%, (25 {+-} 9)%, (26 {+-} 5)%, (24 {+-} 8)%, and (15 {+-} 9)% with five weekly modifications. Conclusions

  16. Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)†,.

    Science.gov (United States)

    Kaufhold, N; Schaller, S J; Stäuble, C G; Baumüller, E; Ulm, K; Blobner, M; Fink, H

    2016-02-01

    The aim of this dose-finding study was to evaluate the dose-response relationship of sugammadex and neostigmine to reverse a commonly observed level of incomplete recovery from rocuronium-induced neuromuscular block, that is, a train-of-four ratio (TOFR) ≥0.2. Ninety-nine anaesthetized patients received rocuronium 0.6 mg kg(-1) i.v. for tracheal intubation and, if necessary, incremental doses of 0.1-0.2 mg kg(-1). Neuromuscular monitoring was performed by calibrated electromyography. Once the TOFR recovered to 0.2, patients were randomized to receive sugammadex (0.25, 0.5, 0.75, 1.0, or 1.25 mg kg(-1) i.v.), neostigmine (10, 25, 40, 55, or 70 µg kg(-1) i.v.), or saline (n=9 per group). Primary and secondary end points were the doses necessary to restore neuromuscular function to a TOFR≥0.9 with an upper limit of 5 and 10 min for 95% of patients, respectively. Neostigmine was not able to fulfil the end points. Based on the best-fitting model, the sugammadex dose estimation for recovery to a TOFR≥0.9 for 95% of patients within 5 and 10 min was 0.49 and 0.26 mg kg(-1), respectively. A residual neuromuscular block of a TOFR of 0.2 cannot be reversed reliably with neostigmine within 10 min. In the conditions studied, substantially lower doses of sugammadex than the approved dose of 2.0 mg kg(-1) may be sufficient to reverse residual rocuronium-induced neuromuscular block at a recovery of TOFR≥0.2. NCT01006720. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. [Neonatal meningitis due to Listeria monocytogenes after 3 weeks of maternal treatment during pregnancy].

    Science.gov (United States)

    Fayol, L; Beizig, S; Le Monnier, A; Lacroze, V; Simeoni, U

    2009-04-01

    We report the case of a pregnant woman with listeriosis at 26 gestational weeks followed by premature labor at 30 gestational weeks. Bacterial meningitis was suspected in the neonate with ventriculitis on sonography, a high level of protein in the cerebrospinal fluid (CSF), and an identified specific bacterial genome of Listeria monocytogenes (PCR 16S rDNA and sequencing and specific amplification of L. monocytogenes hly gene) in CSF. Neonatal meningitis was complicated with cerebral venous sinus thrombosis and ventriculomegaly. Listeriosis during pregnancy can lead to severe complications in the neonate. Thus, listeriosis should be a diagnostic concern in febrile pregnant women at any stage of pregnancy. First-line treatment is based on high-dose amoxicillin (> or =6g/day) and must be used for at least 3 weeks for treatment of listeriosis during pregnancy. If the fetus survives, longer therapy until delivery can be discussed.

  18. Influence of dosing times on cisplatin-induced peripheral neuropathy in rats

    International Nuclear Information System (INIS)

    Seto, Yoshihiro; Okazaki, Fumiyasu; Horikawa, Keiji; Zhang, Jing; Sasaki, Hitoshi; To, Hideto

    2016-01-01

    Although cis-diamminedichloro-platinum (CDDP) exhibits strong therapeutic effects in cancer chemotherapy, its adverse effects such as peripheral neuropathy, nephropathy, and vomiting are dose-limiting factors. Previous studies reported that chronotherapy decreased CDDP-induced nephropathy and vomiting. In the present study, we investigated the influence of dosing times on CDDP-induced peripheral neuropathy in rats. CDDP (4 mg/kg) was administered intravenously at 5:00 or 17:00 every 7 days for 4 weeks to male Sprague–Dawley rats, and saline was given to the control group. To assess the dosing time dependency of peripheral neuropathy, von-Frey test and hot-plate test were performed. In order to estimate hypoalgesia, the hot-plate test was performed in rats administered CDDP weekly for 4 weeks. On day 28, the withdrawal latency to thermal stimulation was significantly prolonged in the 17:00-treated group than in the control and 5:00-treated groups. When the von-Frey test was performed to assess mechanical allodynia, the withdrawal threshold was significantly lower in the 5:00 and 17:00-treated groups than in the control group on day 6 after the first CDDP dose. The 5:00-treated group maintained allodynia throughout the experiment with the repeated administration of CDDP, whereas the 17:00-treated group deteriorated from allodynia to hypoalgesia. It was revealed that the severe of CDDP-induced peripheral neuropathy was inhibited in the 5:00-treated group, whereas CDDP-treated groups exhibited mechanical allodynia. These results suggested that the selection of an optimal dosing time ameliorated CDDP-induced peripheral neuropathy. The online version of this article (doi:10.1186/s12885-016-2777-0) contains supplementary material, which is available to authorized users

  19. ARRRG/FOOD, Doses from Radioactive Release to Food Chain

    International Nuclear Information System (INIS)

    Napier, B.A.; Roswell, R.L.; Kennedy, W.E. Jr.; Strenge, D.L.

    1984-01-01

    radionuclide concentration in food products, ingestion rates, and a radionuclide-specific factor. The equations for calculating internal dose and dose commitment are derived from those given by the International Commission on Radiological Protection (ICRP) for body burden and maximum permissible concentration (MPC). 3 - Restrictions on the complexity of the problem: Maxima of: 23 possible body organs or tissues (ARRRG and FOOD), 5 organs and 100 radionuclides in a mixture (ARRRG and FOOD), 5 ingestion pathways (ARRRG), 3 external pathways (ARRRG), 14 food type pathways (FOOD), 1 external pathway (FOOD)

  20. Comparative Evaluation of Permissiveness to Dengue Virus Serotype 2 Infection in Primary Rodent Macrophages

    Directory of Open Access Journals (Sweden)

    Jeanette Prada-Arismendy

    2012-01-01

    Full Text Available Infection with dengue virus presents a broad clinical spectrum, which can range from asymptomatic cases to severe cases that are characterised by haemorrhagic syndrome and/or shock. The reason for such variability remains unknown. This work evaluated the in vitro permissiveness of mouse, rat, hamster and guinea pig macrophages to infection by dengue virus 2 (DENV2. The results established that macrophages derived from the BALB/c mouse strain showed higher permissiveness to DENV2 infection than macrophages from other rodent species, although all rodent species studied had the C820T mutation in the oligoadenylate synthetase 1b gene, indicating no relationship to the different in vitro susceptibilities of mouse cells at this locus. Other molecular mechanisms related to flavivirus susceptibility remain to be explored.