75 FR 8563 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA

Science.gov (United States)

2010-02-25

...-AA00 Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA AGENCY: Coast Guard... Fleet Week Maritime Festival. This safety zone is necessary as these events have historically resulted... the safety of life and property on navigable waters during the annual Fleet Week Maritime Festival...

Safety of 8-weeks oral administration of Arctium lappa L.

Science.gov (United States)

Bok, So-Hyeon; Cho, Seung Sik; Bae, Chun-Sik; Park, Dae-Hun; Park, Kyung-Mok

2017-09-01

Recently, worldwide dietary reference intakes have been considered an important guideline for public health. Some governments and the World Health Organization (WHO) provide guidelines concerning dietary intake. Although an ingredient may have a history of use as a culinary material, changes in the environment over time suggest that the acceptable maximum intake each of food/culinary material should be regularly evaluated. Arctium lappa L. has been used as a culinary material for many centuries in Korea and Japan and some recent studies have reported related therapeutic effects. However, there are no reports on the safety of repeated oral administration. In this study, we evaluated the safety of a 8-weeks repeated oral intake of A. lappa . We concluded that treatment with lappa , which was within the safety range, resulted in body weight decrease and blood glucose suppression.

Four Weeks of Goal-Directed Learning in Primary Physical Education Classes

NARCIS (Netherlands)

Platvoet, Sebastiaan W. J.; Elferink-Gemser, Marije T.; Kannekens, Rianne; de Niet, Mark; Visscher, Chris

Relatively little is known about how practice relates to children's improvement in gross motor skill performance. The aim of this study is to determine to what extent 6- and 7-year-old children improve their gross motor skill performance in a four-week period, in which goal-directed learning is

Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study.

Science.gov (United States)

Sierra-Madero, Juan; Di Perri, Giovanni; Wood, Robin; Saag, Michael; Frank, Ian; Craig, Charles; Burnside, Robert; McCracken, Jennifer; Pontani, Dennis; Goodrich, James; Heera, Jayvant; Mayer, Howard

2010-01-01

The MERIT study evaluated maraviroc versus efavirenz, both with zidovudine/lamivudine, in treatment-naïve patients with CCR5-tropic (R5) HIV-1. Post hoc analyses previously assessed week 48 outcomes in patients rescreened with R5 virus by a more sensitive tropism assay. Week 96 efficacy (post hoc, n = 614) and safety (n = 721) were assessed. Proportions of subjects <50 copies/mL (58.8% maraviroc, 62.7% efavirenz) and time to loss of virologic response (TLOVR) responders (<50 copies/mL: 60.5% vs 60.7%) were similar. Maraviroc recipients had greater CD4 increases (+ 212 vs + 171 cells/mm(3)) and fewer adverse event discontinuations (6.1% vs 15.5%), malignancies, and category C events. Week 96 data confirm week 48 observations in MERIT.

Colorado's Alternative School Calendar Program and the Four Day Week.

Science.gov (United States)

Brubacher, Roy G.; Stiverson, C. L.

Taking advantage of legislation permitting modified school calendars, the four-day work week has been implemented by 23 small, rural Colorado school districts representing 5,200 children. Thirteen districts implemented the four-day program in the 1980-81 school year. Ten additional districts applied as first year pilot programs in the 1981-82…

[Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

Science.gov (United States)

Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

2011-10-01

To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

Topical Retinol Restores Type I Collagen Production in Photoaged Forearm Skin within Four Weeks

Directory of Open Access Journals (Sweden)

Min Sun

2016-09-01

Full Text Available Production of type I collagen (COL1, the major structural protein of the skin, declines during aging, leading to skin thinning and becoming fragile, which increases the risk of bruising and wound healing disorders in the elderly. Topical treatments that can restore COL1 synthesis and ultimately COL1 content in aged skin hold promise to improve skin health. Much effort has been spent on developing agents that can safely and effectively enhance COL1 synthesis in aged skin. However, how fast and to what extent COL1 production in aged skin can be enhanced by a topical treatment remains unclear. Herein, we investigated a four-week topical retinol (ROL treatment. A one-day occlusion of ROL (0.4% or vehicle was applied on photoaged forearms of elderly (>65 years old subjects once a week for four weeks. Vehicle was also applied on forearms of young (23–33 years subjects in the same manner. Skin samples were obtained one week after the last treatment and analyzed for COL1 synthesis. We found that the ROL treatment increased the level of COL1 mRNA (2.3-fold and proCOL1 protein (1.8-fold in photoaged forearms to levels similar to that of young forearms within four weeks. Our study proves the concept that reduced COL1 production in aged skin can be readily restored. In addition, our study provides an evidence-based foundation for developing COL1-enhancing topical agents, and establishes a reliable and practical efficacy test for evaluating such agents.

Four Weekly Ayahuasca Sessions Lead to Increases in “Acceptance” Capacities: A Comparison Study With a Standard 8-Week Mindfulness Training Program

Science.gov (United States)

Soler, Joaquim; Elices, Matilde; Dominguez-Clavé, Elisabeth; Pascual, Juan C.; Feilding, Amanda; Navarro-Gil, Mayte; García-Campayo, Javier; Riba, Jordi

2018-01-01

Background: The therapeutic effects of the Amazonian plant tea ayahuasca may relate to its ability to enhance mindfulness capacities. Ayahuasca induces a modified state of awareness through the combined action of its active principles: the psychedelic N,N-dimethyltryptamine (DMT) and a series of centrally acting β-carbolines, mainly harmine and tetrahydroharmine. To better understand the therapeutic potential of ayahuasca, here we compared the impact on mindfulness capacities induced by two independent interventions: (a) participation in four ayahuasca sessions without any specific purpose related to improving mindfulness capacities; and (b) participation in a standard mindfulness training course: 8 weeks mindfulness-based stress reduction (MBSR), with the specific goal of improving these skills. Methods: Participants of two independent groups completed two self-report instruments: The Five Facet Mindfulness Questionnaire (FFMQ) and the Experiences Questionnaire (EQ). The MINDSENS Composite Index was also calculated, including those EQ and FFMQ items that have proven to be the most sensitive to meditation practice. Group A (n = 10) was assessed before and after the last of four closely spaced consecutive ayahuasca sessions. Group B (n = 10) was assessed before and after completion of a standard 8-week MBSR course. Results: MBSR training led to greater increases in overall mindfulness scores after the 8-week period. MBSR but not ayahuasca led to increases in the MINDSENS Composite Index. However, the ayahuasca sessions induced comparable increases in the Non-Judging subscale of the FFMQ, specifically measuring “acceptance.” Improving this capacity allows for a more detached and less judgmental stance toward potentially distressing thoughts and emotions. Results: The present findings suggest that a small number of ayahuasca sessions can be as effective at improving acceptance as more lengthy and costly interventions. Future studies should address the benefits of

Four Weekly Ayahuasca Sessions Lead to Increases in “Acceptance” Capacities: A Comparison Study With a Standard 8-Week Mindfulness Training Program

Directory of Open Access Journals (Sweden)

Joaquim Soler

2018-03-01

Full Text Available Background: The therapeutic effects of the Amazonian plant tea ayahuasca may relate to its ability to enhance mindfulness capacities. Ayahuasca induces a modified state of awareness through the combined action of its active principles: the psychedelic N,N-dimethyltryptamine (DMT and a series of centrally acting β-carbolines, mainly harmine and tetrahydroharmine. To better understand the therapeutic potential of ayahuasca, here we compared the impact on mindfulness capacities induced by two independent interventions: (a participation in four ayahuasca sessions without any specific purpose related to improving mindfulness capacities; and (b participation in a standard mindfulness training course: 8 weeks mindfulness-based stress reduction (MBSR, with the specific goal of improving these skills.Methods: Participants of two independent groups completed two self-report instruments: The Five Facet Mindfulness Questionnaire (FFMQ and the Experiences Questionnaire (EQ. The MINDSENS Composite Index was also calculated, including those EQ and FFMQ items that have proven to be the most sensitive to meditation practice. Group A (n = 10 was assessed before and after the last of four closely spaced consecutive ayahuasca sessions. Group B (n = 10 was assessed before and after completion of a standard 8-week MBSR course.Results: MBSR training led to greater increases in overall mindfulness scores after the 8-week period. MBSR but not ayahuasca led to increases in the MINDSENS Composite Index. However, the ayahuasca sessions induced comparable increases in the Non-Judging subscale of the FFMQ, specifically measuring “acceptance.” Improving this capacity allows for a more detached and less judgmental stance toward potentially distressing thoughts and emotions.Results: The present findings suggest that a small number of ayahuasca sessions can be as effective at improving acceptance as more lengthy and costly interventions. Future studies should address the

A four-week clinical study to evaluate and compare the effectiveness of a baking soda dentifrice and an antimicrobial dentifrice in reducing plaque.

Science.gov (United States)

Ghassemi, Annahita; Vorwerk, Linda M; Hooper, William J; Putt, Mark S; Milleman, Kimberly R

2008-01-01

To evaluate and compare the effectiveness in reducing plaque of a fluoride dentifrice containing baking soda and a non-baking soda fluoride dentifrice containing an antimicrobial (triclosan/copolymer) system after a single brushing and over a four-week period of daily brushing. A total of 207 subjects completed this randomized, blinded, parallel-group clinical study. Twenty-four hour plaque buildup was scored at baseline and after two and four weeks of twice-daily use of the products. Additionally, controlled single brushing with the assigned dentifrice, followed by post-brushing plaque assessment, was performed at the start (baseline visit) and end (Week-4 visit) of the study. Plaque was scored using the Turesky, et al. modification of Quigley-Hein Index at six sites per tooth, according to Soparkar's modification. Mean baseline whole mouth plaque scores for the baking soda and triclosan dentifrice groups were 2.90 +/- 0.40 and 2.90 +/- 0.39, respectively, and the difference was not statistically significant. Within-group analysis showed that both products significantly reduced the amount of plaque over the four-week period (p baking soda dentifrice exhibited significantly greater reduction in plaque scores (p baking soda dentifrice group (0.34 +/- 0.32) was 2.22-fold greater than that observed for the triclosan dentifrice group (0.15 +/- 0.24). Similarly, single brushing with the baking soda dentifrice showed a 1.88- to 2.08-fold greater pre- to post-brushing plaque difference as compared to the triclosan dentifrice at the baseline visit (mean plaque reduction: baking soda 0.54 +/- 0.26; triclosan 0.28 +/- 0.18; ratio 1.88X) and Week-4 visit (baking soda 0.47 +/- 0.21; triclosan 0.23 +/- 0.15; ratio 2.08X). Similar to the whole mouth scores, evaluation of various tooth sites (facial, lingual, proximal, and gingival) showed a significantly greater reduction in plaque scores for brushing with the baking soda dentifrice as compared to brushing with the triclosan

The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week, prospective, open‐label, multicenter, single‐arm study

Science.gov (United States)

Liang, Ying; Cao, Changan; Zhu, Cheng; Wang, Chuanyue; Zhang, Congpei; Dong, Fang; Yang, Fude; Deng, Hong; Yu, Jingjie; Tang, Jisheng; Su, Lei; Xin, Limin; Hong, Ling; Gao, Minglong; Tang, Muni; Xie, Shiping; Lu, Shuiping; Liu, Tiebang; Xu, Xiaojin; Wang, Xijin; Li, Xuanzi; Wang, Xueyi; Li, Yi; Zhang, Yong; Chen, Zhiyu

2016-01-01

Abstract Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia. PMID:27020720

The four-day working week, unknown, unloved. Research into the organisational implications of working time reduction

OpenAIRE

Sels, Luc; Dejonckheere, Johan

2000-01-01

This contribution aims to bring clarity into the 'organisational implications' of one specific form of working time reduction, namely the four-day working week. We start by defining the concept of the four-day working week. In the second part, we look at ways Belgian authorities are trying to encourage the four-day working week, met by little enthusiasm from the business world. This reluctance stems from ignorance about the effects on performance and organisation. For this reason, we have con...

76 FR 58711 - National Farm Safety and Health Week, 2011

Science.gov (United States)

2011-09-21

... National Farm Safety and Health Week, 2011 By the President of the United States of America A Proclamation... and processing facilities. Physically demanding and all-encompassing, farm work requires the... worked to create new markets for these products, and to provide assistance to farms, supporting jobs...

3 CFR 8420 - Proclamation 8420 of September 21, 2009. National Farm Safety and Health Week, 2009

Science.gov (United States)

2010-01-01

... accidents, prevent exposure to potential hazards, and save lives. Working long hours at physically demanding... Farm Safety and Health Week, 2009 8420 Proclamation 8420 Presidential Documents Proclamations Proclamation 8420 of September 21, 2009 Proc. 8420 National Farm Safety and Health Week, 2009By the President...

To What Extent Can Adolescent Scoliosis Be Improved in Four Weeks?

Directory of Open Access Journals (Sweden)

Mehmet Ağırman

2016-03-01

Full Text Available Scoliosis is a condition that leads to severe disability and an impaired cosmetic appearance in adolescence. This article presents x-ray images of a patient with adolescent idiopathic scoliosis (AIS in whom the pain and posture improved dramatically over four weeks, emphasizing the importance of physical therapy. A 13-year-old male was admitted because of posture deformity and mild back and lower back pain. He was being followed with the diagnosis of scoliosis for two years and specific exercises were proposed for scoliosis. On physical examination, we observed paravertebral muscle spasm and significant asymmetry of the thoracolumbar region. Neurological examination and laboratory tests were normal. X-ray showed arcuate thoracolumbar scoliosis (cobb angle: 24° with a leftward convexity. Electrical stimulation was applied to the convex and concave sides for 30 minutes, five times a week for four weeks and an exercise program was performed under the supervision of a therapist. The stimulation amplitude was the maximum stimulation intensity with which the patient was comfortable. Analgesic and myorelaxant drugs were not required, and no brace was used. After the treatment, significant improvements were observed in the patient’s posture and radiography (cobb angle: 10°. This work demonstrates that well-planned physical therapy is a rapid and effective option for treating AIS.

Effects and safety of allogenic mesenchymal stem cell intravenous infusion in active ankylosing spondylitis patients who failed NSAIDs: a 20-week clinical trial.

Science.gov (United States)

Wang, Peng; Li, Yuxi; Huang, Lin; Yang, Jiewen; Yang, Rui; Deng, Wen; Liang, Biling; Dai, Lie; Meng, Qingqi; Gao, Liangbin; Chen, Xiaodong; Shen, Jun; Tang, Yong; Zhang, Xin; Hou, Jingyi; Ye, Jichao; Chen, Keng; Cai, Zhaopeng; Wu, Yanfeng; Shen, Huiyong

2014-01-01

Our objective was to evaluate the feasibility, safety, and efficacy of intravenous (IV) infusion of allogenic mesenchymal stem cells (MSCs) in ankylosing spondylitis (AS) patients who are refractory to or cannot tolerate the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs). AS patients enrolled in this study received four IV infusions of MSCs on days 0, 7, 14, and 21. The percentage of ASAS20 responders (the primary endpoint) at the fourth week and the mean ASAS20 response duration (the secondary endpoint) were used to assess treatment response to MSC infusion and duration of the therapeutic effects. Ankylosing Spondylitis Disease Activity Score Containing C-reactive Protein (ASDAS-CRP) and other preestablished evaluation indices were also adopted to evaluate the clinical effects. Magnetic resonance imaging (MRI) was performed to detect changes of bone marrow edema in the spine. The safety of this treatment was also evaluated. Thirty-one patients were included, and the percentage of ASAS20 responders reached 77.4% at the fourth week, and the mean ASAS20 response duration was 7.1 weeks. The mean ASDAS-CRP score decreased from 3.6 ± 0.6 to 2.4 ± 0.5 at the fourth week and then increased to 3.2 ± 0.8 at the 20th week. The average total inflammation extent (TIE) detected by MRI decreased from 533,482.5 at baseline to 480,692.3 at the fourth week (p > 0.05) and 400,547.2 at the 20th week (p < 0.05). No adverse effects were noted. IV infusion of MSCs is a feasible, safe, and promising treatment for patients with AS.

Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment.

Science.gov (United States)

DeJesus, Edwin; Haas, Bernard; Segal-Maurer, Sorana; Ramgopal, Moti N; Mills, Anthony; Margot, Nicolas; Liu, Ya-Pei; Makadzange, Tariro; McCallister, Scott

2018-04-01

We previously demonstrated superior efficacy and safety advantages in HIV-infected, virologically suppressed adults switched to a regimen containing tenofovir alafenamide (TAF) as compared with those remaining on a tenofovir disoproxil fumarate (TDF) regimen through week 48. We now report long-term data through week 96. In this randomized, active-controlled, multicenter, open-label, noninferiority trial (ClinicalTrials.gov No. NCT01815736), we randomized virologically suppressed (HIV-1 RNA TAF group or to continue one of four TDF-containing regimens (TDF group) for 96 weeks. We evaluated efficacy (HIV-1 RNA TAF n = 959, TDF n = 477). At week 96, TAF was superior to TDF in virologic efficacy, with 93% on TAF and 89% on TDF having HIV-1 RNA TAF versus TDF continued through week 96 (p TAF group versus TDF through week 96 (p TAF group as compared with one case in the TDF group. Switching to EVG/COBI/FTC/TAF (E/C/F/TAF) was associated with statistically significant efficacy and safety advantages over remaining on a standard-of-care TDF-based regimen.

The Four Day Week: An Alternative School Calendar.

Science.gov (United States)

Pope, Jean; Gillian, Russ

This booklet surveys the possibilities in instituting a 4-day school week, an approach which has gained favor in some small school districts. The history of the 4-day week and its characteristics are first described. Drawing on case studies of districts that have begun the 4-day schedule, the authors enumerate the steps in proposing and…

Emergency concepts for the safety level four; Notfallkonzepte der Sicherheitsebene Vier

Energy Technology Data Exchange (ETDEWEB)

Richner, Martin [Axpo Power AG, Doettingen (Switzerland). Kernkraftwerk Beznau

2016-04-15

According to the IAEA Guidelines and the Swiss Safety Guidelines the defence-in depth safety concept for a nuclear power plant consists of four safety levels. Emergency measures for the limitation of beyond design basis accidents are of safety level four. They are referred to as incident management. After the Chernobyl accident in 1986, in Switzerland the former regulatory body HSK (today ENSI) requested several retrofit measures in the field of accident management. The importance of accident management was visible again in Fukushima and demands for preventive measures grew.

TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals

NARCIS (Netherlands)

Reynes, Jacques; Arastéh, Keikawus; Clotet, Bonaventura; Cohen, Calvin; Cooper, David A.; Delfraissy, Jean-François; Eron, Joseph J.; Henry, Keith; Katlama, Christine; Kuritzkes, Daniel R.; Lalezari, Jacob P.; Lange, Joep; Lazzarin, Adriano; Montaner, Julio S. G.; Nelson, Mark; O' Hearn, Mary; Stellbrink, Hans-Jürgen; Trottier, Benoit; Walmsley, Sharon L.; Buss, Neil E.; DeMasi, Ralph; Chung, Jain; Donatacci, Lucille; Guimaraes, Denise; Rowell, Lucy; Valentine, Adeline; Wilkinson, Martin; Salgo, Miklos P.

2007-01-01

The additional 48-week optional treatment extension of the T-20 versus Optimized Regimen Only (TORO) studies evaluated long-term safety and efficacy of enfuvirtide (ENF) through week 96 in patients receiving ENF plus optimized background (OB) and patients switching to ENF plus OB from OB alone.

Long-term safety and efficacy of a novel once-weekly oral trelagliptin as monotherapy or in combination with an existing oral antidiabetic drug in patients with type 2 diabetes mellitus: A 52-week open-label, phase 3 study.

Science.gov (United States)

Inagaki, Nobuya; Sano, Hiroki; Seki, Yoshifumi; Kuroda, Shingo; Kaku, Kohei

2016-09-01

Trelagliptin is a novel once-weekly oral dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus that was first approved in Japan. We evaluated long-term safety and efficacy of trelagliptin in Japanese patients with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label study to evaluate long-term safety and efficacy of trelagliptin. Patients with type 2 diabetes mellitus inadequately controlled despite diet/exercise or treatment with one of the existing oral antidiabetic drugs along with diet/exercise received trelagliptin 100 mg orally once weekly for 52 weeks as monotherapy or combination therapies. The primary end-points were the safety variables, and the secondary end-points were glycosylated hemoglobin and fasting plasma glucose. A total of 680 patients received the following antidiabetic therapies: trelagliptin monotherapy (n = 248), combination with a sulfonylurea (n = 158), a glinide (n = 67), an α-glucosidase inhibitor (n = 65), a biguanide (n = 70), or a thiazolidinedione (n = 72). During the study, 79.8% of the patients experienced at least one adverse event for monotherapy, 87.3% for combination with a sulfonylurea, 77.6% for a glinide, 81.5% for an α-glucosidase inhibitor, 64.3% for a biguanide, and 84.7% for a thiazolidinedione, respectively. Most of the adverse events were mild or moderate. The change in glycosylated hemoglobin from baseline at the end of the treatment period was -0.74 to -0.25% for each therapy. Once-weekly oral trelagliptin provides well-tolerated long-term safety and efficacy in both monotherapy and combination therapies in Japanese patients with type 2 diabetes mellitus. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Efficacy and safety of fosaprepitant for the prevention of nausea and emesis during 5 weeks of chemoradiotherapy for cervical cancer (the GAND-emesis study)

DEFF Research Database (Denmark)

Ruhlmann, Christina H; Christensen, Thomas Broe; Dohn, Line Hammer

2016-01-01

and dexamethasone in the prevention of nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly cisplatin in patients with cervical cancer. METHODS: This investigator initiated, multinational, randomised, double-blind, placebo-controlled phase 3 trial, included women with cervical...... weeks of treatment. The modified intention-to-treat population (all patients who received study medication) was used for the statistical analyses. The study was registered with ClinicalTrials.gov, number NCT01074697. FINDINGS: Between June 15, 2010, and March 8, 2015, 246 patients from four countries...

Examining the Transition to a Four-Day School Week and Investigating Post-Change Faculty/Staff Work-Life Balance: A Community College Case Study

Science.gov (United States)

Cardinale, Nelly

2013-01-01

This single descriptive embedded case study examined the process of implementing a four-day work/school week at a community college and investigated post-change faculty/staff work-life balance. All of the students attending this college live at home. The change was implemented due to state funding shortfalls, increasing college utility expenses…

Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.

Science.gov (United States)

Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Findling, Robert L

2011-09-01

Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects (6-17 years) with autistic disorder. A 52-week, open-label, flexibly dosed (2-15 mg/d) study of the safety and tolerability of aripiprazole in outpatients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent, 8-week randomized trials or were enrolled de novo (ie, not treated in the randomized trials). Safety and tolerability measures included incidences of adverse events, extrapyramidal symptoms, weight, metabolic measures, vital signs, and other clinical assessments. Subjects were enrolled between September 2006 and June 2009. Three hundred thirty subjects entered the treatment phase: 86 de novo, 174 prior aripiprazole, and 70 prior placebo. A total of 199 (60.3%) subjects completed 52 weeks of treatment. Adverse events were experienced by 286/330 subjects (86.7%). Common adverse events included weight increase, vomiting, nasopharyngitis, increased appetite, pyrexia, upper respiratory tract infection, and insomnia. Discontinuations due to adverse events occurred in 35/330 randomized subjects (10.6%)-most commonly aggression and weight increase. One patient discontinued from the study due to a laboratory-related adverse event (moderately increased alanine transaminase and aspartate transaminase). Nine subjects experienced serious adverse events-most frequently aggression. Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor (3.0%), psychomotor hyperactivity (2.7%), akathisia (2.4%), and dyskinesia (not tardive, 2.4%). At > 9 months' aripiprazole exposure (n = 220), mean change in body weight z score was 0.33 and body mass index z score was 0.31. The percentages of subjects with clinically significant fasting metabolic abnormalities at > 9 months were 2% for glucose, 5% for total cholesterol, 7% for low-density lipoprotein cholesterol, 30% for high

A 52-week safety study in cynomolgus macaques for genetically modified rice expressing Cry1Ab/1Ac protein.

Science.gov (United States)

Mao, Jie; Sun, Xing; Cheng, Jian-Hua; Shi, Yong-Jie; Wang, Xin-Zheng; Qin, Jun-Jie; Sang, Zhi-Hong; He, Kun; Xia, Qing

2016-09-01

A 52-week feeding study in cynomolgus macaques was carried out to evaluate the safety of Bt rice Huahui 1 (HH1), a transgenic rice line expressing Cry1Ab/1Ac protein. Monkeys were fed a diet with 20% or 60% HH1 rice, 20% or 60% parental rice (Minghui 63, MH63), normal diet, normal diet spiked with purified recombinant Cry1Ab/1Ac fusion protein or bovine serum albumin (BSA) respectively. During the feeding trail, clinical observations were conducted daily, and multiple parameters, including body weight, body temperature, electrocardiogram, hematology, blood biochemistry, serum metabolome and gut microbiome were examined at regular intervals. Upon sacrifice, the organs were weighted, and the macroscopic, microscopic and electron microscopic examinations were performed. The results show no adverse or toxic effects of Bt rice HH1 or Cry1Ab/1Ac fusion protein on monkeys. Therefore, the present 52-week primate feeding study suggests that the transgenic rice containing Cry 1Ab/1Ac is equivalent to its parental rice line MH63. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effect of sexual relationship during the last four weeks of pregnancy on Bishop score

Directory of Open Access Journals (Sweden)

Shayeste Esmaeelzadeh

2008-11-01

Full Text Available Background: Cervical favoring or ripening which is evaluated by Bishop score is an importantfactor for predicting the type of delivery, especially at the induction of labor. Higher bishop scorepredicts more vaginal delivery and reduction of cesarean. The present study is designed to assess theeffect of intercourse during the last four weeks of pregnancy on cervical ripening for giving birth.Material and Method: In this case-control study, cases were included 74 primigravid women withunriped cervix (Bishop4.The two groups were referred for vaginal delivery at term and compared based on times of intercourseand experiencing orgasm during the last four weeks of pregnancy. The data were collected byexamination and interview using a checklist.Results: Case and control group were matched based on age, job and economic situation. Meantimes of intercourse were 1.8±2.3 and 3.1±3.2 in case and control groups, respectively. Mann-Whitneyu test showed that the control group reported more intercourse than the case group in the last fourweeks of pregnancy, significantly (P<0.01, Z=2.8. In case group, 41 persons (55.4% and in thecontrol 72 persons (70.2% experienced orgasm during intercourse. This difference was alsosignificant.Conclusions: According to the results of this study, sexual relationship and orgasm in the last fourweeks of pregnancy are related to cervical favoring and so declining cesarean.

77 FR 35862 - Safety Zone; Fleet Week Maritime Festival, Pier 66 Elliott Bay, Seattle, WA

Science.gov (United States)

2012-06-15

... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2010-0062] Safety Zone; Fleet Week Maritime Festival, Pier 66 Elliott Bay, Seattle, WA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the Fleet Week Maritime...

Effects of four weeks of repeated sprint training on physiological indices in futsal players

Directory of Open Access Journals (Sweden)

Paulo Cesar do Nascimento

2014-12-01

Full Text Available DOI: http://dx.doi.org/10.5007/1980-0037.2015v17n1p91   The aim of this study was to investigate the effects of short repeated-sprint ability (RSA training on the neuromuscular and physiological indices in U17 futsal players during the competitive period. Fourteen players were divided into two groups: intervention group (n = 8 and control group (n = 6. Both groups performed a repeated maximal sprint test (40-m MST, intermittent shuttle-running test (Carminatti’s test and vertical jumps before and after the training period. The intervention group was submitted to an additional four-week repeated sprints program, twice a week, while the control group maintained their normal training routine. There was no significant interaction between time and groups for all variables analysed (p > 0.05. However, a significant main effect was observed for time (p < 0.01 indicating an increase on speed at heart rate deflection point (VHRDP and the continuous jump performance while the peak lactate (40m-LACpeak and sprint decrement decreased after training, in both groups. Still, based on effect sizes (ES the greater changes with practical relevance were verified for intervention group in important variables such as peak velocity (ES = 0,71, VHRDP (ES = 0,83 and 40m-LACpeak (ES = 1,00. This study showed that RSA-based and normal training routine are equally effective in producing changes in the analysed variables during a short period of intervention. However, the effect size suggests that four weeks of RSA training would be a minimum time that could induce the first changes of futsal player’s physical fitness.

Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study.

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Tanaka, Yoshiya; Takeuchi, Tsutomu; Yamanaka, Hisashi; Nakamura, Hiroyuki; Toyoizumi, Shigeyuki; Zwillich, Samuel

2015-07-01

To evaluate oral tofacitinib versus placebo for treatment of active rheumatoid arthritis in Japanese patients with inadequate response to disease-modifying antirheumatic drugs. In this double-blind, placebo-controlled, randomized, parallel-group, 12-week, phase 2 study (clinicaltrials.gov NCT00687193), 317 patients received tofacitinib: 1, 3, 5, 10, or 15 mg as monotherapy or placebo twice daily (BID). response rate by American College of Rheumatology (ACR) ≥ 20% improvement criteria (ACR20) at week 12. ACR20 response rates: 37.7% (20/53), 67.9% (36/53), 73.1% (38/52), 84.9% (45/53), and 90.7% (49/54) with tofacitinib: 1, 3, 5, 10, and 15 mg BID, respectively, versus 15.4% (8/52) with placebo (p tofacitinib versus placebo occurred from week 2 onward (p tofacitinib versus placebo from week 4 (p tofacitinib patients experienced treatment-related serious adverse events (AEs). Most common treatment-emergent AEs: nasopharyngitis (10% vs 12%) and hyperlipidemia (5% vs 0%). Serum creatinine, hemoglobin, and total-, low-, and high-density lipoprotein-cholesterol levels increased with tofacitinib. Tofacitinib produced dose-dependent ACR20 responses and reduced disease activity. The safety profile was consistent with that reported from global monotherapy trials.

Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

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Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

2017-09-01

To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

The Effects of Four-Week Multivitamin Supplementation on Mood in Healthy Older Women: A Randomized Controlled Trial

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Helen Macpherson

2016-01-01

Full Text Available Objective. Nutritional deficiencies have been associated with cognitive decline and mood disturbances. Vitamin intake can influence mood and randomized controlled trials have demonstrated that multivitamin supplements are capable of reducing mild symptoms of mood dysfunction. However, few studies have focussed on healthy older women. Methods. This study investigated the effects of four weeks’ multivitamin supplementation on mood in 76 healthy women aged 50–75 years. Mood was assessed before and after intervention in the laboratory using measures of current mood and retrospective experiences of mood over the past week or longer. Mobile phones were used to assess changes in real-time mood ratings, twice weekly in the home. Results. There were no multivitamin-related benefits identified for measures of current mood or reflections of recent mood when measured in the laboratory. In-home assessments, where mood was rated several hours after dose, revealed multivitamin supplementation improved ratings of stress, with a trend to reduce mental fatigue. Conclusions. Over four weeks, subtle changes to stress produced by multivitamin supplementation in healthy older women may not be detected when only pre- and posttreatment mood is captured. In-home mobile phone-based assessments may be more sensitive to the effects of nutritional interventions compared to traditional in-laboratory assessments.

Pooled efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Data from four double-blind placebo-controlled pivotal phase III clinical studies.

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Elger, Christian; Koepp, Mathias; Trinka, Eugen; Villanueva, Vicente; Chaves, João; Ben-Menachen, Elinor; Kowacs, Pedro A; Gil-Nagel, António; Moreira, Joana; Gama, Helena; Rocha, José-Francisco; Soares-da-Silva, Patrício

2017-12-01

Pooled evaluation of the key efficacy and safety profile of eslicarbazepine acetate (ESL) added-on to stable antiepileptic therapy in adults with focal-onset seizures. Data from 1703 patients enrolled in four phase III double-blind, randomized, placebo-controlled studies were pooled and analyzed. Following a 2 week titration period, ESL was administered at 400 mg, 800 mg, and 1200 mg once-daily doses for 12 weeks (maintenance period). Pooled efficacy variable was standardized (/4 weeks) seizure frequency (SSF) analyzed over the maintenance period as reduction in absolute and relative SSF and proportion of responders (≥50% reduction in SSF). Pooled safety was analyzed by means of adverse events and clinical laboratory assessments. SSF was significantly reduced with ESL 800 mg (P ESL 800 mg and 37.8% for 1200 mg (placebo: 17.6%), and responder rate was 33.8% and 43.1% (placebo: 22.2%). ESL was more efficacious than placebo regardless of gender, geographical region, epilepsy duration, age at time of diagnosis, seizure type, and type of concomitant antiepileptic drugs (AED). Incidence of adverse events (AEs) and AEs leading to discontinuation was dose dependent. Most common AEs (>10% patients) were dizziness, somnolence, and nausea. The incidence of treatment-emergent AEs (dizziness, somnolence, ataxia, vomiting, and nausea) was lower in patients who began taking ESL 400 mg (followed by 400 mg increments to 800 or 1200 mg) than in those who began taking ESL 600 mg or 800 mg. Once-daily ESL 800 mg and 1200 mg showed consistent results across all efficacy and safety endpoints, independent of study population characteristics and type of concomitant AEDs. Treatment initiated with ESL 400 mg followed by 400 mg increments to 800 or 1200 mg provides optimal balance of efficacy and tolerability. © 2017 The Authors. CNS Neuroscience & Therapeutics Published by John Wiley & Sons Ltd.

Long-term (52-week) safety and efficacy of Sacubitril/valsartan in Asian patients with hypertension.

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Supasyndh, Ouppatham; Sun, Ningling; Kario, Kazuomi; Hafeez, Kudsia; Zhang, Jack

2017-05-01

Sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor-neprilysin inhibitor, demonstrated significant reductions in office and 24 h ambulatory blood pressure (BP) over 8 weeks in Asian patients with hypertension. This 52-week extension to the 8-week core study was aimed at evaluating the long-term safety, tolerability and efficacy of sacubitril/valsartan. Patients who completed an 8-week randomized study (the core study) were enrolled in this 52-week open-label study and received sacubitril/valsartan 200 mg QD. The sacubitril/valsartan dose was uptitrated to 400 mg QD if BP was uncontrolled (>140/90 mm Hg) after 4 weeks. Subsequently, in patients with uncontrolled BP, treatment was intensified every 4 weeks with amlodipine 5-10 mg followed by hydrochlorothiazide 6.25-25 mg. Of the 341 patients enrolled, 7 (2.1%) discontinued the study drug due to adverse events (AEs). The incidence of AEs and serious AEs were 63.9 and 3.8%, respectively, and no deaths were reported in this study. The most frequent AEs were nasopharyngitis (18.2%) and dizziness (8.8%). Events that were potentially indicative of low BP were infrequent. One patient reported mild transient angioedema (lasting 2.5 h) that resolved without treatment but led to study drug discontinuation. The sacubitril/valsartan-based regimen provided clinically significant mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) reductions from baseline (-24.7/-16.2 mm Hg). The overall BP control, msSBP and msDBP response rates were 75.3, 90.6 and 87.6%, respectively. Long-term use of sacubitril/valsartan was generally safe and well-tolerated in patients with hypertension and provided significant BP reductions from baseline.

Subchronic (13-week) oral toxicity study of y-cyclodextrin in dogs

NARCIS (Netherlands)

Til, H.P.; Bär, A.

1998-01-01

The oral toxicity of γ-cyclodextrin (γ- CD) was examined in a 13-week feeding study in which four groups of four male and four female Beagle dogs received γ-CD in the diet at concentrations of 0 (control), 5, 10, or 20%. No treatment-related changes were noted in behavior or appearance of the dogs

Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

Science.gov (United States)

2011-01-01

Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the

Four Weeks of Off-Season Training Improves Peak Oxygen Consumption in Female Field Hockey Players

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Lindsey T. Funch; Erik Lind; Larissa True; Deborah Van Langen; John T. Foley; James F. Hokanson

2017-01-01

The purpose of the study was to examine the changes in peak oxygen consumption ( V ˙O2peak) and running economy (RE) following four-weeks of high intensity training and concurrent strength and conditioning during the off-season in collegiate female field hockey players. Fourteen female student-athletes (age 19.29 ± 0.91 years) were divided into two training groups, matched from baseline V ˙O2peak: High Intensity Training (HITrun; n = 8) and High Intensity Interval Training (HIIT; ...

Behavior-based safety on construction sites: a case study.

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Choudhry, Rafiq M

2014-09-01

This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

Safe Kids Week: Analysis of gender bias in a national child safety campaign, 1997-2016.

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Bauer, Michelle E E; Brussoni, Mariana; Giles, Audrey R; Fuselli, Pamela

2017-09-29

Background and Purpose Child safety campaigns play an important role in disseminating injury prevention information to families. A critical discourse analysis of gender bias in child safety campaign marketing materials can offer important insights into how families are represented and the potential influence that gender bias may have on uptake of injury prevention information. Methods Our approach was informed by poststructural feminist theory, and we used critical discourse analysis to identify discourses within the poster materials. We examined the national Safe Kids Canada Safe Kids Week campaign poster material spanning twenty years (1997-2016). Specifically, we analyzed the posters' typeface, colour, images, and language to identify gender bias in relation to discourses surrounding parenting, safety, and societal perceptions of gender. Results The findings show that there is gender bias present in the Safe Kids Week poster material. The posters represent gender as binary, mothers as primary caregivers, and showcase stereotypically masculine sporting equipment among boys and stereotypically feminine equipment among girls. Interestingly, we found that the colour and typeface of the text both challenge and perpetuate the feminization of safety. Discussion It is recommended that future child safety campaigns represent changing family dynamics, include representations of children with non-traditionally gendered sporting equipment, and avoid the representation of gender as binary. This analysis contributes to the discussion of the feminization of safety in injury prevention research and challenges the ways in which gender is represented in child safety campaigns. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain.

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Taber, Louise; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

2016-01-01

To evaluate long-term use of Hysingla(®) ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain. This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20-120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in "average pain over the last 24 h" (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use. Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks. HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of

Changes in concentration of visfatin during four weeks of inpatient treatment of alcohol dependent males

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Damian Czarnecki

2015-09-01

Conclusions: The dynamic of change in the concentration of visfatin during four weeks of abstinence is not associated with a reduction in craving for alcohol at the time and is associated with alcohol drinking and liver functioning.

A 4-week study of four 3-monochloropropane-1,2-diol diesters on lipid metabolism in C57BL/6J mice.

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Lu, Jing; Wang, Zhenning; Ren, Mengrou; Feng, Guangxin; Ye, Beining; Wang, Yi; Fang, Baochen; Deng, Xuming; Guan, Shuang

2015-09-01

3-Monochloropropane-1,2-diol (3-MCPD) esters have been detected in many foods, which have become a new safety issue worldwide. In the study, we investigated the effect of four 3-MCPD diesters (palmitate diester: CDP; stearate diester: CDS; oleate diester: CDO; linoleate diester: CDL) on lipid metabolism in C57BL/6J mice. The results showed that CDP, CDS, CDO and CDL significantly increased the serum TC, LDL-C levels and liver TG, TC levels at dose of 16.5μmol/kg/day. These results indicated that 3-MCPD diesters could potentially cause hyperlipidemia in C57BL/6J mice. Moreover, oil red O staining confirmed fat accumulation in liver induced by 3-MCPD diesters. Our work will provide more information for safety evaluation of 3-MCPD diesters. However, whether free 3-MCPD or free fatty acids or combined action compensates for the hyperlipidemia effects should be elucidated in the future. Copyright © 2015 Elsevier B.V. All rights reserved.

Effects of chilled-then-frozen storage (up to 52weeks) on lamb M. longissimus lumborum quality and safety parameters.

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Coombs, Cassius E O; Holman, Benjamin W B; Collins, Damian; Friend, Michael A; Hopkins, David L

2017-12-01

This study evaluated the effect of chilled followed by frozen storage on lamb quality and safety parameters. Experimental (n=360) M. longissimus lumborum (LL) were randomly sampled from the boning room of a commercial Australian abattoir, at 24 h post-mortem, and assigned to five chilled storage periods (0, 2, 4, 6 and 8 weeks) and six subsequent frozen storage periods (0, 4, 8, 12, 24 and 52 weeks). Upon completion of each storage treatment combination, corresponding LL were sub-sectioned and analysed for colour stability (0, 1, 2 and 3 days), shear force, fluid losses (purge, thaw and cooking losses), intramuscular fat content, sarcomere length, water activity and microbial load (lactic acid bacteria, Enterobacteriaceae sp., Brochothrix thermosphacta, Clostridium perfringens and Escherichia coli). LL stored chilled for 2-4 weeks prior to freezing presented superior results for shear force, display colour and low levels of spoilage microbes, correlating with good eating quality and safety following more than one year of frozen storage. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Four Weeks of Mobility After 8 Weeks of Immobility Fails to Restore Normal Motion

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Trudel, Guy; Zhou, Jian; Uhthoff, Hans K.

2008-01-01

Prolonged immobilization reduces passive range of motion of joints creating joint contractures. Whether and to what extent these iatrogenic contractures can be reduced is unknown. We raised three questions using an animal model: What degree of contracture remains at the end of a defined remobilization period? Do contractures in sham-operated and immobilized joints differ? What is the contribution of the posterior knee capsule in limiting knee extension? We immobilized one knee of 11 adult male rats in flexion to induce a joint contracture; 10 control animals underwent a sham operation. After 8 weeks, the internal fixation device was removed, and the animals were allowed to resume unrestricted activity for 4 weeks at the end of which the knee range of motion was measured with standardized torques. The mean flexion contracture was higher in the immobilized group (51.9° ± 2.8°) than in the sham-operated group (18.9° ± 2.1°). Eighty-eight percent of the contractures remained in the immobilized group after dividing skin and muscle, suggesting an important contribution of the posterior knee capsule in limiting knee mobility. Based on our preliminary study the range of motion of rat knees immobilized for 8 weeks remained substantially reduced after a 4-week period of unassisted remobilization. PMID:18299947

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

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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

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.

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Park, Won; Yoo, Dae Hyun; Miranda, Pedro; Brzosko, Marek; Wiland, Piotr; Gutierrez-Ureña, Sergio; Mikazane, Helena; Lee, Yeon-Ah; Smiyan, Svitlana; Lim, Mie-Jin; Kadinov, Vladimir; Abud-Mendoza, Carlos; Kim, HoUng; Lee, Sang Joon; Bae, YunJu; Kim, SuYeon; Braun, Jürgen

2017-02-01

To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group). Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively. This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment. NCT01571206; 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/.

The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

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Laleh Koohi Habibi

2007-06-01

Full Text Available "nObjective: Exposure to traumatic stressors lead to activation of arousal responses mediated by serotonergic and noradrenergic systems and it may cause a change in numerous neurotransmitters and neuroendocrine systems. There is ample experimental and clinical evidence to suggest that Ginkgo biloba extract is neuroprotective and has antioxidant properties and can restore stress-induced elevation in brain levels of catecholamines, 5-HT and plasma corticosterone to normal level. "nMethod: In a 12-week, double-blind, placebo-controlled study, the efficacy and safety of adding-on a fixed-dose (200mg of Ginkgo TD to the previous treatment regime of adults with PTSD were examined. Subjects were forty male and female outpatients from a public-owned psychiatric clinic who met criteria for PTSD seven month after a 6.3 Richter earthquake in Bam city on December 26, 2003. The changes in five symptom domains including posttraumatic stress, anxiety and affective symptoms, general health and subjective stress after trauma were ssessed at weeks 0, 12 and 16 to examine effectiveness of the added-on Ginkgo TD and stability of its effects. "nResults: Ginkgo TD was associated with a significantly greater improvement than placebo in PTSD patients as measured by five symptom domain scales including: GHQ-28; Watson PTSD Scale; HAM-D; HAM-A and IES (p= 0.02, 0.01, 0.001, 0.01, 0.02 respectively Four weeks after the discontinuation of intervention, no significant difference was determined between the two groups in the five outcome measures (p= 0.005, 0.01, 0.004, 0.005, 0.01 respectively. No significant difference was observed between the two groups in terms of side effects. "nConclusions: We found Ginkgo TD to be superior to placebo as an adding-on in the treatment of PTSD. Although we did not examine the comparative efficacy of Ginkgo TD on the three main elements of PTSD, beneficial effects both on specific PTSD symptomatology and general conditions including

Walking four times weekly for at least 15 min is associated with longevity in a cohort of very elderly people.

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Fortes, Cristina; Mastroeni, Simona; Sperati, Alessandra; Pacifici, Roberta; Zuccaro, PierGiorgio; Francesco, Forastiere; Agabiti, Nerina; Piras, Giovanna; Amleto, D'Amicis; Ebrahim, Shah

2013-03-01

This study investigated the role of walking outdoors on longevity, controlling for individual and other life-style factors as possible confounders. A 10-year cohort study was conducted with 152 self-caring and mobile, mean age 80 years, were enrolled in the study. Information on socio-demographic characteristics, clinical and biochemical data, diet, physical activity, smoking, depression status, cognitive status and anthropometrics measurements, were obtained for all participants. Cox proportional-hazards models were used to determine independent predictors of longevity. During the 10-years of follow-up, 96 (63%) died. Old age, chronic diseases, smoking, depression, CD4/CD8 ratio and coffee consumption were significantly predictors of mortality. Over-all survival was highest for subjects walking at open air for 4 times weekly for at least 15 min in comparison to subjects walking less than 4 times weekly (40% versus 22%). After adjusting for sex, age, education, chronic diseases, smoking, Body Mass Index and CD4/CD8 ratio, elderly people walking at open air for four times weekly had 40% decreased risk of mortality that individuals who walked less than four times weekly [relative risk (RR)=0.53; 95% confidence interval (CI)=0.32-0.88, p=0.01]. Findings suggest an independent and protective effect of walking on mortality and supports the encouragement of physical activity in advanced age for increasing longevity. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The SHIELD (Safety & Health Improvement: Enhancing Law Enforcement Departments Study: Feasibility and Findings

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Kerry Stephen Kuehl

2014-05-01

Full Text Available This randomized prospective trial aimed to assess the feasibility and efficacy of a team-based worksite health and safety intervention for law enforcement personnel. Four-hundred and eight subjects were enrolled and half were randomized to meet participants met for weekly, peer-led sessions delivered from a scripted team-based health and safety curriculum. Curriculum addressed: exercise, nutrition, stress, sleep, body weight, injury, and other unhealthy lifestyle behaviours such as smoking and heavy alcohol use. Health and safety questionnaires administered before and after the intervention found significant improvements for increased fruit and vegetable consumption, overall healthy eating, increased sleep quantity and sleep quality, and reduced personal stress.

More with Four: A Look at the Four Day Week in Oregon's Small Schools.

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Reinke, Joyce M.

The 4-day school week offers solutions to the financial and instructional problems often faced by small rural schools. Two southern Oregon schools implemented the 4-day school week on a trial basis in 1982-83 and, along with five eastern Oregon districts, continue to use this schedule today. The primary purpose of the change to a 4-day week was…

Nonclinical safety and pharmacokinetics of Miglyol 812: A medium chain triglyceride in exenatide once weekly suspension.

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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.

Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study.

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Wu, Yi-Jie; Wu, Wei-Fong; Hung, Chia-Wei; Ku, Ming-Shiu; Liao, Pei-Fen; Sun, Hai-Lun; Lu, Ko-Hsiu; Sheu, Ji-Nan; Lue, Ko-Huang

2017-10-01

The main objective of this study was to evaluate the efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis. The design of this study was a two-center, double-blind, randomized, and placebo-controlled study with two parallel groups to evaluate the efficacy and safety profile of L. rhamnosus in children aged 4-48 months with atopic dermatitis diagnosed using Hanifin and Rajka criteria and with a Scoring of Atopic Dermatitis (SCORAD) ≥ 15 at enrollment. The duration of this study was 8 weeks with a total of five visits. The enrolled patients were allocated into either a treatment group (one ComProbi capsule containing L. rhamnosus a day) or a control group (one capsule of placebo a day) at a ratio of 1:1. The primary endpoint was to compare the mean change from baseline in SCORAD after 8 weeks of treatment. The other secondary end points were to compare the following: the mean changes from baseline in SCORAD at postbaseline visits, the frequency and total amount of the use of corticosteroids during the 8-week treatment, the frequency of atopic dermatitis and the symptom-free duration, the mean changes from baseline in Infant Dermatitis Quality of Life Questionnaire at Week 4 and Week 8, and the mean changes from baseline in the Dermatitis Family Impact Questionnaire at Week 4 and Week 8. The mean changes in SCORAD from baseline at Week 8 was -21.69 ± 16.56 in the L. rhamnosus group and -12.35 ± 12.82 in the placebo group for the intent-to-treat population (p = 0.014). For the per-protocol population, the mean change of SCORAD from baseline was -23.20 ± 15.24 in the L. rhamnosus group and -12.35 ± 12.82 in the placebo group (p = 0.003). Significant differences were demonstrated between groups at Week 8 in intensity in the intent-to-treat population and per-protocol population. Throughout the period, the amount of topical corticosteroids used showed no difference between groups. No significant

Response of Arterial Stiffness Four Weeks After Terminating Short-term Aerobic Exercise Training in a Sedentary Lifestyle.

Science.gov (United States)

Baykara, Murat; Demirel, Adnan; Yavuzatmaca, İhsan; Bilgen, Mehmet

2017-02-01

The purpose of this study was to investigate the response of arterial stiffness in individuals with a sedentary lifestyle at 4 weeks after terminating a 2-week aerobic exercise session. Arterial stiffness was evaluated in 38 participants before starting and after completing a prescribed aerobic exercise program and also at 4 weeks after returning back to their sedentary lifestyle. Parameters regarding arterial compliance, distensibility, wall stress, and the elastic modulus were estimated from the information gained from sonography on the dimensions of carotid and femoral arteries and a sphygmomanometer on the pulse pressure. Primary outcomes included whether short-term aerobic exercise reduced the heart rate, arterial pressure, and intima-media thickness and improved vascular biomechanics in physically inactive but otherwise healthy individuals. The benefits gained in arterial compliance and distensibility deteriorated with termination of exercise, but diastolic wall stress and the elastic modulus improved further. In individuals with sedentary lifestyles, short-term aerobic exercise has strong four-week residual benefits on diastolic wall stress and the elastic modulus, but the effects appear to be negligible on arterial stiffness and distensibility. © 2016 by the American Institute of Ultrasound in Medicine.

Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study

Science.gov (United States)

Takeuchi, Tsutomu; Tanaka, Yoshiya; Iwasaki, Manabu; Ishikura, Hiroaki; Saeki, Satoshi; Kaneko, Yuichiro

2016-01-01

Objective To evaluate the efficacy, safety and dose response of a novel oral Janus kinase inhibitor, peficitinib (ASP015K), as monotherapy in Japanese patients with moderate to severe rheumatoid arthritis (RA). Methods In a 12-week, double-blind study, 281 adult patients with RA with active disease not on concomitant disease-modifying antirheumatic drug therapy were randomised equally to once-daily placebo or peficitinib 25, 50, 100 and 150 mg. The primary endpoint was American College of Rheumatology (ACR) 20 response in the peficitinib treatment groups versus placebo at week 12. Results Mean age was 53.0 years, 81.1% were female and 25.3% had previously used antitumour necrosis factor therapy. Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. The total incidence of treatment-emergent adverse events (TEAEs) was similar between the placebo (64.3%) and peficitinib 25, 50, 100 and 150 mg groups (70.9%, 64.9%, 52.7% and 67.2%, respectively). TEAEs occurring more frequently in the peficitinib group compared with the placebo group included nasopharyngitis, increased blood creatine phosphokinase and diarrhoea. No cases of serious infections were reported. Herpes zoster occurred in four patients (two each in peficitinib 25 and 100 mg). Conclusions Treatment with peficitinib as monotherapy for 12 weeks in Japanese patients with moderate to severe RA is efficacious and showed acceptable safety profile. These findings support further developments of peficitinib for RA treatment. Trial registration number NCT01649999; Results. PMID:26672064

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

Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial.

Science.gov (United States)

Elewski, Boni E; Okun, Martin M; Papp, Kim; Baker, Christopher S; Crowley, Jeffrey J; Guillet, Gérard; Sundaram, Murali; Poulin, Yves; Gu, Yihua; Geng, Ziqian; Williams, David A; Rich, Phoebe A

2018-01-01

Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P psoriasis versus with placebo and no new safety risks were identified. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Influence of the cognitive workload on bicycle safety at four-legged intersections

DEFF Research Database (Denmark)

Kveladze, Irma; Agerholm, Niels

2018-01-01

is the influence of workload capacity on bicyclists spatial behaviour in a natural environment of four-legged intersections. Method: Due to the traffic safety of test participants, the study is divided in two phases. In the first phase, the actual physical environment of the four-legged intersection and bicyclists......-legged intersection. The eye tracking glasses will be used to make video and audio recording of visible field of where or how long bicyclists are allocating their visual attention while riding a bicycle and facing obstacles when crossing the four-legged intersection. On the second phase, a bicycle riding simulator...... riding task. This will allow to understand the allocation of bicyclists attention between primary and secondary tasks, to reveal the limit of the information processing capacity during biking. Results expected: Two experimental results will be incorporated to gain in-depth knowledge on bicycle accidents...

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

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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.

Effect of motivational group interviewing-based safety education on Workers' safety behaviors in glass manufacturing.

Science.gov (United States)

Navidian, Ali; Rostami, Zahra; Rozbehani, Nasrin

2015-09-19

Worker safety education using models that identify and reinforce factors affecting behavior is essential. The present study aimed to determine the effect of safety education based on motivational interviewing on awareness of, attitudes toward, and engagement in worker safety in the glass production industry in Hamedan, Iran, in 2014. This was a quasi-experimental interventional study including a total of 70 production line workers at glass production facilities in Hamedan. The workers were randomly assigned to either an intervention or a control group, with 35 workers in each group. Participants in the control group received four one-hour safety education sessions, in the form of traditional lectures. Those in the intervention group received four educational sessions based on motivational group interviewing, which were conducted in four groups of eight to ten participants each. The instruments used included a researcher-developed questionnaire with checklists addressing safety awareness, and attitude and performance, which were completed before and 12 weeks after the intervention. The data were analyzed using descriptive statistics, independent and paired t-tests, and chi-squared tests. Having obtained the differences in scores before and after the intervention, we determined mean changes in the scores of awareness, attitude, and use of personal protective equipment among workers who underwent motivational group interviewing (3.74 ± 2.16, 1.71 ± 3.16, and 3.2 ± 1.92, respectively, p work environment.

Development of food preservation and processing techniques by radiation - Studies on the safety and consumer acceptance of gamma irradiated meats

Energy Technology Data Exchange (ETDEWEB)

Kang, Il Jun; Lee, Young Jin; Lee, Young Sook; Kim, Ha Kyung [Hallym University, Chunchon (Korea)

2000-04-01

Gamma irradiation was applied to chickens for evaluation of their possible genotoxicity, acute toxicity, four-week oral toxicity and nutritional safety. The results were negative in the bacterial reversion assay with S. typhimurium TA98, TA100, TA1535, TA1537. Clastogenic effects of the irradiated samples tested were not shown in vivo mouse micronucleus assay and in chromosomal aberration tests with CHL cells. In an acute toxicity test, the maximal dose of 5,000 mg/kg did not change any toxic parameter examined in this study. In four-week oral toxicity study, appearance, behavior, mortality, food and water consumption of mouse of treated groups were not affected during the experimental periods(four-weeks). In urine analysis, in hematological examination as well as in serum biochemical experiment, no significant differences were found between the control and treatment groups. Although minor changes in some hematological and biochemical parameters were observed, they were in the normal range and were not dose dependent. In nutritional safety, the proximate composition of foods were not significantly changed by irradiation dose. No significant difference in the components of fatty acids were observed by gamma irradiation. In general, the amount of released free amino acid was not significantly changed by gamma irradiation. There was no difference in total amino acid content between non irradiated and irradiated samples. The SDS electrophoresis patterns of samples were not significantly different between nonirradiated and irradiated samples. The major mineral compositions of chicken were phosphorus, potassium, sodium, magnesium. The content of mineral was not significantly changed by gamma irradiation. 58 refs., 11 figs., 16 tabs. (Author)

Efficacy and safety of saxagliptin in combination with insulin in Japanese patients with type 2 diabetes mellitus: a 16-week double-blind randomized controlled trial with a 36-week open-label extension.

Science.gov (United States)

Kadowaki, Takashi; Muto, Satsuki; Ouchi, Yoshiumi; Shimazaki, Ryutaro; Seino, Yutaka

2017-12-01

We examined the efficacy and safety of saxagliptin as an add-on to insulin in Japanese patients with type 2 diabetes mellitus. We randomized 240 patients with type 2 diabetes mellitus on insulin monotherapy to 5-mg saxagliptin or placebo as add-on therapy for a 16-week, double-blind period. All patients received 5-mg saxagliptin and insulin for an additional 36 weeks (open-label extension). Change in hemoglobin A1c (HbA1c) at Week 16 was the main endpoint. At Week 16, the adjusted change in HbA1c from baseline increased by 0.51% with placebo and decreased by 0.40% with saxagliptin (difference -0.92% [95% confidence interval -1.07%, -0.76%; p 1]). In patients receiving saxagliptin, reductions in HbA1c at Week 16 were maintained to Week 52, while switching from placebo to saxagliptin resulted in a similar reduction in HbA1c. The incidence of hypoglycemia was not markedly increased with saxagliptin versus placebo in the double-blind period and did not increase substantially during the open-label extension period. The efficacy and safety of saxagliptin was similar between the elderly and non-elderly patient groups. Adding saxagliptin to ongoing insulin therapy improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes.

Railway safety climate: a study on organizational development.

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Cheng, Yung-Hsiang

2017-09-07

The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

Study on the efficacy and safety of different antigens and oil formulations of infectious coryza vaccines containing an NAD-independent strain of Avibacterium paragallinarum

Directory of Open Access Journals (Sweden)

B. Dungu

2009-09-01

Full Text Available The present study was designed to assess and compare three different formulations of the new Onderstepoort infectious coryza (IC quadrivalent vaccine, which contain an NAD-independent strain of Avibacterium paragallinarum (previously known as Haemophilus paragallinarum, and a commercial IC vaccine, not containing an NAD-independent strain, for their safety and ability to protect chickens of varying ages against virulent challenges with four different serovars of A. paragallinarum, including the NAD-independent strain of the C-3 serovar. Four groups of 140 chickens each were vaccinated at the age of 17 weeks and revaccinated at the age of 19 weeks with each of the four vaccine formulations. A similar sized group of non-vaccinated chickens was used as control. Two rounds of challenge were conducted: a group of chicken in each vaccination group was challenged between 31 and 35 weeks of age, while another group was challenged between 51 and 55 weeks of age. The ''in-contact'' challenge model was used in this experiment. For each vaccination group, the four challenge strains representing four local serovars were used in each challenge round. The efficacy of the vaccines was compared based on overall protection levels obtained and the duration of protection. The safety of the different vaccines was determined by the severity of post-vaccination reactions. The need for the incorporation of the NAD-independent strain in the vaccine was evidenced by the low protection level against NAD-independent challenge recorded in the group of birds vaccinated with the commercial vaccine. The results obtained confirmed not only the variation in virulence of different South African serovars, with serovar C-3 being the most virulent and serovar B having almost no virulence but also the age related increase in susceptibility. The importance of a suitable formulation of the vaccine is discussed.

Four weeks supplementation with Lactobacillus paracasei subsp. paracasei L. casei W8® shows modest effect on triacylglycerol in young healthy adults

DEFF Research Database (Denmark)

Bjerg, Anne Toksvig; Kristensen, Mette Bredal; Ritz, Christian

2015-01-01

The microbiota has been shown to have the potential to affect appetite and blood lipids positively in animal studies. We investigated if four weeks supplementation with Lactobacillus paracasei subsp. paracasei L. casei W8® (L. casei W8) had an effect on subjective appetite sensation, ad libitum e...

A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of the Rivastigmine Patch in Japanese Patients with Alzheimer’s Disease

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Yu Nakamura

2011-06-01

Full Text Available Background: As of 2010, the rivastigmine patch was licensed for the treatment of Alzheimer’s disease (AD in 64 countries. Methods: This 24-week, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the 5-cm2 (9-mg loading dose; 4.6 mg/24 h delivery rate and 10-cm2 (18-mg loading dose; 9.5 mg/24 h delivery rate rivastigmine patch in Japanese patients with AD. Results: In the primary analysis population (intent-to-treat last observation carried forward at week 24, delayed deterioration was seen with the 10-cm2 patch versus placebo on the Japanese version of the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-J cog; p = 0.005 and the Japanese version of the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC plus-J; p = 0.067. Participants receiving the rivastigmine patch showed numerically less decline versus placebo at week 24 on the CIBIC plus-J, although this did not reach statistical significance. Statistical significance for the CIBIC plus-J was met following adjustment for body weight and baseline Mini-Mental State Examination score as dynamic allocation factors (p = 0.042 and on the Disability Assessment for Dementia (DAD; p = 0.024 and Mental Function Impairment (MENFIS; p = 0.016 subscales. Serious adverse events were rare and were consistent with the known safety profile of the rivastigmine patch. Conclusion: The rivastigmine patch has a favorable efficacy and tolerability profile in Japanese patients with AD.

Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

Science.gov (United States)

Iwamoto, Naoki; Tsuji, Sosuke; Takatani, Ayuko; Shimizu, Toshimasa; Fukui, Shoichi; Umeda, Masataka; Nishino, Ayako; Horai, Yoshiro; Koga, Tomohiro; Kawashiri, Shin-Ya; Aramaki, Toshiyuki; Ichinose, Kunihiro; Hirai, Yasuko; Tamai, Mami; Nakamura, Hideki; Terada, Kaoru; Origuchi, Tomoki; Eguchi, Katsumi; Ueki, Yukitaka; Kawakami, Atsushi

2017-01-01

We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks. Fifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (Ptofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity. Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

Are long physician working hours harmful to patient safety?

Science.gov (United States)

Ehara, Akira

2008-04-01

Pediatricians of Japanese hospitals including not only residents but also attending physicians work long hours, and 8% work for >79 h per week. Most of them work consecutively for >or=32 h when they are on call. The aim of the present study was to evaluate the effect of long work hours on patient safety. The electronic databases MEDLINE and EMBASE to searched identify the English- and Japanese-language literature for studies on work hours, medical errors, patient safety, and malpractice for years 1966-2005. Studies that analyzed the relationship between physician work hours and outcomes directly related to patient safety were selected. Seven studies met the criteria. Four studies suggest that reduction of work hours has a favorable effect on patient safety indicators. In the other three studies no significant changes of the indicators were observed, but no report found that shorter work hours were harmful to patient safety. Decrease of physician work hours is not harmful but favorable to patient safety.

Validity of questionnaire self-reports on computer, mouse and keyboard usage during a four-week period

DEFF Research Database (Denmark)

Mikkelsen, S.; Vilstrup, Imogen; Lassen, C. F.

2007-01-01

OBJECTIVE: To examine the validity and potential biases in self-reports of computer, mouse and keyboard usage times, compared with objective recordings. METHODS: A study population of 1211 people was asked in a questionnaire to estimate the average time they had worked with computer, mouse...... and keyboard during the past four working weeks. During the same period, a software program recorded these activities objectively. The study was part of a one-year follow-up study from 2000-1 of musculoskeletal outcomes among Danish computer workers. RESULTS: Self-reports on computer, mouse and keyboard usage...... times were positively associated with objectively measured activity, but the validity was low. Self-reports explained only between a quarter and a third of the variance of objectively measured activity, and were even lower for one measure (keyboard time). Self-reports overestimated usage times...

Individual and average responses of sleep quality and daytime sleepiness after four weeks of strength training in adolescents

Directory of Open Access Journals (Sweden)

Maria Julia Lyra

2018-01-01

Full Text Available Abstract Aims: To analyze the average and individual responses of sleep quality and daytime sleepiness in adolescents after four weeks of strength training. Methods: 19 adolescents with sleep problems recruited in the Federal Institute of Pernambuco, were subject to anthropometric evaluations as well as those for body composition assessment, a 1 repetition maximum test, the sleep parameters (Pittsburgh Sleep Quality Index-PSQI and Epworth Sleepiness Scale-ESS and were submitted to four weeks of strength-training, performed alternately by segment, two sessions per week, according to recommendations for this population. Results: A decrease in the average PSQI score was observed (10.3±3.3 vs 8.8±4.0; p=0.006, but not in ESS (p>0.05, after intervention. The individual analyses demonstrated that ~63% of adolescents experienced reductions ≥ 3 points in the PSQI and ~58% of them experienced reductions ≥ 3 points in the measure of daytime sleepiness. The prevalence of poor sleep quality and daytime sleepiness reduced from 84.2% to 68.4% and from 52.6% to 31.6%, respectively. The comparisons of high and low responders to exercise training show that adolescents who reduced ≥3 points in the score of a least one sleep parameter presented lower weight, fat mass, and fat percentage (p<0.05. Conclusion: A short-term strength-training program is able to improve global sleep quality, but not daytime sleepiness in adolescents. Furthermore, the changes after training are highly heterogeneous. Further studies are required to better understand the effects of strength training on sleep parameters of adolescents.

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

Science.gov (United States)

Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

2016-01-20

CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events

Increases in plasma plant sterols stabilize within four weeks of plant sterol intake and are independent of cholesterol metabolism.

Science.gov (United States)

Ras, R T; Koppenol, W P; Garczarek, U; Otten-Hofman, A; Fuchs, D; Wagner, F; Trautwein, E A

2016-04-01

Plant sterols (PS) lower plasma LDL-cholesterol through partial inhibition of intestinal cholesterol absorption. Although PS themselves are poorly absorbed, increased intakes of PS result in elevated plasma concentrations. In this paper, we report time curves of changes in plasma PS during 12 weeks of PS intake. Furthermore, the impact of cholesterol synthesis and absorption on changes in plasma PS is explored. The study was a double-blind, randomized, placebo-controlled, parallel-group study with the main aim to investigate the effects of PS on vascular function (clinicaltrials.gov: NCT01803178). Hypercholesterolemic but otherwise healthy men and women (n = 240) consumed low-fat spreads without or with added PS (3 g/d) for 12 weeks after a 4-week run-in period. Blood sampling was performed at week 0, 4, 8 and 12. Basal cholesterol-standardized concentrations of lathosterol and sitosterol + campesterol were used as markers of cholesterol synthesis and absorption, respectively. In the PS group, plasma sitosterol and campesterol concentrations increased within the first 4 weeks of intervention by 69% (95%CI: 58; 82) starting at 7.2 μmol/L and by 28% (95%CI: 19; 39) starting at 11.4 μmol/L, respectively, and remained stable during the following 8 weeks. Placebo-corrected increases in plasma PS were not significantly different between high and low cholesterol synthesizers (P-values >0.05). Between high and low cholesterol absorbers, no significant differences were observed, except for the cholesterol-standardized sum of four major plasma PS (sitosterol, campesterol, brassicasterol and stigmasterol) showing larger increases in low absorbers (78.3% (95%CI: 51.7; 109.5)) compared to high absorbers (40.8% (95%CI: 19.9; 65.5)). Increases in plasma PS stabilize within 4 weeks of PS intake and do not seem impacted by basal cholesterol synthesis or absorption efficiency. This study was registered at clinicaltrials.gov (NCT01803178). Copyright © 2015 The Italian Society of

Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

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Naoki Iwamoto

Full Text Available We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA in a real-world setting.Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.Fifty-eight patients (82.9% continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline. 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX or patients whose treatment with tocilizumab (TCZ failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs previously used was independently associated with achievement of DAS-low disease activity.Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

Studies on the safety and consumer acceptance of gamma irradiated meats

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Kang, Il Jun [Hallym University, Kangwon (Korea); Lee, Cherl Ho [Korea University, Seoul (Korea); Kim, Jung Hee [Seoul Women' s University, Seoul (Korea)

1999-04-01

Gamma irradiation was applied to beefs (0-5 kGy) and porks (0-30 kGy) for evaluation of their possible genotoxicity, acute toxicity and four-week oral toxicity. The results were negative in the bacterial reversion assay with S. typhimurium TA98, TA100, TA1535, TA1537. Clastogenic effects of the irradiated samples tested were not shown in vivo mouse micronucleus assay. In an acute toxicity test, the maximal dose of 5,000 mg/kg did not change any toxic parameter examined in this study. In four-week oral toxicity study, no significant differences were found between the control and treatment groups. In the study of rat hepatocarcinogenesis, the consumption of gamma irradiated beef and pork not only does not affect the formation of lipid peroxide and membrane stability but also has a possibility to inhibit hepatocarcinogenesis. Also, the consumption of {gamma} - irradiated beef and pork does not affect antioxidative defense system. In the study of the biological safety of korean red pepper, no difference was found on microbial growth between pepper extract alone or irradiated pepper extract. In the preservation study of korean traditional rice-cake(garedok), irradiation dose below 10kGy had no influence on typical sensory characteristics. The shelf-life in rice-cakes with different conditions was the longest on 10kGy treatment than 5kGy. In investigation of the consumer attitude toward irradiated foods, the main reason for the concern about irradiated foods is that compounds in the products formed by irradiation. Therefore, regulatory authorities must be encouraged to permit the sale of irradiated items when wholesomeness is established. (author). 94 refs.,31 figs., 62 tabs.

Efficacy and Safety Evaluation of Myostaal Forte, a Polyherbal Formulation, in Treatment of Knee Osteoarthritis: A Randomised Controlled Pilot Study

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Raakhi K Tripathi

2017-10-01

Full Text Available Introduction: Myostaal Forte, a proprietary poly-herbal formulation, is mixture of nine herbal plant extracts which possess analgesic, anti-inflammatory and chondroprotective properties. Aim: A prospective, randomised, active controlled, 2-arm, parallel group, assessor blind study was planned to evaluate clinical efficacy and safety of Myostaal Forte in patients of knee osteoarthritis. Materials and Methods: Idiopathic knee osteoarthritis cases as per American College of Rheumatology (ACR clinical criteria were screened and recruited. A total of sixty patients were assigned to receive Myostaal Forte TDS (n=30 or Paracetamol 650 mg TDS (n=30 for six weeks. Naproxen was rescue analgesia. Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC, Visual Analogue Scale (VAS, global assessment scores determined by orthopaedic physician at baseline, two, four, six weeks and telephonically at eight weeks. Safety was assessed through laboratory investigations at baseline and six weeks, adverse events and tolerability. Data were expressed as Mean±SD and analysed by Chi-square and unpaired t-test. p0.05. No significant adverse events, changes in the laboratory parameters and excellent compliance to treatment were seen in both the groups. Conclusion: Earlier onset analgesic effect with sustained chondroprotection after treatment cessation makes Myostaal Forte, a safe and effective alternative for treatment of knee osteoarthritis.

Determinants of safety outcomes and performance: A systematic literature review of research in four high-risk industries.

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Cornelissen, Pieter A; Van Hoof, Joris J; De Jong, Menno D T

2017-09-01

In spite of increasing governmental and organizational efforts, organizations still struggle to improve the safety of their employees as evidenced by the yearly 2.3 million work-related deaths worldwide. Occupational safety research is scattered and inaccessible, especially for practitioners. Through systematically reviewing the safety literature, this study aims to provide a comprehensive overview of behavioral and circumstantial factors that endanger or support employee safety. A broad search on occupational safety literature using four online bibliographical databases yielded 27.527 articles. Through a systematic reviewing process 176 online articles were identified that met the inclusion criteria (e.g., original peer-reviewed research; conducted in selected high-risk industries; published between 1980-2016). Variables and the nature of their interrelationships (i.e., positive, negative, or nonsignificant) were extracted, and then grouped and classified through a process of bottom-up coding. The results indicate that safety outcomes and performance prevail as dependent research areas, dependent on variables related to management & colleagues, work(place) characteristics & circumstances, employee demographics, climate & culture, and external factors. Consensus was found for five variables related to safety outcomes and seven variables related to performance, while there is debate about 31 other relationships. Last, 21 variables related to safety outcomes and performance appear understudied. The majority of safety research has focused on addressing negative safety outcomes and performance through variables related to others within the organization, the work(place) itself, employee demographics, and-to a lesser extent-climate & culture and external factors. This systematic literature review provides both scientists and safety practitioners an overview of the (under)studied behavioral and circumstantial factors related to occupational safety behavior. Scientists

Modeling safety risk perception due to mobile phone distraction among four wheeler drivers

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Raghunathan Rajesh

2017-04-01

Full Text Available Nowadays, there is an increasing trend in the use of information and communication technology devices in new vehicles. Due to these increasing service facilities, driver distraction has become a major concern for transportation safety. To reduce safety risks, it is crucial to understand how distracting activities affect driver behavior at different levels of vehicle control. The objective of this work is to understand how the vehicle and driver characteristics influence mobile phone usage while driving and associated risk perception of road safety incidents. Based on literature review, a man–machine framework for distracted driving and a mobile phone distraction model is presented. The study highlights the findings from a questionnaire survey conducted in Kerala, India. The questionnaire uses a 5-point Likert scale. Responses from 1203 four-wheeler drivers are collected using random sampling approach. The questionnaire items associated with three driver-drive characteristics are: (i Human Factors (age, experience, emotional state, behavior of driver, (ii Driver space (meter, controls, light, heat, steering, actuators of vehicle, (iii Driving conditions (speed, distance, duration, traffic, signals. This mobile phone distraction model is tested using structural equation modeling procedure. The study indicates that among the three characteristics, ‘Human Factors’ has the highest influence on perceived distraction due to mobile phones. It is also observed that safety risk perception due to mobile phone usage while driving is moderate. The practical relevance of the study is to place emphasis on behavior-based controls and to focus on strategies leveraging perception of distraction due to mobile phones while driving.

Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study.

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Wadsworth, L Tyler; Kent, Jeffrey D; Holt, Robert J

2016-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are standard therapy for osteoarthritis (OA). Topically applied NSAIDs reduce systemic exposure compared with oral NSAIDS, and European guidelines recommend their use. The NSAID diclofenac is available in a range of topical formulations. Diclofenac 1% gel and 1.5% four times daily and 2% twice daily (BID) solutions are approved to reduce pain from OA of the knee(s). The objective of this study was to investigate the efficacy and safety of diclofenac sodium 2% topical solution BID versus vehicle control solution for treating pain associated with OA of the knee. A phase II, 4 week, randomized, double-blind, parallel-group, two-arm, vehicle-controlled study compared pain relief with diclofenac sodium 2% topical solution versus control (vehicle only) in patients aged 40 to 85 years with radiographically confirmed primary OA of the knee. ClinicalTrials.gov identifier NCT01119898. The primary efficacy outcome was change from baseline to the final visit in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes included additional WOMAC subscales and patient global assessment of OA. Treatment-emergent adverse events (TEAEs), skin irritation, and vital signs were assessed and collected throughout the study. Of 260 patients randomized, 259 received ≥1 dose of study drug. Significantly greater reductions in least-squares mean (standard error) WOMAC pain scores were observed for diclofenac-treated (-4.4 [0.4]) versus vehicle-treated patients (-3.4 [0.4]) at the final visit (p = 0.040). The most commonly reported TEAEs were administration site conditions. The vehicle-treated group experienced slightly more TEAEs than the active treatment group (38.8% vs. 31.5%). No serious adverse events were reported. Administration of diclofenac sodium 2% topical solution BID resulted in significantly greater improvement in pain reduction in patients with OA of the knee versus vehicle

Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey.

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Vavricka, Stephan R; Schoepfer, Alain M; Bansky, Georg; Binek, Janek; Felley, Christian; Geyer, Martin; Manz, Michael; Rogler, Gerhard; de Saussure, Philippe; Sauter, Bernhard; Scharl, Michael; Seibold, Frank; Straumann, Alex; Michetti, Pierre

2011-07-01

Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines. Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and 43% to adalimumab. A significant decrease of the Harvey-Bradshaw Index (HBI) was observed under CZP therapy (12.2 ± 4.9 at week 0 versus 6.3 ± 4.7 at week 6 and 6.7 ± 5.3 at week 26, both P < 0.001). Response and remission rates were 70% and 40% (week 6) and 67% and 36%, respectively (week 26). The complete perianal fistula closure rate was 36% at week 6 and 55% at week 26. The frequency of adverse drug reactions attributed to CZP was 5%. CZP was continued in 88% of patients beyond week 6 and in 67% beyond week 26. In a population of CD patients with predominantly complicated disease behavior, CZP proved to be effective in induction and maintenance of response and remission. This series provides the first evidence of CZP's effectiveness in perianal fistulizing CD in clinical practice. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

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Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

2013-01-01

The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

Hepatic steatosis development with four weeks of physical inactivity in previously active, hyperphagic OLETF rats.

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Linden, Melissa A; Meers, Grace M; Ruebel, Meghan L; Jenkins, Nathan T; Booth, Frank W; Laughlin, M Harold; Ibdah, Jamal A; Thyfault, John P; Rector, R Scott

2013-05-01

Physical activity-induced prevention of hepatic steatosis is maintained during short-term (7-day) transitions to an inactive state; however, whether these protective effects are present under a longer duration of physical inactivity is largely unknown. Here, we sought to determine whether previous physical activity had protective effects on hepatic steatosis and metabolic health following 4 wk of physical inactivity. Four-week old, hyperphagic, male Otsuka Long-Evans Tokushima fatty (OLETF) rats were randomly assigned to either a sedentary group for 16 wk (OLETF-SED), given access to running wheels for 16 wk with wheels locked 5 h (OLETF-WL5hr) or given access to running wheels for 12 wk with wheels locked 4 wk (OLETF-WL4wk) prior to death. Four weeks of physical inactivity caused hepatic steatosis development, but liver triglycerides remained 60% lower than OLETF-SED (P inactivity, whereas markers of fatty acid uptake and lipogenesis remained relatively suppressed following 4 wk of inactivity. In addition, 4 wk of inactivity caused a complete loss of activity-induced increases in serum IL-6 and reductions in regulated upon activation, normal T-cell expressed, and secreted (RANTES), and a partial loss in reductions in leptin, monocyte chemoattractant protein-1, and TNF-α. In conclusion, 4 wk of physical inactivity does not result in a complete loss in physical activity-induced benefits but does cause deterioration in the liver phenotype and overall metabolic health in hyperphagic OLETF rats.

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

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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...

Effects of Innovative WALKBOT Robotic-Assisted Locomotor Training on Balance and Gait Recovery in Hemiparetic Stroke: A Prospective, Randomized, Experimenter Blinded Case Control Study With a Four-Week Follow-Up.

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Kim, Soo-Yeon; Yang, Li; Park, In Jae; Kim, Eun Joo; JoshuaPark, Min Su; You, Sung Hyun; Kim, Yun-Hee; Ko, Hyun-Yoon; Shin, Yong-Il

2015-07-01

The present clinical investigation was to ascertain whether the effects of WALKBOT-assisted locomotor training (WLT) on balance, gait, and motor recovery were superior or similar to the conventional locomotor training (CLT) in patients with hemiparetic stroke. Thirty individuals with hemiparetic stroke were randomly assigned to either WLT or CLT. WLT emphasized on a progressive, conventional locomotor retraining practice (40 min) combined with the WALKBOT-assisted, haptic guidance and random variable locomotor training (40 min) whereas CLT involved conventional physical therapy alone (80 min). Both intervention dosages were standardized and provided for 80 min, five days/week for four weeks. Clinical outcomes included function ambulation category (FAC), Berg balance scale (BBS), Korean modified Barthel index (K-MBI), modified Ashworth scale (MAS), and EuroQol-5 dimension (EQ-5D) before and after the four-week program as well as at follow-up four weeks after the intervention. Two-way repeated measure ANOVA showed significant interaction effect (time × group) for FAC (p=0.02), BBS (p=0.03) , and K-MBI (p=0.00) across the pre-training, post-training, and follow-up tests, indicating that WLT was more beneficial for balance, gait and daily activity function than CLT alone. However, no significant difference in other variables was observed. This is the first clinical trial that highlights the superior, augmented effects of the WALKBOT-assisted locomotor training on balance, gait and motor recovery when compared to the conventional locomotor training alone in patients with hemiparetic stroke.

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

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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.

Efficacy and safety of the long-acting β2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease

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Ichinose M

2015-08-01

Full Text Available Masakazu Ichinose,1 Ayako Takizawa,2 Toshiyasu Izumoto,2 Yusuke Tadayasu,2 Alan L Hamilton,3 Christina Kunz,4 Yoshinosuke Fukuchi51Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 2Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany; 5Juntendo University School of Medicine, Tokyo, JapanBackground: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD.Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1 after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC0–3, peak FEV1 from 0 hour to 3 hours (peak FEV1, and corresponding forced vital capacity (FVC responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P<0.0001. Mean increases in peak FEV1 and FEV1 AUC0–3 compared to placebo were also significant (P<0.0001. A clear dose–response relationship was observed across all treatment groups. FVC responses (trough

Feasibility Study Evaluating Four Weeks Stochastic Resonance Whole-Body Vibration Training with Healthy Female Students

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Slavko Rogan

2013-07-01

Full Text Available This study assessed the feasibility of stochastic resonance whole-body vibration (SR-WBV training and its impact on isometric maximal voluntary contraction (IMVC, isometric rate of force development (IRFD and a drop jump test (DJ in healthy female students. Twelve participants were randomised to static squats during SR-WBV 6 Hz, noise level 4, over 4 weeks or to a control group (no training. Feasibility outcomes included the number of students agreeing to participate, the number of drop-outs, the adherence to the SR-WBV and the evaluation of the protocol. Secondary outcomes were IMVC, IRFD and DJ. Results: Among 35 eligible students, 12 agreed to participate and two dropped out. The adherence was 41 of 60 possible sessions. There were moderate to large, but statistically non-significant, gains in the secondary outcomes. Conclusion: These results suggest that such a study would be feasible although with some modifications such as a better familiarisation to the DJ.

Interchangeability of counts of cases and hours of cases for quantifying a hospital's change in workload among four-week periods of 1 year.

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Dexter, Franklin; Epstein, Richard H; Ledolter, Johannes; Wanderer, Jonathan P

2018-05-16

Recent studies have made longitudinal assessments of case counts using State (e.g., United States) and Provincial (e.g., Canada) databases. Such databases rarely include either operating room (OR) or anesthesia times and, even when duration data are available, there are major statistical limitations to their use. We evaluated how to forecast short-term changes in OR caseload and workload (hours) and how to decide whether changes are outliers (e.g., significant, abrupt decline in anesthetics). Observational cohort study. Large teaching hospital. 35 years of annual anesthesia caseload data. Annual data were used without regard to where or when in the year each case was performed, thereby matching public use files. Changes in caseload or hours among four-week periods were examined within individual year-long periods using 159 consecutive four-week periods from the same hospital. Series of 12 four-week periods of the hours of cases performed on workdays lacked trend or correlation among periods for 49 of 50 series and followed normal distributions for 50 of 50 series. These criteria also were satisfied for 50 of 50 series based on counts of cases. The Pearson r = 0.999 between hours of anesthetics and cases. For purposes of time series analysis of total workload at a hospital within 1-year, hours of cases and counts of cases are interchangeable. Simple control chart methods of detecting sudden changes in workload or caseload, based simply on the sample mean and standard deviation from the preceding year, are appropriate. Copyright © 2018 Elsevier Inc. All rights reserved.

Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study.

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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.

Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.

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Rosales, R; Abou Jaoude, E; Al-Arouj, M; Fawwad, A; Orabi, A; Shah, P; DiTommaso, S; Vaz, J; Latif, Z A

2015-06-01

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24 weeks of treatment with vildagliptin with or without metformin. Of 19 331 patients analysed, 3511 received vildagliptin and 15 820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice. © 2015 John Wiley & Sons Ltd.

Bl-1020, a new γ-aminobutyric acid-enhanced antipsychotic: results of 6-week, randomized, double-blind, controlled, efficacy and safety study.

Science.gov (United States)

Geffen, Yona; Keefe, Richard; Rabinowitz, Jonathan; Anand, Ravi; Davidson, Michael

2012-09-01

BL-1020 is a γ-aminobutyric acid (GABA)-enhanced antipsychotic that combines dopamine antagonism with GABA agonist activity. On the basis of animal models, we tested the hypotheses that BL-1020 would be effective in ameliorating both psychotic symptoms and cognitive impairments, with a favorable safety profile in acutely ill schizophrenia patients. 363 hospital-based psychiatric patients in India, Romania, and United States aged 18 to 65 years and meeting criteria for DSM-IV-TR diagnosis of chronic schizophrenia were randomized double-blind to receive BL-1020 10 mg/d, BL-1020 20-30 mg/d, placebo, or risperidone (2-8 mg/d) for 6 weeks. The main outcome measures were the positive and negative syndrome scale (PANSS), brief assessment of cognition in schizophrenia, readiness for discharge questionnaire, clinical global impressions scale (CGI) , and extrapyramidal symptom rating scale. The study ran from July 2008 to June 2009. BL-1020 20-30 mg was significantly better than placebo on PANSS (P = .02) and CGI (P schizophrenia composite score when compared to placebo (effect size = 0.50, P = .009), risperidone (effect size = 0.43, P = .019), and BL-1020 10 mg (effect size = 0.42, P = .013) after 6 weeks. BL-1020 appears to be an effective antipsychotic with possible procognitive effects that will need to be further tested for short- and long-term effects. A further randomized controlled trial using the U.S. Food and Drug Administration-recommended Measurement and Treatment Research to Improve Cognition in Schizophrenia cognitive battery is ongoing. ClinicalTrials.gov identifier: NCT00567710. © Copyright 2012 Physicians Postgraduate Press, Inc.

Pharmacokinetics, Safety, and 48-Week Efficacy of Oral Raltegravir in HIV-1–Infected Children Aged 2 Through 18 Years

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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

Evaluation of Four Bedside Test Systems for Card Performance, Handling and Safety.

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Giebel, Felix; Picker, Susanne M; Gathof, Birgit S

2008-01-01

SUMMARY: OBJECTIVE: Pretransfusion ABO compatibility testing is a simple and required precaution against ABO-incompatible transfusion, which is one of the greatest threats in transfusion medicine. While distinct agglutination is most important for correct test interpretation, protection against infectious diseases and ease of handling are crucial for accurate test performance. Therefore, the aim of this study was to evaluate differences in test card design, handling, and user safety. DESIGN: Four different bedside test cards with pre-applied antibodies were evaluated by 100 medical students using packed red blood cells of different ABO blood groups. Criteria of evaluation were: agglutination, labelling, handling, and safety regarding possible user injuries. Criteria were rated subjectively according to German school notes ranging from 1 = very good to 6 = very bad/insufficient. RESULTS: Overall, all cards received very good/good marks. The ABO blood group was identified correctly in all cases. Three cards (no. 1, no. 3, no. 4) received statistically significant (p labelling (1.5 vs. 2.2-2.4), handling (1.9-2.0 vs. 2.5), and user safety (2.5 vs. 3.4). Analysis of card self-explanation revealed no remarkable differences. CONCLUSION: Despite good performance of all card systems tested, the best results when including all criteria evaluated were obtained with card no. 4 (particularly concerning clear agglutination), followed by cards no. 2, no. 1, and no. 3.

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/.

A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma.

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Kim, Young Saing; Lee, Soon Il; Park, Se Hoon; Park, Silvia; Hwang, In Gyu; Lee, Sang-Cheol; Sun, Jong-Mu; Lee, Jeeyun; Lim, Ho Yeong

2016-02-01

The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic urothelial carcinoma. Weekly docetaxel was well tolerated but demonstrated modest activity, with a response rate of 6%, a median progression-free survival (PFS) of 1.4 months, and a median overall survival (OS) of 8.3 months. The dichotomy between PFS and OS was likely associated with subsequent platinum-based chemotherapy received by 58% of the patients. Docetaxel is commonly used for second-line therapy for metastatic urothelial carcinoma (UC). However, myelosuppression is a substantial concern when the traditional 3-week docetaxel cycle is used. The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic UC. Patients with progression after previous platinum-based chemotherapy for advanced or metastatic disease were treated with docetaxel 30 mg/m(2) on days 1 and 8 every 21 days. The primary endpoint was the response rate. The study enrolled 31 patients. Their median age was 64 years (range, 40-79 years). An Eastern Cooperative Oncology Group performance status of 1, liver metastasis, and a hemoglobin level chemotherapy had been administered for metastatic disease in 29 patients (94%). Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 to 4 toxicities, the safety profiles were generally mild and manageable. Two patients (6%) achieved an objective response, which was maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization (disease control rate, 32%). The median progression-free survival (PFS) and overall survival (OS) were 1.4 months (95% confidence interval [CI], 1.3-1.6) and 8.3 months (95% CI, 5.9-10.6), respectively. A relatively long OS was associated with further salvage platinum-based chemotherapy (n = 18, 58%) showing an encouraging activity (response rate, 44%; median PFS, 4.0 months

Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies.

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Kusawake, Tomohiro; Keirns, James J; Kowalski, Donna; den Adel, Martin; Groenendaal-van de Meent, Dorien; Takada, Akitsugu; Ohtsu, Yoshiaki; Katashima, Masataka

2017-12-01

Amenamevir (ASP2151) is a nonnucleoside antiherpesvirus compound available for the treatment of varicella-zoster virus infections. In this article we summarize the findings of four phase 1 studies in healthy participants. Four randomized phase 1 studies investigated the safety and pharmacokinetics of single and multiple doses of amenamevir, including the assessment of age group effect (nonelderly vs elderly), food effect, and the relative bioavailability of two formulations. Amenamevir was administered orally at various doses as a single dose (5-2400 mg) or daily (300 or 600 mg/day) for 7 days. Following single and multiple oral doses, amenamevir demonstrated a less than dose proportional increase in the pharmacokinetic parameters area under the plasma drug concentration versus time curve from time zero to infinity (AUC inf ) and C max . After single and multiple oral 300-mg doses of amenamevir, no apparent differences in pharmacokinetics were observed between nonelderly and elderly participants. In contrast, with the amenamevir 600-mg dose both the area under the plasma drug concentration versus time curve from time zero to 24 h and C max were slightly increased and renal clearance was decreased in elderly participants. The pharmacokinetics of amenamevir was affected by food, with AUC inf increased by about 90%. In the bioavailability study, AUC inf and C max were slightly lower following tablet versus capsule administration (decreased by 14 and 12%, respectively), with relative bioavailability of 86%. The different amenamevir doses and formulations were safe and well tolerated; no deaths or serious adverse events were reported. Amenamevir had less than dose proportional pharmacokinetic characteristics. Age may have an influence on amenamevir pharmacokinetics; however, the effect was considered minimal. The pharmacokinetics of amenamevir were affected by food, with AUC inf almost doubling when amenamevir was administered with food. The concentration versus

Academic Effects and Cost Benefit of a Four-Day Week at College of DuPage, an Illinois Community College.

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Wallace, Carol C.

The implementation of a four-day week (Monday-Thursday) for on-campus classes at the College of DuPage, an Illinois community college, was assessed in terms of student registration; class enrollment; student success rates; instructional quality; and savings resulting from driving differences, energy use, and building maintenance. Withdrawal and…

Four weeks' inhalation exposure of Long Evans rats to 4-tert-butyltoluene: Effect on evoked potentials, behaviour and brain neurochemistry

DEFF Research Database (Denmark)

Lam, Henrik Rye; Ladefoged, Ole; Østergaard, Grete

2000-01-01

Long-lasting central nervous system (CNS) neurotoxicity of 4-tert-butyltoluene (TBT) has been investigated using electrophysiology, behaviour, and neurochemistry in Long Evans rats exposed by inhalation to 0, 20, or 40 p.p.m. TBT 6 hr/day, 7 days/week for 4 weeks. Flash evoked potentials...... and somatosensory evoked potentials were not affected by TBT In Auditory Brain Stem Response there was no shift in hearing threshold, but the amplitude of the first wave was increased in both exposed groups at high stimulus levels. Three to four months after the end of exposure, behavioural studies in Morris water...... maze and eight-arm maze failed to demonstrate any TBT induced effects. Exposure was followed by a 5 months exposure-free period prior to gross regional and subcellular (synaptosomal) neurochemical investigations of the brain. TBT reduced the NA concentration in whole brain minus cerebellum...

Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.

NARCIS (Netherlands)

Leonardi, C.; Strober, B.; Gottlieb, A.B.; Elewski, B.E.; Ortonne, J.P.; Kerkhof, P.C.M. van de; Chiou, C.F.; Dunn, M.; Jahreis, A.

2010-01-01

BACKGROUND: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. OBJECTIVE: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe

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

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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.

College Rampage Renews School Safety Concerns

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Maxwell, Lesli A.

2007-01-01

Coming just four days before the anniversary of the Columbine school shootings, the mass slayings by a student gunman at Virginia Polytechnic Institute last week revived vexing questions and raised familiar fears for educators across the country who grapple daily with ensuring the safety of their students and staffs. The April 16 killings provoked…

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.

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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.

Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b

Science.gov (United States)

Toyota, J; Ozeki, I; Karino, Y; Asahina, Y; Izumi, N; Takahashi, S; Kawakami, Y; Chayama, K; Kamiya, N; Aoki, K; Yamada, I; Suzuki, Y; Suzuki, F; Kumada, H

2013-01-01

Hepatitis C virus (HCV) subtype 1b, which infects approximately 70% of Japanese carriers, is likely to be more eradicable by a telaprevir regimen than subtype 1a because of the higher genetic barrier of Val36 and Arg155 substitutions. The aims of this exploratory study were to evaluate the virological response and safety of 24-week oral administration of telaprevir alone in chronic HCV subtype 1b infection. Fifteen treatment-naïve patients were treated with telaprevir 750 mg every 8 h for 24 weeks. All patients were Japanese whose median age was 58.0 years (range: 45–68), and six patients (40%) were men. Median baseline HCV RNA level was 6.80 log10 IU/mL (range: 3.55–7.10). The HCV RNA levels decreased to undetectable in five patients (33%) within 8 weeks. Three patients (20%) with negative HCV RNA by Week 4 achieved end of treatment response. One patient (7%) who achieved sustained virological response had a low baseline viraemia of 3.55 log10 IU/mL. Most of the adverse events including anaemia and skin disorders were mild to moderate. Developed variants were T54A and A156V/T/F/Y with or without secondary substitutions rather than V36M ± R155K. Telaprevir alone for 24 weeks in Japanese patients with HCV subtype 1b resulted in an sustained viral response rate of 7% (1/15) and was well tolerated for 24 weeks. These results will support the implementation of further studies on oral combination of telaprevir with other direct-acting antiviral agents in patients infected with HCV subtype 1b. PMID:23383655

The safety of non-incineration waste disposal devices in four hospitals of Tehran.

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

The safe management of hospital waste is a challenge in many developing countries. The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries.

Weekly azathioprine pulse versus daily azathioprine in the treatment of Parthenium dermatitis: A non-inferiority randomized controlled study

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Kaushal K Verma

2015-01-01

Full Text Available Background: Azathioprine in daily doses has been shown to be effective and safe in the treatment of Parthenium dermatitis. Weekly pulses of azathioprine (WAP are also effective, but there are no reports comparing the effectiveness and safety of these two regimens in this condition. Aims: To study the efficacy and safety of WAP and daily azathioprine in Parthenium dermatitis. Methods: Sixty patients with Parthenium dermatitis were randomly assigned to treatment with azathioprine 300 mg weekly pulse or azathioprine 100 mg daily for 6 months. Patients were evaluated every month to assess the response to treatment and side effects. Results: The study included 32 patients in the weekly azathioprine group and 28 in the daily azathioprine group, of whom 25 and 22 patients respectively completed the study. Twenty-three (92% patients on WAP and 21 (96% on daily azathioprine had a good or excellent response. The mean pretreatment clinical severity score decreased from 26.4 ± 14.5 to 4.7 ± 5.1 in the WAP group, and from 36.1 ± 18.1 to 5.7 ± 6.0 in the daily azathioprine group, which was statistically significant and comparable (P = 0.366. Patients on WAP had a higher incidence of adverse effects (P = 0.02. Limitations: The study had a small sample size and the amount of clobetasol propionate used in each patient was not determined, though it may not have affected the study outcome due to its comparable use in both groups. Conclusions: Azathioprine 300 mg weekly pulse and 100 mg daily dose are equally effective and safe in the treatment of Parthenium dermatitis.

Changes in walking associated with perceived neighborhood safety and police-recorded crime: The multi-ethnic study of atherosclerosis.

Science.gov (United States)

Kerr, Zachary; Evenson, Kelly R; Moore, Kari; Block, Richard; Diez Roux, Ana V

2015-04-01

To explore the association of changes in perceived safety and police-recorded crime with changes in transport and leisure walking using longitudinal data from Chicago residents participating in the Multi-Ethnic Study of Atherosclerosis (2000-2012). Main exposures included perceived safety (self-reported as feeling safe walking in the neighborhood and reporting violence to be a problem in the neighborhood), and one-year counts of police-recorded crime occurring within a one-mile buffer of participants' residences. Main outcomes included transport and leisure walking (self-reported and calculated as total minutes/week across four study visits). Fixed effects models assessed the association of change in perceived safety and police-recorded crime with changes in transport and leisure walking over a 10-year period for 796 adults. No associations were found between changes in perceived safety and either changes in transport or leisure walking. Residing in areas with increases in murder was associated with decreases in transport walking. However, no other associations were found with police-recorded crime. There continues to be a need to explore the benefits of cultivating safe neighborhoods that enhance resident health and well-being. Research should continue examining how community initiatives may build safe environments and community identity that promote walking. Copyright © 2015 Elsevier Inc. All rights reserved.

The effects of four weeks of creatine supplementation and high-intensity interval training on cardiorespiratory fitness: a randomized controlled trial

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Cramer Joel T

2009-11-01

Full Text Available Abstract Background High-intensity interval training has been shown to be a time-efficient way to induce physiological adaptations similar to those of traditional endurance training. Creatine supplementation may enhance high-intensity interval training, leading to even greater physiological adaptations. The purpose of this study was to determine the effects of high-intensity interval training (HIIT and creatine supplementation on cardiorespiratory fitness and endurance performance (maximal oxygen consumption (VO2PEAK, time-to-exhaustion (VO2PEAKTTE, ventilatory threshold (VT, and total work done (TWD in college-aged men. Methods Forty-three recreationally active men completed a graded exercise test to determine VO2PEAK, VO2PEAKTTE, and VT. In addition, participants completed a time to exhaustion (TTE ride at 110% of the maximum workload reached during the graded exercise test to determine TWD (TTE (sec × W = J. Following testing, participants were randomly assigned to one of three groups: creatine (creatine citrate (Cr; n = 16, placebo (PL; n = 17, or control (n = 10 groups. The Cr and PL groups completed four weeks of HIIT prior to post-testing. Results Significant improvements in VO2PEAK and VO2PEAKTTE occurred in both training groups. Only the Cr group significantly improved VT (16% vs. 10% improvement in PL. No changes occurred in TWD in any group. Conclusion In conclusion, HIIT is an effective and time-efficient way to improve maximal endurance performance. The addition of Cr improved VT, but did not increase TWD. Therefore, 10 g of Cr per day for five days per week for four weeks does not seem to further augment maximal oxygen consumption, greater than HIIT alone; however, Cr supplementation may improve submaximal exercise performance.

30 CFR 75.364 - Weekly examination.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Weekly examination. 75.364 Section 75.364... MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.364 Weekly examination. (a) Worked-out... bleeder system. (b) Hazardous conditions. At least every 7 days, an examination for hazardous conditions...

Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.

Science.gov (United States)

Ogata, Atsushi; Amano, Koichi; Dobashi, Hiroaki; Inoo, Masayuki; Ishii, Tomonori; Kasama, Tsuyoshi; Kawai, Shinichi; Kawakami, Atsushi; Koike, Tatsuya; Miyahara, Hisaaki; Miyamoto, Toshiaki; Munakata, Yasuhiko; Murasawa, Akira; Nishimoto, Norihiro; Ogawa, Noriyoshi; Ojima, Tomohiro; Sano, Hajime; Shi, Kenrin; Shono, Eisuke; Suematsu, Eiichi; Takahashi, Hiroki; Tanaka, Yoshiya; Tsukamoto, Hiroshi; Nomura, Akira

2015-05-01

To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: What size of data platforms and which study designs do we need to assess safety issues?

NARCIS (Netherlands)

V.E. Valkhoff (Vera); R. Schade (René); G.W. 't Jong (Geert); S.A. Romio (Silvana); M.J. Schuemie (Martijn); A. Arfe (Andrea); C. Garbe (Claus); R.M.C. Herings (Ron); S. Lucchi (Silvia); G. Picelli (Gino); J.C. Schink (Julian); H. Straatman (Huub); M. Villa (Marco); E.J. Kuipers (Ernst); M.C.J.M. Sturkenboom (Miriam)

2013-01-01

textabstractBackground: Data on utilization patterns and safety of non-steroidal anti-inflammatory drugs (NSAIDs) in children are scarce. The purpose of this study was to investigate the utilization of NSAIDs among children in four European countries as part of the Safety Of non-Steroidal

Glycemia and insulinemia concentrations in four-weeks-old male and female broilers and their relationship to weight

Directory of Open Access Journals (Sweden)

José H. Osorio

2016-06-01

Full Text Available Introduction: Glucose metabolism in birds is directly related to insulin secretion, given that this hormone exerts an anabolic function and this response is reflected in the growth of poultry. There is little information on variables such as sex, age and weight, and their effect on insulin secretion and the regulation of glucose concentrations. Objective: To compare concentrations of insulin, glucose, and weight in four-weeks-old male and female broiler chickens, in order to establish reference values for them. Materials and methods: Fasting blood samples were collected from 80 broilers of both sexes (four-weeks-old Cobb 500 line. Enzyme immunoassay (sandwich method was used to determine levels of insulin, glucometer for glycemia levels, and scales for weight. Results were analyzed using the Stata statistical program; a statistically significant difference is accepted when p is < 0.05. Results: Insulin values are 0.60 ± 0.63 ng/mL; regarding glucose levels, males reported values between 415.45 ± 40.52 mg/dL, and females between 350.72 ± 68.37 mg/dL; finally, weight values were 963.73 g in males and 865.64 g in females. Conclusions: Males are heavier than females. Glycemia concentrations are higher in males than in females; reference values according to sex are: in females (mg/dL 350.72 ± 68.37, and in males (mg/dL 415 ± 40.52; finally, insulin levels are higher in females than in males.

Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

Directory of Open Access Journals (Sweden)

Caterson Ian D

2009-10-01

Full Text Available Abstract Background and aims Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine in an overweight and obese cardiovascular high risk population was studied. Methods and results Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT study were analyzed. 2584 patients (24% had diabetes mellitus (DM only, 1748 (16% had cardiovascular disease (CVD only and 6397 (60% had both DM + CVD. Uric acid concentrations (mean ± standard deviation at screening were significantly higher among patients with CVD compared to patients without CVD (p Conclusion A four week daily intake of sibutramine and life style changes was associated with significant reductions in mean uric acid levels. Changes in renal glucose load in diabetes seem to counteract a potential uricosuric effect of sibutramine. Trial Registration The trial is registered at ClinicalTrial.gov number: NCT00234832.

A 12-week clinical and instrumental study evaluating the efficacy of a multisource radiofrequency home-use device for wrinkle reduction and improvement in skin tone, skin elasticity, and dermal collagen content.

Science.gov (United States)

Sadick, Neil S; Harth, Yoram

2016-12-01

This study was performed in order to evaluate the safety and efficacy of a new handheld home-use multisource radiofrequency device on facial rejuvenation. Forty-seven male and female subjects were enrolled. All subjects received a NEWA ® 3DEEP ™ home-use device (EndyMed Medical, Caesarea, Israel) to be used on facial skin three times per week for the first four weeks and then reduced to two times per week for the following eight weeks. Assessments included expert clinical grading for efficacy, instrumental evaluation, image analysis, and photography. Forty-five subjects completed the study; all subjects reported the treatment to be painless with only mild erythema lasting up to 15 minutes post-treatment. No other adverse events were reported. Statistically significant improvements were noted in the appearance of marionette lines, skin brightness, elasticity, firmness, lift (facial), lift (jawline), texture/smoothness, tone, and radiance/luminosity by expert visual assessment. Statistically significant improvements in skin firmness and elasticity were found using a Cutometer MPA 580, as well as in collagen and hemoglobin content of the skin using a SIAscope. The results of this study indicate that the NEWA ® multisource radiofrequency home-use device is effective in self-administered skin rejuvenation.

Predicting safety culture: the roles of employer, operations manager and safety professional.

Science.gov (United States)

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease.

Science.gov (United States)

Zhang, Zhenxin; Wang, Jian; Zhang, Xiaoying; Chen, Shengdi; Wang, Zhenfu; Zhang, Baorong; Liu, Chunfeng; Qu, Qiumin; Cheng, Yan; Zhu, Rongxuan; Li, Jie; Hu, Jingqiu; Cai, Meng

2015-04-01

This open-label extension (OLE) study evaluated the safety profile of ropinirole prolonged release (PR) administered for 24 weeks as adjunctive to levodopa in Chinese patients with advanced Parkinson's disease (PD). This was a 24 week, flexible-dose, OLE study in Chinese patients with advanced PD who received 24 week treatment with ropinirole PR in the preceding double-blind (DB), phase III study (NCT01154166) and had no break in receiving study treatment while switching from the DB study to the OLE study. In the OLE study, patients received ropinirole PR once daily, starting with 2 mg/d and increasing up to 8 mg/d at week 4 (2 mg increment/week); if tolerable, the dose could be further increased in 4 mg increments up to 24 mg/d according to clinical judgment. There were no efficacy assessments. Safety assessments included monitoring adverse events (AEs), neurological examination, Gambling Symptom Assessment Scale questionnaire, liver chemistry, and laboratory tests. Of the 295 enrolled patients, 282 completed the study. The most common reason for withdrawal was AEs (n = 9, 3.1%). The mean duration to ropinirole PR treatment was 173.1 days and an overall median daily dose of ropinirole was 8 mg (range: 2-24 mg). Overall, 114 (38.6%) patients experienced on-treatment AEs; the most frequent reported AEs ( ≥ 2%) were dyskinesia (6.1%), dizziness (4.1%), nausea (3.4%), hallucinations (3.4%), somnolence (2.7%) and decreased weight (2.4%). Sixty-eight patients (23.1%) experienced treatment-related AEs. Six patients experienced serious AEs (SAEs), of which hallucination was determined to be a treatment-related SAE. There were no other significant safety findings. No new safety signals for ropinirole were identified. The safety profile of ropinirole was consistent with the preceding DB study and also with the established safety profile for ropinirole. Results support the long-term use of ropinirole PR as an adjunctive to levodopa in Chinese patients

Psychological well-being in obese in-patients with ischemic heart disease at entry and at discharge from a four-week cardiac rehabilitation program

Directory of Open Access Journals (Sweden)

Gian Mauro Manzoni

2010-08-01

Full Text Available The purposes of this observational pre-post study were twofold: 1- to evaluate psychological health in obese patients with ischemic heart disease (IHD at admission to cardiac rehabilitation (CR and 2 - to examine the effectiveness of a four-week CR residential program in improving obese patients’ psychological well-being at discharge from CR. A sample of 177 obese patients completed the Psychological General Well-Being Inventory (PGWBI at admission to the CR program and at discharge. The equivalence testing method with normative comparisons was used to determine the clinical significance of improvements after having established that baseline mean scores on the PGWBI scales were significantly lower than normal means. Results show that patients scored equally or better than norms on many PGWBI dimensions at admission to CR but scored significantly worse on Global Score, Vitality and Self-control. At discharge, mean scores that were impaired at baseline returned to normal levels at the more conservative equivalence interval. A four-week CR program was thus effective in improving obese patients’ psychological well-being. The equivalence testing method allowed to establish the clinical significance of such improvement.

The safety of non-incineration waste disposal devices in four hospitals of Tehran

Science.gov (United States)

Farshad, Aliasghar; Gholami, Hamid; Farzadkia, Mahdi; Mirkazemi, Roksana; Kermani, Majid

2014-01-01

Background: The safe management of hospital waste is a challenge in many developing countries. Objectives: The aim of this study was to compare volatile organic compounds (VOCs) emissions and the microbial disinfectant safety in non-incineration waste disposal devices. Methods: VOC emissions and microbial infections were measured in four non-incineration waste disposal devices including: autoclave with and without a shredder, dry heat system, and hydroclave. Using NIOSH and US EPA-TO14 guidelines, the concentration and potential risk of VOCs in emitted gases from four devices were assessed. ProSpore2 biological indicators were used to assess the microbial analysis of waste residue. Results: There was a significant difference in the type and concentration of VOCs and microbial infection of residues in the four devices. Emissions from the autoclave with a shredder had the highest concentration of benzene, ethyl benzene, xylene, and BTEX, and emissions from the hydroclave had the highest concentration of toluene. The highest level of microbial infection was observed in the residues of the autoclave without a shredder. Conclusions: There is an increased need for proper regulation and control of non-incinerator devices and for monitoring and proper handling of these devices in developing countries. PMID:25000113

The effect of four-week high-intensity interval training with beta-alanine supplementation on aerobic and anaerobic performance and some blood parameters in girls basketball players

Directory of Open Access Journals (Sweden)

bahareh ketabdar

2017-06-01

Full Text Available Background & Objective: The aim of the present study was to determine the effect of four-week high-intensity interval training with beta-alanine supplementation on aerobic and anaerobic performance and some blood parameters in girls basketball players. Materials & Methods: This was a quasi-experimental study. Twenty female basketball players, with the mean age of 24.65 ± 4.81 years, height of 166.97 ± 4.12 cm, weight of 59.15 ± 5.23 kg and body mass index of 21.5 ± 1.23 kg/m2, were divided into two groups, including intervention (exercise + supplement and control groups. Two days before and after the intervention, the subjects performed Wingate test (to estimate the average aerobic power and Bruce test (to estimate VO2max.The subjects attended basketball training two sessions per week; Intervention group performed high-intensity interval training in addition to the basketball training in every session. The dose of beta-alanine supplementation was 2.4, 3.6, 4.8 g per day. After four weeks, creatine kinase and lactate levels and performance tests were reevaluated. Data were analyzed by SPSS software version 21, with a significance level of P0.05. Conclusion: This study showed that high-intensity interval training with beta-alanine supplementation resulted in delay in the fatigue threshold, stabilization of PH and hydrogen ions balance, increased aerobic-anaerobic capacity and exercise performance in female basketball players.

Ototoxicity in rats exposed to ethylbenzene and to two technical xylene vapours for 13 weeks

Energy Technology Data Exchange (ETDEWEB)

Gagnaire, Francois; Langlais, Cristina; Grossmann, Stephane; Wild, Pascal [Institut National de Recherche et de Securite, Departement Polluants et Sante, Vandoeuvre Cedex (France)

2007-02-15

Male Sprague-Dawley rats were exposed to ethylbenzene (200, 400, 600 and 800 ppm) and to two mixed xylenes (250, 500, 1,000 and 2,000 ppm total compounds) by inhalation, 6 h/day, 6 days/week for 13 weeks and sacrificed for morphological investigation 8 weeks after the end of exposure. Brainstem auditory-evoked responses were used to determine auditory thresholds at different frequencies. Ethylbenzene produced moderate to severe ototoxicity in rats exposed to the four concentrations studied. Increased thresholds were observed at 2, 4, 8 and 16 kHz in rats exposed to 400, 600 and 800 ppm ethylbenzene. Moderate to severe losses of outer hair cells of the organ of Corti occurred in animals exposed to the four concentrations studied. Exposure to both mixed xylenes produced ototoxicity characterized by increased auditory thresholds and losses of outer hair cells. Ototoxicity potentiation caused by ethylbenzene was observed. Depending on the mixed xylene studied and the area of the concentration-response curves taken into account, the concentrations of ethylbenzene in mixed xylenes necessary to cause a given ototoxicity were 1.7-2.8 times less than those of pure ethylbenzene. Given the high ototoxicity of ethylbenzene, the safety margin of less or equal to two (LOAEL/TWA) might be too small to protect workers from the potential risk of ototoxicity. Moreover, the enhanced ototoxicity of ethylbenzene and para-xylene observed in mixed xylenes should encourage the production of mixed xylenes with the lowest possible concentrations of ethylbenzene and para-xylene. (orig.)

Ototoxicity in rats exposed to ethylbenzene and to two technical xylene vapours for 13 weeks.

Science.gov (United States)

Gagnaire, François; Langlais, Cristina; Grossmann, Stéphane; Wild, Pascal

2007-02-01

Male Sprague-Dawley rats were exposed to ethylbenzene (200, 400, 600 and 800 ppm) and to two mixed xylenes (250, 500, 1,000 and 2,000 ppm total compounds) by inhalation, 6 h/day, 6 days/week for 13 weeks and sacrificed for morphological investigation 8 weeks after the end of exposure. Brainstem auditory-evoked responses were used to determine auditory thresholds at different frequencies. Ethylbenzene produced moderate to severe ototoxicity in rats exposed to the four concentrations studied. Increased thresholds were observed at 2, 4, 8 and 16 kHz in rats exposed to 400, 600 and 800 ppm ethylbenzene. Moderate to severe losses of outer hair cells of the organ of Corti occurred in animals exposed to the four concentrations studied. Exposure to both mixed xylenes produced ototoxicity characterized by increased auditory thresholds and losses of outer hair cells. Ototoxicity potentiation caused by ethylbenzene was observed. Depending on the mixed xylene studied and the area of the concentration-response curves taken into account, the concentrations of ethylbenzene in mixed xylenes necessary to cause a given ototoxicity were 1.7-2.8 times less than those of pure ethylbenzene. Given the high ototoxicity of ethylbenzene, the safety margin of less or equal to two (LOAEL/TWA) might be too small to protect workers from the potential risk of ototoxicity. Moreover, the enhanced ototoxicity of ethylbenzene and para-xylene observed in mixed xylenes should encourage the production of mixed xylenes with the lowest possible concentrations of ethylbenzene and para-xylene.

Effect of consuming a purple-fleshed sweet potato beverage on health-related biomarkers and safety parameters in Caucasian subjects with elevated levels of blood pressure and liver function biomarkers: a 4-week, open-label, non-comparative trial.

Science.gov (United States)

Oki, Tomoyuki; Kano, Mitsuyoshi; Watanabe, Osamu; Goto, Kazuhisa; Boelsma, Esther; Ishikawa, Fumiyasu; Suda, Ikuo

2016-01-01

An open-label study with one treatment arm was conducted to investigate changes in health-related biomarkers (blood pressure and liver enzyme activity) and the safety of 4 weeks of consuming a purple-fleshed sweet potato beverage in Caucasian subjects. Twenty healthy adults, 18-70 years of age, with a body mass index >25 kg/m(2), elevated blood pressure and elevated levels of liver function biomarkers consumed two cartons of purple-fleshed sweet potato beverage (125 ml, including 117 mg anthocyanin per carton) daily for 4 weeks. Hematology, serum clinical profile, dipstick urinalysis and blood pressure were determined before consumption, at 2 and 4 weeks of consumption and after a 2-week washout period. A trend was found toward lowering systolic blood pressure during the treatment period (p=0.0590). No significant changes were found in diastolic blood pressure throughout the study period. Systolic blood pressure was significantly lower after 4 weeks of consumption compared with before consumption (p=0.0125) and was significantly higher after the 2-week washout period compared with after consumption (p=0.0496). The serum alanine aminotransferase level significantly increased over time, but aspartate aminotransferase and γ-glutamyltransferase levels stayed within the normal range of reference values. Safety parameters of the blood and urine showed no clinically relevant changes. The consumption of a purple-fleshed sweet potato beverage for 4 weeks resulted in no clinically relevant changes in safety parameters of the blood and urine and showed a trend toward lowering systolic blood pressure.

Pilot study of an 'integrated boost' with fractionation into four weekly sessions in breast radiotherapy; etude pilote de 'boost integre' avec fractionnement en quatre seances hebdomadaires dans la radiotherapie du sein

Energy Technology Data Exchange (ETDEWEB)

Gabelle-Flandin, I.; Beneyton, V.; Dusserre, A.; Sihanath, R.; Villele, C. de; Henry, I.; Vassal, S.; Tessier, A.; Giraud, J.Y. [CHU de Grenoble, Grenoble (France); Balosso, J. [Universite Joseph-Fourier, Grenoble (France)

2011-10-15

The authors report a pilot study which aimed at demonstrating the feasibility of an 'integrated boost' technique within a treatment comprising four sessions a week, in order to increase machine availability. The reduction of the number of sessions resulted in 20 to 30 per cent increase of machine availability. The technique does not increase acute toxicity. Late toxicity is still to be assessed. Short communication

Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study.

Science.gov (United States)

Gadde, Kishore M; Vetter, Marion L; Iqbal, Nayyar; Hardy, Elise; Öhman, Peter

2017-07-01

Glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors treat type 2 diabetes through incretin-signaling pathways. This study compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist exenatide once-weekly (Miglyol) suspension for autoinjection (QWS-AI) with the dipeptidyl peptidase-4 inhibitor sitagliptin or placebo. In this open-label, multicentre study of patients with type 2 diabetes who had suboptimal glycaemic control on metformin monotherapy, 365 patients were randomized to receive exenatide 2.0 mg QWS-AI, sitagliptin 100 mg once daily or oral placebo (3:2:1 ratio). The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to 28 weeks. At 28 weeks, exenatide QWS-AI significantly reduced HbA1c from baseline compared to sitagliptin (-1.13% vs -0.75% [baseline values, 8.42% and 8.50%, respectively]; P  = .02) and placebo (-0.40% [baseline value, 8.50%]; P = .001). More exenatide QWS-AI-treated patients achieved HbA1c <7.0% than did sitagliptin- or placebo-treated patients (43.1% vs 32.0% and 24.6%; both P  < .05). Exenatide QWS-AI and sitagliptin reduced fasting plasma glucose from baseline to 28 weeks (-21.3 and -11.3 mg/dL) vs placebo (+9.6 mg/dL), with no significant difference between the 2 active treatments. Body weight decreased with both active treatments (-1.12 and -1.19 kg), but not with placebo (+0.15 kg). No improvement in blood pressure was observed in any group. The most common adverse events with exenatide QWS-AI were gastrointestinal events and injection-site reactions. This study demonstrated that exenatide QWS-AI reduced HbA1c more than sitagliptin or placebo and was well tolerated. © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Efficacy and safety of concurrent chemoradiation with weekly cisplatin ± low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial.

Science.gov (United States)

Mohammadianpanah, Mohammad; Razmjou-Ghalaei, Sasan; Shafizad, Amin; Ashouri-Taziani, Yaghoub; Khademi, Bijan; Ahmadloo, Niloofar; Ansari, Mansour; Omidvari, Shapour; Mosalaei, Ahmad; Mosleh-Shirazi, Mohammad Amin

2011-01-01

This is the first study that aimed to determine the efficacy and safety of concurrent chemoradiation with weekly cisplatin ± celecoxib 100 mg twice daily in locally advanced undifferentiated nasopharyngeal carcinoma. Eligible patients had newly diagnosed locally advanced (T3-T4, and/or N2-N3, M0) undifferentiated nasopharyngeal carcinoma, no prior therapy, Karnofsky performance status ≥ 70, and normal organ function. The patients were assigned to receive 7 weeks concurrent chemoradiation (70 Gy) with weekly cisplatin 30 mg/m 2 with either celecoxib 100 mg twice daily, (study group, n = 26) or placebo (control group, n = 27) followed by adjuvant combined chemotherapy with cisplatin 70 mg/m 2 on day 1 plus 5-fluorouracil 750 mg/m 2 /d with 8-h infusion on days 1-3, 3-weekly for 3 cycles. Overall clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in the study group and 44% and 56% in the control group, respectively (P > 0.25). The addition of celecoxib to concurrent chemoradiation was associated with improved 2-year locoregional control rate from 84% to 100% (P = 0.039). The addition of celecoxib 100 mg twice daily to concurrent chemoradiation improved 2-year locoregional control rate.

Main lessons for FBR safety study from the CABRI experiments

International Nuclear Information System (INIS)

Sato, Ikken

2006-01-01

CABRI project has been carried out FBR safety study with international cooperation of five nations since 1978. The project consists of four periods such as CABRI-1, CABRI-2, CABRI-FAST and CABRI-RAFT. The objects and the main information for hypothetical core decay accident and safety study of fuel are described. The behavior of core decay accident was studied in the first period (CABRI-1), the safety study of fuel was investigated after the second period (CABRI-2). Change of phenomena at the initial process of core decay accident, comparison between analysis and data of fuel diffusion behavior of neutron horoscope by CABRI-2 experiment, representative in-core experiment under slow TOP conditions, the damaged and undamaged pin under slow TOP conditions, the exterior of CABRI and TREAT and the upper part of CABRI and TREAT reactor are shown. CABRI experiments changed to LWR safety study and a part of TREAT is stated. (S.Y.)

Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study.

Science.gov (United States)

Sirima, Sodiomon B; Tiono, Alfred; Gansané, Zakaria; Siribié, Mohamadou; Zongo, Angèle; Ouédraogo, Alphonse; François, Nancy; Strezova, Ana; Dobbelaere, Kurt; Borys, Dorota

2017-05-01

Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections. In this phase III, open-label, single-center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N = 300): children 8-11 weeks of age (vaccines; children 7-11 months of age (7-11S and 7-11NS groups) received 2 primary doses and a booster dose of PHiD-CV; children 12-23 months of age (12-23S and 12-23NS groups) received 2 catch-up doses of PHiD-CV. Pneumococcal antibody responses were measured using 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity. Responses to other antigens were measured by enzyme-linked immunosorbent assay. Adverse events were recorded. One month postprimary vaccination, for each vaccine serotype ≥98% of infants in the vaccination in children vaccination. Safety and reactogenicity profiles were similar in children with or without SCD. PHiD-CV was immunogenic with an acceptable safety profile in children with and without SCD starting vaccination at 8 weeks to 23 months of age.

A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

Science.gov (United States)

Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

2018-01-01

Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

A comparative study of efficacy and safety of eberconazole versus terbinafine in patients of tinea versicolor

Directory of Open Access Journals (Sweden)

Jyoti Sharma

2018-01-01

Full Text Available Background: Tinea versicolor (TV is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. Aim: This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. Materials and Methods: An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. Results: There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%, respectively. However, early response (at the end of week 1 was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Conclusion: Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

Four Weeks of Off-Season Training Improves Peak Oxygen Consumption in Female Field Hockey Players

Directory of Open Access Journals (Sweden)

Lindsey T. Funch

2017-11-01

Full Text Available The purpose of the study was to examine the changes in peak oxygen consumption ( V ˙O2peak and running economy (RE following four-weeks of high intensity training and concurrent strength and conditioning during the off-season in collegiate female field hockey players. Fourteen female student-athletes (age 19.29 ± 0.91 years were divided into two training groups, matched from baseline V ˙O2peak: High Intensity Training (HITrun; n = 8 and High Intensity Interval Training (HIIT; n = 6. Participants completed 12 training sessions. HITrun consisted of 30 min of high-intensity running, while HIIT consisted of a series of whole-body high intensity Tabata-style intervals (75–85% of age predicted maximum heart rate for a total of four minutes. In addition to the interval training, the off-season training included six resistance training sessions, three team practices, and concluded with a team scrimmage. V ˙O2peak was measured pre- and post-training to determine the effectiveness of the training program. A two-way mixed (group × time ANOVA showed a main effect of time with a statistically significant difference in V ˙O2peak from pre- to post-testing, F(1, 12 = 12.657, p = 0.004, partial η2 = 0.041. Average (±SD V ˙O2peak increased from 44.64 ± 3.74 to 47.35 ± 3.16 mL·kg−1·min−1 for HIIT group and increased from 45.39 ± 2.80 to 48.22 ± 2.42 mL·kg−1·min−1 for HITrun group. Given the similar improvement in aerobic power, coaches and training staff may find the time saving element of HIIT-type conditioning programs attractive.

Abstract of results of safety study. Nuclear fuel cycle field in fiscal 2003

International Nuclear Information System (INIS)

2004-11-01

This report descried the results of studies of nuclear fuel cycle field (nuclear fuel facilities, seismic design, all subjects of environmental radiation and waste disposal, and subjects on nuclear fuel cycle in probabilistic safety assessment) in fiscal 2003 on the basis of the principle project of safety study (from fiscal 2001 to 2005). It consists of four chapters; the first chapter is outline of the principle of project, the second is objects and subjects of safety study in the nuclear fuel cycle field, the third list of questionnaire of results of safety study and the forth investigation of results of safety study in fiscal 2003. There are 49 lists, which include 22 reports on the nuclear fuel facility, one on the seismic design, 4 on the probabilistic safety assessment, 7 on the environmental radiation and 15 on the waste disposal. (S.Y.)

Demonstration of safety in Alzheimer's patients for intervention with an anti-hypertensive drug Nilvadipine: results from a 6-week open label study.

LENUS (Irish Health Repository)

Kennelly, S P

2012-02-01

BACKGROUND: Nilvadipine may lower rates of conversion from mild-cognitive impairment to Alzheimer\\'s disease (AD), in hypertensive patients. However, it remains to be determined whether treatment with nilvadipine is safe in AD patients, given the higher incidence of orthostatic hypotension (OH) in this population, who may be more likely to suffer from symptoms associated with the further exaggeration of a drop in BP. OBJECTIVE: The aim of this study was to investigate the safety and tolerability of nilvadipine in AD patients. METHODS: AD patients in the intervention group (n = 56) received nilvadipine 8 mg daily over 6-weeks, compared to the control group (n = 30) who received no intervention. Differences in systolic (SBP) and diastolic (DBP) blood pressure, before and after intervention, was assessed using automated sphygmomanometer readings and ambulatory BP monitors (ABP), and change in OH using a finometer. Reporting of adverse events was monitored throughout the study. RESULTS: There was a significant reduction in the SBP of treated patients compared to non-treated patients but no significant change in DBP. Individuals with higher initial blood pressure (BP) had greater reduction in BP but individuals with normal BP did not experience much change in their BP. While OH was present in 84% of the patients, there was no further drop in BP recorded on active stand studies. There were no significant differences in adverse event reporting between groups. CONCLUSION: Nilvadipine was well tolerated by patients with AD. This study supports further investigation of its efficacy as a potential treatment for AD.

Effects on quality of life, anti-cancer responses, breast conserving surgery and survival with neoadjuvant docetaxel: a randomised study of sequential weekly versus three-weekly docetaxel following neoadjuvant doxorubicin and cyclophosphamide in women with primary breast cancer

Directory of Open Access Journals (Sweden)

Wiseman Janice

2011-05-01

Full Text Available Abstract Background Weekly docetaxel has occasionally been used in the neoadjuvant to downstage breast cancer to reduce toxicity and possibly enhance quality of life. However, no studies have compared the standard three weekly regimen to the weekly regimen in terms of quality of life. The primary aim of our study was to compare the effects on QoL of weekly versus 3-weekly sequential neoadjuvant docetaxel. Secondary aims were to determine the clinical and pathological responses, incidence of Breast Conserving Surgery (BCS, Disease Free Survival (DFS and Overall Survival (OS. Methods Eighty-nine patients receiving four cycles of doxorubicin and cyclophosphamide were randomised to receive twelve cycles of weekly docetaxel (33 mg/m2 or four cycles of 3-weekly docetaxel (100 mg/m2. The Functional Assessment of Cancer Therapy-Breast and psychosocial questionnaires were completed. Results At a median follow-up of 71.5 months, there was no difference in the Trial Outcome Index scores between treatment groups. During weekly docetaxel, patients experienced less constipation, nail problems, neuropathy, tiredness, distress, depressed mood, and unhappiness. There were no differences in overall clinical response (93% vs. 90%, pathological complete response (20% vs. 27%, and breast-conserving surgery (BCS rates (49% vs. 42%. Disease-free survival and overall survival were similar between treatment groups. Conclusions Weekly docetaxel is well-tolerated and has less distressing side-effects, without compromising therapeutic responses, Breast Conserving Surgery (BCS or survival outcomes in the neoadjuvant setting. Trial registration ISRCTN: ISRCTN09184069

The Effect of Four-Week Period of Aerobic Exercise with Cinnamon Consumption on Lipoprotein Indicates and Blood sugar in Diabetic Female Patients (Type 2

Directory of Open Access Journals (Sweden)

M Dastani

2013-01-01

Full Text Available Introduction: Cinnamon as an herbal medicine has the ability to reduce blood glucose and lipoproteins in diabetic patients. Based on the positive effects of exercise on diabetic patients, the present study was conducted to investigate the effect of Four weeks Period aerobic exercise alongside using cinnamon on lipoprotein parameters and blood glucose in women with type 2 diabetes. Methods: Thirty diabetic women were voluntarily selected and were randomly divided into three groups: 1 aerobic exercise group; 2 aerobic exercise alongside using cinnamon; and 3 control group. Aerobic exercise took four weeks with 60 percent of maximum heart rate. Blood samples were collected at the beginning and end of the study. Results: Blood glucose, the fat percentage and HDL, and the ratio of LDL to HDL in the first group significantly decreased and in the second group increased (P<0.05. Also the first group showed a significant reduction in triglyceride. The only significant change observed in the control group was a significant increase in the level of LDL. Comparing the first and second group, it was observed that in the second group the level of total cholesterol decreased and the ratio of LDL to HDL increased (P<0.05. Conclusion: Using cinnamon alongside aerobic exercise is likely to be beneficial in regulating the concentration of blood glucose and lipids in diabetic patients.

Effects of prolonged stress on salivary cortisol and dehydroepiandrosterone: a study of a two-week teaching practice.

Science.gov (United States)

Izawa, Shuhei; Saito, Keisuke; Shirotsuki, Kentaro; Sugaya, Nagisa; Nomura, Shinobu

2012-06-01

This study investigated variations in salivary levels of cortisol and dehydroepiandrosterone (DHEA) in a prolonged stressful situation (a two-week teaching practice). Thirty-three women for whom a two-week teaching practice at a kindergarten was scheduled were asked to collect saliva samples at awakening, 30 min after awakening, and bedtime at four time points: two weeks before the practice, the first week of the practice, the second week of the practice, and a few days after the practice. In addition, they completed questionnaires for assessing perceived stress and subjective moods on each day. A linear mixed model indicated that cortisol levels significantly increased during the first and second week of the practice compared with those before and after the practice period, and that DHEA levels significantly decreased after the practice period compared with those at the other time points. Further, cortisol awakening response after the practice period significantly reduced compared with that at the other time points. Scores of perceived stress and negative moods were also higher during the practice period. This study showed that prolonged stress affected cortisol and DHEA secretion during as well as after the stress period. Copyright © 2011 Elsevier Ltd. All rights reserved.

Premarket safety and efficacy studies for ADHD medications in children.

Directory of Open Access Journals (Sweden)

Florence T Bourgeois

Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

Mandibular dimensions and growth in 11-to 26-week-old Danish fetuses studied by 3D ultrasound

DEFF Research Database (Denmark)

Hermann, N.V.; Darvann, Tron Andre; Sundberg, K.

2010-01-01

Objective To present normative data on prenatal mandibular morphology and growth. Material and Methods Fifty-four normal fetuses (Danish Caucasian) were included in the study (gestational age: 11-26 weeks). Fetuses were scanned using a GE Voluson 730 Expert 3D scanner. Scans were visualized and a...

Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study.

Science.gov (United States)

Hirose, Takahisa; Suzuki, Manabu; Tsumiyama, Isao

2015-12-01

To assess the efficacy and safety of vildagliptin as add-on therapy in Japanese patients with type 2 diabetes mellitus (T2DM), inadequately controlled on stable long-acting, intermediate-acting, or pre-mixed insulin, with or without concomitant metformin. In this 12-week placebo-controlled study, patients were randomized to receive either vildagliptin 50 mg twice daily (bid) or placebo treatment in a 1:1 ratio. The primary endpoint was change in glycated hemoglobin A1c (HbA1c) from baseline to 12-week endpoint. Secondary endpoints included proportion of patients achieving pre-defined HbA1c targets of ≤6.5%, vildagliptin, n = 76; placebo, n = 75). Patient demographics and clinical characteristics were comparable between the groups at baseline. Addition of vildagliptin resulted in statistically significant reductions in HbA1c after 12 weeks (-1.01 ± 0.06%), with a between-treatment difference of -0.91 ± 0.09% (p vildagliptin group (-1.2 ± 0.2 mmol/L), with a between-treatment difference of -1.2 ± 0.3 mmol/L which was significant (p vildagliptin treatment for all pre-defined responder rate categories. The overall incidence of AEs was comparable between groups (vildagliptin, 46.2% vs. placebo, 43.6%). The overall incidence of hypoglycemic events was low and all events were self-treatable without using drug therapy. No severe hypoglycemic events were reported. Treatment with vildagliptin 50 mg bid as add-on to insulin with or without metformin resulted in statistically significant reductions in HbA1c in Japanese patients with T2DM. Overall, vildagliptin was well tolerated with a safety profile similar to that of placebo in this patient population. ClinicalTrials.gov Identifier, NCT02002221 FUNDING: Novartis Pharma K.K.

Partial unilateral ureteropelvic junction obstruction induced in 2-week-old piglets

DEFF Research Database (Denmark)

Dissing, Thomas; Eskild-Jensen, Anni; Pagh, Christian

2001-01-01

of 4, 12 and 24 weeks. RESULTS: At age 4 weeks hydronephrosis was found in all obstructed kidneys included in the study. Four obstructed kidneys had renographic functional share 40% or greater and 1 deteriorated to less than 40% at 24 weeks. A total of 11 obstructed kidneys had a functional share less...

A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease

Directory of Open Access Journals (Sweden)

Yu Nakamura

2015-09-01

Full Text Available Aim: To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm2 and titrated to 10 cm2 after 4 weeks is well tolerated in Japanese patients with Alzheimer's disease (AD as compared to 3-step titration (initiated at 2.5 cm2 and titrated by 2.5 cm2 every 4 weeks to 10 cm2. Methods: A 24-week, multicenter, randomized, double-blind study was conducted in Japan between July 2012 and May 2014. Patients with mild to moderate AD aged 50-85 years were randomized 1:1 to 1-step or 3-step titration of the rivastigmine once-daily patch. The primary endpoint was the proportion of patients with adverse events leading to discontinuation. Results: Of 216 patients randomized, 215 (1-step, n = 107; 3-step, n = 108 were included in the safety analysis. The primary endpoint outcome was 15.0% in the 1-step group and 18.5% in the 3-step group. The observed treatment difference was −3.6% (95% confidence interval: −17.0, 9.6, falling within the prespecified acceptance range. Conclusion: The tolerability of two different titration schemes was similar in Japanese patients with AD.

Present status of nuclear power safety studies in JAERI

International Nuclear Information System (INIS)

1989-01-01

Japan Atomic Energy Research Institute carries out the safety research required for ensuring safety accompanying the development and utilization of atomic energy, dividing the roles with industrial circules, universities and other public research institutes. First, it carries out the research based on the yearly program of safety research, in which the subjects of safety research that the state should execute are decided. Next, it carries out a series of the safety verification test on atomic energy facilities entrusted by the state using the special account for power source development promotion countermeasures. Besides, it carries out the safety research on the specific subjects entrusted by outside organizations. The object and range of atomic energy safety at present are roughly divided into four fields, that is, nuclear power stations, nuclear fuel facilities, waste treatment and disposal, and environmental radioactivity. In order to advance the research effectively, in addition to the generalization department and the execution department, various committees are organized. In 1988, about 260 persons engaged in these four research fields, and the budget for fiscal year 1988 was about 17.4 billion yen. (K.I.)

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

Directory of Open Access Journals (Sweden)

Nagamu Inoue

2017-07-01

Full Text Available Background/Aims: Intestinal Behçet's disease (BD is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671.Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs were examined. The efficacy was assessed on the basis of marked improvement (MI and complete remission (CR using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years. No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

Secukinumab is Efficacious and Safe in Hispanic Patients with Moderate-to-Severe Plaque Psoriasis: Pooled Analysis of Four Phase 3 Trials.

Science.gov (United States)

Adsit, Sandra; Zaldivar, Enrique Rivas; Sofen, Howard; Dei-Cas, Ignacio; Maldonado-García, César; Peñaranda, Elkin O; Puig, Luís; Meng, Xiangyi; Fox, Todd; Guana, Adriana

2017-06-01

There is little evidence available on the efficacy and safety of biologic therapies for the treatment of psoriasis in Hispanic patients. Secukinumab is demonstrated to be highly effective for clearing psoriasis. The aim of this study was to compare the efficacy and safety of secukinumab in Hispanic and non-Hispanic patients. Data were pooled from four phase 3 studies of secukinumab in patients with moderate-to-severe plaque psoriasis. Patients who self-identified as Hispanic were included in the Hispanic subgroup. Efficacy responses (Psoriasis Area and Severity Index [PASI] 75/90/100 and Investigator's Global Assessment 2011 modified version 0/1) for secukinumab 300 mg were greater than for etanercept at week 12 in the Hispanic and non-Hispanic patient subgroups. At week 12 with secukinumab 300 mg, PASI 90/100 responses were achieved by 70.6%/35.9% of Hispanic patients and 58.0%/28.1% of non-Hispanic patients. At week 12 with secukinumab 150 mg, PASI 90/100 responses were achieved by 59.5%/25.1% of Hispanic patients and 41.2%/13.4% of non-Hispanic patients. In both subgroups, peak efficacy responses with secukinumab were observed at week 16 and were maintained to week 52. Secukinumab is highly effective for clearing psoriasis in both Hispanic and non-Hispanic patients. Novartis Pharmaceutical Corporation.

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.

Preventing errors in administration of parenteral drugs: the results of a four-year national patient safety program.

NARCIS (Netherlands)

Blok, C. de; Schilp, J.; Wagner, C.

2013-01-01

Objectives: To evaluate the implementation of a four-year national patient safety program concerning the parenteral drug administration process in the Netherlands. Methods: Structuring the preparation and administration process of parenteral drugs reduces the number of medication errors. A

Six-Month Results for the Kelly Air Force Base Compressed Work Week Survey

Science.gov (United States)

1993-07-01

plans to continue the CWS past the 1-year original plan. REFERENCES 1. Balch, B.W. The four day week and the older workers. Personnel Journal, 394-396...8217 perceptions of the four - day week . California Management Review, 28, 31-35, 1975. 15. Mills, M.E. Core-12: A controlled study of the impact of 12 hour scheduling

96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection.

Science.gov (United States)

Agarwal, Kosh; Brunetto, Maurizia; Seto, Wai Kay; Lim, Young-Suk; Fung, Scott; Marcellin, Patrick; Ahn, Sang Hoon; Izumi, Namiki; Chuang, Wan-Long; Bae, Ho; Sharma, Manoj; Janssen, Harry L A; Pan, Calvin Q; Çelen, Mustafa Kemal; Furusyo, Norihiro; Shalimar, Dr; Yoon, Ki Tae; Trinh, Huy; Flaherty, John F; Gaggar, Anuj; Lau, Audrey H; Cathcart, Andrea L; Lin, Lanjia; Bhardwaj, Neeru; Suri, Vithika; Mani Subramanian, G; Gane, Edward J; Buti, Maria; Chan, Henry L Y

2018-04-01

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF) through more efficient delivery of tenofovir to hepatocytes. In 48-week results from two ongoing, double-blind, randomized phase III trials, TAF was non-inferior to TDF in efficacy with improved renal and bone safety. We report 96-week outcomes for both trials. In two international trials, patients with chronic HBV infection were randomized 2:1 to receive 25 mg TAF or 300 mg TDF in a double-blinded fashion. One study enrolled HBeAg-positive patients and the other HBeAg-negative patients. We assessed efficacy in each study, and safety in the pooled population. At week 96, the differences in the rates of viral suppression were similar in HBeAg-positive patients receiving TAF and TDF (73% vs. 75%, respectively, adjusted difference -2.2% (95% CI -8.3 to 3.9%; p = 0.47), and in HBeAg-negative patients receiving TAF and TDF (90% vs. 91%, respectively, adjusted difference -0.6% (95% CI -7.0 to 5.8%; p = 0.84). In both studies the proportions of patients with alanine aminotransferase above the upper limit of normal at baseline, who had normal alanine aminotransferase at week 96 of treatment, were significantly higher in patients receiving TAF than in those receiving TDF. In the pooled safety population, patients receiving TAF had significantly smaller decreases in bone mineral density than those receiving TDF in the hip (mean % change -0.33% vs. -2.51%; p TAF remained as effective as TDF, with continued improved renal and bone safety, two years after the initiation of treatment. Clinicaltrials.gov number: NCT01940471 and NCT01940341. At week 96 of two ongoing studies comparing the efficacy and safety of tenofovir alafenamide (TAF) to tenofovir disoproxil fumarate (TDF) for the treatment of chronic hepatitis B patients, TAF continues to be as effective as TDF with continued

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.

Science.gov (United States)

Latkovskis, Gustavs; Saripo, Vita; Sokolova, Emma; Upite, Dana; Vanaga, Ilona; Kletnieks, Ugis; Erglis, Andrejs

2016-01-01

Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM. In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography. Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (PMuscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry. Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Clear progress in nuclear safety worldwide: Convention on nuclear safety concludes

International Nuclear Information System (INIS)

2002-01-01

It has been concluded that a significant progress has been observed in a number of key areas, such as strengthened legislation, regulatory independence, the availability of financial resources, enhanced emergency preparedness and safety improvements at nuclear power plants built to earlier standards. The objective of the Convention is to achieve and maintain a high level of nuclear safety worldwide. During the two week Review Meeting, parties engaged in a 'peer review' process in which the National Reports from individual States were collectively examined and discussed, with written replies provided to all the questions raised. Clear improvement was noted in the quality of the National Reports, the number of questions and the openness and quality of discussion and answers. The Contracting Parties praised the IAEA's various safety review missions and services, which they use widely to help enhance the effectiveness of their national safety arrangements. Forty-six contracting parties participated at the Review Meeting with over 400 delegates attending, including many heads and senior officers from regulatory bodies and experts from industry. To date, the Convention has been signed by sixty-five States and ratified by fifty-four, representing 428 of the 448 nuclear power reactors worldwide

Safety, pharmacokinetics, and antitumor activity of AMG 386, a selective angiopoietin inhibitor, in adult patients with advanced solid tumors.

Science.gov (United States)

Herbst, Roy S; Hong, David; Chap, Linnea; Kurzrock, Razelle; Jackson, Edward; Silverman, Jeffrey M; Rasmussen, Erik; Sun, Yu-Nien; Zhong, Don; Hwang, Yuying C; Evelhoch, Jeffrey L; Oliner, Jonathan D; Le, Ngocdiep; Rosen, Lee S

2009-07-20

PURPOSE AMG 386 is an investigational peptide-Fc fusion protein (ie, peptibody) that inhibits angiogenesis by preventing the interaction of angiopoietin-1 and angiopoietin-2 with their receptor, Tie2. This first-in-human study evaluated the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of AMG 386 in adults with advanced solid tumors. PATIENTS AND METHODS Patients in sequential cohorts received weekly intravenous AMG 386 doses of 0.3, 1, 3, 10, or 30 mg/kg. Results Thirty-two patients were enrolled on the study and received AMG 386. One occurrence of dose-limiting toxicity was seen at 30 mg/kg: respiratory arrest, which likely was caused by tumor burden that was possibly related to AMG 386. The most common toxicities were fatigue and peripheral edema. Proteinuria (n = 11) was observed without clinical sequelae. Only four patients (12%) experienced treatment-related toxicities greater than grade 1. A maximum-tolerated dose was not reached. PK was dose-linear and the mean terminal-phase elimination half-life values ranged from 3.1 to 6.3 days. Serum AMG 386 levels appeared to reach steady-state after four weekly doses, and there was minimal accumulation. No anti-AMG 386 neutralizing antibodies were detected. Reductions in volume transfer constant (K(trans); measured by dynamic contrast-enhanced magnetic resonance imaging) were observed in 10 patients (13 lesions) 48 hours to 8 weeks after treatment. One patient with refractory ovarian cancer achieved a confirmed partial response (ie, 32.5% reduction by Response Evaluation Criteria in Solid Tumors) and withdrew from the study with a partial response after 156 weeks of treatment; four patients experienced stable disease for at least 16 weeks. CONCLUSION Weekly AMG 386 appeared well tolerated, and its safety profile appeared distinct from that of vascular endothelial growth factor-axis inhibitors. AMG 386 also appeared to impact tumor vascularity and showed antitumor activity in this patient

Evaluation of a four- versus six-week length of stay in the Navy's alcohol treatment program.

Science.gov (United States)

Trent, L K

1998-05-01

Attempts to balance escalating health care costs with resource downsizing have prompted alcohol treatment directors in the U.S. Navy to consider reducing the standard length of stay in treatment. The objectives of this study were to (1) determine whether a 4-week inpatient treatment program is as effective as a 6-week program, and (2) explore the potential for matching patients to a 4- or 6-week program according to the severity of their condition at intake. A total of 2,823 active-duty alcohol-dependent inpatients (2,685 men, 138 women) at 12 Navy treatment facilities participated in the evaluation. All facilities conducted a 6-week program until data had been collected for 1,380 participants; they then switched to a 4-week program (n = 1,443). Background information and clinical profile were obtained when patients entered treatment; 1-year outcome data (e.g., alcohol use, behavior problems, job performance, quality of life) were obtained from participants, work supervisors and aftercare advisors. Hierarchical multiple regression analyses were used to assess the effect of length of stay on outcome and to examine patient-program interactions. The single best predictor of success at 1 year was months of aftercare attendance. Program membership failed to explain any of the observed differences in the criterion measures, once the effects of other predictors had been taken into account. Severity of condition and patient-program interactions were likewise nonsignificant. It was concluded that a reduction in length of stay from 6 weeks to 4 weeks in the Navy's inpatient alcohol treatment program would not have an adverse effect on outcome.

Vehicle safety performance improvements using a performance-based standards approach: four case studies

CSIR Research Space (South Africa)

Nordengen, Paul A

2014-01-01

Full Text Available programme is to gain practical experience in the PBS approach and to quantify and evaluate the potential infrastructure preservation, safety and productivity benefits for road freight transport. The Smart Truck demonstration vehicles have been designed...

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.

Clinical safety assessment of oral higenamine supplementation in healthy, young men.

Science.gov (United States)

Bloomer, R J; Schriefer, J M; Gunnels, T A

2015-10-01

Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents. Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel. No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05). This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings. © The Author(s) 2015.

Safety campaigns. TIS Launches New Safety Information Campaign

CERN Multimedia

2001-01-01

Need to start a new installation and worried about safety aspects? Or are you newly responsible for safety matters in a CERN building? Perhaps you're simply interested in how to make the working environment safer for yourself and your colleagues. Whatever the case, a new information campaign launched by TIS this week can help. The most visible aspects of the new campaign will be posters distributed around the Laboratory treating a different subject each month. The Web site - http://safety.cern.ch/ - which provides all safety related information. But these are not the only aspects of the new campaign. Members of the TIS/GS group, whose contact details can be found on the safety web site, are available to give information and advice on a one-to-one basis at any time. The campaign's launch has been timed to coincide with European Safety Week, organized by the European Agency for Safety and Health at Work and the subject treated in the first posters is safety inspection. This particular topic only concerns thos...

Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

Science.gov (United States)

2017-10-01

We aimed to explore the longer-term efficacy and safety of edaravone in an active-treatment extension period following the double-blind period of the second phase III study. Patients who met all the following criteria (scores ≥2 points on all 12 items of the revised amyotrophic lateral sclerosis functional rating scale [ALSFRS-R], forced vital capacity ≥80%, definite or probable ALS, and disease duration ≤2 years) were randomised to 60 mg intravenous edaravone or placebo for six cycles in the double-blind period, and then offered the opportunity to proceed to this 24-week open-label extension period. One hundred and twenty-three of 137 patients continued to the extension period: 65 edaravone-edaravone (E-E group) and 58 placebo-edaravone (P-E group). Change (mean ± standard deviation; SD) in the ALSFRS-R score from baseline in the double-blind period was -4.1 ± 3.4 and -6.9 ± 5.1 in the E-E group and P-E group, respectively, while it was -8.0 ± 5.6 in the E-E group and -10.9 ± 6.9 in the P-E group over the whole 48-week period. The ALSFRS-R score changed almost linearly throughout Cycles 1-12 in the E-E group. The most commonly reported adverse events were constipation, dysphagia, and contusion. There was no sudden deterioration in the ALSFRS-R score of the E-E group. No safety concerns related to edaravone were detected.

Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes

Science.gov (United States)

Hammer, Leslie B.; Truxillo, Donald M.; Bodner, Todd; Rineer, Jennifer; Pytlovany, Amy C.; Richman, Amy

2015-01-01

The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based), followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety. PMID:26557703

Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes

Directory of Open Access Journals (Sweden)

Leslie B. Hammer

2015-01-01

Full Text Available The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based, followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety.

Multi-sectoral action for child safety-a European study exploring implicated sectors.

Science.gov (United States)

Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

2017-06-01

Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Safety study application guide

International Nuclear Information System (INIS)

1993-07-01

Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Included are analyses of existing facilities done under the aegis of the Safety Analysis Report Upgrade Program, and analyses of new and modified facilities. A graded approach is used wherein the level of analysis and documentation for each facility is commensurate with the magnitude of the hazard(s), the complexity of the facility and the stage of the facility life cycle. Safety analysis reports (SARs) for hazard Category 1 and 2 facilities are usually detailed and extensive because these categories are associated with public health and safety risk. SARs for Category 3 are normally much less extensive because the risk to public health and safety is slight. At Energy Systems, safety studies are the name given to SARs for Category 3 (formerly open-quotes lowclose quotes) facilities. Safety studies are the appropriate instrument when on-site risks are limited to irreversible consequences to a few people, and off-site consequences are limited to reversible consequences to a few people. This application guide provides detailed instructions for performing safety studies that meet the requirements of DOE Orders 5480.22, open-quotes Technical Safety Requirements,close quotes and 5480.23, open-quotes Nuclear Safety Analysis Reports.close quotes A seven-chapter format has been adopted for safety studies. This format allows for discussion of all the items required by DOE Order 5480.23 and for the discussions to be readily traceable to the listing in the order. The chapter titles are: (1) Introduction and Summary, (2) Site, (3) Facility Description, (4) Safety Basis, (5) Hazardous Material Management, (6) Management, Organization, and Institutional Safety Provisions, and (7) Accident Analysis

Safety in home care: A research protocol for studying medication management

Directory of Open Access Journals (Sweden)

Easty Anthony

2010-06-01

Full Text Available Abstract Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB, Ontario (ON, Quebec (QC and Nova Scotia (NS, we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange

Treatment of chronic spontaneous urticaria with a single dose of omalizumab: A study of four cases

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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.

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

Energy Technology Data Exchange (ETDEWEB)

Ryan, Patricia C., E-mail: ryanp@medimmune.com [MedImmune, LLC, Gaithersburg, MD (United States); Sleeman, Matthew A. [MedImmune, LLC, Cambridge (United Kingdom); Rebelatto, Marlon [MedImmune, LLC, Gaithersburg, MD (United States); Wang, Bing; Lu, Hong [MedImmune, LLC, Moutain View, CA (United States); Chen, Xiaomin [Novartis, East Hanover, NJ (United States); Wu, Chi-Yuan [MedImmune, LLC, Moutain View, CA (United States); Hinrichs, Mary Jane; Roskos, Lorin [MedImmune, LLC, Gaithersburg, MD (United States); Towers, Heidi [MedImmune, LLC, Cambridge (United Kingdom); McKeever, Kathleen; Dixit, Rakesh [MedImmune, LLC, Gaithersburg, MD (United States)

2014-09-01

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

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

International Nuclear Information System (INIS)

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

2014-01-01

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

Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism.

Science.gov (United States)

Shimatsu, Akira; Teramoto, Akira; Hizuka, Naomi; Kitai, Kazuo; Ramis, Joaquim; Chihara, Kazuo

2013-01-01

The somatostatin analog lanreotide Autogel has proven to be efficacious for treating acromegaly in international studies and in clinical practices around the world. However, its efficacy in Japanese patients has not been extensively evaluated. We examined the dose-response relationship and long-term efficacy and safety in Japanese patients with acromegaly or pituitary gigantism. In an open-label, parallel-group, dose-response study, 32 patients (29 with acromegaly, 3 with pituitary gigantism) received 5 injections of 60, 90, or 120 mg of lanreotide Autogel over 24 weeks. Four weeks after the first injection, 41% of patients achieved serum GH level of gigantism) received lanreotide Autogel once every 4 weeks for a total of 13 injections. Dosing was initiated with 90 mg and adjusted according to clinical responses at Weeks 16 and/or 32. At Week 52, 47% of patients had serum GH levels of gigantism.

Test-retest reliability and four-week changes in cardiopulmonary fitness in stroke patients: evaluation using a robotics-assisted tilt table.

Science.gov (United States)

Saengsuwan, Jittima; Berger, Lucia; Schuster-Amft, Corina; Nef, Tobias; Hunt, Kenneth J

2016-09-06

Exercise testing devices for evaluating cardiopulmonary fitness in patients with severe disability after stroke are lacking, but we have adapted a robotics-assisted tilt table (RATT) for cardiopulmonary exercise testing (CPET). Using the RATT in a sample of patients after stroke, this study aimed to investigate test-retest reliability and repeatability of CPET and to prospectively investigate changes in cardiopulmonary outcomes over a period of four weeks. Stroke patients with all degrees of disability underwent 3 separate CPET sessions: 2 tests at baseline (TB1 and TB2) and 1 test at follow up (TF). TB1 and TB2 were at least 24 h apart. TB2 and TF were 4 weeks apart. A RATT equipped with force sensors in the thigh cuffs, a work rate estimation algorithm and a real-time visual feedback system was used to guide the patients' exercise work rate during CPET. Test-retest reliability and repeatability of CPET variables were analysed using paired t-tests, the intraclass correlation coefficient (ICC), the coefficient of variation (CoV), and Bland and Altman limits of agreement. Changes in cardiopulmonary fitness during four weeks were analysed using paired t-tests. Seventeen sub-acute and chronic stroke patients (age 62.7 ± 10.4 years [mean ± SD]; 8 females) completed the test sessions. The median time post stroke was 350 days. There were 4 severely disabled, 1 moderately disabled and 12 mildly disabled patients. For test-retest, there were no statistically significant differences between TB1 and TB2 for most CPET variables. Peak oxygen uptake, peak heart rate, peak work rate and oxygen uptake at the ventilatory anaerobic threshold (VAT) and respiratory compensation point (RCP) showed good to excellent test-retest reliability (ICC 0.65-0.94). For all CPET variables, CoV was 4.1-14.5 %. The mean difference was close to zero in most of the CPET variables. There were no significant changes in most cardiopulmonary performance parameters during the 4-week period

Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

Science.gov (United States)

Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

2009-06-01

We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P IELT increased to 5.01 +/- 3.69 (P IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

Retrospective Cohort Study of Effectiveness and Safety of Adalimumab Use in Children with Juvenile Idiopathic Arthritis in the Republic of Bashkortostan

Directory of Open Access Journals (Sweden)

V. A. Maliyevskiy

2015-01-01

Full Text Available Background: Methotrexate is the first-line drug for treating patients with juvenile idiopathic arthritis (JIA. If it is ineffective or intolerable, prescription of genetically engineered biopharmaceuticals is indicated. Objective: The study was aimed at assessing effectiveness and safety of genetically engineered biopharmaceutical adalimumab for treating children with JIA. Methods: A retrospective cohort study was conducted to analyze results of treating patients with JIA aged 2–17 years. Adalimumab would be prescribed biweekly in the dose of 24 mg/m2 (body surface subcutaneously (if body weight is under 30 kg or in the dose of 40 mg/m2 (if body weight is > 30 kg. Effectiveness and safety would be assessed after 4–12–24–48–96 weeks. Results: We analyzed treatment results of 17 patients (15 children with active joint syndrome, 2 — with active uveitis. All patients with active joint syndrome had been receiving adalimumab for 12 weeks, 12 patients — for 24 weeks, 8 — for 48 weeks, 5 — for 96 weeks. 30/50/70% improvement in terms of the ACRpedi criteria was observed in 15/11/4 children after 4 weeks, after 12 weeks — in 15/13/11 patients, after 48 weeks — in 7/6/6 patients. The status of inactive disease was established in 5 patients (33% after 12 weeks, after 24 weeks — in 9 children (75%, after 48 weeks — in 7 children (70%, after 96 weeks — in 4 (80% children. Active uveitis was terminated in all 5 patients with signs of eye damage in the treatment onset. 1 patient suffered from exacerbation of the disease after 48 weeks of therapy; the drug was withdrawn. Tubercular infection without local manifestations was established in 1 patient after 96 weeks (positive Mantoux test, papule — 10 mm. Adalimumab injection was terminated for the period of chemotherapy. Conclusion: Adalimumab has a sufficiently high effectiveness and safety for long-term (up to 2 years treatment of children with JIA. 

Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

Science.gov (United States)

Nauck, Michael A; Stewart, Murray W; Perkins, Christopher; Jones-Leone, Angela; Yang, Fred; Perry, Caroline; Reinhardt, Rickey R; Rendell, Marc

2016-02-01

Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. In this placebo-controlled study, 309 patients (aged ≥ 18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0-10.0% [53.00-85.79 mmol/mol], body mass index 20-45 kg/m(2), and fasting C-peptide ≥ 0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was -0.84% (95% CI -1.11%, -0.58%; p < 0.0001) with albiglutide 30 mg and -1.04% (-1.31%, -0.77%; p < 0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

The association between EMS workplace safety culture and safety outcomes.

Science.gov (United States)

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

The association between dog walking, physical activity and owner’s perceptions of safety: cross-sectional evidence from the US and Australia

Directory of Open Access Journals (Sweden)

Hayley Christian

2016-09-01

Full Text Available Abstract Background We examined the relationship between dog walking and physical activity within and between four US cities and Australia and investigated if dog walking is associated with higher perceived safety in US and Australian cities. Methods Dog owners (n = 1113 in the Pet Connections Study completed a cross-sectional survey. Data were collected across four study sites; three in the US (San Diego, Nashville, Portland and a fourth in Australia (Perth. Physical activity, local walking, dog walking, and individual and community perceptions of safety were analysed for dog walkers and non-dog walkers for each study site. Between-city comparisons were examined for dog walkers. Results Across all study sites, dog walkers walked with their dog 5–6 times/week for a total of 93–109 min/week and achieved ≥30mins of physical activity on more days/week and walked in their neighbourhood more often/week, compared with non-dog walkers (all p ≤ 0.01. Compared with Perth, significantly fewer dog walkers walked in their local park in the three US study sites. San Diego dog walkers walked more often in their neighborhood/week compared with Perth dog walkers (all p ≤ 0.05. In Portland, dog walkers perceived significantly more neighborhood problems and in Nashville dog walkers perceived a significantly higher level of neighborhood natural surveillance (i.e., ‘eyes on the street’, compared with non-dog walkers (both p ≤ 0.05. Among dog walkers, females were more likely than males to feel safer walking with their dog in their neighborhood (OR = 2.49; 95 % CI = 1.76, 3.53. Compared with dog walkers in Perth, dog walkers from each of the US study sites felt safer in their neighborhood and perceived there was more neighborhood surveillance (all p ≤ 0.001. Conclusion This multi-site international study provides further support for the potential for dog walking to increase levels of daily physical activity. Walking

Studying the Relationship between Individual and Organizational Factors and Nurses' Perception of Patient Safety Culture

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Farahnaz Abdolahzadeh

2012-11-01

Full Text Available Introduction: Safety culture is considered as an important factor in improving patient safety. Therefore, identifying individual and organizational factors affecting safety culture is crucial. This study was carried out to determine individual and organizational factors associated with nurses' perception of patient safety culture. Methods: The present descriptive study included 940 nurses working in four training hospitals affiliated with Urmia University of Medical Sciences (Iran. Data was collected through the self-report questionnaire of patient safety culture. Descriptive (number, percent, mean, and standard deviation and inferential (t-test and analysis of variance statistics were used to analyze the data in SPSS. Results: Nurses' perception of patient safety culture was significantly correlated with marital status, workplace, and overtime hours. Conclusion: The results of this study revealed that some individual and organizational factors can impact on nurses' perception of patient safety culture. Nursing authorities should thus pay more attention to factors which promote patient safety culture and ultimately the safety of provided services.

Games that "work": using computer games to teach alcohol-affected children about fire and street safety.

Science.gov (United States)

Coles, Claire D; Strickland, Dorothy C; Padgett, Lynne; Bellmoff, Lynnae

2007-01-01

Unintentional injuries are a leading cause of death and disability for children. Those with developmental disabilities, including children affected by prenatal alcohol exposure, are at highest risk for injuries. Although teaching safety skills is recommended to prevent injury, cognitive limitations and behavioral problems characteristic of children with fetal alcohol spectrum disorder make teaching these skills challenging for parents and teachers. In the current study, 32 children, ages 4-10, diagnosed with fetal alcohol syndrome (FAS) and partial FAS, learned fire and street safety through computer games that employed "virtual worlds" to teach recommended safety skills. Children were pretested on verbal knowledge of four safety elements for both fire and street safety conditions and then randomly assigned to one condition. After playing the game until mastery, children were retested verbally and asked to "generalize" their newly acquired skills in a behavioral context. They were retested after 1 week follow-up. Children showed significantly better knowledge of the game to which they were exposed, immediately and at follow-up, and the majority (72%) was able to generalize all four steps within a behavioral setting. Results suggested that this is a highly effective method for teaching safety skills to high-risk children who have learning difficulties.

The Weekly Structure of US Stock Prices

OpenAIRE

Guglielmo Maria Caporale; Luis A. Gil-Alana

2010-01-01

In this paper we use fractional integration techniques to examine the degree of integration of four US stock market indices, namely the Standard and Poor, Dow Jones, Nasdaq and NYSE, at a daily frequency from January 2005 till December 2009. We analyse the weekly structure of the series and investigate their characteristics depending on the specific day of the week. The results indicate that the four series are highly persistent; a small degree of mean reversion (i.e., orders of integration s...

A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog.

Science.gov (United States)

Wang, Yong; Guo, Jin-He; Zhu, Guang-Yu; Zhu, Hai-Dong; Chen, Li; Lu, Jian; Wang, Chao; Teng, Gao-Jun

2017-07-01

Airway stent placement is an effective treatment for the immediate palliation of malignant airway obstruction. However, restenosis caused by tumor ingrowth and/or overgrowth after stenting is common. The purpose of this study was to investigate the feasibility and safety of a novel self-expandable stent loaded with 125 I seeds in healthy beagle dog. Under fluoroscopic guidance, forty-eight self-expandable airway stents loaded with 125 I seeds were perorally placed in the main trachea of 48 healthy beagle dogs, who were randomly divided into four groups (Group A: 0.3 mCi; Group B: 0.6 mCi; Group C: 0.9 mCi; Control group: 0 mCi). The estimated radiation dose was calculated using the isotropic point source approximation. Radiological follow-up examinations and histopathological examinations of stented tracheal segments and their adjacent organs and tissues were performed at 2, 4, 8, and 16 weeks following the stenting. All stents were successfully deployed in the targeted tracheal segment in the beagle dogs without procedure-related complications. Tracheal stenosis became severe gradually in all the four groups, which was not associated with the radioactivity of 125 I seeds (p > 0.05). The tracheal injury scores increased along with the higher dose of radioactive seeds which reached peak at 8 weeks and then turned back slightly at 16 weeks. The adjacent tissue did not show pathohistological changes under microscope, while mild and reversible ultrastructure changes were showed under electronic microscope. This study demonstrates that it is feasible and safe to insert this novel self-expandable airway stent loaded with 125 I seeds in healthy beagle dog.

Functional brain activity changes after four weeks supplementation with a multi-vitamin/mineral combination: A randomized, double-blind, placebo-controlled trial exploring functional Magnetic Resonance Imaging and Steady-State Visual Evoked Potentials during working memory

Directory of Open Access Journals (Sweden)

David J White

2016-12-01

Full Text Available This study explored the neurocognitive effects of four weeks daily supplementation with a multivitamin and mineral combination (MVM in healthy adults (aged 18-40 years. Using a randomized, double-blind, placebo-controlled design, participants underwent assessments of brain activity using functional Magnetic Resonance Imaging (fMRI; n=32, 16 females and Steady-State Visual Evoked Potential recordings (SSVEP; n=39, 20 females during working memory and continuous performance tasks at baseline and following four weeks of active MVM treatment or placebo. There were several treatment-related effects suggestive of changes in functional brain activity associated with MVM administration. SSVEP data showed latency reductions across centro-parietal regions during the encoding period of a spatial working memory task following four weeks of active MVM treatment. Complementary results were observed with the fMRI data, in which a subset of those completing fMRI assessment after SSVEP assessment (n=16 demonstrated increased BOLD response during completion of the Rapid Visual Information Processing task (RVIP within regions of interest including bilateral parietal lobes. No treatment-related changes in fMRI data were observed in those who had not first undergone SSVEP assessment, suggesting these results may be most evident under conditions of fatigue. Performance on the working memory and continuous performance tasks did not significantly differ between treatment groups at follow-up. In addition, within the fatigued fMRI sample, increased RVIP BOLD response was correlated with the change in number of target detections as part of the RVIP task. This study provides preliminary evidence of changes in functional brain activity during working memory associated with four weeks of daily treatment with a multivitamin and mineral combination in healthy adults, using two distinct but complementary measures of functional brain activity.

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

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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.

Four Medication Safety Tips for Older Adults

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... Products For Consumers Home For Consumers Consumer Updates 4 Medication Safety Tips for Older Adults Share Tweet ... you are experiencing could be due to medications. 4. Review Medications with Your Health Care Provider Ideally, ...

Four weeks of running sprint interval training improves cardiorespiratory fitness in young and middle-aged adults.

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Willoughby, Taura N; Thomas, Matthew P L; Schmale, Matthew S; Copeland, Jennifer L; Hazell, Tom J

2016-01-01

The purpose of this study was to determine the effectiveness of a 4-week running sprint interval training protocol to improve both aerobic and anaerobic fitness in middle-aged adults (40-50 years) as well as compare the adaptations to younger adults (20-30 years). Twenty-eight inactive participants - 14 young 20-30-year-olds (n = 7 males) and 14 middle-aged 40-50-year-olds (n = 5 males) - completed 4 weeks of running sprint interval training (4 to 6, 30-s "all-out" sprints on a curved, self-propelled treadmill separated by 4 min active recovery performed 3 times per week). Before and after training, all participants were assessed for maximal oxygen consumption (VO2max), 2000 m time trial performance, and anaerobic performance on a single 30-s sprint. There were no interactions between group and time for any tested variable, although training improved relative VO2max (young = 3.9, middle-aged = 5.2%; P < 0.04), time trial performance (young = 5.9, middle-aged = 8.2%; P < 0.001), peak sprint speed (young = 9.3, middle-aged = 2.2%; P < 0.001), and average sprint speed (young = 6.8, middle-aged = 11.6%; P < 0.001) in both young and middle-aged groups from pre- to post-training on the 30-s sprint test. The current study demonstrates that a 4-week running sprint interval training programme is equally effective at improving aerobic and anaerobic fitness in younger and middle-aged adults.

Plant Operation: Work Week, Administration

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Nation's Schools and Colleges, 1975

1975-01-01

A four-day work week for maintenance workers in the Jefferson County Public Schools in Lakewood, Colorado, reduces absenteeism and increases productivity; a basic manual for physical plant directors is reviewed. (Author/MLF)

Twelve-Week Exercise Influences Memory Complaint but not Memory Performance in Older Adults: A Randomized Controlled Study.

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Iuliano, Enzo; Fiorilli, Giovanni; Aquino, Giovanna; Di Costanzo, Alfonso; Calcagno, Giuseppe; di Cagno, Alessandra

2017-10-01

This study aimed to evaluate the effects of different types of exercise on memory performance and memory complaint after a 12-week intervention. Eighty community-dwelling volunteers, aged 66.96 ± 11.73 years, were randomly divided into four groups: resistance, cardiovascular, postural, and control groups (20 participants for each group). All participants were tested for their cognitive functions before and after their respective 12-week intervention using Rey memory words test, Prose memory test, and Memory Complaint Questionnaire (MAC-Q). Statistical analysis showed that the three experimental groups significantly improved MAC-Q scores in comparison with the control group (p memory tests scores were not correlated. These results indicate that the 12-week interventions exclusively influenced memory complaint but not memory performance. Further investigations are needed to understand the relation between memory complaint and memory performance, and the factors that can influence this relationship.

[Efficacy and safety of levofloxacin to non-gonorrheal urethritis].

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Onodera, Shoichi; Onoe, Yasuhiko; Hosobe, Takahide; Kato, Tetsuro; Yoshida, Masaki

2012-12-01

We investigated the efficacy and safety of levofloxacin (LVFX) 500mg once a day in patients with non-gonorrheal urethritis. Men, aged 20 years or older, with urethritis symptoms, and detection of Chlamydia trachomatis (C. trachomatis) or Mycoplasma genitalium (M. genitalium) by a microbiological examination were eligible for this study. Patients were administered LVFX 500mg, orally, once a day and the dosage period was seven days. We assumed 22 patients for a safety and efficacy analysis. In 22 patients, 17 patients had urethritis with C. trachomatis, 4 patients urethritis with M. genitalium, and one patient mixed infection of C. trachomatis and M. genitalium. In the clinial study, the primary endpoint was set as the bacteriological eradication rate at two to four weeks after completion of treatment. The bacterial eradication rate in the urethritis was 86.4% (19/22). The bacterial eradication rate in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 94.1% (16/17), 50.0% (2/4), 100% (1/1), respectively. A significant difference was not recognized among the three groups. The clinical efficacy at two to four weeks after completion of treatment was 90.9% (20/22). The clinical efficacy rates in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 100% (17/17), 50.0% (2/4), 100% (1/1), respectively. The efficacy rate of urethritis with M. genitalium was significantly low. No adverse drug reactions were observed. These results suggest that once-a-day levofloxacin (500mg) is effective and safe treatment for non-gonorrheal urethritis.

Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.

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Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei

2016-09-01

Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Feasibility, safety and outcomes of playing Kinect Adventures!™ for people with Parkinson's disease: a pilot study.

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Pompeu, J E; Arduini, L A; Botelho, A R; Fonseca, M B F; Pompeu, S M A A; Torriani-Pasin, C; Deutsch, J E

2014-06-01

To assess the feasibility, safety and outcomes of playing Microsoft Kinect Adventures™ for people with Parkinson's disease in order to guide the design of a randomised clinical trial. Single-group, blinded trial. Rehabilitation Center of São Camilo University, Brazil. Seven patients (six males, one female) with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Fourteen 60-minute sessions, three times per week, playing four games of Kinect Adventures! The feasibility and safety outcomes were patients' game performance and adverse events, respectively. The clinical outcomes were the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and Parkinson's Disease Questionnaire (PDQ-39). Patients' scores for the four games showed improvement. The mean [standard deviation (SD)] scores in the first and last sessions of the Space Pop game were 151 (36) and 198 (29), respectively [mean (SD) difference 47 (7), 95% confidence interval 15 to 79]. There were no adverse events. Improvements were also seen in the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and PDQ-39 following training. Kinect-based training was safe and feasible for people with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Patients improved their scores for all four games. No serious adverse events occurred during training with Kinect Adventures!, which promoted improvement in activities (balance and gait), body functions (cardiopulmonary aptitude) and participation (quality of life). Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Safety and Efficacy of Memantine in Children with Autism: Randomized, Placebo-Controlled Study and Open-Label Extension.

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Aman, Michael G; Findling, Robert L; Hardan, Antonio Y; Hendren, Robert L; Melmed, Raun D; Kehinde-Nelson, Ola; Hsu, Hai-An; Trugman, Joel M; Palmer, Robert H; Graham, Stephen M; Gage, Allyson T; Perhach, James L; Katz, Ephraim

2017-06-01

Abnormal glutamatergic neurotransmission is implicated in the pathophysiology of autism spectrum disorder (ASD). In this study, the safety, tolerability, and efficacy of the glutamatergic N-methyl-d-aspartate (NMDA) receptor antagonist memantine (once-daily extended-release [ER]) were investigated in children with autism in a randomized, placebo-controlled, 12 week trial and a 48 week open-label extension. A total of 121 children 6-12 years of age with Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR)-defined autistic disorder were randomized (1:1) to placebo or memantine ER for 12 weeks; 104 children entered the subsequent extension trial. Maximum memantine doses were determined by body weight and ranged from 3 to 15 mg/day. There was one serious adverse event (SAE) (affective disorder, with memantine) in the 12 week study and one SAE (lobar pneumonia) in the 48 week extension; both were deemed unrelated to treatment. Other AEs were considered mild or moderate and most were deemed not related to treatment. No clinically significant changes occurred in clinical laboratory values, vital signs, or electrocardiogram (ECG). There was no significant between-group difference on the primary efficacy outcome of caregiver/parent ratings on the Social Responsiveness Scale (SRS), although an improvement over baseline at Week 12 was observed in both groups. A trend for improvement at the end of the 48 week extension was observed. No improvements in the active group were observed on any of the secondary end-points, with one communication measure showing significant worsening with memantine compared with placebo (p = 0.02) after 12 weeks. This trial did not demonstrate clinical efficacy of memantine ER in autism; however, the tolerability and safety data were reassuring. Our results could inform future trial design in this population and may facilitate the investigation of memantine ER for other clinical applications.

Safety of cupping during bevacizumab therapy.

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Klempner, Samuel J; Costa, Daniel B; Wu, Peggy A; Ariyabuddhiphongs, Kim D

2013-08-01

This study reports on the safety of the complementary and alternative medicine (CAM) practice of cupping in a patient undergoing concomitant therapy with bevacizumab for advanced non-small-cell lung cancer (NSCLC), and raises awareness of the need for improved communication between CAM practitioners and oncologists during the care of patients with cancer. The practice of cupping generates local hyperemia, disrupts superficial vasculature in the dermis, and leads to cutaneous lesions including circular erythema, edema, and subsequently ecchymosis. There are no data on the safety of cupping in patients being treated with bevacizumab. This is a single-institution case report. The setting for this study was a tertiary-care academic medical center. A patient with advanced NSCLC received four cycles of carboplatin AUC 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, and was continued on every-3-week maintenance bevacizumab 15 mg/kg. The patient underwent glass dry cupping during cycle six of maintenance bevacizumab treatment without overt cutaneous adverse events or bleeding. The patient did not realize he should have communicated his cupping plans or recent bevacizumab treatment with his providers.

Why is patient safety so hard? A selective review of ethnographic studies.

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Dixon-Woods, Mary

2010-01-01

Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.

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Bagel, Jerry; Duffin, Kristina Callis; Moore, Angela; Ferris, Laura K; Siu, Kimberly; Steadman, Jennifer; Kianifard, Farid; Nyirady, Judit; Lebwohl, Mark

2017-10-01

Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P psoriasis. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

An integrative review of patient safety in studies on the care and safety of patients with communication disabilities in hospital.

Science.gov (United States)

Hemsley, Bronwyn; Georgiou, Andrew; Hill, Sophie; Rollo, Megan; Steel, Joanne; Balandin, Susan

2016-04-01

To review the research literature on the experiences of patients with communication disabilities in hospital according to the Generic Model of patient safety. In 2014 and 2015, we searched four scientific databases for studies with an aim or result relevant to safety of hospital patients with communication disabilities. The review included 27 studies. A range of adverse event types were outlined in qualitative research. Little detail was provided about contributing or protective factors for safety incidents in hospital for these patients or the impact of the incidents on the patient or organisations involved. Further research addressing the safety of patients with communication disabilities is needed. Sufficient detail is required to identify the nature, timing, and detection of incidents; factors that contribute to or prevent adverse events; and detail the impact of the adverse events. In order to provide safe and effective care to people with communication disabilities in hospital, a priority for health and disability services must be the design and evaluation of ecologically appropriate and evidence-based interventions to improve patient care, communication, and reduce the risk of costly and harmful patient safety incidents. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Cholecalciferol 20 000 IU Once Weekly in HIV-Positive Patients with Low Vitamin D Levels: Result from a Cohort Study.

Science.gov (United States)

Noe, Sebastian; Heldwein, Silke; Pascucchi, Rita; Oldenbüttel, Celia; Wiese, C; von Krosigk, Ariane; Jägel-Guedes, Eva; Jäger, Hans; Mayer, Wolfgang; Spinner, Christoph D; Wolf, Eva

To evaluate efficacy and safety of 20 000 IU cholecalciferol weekly in HIV-infected patients. Longitudinal data for 243 HIV-infected patients with paired 25-OH-vitamin D3 values for the same month in 2 consecutive years were stratified by the initiation of supplementation in this retrospective study. After 1 year of administration of cholecalciferol 20 000 IU weekly, about 78% of patients with initial vitamin D level L achieved vitamin D levels >20 µg/L and 42% achieved levels >30 µg/L. Supplemented patients with baseline vitamin D levels L showed a significant risk reduction for hypocalcemia ( P = .006; risk difference: 20.8%) and a significantly lower increase in alkaline phosphatase (AP) compared to those in the nonsubstituted group. The dose of 20 000 IU of cholecalciferol once weekly was found to be safe and effective. Normalization of vitamin D levels within 1 year was observed in 42% to 75% of the patients.

Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study

International Nuclear Information System (INIS)

Bachelot, Thomas; Wang, Zhixiao; Cesari, Rossano; Tassell, Vanessa; Kern, Kenneth A; Blay, Jean-Yves; Lluch, Ana; Garcia-Saenz, Jose A; Verma, Sunil; Gutierrez, Maya; Pivot, Xavier; Kozloff, Mark F; Prady, Catherine; Huang, Xin; Khosravan, Reza

2014-01-01

This phase II study evaluated the efficacy and safety/tolerability of sunitinib plus trastuzumab in patients with HER2-positive advanced breast cancer (ABC). Eligible patients received sunitinib 37.5 mg/day and trastuzumab administered either weekly (loading, 4 mg/kg; then weekly 2 mg/kg) or 3-weekly (loading, 8 mg/kg; then 3-weekly 6 mg/kg). Prior trastuzumab and/or lapatinib treatment were permitted. The primary endpoint was objective response rate (ORR). Sixty patients were enrolled and evaluable for safety; 57 were evaluable for efficacy. The majority of patients (58%) had received no prior chemotherapy in the metastatic setting. The ORR was 37%; the clinical benefit rate (CBR; percent objective response plus stable disease ≥ 24 weeks) was 56%. Among patients who were treatment-naïve or had received only adjuvant therapy, the ORR was 44% and the CBR was 59%. Overall, median overall survival had not been reached and the 1-year survival rate was 91%. The majority of adverse events (AEs) were mild to moderate in severity. Forty percent of patients experienced AEs related to measured left ventricular ejection fraction (LVEF) declines, which occurred more frequently in patients who had received prior anthracycline treatment. Ten percent of patients exhibited symptoms related to LVEF declines. One patient died on study from cardiogenic shock. Antitumor response and several safety parameters appeared to correlate with sunitinib exposure. Sunitinib plus trastuzumab demonstrated antitumor activity in patients with HER2-positive ABC, particularly those who were treatment-naïve or had only received prior adjuvant treatment. Sunitinib plus trastuzumab had acceptable safety and tolerability in patients with HER2-positive ABC who had not received prior anthracycline therapy. clinicaltrials.gov/ct2/show/NCT00243503

Improving construction site safety through leader-based verbal safety communication.

Science.gov (United States)

Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

2010-10-01

The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

Science.gov (United States)

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

A double-blind study evaluating the long-term safety of varenicline for smoking cessation.

Science.gov (United States)

Williams, Kathryn E; Reeves, Karen R; Billing, Clare B; Pennington, Ann M; Gong, Jason

2007-04-01

We assessed the safety of long-term varenicline administration for smoking cessation. In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of > or =10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits. A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

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.

Effects and safety of daily ingestion of plum extract on blood pressure: randomized, double-blinded, placebo-controlledparallelgroup comparison study

Directory of Open Access Journals (Sweden)

Mie Nishimura

2017-11-01

Full Text Available Background: Hypertension is an increasing health issue in Japan. Plums are widely consumed in Japan and are reported to have various health benefits, including improvements to blood flow. However, clinical trials investigating the effects of plum extract on blood pressure have not yet been conducted. Therefore, we evaluated the effects and safety of plum extract on blood pressure in this randomized, double-blinded, and placebo-controlled parallel group comparison study. Methods: Seventy-four healthy Japanese subjects with systolic blood pressure (SBP ≥130 and <160 mmHg were randomly divided into test and placebo groups. Subjects were given either plum extract-processed food (3.0 g of plum extract, containing 30 mg of mumefural and 1.119 g of citric acid or placebo food daily for 12 weeks. Physical examinations, blood measurements, and medical interviews were performed at weeks 0, 4, 8, and 12 and at 2 weeks after the intake period. Results: SBP and diastolic blood pressure (DBP did not significantly differ between the groups. However, in subjects with grade I hypertension, DBP was significantly lower in the active test food group than in the placebo food group at week 12 and at 2 weeks after the intake period. An exploratory subgroup analysis revealed that plum extract improved DBP in subjects with normal to high obesity/class I obesity at week 12. Moreover, plum extract had positive effects on fatigue and bowel movements as determined by visual analog scale questionnaire evaluation. No abnormal changes or severe adverse events were observed in the physical examinations, blood measurements, or medical interviews in this trial. Conclusion: These results suggest that plum extract is safe for long-term intake and improves DBP in subjects with grade I hypertension.

Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial

International Nuclear Information System (INIS)

Pignata, Sandro; Del Gaizo, Filomena; Naglieri, Emanuele; Ferro, Antonella; Musso, Pietro; D'Arco, Alfonso Maria; Sorio, Roberto; Pisano, Carmela; Di Maio, Massimo; Signoriello, Giuseppe; Annunziata, Annalisa; Scambia, Giovanni; Perrone, Francesco; Savarese, Antonella; Breda, Enrico; Scollo, Paolo; De Vivo, Rocco; Rossi, Emanuela; Gebbia, Vittorio; Natale, Donato

2006-01-01

The MITO-2 (Multicentre Italian Trials in Ovarian cancer) study is a randomized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer. Due to the paucity of published phase I data on the 3-weekly experimental schedule used, an early safety analysis was planned. Patients with ovarian cancer (stage Ic-IV), aged < 75 years, ECOG performance status ≤ 2, were randomized to carboplatin AUC 5 plus paclitaxel 175 mg/m 2 , every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m 2 , every 3 weeks. Treatment was planned for 6 cycles. Toxicity was coded according to the NCI-CTC version 2.0. The pre-planned safety analysis was performed in July 2004. Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated. Median age was 60 years (range 34–75). Forty-three patients (86%) completed 6 cycles. Two thirds of the patients had at least one cycle delayed due to toxicity, but 63% of the cycles were administered on time. In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity. No delay due to palmar-plantar erythrodysesthesia (PPE) was recorded. No toxic death was recorded. Reported hematological toxicities were: grade (G) 3 anemia 16%, G3/G4 neutropenia 36% and 10% respectively, G3/4 thrombocytopenia 22% and 4% respectively. Non-haematological toxicity was infrequent: pulmonary G1 6%, heart rhythm G1 4%, liver toxicity G1 6%, G2 4% and G3 2%. Complete hair loss was reported in 6% of patients, and G1 neuropathy in 2%. PPE was recorded in 14% of the cases (G1 10%, G2 2%, G3 2%). This safety analysis shows that the adopted schedule of carboplatin plus pegylated liposomal doxorubicin given every 3 weeks is feasible as first line treatment in ovarian cancer patients, although 37% of the cycles were delayed due to haematological toxicity. Toxicities that are

Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial

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D'Arco Alfonso

2006-08-01

Full Text Available Abstract Background The MITO-2 (Multicentre Italian Trials in Ovarian cancer study is a randomized phase III trial comparing carboplatin plus paclitaxel to carboplatin plus pegylated liposomal doxorubicin in first-line chemotherapy of patients with ovarian cancer. Due to the paucity of published phase I data on the 3-weekly experimental schedule used, an early safety analysis was planned. Methods Patients with ovarian cancer (stage Ic-IV, aged 2, every 3 weeks or to carboplatin AUC 5 plus pegylated liposomal doxorubicin 30 mg/m2, every 3 weeks. Treatment was planned for 6 cycles. Toxicity was coded according to the NCI-CTC version 2.0. Results The pre-planned safety analysis was performed in July 2004. Data from the first 50 patients treated with carboplatin plus pegylated liposomal doxorubicin were evaluated. Median age was 60 years (range 34–75. Forty-three patients (86% completed 6 cycles. Two thirds of the patients had at least one cycle delayed due to toxicity, but 63% of the cycles were administered on time. In most cases the reason for chemotherapy delay was neutropenia or other hematological toxicity. No delay due to palmar-plantar erythrodysesthesia (PPE was recorded. No toxic death was recorded. Reported hematological toxicities were: grade (G 3 anemia 16%, G3/G4 neutropenia 36% and 10% respectively, G3/4 thrombocytopenia 22% and 4% respectively. Non-haematological toxicity was infrequent: pulmonary G1 6%, heart rhythm G1 4%, liver toxicity G1 6%, G2 4% and G3 2%. Complete hair loss was reported in 6% of patients, and G1 neuropathy in 2%. PPE was recorded in 14% of the cases (G1 10%, G2 2%, G3 2%. Conclusion This safety analysis shows that the adopted schedule of carboplatin plus pegylated liposomal doxorubicin given every 3 weeks is feasible as first line treatment in ovarian cancer patients, although 37% of the cycles were delayed due to haematological toxicity. Toxicities that are common with standard combination of carboplatin

76 FR 63801 - Fire Prevention Week, 2011

Science.gov (United States)

2011-10-13

... Proclamation Fires, whether caused by people or nature, can have devastating effects. Hundreds of thousands of... practice fire safety throughout the year. This year's Fire Prevention Week theme, ``Protect Your Family... mowing dry grasses to two inches or less, and by clearing brush, leaves, green grass, and lumber from...

The benefits of endurance training in cardiomyocyte function in hypertensive rats are reversed within four weeks of detraining.

Science.gov (United States)

Carneiro-Júnior, Miguel Araujo; Quintão-Júnior, Judson Fonseca; Drummond, Lucas Rios; Lavorato, Victor Neiva; Drummond, Filipe Rios; da Cunha, Daise Nunes Queiroz; Amadeu, Marco Aurélio; Felix, Leonardo Bonato; de Oliveira, Edilamar Menezes; Cruz, Jader Santos; Prímola-Gomes, Thales Nicolau; Mill, José Geraldo; Natali, Antonio José

2013-04-01

The aim of the present study was to verify the effects of low-intensity endurance training and detraining on the mechanical and molecular properties of cardiomyocytes from spontaneously hypertensive rats (SHRs). Male SHRs and normotensive control Wistar rats at 16-weeks of age were randomly divided into eight groups of eight animals: NC8 and HC8 (normotensive and hypertensive control for 8weeks); NT8 and HT8 (normotensive and hypertensive trained at 50-60% of maximal exercise capacity for 8weeks); NC12 and HC12 (normotensive and hypertensive control for 12weeks); NDT and HDT (normotensive and hypertensive trained for 8weeks and detrained for 4weeks). The total exercise time until fatigue (TTF) was determined by a maximal exercise capacity test. Resting heart rate (RHR) and systolic arterial pressure (SAP) were measured. After the treatments, animals were killed by cervical dislocation and left ventricular myocytes were isolated by enzymatic dispersion. Isolated cells were used to determine intracellular global Ca(2+) ([Ca(2+)]i) transient and cardiomyocyte contractility (1Hz; ~25°C). [Ca(2+)]i regulatory proteins were measured by Western blot, and the markers of pathologic cardiac hypertrophy by quantitative real-time polymerase chain reaction (q-RT-PCR). Exercise training augmented the TTF (NC8, 11.4±1.5min vs. NT8, 22.5±1.4min; HC8, 11.7±1.4min vs. HT8, 24.5±1.3min; Pendurance training induces positive benefits to left ventricular myocyte mechanical and molecular properties, which are reversed within 4weeks of detraining. Copyright © 2013 Elsevier Ltd. All rights reserved.

Liposomal topical capsaicin in post-herpetic neuralgia: a safety pilot study

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Manoel Jacobsen Teixeira

2015-03-01

Full Text Available Topical treatments have gained popularity for general use as an adjunct to systemic drugs in neuropathic pain, but their use produces variable clinical results and local adverse events. Objective To evaluate the safety and analgesic effect of a formulation of liposomal capsaicin (LC (0.025% in patients with post herpetic neuralgia (PHN. Method Patients who remained symptomatic after first-and second-line treatment were randomized to receive LC for six weeks in a placebo-controlled, crossover design study. Clinical assessment was performed at baseline, in the second, fourth and sixth week of treatment. Results Thirteen patients completed both treatment periods. Visual Analog Scale (VAS was significantly decreased after the end of the study (p = 0.008, however the effect of treatment was not significant (p = 0.076. There was no difference on global impression of change and other pain characteristics. LC was safe and well tolerated. However, at the concentration used, its analgesic effects were marginal and not significant.

Hygienic safety of reusable tap water filters (Germlyser® with an operating time of 4 or 8 weeks in a haematological oncology transplantation unit

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Rochow Markus

2007-05-01

Full Text Available Abstract Background Microbial safe tap water is crucial for the safety of immunosuppressed patients. Methods To evaluate the suitability of new, reusable point-of-use filters (Germlyser®, Aquafree GmbH, Hamburg, Germany, three variations of a reusable filter with the same filter principle but with different outlets (with and without silver and inner surface coating of the filter encasements (with and without nano-crystalline silver were tested. The filter efficacy was monitored over 1, 4 and 8 weeks operating time in a haematological oncology transplantation unit equipped with 18 water outlets (12 taps, 6 showers. Results The filtered water fulfilled the requirements of absence of pathogens over time. From 348 samples, 8 samples (2.3% exceeded 100 cfu/ml (no sample ≥ 500 cfu/ml. As no reprocessed filter exhibited 100% filter efficacy in the final quality control after each reprocessing, these contaminations could be explained by retrograde contamination during use. Conclusion As a consequence of the study, the manufacturer recommends changing filters after 4 weeks in high risk areas and after 8 weeks in moderate infectious risk areas, together with routine weekly alcohol-based surface disinfection and additionally in case of visible contamination. The filter efficacy of the 3 filters types did not differ significantly regarding total bacterial counts. Manual reprocessing proved to be insufficient. Using a validated reprocessing in a washer/disinfector with alkaline, acid treatment and thermic disinfection, the filters were effectively reprocessable and now provide tap water meeting the German drinking water regulations as well as the WHO guidelines, including absence of pathogens.

Effects of eight weeks of an alleged aromatase inhibiting nutritional supplement 6-OXO (androst-4-ene-3,6,17-trione on serum hormone profiles and clinical safety markers in resistance-trained, eugonadal males

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Kreider Richard

2007-10-01

Full Text Available Abstract The purpose of this study was to determine the effects of 6-OXO, a purported nutritional aromatase inhibitor, in a dose dependent manner on body composition, serum hormone levels, and clinical safety markers in resistance trained males. Sixteen males were supplemented with either 300 mg or 600 mg of 6-OXO in a double-blind manner for eight weeks. Blood and urine samples were obtained at weeks 0, 1, 3, 8, and 11 (after a 3-week washout period. Blood samples were analyzed for total testosterone (TT, free testosterone (FT, dihydrotestosterone (DHT, estradiol, estriol, estrone, SHBG, leutinizing hormone (LH, follicle stimulating hormone (FSH, growth hormone (GH, cortisol, FT/estradiol (T/E. Blood and urine were also analyzed for clinical chemistry markers. Data were analyzed with two-way MANOVA. For all of the serum hormones, there were no significant differences between groups (p > 0.05. Compared to baseline, free testosterone underwent overall increases of 90% for 300 mg 6-OXO and 84% for 600 mg, respectively (p 0.05 and clinical safety markers were not adversely affected with ingestion of either supplement dose (p > 0.05. While neither of the 6-OXO dosages appears to have any negative effects on clinical chemistry markers, supplementation at a daily dosage of 300 mg and 600 mg for eight weeks did not completely inhibit aromatase activity, yet significantly increased FT, DHT, and T/E.

Safety and Effectiveness of Vibration Massage by Deep Oscillations: A Prospective Observational Study

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Karin Kraft

2013-01-01

Full Text Available The objective of this study is to assess the safety of treatment with vibration massage using a deep oscillation device and the effects on symptom severity and quality of life in patients with primary fibromyalgia syndrome (FMS. Outpatients with FMS performed an observational prospective study with visits 2–4 weeks after the last treatment (control and after further 2 months (follow-up. Patients were treated with 10 sessions of 45 min deep oscillation massage, 2/week. Primary outcome parameters were safety and tolerability (5-level Likert scale (1 = very good (after each treatment session and at control visit. Secondary outcome parameters were symptom severity (Fibromyalgia Impact Questionnaire (FIQ, pain and quality of life (SF-36. Seventy patients (97.1% females were included. At control visit, 41 patients (58.6% reported 63 mild and short-lasting adverse events, mainly worsening of prevalent symptoms such as pain and fatigue. Tolerability was rated as 1.8 (95% confidence interval: 1.53; 2.07. Symptoms and quality of life were significantly improved at both control and follow-up visits (at least P<0.01. In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather sustained.

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

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Zhao JP

2017-08-01

Full Text Available Jingping Zhao,1,* Lehua Li,1,* Jianguo Shi,2 Yi Li,3 Xiufeng Xu,4 Keqing Li,5 Lili Zhang,6 Shangli Cai,6 Yu Feng,6 Jianmin Zhuo,6 Weihong Liu,6 Huafei Lu6 1Department of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University, 2Department of Psychiatry, Mental Health Center of Xi’an City, 3Department of Psychiatry, Mental Health Center of Wuhan City, 4Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, 5Department of Psychiatry, The Sixth People’s Hospital of Hebei Province, 6Department of Medical Affairs, Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China *These authors contributed equally to this work Rationale: Long-acting injectable (LAI paliperidone palmitate 1-month formulation (PP1M has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.Objective: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.Methods: In this 25-week, open-label, Phase IV study, patients (18–65 years diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS total score of 60–120 (inclusive were enrolled. All patients received injections of PP1M 150 mg eq. (day 1 and 100 mg eq. (day 8, followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq..Results: Of the 353 patients, 234 (66.3% completed the study treatment (mean age, 31.1 years; 52.7% men. The PANSS total score (primary end point improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001. The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points also improved

Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

Science.gov (United States)

Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

2015-07-01

The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

DEFF Research Database (Denmark)

Andersson, Charlotte; Weeke, Peter; Brendorp, Bente

2009-01-01

ABSTRACT: BACKGROUND AND AIMS: Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine) in an overweight and obese cardiovascular high risk population was studied....... METHODS AND RESULTS: Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT) study were analyzed. 2584 patients (24%) had diabetes mellitus (DM) only, 1748 (16%) had cardiovascular disease (CVD) only and 6397 (60%) had both DM + CVD. Uric acid concentrations...... significantly more in patients without DM (p sibutramine induced lower uric acid levels...

Improving safety culture through the health and safety organization: a case study.

Science.gov (United States)

Nielsen, Kent J

2014-02-01

International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

Management commitment to safety vs. employee perceived safety training and association with future injury.

Science.gov (United States)

Huang, Yueng-Hsiang; Verma, Santosh K; Chang, Wen-Ruey; Courtney, Theodore K; Lombardi, David A; Brennan, Melanye J; Perry, Melissa J

2012-07-01

The purpose of this study is to explore and examine, specific to the restaurant industry, two important constructs emerging from the safety climate literature: employee perceptions of safety training and management commitment to safety. Are these two separate constructs? Are there both individual- and shared group-level safety perceptions for these two constructs? What are the relationships between these two constructs and future injury outcomes? A total of 419 employees from 34 limited-service restaurants participated in a prospective cohort study. Employees' perceptions of management commitment to safety and safety training and demographic variables were collected at the baseline. The survey questions were made available in three languages: English, Spanish, and Portuguese. For the following 12 weeks, participants reported their injury experience and weekly work hours. A multivariate negative binomial generalized estimating equation model with compound symmetry covariance structure was used to assess the association between the rate of self-reported injuries and measures of safety perceptions. Even though results showed that the correlation between employees'perceived safety training and management commitment to safety was high, confirmatory factor analysis of measurement models showed that two separate factors fit the model better than as two dimensions of a single factor. Homogeneity tests showed that there was a shared perception of the factor of management commitment to safety for the restaurant workers but there was no consistent perception among them for the factor of perceived safety training. Both individual employees'perceived management commitment to safety and perceptions of safety training can predict employees' subsequent injuries above and beyond demographic variables. However, there was no significant relationship between future injury and employees' shared perception of management commitment to safety. Further, our results suggest that the

Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis

DEFF Research Database (Denmark)

Sorensen, Per S; Lisby, Steen; Grove, Richard

2014-01-01

OBJECTIVES: We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS). METHODS: In this randomized, double-blind, placebo-controlled study, patients received 2 ofatumumab infusions (100 mg, 300 mg......, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed. RESULTS: Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group...

Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study.

Science.gov (United States)

Eron, Joseph J; Clotet, Bonaventura; Durant, Jacques; Katlama, Christine; Kumar, Princy; Lazzarin, Adriano; Poizot-Martin, Isabelle; Richmond, Gary; Soriano, Vincent; Ait-Khaled, Mounir; Fujiwara, Tamio; Huang, Jenny; Min, Sherene; Vavro, Cindy; Yeo, Jane

2013-03-01

Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance. Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort II) while continuing a failing regimen (without RAL) through day 10, after which the background regimen was optimized, when feasible, for cohort I, and at least 1 fully active drug was mandated for cohort II. The primary efficacy end point was the proportion of subjects on day 11 in whom the plasma HIV-1 RNA load decreased by ≥0.7 log(10) copies/mL from baseline or was <400 copies/mL. A rapid antiviral response was observed. More subjects achieved the primary end point in cohort II (23 of 24 [96%]), compared with cohort I (21 of 27 [78%]) at day 11. At week 24, 41% and 75% of subjects had an HIV-1 RNA load of <50 copies/mL in cohorts I and II, respectively. Further integrase genotypic evolution was uncommon. Dolutegravir had a good, similar safety profile with each dosing regimen. Dolutegravir 50 mg twice daily with an optimized background provided greater and more durable benefit than the once-daily regimen. These data are the first clinical demonstration of the activity of any integrase inhibitor in subjects with HIV-1 resistant to RAL.

Study on the KALIMER safety approach

International Nuclear Information System (INIS)

Kim, Eui Kwang; Han, Do Hee; Kim, Young Cheol.

1997-01-01

This study describes KALIMER's safety approach, how to establish the safety criteria and temperature limit, how to define safety evaluation events, and some safety research and development needs items. It is recommended that the KALIMER's approach to safety use seven levels of safety design and a defense-in-depth design approach with particular emphasis on inherent passive features. In order to establish as set DBEs for KALIMER safety evaluation, the procedure is explained how to define safety evaluation events. Final selection is to be determined later with the final establishment of design concepts. On the basis of preliminary studies and evaluation of the plant safety related areas, the KALIMER and PRISM have following three main difference that may require special research and development for KALIMER. (author). 7 refs., 6 tabs., 6 figs

Occupational Safety Precautions among Nurses at Four Hospitals, Nablus District, Palestine

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IA Al-Khatib

2015-10-01

Full Text Available Occupational hazards, exposure to blood and body fluids (BBF accidents and safety precautions constitute an important public health issue. We assessed the prevalence and determinants of exposure to occupational hazards among nurses, and their knowledge of occupational safety precautions. In a cross-sectional study, we surveyed 332 nurses working in 4 hospitals, Nablus, West Bank, Palestine, by a questionnaire. Bivariate analysis tested the associations between ever exposure and the high likelihood of BBF exposure and the independent socio-demographic and occupational variables. Binary logistic regression analysis was used to assess the associations between the same two exposures and selected independent variables (those significant in the bivariate analysis. Prevalence of ever exposure to BBF was 51.7%, and was associated with working in private and charitable hospitals (OR 2.62, 2.68, respectively, having 4–6 family members (OR 0.52 and “nursing” being as one's top career choice at university (OR 0.48. The prevalence of high likelihood of BBF exposure was 62.2%, and was associated with working in charitable and private hospitals (OR 7.81, 2.43, respectively and “nursing” being as one's top career choice (OR 0.57. Regarding knowledge, most respondents believed it is necessary to enact laws and regulations regarding occupational safety precautions, reported the use of sharps containers, immediate disinfection after an accident, reporting an accident, and using personal protective equipment. Nurses had adequate knowledge of the risks of their hospital work. Nevertheless, they exhibited high prevalence of exposure to BBF accidents. Future studies are needed to re-evaluate existing occupational safety guidelines in hospitals, establish monitoring and evaluation protocols for health care workers' adherence to the guidelines, and institute well-defined policies for reporting occupational injury incidents so these can be handled appropriately.

Triangulating case-finding tools for patient safety surveillance: a cross-sectional case study of puncture/laceration.

Science.gov (United States)

Taylor, Jennifer A; Gerwin, Daniel; Morlock, Laura; Miller, Marlene R

2011-12-01

To evaluate the need for triangulating case-finding tools in patient safety surveillance. This study applied four case-finding tools to error-associated patient safety events to identify and characterise the spectrum of events captured by these tools, using puncture or laceration as an example for in-depth analysis. Retrospective hospital discharge data were collected for calendar year 2005 (n=48,418) from a large, urban medical centre in the USA. The study design was cross-sectional and used data linkage to identify the cases captured by each of four case-finding tools. Three case-finding tools (International Classification of Diseases external (E) and nature (N) of injury codes, Patient Safety Indicators (PSI)) were applied to the administrative discharge data to identify potential patient safety events. The fourth tool was Patient Safety Net, a web-based voluntary patient safety event reporting system. The degree of mutual exclusion among detection methods was substantial. For example, when linking puncture or laceration on unique identifiers, out of 447 potential events, 118 were identical between PSI and E-codes, 152 were identical between N-codes and E-codes and 188 were identical between PSI and N-codes. Only 100 events that were identified by PSI, E-codes and N-codes were identical. Triangulation of multiple tools through data linkage captures potential patient safety events most comprehensively. Existing detection tools target patient safety domains differently, and consequently capture different occurrences, necessitating the integration of data from a combination of tools to fully estimate the total burden.

3-year results of transvaginal cystocele repair with transobturator four-arm mesh: A prospective study of 105 patients

OpenAIRE

Kdous, Moez; Zhioua, Fethi

2014-01-01

Objectives To evaluate the long-term efficacy and safety of transobturator four-arm mesh for treating cystoceles. Patients and methods In this prospective study, 105 patients had a cystocele corrected between January 2004 and December 2008. All patients had a symptomatic cystocele of stage ?2 according to the Baden?Walker halfway stratification. We used only the transobturator four-arm mesh kit (Surgimesh?, Aspide Medical, France). All surgical procedures were carried out by the same experien...

Daytime Sleepiness in Men During Early Fatherhood: Implications for Work Safety.

Science.gov (United States)

Mellor, Gary; Van Vorst, Stephen

2015-11-01

This study measured the daytime sleepiness (DS) and work safety of fathers during the first 12 weeks of their babies' lives (i.e., early fatherhood). A questionnaire was developed using the Epworth Sleepiness Scale (ESS), the Safety Behaviour at Work Scale, a self-reported sleep history, and a work-related incident history. Of the 221 participants, the vast majority reported they experienced less than 6 hours of interrupted sleep per night during the 12 weeks of the study, and an increasing frequency and severity of DS. The study also revealed an inverse correlation between ESS and Safety Behaviour at Work scores; fathers were 14% more likely to report a near-miss accident at work at 12 weeks. This study posits that antenatal classes and assessment of fathers' sleepiness at work by occupational health practitioners could assist fathers in reducing daytime sleepiness and mitigating the risk of workplace incidents. © 2015 The Author(s).

The Effect of HMB Supplementation on Cardiovascular Risk Factors after Four Weeks of Resistance Training in Amateur Athletes

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Hamid Arazi

2015-06-01

Full Text Available Background: Nutritional supplements have been widely used in order to enhance athletic performance and improve health. Objectives: This study aimed to investigate the effect of Beta-Hydroxy Beta-Methylbutyrate (HMB supplementation on cardiovascular risk factors after 4 weeks of resistance training in athletes. Patients and Methods: In this double-blind study, 20 male athletes were selected through simple random sampling, were assigned to supplement and control groups, and participated in resistance training 3 sessions a week for 4 weeks. The supplement group consumed 3 g HMB supplement per day and the control group consumed the placebo (rice flour in this period. Before and after the test period, blood pressure was measured and fasting blood samples were obtained to determine blood lipids and hematological parameters. After all, paired and unpaired t-test were used to examine within and between group differences, respectively. P ≤ 0.05 was considered as statistically significant. Results: After the training period, no significant differences were found between HMB and placebo groups regarding blood lipids, blood pressure, and hematological parameters. Conclusions: The results of the present study indicated that HMB supplementation was safe and did not result in any adverse effects. Thus, HMB can be used safely by human as an ergogenic aid for exercise training.

Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.

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Mufuta Tshimanga

Full Text Available We aimed to determine if the adverse event (AE rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46; 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459; 337 (85% on anti-retroviral therapy. Among 385 (96% observed completely healed, median days to complete healing was 42 (IQR: 35-49. There was no association between time to healing and CD4 (p = 0.66. Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5. This was non-inferior to 2% AEs (p = 0.0003. All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.

Safety and PK/PD correlation of TV-1106, a recombinant fused human albumin-growth hormone, following repeat dose administration to monkeys.

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Ashkenazi, Nurit; Rosenstock, Moti; Hallak, Hussein; Bassan, Merav; Rasamoelisolo, Michele; Leuschner, Jost; Shinar, Doron

TV-1106 is a recombinant human albumin genetically fused to growth hormone which is intended to reduce the frequency of injections for GH therapy users. We report the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated subcutaneous injections of TV-1106 in Cynomolgus monkeys. Cynomolgus monkeys received four weekly subcutaneous injections of 0, 5, 10 or 20mg/kg TV-1106 and were monitored for safety signals throughout the study. Serum levels of TV-1106 and insulin-like growth factor 1 (IGF-1) were assayed. Treated animals showed no adverse effects or histopathological changes. TV-1106 serum concentrations showed sustained exposure to the drug. Exposure increased in a dose-dependent manner with peak concentrations at approximately 24h post-dosing and elimination half-lives in the range of 12 to 24h. IGF-1 serum concentrations were elevated throughout the entire study duration, indicative of the pharmacological response. There was a clear correlation between change in IGF-1 levels and dose or exposure to TV-1106. The safety, pharmacokinetic and pharmacodynamic findings support the further development of TV-1106 as a once-weekly administered treatment for patients with GHD. Copyright © 2016 Elsevier Ltd. All rights reserved.

For beginners in anaesthesia, self-training with an audiovisual checklist improves safety during anaesthesia induction: A prospective, randomised, controlled two-centre study.

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Beck, Stefanie; Reich, Christian; Krause, Dorothea; Ruhnke, Bjarne; Daubmann, Anne; Weimann, Jörg; Zöllner, Christian; Kubitz, Jens

2018-01-31

Beginners in residency programmes in anaesthesia are challenged because working environment is complex, and they cannot rely on experience to meet challenges. During this early stage, residents need rules and structures to guide their actions and ensure patient safety. We investigated whether self-training with an electronic audiovisual checklist app on a mobile phone would produce a long-term improvement in the safety-relevant actions during induction of general anaesthesia. During the first month of their anaesthesia residency, we randomised 26 residents to the intervention and control groups. The study was performed between August 2013 and December 2014 in two university hospitals in Germany. In addition to normal training, the residents of the intervention group trained themselves on well tolerated induction using the electronic checklist for at least 60 consecutive general anaesthesia inductions. After an initial learning phase, all residents were observed during one induction of general anaesthesia. The primary outcome was the number of safety items completed during this anaesthesia induction. Secondary outcomes were similar observations 4 and 8 weeks later. Immediately, and 4 weeks after the first learning phase, residents in the intervention group completed a significantly greater number of safety checks than residents in the control group 2.8 [95% confidence interval (CI) 0.4 to 5.1, P = 0.021, Cohen's d = 0.47] and 3.7 (95% CI 1.3 to 6.1, P = 0.003, Cohen's d = 0.61), respectively. The difference between the groups had disappeared by 8 weeks: mean difference in the number of safety checks at 8 weeks was 0.4, 95% CI -2.0 to 2.8, P = 0.736, Cohen's d = 0.07). The use of an audiovisual self-training checklists improves safety-relevant behaviour in the early stages of a residency training programme in anaesthesia.

78 FR 57463 - National Farm Safety and Health Week, 2013

Science.gov (United States)

2013-09-18

... agricultural producers and their families and communities to participate in comprehensive farm safety and... respect farming and ranching families by driving rural roadways with care, and I ask communities to... and ranches safer places to live, work, and raise families. NOW, THEREFORE, I, BARACK OBAMA, President...

Overview of the NKS/RAK-1 project 'Strategies for reactor safety' and linkages to piping reliability studies

International Nuclear Information System (INIS)

Andersson, Kjell

1997-01-01

The NKS/RAK-1 project forms part of a four-year research program (1994-97) in the Nordic countries. The general objective of NKS/RAK-1 project is to explore strategies for reactor safety: to investigate and evaluate the safety work, to increase realism and reliability of safety analysis; and to increase the safety of nuclear installations in selected areas. The project has done extensive interview work at utilities and authorities, and analysed a number of case studies. Brief highlights and overviews of the sub-projects are presented in this paper

Safety, pharmacokinetics and efficacy findings in an open-label, single-arm study of weekly paclitaxel plus lapatinib as first-line therapy for Japanese women with HER2-positive metastatic breast cancer.

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Inoue, Kenichi; Kuroi, Katsumasa; Shimizu, Satoru; Rai, Yoshiaki; Aogi, Kenjiro; Masuda, Norikazu; Nakayama, Takahiro; Iwata, Hiroji; Nishimura, Yuichiro; Armour, Alison; Sasaki, Yasutsuna

2015-12-01

Lapatinib is the human epidermal growth factor receptor 2 (HER2) targeting agent approved globally for HER2-positive metastatic breast cancer (MBC). The efficacy, safety and pharmacokinetics (PK) of lapatinib combined with paclitaxel (L+P) were investigated in this study, to establish clear evidence regarding the combination in Japanese patients. In this two-part, single-arm, open-label study, the tolerability of L+P as first-line treatment in Japanese patients with HER2-positive MBC was evaluated in six patients in the first part, and the safety, efficacy and PK were evaluated in a further six patients (making a total of twelve patients) in the second part. Eligible women were enrolled and received lapatinib 1500 mg once daily and paclitaxel 80 mg/m(2) weekly for at least 6 cycles. The only dose-limiting toxicity reported was Grade 3 diarrhea in one patient. The systemic exposure to maximum plasma concentration and area under the plasma concentration curve (AUC) for lapatinib, as well as the AUC of paclitaxel, were increased when combined. The most common adverse events (AEs) related to the study treatment were alopecia, diarrhea and decreased hemoglobin. The majority of drug-related AEs were Grade 1 or 2. The median overall survival was 35.6 months (95 % confidence interval 23.9, not reached). The response rate and clinical benefit rate were both 83 % (95 % confidence interval 51.6, 97.9). The L+P treatment was well tolerated in Japanese patients with HER2-positive MBC. Although the PK profiles of lapatinib and paclitaxel influenced each other, the magnitudes were not greatly different from those in non-Japanese patients.

Safety and efficacy of neratinib in combination with weekly paclitaxel and trastuzumab in women with metastatic HER2‑positive breast cancer: an NSABP Foundation Research Program phase I study.

Science.gov (United States)

Jankowitz, Rachel C; Abraham, Jame; Tan, Antoinette R; Limentani, Steven A; Tierno, Marni B; Adamson, Laura M; Buyse, Marc; Wolmark, Norman; Jacobs, Samuel A

2013-12-01

Neratinib is an oral, small-molecule inhibitor that irreversibly binds to pan-HER (ErbB) receptor tyrosine kinases. Studies suggest that dual anti-HER therapies utilized in breast cancer patients are more efficacious than single agents in both the metastatic and neoadjuvant settings. In this phase I study, neratinib was combined with trastuzumab and paclitaxel in metastatic HER2-positive patients. Twenty-one patients entered this dose-escalation study to determine the maximum-tolerated dose, safety, and efficacy of neratinib (120 up to 240 mg/day) with trastuzumab (4 mg/kg IV loading dose, then 2 mg/kg IV weekly), and paclitaxel (80 mg/m(2) IV days 1, 8, and 15 of a 28-day cycle) in women with HER2-positive metastatic breast cancer previously treated with anti-HER agent(s) and a taxane. The recommended phase II dose of neratinib with trastuzumab and paclitaxel was 200 mg/day. Common grade 3/4 adverse events were diarrhea (38 %), dehydration (14 %), electrolyte imbalance (19 %), and fatigue (19 %). With mandated primary diarrheal prophylaxis, ≥grade 3 diarrhea was not observed. Objective responses, complete (CR) and partial (PR), occurred in eight patients (38 %), with a clinical benefit of CR + PR+ stable disease (SD) ≥24 weeks in 11 patients (52 %). Median time-to-disease progression was 3.7 months. Dual anti-HER blockade with neratinib and trastuzumab resulted in significant clinical benefit despite prior exposure to trastuzumab, lapatinib, T-DM1, a taxane, and multiple lines of chemotherapy. In selected populations, inhibiting multiple ErbB-family receptors may be more advantageous than single-agent inhibition. Based on favorable tolerance and efficacy, this three-drug combination will be further assessed in a randomized phase II neoadjuvant trial (NSABP FB-7:NCT01008150).

Validation study on reliability analysis of main safety system in Nuclear Power Plant

Energy Technology Data Exchange (ETDEWEB)

Cho, Nam Jin; Cho, Chang Keun; Kim, Yong Hui; Kim, Tae Hyeong; Hong, Seo Kee; Park, Keon Woo; Park, Chang Jea [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of); Cheong, Woo Sik [Institute for Advanced Engineering, Yongin (Korea, Republic of); Park, Moon Kyu [KEPRI, Taejon (Korea, Republic of)

1993-12-15

The scope and contents of this validation study are to review the design changes of the four main safety systems in Wolsong 2/3/4 Nuclear Power Plants, to review the consideration of the above design changes in the AECL reports, the structure of fault trees, and the data base used in the quantification of the fault trees, to quantify the unavailabilities of main safety systems and check them if they meet the requirements, and to recommend desirable design changes in the emergency core cooling system to reduce the unavailability.

The role of cooperatives in food safety management of fresh produce chains: Case studies in four strawberry cooperatives

NARCIS (Netherlands)

Kirezieva, K.K.; Bijman, J.; Jacxsens, L.; Luning, P.A.

2016-01-01

Recent outbreaks with fresh produce have raised questions regarding management of quality and safety in the complex supply chains, where cooperatives play a central role. The overall objective of this article was to investigate the role of cooperatives in food quality and safety management in the

A structural equation modelling approach examining the pathways between safety climate, behaviour performance and workplace slipping

Science.gov (United States)

Swedler, David I; Verma, Santosh K; Huang, Yueng-Hsiang; Lombardi, David A; Chang, Wen-Ruey; Brennan, Melayne; Courtney, Theodore K

2015-01-01

Objective Safety climate has previously been associated with increasing safe workplace behaviours and decreasing occupational injuries. This study seeks to understand the structural relationship between employees’ perceptions of safety climate, performing a safety behaviour (ie, wearing slip-resistant shoes) and risk of slipping in the setting of limited-service restaurants. Methods At baseline, we surveyed 349 employees at 30 restaurants for their perceptions of their safety training and management commitment to safety as well as demographic data. Safety performance was identified as wearing slip-resistant shoes, as measured by direct observation by the study team. We then prospectively collected participants’ hours worked and number of slips weekly for the next 12 weeks. Using a confirmatory factor analysis, we modelled safety climate as a higher order factor composed of previously identified training and management commitment factors. Results The 349 study participants experienced 1075 slips during the 12-week follow-up. Confirmatory factor analysis supported modelling safety climate as a higher order factor composed of safety training and management commitment. In a structural equation model, safety climate indirectly affected prospective risk of slipping through safety performance, but no direct relationship between safety climate and slips was evident. Conclusions Results suggest that safety climate can reduce workplace slips through performance of a safety behaviour as well as suggesting a potential causal mechanism through which safety climate can reduce workplace injuries. Safety climate can be modelled as a higher order factor composed of safety training and management commitment. PMID:25710968

Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

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Haupt, E; Ledermann, H; Köpcke, W

2005-02-01

The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

Directory of Open Access Journals (Sweden)

Schweizer A

2011-02-01

Full Text Available Anja Schweizer1, Sylvie Dejager2, James E Foley3, Wolfgang Kothny31Novartis Pharma AG, Basel, Switzerland; 2Novartis Pharma SAS, Rueil-Malmaison, France; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAAim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs, of vildagliptin based on a large pooled database of Phase II and III clinical trials.Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks' duration. AE profiles of vildagliptin (50 mg bid; N = 6116 were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210. Absolute incidence rates were calculated for all AEs, serious AEs (SAEs, discontinuations due to AEs, and deaths.Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively, whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators. The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas.Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies.Keywords: type 2 diabetes, dipeptidyl peptidase-4, edema, safety, vildagliptin

Libertas: rationale and study design of a multicentre, Phase II, double-blind, randomised, placebo-controlled investigation to evaluate the efficacy, safety and tolerability of locally applied NRL001 in patients with faecal incontinence.

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Siproudhis, L; Jones, D; Shing, R Ng Kwet; Walker, D; Scholefield, J H

2014-03-01

Faecal incontinence affects up to 8% of adults. Associated social isolation and subsequent depression can have devastating effects on quality of life (QoL). Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician. There have been few well-designed, placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies. Libertas, a robustly designed study will investigate the efficacy and safety of NRL001 (1R,2S-methoxamine), an α1 -adrenoceptor agonist, in the treatment of faecal incontinence. Libertas is a multicentre, Phase II, double-blind, randomised, placebo-controlled, parallel group study. Patient recruitment took place across 55 study centres in Europe. Patients suffering with faecal incontinence were randomised into four groups (approximately 110 each) to receive once daily self-administered doses of NRL001 (5, 7.5 or 10 mg or placebo in a suppository formulation) for 8 weeks. The primary objective of Libertas is to assess the impact of once daily administration of NRL001 on the severity and frequency of incontinence episodes as assessed by the Wexner score at 4 weeks, compared with placebo. Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment; safety and tolerability; evaluation of plasma pharmacokinetics; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events; dose-response relationship; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy. Overall patient satisfaction with the treatment will also be evaluated. This is the first randomised controlled study to investigate the efficacy

Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis

DEFF Research Database (Denmark)

Ruuska, Tarja; Küster, Peter; Grahnquist, Lena

2016-01-01

AIM: To investigate efficacy and safety for granulocyte, monocyte apheresis in a population of pediatric patients with ulcerative colitis. METHODS: The ADAPT study was a prospective, open-label, multicenter study in pediatric patients with moderate, active ulcerative colitis with pediatric...... ulcerative colitis activity index (PUCAI) of 35-64. Patients received one weekly apheresis with Adacolumn(®) granulocyte, monocyte/macrophage adsorptive (GMA) apheresis over 5 consecutive weeks, optionally followed by up to 3 additional apheresis treatments over 3 consecutive weeks. The primary endpoint...... mg daily on average from Baseline to week 12. CONCLUSION: Adacolumn(®) GMA apheresis treatment was effective in pediatric patients with moderate active Ulcerative Colitis. No new safety signals were reported. The present data contribute to considering GMA apheresis as a therapeutic option...

Comparative Study of Ureteral Stents Following Endoureterotomy in the Porcine Model: 3 vs 6 Weeks and 7F vs 14F

International Nuclear Information System (INIS)

Soria, Federico; Sanchez, Francisco M.; Sun, Fei; Ezquerra, Javier; Duran, Esther; Uson, Jesus

2005-01-01

The aim of the study was to determine the optimal stent size and stenting duration following retrograde endoureterotomy of experimental ureteral strictures. Twenty healthy Large White female pigs were randomly divided into four groups, depending on stent size (7F vs 14F) and stenting duration (3 weeks vs 6 weeks). Three additional pigs were used as the control group. The internal ureteral diameter was measured 2 cm below the lower pole of the right kidney. Histopathological changes of the urinary tract, ultrasonographic and fluoroscopic studies, urine culture, and serum urea and creatine levels were analyzed during the different phases of the study. The study was divided into three phases. Phase I included premodel documentation of the normal urinary tract and laparoscopic ureteral stricture creation. During the second phase 1 month later, the diagnosis and endourologic treatment of strictures were performed. Phase III began 4 weeks after stent removal; follow-up imaging studies and postmortem evaluation of all animals were performed. Ureteral strictures developed in all animals 4 weeks after model creation. Results from ureteral diameter measurements and pathological studies revealed no statistically significant intergroup differences. However, prevalence of urinary infection proved to be directly related to stent size (14F) and permanence (6 weeks). The chi square results suggest a statistically significant relationship between the urinary tract infection and recurrent strictures (α = 0.046). We recommend the use of 7F stents for a period of 3 weeks or less, as these are more easily positioned and result in the reduction of secondary side effects (lower infection rate, less intramural ureteral lesions). A significant relationship between urinary tract infection and stricture recurrence was found in this experimental study

Once-weekly albiglutide in the management of type 2 diabetes: patient considerations.

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Woodward, Heather N; Anderson, Sarah L

2014-01-01

This review describes the pharmacologic, pharmacokinetic, and pharmacodynamic properties of albiglutide, as well as its clinical efficacy and safety. Albiglutide is a novel, once-weekly, injectable glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes. The European Commission recently granted marketing authorization for the drug in the European Union and on April 15, 2014, the US Food and Drug Administration approved albiglutide (Tanzeum™ [GlaxoSmithKline LLC, Wilmington, DE, USA]) to improve glycemic control in adults with type 2 diabetes. Albiglutide has been studied in Phase I, II, and III clinical trials. In the Phase III clinical trials, known as the Harmony series, weekly dosing of albiglutide demonstrated reductions in fasting plasma glucose, postprandial plasma glucose, and glycated hemoglobin, and was associated with weight loss. In all phases of the clinical trials, albiglutide administered once weekly showed a safety and tolerability profile similar to that of placebo, with mild gastrointestinal-related complaints and injection site erythema being the most commonly encountered adverse effects. Compared with pioglitazone and liraglutide, albiglutide has been shown to be clinically less effective. However, it offers the benefit of weight loss that pioglitazone does not, with fewer gastrointestinal side effects than liraglutide. As guidelines continue to advocate for patient-centered treatment strategies, once-weekly albiglutide will be an important addition to the growing armamentarium of treatment options for adults with type 2 diabetes needing target glycemic control.

Four-Week Consumption of Malaysian Honey Reduces Excess Weight Gain and Improves Obesity-Related Parameters in High Fat Diet Induced Obese Rats

Directory of Open Access Journals (Sweden)

Suhana Samat

2017-01-01

Full Text Available Many studies revealed the potential of honey consumption in controlling obesity. However, no study has been conducted using Malaysian honey. In this study, we investigated the efficacy of two local Malaysian honey types: Gelam and Acacia honey in reducing excess weight gain and other parameters related to obesity. The quality of both honey types was determined through physicochemical analysis and contents of phenolic and flavonoid. Male Sprague-Dawley rats were induced to become obese using high fat diet (HFD prior to introduction with/without honey or orlistat for four weeks. Significant reductions in excess weight gain and adiposity index were observed in rats fed with Gelam honey compared to HFD rats. Moreover, levels of plasma glucose, triglycerides, and cholesterol, plasma leptin and resistin, liver enzymes, renal function test, and relative organ weight in Gelam and Acacia honey treated groups were reduced significantly when compared to rats fed with HFD only. Similar results were also displayed in rats treated with orlistat, but with hepatotoxicity effects. In conclusion, consumption of honey can be used to control obesity by regulating lipid metabolism and appears to be more effective than orlistat.

Four-Week Consumption of Malaysian Honey Reduces Excess Weight Gain and Improves Obesity-Related Parameters in High Fat Diet Induced Obese Rats.

Science.gov (United States)

Samat, Suhana; Kanyan Enchang, Francis; Nor Hussein, Fuzina; Wan Ismail, Wan Iryani

2017-01-01

Many studies revealed the potential of honey consumption in controlling obesity. However, no study has been conducted using Malaysian honey. In this study, we investigated the efficacy of two local Malaysian honey types: Gelam and Acacia honey in reducing excess weight gain and other parameters related to obesity. The quality of both honey types was determined through physicochemical analysis and contents of phenolic and flavonoid. Male Sprague-Dawley rats were induced to become obese using high fat diet (HFD) prior to introduction with/without honey or orlistat for four weeks. Significant reductions in excess weight gain and adiposity index were observed in rats fed with Gelam honey compared to HFD rats. Moreover, levels of plasma glucose, triglycerides, and cholesterol, plasma leptin and resistin, liver enzymes, renal function test, and relative organ weight in Gelam and Acacia honey treated groups were reduced significantly when compared to rats fed with HFD only. Similar results were also displayed in rats treated with orlistat, but with hepatotoxicity effects. In conclusion, consumption of honey can be used to control obesity by regulating lipid metabolism and appears to be more effective than orlistat.

Dichorionic twin ultrasound surveillance: sonography every 4 weeks significantly underperforms sonography every 2 weeks: results of the Prospective Multicenter ESPRiT Study.

Science.gov (United States)

Corcoran, Siobhan; Breathnach, Fionnuala; Burke, Gerard; McAuliffe, Fionnuala; Geary, Michael; Daly, Sean; Higgins, John; Hunter, Alyson; Morrison, John J; Higgins, Shane; Mahony, Rhona; Dicker, Patrick; Tully, Elizabeth; Malone, Fergal D

2015-10-01

A 2-week ultrasound scanning schedule for monochorionic twins is endorsed widely. There is a lack of robust data to inform a schedule for the surveillance of dichorionic gestations. We aimed to determine how ultrasound scanning that is performed at 2- or 4-week intervals (or every 4 weeks before 32 weeks' gestation and every 2 weeks thereafter) may impact the prenatal detection of fetal growth restriction (FGR) and ultimately influence timing of delivery. In a consecutive cohort of 789 dichorionic twin pregnancies that were recruited prospectively for the multicenter Evaluation of Sonographic Predictors of Restricted Growth in Twins study, ultrasound determination of fetal growth and interrogation of umbilical and middle cerebral artery Doppler scans were performed every 2 weeks from 24 weeks' gestation until delivery. Complete delivery and perinatal outcome data were recorded for all pregnancies. Where delivery was prompted by FGR, abnormal umbilical artery Doppler examination or poor biophysical profile and in the absence of ruptured membranes, onset of labor, preeclampsia, or antepartum hemorrhage, the delivery was considered "ultrasound-indicated." For ultrasound-indicated deliveries, detection probabilities for FGR/abnormal umbilical artery Doppler scans/poor biophysical were determined according to the interval between examinations, by the suppression if alternate examination data. Among 789 dichorionic twin pregnancies, 66 pairs (8%) had an "ultrasound indicated" delivery. Detection of FGR was reduced from 88-69%, and detection of abnormal umbilical artery Doppler was reduced from 82-62% when a 4-week ultrasound schedule was simulated. Both of these reductions reached statistical significance. There was a nonsignificant trend toward a reduction in the recording of oligohydramnios with a 4-week interval between examinations. This study suggests that the ultrasound surveillance program of every 2 weeks that is recommended currently for monochorionic twins

Urban women's socioeconomic status, health service needs and utilization in the four weeks after postpartum hospital discharge: findings of a Canadian cross-sectional survey.

Science.gov (United States)

Kurtz Landy, Christine; Sword, Wendy; Ciliska, Donna

2008-10-03

Postpartum women who experience socioeconomic disadvantage are at higher risk for poor health outcomes than more advantaged postpartum women, and may benefit from access to community based postpartum health services. This study examined socioeconomically disadvantaged (SED) postpartum women's health, and health service needs and utilization patterns in the first four weeks post hospital discharge, and compared them to more socioeconomically advantaged (SEA) postpartum women's health, health service needs and utilization patterns. Data collected as part of a large Ontario cross-sectional mother-infant survey were analyzed. Women (N = 1000) who had uncomplicated vaginal births of single 'at-term' infants at four hospitals in two large southern Ontario, Canada cities were stratified into SED and SEA groups based on income, social support and a universally administered hospital postpartum risk screen. Participants completed a self-administered questionnaire before hospital discharge and a telephone interview four weeks after discharge. Main outcome measures were self-reported health status, symptoms of postpartum depression, postpartum service needs and health service use. When compared to the SEA women, the SED women were more likely to be discharged from hospital within the first 24 hours after giving birth [OR 1.49, 95% CI (1.01-2.18)], less likely to report very good or excellent health [OR 0.48, 95% CI (0.35-0.67)], and had higher rates of symptoms of postpartum depression [OR 2.7, 95% CI(1.64-4.4)]. No differences were found between groups in relation to self reported need for and ability to access services for physical and mental health needs, or in use of physicians, walk-in clinics and emergency departments. The SED group were more likely to accept public health nurse home visits [OR 2.24, 95% CI(1.47-3.40)]. Although SED women experienced poorer mental and overall health they reported similar health service needs and utilization patterns to more SEA women

Urban women's socioeconomic status, health service needs and utilization in the four weeks after postpartum hospital discharge: findings of a Canadian cross-sectional survey

Directory of Open Access Journals (Sweden)

Ciliska Donna

2008-10-01

Full Text Available Abstract Background Postpartum women who experience socioeconomic disadvantage are at higher risk for poor health outcomes than more advantaged postpartum women, and may benefit from access to community based postpartum health services. This study examined socioeconomically disadvantaged (SED postpartum women's health, and health service needs and utilization patterns in the first four weeks post hospital discharge, and compared them to more socioeconomically advantaged (SEA postpartum women's health, health service needs and utilization patterns. Methods Data collected as part of a large Ontario cross-sectional mother-infant survey were analyzed. Women (N = 1000 who had uncomplicated vaginal births of single 'at-term' infants at four hospitals in two large southern Ontario, Canada cities were stratified into SED and SEA groups based on income, social support and a universally administered hospital postpartum risk screen. Participants completed a self-administered questionnaire before hospital discharge and a telephone interview four weeks after discharge. Main outcome measures were self-reported health status, symptoms of postpartum depression, postpartum service needs and health service use. Results When compared to the SEA women, the SED women were more likely to be discharged from hospital within the first 24 hours after giving birth [OR 1.49, 95% CI (1.01–2.18], less likely to report very good or excellent health [OR 0.48, 95% CI (0.35–0.67], and had higher rates of symptoms of postpartum depression [OR 2.7, 95% CI(1.64–4.4]. No differences were found between groups in relation to self reported need for and ability to access services for physical and mental health needs, or in use of physicians, walk-in clinics and emergency departments. The SED group were more likely to accept public health nurse home visits [OR 2.24, 95% CI(1.47–3.40]. Conclusion Although SED women experienced poorer mental and overall health they reported similar

Weekly ascorbic acid infusion in castration-resistant prostate cancer patients

DEFF Research Database (Denmark)

Nielsen, Torben K.; Højgaard, Martin; Andersen, Jon T.

2017-01-01

of this treatment.  Methods: This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g...... μg/L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as "serious". Three AEs were directly related to AA, and all of which were related to fluid load.  Conclusions: Infusion...

Future Circular Collider study week 2017

CERN Document Server

2017-01-01

The annual meetings of the worldwide Future Circular Collider study (FCC) are major international events that review the progress in every domain which is relevant to develop feasible concepts for a next generation frontier particle accelerate based high-energy physics research infrastructure. This 3rd meeting is jointly organised by CERN and DESY. It is also the annual meeting of the EuroCirCol EC Horizon 2020 Research and Innovation Action project. Previous events took place in Washington and Rome. In 2017 the FCC Week will take place in Berlin, Germany between May 29 and June 2.

Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema

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Gandy JJ

2011-09-01

Full Text Available Justin J Gandy, Jacques R Snyman, Constance EJ van RensburgDepartment of Pharmacology, Faculty of Health Sciences, University of Pretoria, Pretoria, South AfricaBackground: The purpose of this study was to evaluate the efficacy and safety of carbohydrate-derived fulvic acid (CHD-FA in the treatment of eczema in patients two years and older.Methods: In this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks.Results: All safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results.Conclusion: CHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema.Keywords: fulvic acid, eczema, anti-inflammatory, efficacy, safety

ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia.

Science.gov (United States)

Currow, D; Temel, J S; Abernethy, A; Milanowski, J; Friend, J; Fearon, K C

2017-08-01

Cancer anorexia-cachexia is a debilitating condition frequently observed in NSCLC patients, characterized by decreased body weight, reduced food intake, and impaired quality of life. Anamorelin, a novel selective ghrelin receptor agonist, has anabolic and appetite-enhancing activities. ROMANA 3 was a safety extension study of two phase 3, double-blind studies that assessed safety and efficacy of anamorelin in advanced NSCLC patients with cachexia. Patients with preserved Eastern Cooperative Oncology Group ≤2 after completing 12 weeks (w) on the ROMANA 1 or ROMANA 2 trials (0-12 weeks) could enroll in ROMANA 3 and continue to receive anamorelin 100 mg or placebo once daily for an additional 12w (12-24 weeks). The primary endpoint of ROMANA 3 was anamorelin safety/tolerability (12-24 weeks). Secondary endpoints included changes in body weight, handgrip strength (HGS), and symptom burden (0-24 weeks). Of the 703 patients who completed ROMANA 1 and ROMANA 2, 513 patients entered ROMANA 3 (anamorelin, N = 345, mean age 62.0 years; placebo, N = 168; mean age 62.2 years). During ROMANA 3, anamorelin and placebo groups had similar incidences of treatment-emergent adverse events (TEAEs; 52.2% versus 55.7%), grade ≥3 TEAEs (22.4% versus 21.6%), and serious TEAEs (12.8% versus 12.6%). There were 36 (10.5%) and 23 (13.8%) deaths in the anamorelin and placebo groups, respectively; none were drug-related. Improvements in body weight and anorexia-cachexia symptoms observed in the original trials were consistently maintained over 12-24 weeks. Anamorelin, versus placebo, significantly increased body weight from baseline of original trials at all time points (P cachexia symptoms at weeks 3, 6, 9, 12, and 16 (P < 0.05). No significant improvement in HGS was seen in either group. During the 12-24 weeks ROMANA 3 trial, anamorelin continued to be well tolerated. Over the entire 0-24w treatment period, body weight and symptom burden were improved

Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study

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Dahl R

2013-10-01

Full Text Available Ronald Dahl,1 Dalal Jadayel,2 Vijay KT Alagappan,3 Hungta Chen,3 Donald Banerji31Department of Dermatology, Allergy Centre, Odense University Hospital, Odense, Denmark; 2Novartis Horsham Research Centre, Horsham, UK; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAIntroduction: The BEACON study evaluated the efficacy and safety of QVA149, a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA indacaterol and long-acting muscarinic antagonist (LAMA glycopyrronium (NVA237, in development for the treatment of patients with chronic obstructive pulmonary disease (COPD, compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY.Methods: In this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010 were randomized (1:1 to once-daily QVA149 (110 µg indacaterol/50 µg glycopyrronium or concurrent administration of indacaterol (150 µg and glycopyrronium (50 µg via the Breezhaler® device (Novartis AG, Basel, Switzerland for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1 after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0–4 hours at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period.Results: Of 193 patients randomized, 187 (96.9% completed the study. Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.46 L ± 0.02 and 1.46 L ± 0.18, respectively. The FEV1 AUC0–4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group

Nordic studies in reactor safety

International Nuclear Information System (INIS)

Pershagen, N.

1993-01-01

The Nordic Nuclear Safety Research Programme SIK programme in reactor safety is part of a major joint Nordic research effort in nuclear safety. The report summarizes the achievements of the SIK programme, which was carried out during 1990-1993 in collaboration between Nordic nuclear utilities, safety authorities, and research institutes. Three main projects were successfully completed dealing with: 1) development and application of a living PSA concept for monitoring the risk of core damage, and of safety indicators for early warning of possible safety problems; 2) review and intercomparison of severe accident codes, case studies of potential core melt accidents in nordic reactors, development of chemical models for the MAAP code, and outline of a system for computerized accident management support; 3) compilation of information about design and safety features of neighbouring reactors in Germany, Lithuania and Russia, and for naval reactors and nuclear submarines. The report reviews the state-of-the-art in each subject matter as an introduction to the individual project summaries. The main findings of each project are highlighted. The report also contains an overview of reactor safety research in the Nordic countries and a summary of fundamental reactor safety principles. (au) (69 refs.)

Quality of life in patients with Irritable Bowel Syndrome (IBS), assessed using the IBS-Quality of Life (IBS-QOL) measure after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide: results of an international prospective observational cohort study in Poland, Egypt, Mexico and China.

Science.gov (United States)

Hou, Xiaohua; Chen, Shengliang; Zhang, Yali; Sha, Weihong; Yu, Xiaofeng; Elsawah, Hesham; Afifi, Afifi Fahmy; El-Khayat, Hisham Raafat; Nouh, Alaa; Hassan, Mohamed Fathalla; Fatah, Ayman Abdel; Rucker Joerg, Isabel; Sánchez Núñez, Juan Manuel; Osthoff Rueda, Rodolfo; Jurkowska, Grazyna; Walczak, Michal; Malecka-Panas, Ewa; Linke, Krzysztof; Hartleb, Marek; Janssen-van Solingen, Gwendolyn

2014-11-01

Irritable Bowel Syndrome (IBS) has a substantial impact on health-related quality of life (HR-QoL) but high-quality data pre- and post-treatment using the IBS-Quality of Life (IBS-QOL) measure are limited. The objective of this study was to evaluate the changes from baseline of the IBS-QOL scores, symptom scores and health economic data in IBS patients, after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide. This was a prospective observational cohort study in patients with IBS, diagnosed using the Rome III criteria in four countries (Poland, Egypt, Mexico and China). A total of 607 patients were enrolled. At baseline, the IBS-QOL total scores were 52.0 in Poland, 48.9 in Egypt, 51.9 in Mexico, 76.4 in China and 56.4 overall. Increases in IBS-QOL total score were statistically significant at Weeks 4 and 8 overall and in each country (overall: 11.8 at Week 4, 24.3 at Week 8; p < 0.001). Improvements were shown in all IBS-QOL subscales and scores. Symptoms and health economic outcomes were improved. Furthermore, the favourable safety profile of these treatments was confirmed in this study. This study demonstrated that IBS patients have a substantially reduced HR-QoL and that treatment with mebeverine hydrochloride or pinaverium bromide improved HR-QoL.

Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

Directory of Open Access Journals (Sweden)

Shusaku Ishikawa

2008-09-01

Full Text Available Shusaku Ishikawa1, Yoshimi Nakamura1, Yuko Nakamura1, Hiroshi Sakai1, Shoichi Sawaguchi1, Kazuo Terashima2, Makoto Kanno2, Hidetoshi Yamashita21Department of Ophthalmology, University of the Ryukyus Faculty of Medicine, Okinawa, Japan; 2Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine, Yamagata, JapanPurpose: To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG or ocular hypertension (OH after a change from timolol in combination therapy with latanoprost.Methods: A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SDy] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol. Intraocular pressure (IOP was measured at baseline, 4, 8, and 12 weeks. Blood pressure (BP, pulse rate (PR, and adverse events were also recorded.Results: IOPs at baseline, 4, 8, and 12 weeks were 18.6 ± 2.1 mmHg, 17.8 ± 2.6 mmHg, 17.4 ± 2.5 mmHg, and 17.3 ± 3.5 mmHg, respectively. IOP reduction at 4 and 8 weeks was statistically significant (p < 0.05. The PR was significantly increased at 12 weeks (p < 0.01, but BP was not significantly affected. Four ocular adverse events were noted, but all were mild and transient.Conclusions: Substituting brinzolamide 1% for timolol 0.5% in combination therapy with latanoprost 0.005% demonstrated significant IOP reduction with improvement in PR with POAG or OH. Combination therapy using latanoprost and brinzolamide may be recommended for better IOP control with fewer systemic adverse events.Keywords: open-angle glaucoma, brinzolamide/latanprost combination therapy, timolol/latanoprost combination therapy, intraocular pressure

Esomeprazole use is independently associated with significant reduction of BMD: 1-year prospective comparative safety study of four proton pump inhibitors.

Science.gov (United States)

Bahtiri, Elton; Islami, Hilmi; Hoxha, Rexhep; Qorraj-Bytyqi, Hasime; Rexhepi, Sylejman; Hoti, Kreshnik; Thaçi, Kujtim; Thaçi, Shpetim; Karakulak, Çağla

2016-09-01

Because of the efficacy of proton pump inhibitors (PPIs), their the use is increasing dramatically. The risk of adverse effects of short-term PPI therapy is low, but there are important safety concerns for potential adverse effects of prolonged PPI therapy. Findings from studies assessing the association between PPI use and bone mineral density (BMD) and/or fracture risk are contradictory. The aim of this study was to prospectively assess potential association of PPI treatment with the 12-month change in BMD of the lumbar spine, femur neck, and total hip. The study was performed in 200 PPI users and 50 PPI nonusers. Lumbar spine (L1-L4), femur neck, and total hip BMD were measured by dual-energy X-ray absorptiometry at the baseline and at 12 months. A total of 209 subjects completed the entire 12 months of the study and were included in the final analysis. A Wilcoxon signed-rank test showed that at 12 months PPI use was associated with statistically significant reductions in femur neck and total hip T scores (Z = -2.764, p = 0.005 and Z = -3.281, p = 0.001, respectively). A multiple linear regression analysis showed that only esomeprazole added significantly to the prediction of total lumbar spine and femur neck T scores (p = 0.048 and p = 0.037, respectively). Compared with the baseline, 12 months of PPI treatment resulted in lower femur neck and total hip BMD T scores. Among the four PPIs studied, esomeprazole was independently associated with significant reduction of BMD, whereas omeprazole had no effects on BMD. Considering the widespread use of PPIs, BMD screening should be considered in the case of prolonged PPI use.

77 FR 21448 - Security Zone; 2012 Fleet Week, Port Everglades, Fort Lauderdale, FL

Science.gov (United States)

2012-04-10

... Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children...-AA87 Security Zone; 2012 Fleet Week, Port Everglades, Fort Lauderdale, FL AGENCY: Coast Guard, DHS...

Long-term, interventional, open-label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Poland and Russia who completed the global, international CHERISH trial.

Science.gov (United States)

Opoka-Winiarska, Violetta; Żuber, Zbigniew; Alexeeva, Ekaterina; Chasnyk, Vyacheslav; Nikishina, Irina; Dębowska, Grażyna; Smolewska, Elżbieta

2018-04-13

Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were demonstrated in juvenile idiopathic arthritis (JIA) with polyarticular course (pJIA) in the CHERISH trial. This observational, III phase study evaluated long-term treatment of TCZ in pJIA patients was conducted by members of the Pediatric Rheumatology International Trials Organization (PRINTO) from Poland and Russia. Forty-one patients, who had completed the CHERISH core study (104 weeks), were extensionally treated with TCZ (8 mg/kg, intravenous infusion every 4 weeks). Total treatment time was from 131 to 193 weeks. The long-term safety (the primary endpoint) and efficacy were evaluated. All patients achieved ACR70 response in the core study and continued to achieve at least ACR50 response up to week 24 of this study. The safety population comprised 46.41 patient-years (PY). Rates per 100 PY of adverse (AEs) and serious events (SAEs) were 181.0 and 6.46, respectively. Pharyngitis and respiratory tract infections were the most common AEs. Except one AE (severe neutropenia), all others were classified as mild (24.4%) or moderate (29.3%). The incidence of SAEs was low (7.3%). No new safety findings were observed. The safety profile of over 2.5-year treatment with TCZ is consistent with the pre-marketing CHERISH clinical trial. Presented data and continued efficacy response support the use of TCZ in pJIA. EUDRACT No: 2011-001607-12. https://clinicaltrials.gov/ct2/show/study/NCT01575769?term=ML27783.

Measuring Safety Culture on Ships Using Safety Climate: A Study among Indian Officers

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Yogendra Bhattacharya

2015-12-01

Full Text Available Workplace safety continues to be an area of concern in the maritime industry due to the international nature of the operations. The effectiveness of extensive legislation to manage shipboard safety remains in doubt. The focus must therefore shift towards the human element - seafarers and their perceptions of safety. The study aims to understand the alignment that exists between safety culture and safety climate on board ships as perceived by seafarers. The underlying factors of safety climate were identified using factor analysis which isolated seven factors - Support on Safety, Organizational Support, Resource Availability, Work Environment, Job Demands, ‘Just’ Culture, and Safety Compliance. The perception of safety level of seafarers was found to be low indicating the existence of misalignments between safety culture values and the actual safety climate. The study also reveals that the safety perceptions of officers employed directly by ship owners and those by managers do not differ significantly, nor do they differ between senior and junior officers. A shift in perspective towards how seafarers themselves feel towards safety might provide more effective solutions – instead of relying on regulations - and indeed aid in reducing incidents on board. This paper details practical suggestions on how to identify the factors that contribute towards a better safety climate on board ships.

Novel Pharmaceutical Strontium Malonate Influence on Calcium and Strontium Adsorption by Dog Femur and by Dog Teeth in a Four-Week Toxicity Study

DEFF Research Database (Denmark)

Raffalt, Anders Christer; Christgau, Stephan; Andersen, Jens Enevold Thaulov

of osteoporosis. As part of this development the compound was administered in doses of 0 (placebo), 300, 1000 and 3000 mg/kg/day to beagle dogs for a period of 4 weeks. We measured the incorporation of strontium in bone, marrow and teeth in this study. Analysis by inductively coupled plasma mass spectrometry...... marginally higher incorporation of strontium suggesting that saturation levels were reached with the lowest dose level. There was no gender difference in strontium incorporation. Correlations of strontium levels with Sr/Ca-ratio and other important biological parameters were investigated....

Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

Science.gov (United States)

Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

2017-07-11

The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

Science.gov (United States)

Kent, Justine M; Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

2013-12-01

The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. In this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).

Defining the spatial relationships between eight anatomic planes in the 11+6 to 13+6 weeks fetus: a pilot study.

Science.gov (United States)

Abu-Rustum, Reem S; Ziade, M Fouad; Abu-Rustum, Sameer E

2012-09-01

Our study aims at investigating the spatial relationships between eight anatomic planes in the 11+6 to 13+6 weeks fetus. This is a retrospective pilot study where three-dimensional and four-dimensional stored data sets were manipulated to retrieve eight anatomic planes starting from the midsagittal plane of the fetus. Standardization of volumes was performed at the level of the transverse abdominal circumference plane. Parallel shift was utilized and the spatial relationships between eight anatomic planes were established. The median and the range were calculated for each of the planes, and they were evaluated as a function of the fetal crown-rump length. P planes were found to adhere to normal distribution curves, and most of the planes were in a definable relationship to each other with statistically significant correlations. To our knowledge, this is the first study to describe the possible spatial relationships between eight two-dimensional anatomic planes in the 11+6 to 13+6 weeks fetus, utilizing a standardized approach. Defining these spatial relationships may serve as the first step for the potential future development of automation software for fetal anatomic assessment at 11+6 to 13+6 weeks. © 2012 John Wiley & Sons, Ltd.

Effect of minoxidil topical foam on frontotemporal and vertex androgenetic alopecia in men: a 104-week open-label clinical trial.

Science.gov (United States)

Kanti, V; Hillmann, K; Kottner, J; Stroux, A; Canfield, D; Blume-Peytavi, U

2016-07-01

Topical minoxidil formulations have been shown to be effective in treating androgenetic alopecia (AGA) for 12 months. Efficacy and safety in both frontotemporal and vertex regions over longer application periods have not been studied so far. To evaluate the effect of 5% minoxidil topical foam (5% MTF) in the frontotemporal and vertex areas in patients with moderate AGA over 104 weeks. An 80-week, open-label extension phase was performed, following a 24-week randomized, double-blind, placebo-controlled study in men with AGA grade IIIvertex to VI. Group 1 (n = 22) received ongoing 5% MTF for 104 weeks, Group 2 (n = 23) received placebo topical foam (plaTF) until week 24, followed by 5% MTF until week 104 during the extension phase. Frontotemporal and vertex target area non-vellus hair counts (f-TAHC, v-TAHC) and cumulative hair width (f-TAHW, v-TAHW) were assessed at baseline and at weeks 24, 52, 76 and 104. In Group 1, f-TAHW and f-TAHC showed a statistically significant increase from baseline to week 52 and week 76, respectively, returning to values comparable to baseline at week 104. No significant differences were found between baseline and week 104 in v-TAHC in Group 1 as well as f-TAHC, v-TAHC, f-TAHW and v-TAHW values in Group 2. 5% MTF is effective in stabilizing hair density, hair width and scalp coverage in both frontotemporal and vertex areas over an application period of 104 weeks, while showing a good safety and tolerability profile with a low rate of irritant contact dermatitis. © 2015 European Academy of Dermatology and Venereology.

Music in context : Four case studies

NARCIS (Netherlands)

Randwijck, R.J.C. van

2008-01-01

In his thesis entitled “Music in Context. Four Case Studies”, R.J.C. van Randwijck investigates the context in which music has been created. It is a search in Four Case Studies, approaching four pieces of music from the context in which they were written in order to understand their meaning. The

Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

Science.gov (United States)

Lyons, Vanessa E; Popejoy, Lori L

2014-02-01

The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

Weekly ascorbic acid infusion in castration-resistant prostate cancer patients

DEFF Research Database (Denmark)

Nielsen, Torben K.; Højgaard, Martin; Andersen, Jon T.

2017-01-01

of this treatment. Methods: This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g....../L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as "serious". Three AEs were directly related to AA, and all of which were related to fluid load. Conclusions: Infusion with 60 g of AA did...

Postmarketing study of efficacy and safety of losartan during the treatment of patients with mild and moderate hypertension: Lothar study

Directory of Open Access Journals (Sweden)

Vasiljević Zorana

2013-01-01

Full Text Available Introduction. Losartan, the angiotensin type 1 receptor blocker (ARB exercises its main antihypertensive effect by vasodilatation of peripheral arteries. Objective. The aim of this study was to evaluate the antihypertensive effect and safety of losartan in patients with mild and moderate arterial hypertension (AH. Methods. This was an open post-marketing study with losartan as monotherapy in previously treated or untreated patients with AH. Primary efficacy parameter was the percentage of patients that achieved target blood pressure after 8-week treatment with a single daily dose of losartan of 50-100 mg. Safety parameters were assessed according to the percentage of adverse events and metabolic effects of therapy. Results. The study included 550 patients with AH (59% female and 41% male, mean age 56.8±11.4 years, BMI=27±4 kg/m2. Losartan was applied in 31% of untreated and 69% of previously treatment-resistant patients After 8 weeks target blood pressure was achieved in 67.8% (SBP and in 81.1% (DBP of patients, respectively. The mean decrease was 21.8% for SBP and 21.1% for DBP (p<0.001. Out of all, 65% of patients achieved both target SBP and DBP values. Hydrochlorothiazide was added to the therapy in 11.6% of patients. There were no significant differences in drug efficacy between the entire group and subgroups of patients with diabetes mellitus and impaired renal function (p=ns. Adverse events were rare and metabolic effect was favorable. Conclusion. Monotherapy with losartan in a dosage of 50-100 mg applied during 8 weeks resulted in achieving target values of blood pressure in 65% of patient with mild and moderate hypertension, also including the patients with diabetes mellitus and impaired renal function. Losartan is a safe and metabolically neutral medication.

A structural equation modelling approach examining the pathways between safety climate, behaviour performance and workplace slipping.

Science.gov (United States)

Swedler, David I; Verma, Santosh K; Huang, Yueng-Hsiang; Lombardi, David A; Chang, Wen-Ruey; Brennan, Melayne; Courtney, Theodore K

2015-07-01

Safety climate has previously been associated with increasing safe workplace behaviours and decreasing occupational injuries. This study seeks to understand the structural relationship between employees' perceptions of safety climate, performing a safety behaviour (ie, wearing slip-resistant shoes) and risk of slipping in the setting of limited-service restaurants. At baseline, we surveyed 349 employees at 30 restaurants for their perceptions of their safety training and management commitment to safety as well as demographic data. Safety performance was identified as wearing slip-resistant shoes, as measured by direct observation by the study team. We then prospectively collected participants' hours worked and number of slips weekly for the next 12 weeks. Using a confirmatory factor analysis, we modelled safety climate as a higher order factor composed of previously identified training and management commitment factors. The 349 study participants experienced 1075 slips during the 12-week follow-up. Confirmatory factor analysis supported modelling safety climate as a higher order factor composed of safety training and management commitment. In a structural equation model, safety climate indirectly affected prospective risk of slipping through safety performance, but no direct relationship between safety climate and slips was evident. Results suggest that safety climate can reduce workplace slips through performance of a safety behaviour as well as suggesting a potential causal mechanism through which safety climate can reduce workplace injuries. Safety climate can be modelled as a higher order factor composed of safety training and management commitment. 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.

Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

Science.gov (United States)

Clayton, Anita H; Croft, Harry A; Yuan, James; Brown, Louise; Kissling, Robert

2018-01-01

Depression is often associated with sexual dysfunction, and pharmacologic treatment for hypoactive sexual desire disorder can be considered in women receiving treatment for depression. To evaluate the safety of flibanserin in women treated for depression with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. In this double-blinded, randomized, placebo-controlled trial, women with remitted or mild depression treated with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors who were not postmenopausal and were experiencing symptoms of hypoactive sexual desire disorder (ie, decreased sexual desire and related distress) received flibanserin 50 mg at bedtime (qhs) for 2 weeks and up-titrated to 100 mg qhs, flibanserin 100 mg qhs for the entire treatment period, or placebo for up to 12 weeks. Safety assessment included adverse events and symptoms of depression and anxiety. 73 patients were randomly assigned to flibanserin (both dose groups combined) and 38 to placebo. The sponsor terminated the study early at discontinuation of the development of flibanserin. Treatment duration was at least 8 weeks for 84.9% and 94.7% of patients in the flibanserin and placebo groups, respectively. The most common adverse events (incidence ≥ 2% in the flibanserin group and higher than that in the placebo group) included dry mouth (5.5% for flibanserin vs 2.6% for placebo), insomnia (5.5% vs 2.6%), back pain (4.1% vs 2.6%), and dizziness (4.1% vs 0.0%). There were no serious adverse events and no instances of suicidal ideation or behavior. The proportions of patients with symptom worsening in the flibanserin and placebo groups, respectively, were 6.9% and 21.6% for depression and 1.4% and 2.7% for anxiety. Remission of depression at study end point, as measured by the Quick Inventory of Depressive Symptomatology-Self Report, was experienced by 19.4% of flibanserin-treated patients and 10.8% of patients

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

International Nuclear Information System (INIS)

Oh, Kyemin; Kang, Myoung-suk; Heo, Gyunyoung; Kim, Hyoung-chan

2014-01-01

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

Energy Technology Data Exchange (ETDEWEB)

Oh, Kyemin; Kang, Myoung-suk [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Heo, Gyunyoung, E-mail: gheo@khu.ac.kr [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Kim, Hyoung-chan [National Fusion Research Institute, Daejeon-si 305-333 (Korea, Republic of)

2014-10-15

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial.

Science.gov (United States)

Nel, Annaléne; Martins, Janine; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides.

Impact of Four Weeks of a Multi-Ingredient Performance Supplement on Muscular Strength, Body Composition, and Anabolic Hormones in Resistance-Trained Young Men.

Science.gov (United States)

Kreipke, Vince C; Allman, Brittany R; Kinsey, Amber W; Moffatt, Robert J; Hickner, Robert C; Ormsbee, Michael J

2015-12-01

Although multi-ingredient performance supplements (MIPS) have increased in popularity because of their array of ergogenic ingredients, their efficacy and safety remain in question. The objective of this study was to determine the impact of supplementation with T+ (SUP; Onnit Labs, Austin, TX, USA), an MIPS containing long jack root, beta-alanine, and branched-chain amino acids, and other proprietary blends, on strength, body composition, and hormones in young resistance-trained men. Subjects were randomized to consume either T+ (SUP; n = 14; age, 21 ± 3 years; body fat, 18.3 ± 4.7%) or an isocaloric placebo (PL; n = 13; age, 21 ± 3 years; body fat, 21.5 ± 6.2%) for 4 weeks. Both groups underwent a progressive, 4-week high-intensity resistance training protocol. Before and after the training protocol, mood state, body composition, blood hormones (also collected at midpoint), and maximal strength were measured. SUP had significantly greater increases in bench press (SUP, 102 ± 16 kg to 108 ± 16 kg vs. PL, 96 ± 22 kg to 101 ± 22 kg; p < 0.001) and total weight lifted (SUP, 379 ± 59 kg to 413 ± 60 kg vs. PL, 376 ± 70 kg to 400 ± 75 kg; p < 0.001) compared with PL. Additionally, deadlift strength relative to total body mass (calculated as weight lifted/body mass; kg:kg) (2.08 ± 0.18 to 2.23 ± 0.16; p = 0.036) and lean mass (2.55 ± 0.19 to 2.72 ± 0.16; p = 0.021) increased significantly in SUP but not PL (2.02 ± 0.30 to 2.15 ± 0.36 and 2.56 ± 0.31 to 2.70 ± 0.36, respectively). No other significant differences were detected between groups for the remaining variables. Supplementing with SUP enhanced resistance training adaptations independent of hormonal status, and thus SUP use may warrant inclusion into peri-workout nutrition regimens. This study was registered with clinicaltrials.gov (identifier: NCT01971723).

A phase 1 study to evaluate the safety and LDL cholesterol-lowering effects of RG7652, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9.

Science.gov (United States)

Baruch, Amos; Luca, Diana; Kahn, Robert S; Cowan, Kyra J; Leabman, Maya; Budha, Nageshwar R; Chiu, Cecilia P C; Wu, Yan; Kirchhofer, Daniel; Peterson, Andrew; Davis, John C; Tingley, Whittemore G

2017-07-01

Proprotein convertase subtilisin/kexin type 9 (PCSK9) downregulates low-density lipoprotein (LDL) receptors, thereby leading to a rise in circulating LDL cholesterol (LDL-C). RG7652 is a fully human monoclonal antibody against PCSK9. This placebo-controlled, phase 1 ascending-dose study in healthy subjects evaluated the safety of RG7652 and its efficacy as a potential LDL-C-lowering drug. Anti-PCSK9 antibody therapy safely and effectively reduces LDL-C. Subjects (N = 80) were randomized into 10 cohorts. Six sequential single-dose cohorts received 10, 40, 150, 300, 600, or 800 mg of RG7652 via subcutaneous injection. Four multiple-dose cohorts received 40 or 150 mg of RG7652 once weekly for 4 weeks, either with or without statin therapy (atorvastatin). Adverse events (AEs) were generally mild; the most common AEs were temporary injection-site reactions. No serious AEs, severe AEs, AEs leading to study-drug discontinuation, or dose-limiting toxicities were reported. RG7652 monotherapy reduced mean LDL-C levels by up to 64% and as much as 100 mg/dL at week 2; the effect magnitude and duration increased with dose (≥57 days following a single RG7652 dose ≥300 mg). Exploratory analyses showed reduced oxidized LDL, lipoprotein(a), and lipoprotein-associated phospholipase A2 with RG7652. Antidrug antibody against RG7652 tested positive in 2 of 60 (3.3%) RG7652-treated and in 4 of 20 (20.0%) placebo-treated subjects. Simultaneous atorvastatin administration did not appear to impact the pharmacokinetic profile or lipid-lowering effects of RG7652. Overall, RG7652 elicited substantial and sustained dose-related LDL-C reductions with an acceptable safety profile and minimal immunogenicity. © 2017 Wiley Periodicals, Inc.

13-week dietary study and in vitro and in vivo genotoxicity studies of a structuring fat produced through a microalgal fermentation process

Directory of Open Access Journals (Sweden)

R.A. Matulka

Full Text Available Microalgae are increasingly being utilized as food ingredients for a variety of applications, including as sources of protein, egg and dairy substitutes, and cooking oils. The dietary safety of a new structuring fat produced using a heterotrophic fermentation process by a strain of Prototheca moriformis was evaluated in a 13-week dietary toxicity study and compared with kokum fat, a structuring fat of similar composition used in the food industry and derived from Garcinia indica seeds. The algal structuring fat was evaluated for its genotoxic potential using both in vitro and in vivo assays. No treatment-related adverse events occurred in rats consuming algal structuring fat or kokum fat in the 13-week study; no treatment-related effects were reported for body weight, food consumption, urinalysis, hematology, clinical chemistry, gross pathology, organ weights, or histopathology. While statistically significant effects occurred in some parameters, none were dose-related or considered adverse. Overall, the NOAELs for the algal structuring fat and the kokum fat were 100 000 ppm, the highest concentrations tested. The algal structuring fat was not mutagenic in the bacterial reverse mutation assay in the Salmonella typhimurium or Escherichia coli strains tested and was not clastogenic in the in vivo mouse bone marrow chromosome aberration assay. Keywords: Microalgae, Stearic acid, Subchronic toxicity, Kokum, Prototheca moriformis, Structuring fat

Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study.

Science.gov (United States)

Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Corey-Lisle, Patricia K; Aman, Michael G

2011-06-01

To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder. This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score. Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved). Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.

Therapeutic efficacy and safety of propylthiouracil in psoriasis: An open-label study

Directory of Open Access Journals (Sweden)

Pushpa Gnanaraj

2011-01-01

Full Text Available Background: Psoriasis is a common hyperproliferative disorder of the skin associated with significant morbidity. Most of the drugs used in psoriasis provide only a temporary relief, whereas they are riddled with potential toxicities and cost concerns. Hence, there is a constant need to explore newer, effective, orally administered, and cost-effective drugs with minimal adverse effects. In this scenario, propylthiouracil (PTU, an antithyroid thioureylene has been shown to be effective in psoriasis which satisfies the above criteria. Aim: The objective of our study is to assess the clinical efficacy of PTU in psoriasis. Methods: A total of 25 patients with plaque psoriasis were treated with oral PTU for 12 weeks. Clinical response was assessed using the "Psoriasis Area and Severity Index" (PASI score. Routine blood analyses and thyroid function tests were carried out periodically during the study. Results: Oral PTU produced significant clearing of lesions at 6 weeks and 12 weeks of the study period in all patients, as demonstrated by the reduction in PASI scores (33.9% in 6 weeks and 74.1% reduction in 12 weeks. Four patients experienced near complete clearing of the lesions. One patient developed mild elevation of liver enzymes which reversed on withdrawal of PTU. None of the patients had hypothyroidism or cytopenias. Conclusion: PTU significantly clears the lesions in psoriasis with minimal adverse effects. Hence, it can be considered as a therapeutic option in psoriasis, especially when the standard drugs cannot be used due to their toxicities or forbidding cost.

QT interval correction for drug-induced changes in body temperature during integrated cardiovascular safety assessment in regulatory toxicology studies in dogs: A case study.

Science.gov (United States)

El Amrani, Abdel-Ilah; El Amrani-Callens, Francine; Loriot, Stéphane; Singh, Pramila; Forster, Roy

2016-01-01

Cardiovascular safety assessment requires accurate evaluation of QT interval, which depends on the length of the cardiac cycle and also on core body temperature (BT). Increases in QT interval duration have been shown to be associated with decreases in BT in dogs. An example of altered QT interval duration associated with changes in body temperature observed during a 4-week regulatory toxicology study in dogs is presented. Four groups of Beagle dogs received the vehicle or test item once on Day 1, followed by a 4-week observation period. Electrocardiogram (ECG) parameters were continuously recorded on Days 1 and 26 by jacketed external telemetry (JET). Core body temperature (BT) was measured with a conventional rectal thermometer at appropriate time-points during the Day 1 recording period. Decreased BT was observed approximately 2h after treatment on Day 1, along with increased QT interval duration corrected according to the Van de Water formula (QTcV), but the effect was no longer observed after correction for changes in BT [QTcVcT=QTcV-14(37.5-BT)] according to the Van der Linde formula. No significant changes in QTcV were reported at the end of the observation period, on Day 26. The present study demonstrates that core body (rectal) temperature can easily be monitored at appropriate time-points during JET recording in regulatory toxicology studies in dogs, in order to correct QT interval duration values for treatment-related changes in BT. The successful application of the Van der Linde formula to correct QTc prolongation for changes in BT was demonstrated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

A long-term, open-label safety study of single-entity hydrocodone bitartrate extended release for the treatment of moderate to severe chronic pain

Directory of Open Access Journals (Sweden)

Nalamachu S

2014-11-01

Full Text Available Srinivas Nalamachu,1,2 Richard L Rauck,3 Martin E Hale,4 Orlando G Florete Jr,5 Cynthia Y Robinson,6 Stephen J Farr,6 1International Clinical Research Institute, Overland Park, KS, USA; 2Kansas University Medical Center, Kansas City, KS, USA; 3Carolinas Pain Institute, Center for Clinical Research, Wake Forest University School of Medicine, Winston-Salem, NC, USA; 4Gold Coast Research, LLC, Weston, FL, USA; 5Institute of Pain Management, Jacksonville, FL, USA; 6Zogenix, Inc., Emeryville, CA, USA Objective: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. Methods: This multicenter, open-label study started with a conversion/titration phase (≤6 weeks where subjects (n=638 were converted to individualized doses (range 20–300 mg of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424. The primary objective (safety and tolerability and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain were monitored throughout the study. Results: Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%, nausea (10.7% and 9.9%, vomiting (4.1% and 9.7%, and somnolence (7

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.

Strengths use and work engagement : A weekly diary study

NARCIS (Netherlands)

van Woerkom, M.; Oerlemans, W.; Bakker, A.B.

2016-01-01

The present study among 65 civil engineers investigates the impact of organizational support for strengths use on weekly work engagement and proactive behaviour. Positive psychology postulates that strengths use makes people feel authentic and efficacious. We argue that employees use these positive

Four-Week Course of Radiation for Breast Cancer Using Hypofractionated Intensity Modulated Radiation Therapy With an Incorporated Boost

International Nuclear Information System (INIS)

Freedman, Gary M.; Anderson, Penny R.; Goldstein, Lori J.; Ma Changming; Li Jinsheng; Swaby, Ramona F.; Litwin, Samuel; Watkins-Bruner, Deborah; Sigurdson, Elin R.; Morrow, Monica

2007-01-01

Purpose: Standard radiation for early breast cancer requires daily treatment for 6 to 7 weeks. This is an inconvenience to many women, and for some a barrier for breast conservation. We present the acute toxicity of a 4-week course of hypofractionated radiation. Methods and Materials: A total of 75 patients completed radiation on a Phase II trial approved by the hospital institutional review board. Eligibility criteria were broad to include any patient normally eligible for standard radiation: age ≥18 years, invasive or in situ cancer, American Joint Committee on Cancer Stage 0 to II, breast-conserving surgery, and any systemic therapy not given concurrently. The median age was 52 years (range, 31-81 years). Of the patients, 15% had ductal carcinoma in situ, 67% T1, and 19% T2; 71% were N0, 17% N1, and 12% NX. Chemotherapy was given before radiation in 44%. Using photon intensity-modulated radiation therapy and incorporated electron beam boost, the whole breast received 45 Gy and the lumpectomy bed 56 Gy in 20 treatments over 4 weeks. Results: The maximum acute skin toxicity by the end of treatment was Grade 0 in 9 patients (12%), Grade 1 in 49 (65%) and Grade 2 in 17 (23%). There was no Grade 3 or higher skin toxicity. After radiation, all Grade 2 toxicity had resolved by 6 weeks. Hematologic toxicity was Grade 0 in most patients except for Grade 1 neutropenia in 2 patients, and Grade 1 anemia in 11 patients. There were no significant differences in baseline vs. 6-week posttreatment patient-reported or physician-reported cosmetic scores. Conclusions: This 4-week course of postoperative radiation using intensity-modulated radiation therapy is feasible and is associated with acceptable acute skin toxicity and quality of life. Long-term follow-up data are needed. This radiation schedule may represent an alternative both to longer 6-week to 7-week standard whole-breast radiation and more radically shortened 1-week, partial-breast treatment schedules

A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.

Science.gov (United States)

Blackhall, Leslie; Petroni, Gina; Shu, Jianfen; Baum, Lora; Farace, Elena

2009-05-01

Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinal was self-administered at a dose of 100 mg/d during weeks 1-2, and 200 mg during weeks 3-4. Assessments were performed at baseline, 2, and 4 weeks. BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p < 0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social/family well-being, were improved (p < 0.05) at 2 and 4 weeks. Significant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modafinil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity. In this pilot study modafinil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.

National Chemistry Teacher Safety Survey

Science.gov (United States)

Plohocki, Barbra A.

This study evaluated the status of secondary school instructional chemistry laboratory safety using a survey instrument which focused on Teacher background Information, Laboratory Safety Equipment, Facility Safety, General Safety, and a Safety Content Knowledge Survey. A fifty question survey instrument based on recent research and questions developed by the researcher was mailed to 500 secondary school chemistry teachers who participated in the 1993 one-week Woodrow Wilson National Fellowship Foundation Chemistry Institute conducted at Princeton University, New Jersey. The data received from 303 respondents was analyzed by t tests and Analysis of Variance (ANOVA). The level of significance for the study was set at ~\\ performance on the Safety Content Knowledge Survey and secondary school chemistry teachers who have had undergraduate and/or graduate safety training and those who have not had undergraduate and/or graduate safety training. Secondary school chemistry teachers who attended school district sponsored safety inservices did not score higher on the Safety Content Knowledge Survey than teachers who did not attend school district sponsored safety inservice sessions. The type of school district (urban, suburban, or rural) had no significant correlation to the type of laboratory safety equipment found in the instructional chemistry laboratory. The certification area (chemistry or other type of certificate which may or may not include chemistry) of the secondary school teacher had no significant correlation to the type of laboratory equipment found in the instructional chemistry laboratory. Overall, this study indicated a majority of secondary school chemistry teachers were interested in attending safety workshops applicable to chemistry safety. Throughout this research project, many teachers indicated they were not adequately instructed on the collegiate level in science safety and had to rely on common sense and self-study in their future teaching careers.

Safety and efficacy of AMG 334 for prevention of episodic migraine

DEFF Research Database (Denmark)

Sun, Hong Yan; Dodick, David W; Silberstein, Stephen D

2016-01-01

BACKGROUND: The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention. METHODS: In this multicentre...... in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase. The primary endpoint was calculated using the least squares mean at each timepoint from a generalised linear mixed-effect model for repeated measures. Safety endpoints were adverse events, clinical...... laboratory values, vital signs, and anti-AMG 334 antibodies. The study is registered with ClinicalTrials.gov, number NCT01952574. An open-label extension phase of up to 256 weeks is ongoing and will assess the long-term safety of AMG 334. FINDINGS: From Aug 6, 2013, to June 30, 2014, 483 patients were...

The role of human intrusion in the dutch safety study

International Nuclear Information System (INIS)

Prij, J.; Weers, A.W.v.; Glasbergen, P.; Slot, A.F.M.

1989-01-01

In the Netherlands the OPLA research program in which a large number of possible disposal concepts for radioactive waste is investigated has been carried out recently. The disposal concepts concern three different waste strategies, two disposal techiques and three different types of salt formations. In the OPLA program the post-closure safety of the disposal concepts has been investigated. The paper reviews the role of the human intrusion in this safety study. The hydrological consequences of human activities in the underground are discussed and it has been demonstrated that these effects could be taken into account during the groundwater transport calculations. Four different scenario's for human intrusion in the repository have been studied to obtain an indication of the radiological effects. The results show that extremely high doses may result if, after several hundred years, human beings come into direct contact with highly active waste. For the final assessment the probability that the doses will be received should be calculated. This should be done in a subsequent research

Teaching microbiological food safety through case studies

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Florence Dubois-Brissonnet

2015-10-01

Full Text Available Higher education students usually ask for more training based on case studies. This was addressed by designing a specific food safety module (24 hours in which students were shown how to predict microbiological risks in food products i.e. they were asked to determine product shelf-life according to product formulation, preservation methods and consumption habits using predictive microbiology tools. Working groups of four students first identified the main microbiological hazards associated with a specific product. To perform this task, they were given several documents including guides for good hygiene practices, reviews on microbiological hazards in the food sector, flow sheets, etc…  After three-hours of work, the working groups prepared and gave an oral presentation in front of their classmates and professors. This raised comments and discussion that allowed students to adjust their conclusions before beginning the next step of their work. This second step consisted in the evaluation of the safety risk associated with the two major microbiological hazards of the product studied, using predictive microbiology. Students then attended a general lecture on the different tools of predictive microbiology and tutorials (6 hours that made them familiar with the modelling of bacterial growth or inactivation. They applied these tools (9 hours to predict the shelf-life of the studied product according to various scenarios of preservation (refrigeration, water activity, concentration of salt or acid, modified atmosphere, etc… and/or consumption procedures (cooking. The module was concluded by oral presentations of each working group and included student evaluation (3 hours.

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 ...

Direct and indirect transmission of four Salmonella enterica serotypes in pigs

Directory of Open Access Journals (Sweden)

Österberg Julia

2010-05-01

Full Text Available Abstract Background Feed-borne spread of Salmonella spp. to pigs has been documented several times in recent years in Sweden. Experiences from the field suggest that feed-associated serotypes might be less transmittable and subsequently easier to eradicate from pig herds than other serotypes more commonly associated to pigs. Four Salmonella serotypes were selected for experimental studies in pigs in order to study transmissibility and compare possible differences between feed-assoociated (S Cubana and S Yoruba and pig-associated serotypes (S Derby and S Typhimurium. Methods Direct contact transmission was studied in four groups of pigs formed by six 10-week-old salmonella negative pigs commingled with two fatteners excreting one of the four salmonella serotypes. Indirect transmission was studied by putting six 10-week-old salmonella negative pigs in each of four salmonella contaminated rooms. Each room had previously housed a group of pigs, excreting one of the four selected serotypes. All pigs were monitored for two weeks with respect to the faecal excretion of salmonella and the presence of serum antibodies. At the end of the trial, eight samples from inner tissues and organs were collected from each pig at necropsy. Results In the four direct transmission groups, one pig shed Salmonella (Cubana at one occasion. At necropsy, S Typhimurium was isolated from one pig. In the indirect transmission groups, two pigs in the Yoruba room and one pig in each of the other rooms were excreting detectable levels of Salmonella once during the study period of two weeks. At necropsy, S Derby was isolated from one of six pigs in the Derby room and S Typhimurium was isolated from four of the six pigs in the Typhimurium room. No significant serological response could be detected in any of the 48 pigs. Conclusions These results show that all four selected serotypes were able to be transmitted in at least one of these field-like trials, but the transmission rate

Four Weeks of Classical Altitude Training Increases Resting Metabolic Rate in Highly Trained Middle-Distance Runners.

Science.gov (United States)

Woods, Amy L; Sharma, Avish P; Garvican-Lewis, Laura A; Saunders, Philo U; Rice, Anthony J; Thompson, Kevin G

2017-02-01

High altitude exposure can increase resting metabolic rate (RMR) and induce weight loss in obese populations, but there is a lack of research regarding RMR in athletes at moderate elevations common to endurance training camps. The present study aimed to determine whether 4 weeks of classical altitude training affects RMR in middle-distance runners. Ten highly trained athletes were recruited for 4 weeks of endurance training undertaking identical programs at either 2200m in Flagstaff, Arizona (ALT, n = 5) or 600m in Canberra, Australia (CON, n = 5). RMR, anthropometry, energy intake, and hemoglobin mass (Hb mass ) were assessed pre- and posttraining. Weekly run distance during the training block was: ALT 96.8 ± 18.3km; CON 103.1 ± 5.6km. A significant interaction for Time*Group was observed for absolute (kJ.day -1 ) (F-statistic, p-value: F (1,8) =13.890, p = .01) and relative RMR (F (1,8) =653.453, p = .003) POST-training. No significant changes in anthropometry were observed in either group. Energy intake was unchanged (mean ± SD of difference, ALT: 195 ± 3921kJ, p = .25; CON: 836 ± 7535kJ, p = .75). A significant main effect for time was demonstrated for total Hb mass (g) (F (1,8) =13.380, p = .01), but no significant interactions were observed for either variable [Total Hb mass (g): F (1,8) =1.706, p = .23; Relative Hb mass (g.kg -1 ): F (1,8) =0.609, p = .46]. These novel findings have important practical application to endurance athletes routinely training at moderate altitude, and those seeking to optimize energy management without compromising training adaptation. Altitude exposure may increase RMR and enhance training adaptation,. During training camps at moderate altitude, an increased energy intake is likely required to support an increased RMR and provide sufficient energy for training and performance.

Clinical correlates of weight loss and attrition during a 10-week dietary intervention study

DEFF Research Database (Denmark)

Handjieva-Darlenska, Teodora; Holst, Claus; Grau, Katrine

2012-01-01

clinical centres in 7 European countries, who underwent a 10-week dietary intervention study comparing two hypo-energetic (-600 kcal/day) diets varying in fat content. Results: The multiple regression model showed that weight loss at week 10 was predicted by: 6.55 + 1.27 × early weight loss (kg) at week 1...... kg weight loss at week 5 emerged as an optimal predictor for reaching at least 10% weight loss at week 10. Greater attrition likelihood was predicted by high-fat diet, decreased early and half-way weight losses. Conclusion: Early and half-way weight losses are associated with and could contribute......Objective: The aim of this study was to identify the pre-treatment subject characteristics and weight loss changes as determinants of weight loss and attrition during a 10-week dietary intervention study. Methods: A total of 771 obese subjects (BMI 35.6 kg/m(2)) of both genders were included from 8...

Safety : the challenge of today for transportation safety in the future. General report on theme -V "Safety" at the 14th International Study Week on Traffic Engineering and Safety, Strasbourg, September 7-10, 1982.

NARCIS (Netherlands)

Asmussen, E.

1982-01-01

Transportation (un)safety is the result of a complex process in the transportation system. A large number of variables (characteristics of the system elements) with many interactions, produce a complex network of relationships expressed in "system behaviour". In this network of relationships, man as

A Comparison Study of Quetiapine and Risperidone's Effectiveness and Safety on Treating Alcohol-induced Mental Disorder.

Science.gov (United States)

Lv, Bei; Duan, Haishui

2016-08-25

Compared with Risperidone, Quetiapine's effectiveness and safety on treating alcohol-induced mental disorder is still unclear. To investigate the clinical effectiveness and safety of Quetiapine on treating alcohol-induced mental disorder. One hundred and forty-eight patients with alcohol-induced mental disorder were divided into the experimental group (75 patients) and the control group (73 patients) by the treatments they received. The patients in the experimental group were treated with Quetiapine by taking it three times per day orally. The mean (sd) maintenance dose was 151.2(27.3) mg/d, and the treatment cycle was 6 weeks. Patients in the control group received Risperidone once per day orally with a mean (sd) maintenance dose being 2.3(0.9) mg/d, and the treatment cycle was 6 weeks as well. The PANSS scale was used to assess patients' before and after treatment. The researchers also observed any adverse reactions in both treatment strategies and evaluated the effectiveness and safety of both treatment strategies. The mean (sd) PANSS scale score of the experimental group after two weeks of treatment was 71.9 (10.2), which was clearly better than the mean (sd) score before treatment (82.6 [11.4]), and was significantly better than the control group's mean (sd) score after two weeks (76.5[12.8]). Also, the experimental group's scores after 4 weeks of treatment and 6 weeks of treatment were significantly better than the control group. The experimental group's efficacy rate (94.7%) was higher than the control group's (90.4%); the cure rate of the experimental group (33.3%) was higher than that of the control group (24.7%), and the difference was statistically significant. The rates of adverse reactions in the experimental and control groups were 13.3% and 19.2% respectively, and they were significantly different from each other. Treating alcohol-induced mental disorder with Quetiapine is more effective than treating it with Risperidone. Quetiapine can improve

Safety at CERN

CERN Document Server

2009-01-01

Safety is an integral part of our working lives, and should be in our minds whatever job we do at CERN. Ultimately, safety is the responsibility of the Director General – your safety is my concern. That’s why I have this week appointed a new Safety Policy Committee (SAPOCO) that reflects the new Organizational structure of CERN. CERN’s Staff Rules and Regulations clearly lay out in chapter 3 the scope of safety at CERN as well as my responsibilities and yours in safety matters. At CERN, safety is considered in the broadest sense, encompassing occupational Health and Safety, environmental protection, and the safety of equipment and installations. It is my responsibility to put appropriate measures in place to ensure that these conditions are met. And it is the responsibility of us all to ensure that we are fully conversant with safety provisions applicable in our areas of work and that we comply with them. The appointment of a n...

Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study

Directory of Open Access Journals (Sweden)

Sasaki T

2014-01-01

Full Text Available Tsuyoshi Sasaki,1,2 Kenji Hashimoto,3 Masumi Tachibana,1 Tsutomu Kurata,1 Keiko Okawada,1 Maki Ishikawa,1 Hiroshi Kimura,2 Hideki Komatsu,2 Masatomo Ishikawa,2 Tadashi Hasegawa,2 Akihiro Shiina,1 Tasuku Hashimoto,2 Nobuhisa Kanahara,3 Tetsuya Shiraishi,2 Masaomi Iyo1–31Department of Child Psychiatry, Chiba University Hospital, 2Department of Psychiatry, Chiba University Graduate School of Medicine, 3Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, JapanBackground: Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this open-label trial was to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD.Subjects and methods: This was a 4-week, open-label, proof-of-efficacy pilot study for pediatric subjects with ADHD. Ten pediatric ADHD subjects (70% male; mean age, 9.9 years; combined [inattentive and hyperactive/impulsive] subtype, n=7; inattentive subtype, n=3; hyperimpulsive subtype, n=0 received tipepidine hibenzate taken orally at 30 mg/day for 4 weeks. All subjects were assessed using the ADHD Rating Scale IV (ADHD-RS, Japanese version, and the Das–Naglieri Cognitive Assessment System (DN-CAS, Japanese version.Results: A comparison of baseline scores and 4-week end-point scores showed that all the ADHD-RS scores (total scores, hyperimpulsive subscores, and inattentive subscores

Changes in patient safety culture after restructuring of intensive care units: Two cross-sectional studies.

Science.gov (United States)

Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

2016-02-01

Compare changes in registered nurses' perception of the patient safety culture in restructured and not restructured intensive care units during a four-year period. Two cross-sectional surveys were performed, in 2008/2009 (time 1) and 2012/2013 (time 2). During a period of 0-3 years after time 1, three of six hospitals merged their general and medical intensive care units (restructured). The other hospitals maintained their structure of the intensive care units (not restructured). Intensive care units in hospitals at one Norwegian hospital trust. The safety culture was measured with Hospital Survey on Patient Safety Culture. At times 1 and 2, 217/302 (72%) and 145/289 (50%) registered nurses participated. Restructuring was negatively associated with change in the safety culture, in particular, the dimensions of the safety culture within the unit level. The dimensions most vulnerable for restructuring were manager expectations and actions promoting safety, teamwork within hospital units and staffing. In this study, the restructuring of intensive care units was associated with a negative impact on the safety culture. When restructuring, the management should be particularly aware of changes in the safety culture dimensions manager expectations and actions promoting safety, teamwork within hospital units and staffing. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

War And Reconstruction: Four Comparative Case Studies

African Journals Online (AJOL)

The four case studies are taken from four different continents, four different wars under .... and revolutionary changes in the structures and power relations in society and ..... general public accept nowadays that although states' rights were the ...

Efficacy and safety of cinitapride in functional dyspepsia

International Nuclear Information System (INIS)

Baqi, M.; Malik, M.N.

2013-01-01

Objective: To study the efficacy and safety of cinitapride in the treatment of functional dyspepsia, and to evaluate the improvement of patients quality of life. Methods: The prospective cross-sectional multi-centre phase IV study was conducted at Jinnah Hospital, Lahore, Ziauddin Medical University, Karachi and Pakistan Railways General Hospital, Rawalpindi, from July 2009 to June 2010 and comprised 121 patients of functional dyspepsia who were given cinitapride 1mg thrice daily 15 minutes before meals and were followed up for four weeks. Primary clinical response was assessed by using the Global Index Score. Secondary response was seen by percentage change of the total score as well as of each dyspepsia symptom compared with baseline and the overall subjective assessment of patients by using the 7-point Likert's scale. Reduction in Nepean Dyspepsia Index-Short Farm was used to evaluate the improvement in quality of life of patients at week 2 and 4. SPSS 15 used for statistical analysis. Results: After 4 weeks of treatment, the Global Index Score showed statistically significant reduction in 58 (48.92%) patients (p<0.01). Similar reduction (p<0.01) was seen in individual dyspepsia symptoms; early satiety, post-prandial fullness, and abdominal distension. The 7 point Likert's scale also showed similar improvement in subjective response (p<0.01). The quality of life also improved significantly at week 2 and 4 (p<0.01). No abnormal results were seen in vital signs, physical and laboratory examination except an unexplained rise in globulin level. Only one adverse event (sore throat) was reported during the study. Conclusion: The drug was effective in minimising dyspepsia symptoms, and improving the quality of life of patients. It was well tolerated and was almost free of side effects. (author)

Arizona Traffic Safety Education, K-8. Passenger Safety, Grade 3.

Science.gov (United States)

Mesa Public Schools, AZ.

One in a series designed to assist Arizona elementary and junior high school teachers in developing children's traffic safety skills, this curriculum guide contains four lessons and an appendix of school bus safety tips for use in grade 3. Introductory information provided for the teacher includes basic highway safety concepts, stressing…

Test-Enhanced Learning in Competence-Based Predoctoral Orthodontics: A Four-Year Study.

Science.gov (United States)

Freda, Nicolas M; Lipp, Mitchell J

2016-03-01

Dental educators intend to promote integration of knowledge, skills, and values toward professional competence. Studies report that retrieval, in the form of testing, results in better learning with retention than traditional studying. The aim of this study was to evaluate test-enhanced experiences on demonstrations of competence in diagnosis and management of malocclusion and skeletal problems. The study participants were all third-year dental students (2011 N=88, 2012 N=74, 2013 N=91, 2014 N=85) at New York University College of Dentistry. The 2013 and 2014 groups received the test-enhanced method emphasizing formative assessments with written and dialogic delayed feedback, while the 2011 and 2012 groups received the traditional approach emphasizing lectures and classroom exercises. The students received six two-hour sessions, spaced one week apart. At the final session, a summative assessment consisting of the same four cases was administered. Students constructed a problem list, treatment objectives, and a treatment plan for each case, scored according to the same criteria. Grades were based on the number of cases without critical errors: A=0 critical errors on four cases, A-=0 critical errors on three cases, B+=0 critical errors on two cases, B=0 critical errors on one case, F=critical errors on four cases. Performance grades were categorized as high quality (B+, A-, A) and low quality (F, B). The results showed that the test-enhanced groups demonstrated statistically significant benefits at 95% confidence intervals compared to the traditional groups when comparing low- and high-quality grades. These performance trends support the continued use of the test-enhanced approach.

Safety concerns us all

CERN Multimedia

SC/GS/S

2004-01-01

In spite of periodic safety inspections, risks can never be entirely excluded. The Safety Commission invites you to inform your supervisor or Territorial Safety Officer (TSO) of any hazardous situations you may be aware of. Actions to be taken following the fall of two windowpanes A few weeks ago, a windowpane fell from the third floor of an office building, causing minor damage to a car parked outside. No one was hurt in the incident. The putty holding the window in place had gradually deteriorated over time, and strong winds undoubtedly triggered the incident. A few weeks later, a sudden draft caused a window on the fifth floor of the same building to shatter and fall to the ground below. No one was hurt and there was no material damage. The incident was caused by a fan set into the opening window: as the window slammed shut, the weight of the fan caused the glass to break. What can we do to improve safety? examine the windows of our offices and workshops and report any problems or faults, such as dam...

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Northern Tunisia cohort of the A1chieve study

OpenAIRE

Blouza, Samira; Jamoussi, Henda

2013-01-01

Background: The A 1 chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Northern Tunisia. Results: A total of 443 patients were enrolle...

Ready to Respond: Case Studies in Campus Safety and Security

Science.gov (United States)

Hyatt, James A.

2010-01-01

Is your campus primed for the next big emergency? The National Campus Safety and Security Project (NCSSP), led by NACUBO, sought to help colleges and universities develop comprehensive emergency management plans that address the four phases of emergency management: prevention/mitigation, preparedness, response, and recovery. A major component of…

Review of key Belotero Balance safety and efficacy trials.

Science.gov (United States)

Lorenc, Z Paul; Fagien, Steven; Flynn, Timothy C; Waldorf, Heidi A

2013-10-01

Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

The impact of navigation systems on traffic safety

NARCIS (Netherlands)

Rooijen, T. van; Vonk, T.

2007-01-01

This paper studies the impact of navigation systems on traffic safety in the Netherlands. This study consists of four analyses: a literature survey, a database analysis, a user survey and an instrumented vehicle study. The results of the four sections show that navigation systems have a positive

The impact of navigation systems on traffic safety

NARCIS (Netherlands)

Rooijen, T. van; Vonk, T.

2008-01-01

This paper studies the impact of navigation systems on traffic safety in the Netherlands. This study consists of four analyses: a literature survey, a database analysis, a user survey and an instrumented vehicle study. The results of the four sections show that navigation systems have a positive

Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis.

Science.gov (United States)

Merola, Joseph F; Elewski, Boni; Tatulych, Svitlana; Lan, Shuping; Tallman, Anna; Kaur, Mandeep

2017-07-01

Tofacitinib is an oral Janus kinase inhibitor. Efficacy and safety of tofacitinib in patients with moderate-to-severe plaque psoriasis have been demonstrated. We sought to assess the efficacy of tofacitinib for the treatment of nail psoriasis over a period of 52 weeks. In 2 identical phase 3 studies (OPT Pivotal 1 and 2), patients were randomized 2:2:1 to receive tofacitinib 5 mg, tofacitinib 10 mg, or placebo, twice daily. At week 16, placebo-treated patients were re-randomized to tofacitinib. This post hoc analysis of patients with existing nail psoriasis assessed the Nail Psoriasis Severity Index (NAPSI) score and proportions of patients achieving ≥50% reduction in NAPSI from baseline (NAPSI50), NAPSI75, or NAPSI100. Baseline mean NAPSI scores for patients treated with tofacitinib 5 mg (N = 487), tofacitinib 10 mg (N = 476), and placebo (N = 233) twice daily were 27.0, 27.3, and 26.9, respectively. At week 16, significantly (all P psoriasis versus placebo at week 16; improvements were maintained over 52 weeks [NCT01276639; NCT01309737]. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Defining safety culture and the nexus between safety goals and safety culture. 1. An Investigation Study on Practical Points of Safety Management

International Nuclear Information System (INIS)

Hasegawa, Naoko; Takano, Kenichi; Hirose, Ayako

2001-01-01

In a report after the Chernobyl accident, the International Atomic Energy Agency indicated the definition and the importance of safety culture and the ideal organizational state where safety culture pervades. However, the report did not mention practical approaches to enhance safety culture. In Japan, although there had been investigations that clarified the consciousness of employees and the organizational climate in the nuclear power and railway industries, organizational factors that clarified the level of organization safety and practical methods that spread safety culture in an organization had not been studied. The Central Research Institute of the Electric Power Industry conducted surveys of organizational culture for the construction, chemical, and manufacturing industries. The aim of our study was to clarify the organizational factors that influence safety in an organization expressed in employee safety consciousness, commitment to safety activities, rate of accidents, etc. If these areas were clarified, the level of organization safety might be evaluated, and practical ways could be suggested to enhance the safety culture. Consequently, a series of investigations was conducted to clarify relationships among organizational climate, employee consciousness, safety management and activities, and rate of accidents. The questionnaire surveys were conducted in 1998-1999. The subjects were (a) managers of the safety management sections in the head offices of the construction, chemical, and manufacturing industries; (b) responsible persons in factories of the chemical and manufacturing industries; and (c) general workers in factories of the chemical and manufacturing industries. The number of collected data was (a) managers in the head office: 48 from the construction industry and 58 from the chemical and manufacturing industries, (b) responsible persons in factories: 567, and (c) general workers: from 29 factories. Items in the questionnaires were selected from

Involvement of patients with cancer in patient safety: a qualitative study of current practices, potentials and barriers.

Science.gov (United States)

Martin, Helle Max; Navne, Laura Emdal; Lipczak, Henriette

2013-10-01

Patient involvement in patient safety is widely advocated but knowledge regarding implementation of the concept in clinical practice is sparse. To investigate existing practices for patient involvement in patient safety, and opportunities and barriers for further involvement. A qualitative study of patient safety involvement practices in patient trajectories for prostate, uterine and colorectal cancer in Denmark. Observations from four hospital wards and interviews with 25 patients with cancer, 11 hospital doctors, 10 nurses, four general practitioners and two private practicing gynaecologists were conducted using ethnographic methodology. Patient safety was not a topic of attention for patients or dominant in communication between patients and healthcare professionals. The understanding of patient safety in clinical practice is almost exclusively linked to disease management. Involvement of patients is not systematic, but healthcare professionals and patients express willingness to engage. Invitation and encouragement of patients to become involved could be further systematised and developed. Barriers include limited knowledge of patient safety, of specific patient safety involvement techniques and concern regarding potential negative impact on doctor-patient relationship. Involvement of patients in patient safety must take into account that despite stated openness to the idea of involvement, patients and health professionals may not in practice show immediate concern. Lack of systematic involvement can also be attributed to limited knowledge about how to implement involvement beyond the focus of self-monitoring and compliance and a concern about the consequences of patient involvement for treatment outcomes. To realise the potential of patients' and health professionals' shared openness towards involvement, there is a need for more active facilitation and concrete guidance on how involvement can be practiced by both parties.

A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis.

Science.gov (United States)

Shefner, Jeremy M; Watson, Mary Lou; Meng, Lisa; Wolff, Andrew A

2013-12-01

Abstract Tirasemtiv is a fast skeletal muscle activator that increases the sensitivity of the sarcomere to calcium, increasing the efficiency of muscle contraction when the muscle is stimulated at submaximal contraction frequencies. A previous study showed single doses of tirasemtiv to be well tolerated and associated with potentially important improvements in a variety of functional outcomes. This study determined safety of tirasemtiv when given at doses up to 500 mg daily for three weeks. Tirasemtiv was given as a single daily dose up to 375 mg for two weeks, with and without concomitant riluzole. In a separate cohort, an ascending dose protocol evaluated a total dose of 500 mg daily given in two divided doses. Safety and tolerability were assessed, as well as measures of function, muscle strength and endurance. Results showed that tirasemtiv was well tolerated, with dizziness the most common adverse event. Tirasemtiv approximately doubled the serum concentration of riluzole. Trends were noted for improvement in ALSFRS-R, Maximum Minute Ventilation, and Nasal Inspiratory Pressure. In conclusion, tirasemtiv is well tolerated and can be given safely with a reduced dose of riluzole. Positive trends in multiple exploratory outcome measures support the further study of this agent in ALS.

To dimension safety valves. Probabilist study

International Nuclear Information System (INIS)

Noel, Robert; Couvreur, Denis

1982-01-01

The gauge of safety valves of a steam pressure apparatus is usually determined according to an operating situation envelope which it is admitted covers all that can happen in reality. For the safety of the dryer-superheaters of turbines in nuclear power stations, Electricite de France and Alsthom-Atlantique made a reliability study; its method is exposed and the results are discussed. Such a study is heavy going and complex, but in return it permits a better quantitative understanding of the various dimension and operating parameters of an installation which condition its safety. It is therefore a source of progress [fr

Advantages and disadvantages by using safety culture

DEFF Research Database (Denmark)

Dyhrberg, Mette Bang

2003-01-01

Safety culture is a major issue in accident research. A recently finished ph.d.-study has evaluated the symbolic safety culture approach and found four advantages and two disadvantages. These are presented and discussed in this contribution. It is concluded that the approach can be useful...

A phase II study of concomitant boost radiation plus concurrent weekly cisplatin for locally advanced unresectable head and neck carcinomas

International Nuclear Information System (INIS)

Medina, Jose Antonio; Rueda, Antonio; Sacchetti de Pasos, Antonio; Contreras, Jorge; Cobo, Manuel; Moreno, Paloma; Benavides, Manuel; Villanueva, Asuncion; Alba, Emilio

2006-01-01

Background and purpose: This phase II study evaluated the efficacy and toxicity of weekly cisplatin along with concomitant boost accelerated radiation regimen in patients with locally advanced unresectable head and neck carcinoma. Material and methods: A total of 94 patients (median age, 58 years) with UICC stage III (n=19) and IV (n=75) cancer of the oropharynx, larynx, hypopharynx and oral cavity were included. Patients received radiotherapy with a concomitant boost scheme (1.8 Gy on days 1-40 and 1.5 Gy boost on days 25-40 with a total dose of 72 Gy) and concurrent cisplatin, 40 mg/m 2 weekly, for the first 4 weeks. Results: Most patients (95%) received both radiation and chemotherapy according to protocol. Toxicity was manageable with grade III mucositis and pharyngeal-oesophageal toxicity in 85 and 50% of patients, respectively. Haematological toxicity was mild. Four patients (4%) died due to complications. With a median follow of 41 months, median overall survival and time to progression were 27 and 25 months, respectively. The estimated overall survival at 4 years was 41%. Conclusions: Concomitant boost accelerated radiation plus concurrent weekly cisplatin is a feasible schedule in patients with locally advanced unresectable head and neck carcinoma, with acceptable toxicity and survival data

The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study.

Science.gov (United States)

Zhang, JianZhong; Tsai, Tsen-Fang; Lee, Min-Geol; Zheng, Min; Wang, Gang; Jin, HongZhong; Gu, Jun; Li, RuoYu; Liu, QuanZhong; Chen, Jin; Tu, CaiXia; Qi, ChunMei; Zhu, Hua; Ports, William C; Crook, Tim

2017-10-01

Tofacitinib is an oral Janus kinase inhibitor. This study assessed tofacitinib efficacy and safety vs placebo in Asian patients with moderate to severe chronic plaque psoriasis. Patients from China mainland, Taiwan, and Korea were randomized 2:2:1:1 to tofacitinib 5mg (N=88), tofacitinib 10mg (N=90), placebo→5mg (N=44), or placebo→10mg (N=44), twice daily (BID) for 52 weeks. Placebo-treated patients advanced to tofacitinib at Week 16. Co-primary efficacy endpoints: proportions of patients achieving Physician's Global Assessment (PGA) response ('clear' or 'almost clear') and proportion achieving ≥75% reduction from baseline Psoriasis Area and Severity Index (PASI75) at Week 16. At Week 16, more patients achieved PGA and PASI75 responses with tofacitinib 5mg (52.3%; 54.6%) and 10mg (75.6%; 81.1%) BID vs placebo (19.3%; 12.5%; all ptofacitinib 5mg and 10mg BID, respectively. Over 52 weeks, 2.2-4.5% of patients across treatment groups experienced serious adverse events, and 1.1-6.8% discontinued due to adverse events. Tofacitinib demonstrated efficacy vs placebo at Week 16 in Asian patients with moderate to severe plaque psoriasis; efficacy was maintained through Week 52. No unexpected safety findings were observed. [NCT01815424]. Copyright © 2017 The Authors and Pfizer Inc. Published by Elsevier B.V. All rights reserved.

Systemic study on the safety of immuno-deficient nude mice treated by atmospheric plasma-activated water

Science.gov (United States)

Dehui, XU; Qingjie, CUI; Yujing, XU; Bingchuan, WANG; Miao, TIAN; Qiaosong, LI; Zhijie, LIU; Dingxin, LIU; Hailan, CHEN; Michael, G. KONG

2018-04-01

Cold atmospheric-pressure plasma is a new technology, widely used in many fields of biomedicine, especially in cancer treatment. Cold plasma can selectively kill a variety of tumor cells, and its biological safety in clinical trials is also very important. In many cases, the patient’s immune level is relatively low, so we first studied the safety assessment of plasma treatment in an immuno-compromised animal model. In this study, we examined the safety of immuno-deficient nude mice by oral lavage treatment of plasma-activated water, and studied the growth status, main organs and blood biochemical indexes. Acute toxicity test results showed that the maximum dose of plasma treatment for 15 min had no lethal effect and other acute toxicity. There were no significant changes in body weight and survival status of mice after 2 min and 4 min of plasma-activated water (PAW) treatment for 2 weeks. After treatment, the major organs, including heart, liver, spleen, lung and kidney, were not significantly changed in organ coefficient and tissue structure. Blood biochemical markers showed that blood neutrophils and mononuclear cells were slightly increased, and the others remained unchanged. Liver function, renal function, electrolytes, glucose metabolism and lipid metabolism were not affected by different doses of PAW treatment. The above results indicate that PAW treatment can be used to treat immuno-deficient nude mice without significant safety problems.

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.

Oral curcumin for Alzheimer's disease: tolerability and efficacy in a 24-week randomized, double blind, placebo-controlled study.

Science.gov (United States)

Ringman, John M; Frautschy, Sally A; Teng, Edmond; Begum, Aynun N; Bardens, Jenny; Beigi, Maryam; Gylys, Karen H; Badmaev, Vladimir; Heath, Dennis D; Apostolova, Liana G; Porter, Verna; Vanek, Zeba; Marshall, Gad A; Hellemann, Gerhard; Sugar, Catherine; Masterman, Donna L; Montine, Thomas J; Cummings, Jeffrey L; Cole, Greg M

2012-01-01

Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation. It reduces pathology in transgenic models of Alzheimer's disease (AD) and is a promising candidate for treating human AD. The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD. We performed a 24-week randomized, double blind, placebo-controlled study of Curcumin C3 Complex(®) with an open-label extension to 48 weeks. Thirty-six persons with mild-to-moderate AD were randomized to receive placebo, 2 grams/day, or 4 grams/day of oral curcumin for 24 weeks. For weeks 24 through 48, subjects that were receiving curcumin continued with the same dose, while subjects previously receiving placebo were randomized in a 1:1 ratio to 2 grams/day or 4 grams/day. The primary outcome measures were incidence of adverse events, changes in clinical laboratory tests and the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at 24 weeks in those completing the study. Secondary outcome measures included the Neuropsychiatric Inventory (NPI), the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale, levels of Aβ1-40 and Aβ1-42 in plasma and levels of Aβ1-42, t-tau, p-tau181 and F2-isoprostanes in cerebrospinal fluid. Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured. Mean age of completers (n = 30) was 73.5 years and mean Mini-Mental Status Examination (MMSE) score was 22.5. One subject withdrew in the placebo (8%, worsened memory) and 5/24 subjects withdrew in the curcumin group (21%, 3 due to gastrointestinal symptoms). Curcumin C3 Complex(®) was associated with lowered hematocrit and increased glucose levels that were clinically insignificant. There were no differences between

RAMONA-4B development for SBWR safety studies

Energy Technology Data Exchange (ETDEWEB)

Rohatgi, U.S.; Aronson, A.L.; Cheng, H.S.; Khan, H.J.; Mallen, A.N.

1993-12-31

The Simplified Boiling Water Reactor (SBWR) is a revolutionary design of a boiling-water reactor. The reactor is based on passive safety systems such as natural circulation, gravity flow, pressurized gas, and condensation. SBWR has no active systems, and the flow in the vessel is by natural circulation. There is a large chimney section above the core to provide a buoyancy head for natural circulation. The reactor can be shut down by either of four systems; namely, scram, Fine Motion Control Rod Drive (FMCRD), Alternate Rod Insertion (ARI), and Standby Liquid Control System (SLCS). The safety injection is by gravity drain from the Gravity Driven Cooling System (GDCS) and Suppression Pool (SP). The heat sink is through two types of heat exchangers submerged in the tank of water. These heat exchangers are the Isolation Condenser (IC) and the Passive Containment Cooling System (PCCS). The RAMONA-4B code has been developed to simulate the normal operation, reactivity transients, and to address the instability issues for SBWR. The code has a three-dimensional neutron kinetics coupled to multiple parallel-channel thermal-hydraulics. The two-phase thermal hydraulics is based on a nonhomogeneous nonequilibrium drift-flux formulation. It employs an explicit integration to solve all state equations (except for neutron kinetics) in order to predict the instability without numerical damping. The objective of this project is to develop a Sun SPARC and IBM RISC 6000 based RAMONA-4B code for applications to SBWR safety analyses, in particular for stability and ATWS studies.

RAMONA-4B development for SBWR safety studies

International Nuclear Information System (INIS)

Rohatgi, U.S.; Aronson, A.L.; Cheng, H.S.; Khan, H.J.; Mallen, A.N.

1993-01-01

The Simplified Boiling Water Reactor (SBWR) is a revolutionary design of a boiling-water reactor. The reactor is based on passive safety systems such as natural circulation, gravity flow, pressurized gas, and condensation. SBWR has no active systems, and the flow in the vessel is by natural circulation. There is a large chimney section above the core to provide a buoyancy head for natural circulation. The reactor can be shut down by either of four systems; namely, scram, Fine Motion Control Rod Drive (FMCRD), Alternate Rod Insertion (ARI), and Standby Liquid Control System (SLCS). The safety injection is by gravity drain from the Gravity Driven Cooling System (GDCS) and Suppression Pool (SP). The heat sink is through two types of heat exchangers submerged in the tank of water. These heat exchangers are the Isolation Condenser (IC) and the Passive Containment Cooling System (PCCS). The RAMONA-4B code has been developed to simulate the normal operation, reactivity transients, and to address the instability issues for SBWR. The code has a three-dimensional neutron kinetics coupled to multiple parallel-channel thermal-hydraulics. The two-phase thermal hydraulics is based on a nonhomogeneous nonequilibrium drift-flux formulation. It employs an explicit integration to solve all state equations (except for neutron kinetics) in order to predict the instability without numerical damping. The objective of this project is to develop a Sun SPARC and IBM RISC 6000 based RAMONA-4B code for applications to SBWR safety analyses, in particular for stability and ATWS studies

Model quality and safety studies

DEFF Research Database (Denmark)

Petersen, K.E.

1997-01-01

The paper describes the EC initiative on model quality assessment and emphasizes some of the problems encountered in the selection of data from field tests used in the evaluation process. Further, it discusses the impact of model uncertainties in safety studies of industrial plants. The model...... that most of these have never been through a procedure of evaluation, but nonetheless are used to assist in making decisions that may directly affect the safety of the public and the environment. As a major funder of European research on major industrial hazards, DGXII is conscious of the importance......-tain model is appropriate for use in solving a given problem. Further, the findings from the REDIPHEM project related to dense gas dispersion will be highlighted. Finally, the paper will discuss the need for model quality assessment in safety studies....

Studies on the Effect of Type and Solarization Period on Germination Percentage of Four Weed Species

Directory of Open Access Journals (Sweden)

J. Rostam

2011-01-01

Full Text Available Abstract In order to study the effects of soil solarization on weed control, an experiment with factorial arrangement in a randomized complete block design with four replications was conducted in a fallow farm in Daregaz in 2008. Factors included solarization duration (0, 2, 4 and 6 weeks and soil moisture content (dry and moist. Soil seed bank was sampled (in two depth, 0-10 and 10-20 cm prior to the experiment and immediately after applying treatments, and germination percentage of weed species were determined. Results of this study showed that seed germination percentage in 10 cm soil depth was influenced by soil moisture and solarization and their interactions, while in 20 cm soil depth only solarization period affected the weed seed germination. Germination percentage in moist soil was less than that in dry soil. Seed germination percentage declined more by increasing solarization duration, so that the greatest decline was obtained after 6 weeks solarization. Solarization decreased germination percentage in moist soil more than that in dry soil. Overall, the results of this experiment indicated that solarization of moist soil for 6 weeks was the most effective treatment in controlling common lambsquatres (Chenopodium album, common purslane (Portulaca oleracea, redroot pigweed (Amaranthus retroflexus, and wild mustard (Sinapis arvensis, while solarization of dry soil for 2 weeks was the least effective treatment for weed control. Keywords: Solarization, Soil moisture, Seed bank

Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents

Directory of Open Access Journals (Sweden)

Naohide Yamashita

2014-09-01

Full Text Available Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA with sodium ferrous citrate (SFC in diabetic patients treated with one or more oral hypoglycemic agents (OHAs. Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population. Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively. The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG and hemoglobin A1c (HbA1c. Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent. Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

Science.gov (United States)

Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

2017-10-01

ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cutaneous reaction associated with weekly docetaxel administration.

Science.gov (United States)

Chew, Lita; Chuen, Vivianne Shih Lee

2009-03-01

Docetaxel-based chemotherapy will remain clinically relevant and many of our patients will continue to receive the drug. In a recent phase 2 study of docetaxel 35 mg/m2 (weekly) in patients with metastatic breast cancer, the incidence of grade 3 cutaneous toxicity is 19%. The skin toxicity observed consists of limb/palmar-plantar erythematous reactions, or fixed-plaque erythrodysesthesia. Case series or reports have reported varied manifestations of skin reactions and include erythema multiforme, nail changes (onycholysis, pigmentation, paronychia), scleroderma, supravenous discoloration, radiation recall dermatitis, and flagellate erythema. We would like to report four patients with cutaneous reactions resulting from weekly administration of docetaxel. All cases are heavily pre-treated patients, receiving docetaxel as second or third line therapy. The cutaneous reactions occur at cycle 5. The time between chemotherapy to development of skin lesions is from 1 to 7 days. Lesions usually resolve with desquamation leaving behind areas with hyper-pigmentation or hypo-pigmentation over a period of 2 to 3 weeks. The management strategies include hand elevation, warm or cold compresses, topical and/or systemic antibiotics, topical and/or systemic corticosteroids, and cessation of drug. There is a need for a systematic approach to manage these cutaneous reactions. Oncology trained pharmacists play vital roles in assessing, managing, documenting and patient education.

Hospital safety climate surveys: measurement issues.

Science.gov (United States)

Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

2010-12-01

Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

Safety assessment of Superba™ krill powder: Subchronic toxicity study in rats

Directory of Open Access Journals (Sweden)

Kjetil Berge

2015-01-01

Full Text Available The safety of krill powder was assessed in a subchronic 13-week toxicity study where rats were fed krill powder or control diets. The krill powder inclusion in the test diet was 9.67% (w/w. There were no differences noted in body weight or food consumption in either gender. Differences in clinical chemistry values were noted in the krill powder-treated animals, but these findings were of no toxicological significance. A significant decrease in absolute heart weight, but not relative heart weight, was observed in both sexes given krill powder, although no corresponding histological changes were observed. Hepatocyte vacuolation was noted histologically in males fed krill powder. This finding was not associated with other indications of hepatic dysfunction. The no observed adverse effect level (NOAEL for the conditions of this study was considered to be 9.67% krill powder.

Comparative study of biological activity of four botulinum toxin type A preparations in mice.

Science.gov (United States)

Chung, Myung Eun; Song, Dae Heon; Park, Joo Hyun

2013-01-01

Units of available botulinum toxin preparations are not interchangeable, and the dose-conversion ratios between such preparations remain controversial. To compare the efficacy and safety of four botulinum toxin type A preparations. Murine gastrocnemius compound muscle action potentials (CMAPs) were recorded before and after injecting the four botulinum toxin preparations (onabotulinumtoxinA, abobotulinumtoxinA, new botulinum toxin, and incobotulinumtoxinA). In all preparations, CMAP amplitudes decreased until 4 days after receiving the injection and then gradually recovered. On postinjection day 84, the amplitudes returned to baseline in all groups except the high-dose groups. CMAP amplitude in the contralateral limb also decreased up to postinjection days 4 to 7 and then gradually returned to baseline by postinjection day 28. The dose-conversion ratio between onabotulinumtoxinA and abobotulinumtoxinA was determined to be 1:2.6; previous reports of 1:3 were considered too high. A dose-conversion ratio between onabotulinumtoxinA and new botulinum toxin of 1:1 was deemed appropriate. OnabotulinumtoxinA and incobotulinumtoxinA demonstrated a dose-conversion ratio of 1:1.07. The efficacy of incobotulinumtoxinA was slightly lower than that of onabotulinumtoxinA. These dose-conversion ratios are applicable solely from an efficacy standpoint and not for safety. This study was conducted in mice, so it may not translate perfectly to human applications. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

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

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

2014-01-01

Objectives 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. Design Observational cohort study. Setting Four South African Youth Week tournaments (under-13 Craven Week, under-16 Grant Khomo Week, under-18 Academy Week, under-18 Craven Week). Participants Injury data were collected from 3652 youth rugby union players (population at risk) in 2011 and 2012. Outcome measures 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 χ2 analysis was used to detect linear trends between injuries and increasing match quarters. Results 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). Conclusions 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

Physical and psychological benefits of once-a-week Pilates exercises in young sedentary women: A 10-week longitudinal study.

Science.gov (United States)

Tolnai, Nóra; Szabó, Zsófia; Köteles, Ferenc; Szabo, Attila

2016-09-01

Pilates exercises have several demonstrated physical and psychological benefits. To date, most research in this context was conducted with symptomatic or elderly people with few dependent measures. The current study examined the chronic or longitudinal effects of very low frequency, once a week, Pilates training on several physical and psychological measures, over a 10-week intervention, in young, healthy, and sedentary women. Further, the study gauged the acute effects of Pilates exercises on positive- and negative affect in 10 exercise sessions. Compared to a control group, the Pilates group exhibited significant improvements in skeletal muscle mass, flexibility, balance, core- and abdominal muscle strength, body awareness, and negative affect. This group also showed favorable changes in positive (22.5% increase) and negative affect (12.2% decrease) in nine out of ten exercise sessions. This work clearly demonstrates the acute and chronic benefits of Pilates training on both physical and psychological measures. It also reveals that even only once a week Pilates training is enough to trigger detectable benefits in young sedentary women. While this frequency is below the required levels of exercise for health, it may overcome the 'lack of time' excuse for not exercising and subsequently its tangible benefits may positively influence one's engagement in more physical activity. Copyright © 2016 Elsevier Inc. All rights reserved.

Improving teamwork, trust and safety: an ethnographic study of an interprofessional initiative.

Science.gov (United States)

Jones, Aled; Jones, Delyth

2011-05-01

This study explored the perceptions of staff in an interprofessional team based on a medical rehabilitation ward for older people, following the introduction of a service improvement programme designed to promote better teamworking. The study aimed to address a lack of in-depth qualitative research that could explain the day-to-day realities of interprofessional teamworking in healthcare. All members of the team participated, (e.g. nurses, doctors, physiotherapists, social worker, occupational therapists), and findings suggest that interprofessional teamworking improved over the 12-month period. Four themes emerged from the data offering insights into the development and effects of better interprofessional teamworking: the emergence of collegial trust within the team, the importance of team meetings and participative safety, the role of shared objectives in conflict management and the value of autonomy within the team. Reductions in staff sickness/absence levels and catastrophic/major patient safety incidents were also detected following the introduction of the service improvement programme.

77 FR 27776 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Science.gov (United States)

2012-05-11

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Services Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study... standard grants review and funding cycles pertaining to research issues in occupational safety and health...

76 FR 18220 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Science.gov (United States)

2011-04-01

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Services Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study... standard grants review and funding cycles pertaining to research issues in occupational safety and health...

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

Investigating the safety and efficacy of naltrexone for anti-psychotic induced weight gain in severe mental illness: study protocol of a double-blind, randomized, placebo-controlled trial.

Science.gov (United States)

Tek, Cenk; Guloksuz, Sinan; Srihari, Vinod H; Reutenauer, Erin L

2013-06-27

Obesity is a growing health problem leading to high rates of mortality and morbidity in patients with severe mental illness (SMI). The increased rate of obesity is largely attributed to antipsychotic use. The effect of antipsychotic medications on H1 and 5HT2 receptors has been associated with weight gain, but there is also a substantial amount of evidence showing that D2 receptor blockade may be responsible for weight gain by interacting with the dopamine-opioid system. Unfortunately, current available medications for weight loss have limited efficacy in this population. Naltrexone, an opioid receptor antagonist, may be a promising agent to reduce antipsychotic induced weight gain by decreasing food cravings. We aim to investigate the safety and efficacy of two doses of naltrexone (25 mg & 50 mg) versus placebo for weight and health risk reduction in overweight and obese individuals (BMI ≥ 28) with SMI, who gained weight while being treated with antipsychotics. One hundred and forty four patients will be recruited throughout the greater New Haven area. The participants will be randomized to naltrexone 25 mg/day, naltrexone 50 mg/day, or placebo in a 1:1:1 ratio. Participants will be on the study medication for 52 weeks, and assessed weekly for the first 4 weeks and bi-weekly thereafter. The primary outcome measurements are weight reduction and percentage achieving clinically significant weight loss (5% of total body weight). Waist circumference, body mass index, serum lipid profile, fasting glucose, and glycosylated hemoglobin are the secondary outcome measures. The effect of naltrexone on other outcome measurements such as schizophrenia symptoms, depression, dietary consumption, quality of life, cognitive functioning, physical activity, metabolism/inflammation markers, serum leptin, ghrelin, peptide YY, adinopectin, high sensitivity CRP, interleukin 6, interleukin-1B, interleukin-18, and tumor necrosis factor alpha (TNF-α) will be evaluated. The data will be

Study on Pb Content in 3 Week and 6 Week Old Kangkung (Ipomoea reptans Poir Planted in Pb containing Media

Directory of Open Access Journals (Sweden)

Poppy Hartatie Hardjo

2005-11-01

Full Text Available A study on the content of Pb in kangkung has been conducted. Land kangkung (Ipomoea reptans was used as the sample, and was planted in hydrophonic media, and watered with Multigrow Complete Plant Food (2000 mg/L and Pb solution (2 mg/L twice a day. Samples were taken based on the age (3 and 6 week old, and part of the plant (root and all parts without root. Inductively Coupled Plasma Spectrometer (ICPS Fison 3410+ was used to measure the Pb content. It was shown that in the plant the accumulation was mostly happened in the root. The 6 week-old plant contained Pb not just in the root (3.36 mg/kg sample but also in the other part of the plant (2.09 mg/kg sample and those were exceeded the maximum dietary allowance (2 mg/kg sample regulated by the Indonesian FDA; while in the 3 week-old plant the Pb content in the root was 1.86 mg/kg sample and in the other part of the plan was 1.13 mg/kg, which is not exceeded the dietary allowance. So it is advisable to harvest the kangkung vegetable at the most of 3 week-old.

Safety analyses for NHR-200

Energy Technology Data Exchange (ETDEWEB)

Jincai, Li; Zuying, Gao; Baocheng, Xu; Junxiao, He [Institute of Nuclear Energy and Technology, Tsingua Univ., Beijing (China)

1997-09-01

The NHR-200 is a commercial 200-MW District Heating Reactor developed in China. It is designed on the basis of design, construction and four-year operating experience of the 5MW Experimental Heating Reactor (NHR-5). It has special safety features which are briefly described in this paper. Accident classification and safety criteria are also explained. Some typical and serious accidents are studied theoretically, and their results are detailed in this paper. They demonstrate the excellent safety characteristics of HR-200. (author). 4 refs, 9 figs, 1 tab.

Fusion reactor safety studies, FY 1977

International Nuclear Information System (INIS)

Darby, J.B. Jr.

1978-04-01

This report reviews the technical progress in the fusion reactor safety studies performed during FY 1977 in the Fusion Power Program at the Argonne National Laboratory. The subjects reported on include safety considerations of the vacuum vessel and first-wall design for the ANL/EPR, the thermal responses of a tokamak reactor first wall, the vacuum wall electrical resistive requirements in relationship to magnet safety, and a major effort is reported on considerations and experiments on air detritiation

75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

Science.gov (United States)

2010-05-11

... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...) Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.

Science.gov (United States)

Rauck, Richard L; Hale, Martin E; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W; Malhotra, Bimal K; Wolfram, Gernot

2015-09-01

The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period (P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids.

Safety activities in small businesses

Science.gov (United States)

Sinclair, Raymond C.; Cunningham, Thomas R.

2015-01-01

Background Workplace injuries occur at higher rates in smaller firms than in larger firms, and the number of workplace safety activities appear to be inversely associated with those rates. Predictors of safety activities are rarely studied. Methods This study uses data from a national random survey of firms (n = 722) with less than 250 employees conducted in 2002. Results We found that, regardless of firm size or industry, safety activities were more common in 2002 than they were in a similar 1983 study. Having had an OSHA inspection in the last five years and firm size were stronger predictors of safety activities than industry hazardousness and manager’s perceptions of hazardousness. All four variables were significant predictors (β range .19 to .28; R2 = .27). Conclusions Further progress in the prevention of injuries in small firms will require attention to factors likely subsumed within the firm size variable, especially the relative lack of slack resources that might be devoted to safety activities. PMID:26339124

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

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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

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting

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Armitage Gerry

2011-05-01

Full Text Available Abstract Background Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS, and a patient incident reporting tool (PIRT - to help the NHS prevent patient safety incidents by learning more about when and why they occur. Methods To develop the PMOS 1 literature will be reviewed to identify similar measures and key contributory factors to error; 2 four patient focus groups will ascertain practicality and feasibility; 3 25 patient interviews will elicit approximately 60 items across 10 domains; 4 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis. To develop the PIRT 1 individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2 nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50 will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their

Field studies of safety security rescue technologies through training and response activities

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Murphy, Robin R.; Stover, Sam

2006-05-01

This paper describes the field-oriented philosophy of the Institute for Safety Security Rescue Technology (iSSRT) and summarizes the activities and lessons learned during calendar year 2005 of its two centers: the Center for Robot-Assisted Search and Rescue and the NSF Safety Security Rescue industry/university cooperative research center. In 2005, iSSRT participated in four responses (La Conchita, CA, Mudslides, Hurricane Dennis, Hurricane Katrina, Hurricane Wilma) and conducted three field experiments (NJTF-1, Camp Hurricane, Richmond, MO). The lessons learned covered mobility, operator control units, wireless communications, and general reliability. The work has collectively identified six emerging issues for future work. Based on these studies, a 10-hour, 1 continuing education unit credit course on rescue robotics has been created and is available. Rescue robots and sensors are available for loan upon request.

Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

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Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

2015-07-10

CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards

Study of Androgenesis Ability and Callus Induction in Four Varieties of Tomato (Lycopersicon esculentum Mill by Anther Culture

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R. Najib

2016-02-01

callus were recorded for eightweeks. Diameter of callus was measured using a microscope equipped with a camera and Dino Capture 2.0 software version 4.1. Cytological studies were accomplished by microscopy research Olympus BX51 and photographed by a digital camera DP70. To determine the presence or absence of a significant difference between the observed proportions a chi-square test was used. All analysiswas conducted using statistical software JMP 8. Charts were providedusing Excel software. Results and Discussion: Anther development stage is one of the factors determining the success of anther culture in the production of embryos. The results of most studies showed that the stage between meiosis and mid-stage of unicellular microspores is optimum to androgenesis response in tomatoes. Since microspores in the anthers are at various stages of development, to determine the appropriate size of flower buds, the relative frequency of each of the stages of development should be understood. Based on the obtained results, in all study cultivars, flower buds with a length of 4-4.9 mm (Containing anthers with an approximate length of 3-4 mm, due to having the highest frequency of meiotic and unicellular microspores, can be used for anther culture. Study of deformation and induced callus in this experiment showed that both the Baker and U. S. Agriseeds did not show callus induction. Anthers of varieties over three weeks after culture gradually became yellowish-brown and in the fourth week of the increased frequency of haploid were brown. After six weeks of culture, all anthers in both became brown and died. The anthers of the varieties, Mobil-Netherlands and Khoram, inflated at the second to fourth week, anther wall was eventually broken and callus was observed. At third week the frequency of deformed anthers were gradually increased. Four weeks after culture, the frequency of callus induction reduced and after five weeks of callus induction no change in frequencyof callus

Safety and efficacy of erenumab for preventive treatment of chronic migraine

DEFF Research Database (Denmark)

Tepper, Stewart; Ashina, Messoud; Reuter, Uwe

2017-01-01

BACKGROUND: The calcitonin gene-related peptide (CGRP) pathway is important in migraine pathophysiology. We assessed the efficacy and safety of erenumab, a fully human monoclonal antibody against the CGRP receptor, in patients with chronic migraine. METHODS: This was a phase 2, randomised, double...... assignment. The primary endpoint was the change in monthly migraine days from baseline to the last 4 weeks of double-blind treatment (weeks 9-12). Safety endpoints were adverse events, clinical laboratory values, vital signs, and anti-erenumab antibodies. The efficacy analysis set included patients who...... received at least one dose of investigational product and completed at least one post-baseline monthly measurement. The safety analysis set included patients who received at least one dose of investigational product. The study is registered with ClinicalTrials.gov, number NCT02066415. FINDINGS: From April...

Changing Survival Rate of Infants Born Before 26 Gestational Weeks; Single-centre study

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Asad Rahman

2015-08-01

Full Text Available Objectives: This study aimed to evaluate the changing survival rate and morbidities among infants born before 26 gestational weeks at the Sultan Qaboos University Hospital (SQUH in Muscat, Oman. Methods: This retrospective study assessed the mortality and morbidities of all premature infants born alive at 23–26 gestational weeks at SQUH between June 2006 and May 2013. Infants referred to SQUH within 72 hours of birth during this period were also included. Electronic records were reviewed for gestational age, gender, birth weight, maternal age, mode and place of delivery, antenatal steroid administration, morbidity and outcome. The survival rate was calculated and findings were then compared with those of a previous study conducted in the same hospital from 1991 to 1998. Rates of major morbidities were also calculated. Results: A total of 81 infants between 23–26 gestational weeks were admitted to the neonatal unit during the study period. Of these, 58.0% were male and 42.0% were female. Median gestational age was 25 weeks and mean birth weight was 770 ± 150 g. Of the 81 infants, 49 survived. The overall survival rate was 60.5% compared to 41% reported in the previous study. Respiratory distress syndrome (100.0%, retinopathy of prematurity (51.9%, bronchopulmonary dysplasia (34.6%, intraventricular haemorrhage (30.9% and patent ductus arteriosus (28.4% were the most common morbidities. Conclusion: The overall survival rate of infants between 23–26 gestational weeks during the study period had significantly improved in comparison to that found at the same hospital from 1991 to 1998. There is a need for the long-term neurodevelopmental follow-up of premature infants.

Changing Survival Rate of Infants Born Before 26 Gestational Weeks: Single-centre study.

Science.gov (United States)

Rahman, Asad; Abdellatif, Mohamed; Sharef, Sharef W; Fazalullah, Muhammad; Al-Senaidi, Khalfan; Khan, Ashfaq A; Ahmad, Masood; Kripail, Mathew; Abuanza, Mazen; Bataclan, Flordeliza

2015-08-01

This study aimed to evaluate the changing survival rate and morbidities among infants born before 26 gestational weeks at the Sultan Qaboos University Hospital (SQUH) in Muscat, Oman. This retrospective study assessed the mortality and morbidities of all premature infants born alive at 23-26 gestational weeks at SQUH between June 2006 and May 2013. Infants referred to SQUH within 72 hours of birth during this period were also included. Electronic records were reviewed for gestational age, gender, birth weight, maternal age, mode and place of delivery, antenatal steroid administration, morbidity and outcome. The survival rate was calculated and findings were then compared with those of a previous study conducted in the same hospital from 1991 to 1998. Rates of major morbidities were also calculated. A total of 81 infants between 23-26 gestational weeks were admitted to the neonatal unit during the study period. Of these, 58.0% were male and 42.0% were female. Median gestational age was 25 weeks and mean birth weight was 770 ± 150 g. Of the 81 infants, 49 survived. The overall survival rate was 60.5% compared to 41% reported in the previous study. Respiratory distress syndrome (100.0%), retinopathy of prematurity (51.9%), bronchopulmonary dysplasia (34.6%), intraventricular haemorrhage (30.9%) and patent ductus arteriosus (28.4%) were the most common morbidities. The overall survival rate of infants between 23-26 gestational weeks during the study period had significantly improved in comparison to that found at the same hospital from 1991 to 1998. There is a need for the long-term neurodevelopmental follow-up of premature infants.

A Randomized, Placebo-Controlled, Double-Blind, Parallel Groups Study Evaluating the Performance and Safety of a Steady State Coherent Biomodulator Patch in the Treatment of Subjective Tinnitus.

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Ahnblad, Peter; Nordkvist, Anders

2017-12-01

The objectives of this study were to evaluate the performance and safety of an innovative passive light photon driven microscopic biomodulator patch as an alternative medical device for tinnitus relief. Eighty-two (82) patients were randomized to receive either an active (biomodulator) patch or a placebo patch, for a 3-week treatment period. Patch performance (evaluated with questionnaires related to tinnitus and quality-of-life) and safety were assessed after 3 weeks of treatment (Week 3) and at a follow-up visit 4-weeks after end of treatment (Week 7). The biomodulator patch was safe and well-tolerated and was efficacious, with significant difference (p < 0.05) between the groups at Week 7; active patch had 30% responders compared to 10% for placebo, measured as a decrease from baseline in at least 2 points in tinnitus annoyance visual analogue scale (VAS, 0-10). Tinnitus handicap inventory (THI, 0-100) improved by mean -16 points significantly (p = 0.0005) for the active responder group, but with no statistically significant changes for the placebo group or between the groups. Well-being questionnaire also improved for the active responder group, but not statistically significant. The placebo responder group did not improve in well-being. Other tinnitus related symptoms did not show significant changes. There was no statistically significant difference in performance between the active (biomodulator) and placebo groups directly at the end of treatment (Week 3). In a cost-risk-benefit rationale according to this study it can be reasonable to recommend the biomodulator patch for treatment of tinnitus. Improvements were shown at Week 7 (4 weeks after the end of treatment period).

Determinants of Knowledge and Safety Practices of Occupational Hazards of Textile Dye Workers in Sokoto, Nigeria: A Descriptive Analytic Study.

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Okafoagu, Nneka Christina; Oche, Mansur; Awosan, Kehinde Joseph; Abdulmulmuni, Hashim Bala; Gana, Godwin Jiya; Ango, Jessica Timane; Raji, Ismail

2017-06-23

Textile dye workers are subject to occupational hazards on a daily basis due to exposure to precarious conditions in the workplace. This study aimed to assess the knowledge, attitude and safety practices and its determinants among textile dye workers in Sokoto metropolis, Nigeria. This is a descriptive cross-sectional study conducted among 200 textile dye workers and the respondents were selected by multi stage sampling technique. Data was collected using an interviewer administered questionnaire. Data was processed using SPSS IBM version 20 and analyzed using descriptive and inferential statistics. Majority of the respondents (74.0%) had good knowledge of workplace hazards; (81.0%) had positive attitude and only 20% observed all the safety practices. Formal education (P=0.047); working less than 5 days a week (P=0.001) and permanent employment (P=0.013) were found to be determinants of respondents' knowledge and attitude towards workplace hazards. Although the respondents had good knowledge and positive attitude, their lack of observance of safety practices brings to fore the need for direct safety instruction and training and retraining of textile dye workers on workplace hazards and safety practices.

Effects of an injury and illness prevention program on occupational safety behaviors among rice farmers in Nakhon Nayok Province, Thailand

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Santaweesuk S

2014-03-01

Full Text Available Sapsatree Santaweesuk,1,2 Robert S Chapman,1 Wattasit Siriwong1,3 1College of Public Health Sciences, Chulalongkorn University, Bangkok, Thailand; 2Srinakarinwirot University Ongkharak Campus, Nakhon Nayok, Thailand; 3Thai Fogarty ITREOH Center, Chulalongkorn University, Bangkok, Thailand Abstract: The objective of this study was to determine the effects of an Injury and Illness Prevention (IIP program intervention on occupational safety behavior among rice farmers in Nakhon Nayok province, Thailand. This was a quasi-experimental study in an intervention group and a control group. It was carried out in two rice farming communities, in which most people are rice farmers with similar socio-demographic characteristics. Multistage sampling was employed, selecting one person per rice farming household. The intervention group was 62 randomly selected rice farmers living in a rural area; another 55 rice farmers served as the control group. A structured face-to-face interview questionnaire was administered to participants to evaluate their safety behaviors in four areas: equipment use, pesticide use, ergonomics, and working conditions. The 2-week intervention program consisted of four elements: 1 health education, 2 safety inspection, 3 safety communication, and 4 health surveillance. Data were collected at baseline and 4 months after the intervention (follow-up. We used a general linear model repeated-measures analysis of variance to assess the mean difference between baseline and follow-up occupational safety behavior points between the intervention and control groups. Pesticide safety behaviors significantly increased in the intervention group compared with the control group. Ergonomics and working conditions points also increased in the intervention group, but not significantly so. The equipment use score decreased in the intervention group. It is necessary to identify and develop further measures to improve occupational safety behaviors. Some

Parents' Role in Adolescents' Decision on a College Major: A Weekly Diary Study

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Dietrich, Julia; Kracke, Barbel; Nurmi, Jari-Erik

2011-01-01

This study examined 39 adolescents during their transition to university. In standardized weekly diaries over several weeks (M=8.13) adolescents reported on engagement in career exploration (in-breadth and in-depth self and environmental exploration), their parents' transition-related involvement (frequency of conversations, support, and…

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

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Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Let's Resolve Conflicts Together: High School Classroom Activities. Conflict Management Week, May 1-7, 2000.

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Ohio Commission on Dispute Resolution and Conflict Management, Columbus.

The week of May 1-7, 2000 has been designated by the Governor of Ohio to be Conflict Management Week With heightened awareness to issues of school safety, it is important for high schools to take an active role in promoting constructive responses to conflict. Conflict is a natural and inevitable part of living, but managing conflict is difficult…

Let's Resolve Conflicts Together: Elementary School Classroom Activities. Conflict Management Week, May 1-7, 2000.

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Ohio Commission on Dispute Resolution and Conflict Management, Columbus.

With heightened awareness to issues of school safety, it is important for elementary schools to take an active role in promoting constructive responses to conflict. The week of May 1-7, 2000 has been designated as Conflict Management Week by the Governor of Ohio. Conflict is a natural and inevitable part of living; however, managing conflict is…

Pain perception and low back pain functional disability after a 10-week core and mobility training program: A pilot study.

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Lima, Vicente Pinheiro; de Alkmim Moreira Nunes, Rodolfo; da Silva, Jurandir Baptista; Paz, Gabriel Andrade; Jesus, Marco; de Castro, Juliana Brandão Pinto; Dantas, Estélio Henrique Martin; de Souza Vale, Rodrigo Gomes

2018-03-02

The aim of this study was to evaluate the effects of a 10-week core and mobility training program on pain perception and low back disability score in professors, students and employees of a university. Twenty-four individuals of a university who previously reported pain and low back disability were randomly assigned to an experimental group (EG; n= 8) that received 2 weekly sessions of 50 minutes of core and mobility training for 10 weeks; or to a control group (CG; n= 16). Both groups received a guideline to adopt ergonomic postures during work and activities of daily living. The visual analog pain scale (VAS) and the Roland-Morris questionnaire (RMQ) were applied pre and post intervention. Significant reductions in the pain intensity perception (p= 0.014) and low back functional disability (p= 0.011) were noted in the EG pre and post measures. However, no significant difference was observed in the CG. Thus, there was a significant difference between the EG and the CG in the post-intervention measures (p= 0.001). Core and mobility training and home-ergonomic instructions were effective to reduce the pain intensity perception and low back functional disability in the EG.

Four-week rapamycin treatment improves muscular dystrophy in a fukutin-deficient mouse model of dystroglycanopathy.

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Foltz, Steven J; Luan, Junna; Call, Jarrod A; Patel, Ankit; Peissig, Kristen B; Fortunato, Marisa J; Beedle, Aaron M

2016-01-01

Secondary dystroglycanopathies are a subset of muscular dystrophy caused by abnormal glycosylation of α-dystroglycan (αDG). Loss of αDG functional glycosylation prevents it from binding to laminin and other extracellular matrix receptors, causing muscular dystrophy. Mutations in a number of genes, including FKTN (fukutin), disrupt αDG glycosylation. We analyzed conditional Fktn knockout (Fktn KO) muscle for levels of mTOR signaling pathway proteins by Western blot. Two cohorts of Myf5-cre/Fktn KO mice were treated with the mammalian target of rapamycin (mTOR) inhibitor rapamycin (RAPA) for 4 weeks and evaluated for changes in functional and histopathological features. Muscle from 17- to 25-week-old fukutin-deficient mice has activated mTOR signaling. However, in tamoxifen-inducible Fktn KO mice, factors related to Akt/mTOR signaling were unchanged before the onset of dystrophic pathology, suggesting that Akt/mTOR signaling pathway abnormalities occur after the onset of disease pathology and are not causative in early dystroglycanopathy development. To determine any pharmacological benefit of targeting mTOR signaling, we administered RAPA daily for 4 weeks to Myf5/Fktn KO mice to inhibit mTORC1. RAPA treatment reduced fibrosis, inflammation, activity-induced damage, and central nucleation, and increased muscle fiber size in Myf5/Fktn KO mice compared to controls. RAPA-treated KO mice also produced significantly higher torque at the conclusion of dosing. These findings validate a misregulation of mTOR signaling in dystrophic dystroglycanopathy skeletal muscle and suggest that such signaling molecules may be relevant targets to delay and/or reduce disease burden in dystrophic patients.

Center for Maritime Safety and Health Studies

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Federal Laboratory Consortium — Established in November 2015, the Center for Maritime Safety and Health Studies (CMSHS) promotes safety and health for all maritime workers, including those employed...

The Nordic back pain subpopulation program: course patterns established through weekly follow-ups in patients treated for low back pain

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Leboeuf-Yde Charlotte

2010-01-01

Full Text Available Abstract Background Low back pain (LBP is known to have a fluctuating course. In clinical studies, when deciding on duration of treatment and time for follow-up, it is important to know at what point in time a definite pattern of recovery becomes apparent and at what time a possible recurrence is likely to occur. A detailed description of the pain pattern has been difficult to establish with commonly used methods for follow-up, and we now introduce data collection by means of text messaging on mobile phones. The purpose of this study was to describe the detailed course of LBP during 18 weeks in a population treated in the primary care sector by chiropractors. Methods The study population consisted of 78 patients presenting to a chiropractor with LBP, who for at least 12 weeks responded to the questions sent by text messaging concerning 1 the number of LBP-days the preceding week and 2 the intensity of present LBP. Results A rapid improvement was observed through weeks one to four. After week seven no further improvement happened, and from the 12th week there seemed to be a tendency towards worsening. Conclusions We suggest that follow-ups in studies concerning primary sector LBP care are conducted in week seven after treatment was initiated and at some later point which cannot be established from this study. In clinical practice we recommend that patients' LBP status is systematically followed for the first four weeks since lack of improvement during that period should cause watchfulness.

Comparison between bimatoprost and latanoprost-timolol fixed combination for efficacy and safety after switching patients from latanoprost.

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Maruyama, Yuko; Ikeda, Yoko; Mori, Kazuhiko; Ueno, Morio; Yoshikawa, Haruna; Kinoshita, Shigeru

2015-01-01

The purpose of this study was to prospectively evaluate and compare intraocular pressure (IOP) reduction efficacy and safety between bimatoprost and latanoprost-timolol fixed combination (LTFC) in Japanese patients with open-angle glaucoma. In this prospective, randomized, non-masked study, after enrolling 70 eyes of 70 Japanese open-angle glaucoma patients who had used latanoprost monotherapy for more than 4 weeks, the subjects were randomly divided into a bimatoprost group or an LTFC group. Both groups were switched from latanoprost to bimatoprost or LTFC for 12 weeks. IOP, conjunctival injection score, corneal epitheliopathy score (area density classification; AD score), tear film break-up time, heart rate, and blood pressure were evaluated at 0, 4, and 12 weeks after switching. The paired t-test and Mann-Whitney U-test were used for the statistical analysis. After 13 of the 70 patients dropped out, 57 were analyzed for IOP reduction and safety. There was a significant decrease in mean IOP at 4 weeks compared with week 0 in both groups (both Pbreak-up time, heart rate, and blood pressure. Bimatoprost and LTFC exhibited similar efficacy for reduction of IOP. Safety results indicated that only the conjunctival injection score at 12 weeks was higher in the bimatoprost group compared with the LTFC group.

Putting Safety in the Frame

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Valerie Jean O’Keeffe

2015-06-01

Full Text Available Current patient safety policy focuses nursing on patient care goals, often overriding nurses’ safety. Without understanding how nurses construct work health and safety (WHS, patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used “frames” built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses’ decisions about WHS: (a communicating builds knowledge, (b experiencing situations guides decisions, (c adapting procedures streamlines work, and (d team working promotes safe working. Nurses’ frames question current policy and practice by challenging how nurses’ safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management.

Effects of organizational safety practices and perceived safety climate on PPE usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses.

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DeJoy, David M; Smith, Todd D; Woldu, Henok; Dyal, Mari-Amanda; Steege, Andrea L; Boiano, James M

2017-07-01

Antineoplastic drugs pose risks to the healthcare workers who handle them. This fact notwithstanding, adherence to safe handling guidelines remains inconsistent and often poor. This study examined the effects of pertinent organizational safety practices and perceived safety climate on the use of personal protective equipment, engineering controls, and adverse events (spill/leak or skin contact) involving liquid antineoplastic drugs. Data for this study came from the 2011 National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers which included a sample of approximately 1,800 nurses who had administered liquid antineoplastic drugs during the past seven days. Regression modeling was used to examine predictors of personal protective equipment use, engineering controls, and adverse events involving antineoplastic drugs. Approximately 14% of nurses reported experiencing an adverse event while administering antineoplastic drugs during the previous week. Usage of recommended engineering controls and personal protective equipment was quite variable. Usage of both was better in non-profit and government settings, when workers were more familiar with safe handling guidelines, and when perceived management commitment to safety was higher. Usage was poorer in the absence of specific safety handling procedures. The odds of adverse events increased with number of antineoplastic drugs treatments and when antineoplastic drugs were administered more days of the week. The odds of such events were significantly lower when the use of engineering controls and personal protective equipment was greater and when more precautionary measures were in place. Greater levels of management commitment to safety and perceived risk were also related to lower odds of adverse events. These results point to the value of implementing a comprehensive health and safety program that utilizes available hazard controls and effectively communicates

Efficacy of a food safety comic book on knowledge and self-reported behavior for persons living with AIDS.

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Dworkin, Mark S; Peterson, Caryn E; Gao, Weihua; Mayor, Angel; Hunter, Robert; Negron, Edna; Fleury, Alison; Besch, C Lynn

2013-01-01

Persons living with AIDS are highly vulnerable to foodborne enteric infections with the potential for substantial morbidity and mortality. Educational materials about foodborne enteric infections intended for this immunocompromised population have not been assessed for their efficacy in improving knowledge or encouraging behavior change. AIDS patients in four healthcare facilities in Chicago, New Orleans, and Puerto Rico were recruited using fliers and word of mouth to healthcare providers. Those who contacted research staff were interviewed to determine food safety knowledge gaps and risky behaviors. A food safety educational comic book that targeted knowledge gaps was created, piloted, and provided to these patients who were instructed to read it and return at least 2 weeks later for a follow-up interview. The overall food safety score was determined by the number of the 26 knowledge/belief/behavior questions from the survey answered correctly. Among 150 patients who participated in both the baseline and follow-up questionnaire, the intervention resulted in a substantial increase in the food safety score (baseline 59%, post-intervention 81%, pcomic book format intervention to educate persons living with AIDS was highly effective. Future studies should examine to what extent long-term behavioral changes result.

Effect of a vegetable-oil emulsion on body composition; a 12-week study in overweight women on a meal replacement therapy after an initial weight loss: a randomized controlled trial.

Science.gov (United States)

Olsson, Johan; Sundberg, Birgitta; Viberg, Annika; Haenni, Arvo

2011-06-01

The maintenance of an obtained lower weight level is often found to be difficult. The aim of this study was to determine weight maintenance after an initial weight loss by consumption of a meal replacement with a vegetable-oil emulsion associated with prolonged satiety. After a 6-week weight loss period with very low calorie diet (VLCD), subjects with >5% body weight (BW) loss were randomized to a 12-week weight maintenance follow-up period, comparing a partial meal replacement diet containing a vegetable-oil emulsion (test) or dairy fat (control). Anthropometric data and safety variables were collected at baseline and after 4, 8 and 12 weeks. A significant weight loss was observed during the 12-week weight maintenance diet in the test and control group, respectively; 1.0 ± 2.1 kg (p Body fat mass (BFM) decreased significantly (p initial weight loss using VLCD was associated with decreased BFM by 0.9% without any change in BW between the two groups.

Study on Fusion Safety Infrastructure using ISAM

International Nuclear Information System (INIS)

Oh, Kyemin; Kang, Myungsuk; Heo, Gyunyoung; Kim, Hyoungchan

2013-01-01

The regulation of nuclear facilities have checked and managed safety throughout the entire process from design, construction, operation and decommissioning. Also, the same meaning as the regulatory requirements and design requirements, it will be important indicators for detailed design of K-DEMO. K-DEMO has many uncertainties because it is in conceptual design phase. Also, there is no reference material because demonstration scale fusion power plants were not operated yet in overseas. So, hazard that threaten the integrity of K-DEMO have to be defined preferentially to define regulatory or design requirements. This study proposed method that educe regulatory or design requirements and introduce web-based cloud infrastructure to perform renewal and sharing of information related with safety that is required in the study rapidly as a part of the R and D program funded by National Fusion Research Institute of Korea (NFRI). We have been performing QSR and PIRT in accordance with development of fusion DEMO plant, and preparing OPT, PSA and DPA for regulation requirements. This study introduces our recent research activities about ISAM for fusion and CCI built for expert and extant safety related information. Unlike fission, nuclear fusion's safety goal is non-evacuation of the public during an accident. To satisfy this goal not only various safety issues should be analyzed, but safety objectives, regulatory requirements, and design variables should also be established in detailed design phase. The web-based cloud infrastructure proposed in this paper will be able to offer input data of future studies and, it is expected to contribute on general and technical safety principles for national fusion power plant technology plan

Night work, long work weeks, and risk of accidental injuries. A register-based study.

Science.gov (United States)

Larsen, Ann D; Hannerz, Harald; Møller, Simone V; Dyreborg, Johnny; Bonde, Jens Peter; Hansen, Johnni; Kolstad, Henrik A; Hansen, Åse Marie; Garde, Anne Helene

2017-11-01

Objectives The aims of this study were to (i) investigate the association between night work or long work weeks and the risk of accidental injuries and (ii) test if the association is affected by age, sex or socioeconomic status. Methods The study population was drawn from the Danish version of the European Labour Force Survey from 1999-2013. The current study was based on 150 438 participants (53% men and 47% women). Data on accidental injuries were obtained at individual level from national health registers. We included all 20-59-year-old employees working ≥32 hours a week at the time of the interview. We used Poisson regression to estimate the relative rates (RR) of accidental injuries as a function of night work or long work weeks (>40 hours per week) adjusted for year of interview, sex, age, socioeconomic status (SES), industry, and weekly working hours or night work. Age, sex and SES were included as two-way interactions. Results We observed 23 495 cases of accidental injuries based on 273 700 person years at risk. Exposure to night work was statistically significantly associated with accidental injuries (RR 1.11, 99% CI 1.06-1.17) compared to participants with no recent night work. No associations were found between long work weeks (>40 hours) and accidental injuries. Conclusion We found a modest increased risk of accidental injuries when reporting night work. No associations between long work weeks and risk of accidental injuries were observed. Age, sex and SES showed no trends when included as two-way interactions.

The first symposium of Research Center for Radiation Safety, NIRS. Perspective of future studies of radiation safety

International Nuclear Information System (INIS)

Shimo, Michikuni

2002-03-01

This paper summarizes presentations given in the title symposium, held at the Conference Room of National Institute of Radiological Sciences (NIRS) on November 29 and 30, 2001. Contained are Introductory remarks: Basic presentations concerning exposure dose in man; Environmental levels of radiation and radioactivity, environmental radon level and exposure dose, and radiation levels in the specific environment (like in the aircraft): Special lecture (biological effects given by space environment) concerning various needs for studies of radiation safety; Requirement for open investigations, from the view of utilization, research and development of atomic energy, from the clinical aspect, and from the epidemiological aspect: Special lecture (safety in utilization of atomic energy and radiation-Activities of Nuclear Safety Commission of Japan) concerning present state and perspective of studies of radiation safety; Safety of radiation and studies of biological effects of radiation-perspective, and radiation protection and radiation safety studies: Studies in the Research Center for Radiation Safety; Summary of studies in the center, studies of the biological effects of neutron beam, carcinogenesis by radiation and living environmental factors-complicated effects, and studies of hereditary effects: Panel discussion (future direction of studies of radiation safety for the purpose of the center's direction): and concluding remarks. (N.I.)

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

Science.gov (United States)

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-01-01

ABSTRACT Background: There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. Objective: To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Methods: Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. Results: The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Conclusion: Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care. PMID:26339832

An open, comparative clinical study on the efficacy and safety of 10% trichloroacetic acid, 25% trichloroacetic acid and cryotherapy for verruca plana.

Science.gov (United States)

Cengiz, Fatma Pelin; Emiroglu, Nazan

2015-01-01

Although there are several methods to treat Verruca plana, warts do not respond well to the common therapeutic options. In this study, we compared the safety and efficacy of 10% trichloroacetic acid, 25% trichloroacetic acid, and cryotherapy for the treatment of warts caused by Verruca plana. Ten percent and 25% trichloroacetic acid were applied to warts weekly until all lesions cleared. Cryotherapy was performed by liquid nitrogen spray for 5-10 seconds for each lesion per week until the lesions cleared. The number of Verruca plana lesions and adverse effects were evaluated five times during the treatment (the initial visit, week 2, week 4, week 6, and week 8). The number of lesions decreased through week 8 for all three treatments, and the reductions in the mean numbers of lesions were statistically similar (p > 0.05). Those in the cryotherapy group exhibited more erythema, pain, erosions, bullae, and hyperpigmentation (p cryotherapy group (p cryotherapy are effective methods to treat Verruca plana. 10% trichloroacetic acid offers a safer and easier treatment than either 25% trichloroacetic acid or cryotherapy.

Patient-reported safety incidents in older patients with long-term conditions: a large cross-sectional study.

Science.gov (United States)

Panagioti, Maria; Blakeman, Thomas; Hann, Mark; Bower, Peter

2017-05-30

Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.