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Sample records for system safety efficacy

  1. Efficacy and safety of a transdermal contraceptive system.

    Science.gov (United States)

    Smallwood, G H; Meador, M L; Lenihan, J P; Shangold, G A; Fisher, A C; Creasy, G W

    2001-11-01

    To evaluate the efficacy, cycle control, compliance, and safety of a transdermal contraceptive system that delivers norelgestromin 150 microg and ethinyl estradiol 20 microg daily. In this open-label, 73-center study, 1672 healthy, ovulatory, sexually active women received ORTHO EVRA/EVRA for six (n = 1171) or 13 cycles (n = 501). The treatment regimen for each cycle was three consecutive 7-day patches (21 days) followed by 1 patch-free week. The overall and method-failure probabilities of pregnancy through 13 cycles were 0.7% and 0.4%, respectively. The incidence of breakthrough bleeding was low throughout the study. Perfect compliance (21 consecutive days of dosing, followed by a 7-day drug-free interval; no patch could be worn for more than 7 days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely. Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1.0%). The transdermal contraceptive patch provides effective contraception and cycle control, and is well tolerated. The weekly change schedule for the contraceptive patch is associated with excellent compliance and wearability characteristics.

  2. Safety and efficacy of a new tourniquet system

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    Sato Junko

    2012-08-01

    Full Text Available Abstract Background In upper limb surgery, the pneumatic tourniquet is an essential tool to provide a clean, bloodless surgical field, improving visualization of anatomical structures and preventing iatrogenic failure. Optimal inflation pressure to accomplish these objects without injuring normal tissue and inducing complications is not yet established. Use of the minimum tourniquet pressure necessary to produce a bloodless surgical field is preferable in order to prevent injury to normal tissue. Various methods have been implemented in an effort to lower effective cuff pressure. The purpose of this study is to report clinical experience with a new tourniquet system in which pressure is synchronized with systolic blood pressure (SBP using a vital information monitor. Methods We routinely used the tourniquet system in 120 consecutive upper limb surgeries performed under general anaesthesia in our operating room instead of our clinic. Cuff pressure was automatically regulated to additional 100 mmHg based on the SBP and was renewed every 2.5 minutes intervals. Results An excellent bloodless field was obtained in 119 cases, with the exception of one case of a 44-year-old woman who underwent internal screw fixation of metacarpal fracture. No complications, such as compartment syndrome, deep vein disorder, skin disorder, paresis, or nerve damage, occurred during or after surgery. Conclusions This new tourniquet system, synchronized with SBP, can be varied to correspond with sharp rises or drops in SBP to supply adequate pressure. The system reduces labor needed to deflate and re-inflate to achieve different pressures. It also seemed to contribute to the safety in upper limb surgery, in spite of rare unexpected oozing mid-surgery, by reducing tissue pressure.

  3. Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease

    NARCIS (Netherlands)

    Holvast, A; Huckriede, A; Wilschut, J; Horst, G; De Vries, JJC; Benne, CA; Kallenberg, CGM; Bijl, M

    Objective: to assess the safety and efficacy of influenza vaccination in patients with systemic lupus erythematosus (SLE), and to evaluate the influence of immunosuppressive drugs on the immune response. Methods: SLE patients (n = 56) and healthy controls (n = 18) were studied. All patients had

  4. Comparative instrumental evaluation of efficacy and safety between a binary and a ternary system in chemexfoliation.

    Science.gov (United States)

    Cameli, Norma; Mariano, Maria; Ardigò, Marco; Corato, Cristina; De Paoli, Gianfranco; Berardesca, Enzo

    2017-09-20

    To instrumentally evaluate the efficacy and the safety of a new ternary system chemo exfoliating formulation (water-dimethyl isosorbide-acid) vs traditional binary systems (water and acid) where the acid is maintained in both the systems at the same concentration. Different peelings (binary system pyruvic acid and trichloroacetic acid-TCA, and ternary system pyruvic acid and TCA) were tested on the volar forearm of 20 volunteers of both sexes between 28 and 50 years old. The outcomes were evaluated at the baseline, 10 minutes, 24 hours, and 1 week after the peeling by means of noninvasive skin diagnosis techniques. In vivo reflectance confocal microscopy was used for stratum corneum evaluation, transepidermal waterloss, and Corneometry for skin barrier and hydration, Laser Doppler velocimetry in association with colorimetry for irritation and erythema analysis. The instrumental data obtained showed that the efficacy and safety of the new ternary system peel compounds were significantly higher compared with the binary system formulations tested. The new formulation peels improved chemexfoliation and reduced complications such as irritation, redness, and postinflammatory pigmentation compared to the traditional aqueous solutions. The study showed that ternary system chemexfoliation, using a controlled delivery technology, was able to provide the same clinical effects in term of stratum corneum reduction with a significantly reduced barrier alteration, water loss, and irritation/erythema compared to traditional binary system peels. © 2017 Wiley Periodicals, Inc.

  5. Electronic nicotine delivery systems ("e-cigarettes"): review of safety and smoking cessation efficacy.

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2014-09-01

    Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems ("e-cigarettes") are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. We conducted a structured search of the current literature up to and including November 2013. E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking are suggestive but ultimately inconclusive. Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  6. Electronic Nicotine Delivery Systems (“E-Cigarettes”): Review of Safety and Smoking Cessation Efficacy

    Science.gov (United States)

    Harrell, Paul Truman; Simmons, Vani Nath; Correa, John Bernard; Padhya, Tapan Ashvin; Brandon, Thomas Henry

    2015-01-01

    Background and Objectives Cigarette smoking is common among cancer patients and is associated with negative outcomes. Electronic nicotine delivery systems (“e-cigarettes”) are rapidly growing in popularity and use, but there is limited information on their safety or effectiveness in helping individuals quit smoking. Data Sources The authors searched PubMed, Web of Science, and additional sources for published empirical data on safety and use of electronic cigarettes as an aid to quit smoking. Review Methods We conducted a structured search of the current literature up to and including November 2013. Results E-cigarettes currently vary widely in their contents and are sometimes inconsistent with labeling. Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse effects, and secondhand toxicity exposure. Data on the use of e-cigarettes for quitting smoking is suggestive, but ultimately inconclusive. Conclusions Clinicians are advised to be aware that the use of e-cigarettes, especially among cigarette smokers, is growing rapidly. These devices are unregulated, of unknown safety, and of uncertain benefit in quitting smoking. Implications for Practice In the absence of further data or regulation, oncologists are advised to discuss the known and unknown safety and efficacy information on e-cigarettes with interested patients, and to encourage patients to first try FDA-approved pharmacotherapies for smoking cessation. PMID:24898072

  7. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate) : a phase 2, randomised, controlled trial

    NARCIS (Netherlands)

    Khanna, Dinesh; Denton, Christopher P.; Jahreis, Angelika; van Laar, Jacob M.; Frech, Tracy M.; Anderson, Marina E.; Baron, Murray; Chung, Lorinda; Fierlbeck, Gerhard; Lakshminarayanan, Santhanam; Allanore, Yannick; Pope, Janet E.; Riemekasten, Gabriela; Steen, Virginia; Müller-Ladner, Ulf; Lafyatis, Robert; Stifano, Giuseppina; Spotswood, Helen; Chen-Harris, Haiyin; Dziadek, Sebastian; Morimoto, Alyssa; Sornasse, Thierry; Siegel, Jeffrey; Furst, Daniel E.

    2016-01-01

    Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind,

  8. Efficacy and Safety of Prolonged Rituximab Treatment in Patients with Systemic Juvenile Idiopathic Arthritis

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    E. I. Alexeeva

    2013-01-01

    Full Text Available Aim: to assess efficacy and safety of rituximab treatment in children with systemic juvenile idiopathic arthritis under prolonged follow-up. Patients and methods: results of treatment of 60 children (33 girls and 27 boys with systemic variant of juvenile idiopathic arthritis being followed-up in rheumatology department of the Federal State Institution «Scientific Centre of Children Health» of RAMS (FSI «SCCH» RAMS were analyzed. The mean age of children was 8,7 years. The mean duration of disease course at the moment of first rituximab administration was 5,3 years. At the beginning of rituximab therapy all children had active articular syndrome, severe systemic manifestations and significantly increased laboratory markers of activity. As the signs of improvement the authors used pediatric criteria of the American College of Rheumatology. The treatment was approved by the local ethic committee of the FSI «SCCH» RAMS; the patients’ representatives and patients older than 14 years old had signed informed agreement. Results: remission was induced in 26 of 60 (43% patients: in 9 of them after the 1st course of treatment, in 8 — after the 2nd, in 6 — after the 3d and in 3 — after the 4th. The maximal duration of remission was 5 years 4 months, minimal — 6 months. Other genetically engineered drugs were administered to 34 (57% of the patients: due to the primary inefficiency in 15, secondary inefficiency — in 10; due to partial inefficiency — in 9 children. The drug was well-tolerated in most of the patients. Undesirable effects were represented by transfusional reactions to the rituximab infusion, infections with different severity and granulocytopenia. Conclusions: rituximab has high efficiency in patients with severe systemic variant of juvenile idiopathic arthritis. The drug induced remission in patients who had been considered almost incurable, with low status of physical and social adaptation.

  9. Tolerability, safety and efficacy of Iloprost infusion without peristaltic pump in systemic sclerosis

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    S. Tosi

    2011-09-01

    Full Text Available Objective. To evaluate safety, tolerability and efficacy on Raynaud’s phenomenon (Rp of iloprost infusion without peristaltic pump in patients with systemic sclerosis (SSc. Patients and methods. The inclusion criteria were diagnosis of SSc, age between 18 and 65 years, presence of Rp, and absence of any controindication to the use of iloprost. The treatment was carried out in a day hospital setting and consisted first of 5 consecutive days of iloprost infusion (from an initial dose of 1.0 ng/Kg/min up to 2 ng/kg/min, and then of 2 days of infusions at the maximum possible dose every 45 days for one year. All of the adverse events were carefully recorded and the changes in the Rp were measured by a 5 grade scale (worsened, unmodified, slightly improved, very improved, disappeared. Results. Thirty-eight SSc patients (all females, mean age 49 years (range 18.5-65, disease duration 1.5 years (range 0.5-10.8 were enrolled in the study. During the first cycle of therapy, 14 avderse events occurred in 11 (28.9% patients and during the next cycles, 3 adverse events were seen in 3 (7.9% patients. In all of the cases they were mild and transient. Rp was considered very improved in 15 (39.5% patients, slightly improved in 13 (34.2%, unmodified in 8 (21% and worse in 2 (5.2%. Discussion. In this study intravenous iloprost without peristaltic pump proved to be safe, well tolerated, and as effective as traditional infusion through peristaltic pump in improving Rp in patients with SSc.

  10. ECMO - Safety and efficacy

    International Nuclear Information System (INIS)

    Koul, B.L.

    1991-05-01

    Three adult patient with severe acute respiratory failure were treated with a conventional high flow veno-venous extracorporeal membrane oxygenation (ECMO), using heparin coated ECMO system and low dose of heparin (Study 1). Two patients survived and are living a normal life. The third patient died of candida sepsis. In study 2, 6 healty pigs were subjected to 24 hours of veno-right ventricular ECMO. The veno-right ventricular ECMO substituted the total lung function of the animals at extracorporeal blood flows amounting to 80 of the total cardiac output. In study 3, 6 pigs were subjected to 18 hours of total veno-arterial ECMO. All the animals died within 4 hours of weaning from ECMO. Thus 18 hours of total veno-arterial ECMO is 100% fatal in healthy pigs on account of irreversible ischemic pulmonary damage. In another study, 6 pigs were subjected to 18 hour partial veno-arterial ECMO during which 25% of the cardiac output was diverted through the pulmonary artery to the lungs (study 4). 6 hours after weaning from ECMO, a slight but significant decrease in arterial oxygen tension, a significant increase in the pulmonary vascular resistance (mean = 76%) and a slight increase in the pulmonary clearance of 99m Tc-DPTA was observed. Thus 25% right cardiac output is the border-line safe pulmonary blood flow needed for presevation of adequate lung function during 18 hours of veno-arterial ECMO at normothermia in healthy pigs. 6 healthy pigs were subjected to 24 hours of heparin free total veno-right centricular ECMO, using Carmeda heparin coated system (study 5). Deterioration in the arterial blood gases and in the pulmonary hemodynamics was not clinically significant. Total platelet count and plasma free hemoglobin remained unaffected. The heparin coated surface thus inhibits both the coagulation cascade and the platelet activation during a 24 hour heparin free ECMO in healty pigs. (116 refs.)

  11. Comparative efficacy and safety of local and systemic methotrexate injection in cesarean scar pregnancy

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    Peng P

    2015-01-01

    Full Text Available Ping Peng,1 Ting Gui,1 Xinyan Liu,1 Weilin Chen,1 Zhenzhen Liu2 1Department of Obstetrics and Gynecology, 2Department of Ultrasonography, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China Objective: To investigate the efficacy of methotrexate (MTX injection in treatment of cesarean scar pregnancy (CSP. Method: A randomized controlled study was performed in 104 CSP patients receiving either local or systemic MTX injection at the Peking Union Medical College Hospital from the year 2008 to 2013. Results: Complete cure was defined as regression of ultrasonographic findings and normalization of serum β-hCG within 60 days. It was regarded as delayed cure if additional dilation and curettage (D&C was needed. The overall cure rate (complete cure plus delayed cure was 69.2% versus 67.3% for local injection versus systemic administration (P>0.05. The median time for serum β-hCG remission and uterine mass disappearance after systemic administration (42 [21–69] days and 40 [20–67] days were significantly lower than those receiving local injection (56 [24–92] days and 53 [23–88] days, with P=0.029 and 0.046, respectively. The mean pretreatment serum β-hCG (human chorionic gonadotropin level and lesion size in cured group (21,941±18,351 mIU/mL and 2.9±1.3 cm, respectively were significantly lower than those in the failed group (37,047±30,864 mIU/mL and 3.6±1.3 with P=0.038 and 0.044, respectively. Conclusion: MTX injection is effective in CSP treatment. Systemic administration shows similar overall cure rate compared to local injection, but requires shorter time for serum β-hCG remission and uterine mass disappearance. Keywords: cesarean scar pregnancy, methotrexate injection, local, systemic

  12. A prospective case series evaluating the safety and efficacy of the Klox BioPhotonic System in venous leg ulcers

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    Nikolis A

    2016-09-01

    Full Text Available Andreas Nikolis,1 Doria Grimard,2 Yves Pesant,3 Giovanni Scapagnini,4 Denis Vézina5 1Division of Plastic Surgery, Victoria Park Research Centre, Montreal, 2Q&T Research Chicoutimi, Chicoutimi, 3St-Jerome Medical Research Inc., St-Jerome, Quebec, Canada; 4Department of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso, Italy; 5Klox Technologies, Laval, Quebec, Canada Purpose: To investigate the safety and efficacy of the BioPhotonic System developed by Klox Technologies in a case series of ten patients with venous leg ulcers.Patients and methods: Ten patients with chronic venous leg ulcers, having failed on at least one previous therapy, were enrolled into this case series.Results: Nine patients were evaluable for efficacy. A response (defined as decrease in wound surface area was observed in seven patients (77.8%. Of these, four patients (44.4% achieved wound closure on average 4 months (127.5 days following the beginning of the treatment. Two patients did not respond to the investigational treatment. Quality of life improved over time throughout the study. Compliance was excellent, with 93.2% of visits completed as per protocol. Safety was unremarkable, with only four treatment-emergent-related adverse events, for which no specific intervention was required.Conclusion: The BioPhotonic System was shown to be safe and extremely well tolerated. It also demonstrated potential in terms of wound closure, wound surface area decrease, and wound bed preparation. Keywords: biophotonics, light, photobiomodulation, venous leg ulcers

  13. Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology.

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    Marcet, Marcus M; Shtein, Roni M; Bradley, Elizabeth A; Deng, Sophie X; Meyer, Dale R; Bilyk, Jurij R; Yen, Michael T; Lee, W Barry; Mawn, Louise A

    2015-08-01

    To review the published literature assessing the efficacy and safety of lacrimal drainage system plug insertion for dry eye in adults. Literature searches of the PubMed and Cochrane Library databases were last conducted on March 9, 2015, without date restrictions and were limited to English language abstracts. The searches retrieved 309 unique citations. The primary authors reviewed the titles and abstracts. Inclusion criteria specified reports that provided original data on plugs for the treatment of dry eyes in at least 25 patients. Fifty-three studies of potential relevance were assigned to full-text review. The 27 studies that met the inclusion criteria underwent data abstraction by the panels. Abstracted data included study characteristics, patient characteristics, plug type, insertion technique, treatment response, and safety information. All studies were observational and rated by a methodologist as level II or III evidence. The plugs included punctal, intracanalicular, and dissolving types. Fifteen studies reported metrics of improvement in dry eye symptoms, ocular-surface status, artificial tear use, contact lens comfort, and tear break-up time. Twenty-five studies included safety data. Plug placement resulted in ≥50% improvement of symptoms, improvement in ocular-surface health, reduction in artificial tear use, and improved contact lens comfort in patients with dry eye. Serious complications from plugs were infrequent. Plug loss was the most commonly reported problem with punctal plugs, occurring on average in 40% of patients. Overall, among all plug types, approximately 9% of patients experienced epiphora and 10% required removal because of irritation from the plugs. Canaliculitis was the most commonly reported problem for intracanalicular plugs and occurred in approximately 8% of patients. Other complications were reported in less than 4% of patients on average and included tearing, discomfort, pyogenic granuloma, and dacryocystitis. On the basis of

  14. Efficacy and Safety of Vaccination in Pediatric Patients with Systemic Inflammatory Rheumatic Diseases: a systematic review of the literature

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    Sandra Sousa

    2017-01-01

    Full Text Available Introduction: Children and adolescents with systemic rheumatic diseases have an increased risk of infections. Although some infections are vaccine-preventable, immunization among patients with juvenile rheumatic diseases is suboptimal, partly due to some doubts that still persist regarding its efficacy and safety in this patient population. Objectives: To review the available evidence regarding the immunological response and the safety of vaccination in children and adolescents with systemic inflammatory rheumatic diseases (SIRD. Methods: A systematic review of the current literature until December 2014 using MEDLINE, EMBASE and abstracts from the American College of Rheumatology and European League Against Rheumatism congresses (2011-2014, complemented by hand search was performed. Eligible studies were identified and efficacy (seroprotection and/or seroconversion and safety (reactions to vaccine and relapse of rheumatic disease outcomes were extracted and summarized according to the type of vaccine. Results: Twenty-eight articles concerning vaccination in pediatric patients with SIRDs were found, that included almost 2100 children and adolescents, comprising nearly all standard vaccinations of the recommended immunization schedule. Children with SIRDs generally achieved seroprotection and seroconversion; nevertheless, the antibody levels were often lower when compared with healthy children. Glucocorticoids and conventional disease-modifying anti-rheumatic drugs do not seem to significantly hamper the immune responses, whereas TNF inhibitors may reduce antibody production, particularly in response to pneumococcal conjugate, influenza, meningococcal C and hepatitis A vaccine. There were no serious adverse events, nor evidence of a relevant worsening of the underlying rheumatic disease. Concerning live attenuated vaccines, the evidence is scarce, but no episodes of overt disease were reported, even in patients under biological therapy

  15. Efficacy and Safety of Vaccination in Pediatric Patients with Systemic Inflammatory Rheumatic Diseases: a systematic review of the literature.

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    Sousa, Sandra; Duarte, Ana Catarina; Cordeiro, Inês; Ferreira, Joana; Gonçalves, Maria João; Meirinhos, Tiago; Rocha, Teresa Martins; Romão, Vasco C; Santos, Maria José

    2017-01-01

    Children and adolescents with systemic rheumatic diseases have an increased risk of infections. Although some infections are vaccine-preventable, immunization among patients with juvenile rheumatic diseases is suboptimal, partly due to some doubts that still persist regarding its efficacy and safety in this patient population. To review the available evidence regarding the immunological response and the safety of vaccination in children and adolescents with systemic inflammatory rheumatic diseases (SIRD). A systematic review of the current literature until December 2014 using MEDLINE, EMBASE and abstracts from the American College of Rheumatology and European League Against Rheumatism congresses (2011-2014), complemented by hand search was performed. Eligible studies were identified and efficacy (seroprotection and/or seroconversion) and safety (reactions to vaccine and relapse of rheumatic disease) outcomes were extracted and summarized according to the type of vaccine. Twenty-eight articles concerning vaccination in pediatric patients with SIRDs were found, that included almost 2100 children and adolescents, comprising nearly all standard vaccinations of the recommended immunization schedule. Children with SIRDs generally achieved seroprotection and seroconversion; nevertheless, the antibody levels were often lower when compared with healthy children. Glucocorticoids and conventional disease-modifying anti-rheumatic drugs do not seem to significantly hamper the immune responses, whereas TNF inhibitors may reduce antibody production, particularly in response to pneumococcal conjugate, influenza, meningococcal C and hepatitis A vaccine. There were no serious adverse events, nor evidence of a relevant worsening of the underlying rheumatic disease. Concerning live attenuated vaccines, the evidence is scarce, but no episodes of overt disease were reported, even in patients under biological therapy. Existing literature demonstrates that vaccines are generally well

  16. Efficacy and safety of the urolift® system for the treatment of benign prostate hyperplasia symptoms: systematic review.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Gómez-Sancha, F; Luengo-Matos, S

    2015-06-01

    Interest in having alternatives in the treatment of benign prostate hyperplasia. To assess the efficacy and safety of the Urolift® system for treating the symptoms of benign prostate hyperplasia. Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, Clinical Trials and EuroScan, collecting indicators of efficacy and safety. We included 5 case series and one clinical trial. The patients' mean age ranged from 65-74.3 years, and the mean prostate volume was 41-55cm3. The mean number of Urolif® implants was 3.7-5.5. The maximum follow-up in months was 24, 12 (3 studies) and one (2 studies). Improvements were found in lower urinary tract symptoms, as measured with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), maximum urinary flow (Qmax) and postvoid residual (PVR) volume. Improvements were in found sexual dysfunction symptoms, as measured with the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD), and in quality of life (QoL). In the clinical trial, the differences were significant for International Prostate Symptom Score, BPHII, Qmax and QoL (p<.05). The adverse effects were mild. Although the quality of evidence is low, Urolift® constitutes a good therapeutic alternative for patients with benign prostate hyperplasia. The short to medium-term results show that the technique contributes to improving lower urinary tract symptoms, with no relevant side effects, does not affect sexual function and improves quality of life. Further research is required, especially on long-term results. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Efficacy and safety of Elevate® system on apical and anterior compartment prolapse repair with personal technique modification

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    Daniele Castellani

    Full Text Available ABSTRACT Aim: To evaluate the effectiveness and safety of Anterior Elevate® mesh kit system (AES in woman with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP. Materials and Methods: This retrospective, monocentric, single surgeon study enrolled between May 2010 and January 2013 fifty-six woman experiencing symptomatic anterior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4. All women received a AES and 7 (12.5% received a concomitant transvaginal hysterectomy. Primary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤ 1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL results and patients' safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: ICIQ-UI short form, ICIQ-VS and P-QOL. All patients completed 2-years and 28 women 3-years of follow-up. Surgical approach was modified in women with uterus, moving the two-propylene strips anteriorly around the cervix itself crossing one another, so the left will take place in the right side and the right on the opposite. This modification was made in order to better support the uterus. Results: Vaginal mesh exposure was present in 3 (5,3% patients. Very good anatomical outcomes were seen, with one (1,8% failure at 6-months, 4 (7,1% at 1-year, 6 at 2-years (10,7%. Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up. Conclusion: Our data suggest that AES is a minimally-invasive transvaginal procedure to repair anterior and apical POP, with good evidence related to mid-term safety and efficacy.

  18. Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis.

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    Garber, Caren; Plotnikova, Natalia; Au, Shiu-chung; Sorensen, Eric P; Gottlieb, Alice

    2015-08-01

    Despite the aging population, few studies have documented the treatment of geriatric psoriasis. The purpose of this study is to compare the efficacy, safety, and prescribing patterns of biologics and conventional systemic medications in elderly versus adult psoriasis. All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician's global assessment and the body surface area. 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort ( P=0.004) while biologic prescription rates were significantly lower ( P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events ( P=0.322 for biologics; P=0.581 for conventional systemics) or infection ( P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment ( P=0.033). This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly

  19. The safety and efficacy of robotic image-guided radiosurgery system treatment for intra- and extracranial lesions: A systematic review of the literature

    International Nuclear Information System (INIS)

    Calcerrada Diaz-Santos, Nieves; Blasco Amaro, Juan Antonio; Cardiel, Gloria Ariza; Andradas Aragones, Elena

    2008-01-01

    Background: The CyberKnife is a new, frameless stereotactic radiosurgery system. This work reviews its safety and efficacy in the treatment of intra- and extracranial lesions. Methods: A literature search was made of the Medline, Embase, Pascal Biomed, CINAHL and Cancerlit databases. Health technology assessment reports on stereotactic radiosurgery systems were also consulted. All searches were made in June 2007. Data on efficacy and safety were extracted and then synthesized into the present review. Results: Thirty five clinical studies were identified, the majority of which included no patient comparison group. These studies assessed the use of the CyberKnife mainly in the treatment of primary and metastatic intracranial and spinal tumours. Conclusions: The CyberKnife system allows to carry out standard radiosurgical and fractionated stereotactic radiotherapy procedures. The use of this system offers an alternative for the treatment of inoperable tumours, and of lesions located close to critical structures that cannot be treated using other types of stereotactic radiosurgery system. Unfortunately, the quality of the reviewed papers still does not allow definite conclusions to be drawn regarding the safety and efficacy of these treatments

  20. Safety Systems

    Science.gov (United States)

    Halligan, Tom

    2009-01-01

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

  1. A systematic review on the safety and efficacy of percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk candidates

    DEFF Research Database (Denmark)

    Munkholm-Larsen, Stine; Wan, Benjamin; Tian, David H

    2014-01-01

    BACKGROUND: MitraClip implantation has emerged as a viable option in high surgical risk patients with severe mitral regurgitation (MR). We performed the present systematic review to assess the safety and efficacy of the MitraClip system for high surgical risk candidates with severe organic and....../or functional MR. METHODS: Six electronic databases were searched for original published studies from January 2000 to March 2013. Two reviewers independently appraised studies, using a standard form, and extracted data on methodology, quality criteria, and outcome measures. All data were extracted and tabulated...

  2. Women's perceptions of contraceptive efficacy and safety.

    Science.gov (United States)

    Kakaiya, Roshni; Lopez, Lia L; Nelson, Anita L

    2017-01-01

    Adoption of contraceptive implants and intrauterine devices has been less than might be expected given their superior efficacy and convenience. The purpose of this study was to assess knowledge and beliefs held by women, which may influence their contraceptive choices and theirongoing utilization of contraceptive methods. English speaking, nonpregnant, reproductive-age women, who were not surgically sterilized, were individually interviewed to obtain limited demographic characteristics and to assess their knowledge about the efficacy of various contraceptive methods in typical use and about the relative safety of oral contraceptives. A convenience sample of 500 women aged 18-45 years, with education levels that ranged from middle school to postdoctoral level was interviewed. The efficacy in typical use of both combined oral contraceptives and male condoms was correctly estimated by 2.2%; over two-thirds of women significantly over estimated the efficacy of each of those methods in typical use. Oral contraceptives were thought to be at least as hazardous to a woman's health as pregnancy by 56% of women. The majority of reproductive aged women surveyed substantially overestimated the efficacy of the two most popular contraceptive methods, often saying that they were 99% effective. Women with higher education levels were most likely to overestimate efficacy of oral contraceptives. Women of all ages and education levels significantly overestimated the health hazards of oral contraceptives compared to pregnancy. Overestimation of effectiveness of these methods of contraception, may contribute to lower adoption of implants and intrauterine devices. When individualizing patient counselling, misperceptions must be identified and addressed with women of all educational backgrounds. Not applicable.

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

    Directory of Open Access Journals (Sweden)

    Hopkins MR

    2011-04-01

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

  4. Evaluation of the safety and efficacy of Glycyrrhiza uralensis root extracts produced using artificial hydroponic and artificial hydroponic-field hybrid cultivation systems.

    Science.gov (United States)

    Akiyama, H; Nose, M; Ohtsuki, N; Hisaka, S; Takiguchi, H; Tada, A; Sugimoto, N; Fuchino, H; Inui, T; Kawano, N; Hayashi, S; Hishida, A; Kudo, T; Sugiyama, K; Abe, Y; Mutsuga, M; Kawahara, N; Yoshimatsu, K

    2017-01-01

    Glycyrrhiza uralensis roots used in this study were produced using novel cultivation systems, including artificial hydroponics and artificial hydroponic-field hybrid cultivation. The equivalency between G. uralensis root extracts produced by hydroponics and/or hybrid cultivation and a commercial Glycyrrhiza crude drug were evaluated for both safety and efficacy, and there were no significant differences in terms of mutagenicity on the Ames tests. The levels of cadmium and mercury in both hydroponic roots and crude drugs were less than the limit of quantitation. Arsenic levels were lower in all hydroponic roots than in the crude drug, whereas mean lead levels in the crude drug were not significantly different from those in the hydroponically cultivated G. uralensis roots. Both hydroponic and hybrid-cultivated root extracts showed antiallergic activities against contact hypersensitivity that were similar to those of the crude drug extracts. These study results suggest that hydroponic and hybrid-cultivated roots are equivalent in safety and efficacy to those of commercial crude drugs. Further studies are necessary before the roots are applicable as replacements for the currently available commercial crude drugs produced from wild plant resources.

  5. Antipsychotic agents: efficacy and safety in schizophrenia

    Directory of Open Access Journals (Sweden)

    de Araújo AN

    2012-11-01

    Full Text Available Arão Nogueira de Araújo,1 Eduardo Pondé de Sena,1,2 Irismar Reis de Oliveira,1,3 Mario F Juruena41Postgraduation Program in Interactive Processes of Organs and Systems, 2Department of Pharmacology, Institute of Health Sciences, 3Department of Neurosciences and Mental Health, School of Medicine, Federal University of Bahia, Salvador, Brazil; 4Stress and Affective Disorders Program, Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Sao Paulo, BrazilAbstract: Antipsychotics have provided a great improvement in the management of people with schizophrenia. The first generation antipsychotics could establish the possibility of managing many psychotic subjects in an outpatient setting. With the advent of the second (SGA and third generation antipsychotics (TGA, other psychiatric disorders such as bipolar depression, bipolar mania, autism, and major depressive disorder have now been approved for the use of these drugs for their treatment. Also, the administration of more specific assessment tools has allowed for better delineation of the repercussions of these drugs on symptoms and the quality of life of patients who use antipsychotic agents. In general, the SGA share similar mechanisms of action to achieve these results: dopamine-2 receptor antagonism plus serotonin-2A receptor antagonism. The TGA (eg, aripiprazole have partial agonist activity at the dopamine-2 receptor site, and are also called dopaminergic stabilizers. The pharmacological profile of SGA and TGA may provide better efficacy against negative symptoms, and are less likely to produce extrapyramidal symptoms; however, the SGA and TGA are associated with many other adverse events. The clinician has to balance the risks and benefits of these medications when choosing an antipsychotic for an individual patient.Keywords: antipsychotic agents, schizophrenia, pharmacology, safety

  6. Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial.

    Science.gov (United States)

    Worthley, Stephen G; Tsioufis, Costas P; Worthley, Matthew I; Sinhal, Ajay; Chew, Derek P; Meredith, Ian T; Malaiapan, Yuvi; Papademetriou, Vasilios

    2013-07-01

    Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN(™) multi-electrode system. We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.

  7. System safety education focused on flight safety

    Science.gov (United States)

    Holt, E.

    1971-01-01

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

  8. Safety and efficacy of Bolus administration of magnesium sulphate ...

    African Journals Online (AJOL)

    Safety and efficacy of Bolus administration of magnesium sulphate for preeclampsia. ... On-going research is addressing its administration in terms of dosage, duration and safety. Objective: We evaluated a ... Keywords: safety, efficacy, bolus magnesium sulphate, preeclampsia, University of Benin Teaching Hospital

  9. Reactor system safety assurance

    International Nuclear Information System (INIS)

    Mattson, R.J.

    1984-01-01

    The philosophy of reactor safety is that design should follow established and conservative engineering practices, there should be safety margins in all modes of plant operation, special systems should be provided for accidents, and safety systems should have redundant components. This philosophy provides ''defense in depth.'' Additionally, the safety of nuclear power plants relies on ''safety systems'' to assure acceptable response to design basis events. Operating experience has shown the need to study plant response to more frequent upset conditions and to account for the influence of operators and non-safety systems on overall performance. Defense in depth is being supplemented by risk and reliability assessment

  10. [Human papillomavirus vaccine. Efficacy and safety].

    Science.gov (United States)

    Bruni, Laia; Serrano, Beatriz; Bosch, Xavier; Castellsagué, Xavier

    2015-05-01

    Human papillomavirus (HPV) related disease remains a major cause of morbidity and mortality worldwide. Prophylactic vaccines have been recognized as the most effective intervention to control for HPV-related diseases. This article reviews the major phaseii/iii trials of the bivalent (HPVs16/18), quadrivalent (HPVs6/11/16/18), and the recently approved 9-valent vaccine (HPVs6/11/16/18/31/33/45/52/58). Large trials have been conducted showing the safety, immunogenicity and high efficacy of the bivalent and quadrivalent vaccines in the prevention of pre-invasive lesions and infection, especially when administered at young ages before exposure to HPV. Trials of the 9-valent vaccine have also demonstrated the safety, immunogenicity and efficacy of the vaccine in the prevention of infection and disease associated with the vaccine types, and its potential to substantially increase the overall prevention of HPV-related diseases. Post-licensure country reports have shown the recent and early impact of these vaccines at population level after the implementation of established HPV vaccination programs, including decreases in the prevalence of vaccine HPV types, the incidence of genital warts, and the incidence of high-grade cervical abnormalities. If widely implemented, current HPV vaccines may drastically reduce the incidence of cervical cancer and other HPV-related cancers and diseases. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  11. Efficacy and Safety of the Over-the-Scope Clip (OTSC) System in the Management of Leak and Fistula After Laparoscopic Sleeve Gastrectomy: a Systematic Review.

    Science.gov (United States)

    Shoar, Saeed; Poliakin, Lauren; Khorgami, Zhamak; Rubenstein, Rebecca; El-Matbouly, Moamena; Levin, Jun L; Saber, Alan A

    2017-09-01

    Endoscopic management of leaks/fistulas after laparoscopic sleeve gastrectomy (LSG) is gaining popularity in the bariatric surgery. This study aimed to review the efficacy and safety of over-the-scope-clip (OTSC) system in endoscopic closure of post-LSG leak/fistula. PubMed/Medline and major journals of the field were systematically reviewed for studies on endoscopic closure of post-LSG leaks/fistula by means of the OTSC system. A total of ten eligible studies including 195 patients with post-LSG leaks/fistula were identified. The time between LSG and leak/fistula ranged from 1 day to 803 days. Most of the leaks/fistula were located at the proximal staple line, and they sized from 3 to 20 mm. Time between leak diagnosis and OTSC clipping ranged from 0 to 271 days. Thirty-three out of 53 patients (63.5%) required one clip for closure of the lesion. Regarding the OTSC-related complications, a leak occurred in five patients (9.3%) and OTSC migration, stenosis, and tear each in one patient (1.8%). Of the 73 patients with post-LSG leak treated with OTSC, 63 patients had an overall successful closure (86.3%). OTSC system is a promising endoscopic approach for management of post-LSG leaks in appropriately selected patients. Unfortunately, most studies are series with a small sample size, short-term follow-up, and mixed data of concomitant procedures with OTSC. Further studies should distinguish the net efficacy of the OTSC system from other concomitant procedures in treatment of post-LSG leak.

  12. Safety and efficacy of drugs in pregnancy.

    Science.gov (United States)

    Knoppert, David

    2011-01-01

    Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

  13. Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

    Science.gov (United States)

    Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

    2013-04-01

    Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

  14. Safety and efficacy of venom immunotherapy: a real life study.

    Science.gov (United States)

    Kołaczek, Agnieszka; Skorupa, Dawid; Antczak-Marczak, Monika; Kuna, Piotr; Kupczyk, Maciej

    2017-04-01

    Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. To analyze the safety and efficacy of VIT in a real life setting. One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. Significantly more patients were allergic to wasp than bee venom (146 vs. 34, p bees, and were not associated with angiotensin convertase inhibitors (ACEi) or β-adrenergic antagonists use. Systemic reactions were observed in 4 individuals on wasp VIT (2.7%) and in 6 patients allergic to bees (17.65%). The VIT was efficacious as most patients reported no reactions (50%) or reported only mild local reactions (43.75%) to field stings. The decrease in sIgE at completion of VIT correlated with the dose of vaccine received ( r = 0.53, p = 0.004). Beekeeping (RR = 29.54, p venom allergy. Venom immunotherapy is highly efficacious and safe as most of the adverse events during the induction and maintenance phase are mild and local. Side effects of VIT are more common in subjects on bee VIT. Beekeeping and female sex are associated with a higher risk of allergy to Hymenoptera venom.

  15. Safety, Efficacy and Recurrence rate following tenosynovectomy and ...

    African Journals Online (AJOL)

    Objective: This study was conducted to compare the safety, efficacy and recurrence rate of primary tenosynovectomy versus intralesional steroid injection in the treatment of sclerosing tenosynovitis of deQuervain. Method: A prospective, comparative study of the safety, efficacy and recurrence rate following intralesional ...

  16. Efficacy and safety of histamine-2 receptor antagonists

    NARCIS (Netherlands)

    van der Pol, Rachel; Langendam, Miranda; Benninga, Marc; van Wijk, Michiel; Tabbers, Merit

    2014-01-01

    Histamine-2 receptor antagonists (H2RAs) are frequently used in the treatment of gastroesophageal reflux disease (GERD) in children; however, their efficacy and safety is questionable. To systematically review the literature to assess the efficacy and safety of H2RAs in pediatric GERD. PubMed,

  17. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial

    NARCIS (Netherlands)

    van Kerrebroeck, Philip; Chapple, Christopher; Drogendijk, Ted; Klaver, Monique; Sokol, Roman; Speakman, Mark; Traudtner, Klaudia; Drake, Marcus J.; Kiss, G.; Marberger, M.; Strotski, A. V.; Varaksa, A. N.; Vashchula, V.; Dewilde, T.; Braeckman, J.; Roumeguere, T.; Wyndaele, J. J.; Ameye, F.; Everaert, K.; van Cleynenbruegel, B.; de Leval, J.; Vanderkerken, J.; Ackaert, K.; Hiblbauer, J.; Zhanel, P.; Klecka, J.; Lukes, M.; Novak, J.; Lisec, M.; Vrtal, R.; Ondra, D.; Liehne, J.; Tuma, J.; Azzouzi, A.-R.; Wellerand, H.; Jung, J.-L.; Mourey, E.; Colombel, M.; Claude, R.; Ibrahim, H.; Desgrandchamps, F.; Haab, F.; Zerbib, M.; Ruffion, A.; Vincendeau, S.; Haillot, O.; Hentschel, M.; Gerhardt, U.; Hechelmann, W.; de la Rosette, J.

    2013-01-01

    Storage symptoms are particularly bothersome in men with lower urinary tract symptoms (LUTS) but may not be adequately treated by α-blocker monotherapy. To assess the efficacy and safety of a fixed-dose combination (FDC) of solifenacin and an oral controlled absorption system (OCAS) formulation of

  18. Safety system function trends

    International Nuclear Information System (INIS)

    Johnson, C.

    1989-01-01

    This paper describes research to develop risk-based indicators of plant safety performance. One measure of the safety-performance of operating nuclear power plants is the unavailability of important safety systems. Brookhaven National Laboratory and Science Applications International Corporation are evaluating ways to aggregate train-level or component-level data to provide such an indicator. This type of indicator would respond to changes in plant safety margins faster than the currently used indicator of safety system unavailability (i.e., safety system failures reported in licensee event reports). Trends in the proposed indicator would be one indication of trends in plant safety performance and maintenance effectiveness. This paper summarizes the basis for such an indicator, identifies technical issues to be resolved, and illustrates the potential usefullness of such indicators by means of computer simulations and case studies

  19. Development of intramammary delivery systems containing lasalocid for the treatment of bovine mastitis: impact of solubility improvement on safety, efficacy, and milk distribution in dairy cattle

    Science.gov (United States)

    Wang, Wen; Song, Yunmei; Petrovski, Kiro; Eats, Patricia; Trott, Darren J; Wong, Hui San; Page, Stephen W; Perry, Jeanette; Garg, Sanjay

    2015-01-01

    Background Mastitis is a major disease of dairy cattle. Given the recent emergence of methicillin-resistant Staphylococcus aureus as a cause of bovine mastitis, new intramammary (IMA) treatments are urgently required. Lasalocid, a member of the polyether ionophore class of antimicrobial agents, has not been previously administered to cows by the IMA route and has favorable characteristics for development as a mastitis treatment. This study aimed to develop an IMA drug delivery system (IMDS) of lasalocid for the treatment of bovine mastitis. Methods Minimum inhibitory concentrations (MICs) were determined applying the procedures recommended by the Clinical and Laboratory Standards Institute. Solid dispersions (SDs) of lasalocid were prepared and characterized using differential scanning calorimetry and Fourier transform infrared spectroscopy. IMDSs containing lasalocid of micronized, nano-sized, or as SD form were tested for their IMA safety in cows. Therapeutic efficacy of lasalocid IMDSs was tested in a bovine model involving experimental IMA challenge with the mastitis pathogen Streptococcus uberis. Results Lasalocid demonstrated antimicrobial activity against the major Gram-positive mastitis pathogens including S. aureus (MIC range 0.5–8 μg/mL). The solubility test confirmed limited, ion-strength-dependent water solubility of lasalocid. A kinetic solubility study showed that SDs effectively enhanced water solubility of lasalocid (21–35-fold). Polyvinylpyrrolidone (PVP)-lasalocid SD caused minimum mammary irritation in treated cows and exhibited faster distribution in milk than either nano or microsized lasalocid. IMDSs with PVP-lasalocid SD provided effective treatment with a higher mastitis clinical and microbiological cure rate (66.7%) compared to cloxacillin (62.5%). Conclusion Lasalocid SD IMDS provided high cure rates and effectiveness in treating bovine mastitis with acceptable safety in treated cows. PMID:25653501

  20. Development of intramammary delivery systems containing lasalocid for the treatment of bovine mastitis: impact of solubility improvement on safety, efficacy, and milk distribution in dairy cattle.

    Science.gov (United States)

    Wang, Wen; Song, Yunmei; Petrovski, Kiro; Eats, Patricia; Trott, Darren J; Wong, Hui San; Page, Stephen W; Perry, Jeanette; Garg, Sanjay

    2015-01-01

    Mastitis is a major disease of dairy cattle. Given the recent emergence of methicillin-resistant Staphylococcus aureus as a cause of bovine mastitis, new intramammary (IMA) treatments are urgently required. Lasalocid, a member of the polyether ionophore class of antimicrobial agents, has not been previously administered to cows by the IMA route and has favorable characteristics for development as a mastitis treatment. This study aimed to develop an IMA drug delivery system (IMDS) of lasalocid for the treatment of bovine mastitis. Minimum inhibitory concentrations (MICs) were determined applying the procedures recommended by the Clinical and Laboratory Standards Institute. Solid dispersions (SDs) of lasalocid were prepared and characterized using differential scanning calorimetry and Fourier transform infrared spectroscopy. IMDSs containing lasalocid of micronized, nano-sized, or as SD form were tested for their IMA safety in cows. Therapeutic efficacy of lasalocid IMDSs was tested in a bovine model involving experimental IMA challenge with the mastitis pathogen Streptococcus uberis. Lasalocid demonstrated antimicrobial activity against the major Gram-positive mastitis pathogens including S. aureus (MIC range 0.5-8 μg/mL). The solubility test confirmed limited, ion-strength-dependent water solubility of lasalocid. A kinetic solubility study showed that SDs effectively enhanced water solubility of lasalocid (21-35-fold). Polyvinylpyrrolidone (PVP)-lasalocid SD caused minimum mammary irritation in treated cows and exhibited faster distribution in milk than either nano or microsized lasalocid. IMDSs with PVP-lasalocid SD provided effective treatment with a higher mastitis clinical and microbiological cure rate (66.7%) compared to cloxacillin (62.5%). Lasalocid SD IMDS provided high cure rates and effectiveness in treating bovine mastitis with acceptable safety in treated cows.

  1. Retrospective Evaluation of Safety, Efficacy and Risk Factors for Pneumothorax in Simultaneous Localizations of Multiple Pulmonary Nodules Using Hook Wire System.

    Science.gov (United States)

    Zhong, Yan; Xu, Xiao-Quan; Pan, Xiang-Long; Zhang, Wei; Xu, Hai; Yuan, Mei; Kong, Ling-Yan; Pu, Xue-Hui; Chen, Liang; Yu, Tong-Fu

    2017-09-01

    To evaluate the safety and efficacy of the hook wire system in the simultaneous localizations for multiple pulmonary nodules (PNs) before video-assisted thoracoscopic surgery (VATS), and to clarify the risk factors for pneumothorax associated with the localization procedure. Between January 2010 and February 2016, 67 patients (147 nodules, Group A) underwent simultaneous localizations for multiple PNs using a hook wire system. The demographic, localization procedure-related information and the occurrence rate of pneumothorax were assessed and compared with a control group (349 patients, 349 nodules, Group B). Multivariate logistic regression analyses were used to determine the risk factors for pneumothorax during the localization procedure. All the 147 nodules were successfully localized. Four (2.7%) hook wires dislodged before VATS procedure, but all these four lesions were successfully resected according to the insertion route of hook wire. Pathological diagnoses were acquired for all 147 nodules. Compared with Group B, Group A demonstrated significantly longer procedure time (p pneumothorax (p = 0.019). Multivariate logistic regression analysis indicated that position change during localization procedure (OR 2.675, p = 0.021) and the nodules located in the ipsilateral lung (OR 9.404, p pneumothorax. Simultaneous localizations for multiple PNs using a hook wire system before VATS procedure were safe and effective. Compared with localization for single PN, simultaneous localizations for multiple PNs were prone to the occurrence of pneumothorax. Position change during localization procedure and the nodules located in the ipsilateral lung were independent risk factors for pneumothorax.

  2. Ablation of atrial fibrillation with the Epicor system: a prospective observational trial to evaluate safety and efficacy and predictors of success

    Directory of Open Access Journals (Sweden)

    Diez Claudius

    2010-05-01

    Full Text Available Abstract Background High intensity focused ultrasound (HIFU energy has evolved as a new surgical tool to treat atrial fibrillation (AF. We evaluated safety and efficacy of AF ablation with HIFU and analyzed predictors of success in a prospective clinical study. Methods From January 2007 to June 2008, 110 patients with AF and concomitant open heart surgery were enrolled into the study. Main underlying heart diseases were aortic valve disease (50%, ischemic heart disease (48%, and mitral valve disease (18%. AF was paroxysmal in 29%, persistent in 31%, and long standing persistent in 40% of patients, lasting for 1 to 240 months (mean 24 months. Mean left atrial diameter was 50 ± 7 mm. Each patient underwent left atrial ablation with the Epicor system prior to open heart surgery. After surgery, the patients were treated with amiodarone and coumadin for 6 months. Follow-up studies including resting ECG, 24 h Holter ECG, and echocardiography were obtained at 6 and 12 months. Results All patients had successful application of the system on the beating heart prior to initiation of extracorporeal circulation. On average, 11 ± 1 ultrasound transducer elements were used to create the box lesion. The hand-held probe for additional linear lesions was employed in 83 cases. No device-related deaths occurred. Postoperative pacemaker insertion was necessary in 4 patients. At 6 months, 62% of patients presented with sinus rhythm. No significant changes were noted at 12 months. Type of AF and a left atrial diameter > 50 mm were predictors for failure of AF ablation. Conclusion AF ablation with the Epicor system as a concomitant procedure during open heart surgery is safe and acceptably effective. Our overall conversion rate was lower than in previously published reports, which may be related to the lower proportion of isolated mitral valve disease in our study population. Left atrial size may be useful to determine patients who are most likely to benefit from

  3. Development of intramammary delivery systems containing lasalocid for the treatment of bovine mastitis: impact of solubility improvement on safety, efficacy, and milk distribution in dairy cattle

    Directory of Open Access Journals (Sweden)

    Wang W

    2015-01-01

    Full Text Available Wen Wang,1 Yunmei Song,1 Kiro Petrovski,2 Patricia Eats,2 Darren J Trott,2 Hui San Wong,2 Stephen W Page,3 Jeanette Perry,2 Sanjay Garg11School of Pharmacy and Medical Science, University of South Australia, Adelaide, SA, Australia; 2School of Animal and Veterinary Sciences, University of Adelaide, Adelaide, SA, Australia; 3Luoda Pharma Pty Ltd, Caringbah, NSW, AustraliaBackground: Mastitis is a major disease of dairy cattle. Given the recent emergence of methicillin-resistant Staphylococcus aureus as a cause of bovine mastitis, new intramammary (IMA treatments are urgently required. Lasalocid, a member of the polyether ionophore class of antimicrobial agents, has not been previously administered to cows by the IMA route and has favorable characteristics for development as a mastitis treatment. This study aimed to develop an IMA drug delivery system (IMDS of lasalocid for the treatment of bovine mastitis.Methods: Minimum inhibitory concentrations (MICs were determined applying the procedures recommended by the Clinical and Laboratory Standards Institute. Solid dispersions (SDs of lasalocid were prepared and characterized using differential scanning calorimetry and Fourier transform infrared spectroscopy. IMDSs containing lasalocid of micronized, nano-sized, or as SD form were tested for their IMA safety in cows. Therapeutic efficacy of lasalocid IMDSs was tested in a bovine model involving experimental IMA challenge with the mastitis pathogen Streptococcus uberis.Results: Lasalocid demonstrated antimicrobial activity against the major Gram-positive mastitis pathogens including S. aureus (MIC range 0.5–8 µg/mL. The solubility test confirmed limited, ion-strength-dependent water solubility of lasalocid. A kinetic solubility study showed that SDs effectively enhanced water solubility of lasalocid (21–35-fold. Polyvinylpyrrolidone (PVP-lasalocid SD caused minimum mammary irritation in treated cows and exhibited faster distribution in milk than

  4. Comparison of the efficacy and safety of budesonide turbuhaler ...

    African Journals Online (AJOL)

    Comparison of the efficacy and safety of budesonide turbuhaler administered once daily with twice the dose of beclomethasone dipropionate using pressurised metered dose inhaler in patients with mild to moderate asthma.

  5. Preclinical efficacy and safety of herbal formulation for management ...

    African Journals Online (AJOL)

    Preclinical efficacy and safety of herbal formulation for management of wounds. ... The effects of the treatments on rate of wound closure, epithelialisation time ... inflammation and better tissue remodeling for rats treated with herbal product.

  6. The Efficacy and Safety of the Combination of Total Glucosides of Peony and Leflunomide for the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Zhitao Feng

    2016-01-01

    Full Text Available Objective. To evaluate the efficacy and safety of the total glucosides of peony (TGP and leflunomide (LEF for the treatment of rheumatoid arthritis (RA. Methods. Randomized controlled trials (RCTs on the efficacy and safety of the combination of TGP and LEF versus LEF alone for the treatment of RA were retrieved by searching PubMed, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, and Wanfang database. Results. Eight RCTs including 643 RA patients were included in the present meta-analysis. The quality of included studies was poor. The levels of ESR (P<0.0001, CRP (P<0.0001, and RF (P<0.0001 in RA patients who received the combination of TGP and LEF were significantly lower than RA patients who received LEF therapy alone. The pooled results suggest that the combination of TGP and LEF caused less abnormal liver function than LEF alone (P=0.02. No significant difference in the gastrointestinal discomfort was identified between the combination of TGP and LEF and LEF alone groups (P=0.18. Conclusion. The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

  7. The Efficacy and Safety of the Combination of Total Glucosides of Peony and Leflunomide for the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis.

    Science.gov (United States)

    Feng, Zhitao; Xu, Juan; He, Guochao; Cao, Meiqun; Duan, Lihong; Chen, Liguo; Wu, Zhengzhi

    2016-01-01

    Objective. To evaluate the efficacy and safety of the total glucosides of peony (TGP) and leflunomide (LEF) for the treatment of rheumatoid arthritis (RA). Methods. Randomized controlled trials (RCTs) on the efficacy and safety of the combination of TGP and LEF versus LEF alone for the treatment of RA were retrieved by searching PubMed, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, and Wanfang database. Results. Eight RCTs including 643 RA patients were included in the present meta-analysis. The quality of included studies was poor. The levels of ESR (P TGP and LEF were significantly lower than RA patients who received LEF therapy alone. The pooled results suggest that the combination of TGP and LEF caused less abnormal liver function than LEF alone (P = 0.02). No significant difference in the gastrointestinal discomfort was identified between the combination of TGP and LEF and LEF alone groups (P = 0.18). Conclusion. The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

  8. Safety system status monitoring

    International Nuclear Information System (INIS)

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

    1984-03-01

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

  9. Safety system status monitoring

    Energy Technology Data Exchange (ETDEWEB)

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

    1984-03-01

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

  10. Biologics in pediatric psoriasis - efficacy and safety.

    Science.gov (United States)

    Dogra, Sunil; Mahajan, Rahul

    2018-01-01

    Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety. Areas covered: We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using the MeSH words 'biologics', 'biologic response modifiers' and 'treatment of pediatric/childhood psoriasis'. All clinical trials, randomized double-blind or single-blind controlled trials, open-label studies, retrospective studies, reviews, case reports and letters concerning the use of biologics in pediatric psoriasis were screened. Articles covering the use of biologics in pediatric psoriasis were screened and reference lists in the selected articles were scrutinized to identify other relevant articles that had not been found in the initial search. Articles without relevant information about biologics in general (e.g. its mechanism of action, pharmacokinetics and adverse effects) and its use in psoriasis in particular were excluded. We screened 427 articles and finally selected 41 relevant articles. Expert opinion: The available literature on the use of biologics such as anti-tumor necrosis factor (TNF)-α agents, and anti-IL-12/23 agents like ustekinumab suggests that these are effective and safe in managing severe pediatric psoriasis although there is an urgent need to generate more safety data. Dermatologists must be careful about the potential adverse effects of the biologics before administering them to children with psoriasis. It is likely that with rapidly evolving scenario of biologics in psoriasis, these will prove to be very useful molecules particularly in managing severe and recalcitrant

  11. Efficacy and safety of solifenacin plus tamsulosin oral controlled absorption system in men with lower urinary tract symptoms: a meta-analysis

    Directory of Open Access Journals (Sweden)

    Ming-Chao Li

    2015-02-01

    Full Text Available We performed a meta-analysis to compare treatment with a combination of solifenacin plus tamsulosin oral controlled absorption system (TOCAS with placebo or TOCAS monotherapy. The aim of the meta-analysis was to clarify the efficacy and safety of the combination treatments method for lower urinary tract symptoms (LUTS. We searched for trials of men with LUTS that were randomized to combination treatment compared with TOCAS monotherapy or placebo. We pooled data from three placebo-controlled trials meeting inclusion criteria. Primary outcomes of interest included changes in International Prostate Symptom Score (IPSS and urinary frequency. We also assessed postvoid residual, maximum urinary flow rate, incidence of urinary retention (UR, adverse events. Data were pooled using random or fixed effect models for continuous outcomes and the Mantel-Haenszel method to generate risk ratio. Reductions in IPSS storage subscore and total urgency and frequency score (TUFS were observed with solifenacin 6 mg plus TOCAS compared with placebo (P< 0.0001 and P< 0.0001, respectively. Reductions in IPSS storage subscore and TUFS were observed with solifenacin 9 mg plus TOCAS compared with placebo (P = 0.003 and P= 0.0006, respectively. Reductions in TUFS was observed with solifenacin 6 mg plus TOCAS compared with TOCAS (P = 0.01. Both combination treatments were well tolerated, with low incidence of UR. Solifenacin 6 mg plus TOCAS significantly improved total IPSS, storage and voiding symptoms compared with placebo. Solifenacin 6 mg plus TOCAS also improved storage symptoms compared with TOCAS alone. There was no additional benefit of solifenacin 9 mg compared with 6 mg when used in combination with TOCAS.

  12. Reactor safety systems

    International Nuclear Information System (INIS)

    Kafka, P.

    1975-01-01

    The spectrum of possible accidents may become characterized by the 'maximum credible accident', which will/will not happen. Similary, the performance of safety systems in a multitude of situations is sometimes simplified to 'the emergency system will/will not work' or even 'reactors are/ are not safe'. In assessing safety, one must avoid this fallacy of reducing a complicated situation to the simple black-and-white picture of yes/no. Similarly, there is a natural tendency continually to improve the safety of a system to assure that it is 'safe enough'. Any system can be made safer and there is usually some additional cost. It is important to balance the increased safety against the increased costs. (orig.) [de

  13. Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

    Science.gov (United States)

    Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

    2017-01-01

    Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

  14. Desonide: a review of formulations, efficacy and safety.

    Science.gov (United States)

    Kahanek, Nr; Gelbard, Cg; Hebert, Aa

    2008-07-01

    Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

  15. MR arthrography: pharmacology, efficacy and safety in clinical trials

    International Nuclear Information System (INIS)

    Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

    2003-01-01

    A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

  16. Software system safety

    Science.gov (United States)

    Uber, James G.

    1988-01-01

    Software itself is not hazardous, but since software and hardware share common interfaces there is an opportunity for software to create hazards. Further, these software systems are complex, and proven methods for the design, analysis, and measurement of software safety are not yet available. Some past software failures, future NASA software trends, software engineering methods, and tools and techniques for various software safety analyses are reviewed. Recommendations to NASA are made based on this review.

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

    Directory of Open Access Journals (Sweden)

    White H

    2014-08-01

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

  18. Reactor Safety Assessment System

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  19. Reactor safety assessment system

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSA is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  20. Safety Information System Guide

    International Nuclear Information System (INIS)

    Bullock, M.G.

    1977-03-01

    This Guide provides guidelines for the design and evaluation of a working safety information system. For the relatively few safety professionals who have already adopted computer-based programs, this Guide may aid them in the evaluation of their present system. To those who intend to develop an information system, it will, hopefully, inspire new thinking and encourage steps towards systems safety management. For the line manager who is working where the action is, this Guide may provide insight on the importance of accident facts as a tool for moving ideas up the communication ladder where they will be heard and acted upon; where what he has to say will influence beneficial changes among those who plan and control his operations. In the design of a safety information system, it is suggested that the safety manager make friends with a computer expert or someone on the management team who has some feeling for, and understanding of, the art of information storage and retrieval as a new and better means for communication

  1. Programmable electronic safety systems

    International Nuclear Information System (INIS)

    Parry, R.R.

    1993-01-01

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

  2. Programmable Electronic Safety Systems

    International Nuclear Information System (INIS)

    Parry, R.

    1993-05-01

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

  3. Efficacy and safety of methimazole ointment for patients with hyperthyroidism.

    Science.gov (United States)

    Wu, Xi; Liu, Hong; Zhu, Xixing; Shen, Jun; Shi, Yongquan; Liu, Zhimin; Gu, Mingjun; Song, Zhimin

    2013-11-01

    Oral methimazole has been widely used to treat hyperthyroidism, but its usage is restricted by its adverse systemic effects. The aim of this study was to investigate the efficacy and safety of methimazole ointment for the treatment of hyperthyroidism. One hundred forty-four subjects with hyperthyroidism were initially enrolled. These patients were initially divided into two groups and given the following treatments for 12 weeks: patients in group A received 5% methimazole ointment applied to the skin around the thyroid and an oral placebo; and patients in group B received methimazole tablets and placebo ointment. One hundred thirty-one subjects were included in the final analysis. Therapeutic efficacy was assessed via the levels of free triiodothyronine and thyroxine in the serum and by biweekly monitoring of the symptoms of thyrotoxicosis. Adverse effects were recorded. Fifty-nine (89.40%) patients in group A and 57 (87.69%) patients in group B were euthyroid and experienced alleviation of thyrotoxicosis symptoms (complete control; p>0.05). The median times required to achieve complete control for the patients in the two groups were 6.5 weeks and 6.4 weeks for groups A and B, respectively (p>0.05). Systemic adverse effects (e.g., rash, liver dysfunction, leucopenia, etc.) were significantly less common in group A (1.5%) than in group B (12.3%; peffects in patients with hyperthyroidism. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. Polyhexanide - safety and efficacy as an antiseptic.

    Science.gov (United States)

    Fjeld, Hilde; Lingaas, Egil

    2016-05-01

    BACKGROUND Polyhexamethylene biguanide hydrochloride/polyhexanide/polyaminopropyl biguanide (PHMB) is used as a disinfectant and antiseptic. This article discusses the use of the substance as an antiseptic. We summarise published data on its antimicrobial effect in vitro and its clinical effect and safety when used on skin, wounds and mucosa.MATERIAL AND METHOD A literature search was conducted in PubMed for articles published in the last five years. Articles available as of June 2014 were considered.RESULTS Of 332 articles identified, 27 were included. In vitro studies have demonstrated an antimicrobial effect on Gram-negative bacteria, Gram-positive bacteria and Candida albicans. The clinical studies are small, not well controlled and frequently sponsored by industry. Few adverse effects from the substance were reported.INTERPRETATION Better designed, larger-scale clinical studies of effect and safety are needed in order to give recommendations on the use of polyhexanide on skin, wounds and mucosa.

  5. Systems Safety and Engineering Division

    Data.gov (United States)

    Federal Laboratory Consortium — Volpe's Systems Safety and Engineering Division conducts engineering, research, and analysis to improve transportation safety, capacity, and resiliency. We provide...

  6. Clinical efficacy and safety of edaravone therapy in acute cerebral ...

    African Journals Online (AJOL)

    Purpose: To evaluate the clinical efficacy and safety of edaravone in the treatment of acute cerebral haemorrhage (ACH). Methods: This study recruited 120 patients who developed ACH. The patients were divided into control and treatment groups with 60 patients per group. The control group underwent conventional ...

  7. Efficacy and safety of telmisartan monotherapy in the black ...

    African Journals Online (AJOL)

    The use of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in addition to control of blood pressure delays the development of end organ damage associated with hypertension. This study was undertaken to investigate the efficacy and safety of telmisartan as monotherapy in Nigerian black ...

  8. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

  9. Safety and efficacy of procedural sedation and analgesia (PSA ...

    African Journals Online (AJOL)

    Safety and efficacy of procedural sedation and analgesia (PSA) conducted by medical officers in a level 1 hospital in Cape Town. ... Respiratory complications were treated with simple airway manoeuvres; no patient required intubation or experienced respiratory problems after waking up. There was no significant difference ...

  10. Efficacy and safety of ginger in osteoarthritis patients

    DEFF Research Database (Denmark)

    Bartels, E M; Folmer, V N; Bliddal, Henning

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing ...

  11. Safety and efficacy of opicinumab in acute optic neuritis (RENEW)

    DEFF Research Database (Denmark)

    Cadavid, Diego; Balcer, Laura J; Galetta, Steven L

    2017-01-01

    BACKGROUND: The human monoclonal antibody opicinumab (BIIB033, anti-LINGO-1) has shown remyelinating activity in preclinical studies. We therefore assessed the safety and tolerability, and efficacy of opicinumab given soon after a first acute optic neuritis episode. METHODS: This randomised, doub...

  12. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  13. Hospital disinfection: efficacy and safety issues.

    Science.gov (United States)

    Dettenkofer, Markus; Block, Colin

    2005-08-01

    To review recent publications relevant to hospital disinfection (and cleaning) including the reprocessing of medical instruments. The key question as to whether the use of disinfectants on environmental surfaces rather than cleaning with detergents only reduces nosocomial infection rates still awaits conclusive studies. New disinfectants, mainly peroxygen compounds, show good sporicidal properties and will probably replace more problematical substances such as chlorine-releasing agents. The safe reprocessing of medical devices requires a well-coordinated approach, starting with proper cleaning. New methods and substances show promising activity for preventing the transmission of prions. Different aspects of virus inactivation have been studied, and the transmissibility, e.g. of norovirus, shows the need for sound data on how different disinfectant classes perform. Biofilms or other forms of surface-adherent organisms pose an extraordinary challenge to decontamination. Although resistance to biocides is generally not judged to be as critical as antibiotic resistance, scientific data support the need for proper use, i.e. the avoidance of widespread application, especially in low concentrations and in consumer products. Chemical disinfection of heat-sensitive instruments and targeted disinfection of environmental surfaces are established components of hospital infection control. To avoid danger to staff, patients and the environment, prudent use as well as established safety precautions are required. New technologies and products should be evaluated with sound methods. As emerging resistant pathogens will challenge healthcare facilities in the future even more than at present, there is a need for well-designed studies addressing the role of disinfection in hospital infection control.

  14. A systemic review and meta-analysis of the clinical efficacy and safety of total glucosides of peony combined with methotrexate in rheumatoid arthritis.

    Science.gov (United States)

    Feng, Zhi-Tao; Xu, Juan; He, Guo-Chao; Cai, San-Jin; Li, Juan; Mei, Zhi-Gang

    2018-01-01

    To assess the efficacy and safety of the combination of total glucoside of peony (TGP) and methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). Randomized controlled trial (RCT) data on the traditional Chinese active component TGP combined with MTX vs. MTX alone for the treatment of RA was collected by searching the Pubmed, Embase, Cochrane Library, CNKI, VIP Journals database, and Wanfang database up to February 2017. Study selection, data extraction, data synthesis, and data analyses were performed according to the Cochrane standards. A total of eight RCTs involving 522 participants were included in this meta-analysis. Compared with MTX alone, the use of TGP combined with MTX exhibited better therapeutic effects for the treatment of RA (P = 0.004). In addition, TGP combined with MTX caused a more significant decrease in erythrocyte sedimentation rate (ESR) (P TGP and MTX combination group (P = 0.0007). Our study demonstrates that TGP combined with MTX is more effective than MTX alone for the treatment of RA. Nevertheless, the adverse effects of the combination of TGP and MTX need to be further assessed. Due to the poor methodological quality of included trials, well-designed, multi-center, and large-scale RCTs are necessary to draw a more definitive conclusion.

  15. Safety of huge systems

    International Nuclear Information System (INIS)

    Kondo, Jiro.

    1995-01-01

    Recently accompanying the development of engineering technology, huge systems tend to be constructed. The disaster countermeasures of huge cities become large problems as the concentration of population into cities is conspicuous. To make the expected value of loss small, the knowledge of reliability engineering is applied. In reliability engineering, even if a part of structures fails, the safety as a whole system must be ensured, therefore, the design having margin is carried out. The degree of margin is called redundancy. However, such design concept makes the structure of a system complex, and as the structure is complex, the possibility of causing human errors becomes high. At the time of huge system design, the concept of fail-safe is effective, but simple design must be kept in mind. The accident in Mihama No. 2 plant of Kansai Electric Power Co. and the accident in Chernobyl nuclear power station, and the accident of Boeing B737 airliner and the fatigue breakdown are described. The importance of safety culture was emphasized as the method of preventing human errors. Man-system interface and management system are discussed. (K.I.)

  16. Nuclear reactor safety system

    International Nuclear Information System (INIS)

    Ball, R.M.; Roberts, R.C.

    1983-01-01

    The invention provides a safety system for a nuclear reactor which uses a parallel combination of computer type look-up tables each of which receives data on a particular parameter (from transducers located in the reactor system) and each of which produces the functional counterpart of that particular parameter. The various functional counterparts are then added together to form a control signal for shutting down the reactor. The functional counterparts are developed by analysis of experimental thermal and hydraulic data, which are used to form expressions that define safe conditions

  17. Nuclear reactor safety systems

    International Nuclear Information System (INIS)

    Ball, R.M.; Roberts, R.C.

    1980-01-01

    A safety system for shutting down a nuclear reactor under overload conditions is described. The system includes a series of parallel-connected computer memory type look-up tables each of which receives data on a particular reactor parameter and in each of which a precalculated functional value for that parameter is stored indicative of the percentage of maximum reactor load that the parameter contributes. The various functional values corresponding to the actual measured parameters are added together to provide a control signal used to shut down the reactor under overload conditions. (U.K.)

  18. The efficacy and safety of dual blockage of the renin-angiotensin-aldosterone system in patients with type 2 diabetes, hypertension and obesity without renal dysfunction

    Directory of Open Access Journals (Sweden)

    2012-09-01

    Full Text Available The purpose of the study was to evaluate the clinical efficacy and safety of dual RAAS blockage during treatment with angiotensin-converting enzyme (ACE inhibitors in combination with a direct renin inhibitor (PIR aliskiren versus combination therapy with ACE inhibitors and angiotensin receptor blocker II (ARB valsartan in patients with type 2 diabetes mellitus (T2DM, arterial hypertension (AH and obesity, without renal dysfunction. Materials and methods. The study included 26 patients with T2DM (10 men and 16 women, mean age 59,0±6,2 years with inadequate control of blood pressure (over 130 and/or 80 mm Hg on prior antihypertensive therapy and without renal dysfunctions (glomerular filtration rate (GFR> 60 ml/min/1, 73 m2 and the of albumin/creatinine (A/C ratio in the morning urine sample <10 mg/mol. After screening with the continuation of the initial therapy, including ACE inhibitors, 14 patients were added aliskiren 150–300 mg/day, 12 patients – valsartan 80–160 mg/day. Evaluation of the treatment effectiveness in terms of blood pressure (mean of three consecutive measurements in the sitting position and the parameters of renal function (serum creatinine and potassium, GFR, A/C ratio in the urine was performed at 4, 12 and 24 weeks of therapy. Results. In the group of patients treated with aliskiren, after 4 weeks of treatment a significant decrease in systolic and diastolic blood pressure (SBP and DBP, respectively was noted as compared to baseline: 146,1 and 138,9 mm Hg, p<0,05, 87,1 and 81,1 mm Hg, p <0,05, respectively; with systolic BP after 24 weeks of treatment decreased to 127,8 (-18,2 mm Hg, p<0,05, diastolic BP to 75,0 (-12, 1 mm Hg, p<0,05, the target blood pressure (≤130/80 mm Hg was achieved in 83% of patients. The group of patients treated with valsartan, after 4 weeks of therapy showed a significant reduction in systolic BP 148 and 141,6 mm Hg, p <0,05, diastolic BP - to 85,8 and 81,7 mm Hg, p=0,059; after 24 weeks

  19. Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk

    DEFF Research Database (Denmark)

    De Backer, Ole; Götberg, Matthias; Ihlberg, Leo

    2016-01-01

    increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC......)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3...

  20. Anticonvulsant treatment of asphyxiated newborns under hypothermia with lidocaine : efficacy, safety and dosing

    NARCIS (Netherlands)

    van den Broek, Marcel P. H.; Rademaker, Carin M. A.; van Straaten, Henrica L. M.; Huitema, Alwin D. R.; Toet, Mona C.; de Vries, Linda S.; Egberts, Antoine C. G.; Groenendaal, Floris

    BACKGROUND: Lidocaine is an antiarrythmicum used as an anticonvulsant for neonatal seizures, also during therapeutic hypothermia following (perinatal) asphyxia. Hypothermia may affect the efficacy, safety and dosing of lidocaine in these patients. OBJECTIVE: To study the efficacy and safety of

  1. Determining animal drug combinations based on efficacy and safety.

    Science.gov (United States)

    Kratzer, D D; Geng, S

    1986-08-01

    A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

  2. Safety and efficacy of aneurysm treatment with WEB

    DEFF Research Database (Denmark)

    Pierot, Laurent; Costalat, Vincent; Moret, Jacques

    2016-01-01

    OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide......-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical....... RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting...

  3. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

    Science.gov (United States)

    Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

    2010-01-01

    Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

  4. Sibutramine: efficacy and safety of prescribing in routine clinical practice

    Directory of Open Access Journals (Sweden)

    Tat'yana Ivanovna Romantsova

    2015-11-01

    Full Text Available The 17th European Congress of endocrinology was held in Dublin in May 2015. Within the section «Obesity» the preliminary results of the observational program "PRIMAVERA" in the form of an oral report were presented. This article presents a brief review of the literature, reflecting the issues of mechanism of action, efficacy and safety of sibutramine and also includes an extended version of the main provisions of the report.

  5. Testosterone Replacement Therapy: Long-Term Safety and Efficacy

    Directory of Open Access Journals (Sweden)

    Giovanni Corona

    2017-08-01

    Full Text Available Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG or late-onset hypogonadism (LOH. The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T therapy (TTh. In addition, concerns related to cardiovascular (CV safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented.

  6. EFFICACY AND SAFETY OF THE INFLUENZA VACCINE AMONG CHILDREN WITH DIFFERENT HEALTH CONDITIONS

    OpenAIRE

    M.G. Galitskaya

    2007-01-01

    Efficacy and safety of vaccine «Grippol» among children with different health status was analyzed. The most efficacy of the influenza vaccine revealed in the group of children with compromised health status, as well as in the group of allergic children. The safety of influenza vaccination was confirmed in children with different health conditions.Key words: children, vaccination, influenza, efficacy, safety.

  7. Safety significance evaluation system

    International Nuclear Information System (INIS)

    Lew, B.S.; Yee, D.; Brewer, W.K.; Quattro, P.J.; Kirby, K.D.

    1991-01-01

    This paper reports that the Pacific Gas and Electric Company (PG and E), in cooperation with ABZ, Incorporated and Science Applications International Corporation (SAIC), investigated the use of artificial intelligence-based programming techniques to assist utility personnel in regulatory compliance problems. The result of this investigation is that artificial intelligence-based programming techniques can successfully be applied to this problem. To demonstrate this, a general methodology was developed and several prototype systems based on this methodology were developed. The prototypes address U.S. Nuclear Regulatory Commission (NRC) event reportability requirements, technical specification compliance based on plant equipment status, and quality assurance assistance. This collection of prototype modules is named the safety significance evaluation system

  8. Evaluating safety management system implementation

    International Nuclear Information System (INIS)

    Preuss, M.

    2009-01-01

    Canada is committed to not only maintaining, but also improving upon our record of having one of the safest aviation systems in the world. The development, implementation and maintenance of safety management systems is a significant step towards improving safety performance. Canada is considered a world leader in this area and we are fully engaged in implementation. By integrating risk management systems and business practices, the aviation industry stands to gain better safety performance with less regulatory intervention. These are important steps towards improving safety and enhancing the public's confidence in the safety of Canada's aviation system. (author)

  9. Safety and efficacy of the Aperio thrombectomy device when compared to the Solitaire AB/FR and the Revive devices in a pulsatile flow system.

    Science.gov (United States)

    Saleh, Mahdi; Spence, John Nathan; Nayak, Sanjeev; Pearce, Gillian; Tennuci, Christopher; Roffe, Christine

    2012-01-01

    There are a limited number of studies comparing the Aperio mechanical thrombectomy device to other stent-based devices. In this paper, we compared the Aperio thrombectomy device to the Solitaire AB, FR and Revive devices in a model of the middle cerebral artery (MCA) within a modified pulsatile flow system. Thrombi made of lamb's blood were placed into a pulsatile flow system perfused with Hartmann's solution at 80 bpm with a mean pressure of 90 mm Hg. 30 experiments were run with each device. Recanalization rates were similar for all three devices (90% with the Solitaire AB, FR, 80% with the Revive, and 90% with the Aperio). The mean number of attempts to retrieve the thrombus was also similar for all three devices (1.7 with the Solitaire AB, FR, 2.1 with the Revive, 1.6 with the Aperio). Clot fragmentation and embolization rates revealed no statistical significance but there was a trend towards lower embolization rates with the Aperio (23% compared to 40% with the Solitaire AB, FR and 47% with the Revive). The Aperio was the fastest to recanalize the MCA (mean of 66 seconds compared to 186 seconds for the Solitaire AB, FR and 169 seconds for the Revive). In this in vitro setting, the Aperio device seems to be an efficacious and safe device when compared to other similar clinically used mechanical thrombectomy devices. Larger clinical trials are warranted.

  10. Novel electric power-driven hydrodynamic injection system for gene delivery: safety and efficacy of human factor IX delivery in rats.

    Science.gov (United States)

    Yokoo, T; Kamimura, K; Suda, T; Kanefuji, T; Oda, M; Zhang, G; Liu, D; Aoyagi, Y

    2013-08-01

    The development of a safe and reproducible gene delivery system is an essential step toward the clinical application of the hydrodynamic gene delivery (HGD) method. For this purpose, we have developed a novel electric power-driven injection system called the HydroJector-EM, which can replicate various time-pressure curves preloaded into the computer program before injection. The assessment of the reproducibility and safety of gene delivery system in vitro and in vivo demonstrated the precise replication of intravascular time-pressure curves and the reproducibility of gene delivery efficiency. The highest level of luciferase expression (272 pg luciferase per mg of proteins) was achieved safely using the time-pressure curve, which reaches 30 mm Hg in 10 s among various curves tested. Using this curve, the sustained expression of a therapeutic level of human factor IX protein (>500 ng ml(-1)) was maintained for 2 months after the HGD of the pBS-HCRHP-FIXIA plasmid. Other than a transient increase in liver enzymes that recovered in a few days, no adverse events were seen in rats. These results confirm the effectiveness of the HydroJector-EM for reproducible gene delivery and demonstrate that long-term therapeutic gene expression can be achieved by automatic computer-controlled hydrodynamic injection that can be performed by anyone.

  11. Management of atopic dermatitis: safety and efficacy of phototherapy

    Directory of Open Access Journals (Sweden)

    Patrizi A

    2015-10-01

    Full Text Available Annalisa Patrizi, Beatrice Raone, Giulia Maria RavaioliDepartment of Specialized, Diagnostic and Experimental Medicine, Division of Dermatology, University of Bologna, Bologna, ItalyAbstract: Atopic dermatitis (AD is a common chronic inflammatory skin disease that can affect all age groups. It is characterized by a relapsing course and a dramatic impact on quality of life for patients. Environmental interventions together with topical devices represent the mainstay of treatment for AD, in particular emollients, corticosteroids, and calcineurin inhibitors. Systemic treatments are reserved for severe cases. Phototherapy represents a valid second-line intervention in those cases where non-pharmacological and topical measures have failed. Different forms of light therapy are available, and have showed varying degrees of beneficial effect against AD: natural sunlight, narrowband (NB-UVB, broadband (BB-UVB, UVA, UVA1, cold-light UVA1, UVA and UVB (UVAB, full-spectrum light (including UVA, infrared and visible light, saltwater bath plus UVB (balneophototherapy, Goeckerman therapy (coal tar plus UVB radiation, psoralen plus UVA (PUVA, and other forms of phototherapy. In particular, UVA1 and NB-UVB have gained importance in recent years. This review illustrates the main trials comparing the efficacy and safety of the different forms of phototherapy. No sufficiently large randomized controlled studies have been performed as yet, and no light modality has been defined as superior to all. Parameters and dosing protocols may vary, although clinicians mainly refer to the indications included in the American Academy of Dermatology psoriasis guidelines devised by Menter et al in 2010. The efficacy of phototherapy (considering all forms in AD has been established in adults and children, as well as for acute (UVA1 and chronic (NB-UVB cases. Its use is suggested with strength of recommendation B and level of evidence II. Home phototherapy can also be performed

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

    Science.gov (United States)

    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.

  13. The aviation safety reporting system

    Science.gov (United States)

    Reynard, W. D.

    1984-01-01

    The aviation safety reporting system, an accident reporting system, is presented. The system identifies deficiencies and discrepancies and the data it provides are used for long term identification of problems. Data for planning and policy making are provided. The system offers training in safety education to pilots. Data and information are drawn from the available data bases.

  14. Efficacy and Safety of Antiintegrin Antibody for Inflammatory Bowel Disease

    Science.gov (United States)

    Lin, Lianjie; Liu, Xiang; Wang, Dongxu; Zheng, Changqing

    2015-01-01

    Abstract We sought to evaluate the safety and efficacy of available biologics that inhibit T-cell migration by blocking α4β7 integrins in inflammatory bowel diseases. The aim of this study is to evaluate whether Crohn disease (CD) patients receiving either vedolizumab or natalizumab have any different effect in CD Activity Index (CDAI). Using Medline, Excerpta Medica dataBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar until October 31, 2013, we identified 10 studies examining the safety and efficacy of specific integrin inhibitors—vedolizumab, which targets an epitope comprising the α4β7 heterodimer; natalizumab, which recognizes the α4 integrin subunit; etrolizumab, which is specific for the β7 subunit—in the treatment of CD and ulcerative colitis (UC). CD patients receiving either vedolizumab or natalizumab demonstrated a modest increase in remission rate, when compared with that of the placebo group. Further, although both treatments reduced the CDAI slightly, the observed clinical response was less robust than that of the remission rate. UC patients treated with vedolizumab and natalizumab were found to show more prominent increases in both remission and clinical response, compared with placebo, than patients with CD. Etrolizumab, however, was not found to significantly affect either response or remission rates in UC patients. Biologics targeting integrins show promise as therapeutics in the treatment of inflammatory bowel disease in patients who are either nonresponsive or intolerant to traditional approaches, though further research is necessary to optimize treatment efficacies. PMID:25761174

  15. Efficacy and Safety of Fingolimod in an Unselected Patient Population.

    Directory of Open Access Journals (Sweden)

    Maria Rasenack

    Full Text Available Fingolimod is a first in class oral compound approved for the treatment of relapsing-remitting multiple sclerosis (RR-MS. The aim of this study was to evaluate clinical and neuroradiological responses to fingolimod as well as the safety and tolerability in RR-MS patients in clinical practice. In addition, a panel of pro-inflammatory serum cytokines was explored as potential biomarker for treatment response.We conducted a retrospective, non-randomized, open-label, observational study in 105 patients with RR-MS and measured cytokines in longitudinal serum samples.Compared to the year before fingolimod start the annualized relapse rate was reduced by 44%. Also, the percentage of patients with a worsening of the EDSS decreased. Accordingly, the fraction of patients with no evidence of disease activity (no relapse, stable EDSS, no new active lesions in MRI increased from 11% to 38%. The efficacy and safety were comparable between highly active patients or patients with relevant comorbidities and our general patient population.The efficacy in reducing relapses was comparable to that observed in the phase III trials. In our cohort fingolimod was safe and efficacious irrespective of comorbidities and previous treatment.

  16. Approaches to document the efficacy and safety of microdermabrasion procedure.

    Science.gov (United States)

    Spencer, James M; Kurtz, Ellen S

    2006-11-01

    Microdermabrasion is a popular cosmetic procedure for skin rejuvenation, which is achieved by mechanical abrasion of the skin at a superficial level. The objective was to study the efficacy of microdermabrasion in photoaging and to investigate the compatibility of a cleanser and a lotion with microdermabrasion. Sixteen women underwent microdermabrasion to the face once a week for a total of six treatments. Subjects were also given a personal skin care regimen (cleanser and lotion). Colorimetry values as well as investigator and patients ratings for safety and efficacy were analyzed at various time points and compared to baseline. There were no significant changes in safety and tolerance variables throughout the study. Clinical efficacy variables (fine wrinkles, dullness, pigmentation, and large pores) significantly improved by the third treatment, with further improvement by the end of the study (six treatments). Subjects perceived improvement in facial photoaging variables. Colorimetry showed increased brightness and decreased yellowness of target skin sites on the face throughout the study. Multiple microdermabrasions were effective in significantly improving various facial photoaging variables. The personal skin care regimen used was well tolerated by the subjects.

  17. Safety logic systems of PFBR

    International Nuclear Information System (INIS)

    Sambasivan, S. Ilango

    2004-01-01

    Full text : PFBR is provided with two independent, fast acting and diverse shutdown systems to detect any abnormalities and to initiate safety action. Each system consists of sensors, signal processing systems, logics, drive mechanisms and absorber rods. The absorber rods of the first system are Control and Safety Rods (CSR) and that of the second are called as Diverse Safety Rods (DSR). There are nine CSR and three DSR. While CSR are used for startup, control of reactor power, controlled shutdown and SCRAM, the DSR are used only for SCRAM. The respective drive mechanisms are called as CSRDM and DSRDM. Each of these two systems is capable of executing the shutdown satisfactorily with single failure criteria. Two independent safety logic systems based on diverse principles have been designed for the two shut down systems. The analog outputs of the sensors of Core Monitoring Systems comprising of reactor flux monitoring, core temperature monitoring, failed fuel detection and core flow monitoring systems are processed and converted into binary signals depending on their instantaneous values. Safety logic systems receive the binary signals from these core-monitoring systems and process them logically to protect the reactor against postulated initiating events. Neutronic and power to flow (P/Q) signals form the inputs to safety logic system-I and temperature signals are inputs to the safety logic system II. Failed fuel detection signals are processed by both the shut down systems. The two logic systems to actuate the safety rods are also based on two diverse designs and implemented with solid-state devices to meet all the requirements of safety systems. Safety logic system I that caters to neutronic and P/Q signals is designed around combinational logic and has an on-line test facility to detect struck at faults. The second logic system is based on dynamic logic and hence is inherently safe. This paper gives an overview of the two logic systems that have been

  18. Safety and efficacy of Labisia pumila containing products

    Directory of Open Access Journals (Sweden)

    Muhammad Syafiq Saleh

    2016-01-01

    Full Text Available Labisia pumila is a traditional medicinal plant which has wide therapeutic application including induction of labor and treatment of dysentery, dysmenorrhea and gonorrhea. We aimed for systematic review of the efficacy andsafety of L. pumila extract or its other commercial products availabe in Malaysian market. The marketed 500 mg capsule is composed of 40 mg L. pumila, 10 mg C. caudatum extract and 450 mg excipient. The commercial products did not follow the registration guidelines of Malaysian National Pharmaceutical Control Bureau (NPCB and advertisement guidelines of Malaysian Advertisement Board. Randomized, placebo controlled clinical trials reported the safe consumpotion of L. pumila water extract on postmanoposal women. Information on the efficacy and safety of commercial products are not sufficiently available. Many unregistered products (mostly capsule form are flooded in Malaysian market without having scientific information. Consumption of those products may seriously impair the health of the people.

  19. Aviation Safety Hotline Information System -

    Data.gov (United States)

    Department of Transportation — The Aviation Safety Hotline Information System (ASHIS) collects, stores, and retrieves reports submitted by pilots, mechanics, cabin crew, passengers, or the public...

  20. Traceability of Software Safety Requirements in Legacy Safety Critical Systems

    Science.gov (United States)

    Hill, Janice L.

    2007-01-01

    How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

  1. 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.

  2. [Safety and efficacy of ketamine for pain relief].

    Science.gov (United States)

    Niesters, Marieke; Dahan, Albert; van Kleef, Maarten

    2016-01-01

    Intravenous ketamine treatment is frequently used for the management of chronic pain, especially in those patients who do not benefit from other therapies. In this commentary we discuss the efficacy of ketamine for relief of chronic pain and ketamine's safety profile. A review of the literature indicates that only a few studies show that intravenous ketamine has analgesic effects that persist beyond the infusion period, an effect that occurs in about two-thirds of patients. Ketamine has multiple safety issues, ranging from psychotomimetic and schizotypal symptoms, sympathetic stimulation, tachycardia and hypertension, and damage to the liver and the urogenital tract. Damage to the urogenital tract seems to be restricted to individuals who chronically abuse ketamine. We indicate the need for large randomized trials in which ketamine is compared with an 'active' placebo.

  3. Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

    Directory of Open Access Journals (Sweden)

    Sandeep Devabhakthuni

    2013-01-01

    Full Text Available The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects.

  4. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

    Science.gov (United States)

    Granel, Brigitte; Daumas, Aurélie; Jouve, Elisabeth; Harlé, Jean-Robert; Nguyen, Pierre-Sébastien; Chabannon, Christian; Colavolpe, Nathalie; Reynier, Jean-Charles; Truillet, Romain; Mallet, Stéphanie; Baiada, Antoine; Casanova, Dominique; Giraudo, Laurent; Arnaud, Laurent; Veran, Julie; Sabatier, Florence; Magalon, Guy

    2015-12-01

    In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. GFRS (Groupe Francophone de Recherche sur la Sclérodermie). NCT01813279. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  5. CYD-TDV dengue vaccine: systematic review and meta-analysis of efficacy, immunogenicity and safety.

    Science.gov (United States)

    Godói, Isabella Piassi; Lemos, Livia Lovato Pires; de Araújo, Vânia Eloisa; Bonoto, Braúlio Cesar; Godman, Brian; Guerra Júnior, Augusto Afonso

    2017-03-01

    Dengue virus (DENV) is a serious global health problem. CYD-TDC (Dengvaxia ® ) was the first vaccine to gain regulatory approval to try and address this problem. Summarize all available evidence on the immunogenicity, efficacy and safety of the CYD-TDV dengue vaccine. Meta-analysis and systematic review. The best and worst immunogenicity results were for DENV4 and DENV1, respectively. Vaccine efficacy of 60% was derived from studies with participants aged 2-16 years old, with DENV4 and DENV2 presenting the best and worst results, respectively. Erythema and swelling were more frequent with CYD-TDV. No differences were detected for systemic adverse events. CYD-TDV showed moderate efficacy in children and adolescents. From the immunogenicity results in adults, we can expect satisfactory efficacy from vaccination in this population.

  6. Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents

    DEFF Research Database (Denmark)

    Halken, Susanne; Agertoft, Lone; Seidenberg, Jürgen

    2010-01-01

    The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergènes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and o...

  7. System safety engineering analysis handbook

    Science.gov (United States)

    Ijams, T. E.

    1972-01-01

    The basic requirements and guidelines for the preparation of System Safety Engineering Analysis are presented. The philosophy of System Safety and the various analytic methods available to the engineering profession are discussed. A text-book description of each of the methods is included.

  8. Efficacy and safety of adalimumab in ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Mounach A

    2014-08-01

    Full Text Available Aziza Mounach, Abdellah El MaghraouiRheumatology Department, Military Hospital Mohammed V, Rabat, MoroccoAbstract: Ankylosing spondylitis (AS is the most common and most severe subtype of spondyloarthritis. It also may be an outcome of any of the other spondyloarthritis subtypes. AS preferentially affects the sacroiliac joints and the tip of the column, with a tendency to later ankylosis. Peripheral joints, enthesis, and other extra-articular involvement may be observed. Tumor necrosis factor (TNF inhibitors are now well-established, effective drugs in the treatment of AS symptoms. Adalimumab, which is a fully human monoclonal antibody that binds to and neutralizes TNF, has demonstrated efficacy in treating AS symptoms, including axial involvement, peripheral arthritis, enthesitis, uveitis, gut involvement, and psoriasis. Furthermore, adalimumab has showed an overall acceptable safety profile. In this paper, we review the efficacy and safety profile of adalimumab in the treatment of AS, and discuss its differences from the other anti-TNF drugs reported in the literature.Keywords: ankylosing spondylitis, spondyloarthritis, adalimumab, tumor necrosis factor-α

  9. Animal models for microbicide safety and efficacy testing.

    Science.gov (United States)

    Veazey, Ronald S

    2013-07-01

    Early studies have cast doubt on the utility of animal models for predicting success or failure of HIV-prevention strategies, but results of multiple human phase 3 microbicide trials, and interrogations into the discrepancies between human and animal model trials, indicate that animal models were, and are, predictive of safety and efficacy of microbicide candidates. Recent studies have shown that topically applied vaginal gels, and oral prophylaxis using single or combination antiretrovirals are indeed effective in preventing sexual HIV transmission in humans, and all of these successes were predicted in animal models. Further, prior discrepancies between animal and human results are finally being deciphered as inadequacies in study design in the model, or quite often, noncompliance in human trials, the latter being increasingly recognized as a major problem in human microbicide trials. Successful microbicide studies in humans have validated results in animal models, and several ongoing studies are further investigating questions of tissue distribution, duration of efficacy, and continued safety with repeated application of these, and other promising microbicide candidates in both murine and nonhuman primate models. Now that we finally have positive correlations with prevention strategies and protection from HIV transmission, we can retrospectively validate animal models for their ability to predict these results, and more importantly, prospectively use these models to select and advance even safer, more effective, and importantly, more durable microbicide candidates into human trials.

  10. Efficacy and safety of febuxostat in elderly female patients

    Directory of Open Access Journals (Sweden)

    Mizuno T

    2014-09-01

    Full Text Available Tomohiro Mizuno,1,2 Takahiro Hayashi,3 Sayo Hikosaka,1 Yuka Shimabukuro,1 Maho Murase,1 Kazuo Takahashi,2 Hiroki Hayashi,2 Yukio Yuzawa,2 Tadashi Nagamatsu,1 Shigeki Yamada3 1Department of Analytical Pharmacology, Graduate School of Pharmacy, Meijo University, Nagoya, Japan; 2Department of Nephrology, School of Medicine, Fujita Health University, Toyoake, Japan; 3Department of Clinical Pharmacy, School of Medicine, Fujita Health University, Toyoake, Japan Background: Maintenance of low serum urate levels is important for the management of gout. Achieving the recommended serum urate levels of less than 6.0 mg/dL is difficult in elderly (65 years of age or older patients with renal impairment. Xanthine oxidase inhibitors allopurinol and febuxostat are used for this purpose. Although febuxostat had been shown to be efficacious in elderly patients, its safety and efficacy in elderly female patients with hyper­uricemia remain unclear.Objective: The aim of this study was to assess the efficacy and safety of febuxostat in elderly female patients.Methods: We studied a retrospective cohort study. The study included elderly Japanese patients (65 years of age or older who were treated with febuxostat at Fujita Health University Hospital from January 2012 to December 2013. The treatment goal was defined as achievement of serum urate levels of 6.0 mg/dL or lower within 16 weeks; this was the primary endpoint in the present study. Adverse events of febuxostat were defined as more than twofold increases in Common Terminology Criteria for adverse events scores from baseline. Results: We evaluated 82 patients treated with febuxostat during the observation period and classified them into male (n=53 and female (n=29 groups. The mean time to achievement of the treatment goal was significantly shorter in the female group (53 days than in the male group (71 days. There were no significant differences in adverse events between the 2 groups.Conclusion: Our

  11. Efficacy and Safety of Human Retinal Progenitor Cells

    Science.gov (United States)

    Semo, Ma'ayan; Haamedi, Nasrin; Stevanato, Lara; Carter, David; Brooke, Gary; Young, Michael; Coffey, Peter; Sinden, John; Patel, Sara; Vugler, Anthony

    2016-01-01

    Purpose We assessed the long-term efficacy and safety of human retinal progenitor cells (hRPC) using established rodent models. Methods Efficacy of hRPC was tested initially in Royal College of Surgeons (RCS) dystrophic rats immunosuppressed with cyclosporine/dexamethasone. Due to adverse effects of dexamethasone, this drug was omitted from a subsequent dose-ranging study, where different hRPC doses were tested for their ability to preserve visual function (measured by optokinetic head tracking) and retinal structure in RCS rats at 3 to 6 months after grafting. Safety of hRPC was assessed by subretinal transplantation into wild type (WT) rats and NIH-III nude mice, with analysis at 3 to 6 and 9 months after grafting, respectively. Results The optimal dose of hRPC for preserving visual function/retinal structure in dystrophic rats was 50,000 to 100,000 cells. Human retinal progenitor cells integrated/survived in dystrophic and WT rat retina up to 6 months after grafting and expressed nestin, vimentin, GFAP, and βIII tubulin. Vision and retinal structure remained normal in WT rats injected with hRPC and there was no evidence of tumors. A comparison between dexamethasone-treated and untreated dystrophic rats at 3 months after grafting revealed an unexpected reduction in the baseline visual acuity of dexamethasone-treated animals. Conclusions Human retinal progenitor cells appear safe and efficacious in the preclinical models used here. Translational Relevance Human retinal progenitor cells could be deployed during early stages of retinal degeneration or in regions of intact retina, without adverse effects on visual function. The ability of dexamethasone to reduce baseline visual acuity in RCS dystrophic rats has important implications for the interpretation of preclinical and clinical cell transplant studies. PMID:27486556

  12. Safety balance: Analysis of safety systems

    International Nuclear Information System (INIS)

    Delage, M.; Giroux, C.

    1990-12-01

    Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

  13. Deep Brain Stimulation in Huntington’s Disease—Preliminary Evidence on Pathophysiology, Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Lars Wojtecki

    2016-08-01

    Full Text Available Huntington’s disease (HD is one of the most disabling degenerative movement disorders, as it not only affects the motor system but also leads to cognitive disabilities and psychiatric symptoms. Deep brain stimulation (DBS of the pallidum is a promising symptomatic treatment targeting the core motor symptom: chorea. This article gives an overview of preliminary evidence on pathophysiology, safety and efficacy of DBS in HD.

  14. [Legislation and inspection for the health and safety of workers. Efficacy and limits].

    Science.gov (United States)

    Tozzi, G A

    2009-01-01

    To provide information regarding Occupational Health and Safety (OHS) Inspections in Europe. The dynamics that are transforming regulatory subsystems and complementary inspection services are described. Simplification initiatives, the limits and difficulties of applying the different models of Health and Safety Management Systems are discussed. Examples are given on how to evaluate legislation and technical standards during planning and enforcement. Different approaches for studying characteristics, methodologies and efficacy in practice of OHS Inspection are provided. Targeted inspections need to respond to the needs of enterprises and workers. Impartiality must be guaranteed and workers' participation should be facilitated.

  15. Safety and efficacy of antibiotics among acutely decompensated cirrhosis patients.

    Science.gov (United States)

    Habib, Shahid; Patel, Nehali; Yarlagadda, Sandeep; Hsu, Chiu-Hsieh; Patel, Sarah; Schader, Lindsey; Walker, Courtney; Twesigye, Innocent

    2018-04-26

    Infection is a leading precipitant of acute-on-chronic liver failure. This study aims to determine the safety and efficacy of antibiotics within acute-on-chronic liver failure. Retrospective study of 457 acute-on-chronic liver failure patients admitted to the University of Arizona Health Network between January 1 and December 31, 2014. Eligibility criteria were as follows: at least 18 years of age and 6 months follow-up, data available to calculate systemic inflammatory response syndrome (SIRS), and acute-on-chronic liver failure. This study collected patient's clinical features and historical data. Key data points were infection, antibiotic use, and SIRS. This study used Cox proportional hazards to model the effects of clinical factors on risk of death. A total of 521 of 1243 met the inclusion criteria, and 64 had missing data, leaving 457 patients. Infection resulted in higher hazard (hazard ratio [HR] = 1.6, confidence interval [CI]: 1.1-1.3, P = 0.01). Patients with infections and antibiotics, compared with non-infected patients without antibiotics, had higher hazard (HR = 1.633, CI: 1.022-2.609, P = .04). Of those infected patients with antibiotics, SIRS patients experienced higher hazard (HR = 1.9, CI: 1.1-3.0, P = .007). Multivariable Cox proportional hazards associated the following with higher hazard: SIRS (HR = 1.866, CI: 1.242-2.804, P = 0.003), vancomycin (HR = 1.640, CI: 1.119-2.405, P = 0.011), Model for End-Stage Liver Disease (HR = 1.051, CI: 1.030-1.073, P < 0.001), gastrointestinal bleeding (HR = 1.727, CI: 1.180-2.527, P = 0.005), and hepatic encephalopathy (HR = 1.807, CI: 1.247-2.618, P = 0.002). Overall, treatment of infection with antibiotics did not improve survival; however, patients not meeting SIRS criteria had better outcomes, and vancomycin was associated with poorer survival among acute-on-chronic liver failure patients. © 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley

  16. System safety education focused on system management

    Science.gov (United States)

    Grose, V. L.

    1971-01-01

    System safety is defined and characteristics of the system are outlined. Some of the principle characteristics include role of humans in hazard analysis, clear language for input and output, system interdependence, self containment, and parallel analysis of elements.

  17. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Efficacy and safety of intravenous fentanyl administered by ambulance personnel

    DEFF Research Database (Denmark)

    Friesgaard, Kristian Dahl; Nikolajsen, Lone; Giebner, Matthias

    2016-01-01

    BACKGROUND: Management of pain in the pre-hospital setting is often inadequate. In 2011, ambulance personnel were authorized to administer intravenous fentanyl in the Central Denmark Region. The aim of this study was to evaluate the efficacy and safety of intravenous fentanyl administered...... by ambulance personnel. METHODS: Pre-hospital medical charts from 2348 adults treated with intravenous fentanyl by ambulance personnel during a 6-month period were reviewed. The primary outcome was the change in pain intensity on a numeric rating scale (NRS) from before fentanyl treatment to hospital arrival...... patients (1.3%) and hypotension observed in 71 patients (3.0%). CONCLUSION: Intravenous fentanyl caused clinically meaningful pain reduction in most patients and was safe in the hands of ambulance personnel. Many patients had moderate to severe pain at hospital arrival. As the protocol allowed higher doses...

  19. Home electrical system safety in Italy

    Energy Technology Data Exchange (ETDEWEB)

    Auditor,

    1990-06-01

    Italy, amongst the industrialized countries, has the highest mortality rate due to accidents associated with the improper use or maintenance of home electrical systems. The increasing use of domestic electrical appliances has raised the risk of accidents, especially in homes equipped with out-dated, low-capacity electrical plants and worn wiring. Within this context, this paper reports on the results of survey to establish the worthiness and type of electrical systems in use in a sample of 1,000 residential buildings. The paper then assesses the efficacy of recent normatives designed to increase the safety and efficiency of home electrical installations.

  20. Software Safety Risk in Legacy Safety-Critical Computer Systems

    Science.gov (United States)

    Hill, Janice L.; Baggs, Rhoda

    2007-01-01

    Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

  1. Bitter melon (Momordica charantia): a review of efficacy and safety.

    Science.gov (United States)

    Basch, Ethan; Gabardi, Steven; Ulbricht, Catherine

    2003-02-15

    The pharmacology, clinical efficacy, adverse effects, drug interactions, and place in therapy of bitter melon are described. Bitter melon (Momordica charantia) is an alternative therapy that has primarily been used for lowering blood glucose levels in patients with diabetes mellitus. Components of bitter melon extract appear to have structural similarities to animal insulin. Antiviral and antineoplastic activities have also been reported in vitro. Four clinical trials found bitter melon juice, fruit, and dried powder to have a moderate hypoglycemic effect. These studies were small and were not randomized or double-blind, however. Reported adverse effects of bitter melon include hypoglycemic coma and convulsions in children, reduced fertility in mice, a favism-like syndrome, increases in gamma-glutamyltransferase and alkaline phosphatase levels in animals, and headaches. Bitter melon may have additive effects when taken with other glucose-lowering agents. Adequately powered, randomized, placebo-controlled trials are needed to properly assess safety and efficacy before bitter melon can be routinely recommended. Bitter melon may have hypoglycemic effects, but data are not sufficient to recommend its use in the absence of careful supervision and monitoring.

  2. Safety and efficacy of quetiapine in bipolar depression.

    Science.gov (United States)

    Bogart, Gregory T; Chavez, Benjamin

    2009-11-01

    To review the clinical data investigating the efficacy and safety of quetiapine in bipolar depression. Searches of MEDLINE and PubMed (1977-July 2009) were conducted using the key words quetiapine and bipolar depression. The references of literature found were cross-referenced. The pharmaceutical company that produces quetiapine was contacted to obtain the posters for the EMBOLDEN I and EMBOLDEN II trials. Only double-blind, placebo-controlled trials were included for review, as well as any subanalyses of the literature that matched this criterion. There was a total of 5 double-blind, placebo-controlled trials and 5 subanalyses reviewed. The results of these data demonstrated quetiapine's efficacy in the treatment of depressive phases of bipolar disorder, including statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS). In the trials reviewed in this article, the change in MADRS scores ranged from -15.4 to -16.94 within the quetiapine groups, and from -10.26 to -11.93 in the placebo groups. There were also statistically significant improvements in the Hamilton Anxiety Rating Scale, the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire, the Pittsburgh Sleep Quality Index, and the Sheehan Disability Scale. All of these trials had a duration of 8 weeks and therefore cannot be applied to the long-term use of quetiapine in bipolar depression. The most common adverse events were sedation, somnolence, and dry mouth. The overall dropout rates for the trials reviewed ranged from 24% to 47%. Based on the literature reviewed here, quetiapine appears to be a safe and efficacious short-term treatment option for bipolar depression. Patients with bipolar type I showed greater improvement on the MADRS than those with bipolar type II. Patients with a rapid-cycling disease course showed an improvement in depressive symptoms, regardless of bipolar type.

  3. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  4. 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.

  5. The efficacy and safety of oral Tamsulosin controlled absorption system (OCAS for the treatment of lower urinary tract symptoms due to bladder outlet obstruction associated with benign prostatic hyperplasia: an open-label preliminary study

    Directory of Open Access Journals (Sweden)

    Bannakij Lojanapiwat

    2011-08-01

    Full Text Available AIMS: Tamsulosin, a superselective subtype alpha 1a and 1d blocker, is used for the treatment of male lower urinary tract symptoms (LUTS commonly caused by benign prostatic hyperplasia (BPH. This prospective study evaluated the efficacy and safety of a new formulation, Tamsulosin OCAS® (Oral Controlled Absorption System, for LUTS associated with BPH in Thai patients. MATERIALS AND METHODS: Fifty one patients over 40 years old with complaints of LUTS associated with BPH were recruited. Patients received an 8 week course of once daily 0.4 mg tamsulosin OCAS®, and were followed up at 2 (visit 3, 4 (visit 4 and 8 (visit 5 weeks post-treatment. At each visit, patients were assessed using the International Prostate Symptom Score (IPSS, Nocturia Quality of Life (N-QoL Questionnaire, QoL Assessment Index (IPSS-QoL, and International Index of Erectile Function (IIEF. The primary outcome was efficacy of Tamsulosin. The secondary outcomes included change in the mean number of nocturia episodes, hours of undisturbed sleep (HUS and uroflowmetry measurements. RESULTS: Total IPSS significantly decreased at week 8 from baseline (from 19.52 to 6.08; p < 0.001. Similarly, the voiding and storage subscores of IPSS also continued to improve significantly starting from the second and third visits, respectively (p < 0.001 versus baseline. The IPSS-QoL and N-QoL scores significantly improved at visit 3 through end of study. In addition, we observed significant nocturia and HUS improvement in their last clinic visit. Uroflowmetry parameters, Qmax and Qave, improved significantly at 3rd clinic visit . Three patients experienced mild dizziness. CONCLUSION: Tamsulosin OCAS® treatment led to significant improvements in LUTS, HUS and QoL in Thai patients with bladder outlet obstruction from BPH with few side effects.

  6. Long-term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis.

    NARCIS (Netherlands)

    Kerkhof, P.C.M. van de; Berth-Jones, J.; Griffiths, C.E.; Harrison, P.V.; Honigsmann, H.; Marks, R.; Roelandts, R.; Schopf, E.; Trompke, C.

    2002-01-01

    BACKGROUND: As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. OBJECTIVES: The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 microg g(-1)) ointment

  7. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis

    DEFF Research Database (Denmark)

    Wahn, Ulrich; Tabar, Ana; Kuna, Piotr

    2009-01-01

    BACKGROUND: The efficacy and safety of the 300-index of reactivity (IR) dose of 5-grass-pollen sublingual immunotherapy (SLIT) tablets (Stallergènes, Antony, France) have been demonstrated for the treatment of hay fever in adults. OBJECTIVE: We sought to assess the efficacy and safety of this tab...

  8. Efficacy and safety of pregabalin in generalised anxiety disorder : A critical review of the literature

    NARCIS (Netherlands)

    Baldwin, David S.; den Boer, Johan A.; Lyndon, Gavin; Emir, Birol; Schweizer, Edward; Haswell, Hannah

    2015-01-01

    The aim of this review is to summarise the literature on the efficacy and safety of pregabalin for the treatment of generalised anxiety disorder (GAD). Of 241 literature citations, 13 clinical trials were identified that were specifically designed to evaluate the efficacy and safety of pregabalin in

  9. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    Directory of Open Access Journals (Sweden)

    Wehrenberg Scott

    2010-01-01

    Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541.

  10. Tranexamic Acid in Total Joint Arthroplasty: Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Rasouli

    2015-01-01

    relatively rare, the majority of studies that evaluated the efficacy of TA are underpowered for evaluation of its safety. In a recent study by Poeran et al. using a large national database including 872,416 patients who had total hip or knee arthroplasty, the authors suggested that TA is effective in reducing the need for blood transfusions while not increasing the risk of VTE and renal complications (8. However, it is still advised that patients with cardiac stents and previous thromboembolic events including ischemic stroke not be administered TA. TA can also cause gastrointestinal disturbance and its dose needs to be adjusted in patients with renal impairment (5.   In conclusion, administration of TA in TJA patient is a cost-effective blood conservation strategy and there is strong evidence to support the efficacy and safety of the drug in reducing blood loss and transfusion in TJA patients. Given the adverse effects of allogeneic blood transfusion on the outcome of TJA, administration of TA should be considered in patients with no contraindication for its use.

  11. Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI.

    Science.gov (United States)

    Giustino, Gennaro; Chieffo, Alaide; Palmerini, Tullio; Valgimigli, Marco; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Kim, Hyo-Soo; Park, Kyung Woo; Gilard, Martine; Morice, Marie-Claude; Sawaya, Fadi; Sardella, Gennaro; Genereux, Philippe; Redfors, Bjorn; Leon, Martin B; Bhatt, Deepak L; Stone, Gregg W; Colombo, Antonio

    2016-10-25

    Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction  = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction  = 0.96). Results were consistent by per-treatment landmark analysis. Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT. Copyright © 2016 American College

  12. CERN safety system monitoring - SSM

    International Nuclear Information System (INIS)

    Hakulinen, T.; Ninin, P.; Valentini, F.; Gonzalez, J.; Salatko-Petryszcze, C.

    2012-01-01

    CERN SSM (Safety System Monitoring) is a system for monitoring state-of-health of the various access and safety systems of the CERN site and accelerator infrastructure. The emphasis of SSM is on the needs of maintenance and system operation with the aim of providing an independent and reliable verification path of the basic operational parameters of each system. Included are all network-connected devices, such as PLCs (local purpose control unit), servers, panel displays, operator posts, etc. The basic monitoring engine of SSM is a freely available system-monitoring framework Zabbix, on top of which a simplified traffic-light-type web-interface has been built. The web-interface of SSM is designed to be ultra-light to facilitate access from hand-held devices over slow connections. The underlying Zabbix system offers history and notification mechanisms typical of advanced monitoring systems. (authors)

  13. The Efficacy, Safety and Applications of Medical Hypnosis.

    Science.gov (United States)

    Häuser, Winfried; Hagl, Maria; Schmierer, Albrecht; Hansen, Ernil

    2016-04-29

    The efficacy and safety of hypnotic techniques in somatic medicine, known as medical hypnosis, have not been supported to date by adequate scientific evidence. We systematically reviewed meta-analyses of randomized controlled trials (RCTs) of medical hypnosis. Relevant publications (January 2005 to June 2015) were sought in the Cochrane databases CDSR and DARE, and in PubMed. Meta-analyses involving at least 400 patients were included in the present analysis. Their methodological quality was assessed with AMSTAR (A Measurement Tool to Assess Systematic Reviews). An additional search was carried out in the CENTRAL and PubMed databases for RCTs of waking suggestion (therapeutic suggestion without formal trance induction) in somatic medicine. Out of the 391 publications retrieved, five were reports of metaanalyses that met our inclusion criteria. One of these meta-analyses was of high methodological quality; three were of moderate quality, and one was of poor quality. Hypnosis was superior to controls with respect to the reduction of pain and emotional stress during medical interventions (34 RCTs, 2597 patients) as well as the reduction of irritable bowel symptoms (8 RCTs, 464 patients). Two meta-analyses revealed no differences between hypnosis and control treatment with respect to the side effects and safety of treatment. The effect size of hypnosis on emotional stress during medical interventions was low in one meta-analysis, moderate in one, and high in one. The effect size on pain during medical interventions was low. Five RCTs indicated that waking suggestion is effective in medical procedures. Medical hypnosis is a safe and effective complementary technique for use in medical procedures and in the treatment of irritable bowel syndrome. Waking suggestions can be a component of effective doctor-patient communication in routine clinical situations.

  14. Efficacy and safety of a polyherbal formulation in hemorrhoids

    Directory of Open Access Journals (Sweden)

    Raakhi K Tripathi

    2015-01-01

    Full Text Available Background: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is "Arshkeyt™, a 7 day kit," which consists of oral tablets and powder along with topical cream. Objective: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. Materials and Methods: Patients (n = 90 with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a "composite score" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14. Inter-group analysis was done using Chi-square test. Results: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score score (P = 0.047, anal sphincter spasm (P = 0.0495 and a decrease in the grade of hemorrhoids (P = 0.0205 on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05. The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. Conclusion: "Arshkeyt™, a 7 day kit," was effective in the treatment of hemorrhoids and had a good safety profile.

  15. Efficacy and Safety of Ethanol Ablation for Branchial Cleft Cysts.

    Science.gov (United States)

    Ha, E J; Baek, S M; Baek, J H; Shin, S Y; Han, M; Kim, C-H

    2017-12-01

    Branchial cleft cyst is a common congenital lesion of the neck. This study evaluated the efficacy and safety of ethanol ablation as an alternative treatment to surgery for branchial cleft cyst. Between September 2006 and October 2016, ethanol ablation was performed in 22 patients who refused an operation for a second branchial cleft cyst. After the exclusion of 2 patients who were lost to follow-up, the data of 20 patients were retrospectively evaluated. All index masses were confirmed as benign before treatment. Sonography-guided aspiration of the cystic fluid was followed by injection of absolute ethanol (99%) into the lesion. The injected volume of ethanol was 50%-80% of the volume of fluid aspirated. Therapeutic outcome, including the volume reduction ratio, therapeutic success rate (volume reduction ratio of >50% and/or no palpable mass), and complications, was evaluated. The mean index volume of the cysts was 26.4 ± 15.7 mL (range, 3.8-49.9 mL). After ablation, the mean volume of the cysts decreased to 1.2 ± 1.1 mL (range, 0.0-3.5 mL). The mean volume reduction ratio at last follow-up was 93.9% ± 7.9% (range, 75.5%-100.0%; P branchial cleft cysts who refuse, or are ineligible for, an operation. © 2017 by American Journal of Neuroradiology.

  16. Potential benefit of dolutegravir once daily: efficacy and safety

    Directory of Open Access Journals (Sweden)

    Fantauzzi A

    2013-02-01

    Full Text Available Alessandra Fantauzzi,1 Ombretta Turriziani,2 Ivano Mezzaroma11Department of Clinical Medicine, 2Department of Molecular Medicine, Sapienza, University of Rome, Rome, ItalyAbstract: The viral integrase enzyme has recently emerged as a primary alternative target to block HIV-1 replication, and integrase inhibitors are considered a pivotal new class of antiretroviral drugs. Dolutegravir is an investigational next-generation integrase inhibitor showing some novel and intriguing characteristics, ie, it has a favorable pharmacokinetic profile with a prolonged intracellular half-life, rendering feasible once-daily dosing without the need for ritonavir boosting and without regard to meals. Moreover, dolutegravir is primarily metabolized via uridine diphosphate glucuronosyltranferase 1A1, with a minor component of the cytochrome P450 3A4 isoform, thereby limiting drug–drug interactions. Furthermore, its metabolic profile enables coadministration with most of the other available antiretroviral agents without dose adjustment. Recent findings also demonstrate that dolutegravir has significant activity against HIV-1 isolates with resistance mutations associated with raltegravir and/or elvitegravir. The attributes of once-daily administration and the potential to treat integrase inhibitor-resistant viruses make dolutegravir an interesting and promising investigational drug. In this review, the main concerns about the efficacy and safety of dolutegravir as well as its resistance profile are explored by analysis of currently available data from preclinical and clinical studies.Keywords: antiretroviral drugs, HIV-1 integrase, integrase inhibitors, dolutegravir, once daily

  17. Ibuprofen versus steroids: risk and benefit, efficacy and safety

    Directory of Open Access Journals (Sweden)

    M. Giovannini

    2013-10-01

    Full Text Available In the last few years we have observed an upward trend in the employment of ibuprofen as anti-inflammatory and antipyretic therapy. Therefore the pediatrician has often a precious option in the anti-inflammatory and antipyretic treatment in children instead of using steroids and paracetamol. In clinical practice ibuprofen can be used in the treatment of headache, toothache, otalgy, dysmenorrhea, neuralgia, arthralgia, myalgia, abdominal pain and fever: it is the first choice for these common diseases. However, the use of steroids is a routine, even if non-corticosteroid anti-inflammatory molecules could be useful. Certainly steroids are powerful anti-inflammatory, indicated for the treatment of chronic inflammatory disorders and in acute respiratory and allergic diseases. Beside, thanks to their chemical and pharmacological profile, they also provide patients with an antipyretic effect. However, the use of steroids must be reserved to cases in which other classical antipyretics such as non-steroidal anti-inflammatory drugs are not effective. The possible side effects and risks associated with stepping down steroids must be considered. Although “steroids-phobia” should be discouraged, steroids are to be reserved only as the first indication. In all other cases the pediatrician can use ibuprofen, whose efficacy and safety are widely demonstrated by now.

  18. Safety and Efficacy of Warfarin Therapy in Kawasaki Disease.

    Science.gov (United States)

    Baker, Annette L; Vanderpluym, Christina; Gauvreau, Kimberly A; Fulton, David R; de Ferranti, Sarah D; Friedman, Kevin G; Murray, Jenna M; Brown, Loren D; Almond, Christopher S; Evans-Langhorst, Margaret; Newburger, Jane W

    2017-10-01

    To describe the safety and efficacy of warfarin for patients with Kawasaki disease and giant coronary artery aneurysms (CAAs, ≥8 mm). Giant aneurysms are managed with combined anticoagulation and antiplatelet therapies, heightening risk of bleeding complications. We reviewed the time in therapeutic range; percentage of international normalization ratios (INRs) in range (%); bleeding events, clotting events; INRs ≥6; INRs ≥5 and warfarin therapy was 7.2 years (2.3-13.3 years). Goal INR was 2.0-3.0 (n = 6) or 2.5-3.5 (n = 3), based on CAA size and history of CAA thrombosis. All patients were treated with aspirin; 1 was on dual antiplatelet therapy and warfarin. The median time in therapeutic range was 59% (37%-85%), and median percentage of INRs in range was 68% (52%-87%). INR >6 occurred in 3 patients (4 events); INRs ≥5 warfarin and aspirin, with INRs in range only two-thirds of the time. Future studies should evaluate the use of direct oral anticoagulants in children as an alternative to warfarin. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Seithikurippu R. Pandi-Perumal

    2011-01-01

    Full Text Available Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT 1 and MT 2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.

  20. Current treatment for anorexia nervosa: efficacy, safety, and adherence

    Directory of Open Access Journals (Sweden)

    Lindsay P Bodell

    2010-10-01

    Full Text Available Lindsay P Bodell, Pamela K KeelDepartment of Psychology, Florida State University, Tallahassee, FL, USAAbstract: Anorexia nervosa (AN is a serious psychiatric illness associated with significant medical and psychiatric morbidity, psychosocial impairment, increased risk of death, and chronicity. Given the severity of the disorder, the establishment of safe and effective treatments is necessary. Several treatments have been tried in AN, but few favorable results have emerged. This paper reviews randomized controlled trials in AN, and provides a synthesis of existing data regarding the efficacy, safety, and adherence associated with pharmacologic and psychological interventions. Randomized controlled trials for the treatment of AN published in peer-reviewed journals were identified by electronic and manual searches. Overall, pharmacotherapy has limited benefits in the treatment of AN, with some promising preliminary findings associated with olanzapine, an antipsychotic agent. No single psychological intervention has demonstrated clear superiority in treating adults with AN. In adolescents with AN, the evidence base is strongest for the use of family therapy over alternative individual psychotherapies. Results highlight challenges in both treating individuals with AN and in studying the effects of those treatments, and further emphasize the importance of continued efforts to develop novel interventions. Treatment trials currently underway and areas for future research are discussed.Keywords: anorexia nervosa, treatment, pharmacotherapy, psychotherapy, randomized controlled trials

  1. Rotavirus vaccines: safety, efficacy and public health impact.

    Science.gov (United States)

    Gray, J

    2011-09-01

    Rotaviruses are the cause of acute gastroenteritis, and disease is widespread amongst infants and young children throughout the world. Also, rotavirus is associated with significant mortality in developing countries with more than 500 000 children dying each year as a result of the severe dehydration associated with rotavirus disease. Efforts have been ongoing for more than 30 years to develop a safe and effective rotavirus vaccine. Currently, two vaccines, RotaRix and RotaTeq, have been licensed for use in many countries throughout the world following comprehensive safety and efficiency trials. Monitoring their effectiveness after licensure has confirmed that their incorporation into early childhood vaccination schedules can significantly prevent severe rotavirus diarrhoea, which would have resulted in hospitalizations, emergency room visits or increased diarrhoea-related mortality. Although the efficacy of both vaccines is lower at approximately 40-59% in developing countries, their use could significantly reduce the mortality associated with rotavirus disease that is concentrated in these countries. © 2011 The Association for the Publication of the Journal of Internal Medicine.

  2. Safety of mechanical devices. Safety of automation systems

    International Nuclear Information System (INIS)

    Pahl, G.; Schweizer, G.; Kapp, K.

    1985-01-01

    The paper deals with the classic procedures of safety engineering in the sectors mechanical engineering, electrical and energy engineering, construction and transport, medicine technology and process technology. Particular stress is laid on the safety of automation systems, control technology, protection of mechanical devices, reactor safety, mechanical constructions, transport systems, railway signalling devices, road traffic and protection at work in chemical plans. (DG) [de

  3. Comparison of Efficacy and Safety of Lispro and Aspart Evaluated by Continuous Glucose Monitoring System in Patients with Newly Diagnosed Type 2 Diabetes

    Directory of Open Access Journals (Sweden)

    Bing-li Liu

    2018-01-01

    Full Text Available Objective. To compare the effect of the rapid-acting insulin analogues (RAIAs aspart (NovoRapid and lispro (Prandilin on glycemic variations by continuous glucose monitoring system (CGMS in patients within newly diagnosed type 2 diabetes mellitus (T2DM receiving continuous subcutaneous insulin infusion (CSII and metformin intensive therapy. Methods. This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c% above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group and group Lis (Prandilin group. They all received CSII and metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. C-peptide and insulin and fructosamine were determined. CGMS was continuously applied for 4 days after reaching the glycemic target. Results. There were no significant differences in daily dosages of insulin, fasting plasma C-P and 2 h postprandial C-P and insulin, and fructosamine at the baseline and endpoint between the groups Asp and Lis. No significant differences were seen in the 24 h mean amplitude of glycemic excursions (MAGE, 24 h mean blood glucose (MBG, the standard deviation of the MBG (SDBG, fasting blood glucose, number of glycemic excursion (NGE, and the incidence of hypoglycemia between the two groups. Similarly, no significant differences were found in areas under the curve (AUC of glucose above 10.0 mmol/L or the decremental area over the curve (AOC of glucose below 3.9 mmol/L between the two groups. Conclusions. Lispro and aspart had the similar ability to control the glycemic variations in patients with newly diagnosed T2DM. This study was registered with ClinicalTrials.gov, number ChiCTR-IPR-17010338.

  4. Efficacy and safety evaluation of systemic extremely low frequency magnetic fields used in the healing of diabetic foot ulcers--phase II data.

    Science.gov (United States)

    Cañedo-Dorantes, Luis; Soenksen, Luis R; García-Sánchez, Clara; Trejo-Núñez, Daphny; Pérez-Chávez, Fernando; Guerrero, Arturo; Cardona-Vicario, Melisa; García-Lara, Carlos; Collí-Magaña, Dianelly; Serrano-Luna, Gregorio; Angeles Chimal, José S; Cabrera, Guillermo

    2015-08-01

    Cellular and animal models investigating extremely low frequency magnetic fields (ELF-MF) have reported promotion of leukocyte-endothelial interactions, angiogenesis, myofibroblast and keratinocyte proliferation, improvement of peripheral neuropathy and diabetic wound healing. In humans, it has also been reported that systemic exposure to ELF-MF stimulates peripheral blood mononuclear cells, promoting angiogenesis and healing of chronic leg ulcers. The aim of the study was to investigate the effect of exposing different blood volumes to specific ELF-MFs (120 Hz sinusoidal waves of 0.4-0.9 mT RMS) to induce healing of diabetic foot ulcers (DFUs). Twenty six diabetic patients with non-responsive DFUs were divided into two exposure groups to receive treatment and record healing time. The forearm group, exposed to ELF-MF 2 h/day, twice weekly (3.6 l of blood/session); and the thorax group, exposed 25 min/day, 2 times/week (162.5 l of blood/session). Treatment period was 100 days or upon complete healing. Ulcer recurrences and adverse effects were investigated during short-term (<1 year) and long-term (3.4-7.8 years) follow-up. Mean healing time was 61.48 ± 33.08 days in the forearm group and 62.56 ± 29.33 days for the thorax group. No adverse effects or ulcer recurrences in the original ulcer site were reported during treatment, the short-term follow-up period or the long-term follow-up period in both groups. Healing time was independent of the amount of blood exposed to ELF-MF used in this trial. ELF-MFs are effective and safe and could be applied to non-healing DFUs in conjunction with other preventive interventions to reduce DFUs complications. Copyright © 2015 IMSS. Published by Elsevier Inc. All rights reserved.

  5. Efficacy and safety of a new microneedle patch for skin brightening: A Randomized, split-face, single-blind study.

    Science.gov (United States)

    Park, Kui Young; Kwon, Hyun Jung; Lee, Changjin; Kim, Daegun; Yoon, Jun Jin; Kim, Myeong Nam; Kim, Beom Joon

    2017-09-01

    Although microneedles are one of the best transdermal drug delivery systems for active compounds, few clinical trials have examined the safety and efficacy of brightening microneedle patches. To determine the efficacy and safety of a newly developed whitening microneedle patch. A split-face study was designed for efficacy assessment with 34 Korean women applying the tested product (a whitening microneedle patch) on one cheek and a control whitening essence on the other. We objectively measured changes in melanin index values and skin brightness by mexameter and chromameter. Each participant also used global assessment to determine skin whitening. In addition, 55 participants were selected for primary skin irritation tests and repeated insult patch tests for safety assessments. Mean skin brightness and melanin indexes improved (Pmicroneedle patch was effective and safe for skin brightening and would be a promising functional cosmetic product. © 2017 Wiley Periodicals, Inc.

  6. Nuclear reactor safety system

    International Nuclear Information System (INIS)

    Sato, Takashi.

    1979-01-01

    Purpose: To allow sufficient removal of radioactive substance released in the reactor containment shell upon loss of coolants accidents thus to sufficiently decrease the exposure dose to human body. Constitution: A clean-up system is provided downstream of a heat exchanger and it is branched into a pipeway to be connected to a spray nozzle and further connected by way of a valve to a reactor container. After the end of sudden transient changes upon loss of coolants accidents, the pool water stored in the pressure suppression chamber is purified in the clean-up system and then sprayed in the dry-well by way of a spray nozzle. The sprayed water dissolves to remove water soluble radioactive substances floating in the dry-well and then returns to the pressure suppression chamber. Since radioactive substances in the dry-well can thus removed rapidly and effectively and the pool water can be reused, public hazard can also be decreased. (Horiuchi, T.)

  7. The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety.

    Science.gov (United States)

    Heal, D J; Cheetham, S C; Smith, S L

    2009-12-01

    Results from in vivo techniques, especially intracerebral microdialysis in freely-moving rats, have provided insights into potential mechanisms responsible for the efficacy and safety of catecholaminergic drugs for ADHD treatment. The drugs reviewed come from distinct pharmacological classes: psychostimulant releasing agents, eg d-amphetamine; psychostimulant reuptake inhibitors, eg dl-threo-methylphenidate (dl-MPH), and non-stimulant reuptake inhibitors, eg atomoxetine. Psychostimulants, which currently deliver the best efficacy in treating ADHD, exhibit the following characteristics on extraneuronal catecholamine concentrations in rodent brain in vivo: 1) They enhance the efflux and function of both noradrenaline and dopamine in the central nervous system. 2) The increase of dopamine efflux that they produce is not limited to cortical regions. 3) They have a rapid onset of action with no ceiling on drug effect. d-Amphetamine has a mechanism independent of neuronal firing rate, displacing intraneuronal stores of catecholamines, delaying their reuptake and inhibiting catabolism by monoamine oxidase. dl-MPH has an enigmatic, extraneuronal action that is neuronal firing rate-dependent and reuptake transporter-mediated, yet paradoxically, almost as powerful as that of d-amphetamine. In safety terms, these powerful catecholaminergic effects also make the psychostimulants liable for abuse. Since efficacy and safety derive from the same pharmacological mechanisms, it has not yet been possible to separate these two components. However, the development of once-daily psychostimulant formulations and a prodrug, lisdexamfetamine, has improved patient compliance and markedly reduced scope for their diversion/abuse. This review will discuss the in vivo pharmacological profiles of approved catecholaminergic drugs for treatment of ADHD and implications for their clinical efficacy and abuse liability.

  8. Investigating Change in Adolescent Self-Efficacy of Food Safety through Educational Interventions

    Science.gov (United States)

    Beavers, Amy S.; Murphy, Lindsay; Richards, Jennifer K.

    2015-01-01

    A successfully targeted intervention can influence food safety knowledge, attitudes, and behaviors, as well as encourage participants to recognize their own responsibility for safe food handling. This acknowledgement of an individual's responsibility and capacity to address food safety can be understood as self-efficacy of food safety (SEFS). This…

  9. The LHC personnel safety system

    International Nuclear Information System (INIS)

    Ninin, P.; Valentini, F.; Ladzinski, T.

    2011-01-01

    Large particle physics installations such as the CERN Large Hadron Collider require specific Personnel Safety Systems (PSS) to protect the personnel against the radiological and industrial hazards. In order to fulfill the French regulation in matter of nuclear installations, the principles of IEC 61508 and IEC 61513 standard are used as a methodology framework to evaluate the criticality of the installation, to design and to implement the PSS.The LHC PSS deals with the implementation of all physical barriers, access controls and interlock devices around the 27 km of underground tunnel, service zones and experimental caverns of the LHC. The system shall guarantee the absence of personnel in the LHC controlled areas during the machine operations and, on the other hand, ensure the automatic accelerator shutdown in case of any safety condition violation, such as an intrusion during beam circulation. The LHC PSS has been conceived as two separate and independent systems: the LHC Access Control System (LACS) and the LHC Access Safety System (LASS). The LACS, using off the shelf technologies, realizes all physical barriers and regulates all accesses to the underground areas by identifying users and checking their authorizations.The LASS has been designed according to the principles of the IEC 61508 and 61513 standards, starting from a risk analysis conducted on the LHC facility equipped with a standard access control system. It consists in a set of safety functions realized by a dedicated fail-safe and redundant hardware guaranteed to be of SIL3 class. The integration of various technologies combining electronics, sensors, video and operational procedures adopted to establish an efficient personnel safety system for the CERN LHC accelerator is presented in this paper. (authors)

  10. Safety in nuclear power systems

    International Nuclear Information System (INIS)

    Myers, L.C.

    1987-05-01

    This paper discusses the issue of safety in complex energy systems and provides brief accounts of some of the most serious reactor accidents that have occurred to date. Details are also provided of Ontario Hydro's problems with Unit 2 at Pickering

  11. Firefighter Safety for PV Systems

    DEFF Research Database (Denmark)

    Mathe, Laszlo; Sera, Dezso; Spataru, Sergiu

    2015-01-01

    An important and highly discussed safety issue for photovoltaic (PV) systems is that as long as the PV panels are illuminated, a high voltage is present at the PV string terminals and cables between the string and inverters that is independent of the state of the inverter's dc disconnection switch...

  12. NASA aviation safety reporting system

    Science.gov (United States)

    1981-01-01

    Aviation safety reports that relate to loss of control in flight, problems that occur as a result of similar sounding alphanumerics, and pilot incapacitation are presented. Problems related to the go around maneuver in air carrier operations, and bulletins (and FAA responses to them) that pertain to air traffic control systems and procedures are included.

  13. Safety design guide for safety related systems for CANDU 9

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young [Korea Atomic Energy Research Institute, Daeduk (Korea, Republic of); Wright, A.C.D. [Atomic Energy of Canada Ltd., Toronto (Canada)

    1996-03-01

    In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new.

  14. Safety design guide for safety related systems for CANDU 9

    International Nuclear Information System (INIS)

    Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young; A. C. D. Wright

    1996-03-01

    In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new

  15. EFFICACY AND SAFETY OF ALENDRONIC ACID IN PATIENTS WITH JUVENILE RHEUMATOID ARTHRITIS AND OSTEOPOROSIS

    Directory of Open Access Journals (Sweden)

    A.O. Lisitsin

    2010-01-01

    Full Text Available Search for and practical application of new medications to treat of osteoporosis is one of the critical issues in pediatric rheumatology. The article reviews the efficacy and safety of alendronic acid in 64 subjects with juvenile rheumatoid arthritis and systemic osteoporosis. It is demonstrated that alendronate-based therapy in weekly 1 mg/kg doses over 12 months facilitated reliably increased bonedensity, decreased intensity of pain syndrome, and lowered C-terminal telopeptide serum concentration, which indicates improved bone metabolism processes.Key words: juvenile rheumatoid arthritis, osteoporosis, children, treatment, bisphosphonates, alendronic acid. (Pediatric Pharmacology. – 2010; 7(1:48-54

  16. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study.

    Directory of Open Access Journals (Sweden)

    Lamberto Manzoli

    Full Text Available To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes, directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both.Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up.Direct contact and structured questionnaires by phone or via internet.Adults (30-75 years were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers, users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers, or smokers of both tobacco and e-cigarettes (dual smokers. Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence.Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily.We used linear and logistic regression, with region as cluster unit.Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%. All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35-8.02, whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall.Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e

  17. The Daresbury personnel safety system

    International Nuclear Information System (INIS)

    Poole, D.E.; Ring, T.

    1989-01-01

    The personnel safety system designed for the SRS at Daresbury is a unified system covering the three accelerators of the source itself, the beamlines and the experimental stations. The system has also been applied to the experimental areas of the Nuclear Structure Facility, and is therefore established as a site standard. A dual guardline interlock module forms a building block for a relay based interlock system completely independent of the machine control system, although comprehensive monitoring of the system status via the control system computer is a feature. An outline of the design criteria adopted for the system is presented together with a more detailed description of the philosophy of the guardline logic and the way this is implemented in a standard modular form. The emphasis is on the design features of a modern microprocessor based variant of the original SRS system. Experience with the original system during build-up and operation of the SRS facility is described. 2 refs., 4 figs

  18. Safety implications of control systems

    International Nuclear Information System (INIS)

    Smith, O.L.

    1983-01-01

    The Safety Implications of Control Systems Program has three major activities in support of USI-A47. The first task is a failure mode and effects analysis of all plant systems which may potentially induce control system disturbance that have safety implications. This task has made a preliminary study of overfill events and recommended cases for further analysis on the hybrid simulator. Work continues on overcooling and undercooling. A detailed investigation of electric power network is in progress. LERs are providing guidance on important failure modes that will provide initial conditions for further simulator studies. The simulator taks is generating a detailed model of the control system supported by appropriate neutronics, hydraulics, and thermodynamics submodels of all other principal plant components. The simulator is in the last stages of development. Checkout calculations are in progress to establish model stability, robustness, and qualitative credibility. Verification against benchmark codes and plant data will follow

  19. 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)

  20. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations.

    Science.gov (United States)

    Smith, Mark C; Zimmerman, M Bridget; Burke, Diane K; Bauman, Nancy M; Sato, Yutaka; Smith, Richard J H

    2009-01-01

    To determine the efficacy and safety of the immunostimulant OK-432 (Picibanil) as a treatment option in the management of children with cervicofacial lymphatic malformations. A prospective, randomized, multi-institutional phase II clinical trial at 27 U.S. academic medical centers. 182 patients with lymphatic malformations (LM) were enrolled between January 1998 and November 2004. Of the 151 patients with complete case report forms, 117 patients were randomized into immediate or delayed treatment groups; 34 patients were nonrandomized and assigned to the open-label group. Treatment consisted of a four-dose intralesional injection series of OK-432 at eight-week intervals. Patients randomized into the delayed treatment group served as observational controls for spontaneous regression. Response to therapy was measured radiographically by quantitating change in lesion size and graded as complete (90%-100%), substantial (60%-89%), intermediate (20%-59%), or none (<20%). Of 117 patients randomized with intent-to-treat, 68% demonstrated a complete or substantial response to OK-432 immunotherapy. Response data for macrocystic LM were higher, with a complete or substantial response in 94% of patients; 63% of patients with mixed macrocystic-microcystic LM responded to treatment; no patients with microcystic LM responded to treatment. Spontaneous resolution occurred in less than 2% of patients. Median follow-up of 2.9 years demonstrated a 9% recurrence rate. Major adverse effects related to therapy occurred in 11 patients. As compared to historical surgical data on LM, OK-432 immunotherapy is more effective (P < .001) and has a lower morbidity (P < .001). OK-432 immunotherapy is an effective, safe, and simple treatment option for the management of macrocystic cervicofacial LM. ClinicalTrials.gov Identifier: NCT00010452.

  1. Efficacy and Safety of Topical Niacinamide for Acne Vulgaris

    Directory of Open Access Journals (Sweden)

    Zeynep Nurhan Saraçoğlu

    2011-06-01

    Full Text Available Background and Design: To investigate the efficacy and safety of topical 4% naicinamide gel cream in the treatment of mild to moderate acne vulgaris and to assess the quality of life of acne patients.Material and Method: Twenty-nine female patients aged 16-38 (mean: 23.57±5.42 years with mild to moderate acne vulgaris who presented in dermatology outpatient clinic were enrolled in the study. All patients applied 4% niacinamide gel cream (Vivatinell-acnecinamide gel cream® on their faces twice daily for eight weeks. The number of lesions (inflammatory and non-inflammatory was counted at 0, 2, 4 and 8 weeks. The side effects (erythema, desquamation, burning and dryness were recorded. The Skindex-29, a quality-of-life measure for patients with skin disease, was administered to the subjects at the beginning and the end of treatment.Results: The decrease in the mean number of inflammatory lesions was statistically significant at the end of the treatment (pre-treatment vs. post-treatment: 12.24 vs. 6.14; p =0.000. However, there was no statistically significant decrease in the number of non-inflammatory lesions at the end of the eight weeks. The niacinamide gel cream was generally well tolerated. There was statistically significant improvement in the Skindex-29 scale scores (p =0.000 at the end of the treatment.Conclusion: Topical 4% niacinamide gel cream may be an alternative treatment for inflammatory lesions of mild to moderate acne vulgaris.

  2. Efficacy and safety of topical tranexamic acid in knee arthroplasty.

    Science.gov (United States)

    López-Hualda, Álvaro; Dauder-Gallego, Cristina; Ferreño-Márquez, David; Martínez-Martín, Javier

    2018-02-26

    Tranexamic acid (TXA) is commonly used to control postoperative blood loss in total knee arthroplasty. In order to avoid adverse effects associated with intravenous administration, topical use has been proposed as an alternative. Our aim was to evaluate the efficacy and safety of topical TXA in total knee arthroplasty. A total of 90 patients scheduled for unilateral total knee arthroplasty were included in a prospective randomised study. All surgeries were performed under spinal anaesthesia, tourniquet and the same postoperative protocol. Patients were allocated to one of the 3 groups according to the application of TXA: group A (n=30) 1g of topical TXA; group B (n=30) 1g of TXA intravenous and in group C or the control group (n=30) no drug was administrated. Parameters related to blood loss and drain outputs were compared between the 3 groups. The results revealed that post-operative decrease in haemoglobin level was significantly lower in group A (1.95g/dL) than group B (2.25g/dL) and group C (2.96g/dL), P<.01. Total postoperative blood loss was lower in group A (195mL) than group B (466mL) and group C (718mL), P<.01. There was no significant difference in complications and allogenic blood transfusion rate between the 3 groups. According to the results, topical application of 1g TXA significantly reduced blood loss in patients undergoing total knee arthroplasty more than intravenous or no administration of TXA. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

  3. System safety education focused on industrial engineering

    Science.gov (United States)

    Johnston, W. L.; Morris, R. S.

    1971-01-01

    An educational program, designed to train students with the specific skills needed to become safety specialists, is described. The discussion concentrates on application, selection, and utilization of various system safety analytical approaches. Emphasis is also placed on the management of a system safety program, its relationship with other disciplines, and new developments and applications of system safety techniques.

  4. Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa's Efficacy and Safety for Climacteric Complaints.

    Science.gov (United States)

    Beer, A-M; Neff, A

    2013-01-01

    Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited to Cimicifuga racemosa products holding a marketing authorisation for treating climacteric complaints.

  5. How could intelligent safety transport systems enhance safety ?

    NARCIS (Netherlands)

    Wiethoff, M. Heijer, T. & Bekiaris, E.

    2017-01-01

    In Europe, many deaths and injured each years are the cost of today's road traffic. Therefore, it is wise to look for possible solutions for enhancing traffic safety. Some Advanced Driver Assistance Systems (ADAS) are expected to increase safety, but they may also evoke new safety hazards. Only

  6. Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures.

    Science.gov (United States)

    Mash, D C; Kovera, C A; Pablo, J; Tyndale, R F; Ervin, F D; Williams, I C; Singleton, E G; Mayor, M

    2000-09-01

    Ibogaine is an indole alkaloid found in the roots of Tabernanthe Iboga (Apocynaceae family), a rain forest shrub that is native to western Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and opiates. Anecdotal reports attest that a single dose of ibogaine eliminates opiate withdrawal symptoms and reduces drug craving for extended periods of time. The purported efficacy of ibogaine for the treatment of drug dependence may be due in part to an active metabolite. The majority of ibogaine biotransformation proceeds via CYP2D6, including the O-demethylation of ibogaine to 12-hydroxyibogamine (noribogaine). Blood concentration-time effect profiles of ibogaine and noribogaine obtained for individual subjects after single oral dose administrations demonstrate complex pharmacokinetic profiles. Ibogaine has shown preliminary efficacy for opiate detoxification and for short-term stabilization of drug-dependent persons as they prepare to enter substance abuse treatment. We report here that ibogaine significantly decreased craving for cocaine and heroin during inpatient detoxification. Self-reports of depressive symptoms were also significantly lower after ibogaine treatment and at 30 days after program discharge. Because ibogaine is cleared rapidly from the blood, the beneficial aftereffects of the drug on craving and depressed mood may be related to the effects of noribogaine on the central nervous system.

  7. Nuclear power systems: Their safety

    International Nuclear Information System (INIS)

    Myers, L.C.

    1993-01-01

    Mankind utilizes energy in many forms and from a variety of sources. Canada is one of a growing number of countries which have chosen to embrace nuclear-electric generation as a component of their energy systems. As of August 1992 there were 433 power reactors operating in 35 countries and accounting for more than 15% of the world's production of electricity. In 1992, thirteen countries derived at least 25% of their electricity from nuclear units, with France leading at nearly 70%. In the same year, Canada produced about 16% of its electricity from nuclear units. Some 68 power reactors are under construction in 16 countries, enough to expand present generating capacity by close to 20%. No human endeavour carries the guarantee of perfect safety and the question of whether or not nuclear-electric generation represents an 'acceptable' risk to society has long been vigorously debated. Until the events of late April 1986, nuclear safety had indeed been an issue for discussion, for some concern, but not for alarm. The accident at the Chernobyl reactor in the USSR has irrevocably changed all that. This disaster brought the matter of nuclear safety back into the public mind in a dramatic fashion. This paper discusses the issue of safety in complex energy systems and provides brief accounts of some of the most serious reactor accidents which have occurred to date. (author). 7 refs

  8. Radiation safety systems at the NSLS

    International Nuclear Information System (INIS)

    Dickinson, T.

    1987-04-01

    This report describes design principles that were used to establish the radiation safety systems at the National Synchrotron Light Source. The author described existing safety systems and the history of partial system failures. 1 fig

  9. IAEA Safety Standards on Management Systems and Safety Culture

    International Nuclear Information System (INIS)

    Persson, Kerstin Dahlgren

    2007-01-01

    The IAEA has developed a new set of Safety Standard for applying an integrated Management System for facilities and activities. The objective of the new Safety Standards is to define requirements and provide guidance for establishing, implementing, assessing and continually improving a Management System that integrates safety, health, environmental, security, quality and economic related elements to ensure that safety is properly taken into account in all the activities of an organization. With an integrated approach to management system it is also necessary to include the aspect of culture, where the organizational culture and safety culture is seen as crucial elements of the successful implementation of this management system and the attainment of all the goals and particularly the safety goals of the organization. The IAEA has developed a set of service aimed at assisting it's Member States in establishing. Implementing, assessing and continually improving an integrated management system. (author)

  10. Integrated therapy safety management system.

    Science.gov (United States)

    Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

    2013-09-01

    The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an 'integrated therapy safety management' is drafted. This concept could serve as a basis to improve resilience. The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for 'integrated therapy safety management'. The concept is applied by way of example for the 'medication process' to demonstrate its practical implementation. The 'integrated therapy safety management' is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of 'bridge managers'. 'Bridge managers' anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the 'bridge managers' and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

  11. Integrated therapy safety management system

    Science.gov (United States)

    Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

    2013-01-01

    Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

  12. The ATLAS Detector Safety System

    CERN Multimedia

    Helfried Burckhart; Kathy Pommes; Heidi Sandaker

    The ATLAS Detector Safety System (DSS) has the mandate to put the detector in a safe state in case an abnormal situation arises which could be potentially dangerous for the detector. It covers the CERN alarm severity levels 1 and 2, which address serious risks for the equipment. The highest level 3, which also includes danger for persons, is the responsibility of the CERN-wide system CSAM, which always triggers an intervention by the CERN fire brigade. DSS works independently from and hence complements the Detector Control System, which is the tool to operate the experiment. The DSS is organized in a Front- End (FE), which fulfills autonomously the safety functions and a Back-End (BE) for interaction and configuration. The overall layout is shown in the picture below. ATLAS DSS configuration The FE implementation is based on a redundant Programmable Logical Crate (PLC) system which is used also in industry for such safety applications. Each of the two PLCs alone, one located underground and one at the s...

  13. Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

    Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

  14. Safety, feasibility and efficacy of a rapid ART initiation in pregnancy ...

    African Journals Online (AJOL)

    Safety, feasibility and efficacy of a rapid ART initiation in pregnancy pilot programme in Cape Town, South Africa. S Black, R Zulliger, L Myer, R Marcus, S Jeneker, R Taliep, D Pienaar, R Wood, L-G Bekker ...

  15. Diode laser cyclophotocoagulation in Indian eyes: efficacy and safety.

    Science.gov (United States)

    Singh, Kirti; Jain, Divya; Veerwal, Vikas

    2017-02-01

    Diode laser cyclophotocoagulation (DLCP) has emerged as a time-tested procedure for end-stage glaucoma with fewer complications. By means of this study, we have evaluated its wide indications, its efficacy, and safety in darkly pigmented Asian Indian eyes. Ninety-one eyes with uncontrolled glaucoma presenting to glaucoma clinic of a tertiary care center over a period of 6 years were scheduled for DLCP. The semiconductor diode laser with a G probe was used with laser energy delivered about 1.5 mm behind the surgical limbus. The extent of clock hours of laser application was determined by pretreatment intraocular pressure (IOP) and superior area was spared in cases where future filtration surgery was contemplated. The DLCP was repeated earliest at 1 month in case of non-response and a maximum of three laser procedures were performed for any patient. Ninety-one eyes of 89 patients (40 males, 49 females) were included. Common indications included secondary glaucoma (37.3 %), failed trabeculectomies (27.4 %), angle closure glaucoma (17.5 %), etc. Laser power delivered ranged from 990 to 1800 mW, (mean 1396 + 182.14 mW) with an average of 17 spots. Patients improved from pretreatment IOP of 38.18 + 8.96 mmHg (range 20.6-64) to post treatment IOP of 17.86 + 7.75 mmHg (range 10-42). Qualified success was defined as final IOP of 20 mm Hg or less on topical medications that could be achieved in 70 % eyes with one or repeat treatment. Pre op visual acuity ranged from PL+ to 6/18 showing a slight improvement to PL+ to 6/12 post op. A 58.5 % reduction of IOP was noted. No incidence of serious complications was noted during follow-up ranging from 9 months to 3 years. DLCP is an effective and safe tool to be used in Indian population for control of IOP. It can be safely used as a primary modality to bring IOP to permissible levels before trabeculectomy.

  16. Efficacy and safety of pirfenidone for idiopathic pulmonary fibrosis

    Directory of Open Access Journals (Sweden)

    Takeda Y

    2014-03-01

    many of these are mild and manageable. Clinical experience has shown that reduction in pirfenidone dose and the supportive use of gastrointestinal drugs are effective ways to manage these symptoms. Thus, pirfenidone treatment provides a means of intervention in the clinical course of IPF, and is a promising candidate for improving patient prognosis. For future development, it is important to establish the appropriate modality of treatment with pirfenidone and/or novel potential drugs. Keywords: pirfenidone, safety, efficacy, anti-fibrotic drugs

  17. Efficacy and safety of benazepril for advanced chronic renal insufficiency.

    Science.gov (United States)

    Hou, Fan Fan; Zhang, Xun; Zhang, Guo Hua; Xie, Di; Chen, Ping Yan; Zhang, Wei Ru; Jiang, Jian Ping; Liang, Min; Wang, Guo Bao; Liu, Zheng Rong; Geng, Ren Wen

    2006-01-12

    Angiotensin-converting-enzyme inhibitors provide renal protection in patients with mild-to-moderate renal insufficiency (serum creatinine level, 3.0 mg per deciliter or less). We assessed the efficacy and safety of benazepril in patients without diabetes who had advanced renal insufficiency. We enrolled 422 patients in a randomized, double-blind study. After an eight-week run-in period, 104 patients with serum creatinine levels of 1.5 to 3.0 mg per deciliter (group 1) received 20 mg of benazepril per day, whereas 224 patients with serum creatinine levels of 3.1 to 5.0 mg per deciliter (group 2) were randomly assigned to receive 20 mg of benazepril per day (112 patients) or placebo (112 patients) and then followed for a mean of 3.4 years. All patients received conventional antihypertensive therapy. The primary outcome was the composite of a doubling of the serum creatinine level, end-stage renal disease, or death. Secondary end points included changes in the level of proteinuria and the rate of progression of renal disease. Of 102 patients in group 1, 22 (22 percent) reached the primary end point, as compared with 44 of 108 patients given benazepril in group 2 (41 percent) and 65 of 107 patients given placebo in group 2 (60 percent). As compared with placebo, benazepril was associated with a 43 percent reduction in the risk of the primary end point in group 2 (P=0.005). This benefit did not appear to be attributable to blood-pressure control. Benazepril therapy was associated with a 52 percent reduction in the level of proteinuria and a reduction of 23 percent in the rate of decline in renal function. The overall incidence of major adverse events in the benazepril and placebo subgroups of group 2 was similar. Benazepril conferred substantial renal benefits in patients without diabetes who had advanced renal insufficiency. (ClinicalTrials.gov number, NCT00270426.) Copyright 2006 Massachusetts Medical Society.

  18. Symptomatic efficacy and safety of diacerein in the treatment of osteoarthritis

    DEFF Research Database (Denmark)

    Bartels, E. M.; Bliddal, Henning; Schøndorff, P. K.

    2010-01-01

    To estimate the efficacy and safety of diacerein as a pain-reducing agent in the treatment of osteoarthritis (OA), using meta-analysis of published randomized placebo-controlled trials (RCTs).......To estimate the efficacy and safety of diacerein as a pain-reducing agent in the treatment of osteoarthritis (OA), using meta-analysis of published randomized placebo-controlled trials (RCTs)....

  19. Efficacy and Safety of Antidepressants for the Treatment of Irritable Bowel Syndrome: A Meta-Analysis

    OpenAIRE

    Xie, Chen; Tang, Yurong; Wang, Yunfeng; Yu, Ting; Wang, Yun; Jiang, Liuqin; Lin, Lin

    2015-01-01

    Aim The aim of this meta-analysis was to analyze the efficacy and safety of antidepressants for the treatment of irritable bowel syndrome. Methods We searched MEDLINE, EMBASE, Scopus and The Cochrane Library for randomized controlled trials investigating the efficacy and safety of antidepressants in the treatment of irritable bowel syndrome. Article quality was evaluated by Jadad score. RevMan 5.0 and Stata 12.0 were used for the meta-analysis. Results Twelve randomized controlled trials were...

  20. The Evidence Base on the Efficacy and Safety of Ibuprofen in Pediatrics

    Directory of Open Access Journals (Sweden)

    Yu.V. Marushko

    2013-10-01

    Full Text Available The article deals with an analysis of the world literature of recent years, the aim of which was to study the efficacy and safety of ibuprofen use as first-line antipyretic in pediatric practice. Special attention was paid to researches on the study the pharmacokinetics, efficacy and safety of ibuprofen in fever in children of all ages, as well as the use of different forms of ibuprofen (suspension, suppositories.

  1. Safety and efficacy of fenproporex for obesity treatment: a systematic review

    OpenAIRE

    Paumgartten,Francisco José Roma; Pereira,Sabrina Schaaf Teixeira Costa; Oliveira,Ana Cecilia Amado Xavier de

    2016-01-01

    ABSTRACT OBJECTIVE To evaluate clinical evidence on the safety and efficacy of fenproporex for treating obesity. METHODS MEDLINE, LILACS and Cochrane Controlled Trials Register were searched as well as references cited by articles and relevant documents. Two authors independently assessed the studies for inclusion and regarding risk of bias, collected data, and accuracy. Eligible studies were all those placebo-controlled that provided data on the efficacy and safety of Fenproporex to trea...

  2. Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

    Directory of Open Access Journals (Sweden)

    Matricciani Lisa

    2011-12-01

    Full Text Available Abstract Background Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. Methods The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science was undertaken (6/1/11. The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. Results The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. Conclusions This review indicates that there is good evidence (Level II to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of

  3. comparative efficacy and safety of cefixime and ciprofloxacin

    African Journals Online (AJOL)

    2011-09-31

    common cause of hospital admission in Nigeria, and, ... respiratory pathogens to antibacterials have raised concerns about the decreasing efficacy of currently ... community-acquired pneumonia, between July 1 and September 31, 2011 at two.

  4. Efficacy and Safety of Tribendimidine Against Clonorchis sinensis

    OpenAIRE

    Qian, Men-Bao; Yap, Peiling; Yang, Yi-Chao; Liang, Hai; Jiang, Zhi-Hua; Li, Wei; Tan, Yu-Guang; Zhou, Hui; Utzinger, Jürg; Zhou, Xiao-Nong; Keiser, Jennifer

    2017-01-01

    In this randomized open-label trial, tribendimidine was shown to have an efficacy comparable to praziquantel for the treatment of Clonorchis sinensis infection. Patients treated with praziquantel experienced significantly more adverse events than tribendimidine recipients.

  5. Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

    DEFF Research Database (Denmark)

    Egeberg, A; Ottosen, M B; Gniadecki, R

    2018-01-01

    BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

  6. Safety performance monitoring of autonomous marine systems

    International Nuclear Information System (INIS)

    Thieme, Christoph A.; Utne, Ingrid B.

    2017-01-01

    The marine environment is vast, harsh, and challenging. Unanticipated faults and events might lead to loss of vessels, transported goods, collected scientific data, and business reputation. Hence, systems have to be in place that monitor the safety performance of operation and indicate if it drifts into an intolerable safety level. This article proposes a process for developing safety indicators for the operation of autonomous marine systems (AMS). The condition of safety barriers and resilience engineering form the basis for the development of safety indicators, synthesizing and further adjusting the dual assurance and the resilience based early warning indicator (REWI) approaches. The article locates the process for developing safety indicators in the system life cycle emphasizing a timely implementation of the safety indicators. The resulting safety indicators reflect safety in AMS operation and can assist in planning of operations, in daily operational decision-making, and identification of improvements. Operation of an autonomous underwater vehicle (AUV) exemplifies the process for developing safety indicators and their implementation. The case study shows that the proposed process leads to a comprehensive set of safety indicators. It is expected that application of the resulting safety indicators consequently will contribute to safer operation of current and future AMS. - Highlights: • Process for developing safety indicators for autonomous marine systems. • Safety indicators based on safety barriers and resilience thinking. • Location of the development process in the system lifecycle. • Case study on AUV demonstrating applicability of the process.

  7. Compartmentalized safety coolant injection system

    International Nuclear Information System (INIS)

    Johnson, F.T.

    1983-01-01

    A safety coolant injection system for nuclear reactors wherein a core reflood tank is provided to afford more reliable reflooding of the reactor core in the event of a break in one of the reactor coolant supply loops. Each reactor coolant supply loop is arranged in a separate compartment in the containment structure to contain and control the flow of spilled coolant so as to permit its use during emergency core cooling procedures. A spillway allows spilled coolant in the compartment to pass into the emergency water storage tank from where it can be pumped back to the reactor vessel. (author)

  8. Perceived Indications, Safety and Efficacy of Perinatal Use of ...

    African Journals Online (AJOL)

    Cheboi SK

    Subjects and Methods: A descriptive cross- sectional ... easy labour and safe delivery (39.6%); and treatment of common ailments (28.5%). Majority ... structures for censoring, training, regulation of TM practice and safety of remedies used.

  9. CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations

    International Nuclear Information System (INIS)

    Camacho, Luis H

    2015-01-01

    Melanoma remains a critical public health problem worldwide. Patients with stage IV disease have very poor prognosis and their 1-year survival rate is only 25%. Until recently, systemic treatments with a positive impact on overall survival (OS) had remained elusive. In recent years, the United States Food and Drug Administration (FDA) – approved several novel agents targeting the RAS/RAF/MEK/ERK pathway (vemurafenib, dabrafenib, and trametinib) – critical in cell division and proliferation of melanoma, and an immune checkpoint inhibitor (ipilimumab) directed against the cytotoxic T lymphocyte Antigen - (CTLA-4). Moreover, recent reports of clinical trials studying other immune checkpoint modulating agents will most likely result in their FDA approval within the next months. This review focuses on ipilimumab, its safety and efficacy, and future considerations. Ipilimumab has demonstrated a positive OS impact after a several-year follow-up. It is also recognized that due to its mechanism of action, the response patterns to ipilimumab can differ from those observed in patients following treatment with conventional cytotoxic agents and even the most recently approved BRAF inhibitors. Most patients (84.8%) experience drug-related adverse events (AEs) of any grade; most of these are mild to moderate and immune mediated. However, a minority of patients may also experience severe and life-threatening AEs. In clinical studies, AEs were managed according to guidelines that emphasized close clinical monitoring and early use of corticosteroids when appropriate. Preliminary results have taught us the potential greater toxicity when in combination with vemurafenib, and the greater antitumor efficacy when combined with nivolumab, a monoclonal antibody directed against programmed death receptor-1 (PD-1), another immune checkpoint inhibitor. Future challenges include the optimization of dosing and toxicities when used as a single agent, and studying the safety and efficacy of

  10. Efficacy and safety of intermittent preventive treatment for malaria in schoolchildren: a systematic review.

    Science.gov (United States)

    Matangila, Junior R; Mitashi, Patrick; Inocêncio da Luz, Raquel A; Lutumba, Pascal T; Van Geertruyden, Jean-Pierre

    2015-11-14

    Intermittent preventive treatment (IPT) is a proven malaria control strategy in infants and pregnancy. School-aged children represent 26 % of the African population, and an increasing percentage of them are scholarized. Malaria is causing 50 % of deaths in this age group and malaria control efforts may shift the malaria burden to older age groups. Schools have been suggested as a platform for health interventions delivery (deworming, iron-folic acid, nutrients supplementation, (boost-)immunization) and as a possible delivery system for IPT in schoolchildren (IPTsc). However, the current evidence on the efficacy and safety of IPTsc is limited and the optimal therapeutic regimen remains controversial. A systematic search for studies reporting efficacy and safety of IPT in schoolchildren was conducted using PubMed, Web of Science, Clinicaltrials and WHO/ICTRP database, and abstracts from congresses with the following key words: intermittent, preventive treatment AND malaria OR Plasmodium falciparum AND schoolchildren NOT infant NOT pregnancy. Five studies were identified. Most IPTsc regimes demonstrated substantial protection against malaria parasitaemia, with dihydroartemisinin-piperaquine (DP) given monthly having the highest protective effect (PE) (94 %; 95 % CI 93-96). Contrarily, SP did not provide any PE against parasitaemia. However, no IPT regimen provided a PE above 50 % in regard to anaemia, and highest protection was provided by SP+ amodiaquine (AQ) given four-monthly (50 %; 95 % CI 41-53). The best protection against clinical malaria was observed in children monthly treated with DP (97 %; 95 % CI 87-98). However, there was no protection when the drug was given three-monthly. No severe adverse events were associated with the drugs used for IPTsc. IPTsc may reduce the malaria-related burden in schoolchildren. However, more studies assessing efficacy of IPT in particular against malaria-related anaemia and clinical malaria in schoolchildren must be conducted.

  11. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    OpenAIRE

    Vlachojannis, Christian; Zimmermann, Benno F.; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate ...

  12. Evaluating the safety and efficacy of dextromethorphan/quinidine in the treatment of pseudobulbar affect

    Directory of Open Access Journals (Sweden)

    Schoedel KA

    2014-06-01

    Full Text Available Kerri A Schoedel,1 Sarah A Morrow,2 Edward M Sellers3,4 1Altreos Research Partners, Inc., Toronto, 2Western University, London, 3DL Global Partners, Inc., Toronto, 4University of Toronto, Toronto, Ontario, Canada Abstract: Pseudobulbar affect (PBA is a common manifestation of brain pathology associated with many neurological diseases, including amyotrophic lateral sclerosis, Alzheimer’s disease, stroke, multiple sclerosis, Parkinson’s disease, and traumatic brain injury. PBA is defined by involuntary and uncontrollable expressed emotion that is exaggerated and inappropriate, and also incongruent with the underlying emotional state. Dextromethorphan/quinidine (DM/Q is a combination product indicated for the treatment of PBA. The quinidine component of DM/Q inhibits the cytochrome P450 2D6-mediated metabolic conversion of dextromethorphan to its active metabolite dextrorphan, thereby increasing dextromethorphan systemic bioavailability and driving the pharmacology toward that of the parent drug and away from adverse effects of the dextrorphan metabolite. Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point, the Center for Neurologic Study-Lability Scale, as well as secondary efficacy end points and quality of life. While concentration–effect relationships appear relatively weak for efficacy parameters, concentrations of DM/Q may have an impact on safety. Some special safety concerns exist with DM/Q, primarily because of the drug interaction and QT prolongation potential of the quinidine component. However, because concentrations of dextrorphan (which is responsible for many of the parent drug’s side effects and quinidine are lower than those observed in clinical practice with these drugs administered alone, some of the perceived safety issues may not be as relevant with this low dose combination product. However, since patients with PBA have a

  13. Efficacy and Safety Profile of Tricyclo-DNA Antisense Oligonucleotides in Duchenne Muscular Dystrophy Mouse Model

    Directory of Open Access Journals (Sweden)

    Karima Relizani

    2017-09-01

    Full Text Available Antisense oligonucleotides (AONs hold promise for therapeutic splice-switching correction in many genetic diseases. However, despite advances in AON chemistry and design, systemic use of AONs is limited due to poor tissue uptake and sufficient therapeutic efficacy is still difficult to achieve. A novel class of AONs made of tricyclo-DNA (tcDNA is considered very promising for the treatment of Duchenne muscular dystrophy (DMD, a neuromuscular disease typically caused by frameshifting deletions or nonsense mutations in the gene-encoding dystrophin and characterized by progressive muscle weakness, cardiomyopathy, and respiratory failure in addition to cognitive impairment. Herein, we report the efficacy and toxicology profile of a 13-mer tcDNA in mdx mice. We show that systemic delivery of 13-mer tcDNA allows restoration of dystrophin in skeletal muscles and to a lower extent in the brain, leading to muscle function improvement and correction of behavioral features linked to the emotional/cognitive deficiency. More importantly, tcDNA treatment was generally limited to minimal glomerular changes and few cell necroses in proximal tubules, with only slight variation in serum and urinary kidney toxicity biomarker levels. These results demonstrate an encouraging safety profile for tcDNA, albeit typical of phosphorothiate AONs, and confirm its therapeutic potential for the systemic treatment of DMD patients. Keywords: antisense oligonucleotides, Duchenne muscular dystrophy, preclinical, splice switching, tcDNA-AONs

  14. Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study.

    Science.gov (United States)

    Chiu, Chih-Wen; Lee, Tsung-Chieh; Hsu, Po-Chi; Chen, Chia-Yun; Chang, Shun-Chang; Chiang, John Y; Lo, Lun-Chien

    2015-06-09

    Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often applied for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. There are several research articles providing evidence of acupuncture treating dizziness and vertigo but few studies of acupuncture as an emergent intervention in ED. We performed a pilot cohort study to evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED. A total of 60 participants, recruited in ED, were divided into acupuncture and control group. Life-threatening conditions or central nervous system disorders were excluded to ensure participants' safety. The clinical effect of treating dizziness and vertigo was evaluated by performing statistical analyses on data collected from questionnaires of Dizziness Handicap Inventory (DHI), Visual Analog Scale (VAS) of dizziness and vertigo, and heart rate variability (HRV). The variation of VAS demonstrated a significant decrease (p-value: 0.001 and p-value: 0.037) between two groups after two different durations: 30 mins and 7 days. The variation of DHI showed no significant difference after 7 days. HRV revealed a significant increase in high frequency (HF) in the acupuncture group. No adverse event was reported in this study. Acupuncture demonstrates a significant immediate effect in reducing discomforts and VAS of both dizziness and vertigo. This study provides clinical evidence on the efficacy and safety of acupuncture to treat dizziness and vertigo in the emergency department. ClinicalTrials.gov ID: NCT02358239 . Registered 5 February 2015.

  15. Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

    Directory of Open Access Journals (Sweden)

    Huss M

    2017-07-01

    Full Text Available Michael Huss,1 Praveen Duhan,2 Preetam Gandhi,3 Chien-Wei Chen,4 Carsten Spannhuth,3 Vinod Kumar5 1Child and Adolescent Psychiatry, University Medicine, Mainz, Germany; 2Global Medical Affairs, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 3Development Franchise, Established Medicine Neuroscience, Novartis Pharma AG, Basel, Switzerland; 4Biostatistics Cardio-Metabolic & Established Medicine, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Established Medicines, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Abstract: Attention-deficit/hyperactivity disorder (ADHD is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH, a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. Keywords: methylphenidate, dose optimization, attention-deficit/hyperactivity disorder, ADHD

  16. Systems engineered health and safety criteria for safety analysis reports

    International Nuclear Information System (INIS)

    Beitel, G.A.; Morcos, N.

    1993-01-01

    The world of safety analysis is filled with ambiguous words: codes and standards, consequences and risks, hazard and accident, and health and safety. These words have been subject to disparate interpretations by safety analysis report (SAR) writers, readers, and users. open-quotes Principal health and safety criteriaclose quotes has been one of the most frequently misused phrases; rarely is it used consistently or effectively. This paper offers an easily understood definition for open-quotes principal health and safety criteriaclose quotes and uses systems engineering to convert an otherwise mysterious topic into the primary means of producing an integrated SAR. This paper is based on SARs being written for environmental restoration and waste management activities for the U.S. Department of Energy (DOE). Requirements for these SARs are prescribed in DOE Order 5480-23, open-quotes Nuclear Safety Analysis Reports.close quotes

  17. Considerations on nuclear reactor passive safety systems

    International Nuclear Information System (INIS)

    2016-01-01

    After having indicated some passive safety systems present in electronuclear reactors (control bars, safety injection system accumulators, reactor cooling after stoppage, hydrogen recombination systems), this report recalls the main characteristics of passive safety systems, and discusses the main issues associated with the assessment of new passive systems (notably to face a sustained loss of electric supply systems or of cold water source) and research axis to be developed in this respect. More precisely, the report comments the classification of safety passive systems as it is proposed by the IAEA, outlines and comments specific aspects of these systems regarding their operation and performance. The next part discusses the safety approach, the control of performance of safety passive systems, issues related to their reliability, and the expected contribution of R and D (for example: understanding of physical phenomena which have an influence of these systems, capacities of simulation of these phenomena, needs of experimentations to validate simulation codes)

  18. 77 FR 70409 - System Safety Program

    Science.gov (United States)

    2012-11-26

    ...-0060, Notice No. 2] 2130-AC31 System Safety Program AGENCY: Federal Railroad Administration (FRA... rulemaking (NPRM) published on September 7, 2012, FRA proposed regulations to require commuter and intercity passenger railroads to develop and implement a system safety program (SSP) to improve the safety of their...

  19. Preliminary safety evaluation for CSR1000 with passive safety system

    International Nuclear Information System (INIS)

    Wu, Pan; Gou, Junli; Shan, Jianqiang; Zhang, Bo; Li, Xiang

    2014-01-01

    Highlights: • The basic information of a Chinese SCWR concept CSR1000 is introduced. • An innovative passive safety system is proposed for CSR1000. • 6 Transients and 3 accidents are analysed with system code SCTRAN. • The passive safety systems greatly mitigate the consequences of these incidents. • The inherent safety of CSR1000 is enhanced. - Abstract: This paper describes the preliminary safety analysis of the Chinese Supercritical water cooled Reactor (CSR1000), which is proposed by Nuclear Power Institute of China (NPIC). The two-pass core design applied to CSR1000 decreases the fuel cladding temperature and flattens the power distribution of the core at normal operation condition. Each fuel assembly is made up of four sub-assemblies with downward-flow water rods, which is favorable to the core cooling during abnormal conditions due to the large water inventory of the water rods. Additionally, a passive safety system is proposed for CSR1000 to increase the safety reliability at abnormal conditions. In this paper, accidents of “pump seizure”, “loss of coolant flow accidents (LOFA)”, “core depressurization”, as well as some typical transients are analysed with code SCTRAN, which is a one-dimensional safety analysis code for SCWRs. The results indicate that the maximum cladding surface temperatures (MCST), which is the most important safety criterion, of the both passes in the mentioned incidents are all below the safety criterion by a large margin. The sensitivity analyses of the delay time of RCPs trip in “loss of offsite power” and the delay time of RMT actuation in “loss of coolant flowrate” were also included in this paper. The analyses have shown that the core design of CSR1000 is feasible and the proposed passive safety system is capable of mitigating the consequences of the selected abnormalities

  20. Comprehensive Lifecycle for Assuring System Safety

    Science.gov (United States)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

    CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

  1. FOOD SAFETY CONTROL SYSTEM IN CHINA

    Institute of Scientific and Technical Information of China (English)

    Liu Wei-jun; Wei Yi-min; Han Jun; Luo Dan; Pan Jia-rong

    2007-01-01

    Most countries have expended much effort to develop food safety control systems to ensure safe food supplies within their borders. China, as one of the world's largest food producers and consumers,pays a lot of attention to food safety issues. In recent years, China has taken actions and implemented a series of plans in respect to food safety. Food safety control systems including regulatory, supervisory,and science and technology systems, have begun to be established in China. Using, as a base, an analysis of the current Chinese food safety control system as measured against international standards, this paper discusses the need for China to standardize its food safety control system. We then suggest some policies and measures to improve the Chinese food safety control system.

  2. Safety Management System in Croatia Control Ltd.

    OpenAIRE

    Pavlin, Stanislav; Sorić, Vedran; Bilać, Dragan; Dimnik, Igor; Galić, Daniel

    2009-01-01

    International Civil Aviation Organization and other international aviation organizations regulate the safety in civil aviation. In the recent years the International Civil Aviation Organization has introduced the concept of the safety management system through several documents among which the most important is the 2006 Safety Management Manual. It treats the safety management system in all the segments of civil aviation, from carriers, aerodromes and air traffic control to design, constructi...

  3. Safety and efficacy of health supplement (Pegaga based product

    Directory of Open Access Journals (Sweden)

    Firdaus Abd Rahman

    2016-01-01

    Conclusions: Most traditional products claim contained herbs and have many indication although not proven by evidence based. Hence, consumers must be more selective before buying any health products. MOH continuing demonstrate enforcement action and educating the public in this matter. More research also must be conducted to confirm the efficacy and the appropriate dose for a particular situation either for prevention or treatment of disease.

  4. System Design and the Safety Basis

    International Nuclear Information System (INIS)

    Ellingson, Darrel

    2008-01-01

    The objective of this paper is to present the Bechtel Jacobs Company, LLC (BJC) Lessons Learned for system design as it relates to safety basis documentation. BJC has had to reconcile incomplete or outdated system description information with current facility safety basis for a number of situations in recent months. This paper has relevance in multiple topical areas including documented safety analysis, decontamination and decommissioning (D and D), safety basis (SB) implementation, safety and design integration, potential inadequacy of the safety analysis (PISA), technical safety requirements (TSR), and unreviewed safety questions. BJC learned that nuclear safety compliance relies on adequate and well documented system design information. A number of PIS As and TSR violations occurred due to inadequate or erroneous system design information. As a corrective action, BJC assessed the occurrences caused by systems design-safety basis interface problems. Safety systems reviewed included the Molten Salt Reactor Experiment (MSRE) Fluorination System, K-1065 fire alarm system, and the K-25 Radiation Criticality Accident Alarm System. The conclusion was that an inadequate knowledge of system design could result in continuous non-compliance issues relating to nuclear safety. This was especially true with older facilities that lacked current as-built drawings coupled with the loss of 'historical knowledge' as personnel retired or moved on in their careers. Walkdown of systems and the updating of drawings are imperative for nuclear safety compliance. System design integration with safety basis has relevance in the Department of Energy (DOE) complex. This paper presents the BJC Lessons Learned in this area. It will be of benefit to DOE contractors that manage and operate an aging population of nuclear facilities

  5. Ayurpharmacoepidemiology en Route to Safeguarding Safety and Efficacy of Ayurvedic Drugs in Global Outlook

    Science.gov (United States)

    Debnath, Parikshit; Banerjee, Subhadip; Adhikari, Anjan; Debnath, Pratip K.

    2016-01-01

    Ayurpharmacoepidemiology is a new field developed by synergy of the fields of clinical pharmacology, epidemiology, and ayurveda. It will use the effects of ayurvedic medicinal products on large populations to describe and analyze the practices, evaluate the safety and efficacy, and carry out medicoeconomic evaluations. Good pharmacoepidemiology practices in ayurveda is projected to assist with issues of ayurpharmacoepidemiologic research. The embraced good pharmacoepidemiology practices guideline in this viewpoint will be able to provide valuable evidence about the health effects of ayurvedic herbs/drugs and consider different fields like pharmacovigilance, pharmacoeconomics, and drug discovery with ayurvedic reverse pharmacology approach, also pass out significant data for further basic sciences study in ayurveda biology, ayurgenomics, ayurnutrigenomics, and systems biology. Several unanswered questions about ayurvedic drug use and informed interventions or policies that can be addressed by informatics database, which will eventually demonstrate the credibility and rationality of ayurceuticals in the future. PMID:26721554

  6. Safety assessment for Generation IV nuclear systems

    International Nuclear Information System (INIS)

    Leahy, T.J.

    2012-01-01

    The Generation IV International Forum (GIF) Risk and Safety Working Group (RSWG) was created to develop an effective approach for the safety of Generation IV advanced nuclear energy systems. Recent RSWG work has focused on the definition of an integrated safety assessment methodology (ISAM) for evaluating the safety of Generation IV systems. ISAM is an integrated 'tool-kit' consisting of 5 analytical techniques that are available and matched to appropriate stages of Generation IV system concept development: 1) qualitative safety features review - QSR, 2) phenomena identification and ranking table - PIRT, 3) objective provision tree - OPT, 4) deterministic and phenomenological analyses - DPA, and 5) probabilistic safety analysis - PSA. The integrated methodology is intended to yield safety-related insights that help actively drive the evolving design throughout the technology development cycle, potentially resulting in enhanced safety, reduced costs, and shortened development time

  7. Intermediate probabilistic safety assessment approach for safety critical digital systems

    International Nuclear Information System (INIS)

    Taeyong, Sung; Hyun Gook, Kang

    2001-01-01

    Even though the conventional probabilistic safety assessment methods are immature for applying to microprocessor-based digital systems, practical needs force to apply it. In the Korea, UCN 5 and 6 units are being constructed and Korean Next Generation Reactor is being designed using the digital instrumentation and control equipment for the safety related functions. Korean regulatory body requires probabilistic safety assessment. This paper analyzes the difficulties on the assessment of digital systems and suggests an intermediate framework for evaluating their safety using fault tree models. The framework deals with several important characteristics of digital systems including software modules and fault-tolerant features. We expect that the analysis result will provide valuable design feedback. (authors)

  8. THE EFFICACY AND SAFETY OF OXCARBAZEPINE AS ADD-ON THERAPY IN INTRACTABLE EPILEPSY IN CHILDREN

    OpenAIRE

    Azita TAVASSOLI; Mohammad GHOFRANI; Mohsen ROUZROKH; Eznollah AZARGASHB

    2010-01-01

    Objective1-3% of the population suffer from epilepsy. Up to 30% of them develop refractory epilepsy and their seizures occur more than once per month despite receiving at least 2 first line antiepileptic drugs. In  this group, more efficacious antiepileptics are needed. This study was undertaken to evaluate the efficacy and safety of Oxcarbazepine as an adjunction therapy in children with refractory epilepsy.Materials & MethodsFrom Feb 2004 until Sep 2006, 30 patients with refractory epilepsy...

  9. Software Quality Assurance for Nuclear Safety Systems

    International Nuclear Information System (INIS)

    Sparkman, D R; Lagdon, R

    2004-01-01

    The US Department of Energy has undertaken an initiative to improve the quality of software used to design and operate their nuclear facilities across the United States. One aspect of this initiative is to revise or create new directives and guides associated with quality practices for the safety software in its nuclear facilities. Safety software includes the safety structures, systems, and components software and firmware, support software and design and analysis software used to ensure the safety of the facility. DOE nuclear facilities are unique when compared to commercial nuclear or other industrial activities in terms of the types and quantities of hazards that must be controlled to protect workers, public and the environment. Because of these differences, DOE must develop an approach to software quality assurance that ensures appropriate risk mitigation by developing a framework of requirements that accomplishes the following goals: (sm b ullet) Ensures the software processes developed to address nuclear safety in design, operation, construction and maintenance of its facilities are safe (sm b ullet) Considers the larger system that uses the software and its impacts (sm b ullet) Ensures that the software failures do not create unsafe conditions Software designers for nuclear systems and processes must reduce risks in software applications by incorporating processes that recognize, detect, and mitigate software failure in safety related systems. It must also ensure that fail safe modes and component testing are incorporated into software design. For nuclear facilities, the consideration of risk is not necessarily sufficient to ensure safety. Systematic evaluation, independent verification and system safety analysis must be considered for software design, implementation, and operation. The software industry primarily uses risk analysis to determine the appropriate level of rigor applied to software practices. This risk-based approach distinguishes safety

  10. Safety and clinical efficacy of tenvermectin, a novel antiparasitic 16-membered macrocyclic lactone antibiotics.

    Science.gov (United States)

    Fei, Chenzhong; She, Rufeng; Li, Guiyu; Zhang, Lifang; Fan, Wushun; Xia, Suhan; Xue, Feiqun

    2018-05-30

    Tenvermectin (TVM) is a novel 16-membered macrocyclic lactone antibiotics, which contains component TVM A and TVM B. However there is not any report on safety and clinical efficacy of TVM for developing as a potential drug. In order to understand the part of safety and clinical efficacy of TVM, we conducted the acute toxicity test, the standard bacterial reverse mutation (Ames) test and the clinical deworming test. In the acute toxicity studies, TVM, TVM A and ivermectin (IVM) were administrated once by oral gavage to mice and rats. Results showed that the oral LD 50 values of TVM, TVM A and IVM in mice were 74.41, 106.95 and 53.06 mg/kg respectively. The oral LD 50 values of TVM and TVM A in rats were determined to be 164.22 and 749.34 mg/kg respectively. TVM and IVM are moderately toxic substances, meanwhile the TVM A belongs to low toxic compounds, implying that the acute toxicity is highly related to the length of side chain of TVM at position C25. In the Ames test, results showed that TVM did not induce mutagenicity in Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation system, speculating that the mutagenicity is probably not related to the side chain at position C25 of 16-membered macrocyclic lactone antibiotics. In the efficacy trail of TVM against swine nematodes, growing pigs natural infection of Ascaris suum and Trichuris suis were treated with a single subcutaneous injection 0.3 mg/kg b.w.. Results showed that TVM and IVM had excellent effect in expelling Ascaris suum, and TVM had potential efficacy against Trichuris suis, however IVM had no effect on Trichuris suis. This study suggests that the side chain of TVM at position C25 may have important biological functions, which is one of the key sites of the studies on structure-activity relationship of 16-membered macrocyclic lactone compounds. TVM is a new compound exhibited some advantages worthy of developing. Copyright © 2018 Elsevier B.V. All

  11. Safety and efficacy of personal care products containing colloidal oatmeal

    OpenAIRE

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vu...

  12. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    Science.gov (United States)

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  13. Autonomous system for launch vehicle range safety

    Science.gov (United States)

    Ferrell, Bob; Haley, Sam

    2001-02-01

    The Autonomous Flight Safety System (AFSS) is a launch vehicle subsystem whose ultimate goal is an autonomous capability to assure range safety (people and valuable resources), flight personnel safety, flight assets safety (recovery of valuable vehicles and cargo), and global coverage with a dramatic simplification of range infrastructure. The AFSS is capable of determining current vehicle position and predicting the impact point with respect to flight restriction zones. Additionally, it is able to discern whether or not the launch vehicle is an immediate threat to public safety, and initiate the appropriate range safety response. These features provide for a dramatic cost reduction in range operations and improved reliability of mission success. .

  14. 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...

  15. Safety design requirements for safety systems and components of JSFR

    International Nuclear Information System (INIS)

    Kubo, Shigenobu; Shimakawa, Yoshio; Yamano, Hidemasa; Kotake, Shoji

    2011-01-01

    Safety design requirements for JSFR were summarized taking the development targets of the FaCT project and design feature of JSFR into account. The related safety principle and requirements for Monju, CRBRP, PRISM, SPX, LWRs, IAEA standards, goals of GIF, basic principle of INPRO etc. were also taken into account so that the safety design requirements can be a next-generation global standard. The development targets for safety and reliability are set based on those of FaCT, namely, ensuring safety and reliability equal to future LWR and related fuel cycle facilities. In order to achieve these targets, the defence-in-depth concept is used as the basic safety design principle. General features of the safety design requirements are 1) Achievement of higher reliability, 2) Achievement of higher inspectability and maintainability, 3) Introduction of passive safety features, 4) Reduction of operator action needs, 5) Design consideration against Beyond Design Basis Events, 6) In-Vessel Retention of degraded core materials, 7) Prevention and mitigation against sodium chemical reactions, and 8) Design against external events. The current specific requirements for each system and component are summarized taking the basic design concept of JSFR into account, which is an advanced loop-type large-output power plant with a mixed-oxide-fuelled core. (author)

  16. The PIANC Safety Factor System for Breakwaters

    DEFF Research Database (Denmark)

    Burcharth, H. F.

    2000-01-01

    The paper presents a summary of the recommendations for implementation of safety in breakwater designs given by the PIANC PTC IT Working Group No 12 on Analysis of Rubble Mound Breakwaters with Vertical and Inclined Concrete Walls. The working groups developed for the most important failure modes...... a system of partial safety factors which facilitate design to any target safety level....

  17. Safety-related control air systems

    International Nuclear Information System (INIS)

    Anon.

    1977-01-01

    This Standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This Standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this Standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements

  18. Efficacy and safety of a combined Porcine Circovirus and Mycoplasma hyopneumoniae vaccine in finishing pigs

    Directory of Open Access Journals (Sweden)

    Maarten Witvliet

    2015-01-01

    Full Text Available The safety and protective efficacy of a new one dose combination vaccine containing Porcine Circovirus type 2 (PCV2 and M. hyopneumoniae antigens – Porcilis® PCV M Hyo - was evaluated in laboratory studies and under field conditions. Vaccination resulted in a moderate temperature increase on the day of vaccination and mild systemic and local reactions were found in only a low percentage of the vaccinated pigs. The local reactions observed were small (max. 2 cm and transient (max. 1 day. In short term (onset of immunity and long term (duration of immunity challenge studies with the individual pathogens, the vaccine significantly reduced the PCV2 load in lymphoid tissue and lungs and M. hyopneumoniae-induced lung lesions. In a placebo-controlled field trial on a farm where both PCV2 and M. hyopneumoniae were present, vaccination of piglets at 3 weeks of age resulted in a reduction of PCV2 viremia and shedding and lower lung lesion scores at slaughter. In addition, a positive effect on the average daily weight gain (+ 34 g/day in the finishing phase was observed. It can therefore be concluded that this new ready to use combination vaccine is safe and efficacious against PCV2 and M. hyopneumoniae single and combined infections.

  19. Treatment of Chronic Migraine with OnabotulinumtoxinA: Mode of Action, Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Délia Szok

    2015-07-01

    Full Text Available Background: Chronic migraine is a common, highly disabling, underdiagnosed and undertreated entity of migraine. It affects 0.9%–2.2% of the general adult population. The present paper overviews the preclinical and clinical data regarding the therapeutic effect of onabotulinumtoxinA in chronic migraineurs. Methods: A literature search was conducted in the database of PubMed up to 20 May 2015 for articles related to the pathomechanism of chronic migraine, the mode of action, and the efficacy, safety and tolerability of onabotulinumtoxinA for the preventive treatment of chronic migraine. Results: The pathomechanism of chronic migraine has not been fully elucidated. The mode of action of onabotulinumtoxinA in the treatment of chronic migraine is suggested to be related to the inhibition of the release of calcitonin gene-related peptide and substance P in the trigeminovascular system. Randomized clinical trials demonstrated that long-term onabotulinumtoxinA fixed-site and fixed-dose (155–195 U intramuscular injection therapy was effective and well tolerated for the prophylactic treatment of chronic migraine. Conclusions: Chronic migraine is a highly devastating entity of migraine. Its exact pathomechanism is unrevealed. Two-third of chronic migraineurs do not receive proper preventive medication. Recent clinical studies revealed that onabotulinumtoxinA was an efficacious and safe treatment for chronic migraine.

  20. A philosophy for space nuclear systems safety

    International Nuclear Information System (INIS)

    Marshall, A.C.

    1992-01-01

    The unique requirements and contraints of space nuclear systems require careful consideration in the development of a safety policy. The Nuclear Safety Policy Working Group (NSPWG) for the Space Exploration Initiative has proposed a hierarchical approach with safety policy at the top of the hierarchy. This policy allows safety requirements to be tailored to specific applications while still providing reassurance to regulators and the general public that the necessary measures have been taken to assure safe application of space nuclear systems. The safety policy used by the NSPWG is recommended for all space nuclear programs and missions

  1. Safety and efficacy of personal care products containing colloidal oatmeal.

    Science.gov (United States)

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.

  2. Safety and efficacy of personal care products containing colloidal oatmeal

    Directory of Open Access Journals (Sweden)

    Criquet M

    2012-11-01

    Full Text Available Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized.Methods: In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin.Results: We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation.Conclusion: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.Keywords: Avena sativa, colloids, protective agents, atopic dermatitis, irritant dermatitis, allergenic dermatitis, skin

  3. Automation for System Safety Analysis

    Science.gov (United States)

    Malin, Jane T.; Fleming, Land; Throop, David; Thronesbery, Carroll; Flores, Joshua; Bennett, Ted; Wennberg, Paul

    2009-01-01

    This presentation describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

  4. Early safety and efficacy of fingolimod treatment in Denmark

    DEFF Research Database (Denmark)

    Voldsgaard, A; Koch-Henriksen, N; Magyari, M

    2017-01-01

    BACKGROUND: Initiation of fingolimod treatment is associated with a transient decrease of heart rate, and atrioventricular (AV) conduction block may occur. OBJECTIVE: To evaluate the therapeutic effect and safety of fingolimod treatment in MS patients in Denmark with focus on cardiac and pulmonary...... to bradycardia and/or second-degree AV block type I. All patients recovered spontaneously. Two patients discontinued fingolimod. Eleven (5.4%) patients reported respiratory complaints and two of these patients discontinued treatment. CONCLUSIONS: Fingolimod appears to be safe and effective in MS patients...

  5. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation

    Directory of Open Access Journals (Sweden)

    Mary E. Westerman

    Full Text Available ABSTRACT Introduction: Hemorrhagic cystitis (HC represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regarding safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. Materials and Methods: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. Results: Median patient age was 76.5 years (IQR 69, 83. Pelvic radiation was the most common etiology for HC (n=38, 95%. Alum use decreased patient's transfusion requirement, with 82% (32/39 receiving a transfusion within 30 days before alum instillation (median 4 units versus 59% (23/39 within 30 days after completing alum (median 3 units (p=0.05. In total, 24 patients (60% required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5, 13 patients (32.5% remained without additional treatment for HC. Adverse effects were reported in 15 patients (38%, with bladder spasms representing the most common event (14/40; 35%. No clinical evidence of clinically significant systemic absorption was detected. Conclusion: Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC.

  6. Probabilistic safety criteria at the safety function/system level

    International Nuclear Information System (INIS)

    1989-09-01

    A Technical Committee Meeting was held in Vienna, Austria, from 26-30 January 1987. The objectives of the meeting were: to review the national developments of PSC at the level of safety functions/systems including future trends; to analyse basic principles, assumptions, and objectives; to compare numerical values and the rationale for choosing them; to compile the experience with use of such PSC; to analyse the role of uncertainties in particular regarding procedures for showing compliance. The general objective of establishing PSC at the level of safety functions/systems is to provide a pragmatic tool to evaluate plant safety which is placing emphasis on the prevention principle. Such criteria could thus lead to a better understanding of the importance to safety of the various functions which have to be performed to ensure the safety of the plant, and the engineering means of performing these functions. They would reflect the state-of-the-art in modern PSAs and could contribute to a balance in system design. This report, prepared by the participants of the meeting, reviews the current status and future trends in the field and should assist Member States in developing their national approaches. The draft of this document was also submitted to INSAG to be considered in its work to prepare a document on safety principles for nuclear power plants. Five papers presented at the meeting are also included in this publication. A separate abstract was prepared for each of these papers. Refs, figs and tabs

  7. Review of the Safety and Efficacy of Moringa oleifera.

    Science.gov (United States)

    Stohs, Sidney J; Hartman, Michael J

    2015-06-01

    Moringa oleifera leaves, seeds, bark, roots, sap, and flowers are widely used in traditional medicine, and the leaves and immature seed pods are used as food products in human nutrition. Leaf extracts exhibit the greatest antioxidant activity, and various safety studies in animals involving aqueous leaf extracts indicate a high degree of safety. No adverse effects were reported in association with human studies. Five human studies using powdered whole leaf preparations of M. oleifera have been published, which have demonstrated anti-hyperglycemic (antidiabetic) and anti-dyslipidemic activities. These activities have been confirmed using extracts as well as leaf powders in animal studies. A rapidly growing number of published studies have shown that aqueous, hydroalcohol, or alcohol extracts of M. oleifera leaves possess a wide range of additional biological activities including antioxidant, tissue protective (liver, kidneys, heart, testes, and lungs), analgesic, antiulcer, antihypertensive, radioprotective, and immunomodulatory actions. A wide variety of polyphenols and phenolic acids as well as flavonoids, glucosinolates, and possibly alkaloids is believed to be responsible for the observed effects. Standardization of products is an issue. However, the results of published studies to date involving M. oleifera are very promising. Additional human studies using standardized extracts are highly desirable. © 2015 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

  8. Architecture Level Safety Analyses for Safety-Critical Systems

    Directory of Open Access Journals (Sweden)

    K. S. Kushal

    2017-01-01

    Full Text Available The dependency of complex embedded Safety-Critical Systems across Avionics and Aerospace domains on their underlying software and hardware components has gradually increased with progression in time. Such application domain systems are developed based on a complex integrated architecture, which is modular in nature. Engineering practices assured with system safety standards to manage the failure, faulty, and unsafe operational conditions are very much necessary. System safety analyses involve the analysis of complex software architecture of the system, a major aspect in leading to fatal consequences in the behaviour of Safety-Critical Systems, and provide high reliability and dependability factors during their development. In this paper, we propose an architecture fault modeling and the safety analyses approach that will aid in identifying and eliminating the design flaws. The formal foundations of SAE Architecture Analysis & Design Language (AADL augmented with the Error Model Annex (EMV are discussed. The fault propagation, failure behaviour, and the composite behaviour of the design flaws/failures are considered for architecture safety analysis. The illustration of the proposed approach is validated by implementing the Speed Control Unit of Power-Boat Autopilot (PBA system. The Error Model Annex (EMV is guided with the pattern of consideration and inclusion of probable failure scenarios and propagation of fault conditions in the Speed Control Unit of Power-Boat Autopilot (PBA. This helps in validating the system architecture with the detection of the error event in the model and its impact in the operational environment. This also provides an insight of the certification impact that these exceptional conditions pose at various criticality levels and design assurance levels and its implications in verifying and validating the designs.

  9. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Kivelevitch D

    2014-04-01

    Full Text Available Dario Kivelevitch, Bobbak Mansouri, Alan Menter Department of Dermatology, Baylor University Medical Center, Dallas, TX, USA Abstract: Psoriasis is a chronic, immune-mediated inflammatory disease affecting both the skin and joints. Approximately 20% of patients suffer a moderate to severe form of skin disease and up to 30% have joint involvement. Standard therapies for psoriasis include topical medications, phototherapy, and both oral systemic and biological therapies whereas therapies for psoriatic arthritis include nonsteroidal anti-inflammatory drugs followed by disease modifying antirheumatic drugs and/or tumor necrosis factor (TNF-α inhibitors and interleukin-12/23p40 inhibitors. Treatment of both diseases is typically driven by disease severity. In the past decade, major advances in the understanding of the immunopathogenesis of psoriasis and psoriatic arthritis have led to the development of numerous biological therapies, which have revolutionized the treatment for moderate to severe plaque psoriasis and psoriatic arthritis. Anti-TNF-α agents are currently considered as first line biological therapies for the treatment of moderate to severe psoriasis and psoriatic arthritis. Currently approved anti-TNF-α agents include etanercept, adalimumab, and infliximab for psoriasis and psoriatic arthritis as well as golimumab and certolizumab for psoriatic arthritis. In this article, we aim to evaluate the long term safety and efficacy of etanercept in psoriasis and psoriatic arthritis. Keywords: psoriasis, psoriatic arthritis, etanercept, biological therapy, tumor necrosis factor, safety

  10. Efficacy and safety of superficial chemical peeling in treatment of active acne vulgaris.

    Science.gov (United States)

    Al-Talib, Hassanain; Al-Khateeb, Alyaa; Hameed, Ayad; Murugaiah, Chandrika

    2017-01-01

    Acne vulgaris is an extremely common condition affecting the pilosebaceous unit of the skin and characterized by presence of comedones, papules, pustules, nodules, cysts, which might result in permanent scars. Acne vulgaris commonly involve adolescents and young age groups. Active acne vulgaris is usually associated with several complications like hyper or hypopigmentation, scar formation and skin disfigurement. Previous studies have targeted the efficiency and safety of local and systemic agents in the treatment of active acne vulgaris. Superficial chemical peeling is a skin-wounding procedure which might cause some potentially undesirable adverse events. This study was conducted to review the efficacy and safety of superficial chemical peeling in the treatment of active acne vulgaris. It is a structured review of an earlier seven articles meeting the inclusion and exclusion criteria. The clinical assessments were based on pretreatment and post-treatment comparisons and the role of superficial chemical peeling in reduction of papules, pustules and comedones in active acne vulgaris. This study showed that almost all patients tolerated well the chemical peeling procedures despite a mild discomfort, burning, irritation and erythema have been reported; also the incidence of major adverse events was very low and easily manageable. In conclusion, chemical peeling with glycolic acid is a well-tolerated and safe treatment modality in active acne vulgaris while salicylic acid peels is a more convenient for treatment of darker skin patients and it showed significant and earlier improvement than glycolic acid.

  11. Golimumab in the treatment of psoriatic arthritis: efficacy and safety

    Directory of Open Access Journals (Sweden)

    Tatiana Viktorovna Korotaeva

    2015-01-01

    Full Text Available Tumor necrosis factor-α (TNF-α holds a central position in the pathogenesis of autoimmune inflammatory diseases of the locomotor apparatus. A separate class of drugs, namely, TNF-α inhibitors, that are effective against multicomponent diseases, such as psoriatic arthritis (PsA, is now available to physicians. The paper reviews the results of clinical trials of the TNF-α inhibitor golimumab, a human TNF-α monoclonal antibody. Golimumab exerts a positive effect on all manifestations of PsA: arthritis, psoriatic skin and nail lesions, dactylitis, enthesitis, and quality of life. The drug is noted for its convenient route of administration – its standard dose is 50 mg injected subcutaneously once a month and for its low molecular immunogenicity. Recent data suggest that golimumab is an effective drug with a safety profile similar to that of the entire class of TNF-α inhibitors.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production of ...... and safety of long-term treatment with rifaximin and evaluate effects of combination therapy with lactulose and branched-chain amino acids for patients with liver cirrhosis and hepatic encephalopathy.......Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production...... of ammonia by gut bacteria and, to some extent, other toxic derivatives from the gut. Clinical trials show that these effects improve episodes of hepatic encephalopathy. A large randomized trial found that rifaximin prevents recurrent episodes of hepatic encephalopathy. Most patients were treated...

  13. Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Raghavendra Charan P Makam

    Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.

  14. Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

    Science.gov (United States)

    Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

    2013-11-01

    Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

  15. Efficacy and Safety of Leucine Supplementation in the Elderly.

    Science.gov (United States)

    Borack, Michael S; Volpi, Elena

    2016-12-01

    Leucine supplementation has grown in popularity due to the discovery of its anabolic effects on cell signaling and protein synthesis in muscle. The current recommendation is a minimum intake of 55 mg ⋅ kg -1 . d -1 Leucine acutely stimulates skeletal muscle anabolism and can overcome the anabolic resistance of aging. The value of chronic leucine ingestion for muscle growth is still unclear. Most of the research into leucine consumption has focused on efficacy. To our knowledge, very few studies have sought to determine the maximum safe level of intake. Limited evidence suggests that intakes of ≤1250 mg ⋅ kg -1 . d -1 do not appear to have any health consequences other than short-term elevated plasma ammonia concentrations. Similarly, no adverse events have been reported for the leucine metabolite β-hydroxy-β-methylbutyrate (HMB), although no studies have tested HMB toxicity in humans. Therefore, future research is needed to evaluate leucine and HMB toxicity in the elderly and in specific health conditions. © 2016 American Society for Nutrition.

  16. Antipsychotic treatments for the elderly: efficacy and safety of aripiprazole

    Directory of Open Access Journals (Sweden)

    Izchak Kohen

    2010-03-01

    Full Text Available Izchak Kohen1, Paula E Lester2, Sum Lam31Division of Geriatric Psychiatry, Zucker-Hillside Hospital, Glen Oaks, NY, USA; 2Division of Geriatric Medicine, Winthrop University Hospital, Mineola, NY, USA; 3Division of Pharmacy and Geriatrics, St. John’s University College of Pharmacy and Allied Health Professions, Queens, NY, USAAbstract: Delusions, hallucinations and other psychotic symptoms can accompany a number of conditions in late life. As such, elderly patients are commonly prescribed antipsychotic medications for the treatment of psychosis in both acute and chronic conditions. Those conditions include schizophrenia, bipolar disorder, depression and dementia. Elderly patients are at an increased risk of adverse events from antipsychotic medications because of age-related pharmacodynamic and pharmacokinetic changes as well as polypharmacy. Drug selection should be individualized to the patient’s previous history of antipsychotic use, current medical conditions, potential drug interactions, and potential side effects of the antipsychotic. Specifically, metabolic side effects should be closely monitored in this population. This paper provides a review of aripiprazole, a newer second generation antipsychotic agent, for its use in a variety of psychiatric disorders in the elderly including schizophrenia, bipolar disorder, dementia, Parkinson’s disease and depression. We will review the pharmacokinetics and pharmacodynamics of aripiprazole as well as dosing, diagnostic indications, efficacy studies, and tolerability including its metabolic profile. We will also detail patient focused perspectives including quality of life, patient satisfaction and adherence.Keywords: aripiprazole, antipsychotics, elderly, adverse drug reaction

  17. The safety interlocking system at the NAC

    International Nuclear Information System (INIS)

    Visser, K.; Mostert, H.

    1984-01-01

    The central safety interlocking system (CSIS) controls the higher level of interlocking between the various cyclotron subsystems. It ensures the safe operation of the entire cyclotron facility as regards personnel safety and proper instrument operation. The system consists of a micro-processor with a ROM-based safety interlocking program, relay output modules providing ''safety OK'' instructions to all interlocked apparatus, alarm input modules connected to transducers providing binary alarm status signals and an interface to the central control computer. All solid state electronic components of the system are situated in a low level radiation area and are interfaced to cyclotron equipment by means of 24 V relays

  18. Safety and efficacy of low-dose, subacute exposure of mature ewes to sodium chlorate

    Science.gov (United States)

    The objective was to determine the safety and efficacy of low-dose, subacute exposure of mature ewes to NaClO3 in the drinking water. Twenty-five ewes (BW = 62.5 ± 7.3 kg) were placed indoors in individual pens with ad libitum access to water and feed. After 7 d of adaptation, ewes were assigned ran...

  19. Safety and protective efficacy of porcine reproductive and respiratory syndrome recombinant virus vaccines in young pigs.

    NARCIS (Netherlands)

    Verheije, M.H.; Kroese, M.V.; Linden, van der I.F.A.; Boer-Luijtze, de E.A.; Rijn, van P.A.; Pol, J.M.A.; Meulenberg, J.J.M.; Steverink, P.J.G.M.

    2003-01-01

    Three porcine reproductive and respiratory syndrome virus (PRRSV) recombinants, generated by mutagenesis of an infectious cDNA clone of the Lelystad virus (LV) isolate, were tested for their safety and protective efficacy as potential PRRSV vaccines in pigs. Recombinant vABV688 contains two amino

  20. Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

    Science.gov (United States)

    Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

    2018-01-01

    Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

  1. Assessment of efficacy and safety of praziquantel in the treatment of ...

    African Journals Online (AJOL)

    This study assessed the efficacy and safety of PZQ in school-aged children in four ... All pupils were also treated with a single dose of PZQ at 40 mg/kg. ... The presence of S. haematobium was neither age nor sex dependent (p>0.05).

  2. Efficacy and Safety of Canagliflozin in Patients with Type 2 Diabetes and Stage 3 Nephropathy

    NARCIS (Netherlands)

    Yamout, Hala; Perkovic, Vlado; Davies, Melanie; Woo, Vincent; de Zeeuw, Dick; Mayer, Cristiana; Vijapurkar, Ujjwala; Kline, Irina; Usiskin, Keith; Meininger, Gary; Bakris, George

    2014-01-01

    Background/Aims: Some sodium glucose co-transporter 2 (SGLT2) inhibitors are approved for the treatment of patients with type 2 diabetes mellitus (T2DM) with an estimated glomerular filtration rate (eGFR) of >= 45 ml/mm/1.73 m(2). The efficacy and safety of canagliflozin, an approved SGLT(2)

  3. Safety and efficacy of Profermin(R) to induce remission in ulcerative colitis

    DEFF Research Database (Denmark)

    Krag, Aleksander; Israelsen, Hans; von Ryberg, Bjørn

    2012-01-01

    AIM: To test the efficacy and safety of Profermin(R) in inducing remission in patients with active ulcerative colitis (UC). METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated ope...

  4. Neonatal pearls : safety and efficacy of medication use in fetus and neonate

    NARCIS (Netherlands)

    Lugt, Neeltje Margaretha van der

    2013-01-01

    Neonatal health care is provided with medication and protocols for almost all morbidities. Before the use of these medicines is allowed, they are extensively studied and tested for efficacy and safety. As patient population and knowledge on specific diseases changes with time, repeated evaluation

  5. A meta-analysis of the efficacy of preoperative surgical safety ...

    African Journals Online (AJOL)

    A meta-analysis of the efficacy of preoperative surgical safety checklists to improve perioperative outcomes. BM Biccard, RN Rodseth, L Cronje, P Agaba, E Chikumba, L du Toit, Z Farina, S Fischer, PD Gopalan, K Govender, J Kanjee, AC Kingwill, F Madzimbamuto, D Mashava, B Mrara, M Mudely, E Ninise, J Swanevelder, ...

  6. Clinical assessment of the efficacy and safety of T-Angelica Herbal ...

    African Journals Online (AJOL)

    The safety, efficacy, and acceptability of T-Angelica Herbal Tonic (THAT), a phytomedicinal beverage was studied over a period of one week in ten healthy volunteers for regulatory purposes. The study started after an overnight fast with each subject drinking 150ml of the beverage every night and every morning for a period ...

  7. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy

    NARCIS (Netherlands)

    Kondrackiene, Jurate; Beuers, Ulrich; Kupcinskas, Limas

    2005-01-01

    BACKGROUND & AIMS: Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far. The aim of this randomized study was to evaluate the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine. METHODS: Eighty-four

  8. Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

    DEFF Research Database (Denmark)

    Pedersen, Søren; Engelstätter, Renate; Weber, Hans-Jochen

    2009-01-01

    BACKGROUND: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. OBJECTIVE: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the ...

  9. Translational PKPD modeling in schizophrenia: linking receptor occupancy of antipsychotics to efficacy and safety

    NARCIS (Netherlands)

    Pilla Reddy, Venkatesh; Kozielska, Magdalena; Johnson, Martin; Vermeulen, An; Liu, Jing; de Greef, Rik; Groothuis, Genoveva; Danhof, Meindert; Proost, Johannes

    2012-01-01

    Objectives: To link the brain dopamine D2 receptor occupancy (D2RO) of antipsychotic drugs with clinical endpoints of efficacy and safety to assess the therapeutic window of D2RO. Methods: Pharmacokinetic-Pharmacodynamic (PK-PD) models were developed to predict the D2 receptor occupancy of

  10. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies

    DEFF Research Database (Denmark)

    Eron, Joseph J; Cooper, David A; Steigbigel, Roy T

    2013-01-01

    Two randomised, placebo-controlled trials-BENCHMRK-1 and BENCHMRK-2-investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end ...

  11. Acupuncture therapy: mechanism of action, efficacy, and safety: a potential intervention for psychogenic disorders?

    Science.gov (United States)

    2014-01-01

    Scientific bases for the mechanism of action of acupuncture in the treatment of pain and the pathogenic mechanism of acupuncture points are briefly summarized. The efficacy and safety of acupuncture therapy is discussed based on the results of German clinical trials. A conclusion on the role for acupuncture in the treatment of psychogenic disorders could not be reached. PMID:24444292

  12. Safety and Efficacy of Ferric Carboxymaltose in Anemic Pregnant Women: A Retrospective Case Control Study

    NARCIS (Netherlands)

    Pels, Anouk; Ganzevoort, Wessel

    2015-01-01

    Background. Anemia during pregnancy is commonly caused by iron deficiency and can have severe consequences for both the mother and the developing fetus. The aim of this retrospective study was to assess the safety and efficacy of intravenous ferric carboxymaltose (FCM) in pregnant women. Methods.

  13. Gamma-Knife surgery (GKS) in patients with acromegaly: safety and efficacy

    International Nuclear Information System (INIS)

    Katz, D.; Miragaya, K.; Tenca, E.; Margni, A.; Artes, C.; Antico, J.

    2007-01-01

    The acromegaly is associated with increased morbidity and mortality than the general population. Since the surgical and pharmacological treatment for acromegaly have specific limitations, the GKS has been used as a therapeutic option in selected patients. The object is to evaluate the efficacy and safety of GKS in patients with acromegaly [es

  14. Safety and efficacy of anticoagulation for secondary stroke prevention in atrial fibrillation patients: The AMADEUS trial

    NARCIS (Netherlands)

    Lane, D.A.; Kamphuisen, P.W.; Minini, P.; Buller, H.R.; Lip, G.Y.H.

    2010-01-01

    ackground: Patients with atrial fibrillation (AF) and previous ischemic stroke are at high risk of recurrent stroke, but are also perceived to be at increased bleeding risk while treated with anticoagulants. Methods: Post-hoc analyses examined the efficacy and safety of anticoagulation of 4576 AF

  15. Efficacy, safety and tolerability of simvastatin in children with familial hypercholesterolaemia - Rationale, design and baseline characteristics

    NARCIS (Netherlands)

    de Jongh, S.; Stalenhoef, A. F. H.; Tuohy, M. B.; Mercuri, M.; Bakker, H. D.; Kastelein, J. J. P.

    2002-01-01

    Objective: To describe the rationale, design and baseline data of a study conducted to determine the efficacy, safety and tolerability of simvastatin in children and adolescents with heterozygous familial hypercholesterolaemia (heFH). Methods: Patients were recruited from nine lipid clinics

  16. Safety and Efficacy of BAY 94-9027, a Prolonged-Half-Life Factor VIII

    DEFF Research Database (Denmark)

    Reding, M T; Ng, H J; Poulsen, Lone Hvitfeldt

    2017-01-01

    BACKGROUND: BAY 94-9027 is a B-domain-deleted prolonged-half-life recombinant factor VIII (FVIII) conjugates in a site-specific manner with polyethylene glycol. OBJECTIVE: Assess efficacy and safety of BAY 94-9027 for prophylaxis and treatment of bleeds in patients with severe hemophilia A PATIEN...

  17. Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder

    Science.gov (United States)

    Findling, Robert L.; Childress, Ann C.; Cutler, Andrew J.; Gasior, Maria; Hamdani, Mohamed; Ferreira-Cornwell, M. Celeste; Squires, Liza

    2011-01-01

    Objective: To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD). Method: Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score greater than or equal to 28) were randomized to…

  18. Meeting the maglev system's safety requirements

    Energy Technology Data Exchange (ETDEWEB)

    Pierick, K

    1983-12-01

    The author shows how the safety requirements of the maglev track system derive from the general legal conditions for the safety of tracked transport. It is described how their compliance beyond the so-called ''development-accompanying'' and ''acceptance-preparatory'' safety work can be assured for the Transrapid test layout (TVE) now building in Emsland and also for later application as public transport system in Germany within the meaning of the General Railway Act.

  19. The Evolution of System Safety at NASA

    Science.gov (United States)

    Dezfuli, Homayoon; Everett, Chris; Groen, Frank

    2014-01-01

    The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

  20. Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion

    DEFF Research Database (Denmark)

    Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir

    2015-01-01

    OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...

  1. Efficacy and safety of fentanyl buccal for cancer pain management by administration through a soluble film: an update

    Directory of Open Access Journals (Sweden)

    Marvin Omar Delgado-Guay

    2010-11-01

    Full Text Available Marvin Omar Delgado-GuayDivision of Geriatrics and Palliative Medicine, The University of Texas, Medical School at Houston, Houston, TX, USAAbstract: More than half of patients receiving prescription medicine for cancer pain have been reported to experience inadequate pain relief or breakthrough pain. Buccal administration can deliver lipophilic opioids rapidly to the systemic circulation through the buccal mucosa, limiting gastrointestinal motility and first-pass metabolism. This review updates the safety and efficacy of fentanyl buccal soluble film (FBSF in patients with cancer pain. Literature was identified through searches of Medline (PubMed. Search terms included combinations of the following: cancer pain, fentanyl, fentanyl buccal soluble film, pharmacology, kinetics, safety, efficacy and toxicity. FBSF is an oral transmucosal form of fentanyl citrate developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. Studies have shown that it is well tolerated in the oral cavity, with adequate bioavailability and safety in cancer patients. Further studies are warranted to evaluate, in comparison with other short-acting opioids, its efficacy in the management of breakthrough cancer pain, its addictive potential and its economic impact in cancer patients.Keywords: fentanyl buccal soluble film, cancer pain

  2. Efficacy and safety of fentanyl buccal for cancer pain management by administration through a soluble film: an update

    International Nuclear Information System (INIS)

    Delgado-Guay, Marvin Omar

    2010-01-01

    More than half of patients receiving prescription medicine for cancer pain have been reported to experience inadequate pain relief or breakthrough pain. Buccal administration can deliver lipophilic opioids rapidly to the systemic circulation through the buccal mucosa, limiting gastrointestinal motility and first-pass metabolism. This review updates the safety and efficacy of fentanyl buccal soluble film (FBSF) in patients with cancer pain. Literature was identified through searches of Medline (PubMed). Search terms included combinations of the following: cancer pain, fentanyl, fentanyl buccal soluble film, pharmacology, kinetics, safety, efficacy and toxicity. FBSF is an oral transmucosal form of fentanyl citrate developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. Studies have shown that it is well tolerated in the oral cavity, with adequate bioavailability and safety in cancer patients. Further studies are warranted to evaluate, in comparison with other short-acting opioids, its efficacy in the management of breakthrough cancer pain, its addictive potential and its economic impact in cancer patients

  3. Safety and efficacy assessment of standardized herbal formula PM012

    Science.gov (United States)

    2012-01-01

    Background This study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m), and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration. Methods Spatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male and female SD rats (15/sex/group) at doses of 0 (vehicle control), 500, 1,000 and 2,000 mg/kg/day for 4 or 26 weeks. To evaluate the recovery potential, 5 animals of each sex were assigned to vehicle control and 2,000 mg/kg/day groups during the 4-week recovery period. Results The results showed that PM012-treated hPS2m transgenic mice showed significantly reduced escape latency when compared with the hPS2m transgenic mice. The repeated oral administration of PM012 over 26 weeks in male and female rats induced an increase and increasing trend in thymus weight in the female treatment groups (main and recovery groups), but the change was judged to be toxicologically insignificant. In addition, the oral administration of the herbal medicine PM012 did not cause adverse effects as assessed by clinical signs, mortality, body weight, food and water consumption, ophthalmology, urinalysis, hematology, serum biochemistry, blood clotting time, organ weights and histopathology. The No Observed Adverse Effects Levels of PM012 was determined to be 2,000 mg/kg/day for both sexes, and the target organ was not identified. Conclusion These results suggest that PM012 has potential for use in the treatment of the Alzheimer's disease without serious adverse effects. PMID:22458507

  4. Efficacy and safety of Saccharomyces boulardii for acute diarrhea.

    Science.gov (United States)

    Feizizadeh, Sahar; Salehi-Abargouei, Amin; Akbari, Vajihe

    2014-07-01

    The efficacy of Saccharomyces boulardii for treatment of childhood diarrhea remains unclear. Our objective was to systematically review data on the effect of S. boulardii on acute childhood diarrhea. Our data sources included Medline, Embase, CINAHL, Scopus, and The Cochrane Library up to September 2013 without language restrictions. Randomized controlled trials and non-randomized trials that evaluated effectiveness of S. boulardii for treatment of acute diarrhea in children were included. Two reviewers independently evaluated studies for eligibility and quality and extracted the data. In total, 1248 articles were identified, of which 22 met the inclusion criteria. Pooling data from trials showed that S. boulardii significantly reduced the duration of diarrhea (mean difference [MD], -19.7 hours; 95% confidence interval [CI], -26.05 to -13.34), stool frequency on day 2 (MD, -0.74; 95% CI, -1.38 to -0.10) and day 3 (MD, -1.24; 95% CI, -2.13 to -0.35), the risk for diarrhea on day 3 (risk ratio [RR], 0.41; 95% CI, 0.27 to 0.60) and day 4 (RR, 0.38; 95% CI, 0.24 to 0.59) after intervention compared with control. The studies included in this review were varied in the definition of diarrhea, the termination of diarrhea, inclusion and exclusion criteria, and their methodological quality. This review and meta-analysis show that S. boulardii is safe and has clear beneficial effects in children who have acute diarrhea. However, additional studies using head-to-head comparisons are needed to define the best dosage of S. boulardii for diarrhea with different causes. Copyright © 2014 by the American Academy of Pediatrics.

  5. Safety-efficacy balance of S-ketamine and S-norketamine in acute and chronic pain

    NARCIS (Netherlands)

    Noppers, Ingeborg Marieke

    2011-01-01

    The balance between safety and efficacy is important in pharmacotherapy. When the indication of a registered drug shifts to another disease or a different patient population, studies on safety and efficacy need to be performed. Ketamine is a relatively ‘old’ drug and used for almost 50 years as an

  6. 78 FR 60290 - Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of...

    Science.gov (United States)

    2013-10-01

    ..., 2013, on the following topics: (1) What factors should be considered in masking study data (e.g., data...] Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Reopening of Comment Period... of Masked and De- identified Non-Summary Safety and Efficacy Data; Request for Comments,'' which...

  7. Efficacy and safety of sotagliflozin in treating diabetes type 1.

    Science.gov (United States)

    Rendell, Marc S

    2018-02-01

    Sotagliflozin is the first dual SGLT1/SGLT2 inhibitor developed for use in diabetes. Sotagliflozin blocks SGLT2 in the kidneys and SGLT1 in the intestines resulting in reduced early phase glucose absorption and increased blood levels of GLP-1 and PYY. Urinary glucose excretion is lower than with other agents as a result of decreased glucose absorption. The primary development effort to date has been in Type 1 diabetes. Areas covered: The published information on sotagliflozin is reviewed, along with the recent results of several pivotal Type 1 diabetes trials. Expert opinion: Sotagliflozin treatment lowers HbA1c and reduces glucose variability, with a trend to less hypoglycemic events. In the Type 1 trials, sotagliflozin treated individuals experienced DKA at a higher rate than placebo treated patients. An additional safety issue arises from the as yet unknown potential risks in women of child bearing potential in whom DKA is of utmost concern. The sotagliflozin development program has now been extended to trials in Type 2 diabetes, and long term studies will be needed to assess the benefits and risks of the agent in comparison to other currently marketed SGLT2 inhibitors.

  8. Safety Verification for Probabilistic Hybrid Systems

    DEFF Research Database (Denmark)

    Zhang, Lijun; She, Zhikun; Ratschan, Stefan

    2010-01-01

    The interplay of random phenomena and continuous real-time control deserves increased attention for instance in wireless sensing and control applications. Safety verification for such systems thus needs to consider probabilistic variations of systems with hybrid dynamics. In safety verification o...... on a number of case studies, tackled using a prototypical implementation....

  9. Ergonomics in the context of system safety

    International Nuclear Information System (INIS)

    Donnelly, K.E.

    1984-01-01

    In a complex industrial environment, ergonomics must be combined with management science and systems analysis to produce a program which can create effective change and improve safety performance. We give an overview of such an approach, namely System Safety, so that its ergonomic content may be seen

  10. Technical self reliance of digital safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Dong Young [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Kim, Kook Hun [Doosan Heavy Industries and Construction, Changwon (Korea, Republic of); Choi, Seung Gap [POSCON, Pohang (Korea, Republic of)

    2009-04-15

    This paper summarizes the development results of the Korea Nuclear Instrumentation and Control System (KNICS) project sponsored by the Korean government. In this project, Man Machine Interface System (MMIS) architecture, two digital platforms, and several control systems are developed. One platform is a programmable Logic Controller (PLC) for a safety system and another platform is a Distributed Control System (DCS) for a non safety system. With the POSAFE Q PLC, a Reactor Protection System (RPS) and an Engineered Safety Feature Component Control System (ESF CCS) are developed. A Power Control System (PCS) is developed based on the DCS. The safety grade platform and the digital safety systems obtained approval for the Topical Report from the Korean regulatory body in February of 2009. Also a Korean utility and a vendor company determined KNICS results to apply them to the planned Nuclear Power Plant (NPP) in March 2009. This paper introduces the technical self reliance experiences of the safety grade platform and the digital safety systems developed in the KNICS R and D project.

  11. Systems Thinking and Patient Safety

    National Research Council Canada - National Science Library

    Schyve, Paul M

    2005-01-01

    Patient safety is a prominent theme in health care delivery today. This should come as no surprise, given that "first, do no harm" has been the ethical watchword throughout the history of medicine, nursing, and pharmacy...

  12. Efficacy, safety and tolerability of rasagiline as adjunctive therapy in elderly patients with Parkinson's disease.

    Science.gov (United States)

    Tolosa, E; Stern, M B

    2012-02-01

    Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. Rasagiline decreased daily OFF time versus placebo (Prasagiline but were not significant. Between-group comparisons (≥70 vs. efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

  13. 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...

  14. THE STUDY THE EFFICACY AND SAFETY OF ANTIMICROBIAL AGENTS

    Directory of Open Access Journals (Sweden)

    V. V. Bagaeva

    2015-01-01

    Full Text Available Abstract:Effective treatment of patients with infectious and inflammatory diseases of the skin and mucous membranes often involves the use of antimicrobial agents.The purpose of the study was an in vitro estimation of cytotoxicity and the efficiency of national resources for local use: gel with bacteriophages («Otofag», «Fagogin», «Fagoderm», «Fagodent» and antiseptic — «Сhlorhexidine» and «Miramistin».Materials and Methods. To study the effectiveness of antimicrobial agents they used to provide crop strains of Staphylococcus aureus and Streptococcus pyogenes as one of the most common representatives of pathogens. The study of cell viability and cytotoxicity antimicrobials performed on cell lines KB — epidermoid carcinoma of the oral cavity of a human. For this purpose we use mikrotetrazoly test, which is widely used in the assessment of the effects on the cells of toxins, pharmaceuticals, adverse environmental factors, allowing to evaluate the toxicity of investigational drugs in vitro.The results showed that the efficacy against pathogens Staphylococcus aureus and Streptococcus pyogenes, has even a 10‑fold dilution of «Сhlorhexidine» 0.05% and gels with bacteriophages. Antiseptic «Miramistin» is effective only on the initial concentration. The study of cytotoxicity showed that the processing of epidermoid carcinoma cells with «Chlorhexidine» and «Мiramistin» invokes the irreversible reactions, while the composition processing of gels based on bacteriophages not further affect cell viability.Conclusions The results of the experiment confirmed the significant toxicity of tools such as «Сhlorhexidine» and «Miramistin» in proposed concentrations in the pharmacy network. Despite the high efficiency of these vehicles with regard to the studied pathogens, their long-term use in treatment of inflammatory diseases of the skin and mucous membranes can cause a slowing of repair processes. Gel means with bacteriophages

  15. Antiangiogenic treatment in hepatocellular carcinoma: the balance of efficacy and safety

    Science.gov (United States)

    Welker, Martin-Walter; Trojan, Joerg

    2013-01-01

    Hepatocellular carcinoma (HCC) is a severe complication of advanced liver disease with a worldwide incidence of more than 600,000 patients per year. Liver function, clinical performance status, and tumor size are considered in the Barcelona Clinic Liver Cancer (BCLC) system. While curative treatment options are available for early stages, most patients present with intermediate- or advanced-stage HCC, burdened with a poor prognosis, substantially influenced by the degree of liver-function impairment. Hypervascularization is a major characteristic of HCC, and antiangiogenic treatments are the basis of treatment in noncurative stages, including interventional and pharmacological treatments. Currently, the tyrosine-kinase inhibitor sorafenib is still the only approved drug for HCC. Further improvements in survival in patients with intermediate- and advanced-stage HCC may be anticipated by both multimodal approaches, such as combination of interventional and systemic treatments, and new systemic treatment options. Until now, the Phase III development of other tyrosine-kinase inhibitors in patients with advanced HCC has failed due to minor efficacy and/or increased toxicity compared to sorafenib. However, promising Phase II data have been reported with MET inhibitors in this hard-to-treat population. This review gives a critical overview of antiangiogenic drugs and strategies in intermediate- and advanced-stage HCC, with a special focus on safety. PMID:24204170

  16. Antiangiogenic treatment in hepatocellular carcinoma: the balance of efficacy and safety

    Directory of Open Access Journals (Sweden)

    Welker MW

    2013-10-01

    Full Text Available Martin-Walter Welker, Joerg TrojanMedizinische Klinik 1, Universitätsklinikum Frankfurt, GermanyAbstract: Hepatocellular carcinoma (HCC is a severe complication of advanced liver disease with a worldwide incidence of more than 600,000 patients per year. Liver function, clinical performance status, and tumor size are considered in the Barcelona Clinic Liver Cancer (BCLC system. While curative treatment options are available for early stages, most patients present with intermediate- or advanced-stage HCC, burdened with a poor prognosis, substantially influenced by the degree of liver-function impairment. Hypervascularization is a major characteristic of HCC, and antiangiogenic treatments are the basis of treatment in noncurative stages, including interventional and pharmacological treatments. Currently, the tyrosine-kinase inhibitor sorafenib is still the only approved drug for HCC. Further improvements in survival in patients with intermediate- and advanced-stage HCC may be anticipated by both multimodal approaches, such as combination of interventional and systemic treatments, and new systemic treatment options. Until now, the Phase III development of other tyrosine-kinase inhibitors in patients with advanced HCC has failed due to minor efficacy and/or increased toxicity compared to sorafenib. However, promising Phase II data have been reported with MET inhibitors in this hard-to-treat population. This review gives a critical overview of antiangiogenic drugs and strategies in intermediate- and advanced-stage HCC, with a special focus on safety.Keywords: HCC, sorafenib, antiangiogenesis, TACE, MET

  17. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; de Morales, José M. García Ruiz; Herreras, Jose M.; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-01-01

    Abstract Background: To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Methods: Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). Results: We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Conclusions: Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients. PMID:29049193

  18. Efficacy and safety of immunomodulatory drugs in patients with anterior uveitis: A systematic literature review.

    Science.gov (United States)

    Gómez-Gómez, Alejandro; Loza, Estíbaliz; Rosario, Maria Piedad; Espinosa, Gerard; Morales, José M García Ruiz de; Herreras, Jose M; Muñoz-Fernández, Santiago; Cordero-Coma, Miguel

    2017-10-01

    To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies. The study quality was assessed using the Jadad scale and according to The Oxford Centre for Evidence-based Medicine (update 2009). We included 13 studies of moderate-poor quality, with a mean duration from 5 months to 20 years, and number of AU patients ranging from 9 to 274. Patient's demographic and clinical characteristics were very heterogeneous. In most cases, uveitis anatomic classification criteria and outcomes definitions were unclear. Some of the studies only included AU patients with a systemic disease associated, mostly spondyloarthritis, others, mixed populations (idiopathic and systemic disease associated patients), and in some articles this data is not described. We found that methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might prevent AU flares, improve ocular inflammation and visual acuity, and decrease systemic steroids doses. Although there is a lack of robust evidence, methotrexate, cyclosporine A, azathioprine, adalimumab, and golimumab might be effective in AU patients.

  19. Safety-critical Java for embedded systems

    DEFF Research Database (Denmark)

    Schoeberl, Martin; Dalsgaard, Andreas Engelbredt; Hansen, René Rydhof

    2016-01-01

    This paper presents the motivation for and outcomes of an engineering research project on certifiable Javafor embedded systems. The project supports the upcoming standard for safety-critical Java, which defines asubset of Java and libraries aiming for development of high criticality systems....... The outcome of this projectinclude prototype safety-critical Java implementations, a time-predictable Java processor, analysis tools formemory safety, and example applications to explore the usability of safety-critical Java for this applicationarea. The text summarizes developments and key contributions...

  20. Operation safety of complex industrial systems

    International Nuclear Information System (INIS)

    Zwingelstein, G.

    1999-01-01

    Zero fault or zero risk is an unreachable goal in industrial activities like nuclear activities. However, methods and techniques exist to reduce the risks to the lowest possible and acceptable level. The operation safety consists in the recognition, evaluation, prediction, measurement and mastery of technological and human faults. This paper analyses each of these points successively: 1 - evolution of operation safety; 2 - definitions and basic concepts: failure, missions and functions of a system and of its components, basic concepts and operation safety; 3 - forecasting analysis of operation safety: reliability data, data-banks, precautions for the use of experience feedback data; realization of an operation safety study: management of operation safety, quality assurance, critical review and audit of operation safety studies; 6 - conclusions. (J.S.)

  1. Intragastric Balloon for Obesity Treatment: Safety, Tolerance, and Efficacy

    Directory of Open Access Journals (Sweden)

    Joana Ribeiro da Silva

    2017-12-01

    Full Text Available Background: Obesity is an increasing worldwide problem associated with a vast number of comorbidities. Decreasing body weight by only 5-10% has been shown to slow and even prevent the onset of obesity-related comorbidities. Between pharmacological therapy and bariatric surgery a great variety of endoscopic techniques are available, the most common being intragastric balloon (IGB. The purpose of this study was to assess the safety, tolerance, and kinetics of IGBs in weight loss. The kinetics of weight loss were evaluated in 2 different contexts and phases: after the IGB's removal and after follow-up that varied between 6 and 12 months. Successful weight loss was defined as ≥10% weight loss after 6-12 months. Methods: The study included 51 patients who had undergone Orbera® IGB placement between September 2014 and February 2016. Inclusion criteria were age between 18 and 65 years; body mass index (BMI 28-35 with severe obesity-related disorders; or BMI 35-40. The IGB was removed 6 months later. All patients were followed for a minimum period of 6-12 months. Results: Of 51 patients, 16 were excluded (7 due to intolerance and 35 patients entered the study, of which 83% were followed for more than 6-12 months. The average weight loss (WL and % excess WL (%EWL after 6 months of treatment were 11.94 kg and 42.16%, respectively. At 6-12 months, after removal of the IGB, the mean WL was 8.25 kg and %EWL was 30.27%. Nineteen patients attained a WL of ≥10% the baseline value at IGB removal and 12 maintained their weight below this threshold during the 6-12 following months. Conclusions: After temporary IGB implantation in overweight or obese individuals, a WL that was ≥10% of weight at baseline was achieved in 54.3% and sustained at 6-12 months in 41.4% of participants. IGBs are an attractive intermediate option between diet and exercise programs and bariatric surgery. In general, IGB placement is a safe and well-tolerated procedure.

  2. Probiotics: immunomodulation and evaluation of safety and efficacy.

    NARCIS (Netherlands)

    Ezendam, Janine; Loveren, Henk van

    2006-01-01

    The intake of probiotics has been associated with beneficial effects on the immune system, such as improved disease resistance and diminished risk of allergies. This review gives an overview of the immunomodulatory effects of probiotics investigated with in vitro assays, experimental animal models,

  3. OBTAINING FOOD SAFETY BY APPLYING HACCP SYSTEM

    Directory of Open Access Journals (Sweden)

    ION CRIVEANU

    2012-01-01

    Full Text Available In order to increase the confidence of the trading partners and consumers in the products which are sold on the market, enterprises producing food are required to implement the food safety system HACCP,a particularly useful system because the manufacturer is not able to fully control finished products . SR EN ISO 22000:2005 establishes requirements for a food safety management system where an organization in the food chain needs to proove its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. This paper presents the main steps which ensure food safety using the HACCP system, and SR EN ISO 20000:2005 requirements for food safety.

  4. Technical features of ABWR safety systems

    International Nuclear Information System (INIS)

    Sugisaki, Toshihiko; Tominaga, Kenji; Horiuchi, Tetsuo

    1986-01-01

    The engineering safety facilities of ABWRs have been disigned so as to have many excellent characteristics such as safety, reliability and economy, reflecting the merit of adopting new technology such as internal pumps and new control rod driving mechanism, and coupled with the safety peculiar to BWRs. In this paper, about ECCS, containment vessels and others which compose the engineering safety facilities of ABWRs, the characteristics related to the safety owing to the adoption of internal pumps and others, and the evaluation of the performance at the time of various accidents are discussed. As the results of safety evaluation, it was clarified that due to the safety peculiar to ABWRs and the characteristics of the safety facilities, the large increases of safety, reliability and economy have been planned in the ABWRs, and for example, core flooding can be maintained even at the time of a hypothetical loss of coolant accident. BWRs have the simple system constitution, good self controllability, large natural circulation ability, simple operation control method and excellent ability of confining heat and radioactivity. BWRs have three safety functions to stop reactors, to remove heat from reactors, and to confine radioactive substances. These functions of ABWRs were evaluated, and very high safety was confirmed. (Kako, I.)

  5. Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

    Directory of Open Access Journals (Sweden)

    Joyce K. Keithley

    2013-01-01

    Full Text Available Background. Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods. Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results. A total of 53 participants (18–65 years of age; BMI 25–35 kg/m2 were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (−.40±.06 and −.43±.07, resp. or other efficacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600.

  6. Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months.

    Science.gov (United States)

    Ziesenitz, Victoria C; Zutter, Andreas; Erb, Thomas O; van den Anker, Johannes N

    2017-08-01

    Ibuprofen is a non-steroidal anti-inflammatory drug frequently administered to children of various ages for relief of fever and pain and is approved as an over-the-counter medication in many countries worldwide. Although there are extensive data on its efficacy and safety in children and adults, there are divergent dosing recommendations for analgesia and treatment of fever in infants, especially in the age group between 3 and 6 months of age. In this article, we have assessed the safety and efficacy of ibuprofen use in infants in an attempt to find the optimal method of pain and fever management in this specific age group. Based on the current evidence, short-term use of ibuprofen is considered safe in infants older than 3 months of age having a body weight above 5-6 kg when special attention is given to the hydration of the patient. Ibuprofen should be prescribed based on body weight using a dose of 5-10 mg/kg. This dose can be administered 3-4 times a day resulting in a maximum total daily dose of 30-40 mg/kg. The rectal route has been shown to be less reliable because of erratic absorption, especially in young infants. Since most efficacy and safety data have been derived from trials in infants with fever, future studies should focus on the efficacy of ibuprofen in young infants with pain.

  7. Safety and Efficacy of AAV Retrograde Pancreatic Ductal Gene Delivery in Normal and Pancreatic Cancer Mice.

    Science.gov (United States)

    Quirin, Kayla A; Kwon, Jason J; Alioufi, Arafat; Factora, Tricia; Temm, Constance J; Jacobsen, Max; Sandusky, George E; Shontz, Kim; Chicoine, Louis G; Clark, K Reed; Mendell, Joshua T; Korc, Murray; Kota, Janaiah

    2018-03-16

    Recombinant adeno-associated virus (rAAV)-mediated gene delivery shows promise to transduce the pancreas, but safety/efficacy in a neoplastic context is not well established. To identify an ideal AAV serotype, route, and vector dose and assess safety, we have investigated the use of three AAV serotypes (6, 8, and 9) expressing GFP in a self-complementary (sc) AAV vector under an EF1α promoter (scAAV.GFP) following systemic or retrograde pancreatic intraductal delivery. Systemic delivery of scAAV9.GFP transduced the pancreas with high efficiency, but gene expression did not exceed >45% with the highest dose, 5 × 10 12 viral genomes (vg). Intraductal delivery of 1 × 10 11 vg scAAV6.GFP transduced acini, ductal cells, and islet cells with >50%, ∼48%, and >80% efficiency, respectively, and >80% pancreatic transduction was achieved with 5 × 10 11 vg. In a Kras G12D -driven pancreatic cancer mouse model, intraductal delivery of scAAV6.GFP targeted acini, epithelial, and stromal cells and exhibited persistent gene expression 5 months post-delivery. In normal mice, intraductal delivery induced a transient increase in serum amylase/lipase that resolved within a day of infusion with no sustained pancreatic inflammation or fibrosis. Similarly, in PDAC mice, intraductal delivery did not increase pancreatic intraepithelial neoplasia progression/fibrosis. Our study demonstrates that scAAV6 targets the pancreas/neoplasm efficiently and safely via retrograde pancreatic intraductal delivery.

  8. Safety and Efficacy of AAV Retrograde Pancreatic Ductal Gene Delivery in Normal and Pancreatic Cancer Mice

    Directory of Open Access Journals (Sweden)

    Kayla A. Quirin

    2018-03-01

    Full Text Available Recombinant adeno-associated virus (rAAV-mediated gene delivery shows promise to transduce the pancreas, but safety/efficacy in a neoplastic context is not well established. To identify an ideal AAV serotype, route, and vector dose and assess safety, we have investigated the use of three AAV serotypes (6, 8, and 9 expressing GFP in a self-complementary (sc AAV vector under an EF1α promoter (scAAV.GFP following systemic or retrograde pancreatic intraductal delivery. Systemic delivery of scAAV9.GFP transduced the pancreas with high efficiency, but gene expression did not exceed >45% with the highest dose, 5 × 1012 viral genomes (vg. Intraductal delivery of 1 × 1011 vg scAAV6.GFP transduced acini, ductal cells, and islet cells with >50%, ∼48%, and >80% efficiency, respectively, and >80% pancreatic transduction was achieved with 5 × 1011 vg. In a KrasG12D-driven pancreatic cancer mouse model, intraductal delivery of scAAV6.GFP targeted acini, epithelial, and stromal cells and exhibited persistent gene expression 5 months post-delivery. In normal mice, intraductal delivery induced a transient increase in serum amylase/lipase that resolved within a day of infusion with no sustained pancreatic inflammation or fibrosis. Similarly, in PDAC mice, intraductal delivery did not increase pancreatic intraepithelial neoplasia progression/fibrosis. Our study demonstrates that scAAV6 targets the pancreas/neoplasm efficiently and safely via retrograde pancreatic intraductal delivery.

  9. Safety features of subcritical fluid fueled systems

    International Nuclear Information System (INIS)

    Bell, C.R.

    1995-01-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible

  10. Safety features of subcritical fluid fueled systems

    International Nuclear Information System (INIS)

    Bell, C.R.

    1994-01-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved in very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible

  11. Safety features of subcritical fluid fueled systems

    Energy Technology Data Exchange (ETDEWEB)

    Bell, C.R. [Los Alamos National Laboratory, NM (United States)

    1995-10-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.

  12. Integrating system safety into the basic systems engineering process

    Science.gov (United States)

    Griswold, J. W.

    1971-01-01

    The basic elements of a systems engineering process are given along with a detailed description of what the safety system requires from the systems engineering process. Also discussed is the safety that the system provides to other subfunctions of systems engineering.

  13. Drug monitoring in child and adolescent psychiatry for improved efficacy and safety of psychopharmacotherapy

    Directory of Open Access Journals (Sweden)

    Fegert Jörg M

    2009-04-01

    Full Text Available Abstract Most psychotropic drugs used in the treatment of children and adolescents are applied "off label" with a direct risk of under- or overdosing and a delayed risk of long-term side effects. The selection of doses in paediatric psychiatric patients requires a consideration of pharmacokinetic parameters and the development of central nervous system, and warrants specific studies in children and adolescents. Because these are lacking for most of the psychotropic drugs applied in the Child and Adolescent and Psychiatry, therapeutic drug monitoring (TDM is a valid tool to optimise pharmacotherapy and to enable to adjust the dosage of drugs according to the characteristics of the individual patient. Multi-centre TDM studies enable the identification of age- and development-dependent therapeutic ranges of blood concentrations and facilitate a highly qualified standardized documentation in the child and adolescent health care system. In addition, they will provide data for future research on psychopharmacological treatment in children and adolescents, as a baseline for example for clinically relevant interactions with various co-medications. Therefore, a German-Austrian-Swiss "Competence Network on Therapeutic Drug Monitoring in Child and Adolescent Psychiatry" was founded 1 introducing a comprehensive internet data base for the collection of demographic, safety and efficacy data as well as blood concentrations of psychotropic drugs in children and adolescents.

  14. Evaluation of the efficacy and safety of endovascular management for transplant renal artery stenosis

    Directory of Open Access Journals (Sweden)

    Leonardo G.M. Valle

    Full Text Available OBJECTIVES: To evaluate the safety and efficacy of endovascular intervention with angioplasty and stent placement in patients with transplant renal artery stenosis. METHODS: All patients diagnosed with transplant renal artery stenosis and graft dysfunction or resistant systemic hypertension who underwent endovascular treatment with stenting from February 2011 to April 2016 were included in this study. The primary endpoint was clinical success, and the secondary endpoints were technical success, complication rate and stent patency. RESULTS: Twenty-four patients with transplant renal artery stenosis underwent endovascular treatment, and three of them required reinterventions, resulting in a total of 27 procedures. The clinical success rate was 100%. All graft dysfunction patients showed decreased serum creatinine levels and improved estimated glomerular filtration rates and creatinine levels. Patients with high blood pressure also showed improved control of systemic blood pressure and decreased use of antihypertensive drugs. The technical success rate of the procedure was 97%. Primary patency and assisted primary patency rates at one year were 90.5% and 100%, respectively. The mean follow-up time of patients was 794.04 days after angioplasty. CONCLUSION: Angioplasty with stent placement for the treatment of transplant renal artery stenosis is a safe and effective technique with good results in both the short and long term.

  15. The Safety and Efficacy of Methylphenidate and Dexmethylphenidate in Adults with Attention Deficit/Hyperactivity Disorder

    Directory of Open Access Journals (Sweden)

    Michael A. Sopko

    2010-01-01

    Full Text Available Objective To review the literature on the safety and efficacy of methylphenidate, OROS-methylphenidate, methylphenidate ER, and dexmethylphenidate in adults with Attention-Deficit/Hyperactivity Disorder (ADHD. To analyze the effects of different doses of methylphenidate, it's various formulations, and methylphenidate on efficacy and safety in this population. Data Sources Literature retrieval was performed through Pubmed/MEDLINE (Up to May 2010 using the terms methylphenidate, dexmethylphenidate, and attention-deficit hyperactivity disorder. In addition, reference citations from publications identified were reviewed. Study Selection and Data Extraction Double-blinded, placebo-controlled clinical trials, as well as crossover and open-label trials found using the search criteria listed above were included for review. Case reports were not included in this review. Data Synthesis Attention-deficit/hyperactivity disorder (ADHD is a psychiatric condition that is commonly seen in children and adolescents, that persists into adulthood for about 50% of patients. Methylphenidate and dexmethylphenidate are often prescribed to treat the symptoms associated with ADHD. The literature validating the safety and efficacy of methylphenidate and dexmethylphenidate in children and adolescents with ADHD is substantial. However, the literature specifically addressing the safety and efficacy of these medications in the adult population is less extensive and prescribing is often anecdotal based on child and adolescent data. Understanding the literature regarding methylphenidate and dexmethylphenidate and its effects in adults can enhance evidence-based medicine (EBM and improve treatment outcomes Conclusion Methylphenidate and dexmethylphenidate are safe and effective medications to treat the symptoms of ADHD in adults. Based on the literature, increased doses are associated with better treatment response with moderate safety concerns. The different dosage forms

  16. Safety management system needs assessment.

    Science.gov (United States)

    2016-04-01

    The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

  17. Efficacy and safety of the probiotic Saccharomyces boulardii for the prevention and therapy of gastrointestinal disorders

    Science.gov (United States)

    Kelesidis, Theodoros

    2012-01-01

    Several clinical trials and experimental studies strongly suggest a place for Saccharomyces boulardii as a biotherapeutic agent for the prevention and treatment of several gastrointestinal diseases. S. boulardii mediates responses resembling the protective effects of the normal healthy gut flora. The multiple mechanisms of action of S. boulardii and its properties may explain its efficacy and beneficial effects in acute and chronic gastrointestinal diseases that have been confirmed by clinical trials. Caution should be taken in patients with risk factors for adverse events. This review discusses the evidence for efficacy and safety of S. boulardii as a probiotic for the prevention and therapy of gastrointestinal disorders in humans. PMID:22423260

  18. Safety standards of IAEA for management systems

    International Nuclear Information System (INIS)

    Vincze, P.

    2005-01-01

    IAEA has developed a new series of safety standards which are assigned for constitution of the conditions and which give the instruction for setting up the management systems that integrate the aims of safety, health, life environment and quality. The new standard shall replace IAEA 50-C-Q - Requirements for security of the quality for safety in nuclear power plants and other nuclear facilities as well as 14 related safety instructions mentioned in the Safety series No. 50-C/SG-Q (1996). When developing of this complex, integrated set of requirements for management systems, the IAEA requirements 50-C-Q (1996) were taken into consideration as well as the publications developed within the International organisation for standardization (ISO) ISO 9001:2000 and ISO14001: 1996. The experience of European Union member states during the development, implementation and improvement of the management systems were also taken into consideration

  19. Reliability analysis of Angra I safety systems

    International Nuclear Information System (INIS)

    Oliveira, L.F.S. de; Soto, J.B.; Maciel, C.C.; Gibelli, S.M.O.; Fleming, P.V.; Arrieta, L.A.

    1980-07-01

    An extensive reliability analysis of some safety systems of Angra I, are presented. The fault tree technique, which has been successfully used in most reliability studies of nuclear safety systems performed to date is employed. Results of a quantitative determination of the unvailability of the accumulator and the containment spray injection systems are presented. These results are also compared to those reported in WASH-1400. (E.G.) [pt

  20. EFFICACY AND SAFETY OF 23-VALENT PNEUMOCOCCAL POLYSACCHARIDE VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS

    Directory of Open Access Journals (Sweden)

    M. S. Naumtseva

    2015-01-01

    Full Text Available Objective: to study the clinical efficacy, immunogenicity, and safety of a 23-valent pneumococcal vaccine in patients with rheumatoid arthritis (RA. Subjects and methods. The investigation enrolled 70 patients (55 women and 15 men aged 23–70 years, including 40 patients with RA and 30 people without systemic inflammatory rheumatic diseases (a control group who had a recent history of 2 and more cases of lower respiratory tract infections (bronchitis, pneumonia. When included, all the patients received anti-inflammatory therapy with methotrexate (MT (n = 24, leflunomide (LEF (n = 6, or MT + tumor necrosis factor-α (TNF-α inhibitors (n = 10. A single 0.5-ml dose of the 23-valent pneumococcal vaccine Pneumo-23 (Sanofi Pasteur was administered subcutaneously or intramuscularly during continuous MT or LEF therapy for the underlying disease or 3–4 weeks before the use of a TNF-α inhibitor. During control visits (1 and 3 months and 1 year after administration of the vaccine, the patients underwent physical examination and routine clinical and laboratory studies. Results. No clinical and radiological symptoms of pneumonia were recorded in any case during a 12-month follow-up. The RA and control groups showed a more than 2-fold increase in anti-pneumococcal antibody levels 1 year after vaccination. The vaccine was well tolerated by 50 patients. Sixteen patients were observed to have pain, cutaneous swelling and hyperemia and 4 had subfebrility. There were neither episodes of RA exacerbation nor new autoimmune disorders during the follow-up. Conclusion. The findings suggest that 23-valent pneumococcal vaccine shows a good clinical efficacy, adequate immunogenicity, and good tolerability in the patients with RA. 

  1. NASA Aviation Safety Reporting System (ASRS)

    Science.gov (United States)

    Connell, Linda J.

    2017-01-01

    The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

  2. LOFT integral test system final safety analysis report

    International Nuclear Information System (INIS)

    1974-03-01

    Safety analyses are presented for the following LOFT Reactor systems: engineering safety features; support buildings and facilities; instrumentation and controls; electrical systems; and auxiliary systems. (JWR)

  3. Comparison of standard (self-directed) versus intensive patient training for the human insulin inhalation powder (HIIP) delivery system in patients with type 2 diabetes: efficacy, safety, and training measures.

    Science.gov (United States)

    Rosenstock, Julio; Nakano, Masako; Silverman, Bernard L; Sun, Bin; de la Peña, Amparo; Suri, Ajit; Muchmore, Douglas B

    2007-02-01

    The Lilly/Alkermes human insulin inhalation powder (HIIP) delivery system [AIR (a registered trademark of Alkermes, Inc., Cambridge, MA) Inhaled Insulin System] was designed to be easy to use. Training methods were compared in insulin-naive patients with type 2 diabetes. Patients (n = 102) were randomized to standard or intensive training. With standard training, patients learned how to use the HIIP delivery system by reading directions for use (DFU) and trying on their own. Intensive training included orientation to the HIIP delivery system with individual coaching and inspiratory flow rate training. Both groups received preprandial HIIP + metformin with or without a thiazolidinedione for 4 weeks. Overall 2-h postprandial blood glucose (PPBG) excursion was the primary measure. Noninferiority was defined as the upper limit of the two-sided 95% confidence interval of the mean difference between groups being 1.2 training) and 0.23 +/- 0.36 (intensive training) mmol/L. The mean difference (standard minus intensive training) and two-sided 95% confidence interval were -0.35 (-1.02, 0.33) mmol/L. No statistically or clinically significant differences were observed between training methods in premeal, postmeal, or bedtime blood glucose values, HIIP doses at endpoint, or blood glucose values after a test meal. No discontinuations occurred because of difficulty of use or dislike of the HIIP system. DFU compliance was >90% in both training groups. There were no significant differences between training methods in safety measures. The HIIP delivery system is easy to use, and most patients can learn to use it by reading the DFU without assistance from health care professionals.

  4. Safety status system for operating room devices.

    Science.gov (United States)

    Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J

    2014-01-01

    Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.

  5. Safety and Efficacy of Bevacizumab With Hypofractionated Stereotactic Irradiation for Recurrent Malignant Gliomas

    International Nuclear Information System (INIS)

    Gutin, Philip H.; Iwamoto, Fabio M.; Beal, Kathryn; Mohile, Nimish A.; Karimi, Sasan; Hou, Bob L.; Lymberis, Stella; Yamada, Yoshiya; Chang, Jenghwa

    2009-01-01

    Purpose: Preclinical studies suggest that inhibition of vascular endothelial growth factor (VEGF) improves glioma response to radiotherapy. Bevacizumab, a monoclonal antibody against VEGF, has shown promise in recurrent gliomas, but the safety and efficacy of concurrent bevacizumab with brain irradiation has not been extensively studied. The objectives of this study were to determine the safety and activity of this combination in malignant gliomas. Methods and Materials: After prior treatment with standard radiation therapy patients with recurrent glioblastoma (GBM) and anaplastic gliomas (AG) received bevacizumab (10 mg/kg intravenous) every 2 weeks of 28-day cycles until tumor progression. Patients also received 30 Gy of hypofractionated stereotactic radiotherapy (HFSRT) in five fractions after the first cycle of bevacizumab. Results: Twenty-five patients (20 GBM, 5 AG; median age 56 years; median Karnofsky Performance Status 90) received a median of seven cycles of bevacizumab. One patient did not undergo HFSRT because overlap with prior radiotherapy would exceed the safe dose allowed to the optic chiasm. Three patients discontinued treatment because of Grade 3 central nervous system intratumoral hemorrhage, wound dehiscence, and bowel perforation. Other nonhematologic and hematologic toxicities were transient. No radiation necrosis was seen in these previously irradiated patients. For the GBM cohort, overall response rate was 50%, 6-month progression-free survival was 65%; median overall survival was 12.5 months, and 1-year survival was 54%. Discussion: Bevacizumab with HFSRT is safe and well tolerated. Radiographic responses, duration of disease control, and survival suggest that this regimen is active in recurrent malignant glioma.

  6. Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

    Science.gov (United States)

    Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

    2011-06-01

    Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

  7. Aviation Safety Reporting System: Process and Procedures

    Science.gov (United States)

    Connell, Linda J.

    1997-01-01

    The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

  8. Efficacy, safety, and patient preference of monoamine oxidase B inhibitors in the treatment of Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Bradley J Robottom

    2011-01-01

    Full Text Available Bradley J RobottomDepartment of Neurology, University of Maryland School of Medicine, Baltimore, MD, USAAbstract: Parkinson's disease (PD is the second most common neurodegenerative disease and the most treatable. Treatment of PD is symptomatic and generally focuses on the replacement or augmentation of levodopa. A number of options are available for treatment, both in monotherapy of early PD and to treat complications of advanced PD. This review focuses on rasagiline and selegiline, two medications that belong to a class of antiparkinsonian drugs called monoamine oxidase B (MAO-B inhibitors. Topics covered in the review include mechanism of action, efficacy in early and advanced PD, effects on disability, the controversy regarding disease modification, safety, and patient preference for MAO-B inhibitors.Keywords: monoamine oxidase inhibitors, rasagiline, selegiline, Parkinson's disease, efficacy, safety

  9. Increasing the safety and efficacy of chimeric antigen receptor T cell therapy

    Directory of Open Access Journals (Sweden)

    Hua Li

    2017-04-01

    Full Text Available Abstract Chimeric antigen receptor (CAR T cell therapy is a promising cancer treatment that has recently been undergoing rapid development. However, there are still some major challenges, including precise tumor targeting to avoid off-target or “on-target/off-tumor” toxicity, adequate T cell infiltration and migration to solid tumors and T cell proliferation and persistence across the physical and biochemical barriers of solid tumors. In this review, we focus on the primary challenges and strategies to design safe and effective CAR T cells, including using novel cutting-edge technologies for CAR and vector designs to increase both the safety and efficacy, further T cell modification to overcome the tumor-associated immune suppression, and using gene editing technologies to generate universal CAR T cells. All these efforts promote the development and evolution of CAR T cell therapy and move toward our ultimate goal—curing cancer with high safety, high efficacy, and low cost.

  10. Preclinical imaging methods for assessing the safety and efficacy of regenerative medicine therapies

    Science.gov (United States)

    Scarfe, Lauren; Brillant, Nathalie; Kumar, J. Dinesh; Ali, Noura; Alrumayh, Ahmed; Amali, Mohammed; Barbellion, Stephane; Jones, Vendula; Niemeijer, Marije; Potdevin, Sophie; Roussignol, Gautier; Vaganov, Anatoly; Barbaric, Ivana; Barrow, Michael; Burton, Neal C.; Connell, John; Dazzi, Francesco; Edsbagge, Josefina; French, Neil S.; Holder, Julie; Hutchinson, Claire; Jones, David R.; Kalber, Tammy; Lovatt, Cerys; Lythgoe, Mark F.; Patel, Sara; Patrick, P. Stephen; Piner, Jacqueline; Reinhardt, Jens; Ricci, Emanuelle; Sidaway, James; Stacey, Glyn N.; Starkey Lewis, Philip J.; Sullivan, Gareth; Taylor, Arthur; Wilm, Bettina; Poptani, Harish; Murray, Patricia; Goldring, Chris E. P.; Park, B. Kevin

    2017-10-01

    Regenerative medicine therapies hold enormous potential for a variety of currently incurable conditions with high unmet clinical need. Most progress in this field to date has been achieved with cell-based regenerative medicine therapies, with over a thousand clinical trials performed up to 2015. However, lack of adequate safety and efficacy data is currently limiting wider uptake of these therapies. To facilitate clinical translation, non-invasive in vivo imaging technologies that enable careful evaluation and characterisation of the administered cells and their effects on host tissues are critically required to evaluate their safety and efficacy in relevant preclinical models. This article reviews the most common imaging technologies available and how they can be applied to regenerative medicine research. We cover details of how each technology works, which cell labels are most appropriate for different applications, and the value of multi-modal imaging approaches to gain a comprehensive understanding of the responses to cell therapy in vivo.

  11. Proactive Management of Aviation System Safety Risk

    Data.gov (United States)

    National Aeronautics and Space Administration — Aviation safety systems have undergone dramatic changes over the past fifty years. If you take a look at the early technology in this area, you'll see that there was...

  12. Safety considerations for compressed hydrogen storage systems

    International Nuclear Information System (INIS)

    Gleason, D.

    2006-01-01

    An overview of the safety considerations for various hydrogen storage options, including stationary, vehicle storage, and mobile refueling technologies. Indications of some of the challenges facing the industry as the demand for hydrogen fuel storage systems increases. (author)

  13. Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Abrouk M

    2016-12-01

    Full Text Available Michael Abrouk,1 Ethan Levin,2 Merrick Brodsky,1 Jessica R Gandy,1 Mio Nakamura,2 Tian Hao Zhu,3 Benjamin Farahnik,4 John Koo,2 Tina Bhutani2 1Irvine School of Medicine, Irvine, 2Department of Dermatology, Psoriasis and Skin Treatment Center, University of California, San Francisco, 3Department of Dermatology, University of Southern California Keck School of Medicine, Los Angeles, CA, 4Department of Dermatology, University of Vermont College of Medicine, Burlington, VT, USA Introduction: The 308 nm excimer laser is a widely used device throughout the field of dermatology for many diseases including psoriasis. Although the laser has demonstrated clinical efficacy, there is a lack of literature outlining the safety, efficacy, and patient acceptability of the excimer laser. Methods: A literature search on PubMed was used with combinations of the terms “excimer”, “excimer laser”, “308 nm”, “psoriasis”, “protocol”, “safety”, “efficacy”, acceptability”, “side effects”, and “dose”. The search results were included if they contained information pertaining to excimer laser and psoriasis treatment and description of the safety, efficacy, and patient acceptability of the treatment. Results: The 308 nm excimer laser is generally safe and well tolerated with minimal side effects including erythema, blistering, and pigmentary changes. It has a range of efficacies depending on the protocol used with several different treatment protocols, including the induration protocol, the minimal erythema dose protocol, and the newer minimal blistering dose protocol. Conclusion: Although the excimer laser is not a first-line treatment, it remains an excellent treatment option for psoriasis patients and has been demonstrated to be an effective treatment with little to no side effects. Keywords: excimer, laser, 308 nm, psoriasis, safety, efficacy

  14. Tincture of opium for treating opioid dependence: a systematic review of safety and efficacy.

    Science.gov (United States)

    Nikoo, Mohammadali; Nikoo, Nooshin; Anbardan, Sanam Javid; Amiri, Afshar; Vogel, Marc; Choi, Fiona; Sepehry, Amir Ali; Bagheri Valoojerdi, Amir Hooshang; Jang, Kerry; Schütz, Christian; Akhondzadeh, Shahin; Krausz, Michael

    2017-03-01

    Recently, there has been a growing interest in using opium tincture (OT) for treating opioid dependence in certain regions. We aimed to assess the evidence on its safety and efficacy for this indication. We searched several databases (CENTRAL, Medline, EMBASE, Web of Science, PsychINFO, ProQuest Dissertation and Theses Database, Iran Medex, clinicaltrials.gov and who.int/trialsearch) with no language or publication date limitations. Two reviewers selected randomized controlled trials (RCT), cohort/case-control/cross-sectional studies and case-series on safety or efficacy of OT for treating opioid dependence and then extracted reported measures of mentioned outcomes from selected studies. We used the Effective Public Health Practice Project (EPHPP) Quality Assessment tool for appraisal. From nine selected studies; in three RCTs and one cohort analytical analysis on detoxification, 110 patients were treated with 15-140 morphine equivalents/day (mEq/d) of OT; in four prospective and one retrospective uncontrolled case-series on long-term/maintenance treatment, 570 patients were treated with 100-400 mEq/d of OT. Only two studies on detoxification included a comparison: one concluded equal efficacy of OT and methadone in suppressing withdrawal symptoms (P = 0.32) and the other concluded OT to be less efficacious than buprenorphine/naloxone in suppressing withdrawal [OT = 12.20, 95% confidence interval (CI) = 11.00, 13.40]; control: 5.20 (95% CI = 4.69, 5.71) and craving (OT = 303.0, 95% CI = -144.664, 750.664; control: 0.0) but not significantly different (P = 0.26) in retaining participants in treatment. No major adverse events were reported. Conclusive recommendations about the safety and efficacy of opium tincture for treating opioid dependence are not possible at this time. © 2016 Society for the Study of Addiction.

  15. A Safety and Efficacy Study of Tolvaptan Following Open Heart Surgery in 109 Cases.

    Science.gov (United States)

    Kono, Takanori; Tayama, Eiki; Hori, Hidetsugu; Ueda, Tomohiro; Yamaki, Yuta; Tanaka, Hiroyuki

    2016-07-27

    This study was conducted to evaluate the safety and efficacy of tolvaptan following open heart surgery.We retrospectively reviewed 109 patients who were administered tolvaptan following open heart surgery between August 2011 and July 2014. We divided the patients according to their urine output index (amount of urine output/body surface area) into tertiles as follows: T1 (low responders; n = 36), T2 (intermediate responders; n = 36), and T3 (high responders; n = 37). No fatal adverse events were observed following tolvaptan administration. The factors that showed a significant difference among the 3 groups were body surface area (BSA) and preoperative body weight. Body weight rapidly decreased and a greater increase in the serum sodium level was observed on day 1 in the T3 group than in the other 2 groups. No decrease in blood pressure and no significant differences in the occurrence of atrial fibrillation were observed among the 3 groups during tolvaptan administration.Tolvaptan can be safely and effectively administered to increase the urine output without adversely affecting the cardiovascular system or renal function following open heart surgery. However, careful attention is required regarding the possibility of a rapid increase in the serum sodium level so it is important to monitor changes in serum Na levels.

  16. [Safety and short-term efficacy of renal sympathetic denervation in the treatment of resistant hypertension].

    Science.gov (United States)

    Jiang, Xiong-jing; Liang, Tuo; Dong, Hui; Peng, Meng; Ma, Wen-jun; Guan, Ting; Zhang, Hui-min; Bian, Jin; Xu, Bo; Gao, Run-lin

    2012-12-11

    Transcatheter renal sympathetic denervation (RDN) is a novel technology/therapy in treating resistant hypertension. The present study aims to evaluate the safety and short-term efficacy of RDN for the treatment of resistant hypertension in a Chinese population. This prospective single-center pilot study was the first one conducted in China with Medtronic Ardian Symplicity Catheter System. Eight patients (6 males and 2 females) with resistant hypertension underwent RDN at our hospital from February to April 2012. All patients were followed up at one month and three months post-RDN. Blood pressure, use of antihypertensive medications, renal function and complications were recorded and analyzed. At one month and three months post-RDN, 24-hour ambulatory blood pressure monitoring showed mean systolic blood pressure and diastolic blood pressure decreased 10 (0 - 18) 13 (3 - 19) and 8 (-2 - 15), 9 (2 - 16) mm Hg throughout 24 hours respectively (P renal function (P > 0.05). No complications were observed. The preliminary results revealed that RDN was safe and effective for the treatment of resistant hypertension in the Chinese population during a 3-month follow-up. Further large and long-term studies are warranted.

  17. Safety, efficacy and patient acceptability of the combined estrogen and progestin transdermal contraceptive patch: a review

    Directory of Open Access Journals (Sweden)

    Alessandra Graziottin

    2008-11-01

    Full Text Available Alessandra GraziottinCenter of Gynecology and Medical Sexology, H San Raffaele Resnati, Via Santa Croce 10/a, 20123 Milano, ItalyAbstract: The worldwide introduction of the first, unique patch for hormonal contraception (ethinyl estradiol/norelgestromin, EE/NGMN patch was widely recognized as a significant event in the development of drug delivery systems. This innovation offers a number of advantages over the oral route, and extensive clinical trials have proved its safety, efficacy, effectiveness, and tolerability. The weekly administration and ease of use/simplicity of the EE/NGMN patch contribute to its acceptability, and help to resolve the two main problems of non-adherence, namely early discontinuation and inconsistent use. The patch offers additional benefits to adolescents (improvement of dysmenorrhea and acne, adults (improvement in emotional and physical well-being, premenstrual syndrome, and menstrual irregularities, and perimenopausal women (correction of hormonal imbalance, modulation of premenopausal symptoms, thus providing high satisfaction rates (in nearly 90% of users. Since its introduction, the transdermal contraceptive patch has proved to be a useful choice for women who seek a convenient formulation which is easy to use, with additional, non-contraceptive tailored benefits for all the ages.Keywords: transdermal, hormonal contraceptive, patient satisfaction, patient adherence

  18. Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation.

    Science.gov (United States)

    Levy, Jerrold H

    2005-09-15

    The pharmacologic management of hemostasis in patients undergoing surgery with cardiopulmonary bypass is discussed. Nearly 45 studies involving 7,000 patients have reported efficacy of aprotinin in blood conservation. Both in primary coronary artery bypass graft (CABG) surgeries and in repeat surgeries, aprotinin treatment significantly reduces the incidence of blood transfusions and the number of units of blood transfused. These effects have been observed for red blood cell, platelet, and other blood products. The safety of aprotinin treatment has been extensively evaluated in randomized clinical trials, in postmarketing databases, and in systematic reviews of the literature. Overall, data do not indicate that aprotinin treatment increases mortality, myocardial infarction, or renal failure. These findings are supported by the results of a recent meta-analysis of 35 studies in patients undergoing CABG surgery. In addition, the meta-analysis suggests that aprotinin treatment was associated with a reduced incidence of stroke and a trend toward a reduced incidence of atrial fibrillation. Although lysine analogs, desmopressin, and recombinant factor VIIa are sometimes used to reduce bleeding, only aprotinin is indicated for use during CABG surgery. The future of cardiac surgery will be marked by an increasingly complex, high-risk group of patients and a greater need for multiple pharmacologic options for reducing bleeding. Pharmacologic approaches that attenuate the activation of the hemostatic system and inflammation need to be employed to decrease coagulopathies and the need for allogeneic blood administration.

  19. Efficacy and safety of icotinib in patients with brain metastases from lung adenocarcinoma

    OpenAIRE

    Xu, Jianping; Liu, Xiaoyan; Yang, Sheng; Zhang, Xiangru; Shi, Yuankai

    2016-01-01

    Jianping Xu, Xiaoyan Liu, Sheng Yang, Xiangru Zhang, Yuankai Shi Department of Internal Medicine, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China Objective: The objective of this study was to evaluate the efficacy and safety of icotinib in patients with brain metastases (BMs) from lung adenocarcinoma.Patients and methods: Clinical data of 28 cases with BMs from lung adenocarcinoma were retrospectively analyzed. All the patients took 125&am...

  20. The Safety and Efficacy of Adjustable Postoperative Position after Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment

    OpenAIRE

    Lin, Zhong; Sun, Jin Tao; Wu, Rong Han; Moonasar, Nived; Zhou, Ye Hui

    2017-01-01

    Purpose. To report the safety and efficacy of adjustable postoperative position for rhegmatogenous retinal detachment (RRD). Methods. Retrospective review of 536 consecutive RRD eyes that underwent vitrectomy surgery for retina repair from year 2008 to 2014. The retinal breaks were divided into superior, lateral (nasal, temporal, and macular), and inferior locations, according to the clock of breaks. Patients with superior and lateral break location were allowed to have facedown position or l...

  1. Safety and efficacy of herbal tea for patients with diabetes mellitus

    OpenAIRE

    Siti Syarihan Abdullah; Ali Saleh Alkhoshaiban; Vasudevan Mani; Muhammad Eid Akkawi; Long Chiau Ming

    2016-01-01

    Purpose: The aim of this report is to review (i) safety and efficacy and (ii) medical marketing and regulation of Glucos Cut (GC) Tea. Methodology: The electronic databases such as PubMed, ScienceDirect, Google Scholar, and MEDLINE via EBSCOhost were searched with no limit to year of publication. Additional information was obtained from the Micromedex, “Medicines (Advertisement and Sales) Act 1956” and the “Guideline on Advertising of Medicines and Medicinal Products to General Public 2006...

  2. Efficacy and Safety of Topical Corticosteroids for Management of Oral Chronic Graft versus Host Disease

    OpenAIRE

    Elsaadany, Basma Abdelaleem; Ahmed, Eman Magdy; Aghbary, Sana Maher Hasan

    2017-01-01

    Background. Oral chronic graft versus host disease (cGVHD) is a major complication in transplantation community, a problem that can be addressed with topical intervention. Topical corticosteroids are the first line of treatment although the choice remains challenging as none of the available treatments is supported by strong clinical evidence. Objective. This systematic review aims to determine the clinical efficacy and safety of topical corticosteroids for the management of the mucosal alter...

  3. Safety and efficacy evaluation of gelatin-based nanoparticles associated with UV filters.

    Science.gov (United States)

    Oliveira, Camila Areias de; Dario, Michelli Ferrera; Sarruf, Fernanda Daud; Mariz, Inês Fátima Afonso; Velasco, Maria Valéria Robles; Rosado, Catarina; Baby, André Rolim

    2016-04-01

    The safety and efficacy assessment of nanomaterials is a major concern of industry and academia. These materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. The encapsulation of natural ingredients can provide marked improvements in sun protection efficacy. This strategy promotes solubility enhancement of flavonoids and yields an improved active ingredient with innovative physical, physicochemical and functional characteristics. Rutin, a flavonoid, has chemical and functional stability in topical vehicles exerting a synergistic effect in association with ultraviolet (UV) filters. However, the solubility of rutin is a limiting factor. Additionally, this bioactive compound does not have tendency to permeate across the stratum corneum. As an alternative to common synthetic based sunscreens, rutin-entrapped gelatin nanoparticles were designed. The present study investigated the pre-clinical safety of gelatin nanoparticles (GNPs) using an in vitro method and also assessed the clinical safety and efficacy of the association of GNPs with three commonly used chemical UV filters (ethylhexyl dimethyl PABA, ethylhexyl methoxycinnamate and methoxydibenzoylmethane). The non-irritant and adequate safety profile under sun-exposed skin conditions of the nanomaterials and the emulsions qualified the products for clinical efficacy assays. The in vivo results indicated that the GNPs increased the antioxidant protection of the emulsions developed. However, the presence of rutin in the nanosized material did not enhance performance on the SPF test. In conclusion, these findings characterized the nanomaterials as an innovative platform for multifunctional bioactive sunscreens. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Safety and efficacy of generic drugs with respect to brand formulation

    OpenAIRE

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-01-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

  5. Cost benefit analysis of reactor safety systems

    International Nuclear Information System (INIS)

    Maurer, H.A.

    1984-01-01

    Cost/benefit analysis of reactor safety systems is a possibility appropriate to deal with reactor safety. The Commission of the European Communities supported a study on the cost-benefit or cost effectiveness of safety systems installed in modern PWR nuclear power plants. The following systems and their cooperation in emergency cases were in particular investigated in this study: the containment system (double containment), the leakage exhaust and control system, the annulus release exhaust system and the containment spray system. The benefit of a safety system is defined according to its contribution to the reduction of the radiological consequences for the environment after a LOCA. The analysis is so far performed in two different steps: the emergency core cooling system is considered to function properly, failure of the emergency core cooling system is assumed (with the possible consequence of core melt-down) and the results may demonstrate the evidence that striving for cost-effectiveness can produce a safer end result than the philosophy of safety at any cost. (orig.)

  6. COMPRESS - a computerized reactor safety system

    International Nuclear Information System (INIS)

    Vegh, E.

    1986-01-01

    The computerized reactor safety system, called COMPRESS, provides the following services: scram initiation; safety interlockings; event recording. The paper describes the architecture of the system and deals with reliability problems. A self-testing unit checks permanently the correct operation of the independent decision units. Moreover the decision units are tested by short pulses whether they can initiate a scram. The self-testing is described in detail

  7. Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee-Choon; Lee, Jang-Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Jee, Eunkyoung [KAIST, Daejeon (Korea, Republic of)

    2016-10-15

    Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents.

  8. Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

    International Nuclear Information System (INIS)

    Kwon, Kee-Choon; Lee, Jang-Soo; Jee, Eunkyoung

    2016-01-01

    Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents

  9. [Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

    Science.gov (United States)

    Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

    2015-06-01

    To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  10. Simultaneous sequential monitoring of efficacy and safety led to masking of effects.

    Science.gov (United States)

    van Eekelen, Rik; de Hoop, Esther; van der Tweel, Ingeborg

    2016-08-01

    Usually, sequential designs for clinical trials are applied on the primary (=efficacy) outcome. In practice, other outcomes (e.g., safety) will also be monitored and influence the decision whether to stop a trial early. Implications of simultaneous monitoring on trial decision making are yet unclear. This study examines what happens to the type I error, power, and required sample sizes when one efficacy outcome and one correlated safety outcome are monitored simultaneously using sequential designs. We conducted a simulation study in the framework of a two-arm parallel clinical trial. Interim analyses on two outcomes were performed independently and simultaneously on the same data sets using four sequential monitoring designs, including O'Brien-Fleming and Triangular Test boundaries. Simulations differed in values for correlations and true effect sizes. When an effect was present in both outcomes, competition was introduced, which decreased power (e.g., from 80% to 60%). Futility boundaries for the efficacy outcome reduced overall type I errors as well as power for the safety outcome. Monitoring two correlated outcomes, given that both are essential for early trial termination, leads to masking of true effects. Careful consideration of scenarios must be taken into account when designing sequential trials. Simulation results can help guide trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis.

    Science.gov (United States)

    Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

    2015-03-14

    A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint 'overall improvement' was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. British Veterinary Association.

  12. Safety and clinical efficacy of golimumab in the treatment of arthritides

    Directory of Open Access Journals (Sweden)

    Ismail Simsek

    2010-09-01

    Full Text Available Ismail Simsek, Yusuf YaziciNew York University School of Medicine, NYU Hospital for Joint Diseases, New York, USAAbstract: Golimumab is a human anti-tumor necrosis factor (TNF-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions.Keywords: arthritis, rheumatoid, psoriatic arthritis, ankylosing spondylitis

  13. The role of attitudes about vaccine safety, efficacy, and value in explaining parents' reported vaccination behavior.

    Science.gov (United States)

    Lavail, Katherine Hart; Kennedy, Allison Michelle

    2013-10-01

    To explain vaccine confidence as it related to parents' decisions to vaccinate their children with recommended vaccines, and to develop a confidence measure to efficiently and effectively predict parents' self-reported vaccine behaviors. A sample of parents with at least one child younger than 6 years (n = 376) was analyzed using data from the HealthStyles 2010 survey. Questions were grouped into block variables to create three confidence constructs: value, safety, and efficacy. Regression equations controlling for demographic characteristics were used to identify the confidence construct(s) that best predicted parents' self-reported vaccination decisions (accept all, some, or none of the recommended childhood vaccines). Among the three constructs evaluated, confidence in the value of vaccines, that is the belief that vaccines are important and vaccinating one's children is the right thing to do, was the best predictor of parents' vaccine decisions, F(2, 351) = 119.199, p parents' self-reported vaccine decisions. Confidence in the safety or efficacy of vaccines failed to account for additional significant variance in parent-reported vaccination behavior. Confidence in the value of vaccines is a helpful predictor of parent-reported vaccination behavior. Attitudinal constructs of confidence in the safety and efficacy of vaccines failed to account for additional significant variance in parents' vaccination behaviors. Future research should assess the role of vaccine knowledge and tangible barriers, such as access and cost, to further explain parents' vaccination behaviors.

  14. Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Geng, Hua; Wang, Chengzhong

    2017-01-01

    To assess the efficacy and safety of oxcarbazepine (OXC) in the treatment of children with epilepsy. Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China), and Chinese National Knowledge Infrastructure (China) database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR) with 95% confidence intervals (95% CIs) was calculated using fixed-effects or random-effects model. Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo), OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P =0.366) and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P =0.310; for 50%-75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P =0.301; for effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings.

  15. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    Science.gov (United States)

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

  16. Design of an Active Automotive Safety System

    Directory of Open Access Journals (Sweden)

    Y. Wang

    2013-07-01

    Full Text Available With the development of the national economy, the people's standard of living got corresponding improvement, cars has been one of the indispensable traffic tools in many families. An active safety system is proposed, which can real-time detect the vehicle's running status and judge the security status of the vehicle. The system, which takes single-chip microcomputer as the controlling core and combines with millimeter-wave and ultrasonic distance measurement technology, can detect the distance from vehicle to vehicle and judge the security status of the vehicle. The hardware composition of the system and the data acquiring circuit are proposed, the mathematic model for different situation is established, and the controlling algorithm is completed. This system can accurately measure speed and distance between vehicles; the active safety control system can meet the relevant data measurement and transmission requirement; and can meet the functional requirement of the active safety control system

  17. Strategy to safety grade systems replacements

    International Nuclear Information System (INIS)

    Stimler, M.; Sullivan, K.E.; Trebincevic, I.

    1993-01-01

    The introduction of digital instrumentation and control systems in nuclear power plants is characterized by the need to satisfy the requirements of safety, reliability and man-machine ergonomics. Today digital instrumentation and control systems meet these requirements and the trend in Europe is towards full digital based nuclear power plant control systems. This paper describes Siemens (KWU) experience in nuclear power plants and development in trends within Europe. Topics which are the subject of major concern to NPP operators addressed in this paper are: human performance factors - man-machine interface; operating philosophy; safety, availability and reliability. Other aspects addressed are: Siemens open-quotes defense in depthclose quotes concept, description of Siemens digital I ampersand C systems, safety requirements and systems, I ampersand C qualification, control room ergonomics, information systems and retrofitting experience

  18. Safety and interlock system for Tristan

    International Nuclear Information System (INIS)

    Takeda, S.; Kudo, K.; Katoh, T.; Akiyama, A.

    1987-01-01

    This report describes alarm and interlock system of TRISTAN, concentrating on personnel safety. The basis of TRISTAN machine-control system (TMS) is an N-to-N computer network and KEK NODAL which offers high software productivity. TMC achieves high flexibility of operation both for normal operation and for the fast commissioning. However, to assure the safety of personnel and the TRISTAN machine operation, the safety system has to continue functioning during TMC failure as well. A distributed safety and interlock system (DSIS) is used for diversification of risks in TRISTAN system. DSIS is functionally subdivided along local system lines and has a hierarchical structure of 12 programmable sequence controllers (PSCs). Optical fiber links connect the PSCs at subsystem level and a PSC at the supervisory level of TRISTAN central control room (TCCR). The subsystem PSCs provide the interlock functions between their local devices. The local PSCs interact with the central system through a limited number of summarized signals. The central PSC provides the interlock functions between the subsystems and interacts with an operator's panel. Personnel safety is based on a system of electrical interlock keys, emergency push-buttons around the tunnel, at the entrance gates or in the control room

  19. System containing a safety disk

    International Nuclear Information System (INIS)

    Schupp, W.

    1975-01-01

    The safety element is not overdimensioned at pressures between 2 and 150 atmospheric excess pressure. Therefore the flat bursting disc is mounted within a supporting and stopping holding and the rated breaking point is covered by a supporting body. Its outer diameter sufficiently overlaps the recesses on both sides of the rated breaking point. It absorbs the total load given by the operating pressure. Only a release mechanism with slide wedge, eccentric disc, magnet, and rocker arm releases the supporting body, e.g. if the blow-down pressure is reached, so that the operating pressure may work on the bursting disc. An insulated copper wire layed in the breaking region within the bursting disc in case of shearing off signalizes the instant of failing of the breaking point because of current interruption. (DG) [de

  20. 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...

  1. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.

    Science.gov (United States)

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year. © 2014.

  2. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

    Energy Technology Data Exchange (ETDEWEB)

    Calderas, Carlos [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Condado, Jose Francisco; Condado, Jose Antonio [Hospital Centro Medico de Caracas y Hospital Miguel Perez Carreno, Caracas (Venezuela, Bolivarian Republic of); Flores, Alejandra [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Mueller, Amy; Thomas, Jack [Medlogics Device Corporation, Santa Rosa, CA (United States); Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa [Stanford University, Stanford, CA (United States); Fitzgerald, Peter, E-mail: crci-cvmed@stanford.edu [Stanford University, Stanford, CA (United States)

    2014-01-15

    Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.

  3. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

    International Nuclear Information System (INIS)

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year

  4. Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Carcinoma Extracranial Metastases

    International Nuclear Information System (INIS)

    Wang, Chiachien Jake; Christie, Alana; Lin, Mu-Han; Jung, Matthew; Weix, Derek; Huelsmann, Lorel; Kuhn, Kristin; Meyer, Jeffrey; Desai, Neil; Kim, D. W. Nathan; Pedrosa, Ivan; Margulis, Vitaly; Cadeddu, Jeffrey; Sagalowsky, Arthur; Gahan, Jeffrey; Laine, Aaron; Xie, Xian-Jin; Choy, Hak; Brugarolas, James; Timmerman, Robert

    2017-01-01

    Purpose: Renal cell carcinoma is refractory to conventional radiation therapy but responds to higher doses per fraction. However, the dosimetric data and clinical factors affecting local control (LC) are largely unknown. We aimed to evaluate the safety and efficacy of stereotactic ablative radiation therapy (SAbR) for extracranial renal cell carcinoma metastases. Methods and Materials: We reviewed 175 metastatic lesions from 84 patients treated with SAbR between 2005 and 2015. LC and toxicity after SAbR were assessed with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Predictors of local failure were analyzed with χ 2 , Kaplan-Meier, and log-rank tests. Results: In most cases (74%), SAbR was delivered with total doses of 40 to 60 Gy, 30 to 54 Gy, and 20 to 40 Gy in 5 fractions, 3 fractions, and a single fraction, respectively. The median biologically effective dose (BED) using the universal survival model was 134.5 Gy. The 1-year LC rate after SAbR was 91.2% (95% confidence interval, 84.9%-95.0%; median follow-up, 16.7 months). Local failures were associated with prior radiation therapy (hazard ratio [HR], 10.49; P<.0001), palliative-intent radiation therapy (HR, 4.63; P=.0189), spinal location (HR, 5.36; P=.0041), previous systemic therapy status (0-1 vs >1; HR, 3.52; P=.0217), and BED <115 Gy (HR, 3.45; P=.0254). Dose received by 99% of the target volume was the strongest dosimetric predictor for LC. Upon multivariate analysis, dose received by 99% of the target volume greater than BED of 98.7 Gy and systemic therapy status remained significant (HR, 0.12 and 3.64, with P=.0014 and P=.0472, respectively). Acute and late grade 3 toxicities attributed to SAbR were observed in 3 patients (1.7%) and 5 patients (2.9%), respectively. Conclusions: SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose and

  5. Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Carcinoma Extracranial Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Chiachien Jake [Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Christie, Alana [Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Lin, Mu-Han; Jung, Matthew; Weix, Derek; Huelsmann, Lorel; Kuhn, Kristin; Meyer, Jeffrey; Desai, Neil; Kim, D. W. Nathan [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Pedrosa, Ivan [Department of Radiology, Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Margulis, Vitaly; Cadeddu, Jeffrey; Sagalowsky, Arthur; Gahan, Jeffrey [Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Laine, Aaron [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Xie, Xian-Jin [Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Choy, Hak [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Brugarolas, James [Kidney Cancer Program, Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Division of Hematology/Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Timmerman, Robert [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); and others

    2017-05-01

    Purpose: Renal cell carcinoma is refractory to conventional radiation therapy but responds to higher doses per fraction. However, the dosimetric data and clinical factors affecting local control (LC) are largely unknown. We aimed to evaluate the safety and efficacy of stereotactic ablative radiation therapy (SAbR) for extracranial renal cell carcinoma metastases. Methods and Materials: We reviewed 175 metastatic lesions from 84 patients treated with SAbR between 2005 and 2015. LC and toxicity after SAbR were assessed with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Predictors of local failure were analyzed with χ{sup 2}, Kaplan-Meier, and log-rank tests. Results: In most cases (74%), SAbR was delivered with total doses of 40 to 60 Gy, 30 to 54 Gy, and 20 to 40 Gy in 5 fractions, 3 fractions, and a single fraction, respectively. The median biologically effective dose (BED) using the universal survival model was 134.5 Gy. The 1-year LC rate after SAbR was 91.2% (95% confidence interval, 84.9%-95.0%; median follow-up, 16.7 months). Local failures were associated with prior radiation therapy (hazard ratio [HR], 10.49; P<.0001), palliative-intent radiation therapy (HR, 4.63; P=.0189), spinal location (HR, 5.36; P=.0041), previous systemic therapy status (0-1 vs >1; HR, 3.52; P=.0217), and BED <115 Gy (HR, 3.45; P=.0254). Dose received by 99% of the target volume was the strongest dosimetric predictor for LC. Upon multivariate analysis, dose received by 99% of the target volume greater than BED of 98.7 Gy and systemic therapy status remained significant (HR, 0.12 and 3.64, with P=.0014 and P=.0472, respectively). Acute and late grade 3 toxicities attributed to SAbR were observed in 3 patients (1.7%) and 5 patients (2.9%), respectively. Conclusions: SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose

  6. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.

    Science.gov (United States)

    Drake, Marcus J; Chapple, Christopher; Sokol, Roman; Oelke, Matthias; Traudtner, Klaudia; Klaver, Monique; Drogendijk, Ted; Van Kerrebroeck, Philip

    2015-02-01

    Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms (LUTS). The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS (oral controlled absorption system) in Males with Lower Urinary Tract Symptoms (NEPTUNE) II is the first long-term study using solifenacin (Soli) and the oral controlled absorption system formulation of tamsulosin (TOCAS). To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms. Patients with both storage and voiding LUTS, maximum urinary flow rate of 4.0-12.0 ml/s, prostate size storage and voiding subscores, micturition diary variables, and quality of life parameters. In all, 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II. Treatment-emergent adverse events were reported in 499 (46.8%) patients who participated in NEPTUNE II; most were mild or moderate. Urinary retention occurred in 13 of 1208 (1.1%) patients receiving one or more FDCs in NEPTUNE and/or NEPTUNE II; 8 (0.7%) required catheterisation (acute urinary retention [AUR]). Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment, with mean reductions of 9.0 (standard deviation [SD]: 5.7) and 10.1 (SD: 9.2), respectively, from baseline to end of treatment. Clinically relevant improvements were also observed for secondary efficacy end points. Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS, with a low incidence of AUR. Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms. Improvements in symptoms were achieved after 4 wk of treatment, with further improvements at week 16 maintained for up to 52 wk

  7. NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

    Science.gov (United States)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

    2015-01-01

    This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

  8. Safety of emerging nuclear energy systems

    International Nuclear Information System (INIS)

    Novikov, V.M.; Slesarev, I.S.

    1989-01-01

    The first stage of world nuclear power development based on light water fission reactors has demonstrated not only rather high rate but at the same time too optimistic attitude to safety problems. Large accidents at Three Mile Island and Chernobyl essentially affects the concept of NP development. As a result the safety and social acceptance of NP became of absolute priority among other problems. That's why emerging nuclear power systems should be first of all estimated from this point of view. In the paper some quantitative criteria of safety derived from estimations of social risk and economic-ecological damage from hypothetical accidents are formulated. On the base of these criteria we define two stages of possible way to meet safety demands: first--development of high safety fission reactors and second--that of asymptotic high safety ENEs. The limits of tolorated expenses for safety are regarded. The basis physical factors determining hazards of NES accidents are considered. This permits to classify the ways of safety demands fulfillment due to physical principals used

  9. K West integrated water treatment system subproject safety analysis document

    International Nuclear Information System (INIS)

    SEMMENS, L.S.

    1999-01-01

    This Accident Analysis evaluates unmitigated accident scenarios, and identifies Safety Significant and Safety Class structures, systems, and components for the K West Integrated Water Treatment System

  10. K West integrated water treatment system subproject safety analysis document

    Energy Technology Data Exchange (ETDEWEB)

    SEMMENS, L.S.

    1999-02-24

    This Accident Analysis evaluates unmitigated accident scenarios, and identifies Safety Significant and Safety Class structures, systems, and components for the K West Integrated Water Treatment System.

  11. Classification of Aeronautics System Health and Safety Documents

    Data.gov (United States)

    National Aeronautics and Space Administration — Most complex aerospace systems have many text reports on safety, maintenance, and associated issues. The Aviation Safety Reporting System (ASRS) spans several...

  12. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety on dental hygienist

    International Nuclear Information System (INIS)

    Han, Eun Ok; Jun, Sung Hee

    2008-01-01

    The objective of this study is to draw an educational plant for reducing the probability of troubles caused by radiation for dental hygienists who are the major applicants of radiation equipments used in dental offices. This study investigated the knowledge and self-efficacy, which is the major variable that affects the attitude and behavior, on the radiation safety that is an educational approach. Also, this study obtained following results from a survey for 25 days from June 15, 2008 that was applied for 225 dental hygienists worked at dental offices and clinics in the area of Youngnam in order to verify the relationship between such variables. The average scores for the knowledge, attitude, and behavior were 54.28±16.33, 87.93±9.75, and 59.85±14.76, respectively. Also, the average score of the self-efficacy was 72.88±8.60. In the knowledge level for the radiation safety, ‘a case that prepares personal dosimeters’, ‘a case that establishes protection facilities’, ‘a case that presents 6⁓10 dental hygienists’, ‘a case that presents radiological technologists’, and ‘a case that is a general hospital’ represented high values. In the attitude level for the radiation safety, ‘a case who is a married person’, ‘a case that prepares personal dosimeters’, and ‘a case that is a general hospital’ showed high values. In the behavior level for the radiation safety, ‘a case that shows a career in dental hygienist or radiographic for 6⁓10 years’, ‘a case that attends radiation safety education’, ‘a case that establishes protection facilities’ showed high values. Also, in the self-efficacy level, ‘a case that who has a high education level more than graduate school education’ and ‘a case that establishes protection facilities’ represented high values. In the relationship between the knowledge, attitude, behavior, and self-efficacy for the radiation safety, it showed statistically significant differences in this

  13. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety on dental hygienist

    Energy Technology Data Exchange (ETDEWEB)

    Han, Eun Ok; Jun, Sung Hee [Daegu Health College, Daegu (Korea, Republic of)

    2008-11-15

    The objective of this study is to draw an educational plant for reducing the probability of troubles caused by radiation for dental hygienists who are the major applicants of radiation equipments used in dental offices. This study investigated the knowledge and self-efficacy, which is the major variable that affects the attitude and behavior, on the radiation safety that is an educational approach. Also, this study obtained following results from a survey for 25 days from June 15, 2008 that was applied for 225 dental hygienists worked at dental offices and clinics in the area of Youngnam in order to verify the relationship between such variables. The average scores for the knowledge, attitude, and behavior were 54.28±16.33, 87.93±9.75, and 59.85±14.76, respectively. Also, the average score of the self-efficacy was 72.88±8.60. In the knowledge level for the radiation safety, ‘a case that prepares personal dosimeters’, ‘a case that establishes protection facilities’, ‘a case that presents 6⁓10 dental hygienists’, ‘a case that presents radiological technologists’, and ‘a case that is a general hospital’ represented high values. In the attitude level for the radiation safety, ‘a case who is a married person’, ‘a case that prepares personal dosimeters’, and ‘a case that is a general hospital’ showed high values. In the behavior level for the radiation safety, ‘a case that shows a career in dental hygienist or radiographic for 6⁓10 years’, ‘a case that attends radiation safety education’, ‘a case that establishes protection facilities’ showed high values. Also, in the self-efficacy level, ‘a case that who has a high education level more than graduate school education’ and ‘a case that establishes protection facilities’ represented high values. In the relationship between the knowledge, attitude, behavior, and self-efficacy for the radiation safety, it showed statistically significant differences in this

  14. System Safety in an IT Service Organization

    Science.gov (United States)

    Parsons, Mike; Scutt, Simon

    Within Logica UK, over 30 IT service projects are considered safetyrelated. These include operational IT services for airports, railway infrastructure asset management, nationwide radiation monitoring and hospital medical records services. A recent internal audit examined the processes and documents used to manage system safety on these services and made a series of recommendations for improvement. This paper looks at the changes and the challenges to introducing them, especially where the service is provided by multiple units supporting both safety and non-safety related services from multiple locations around the world. The recommendations include improvements to service agreements, improved process definitions, routine safety assessment of changes, enhanced call logging, improved staff competency and training, and increased safety awareness. Progress is reported as of today, together with a road map for implementation of the improvements to the service safety management system. A proposal for service assurance levels (SALs) is discussed as a way forward to cover the wide variety of services and associated safety risks.

  15. Upgrading safety systems of industrial irradiation facilities

    International Nuclear Information System (INIS)

    Gomes, R.S.; Gomes, J.D.R.L.; Costa, E.L.C.; Costa, M.L.L.; Thomé, Z.D.

    2017-01-01

    The first industrial irradiation facility in operation in Brazil was designed in the 70s. Nowadays, twelve commercial and research facilities are in operation and two already decommissioned. Minor modifications and upgrades, as sensors replacement, have been introduced in these facilities, in order to reduce the technological gap in the control and safety systems. The safety systems are designed in agreement with the codes and standards at the time. Since then, new standards, codes and recommendations, as well as lessons learned from accidents, have been issued by various international committees or regulatory bodies. The rapid advance of the industry makes the safety equipment used in the original construction become obsolete. The decreasing demand for these older products means that they are no longer produced, which can make it impossible or costly to obtain spare parts and the expansion of legacy systems to include new features. This work aims to evaluate existing safety systems at Brazilian irradiation facilities, mainly the oldest facilities, taking into account the recommended IAEA's design requirements. Irrespective of the fact that during its operational period no event with victims have been recorded in Brazilian facilities, and that the regulatory inspections do not present any serious deviations regarding the safety procedures, it is necessary an assessment of safety system with the purpose of bringing their systems to 'the state of the art', avoiding their rapid obsolescence. This study has also taken into account the knowledge, concepts and solutions developed to upgrading safety system in irradiation facilities throughout the world. (author)

  16. Upgrading safety systems of industrial irradiation facilities

    Energy Technology Data Exchange (ETDEWEB)

    Gomes, R.S.; Gomes, J.D.R.L.; Costa, E.L.C.; Costa, M.L.L., E-mail: rogeriog@cnen.gov.br, E-mail: jlopes@cnen.gov.br, E-mail: evaldo@cnen.gov.br, E-mail: mara@cnen.gov.br [Comissão Nacional de Energia Nuclear (CNEN), Rio de Janeiro, RJ (Brazil). Diretoria de Radioproteção e Segurança Nuclear; Thomé, Z.D., E-mail: zielithome@gmail.com [Instituto Militar de Engenharia (IME), Rio de Janeiro, RJ (Brazil). Seção de Engenharia Nuclear

    2017-07-01

    The first industrial irradiation facility in operation in Brazil was designed in the 70s. Nowadays, twelve commercial and research facilities are in operation and two already decommissioned. Minor modifications and upgrades, as sensors replacement, have been introduced in these facilities, in order to reduce the technological gap in the control and safety systems. The safety systems are designed in agreement with the codes and standards at the time. Since then, new standards, codes and recommendations, as well as lessons learned from accidents, have been issued by various international committees or regulatory bodies. The rapid advance of the industry makes the safety equipment used in the original construction become obsolete. The decreasing demand for these older products means that they are no longer produced, which can make it impossible or costly to obtain spare parts and the expansion of legacy systems to include new features. This work aims to evaluate existing safety systems at Brazilian irradiation facilities, mainly the oldest facilities, taking into account the recommended IAEA's design requirements. Irrespective of the fact that during its operational period no event with victims have been recorded in Brazilian facilities, and that the regulatory inspections do not present any serious deviations regarding the safety procedures, it is necessary an assessment of safety system with the purpose of bringing their systems to 'the state of the art', avoiding their rapid obsolescence. This study has also taken into account the knowledge, concepts and solutions developed to upgrading safety system in irradiation facilities throughout the world. (author)

  17. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study - Efficacy, safety, and pharmacokinetics

    NARCIS (Netherlands)

    Sparr, Harald J.; Vermeyen, Karel M.; Beaufort, Anton M.; Rietbergen, Henk; Proost, Johannes H.; Saldien, Vera; Velik-Salchner, Corinna; Wierda, J. Mark K. H.

    Background: Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated. Methods: Ninety-eight male adult patients were

  18. Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan

    Directory of Open Access Journals (Sweden)

    Maki Goto

    2015-06-01

    Conclusion: The current study demonstrates the safety and efficacy of enoxaparin for thromboprophylaxis after C/S. Further studies are required to determine the best method of preventing asymptomatic DVT.

  19. Safety assessment of high consequence robotics system

    International Nuclear Information System (INIS)

    Robinson, D.G.; Atcitty, C.B.

    1996-01-01

    This paper outlines the use of a failure modes and effects analysis for the safety assessment of a robotic system being developed at Sandia National Laboratories. The robotic system, the weigh and leak check system, is to replace a manual process for weight and leakage of nuclear materials at the DOE Pantex facility. Failure modes and effects analyses were completed for the robotics process to ensure that safety goals for the systems have been met. Due to the flexible nature of the robot configuration, traditional failure modes and effects analysis (FMEA) were not applicable. In addition, the primary focus of safety assessments of robotics systems has been the protection of personnel in the immediate area. In this application, the safety analysis must account for the sensitivities of the payload as well as traditional issues. A unique variation on the classical FMEA was developed that permits an organized and quite effective tool to be used to assure that safety was adequately considered during the development of the robotic system. The fundamental aspects of the approach are outlined in the paper

  20. The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.

    Science.gov (United States)

    Ritter, Philippe; Duray, Gabor Z; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight

    2015-05-01

    Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  1. Understanding Nuclear Safety Culture: A Systemic Approach

    International Nuclear Information System (INIS)

    Afghan, A.N.

    2016-01-01

    The Fukushima accident was a systemic failure (Report by Director General IAEA on the Fukushima Daiichi Accident). Systemic failure is a failure at system level unlike the currently understood notion which regards it as the failure of component and equipment. Systemic failures are due to the interdependence, complexity and unpredictability within systems and that is why these systems are called complex adaptive systems (CAS), in which “attractors” play an important role. If we want to understand the systemic failures we need to understand CAS and the role of these attractors. The intent of this paper is to identify some typical attractors (including stakeholders) and their role within complex adaptive system. Attractors can be stakeholders, individuals, processes, rules and regulations, SOPs etc., towards which other agents and individuals are attracted. This paper will try to identify attractors in nuclear safety culture and influence of their assumptions on safety culture behavior by taking examples from nuclear industry in Pakistan. For example, if the nuclear regulator is an attractor within nuclear safety culture CAS then how basic assumptions of nuclear plant operators and shift in-charges about “regulator” affect their own safety behavior?

  2. Direct-acting antiviral agent efficacy and safety in renal transplant recipients with chronic hepatitis C virus infection

    OpenAIRE

    Chen, Keliang; Lu, Pei; Song, Rijin; Zhang, Jiexiu; Tao, Rongzhen; Wang, Zijie; Zhang, Wei; Gu, Min

    2017-01-01

    Abstract Background: The efficacy and safety of direct-acting antivirals (DAAs) for treating hepatitis C virus (HCV)-infected renal transplant recipients (RTRs) has not been determined. Methods: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and assessed the quality of eligible studies using the Joanna Briggs Institute scale. DAA efficacy and safety were assessed using standard mean difference (SMD) with 95% confidence intervals (95%CIs). Results: Six studi...

  3. Safety parameter display system for Kalinin NPP

    International Nuclear Information System (INIS)

    Andreev, V.I.; Videneev, E.N.; Tissot, J.C.; Joonekindt, D.; Davidenko, N.N.; Shaftan, G.I.; Dounaev, V.G.; Neboyan, V.T.

    1995-01-01

    The paper discusses the safety parameter display system (SPDS), which is being designed for Kalinin NPP. The assessment of the safety status of the plant is done by the continuous monitoring of six critical safety functions and the corresponding status trees. Besides, a number of additional functions are realized within the scope of KlnNPP, aimed at providing the operator and the safety engineer in the main control room with more detailed information in accidental situation as well as during the normal operation. In particular, these functions are: archiving, data logs and alarm handling, safety actions monitoring, mnemonic diagrams indicating the state of main technological equipment and basic plant parameters, reference data, etc. As compared with the traditional scope of functions of this kind of systems, the functionality of KlnNPP SPDS is significantly expanded due to the inclusion in it the operator support function ''computerized procedures''. The basic SPDS implementation platform is ADACS of SEMA GROUP design. The system architecture includes two workstations in the main control room: one is for reactor operator and the other one for safety engineer. Every station has two CRT screens which ensures computerized procedures implementation and provides for extra services for the operator. Also, the information from the SPDS is transmitted to the local crisis center and to the crisis center of the State utility organization concern ''Rosenergoatom''. (author). 3 refs, 6 figs, 1 tab

  4. Quantitative risk assessment of digitalized safety systems

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Sung Min; Lee, Sang Hun; Kang, Hym Gook [KAIST, Daejeon (Korea, Republic of); Lee, Seung Jun [UNIST, Ulasn (Korea, Republic of)

    2016-05-15

    A report published by the U.S. National Research Council indicates that appropriate methods for assessing reliability are key to establishing the acceptability of digital instrumentation and control (I and C) systems in safety-critical plants such as NPPs. Since the release of this issue, the methodology for the probabilistic safety assessment (PSA) of digital I and C systems has been studied. However, there is still no widely accepted method. Kang and Sung found three critical factors for safety assessment of digital systems: detection coverage of fault-tolerant techniques, software reliability quantification, and network communication risk. In reality the various factors composing digitalized I and C systems are not independent of each other but rather closely connected. Thus, from a macro point of view, a method that can integrate risk factors with different characteristics needs to be considered together with the micro approaches to address the challenges facing each factor.

  5. Safety assessment of HLW geological disposal system

    International Nuclear Information System (INIS)

    Naito, Morimasa

    2006-01-01

    In accordance with the Japanese nuclear program, the liquid waste with a high level of radioactivity arising from reprocessing is solidified in a stable glass matrix (vitrification) in stainless steel fabrication containers. The vitrified waste is referred to as high-level radioactive waste (HLW), and is characterized by very high initial radioactivity which, even though it decreases with time, presents a potential long-term risk. It is therefore necessary to thoroughly manage HLW from human and his environment. After vitrification, HLW is stored for a period of 30 to 50 years to allow cooling, and finally disposed of in a stable geological environment at depths greater than 300 m below surface. The deep underground environment, in general, is considered to be stable over geological timescales compared with surface environment. By selecting an appropriate disposal site, therefore, it is considered to be feasible to isolate the waste in the repository from man and his environment until such time as radioactivity levels have decayed to insignificance. The concept of geological disposal in Japan is similar to that in other countries, being based on a multibarrier system which combines the natural geological environment with engineered barriers. It should be noted that geological disposal concept is based on a passive safety system that does not require any institutional control for assuring long term environmental safety. To demonstrate feasibility of safe HLW repository concept in Japan, following technical steps are essential. Selection of a geological environment which is sufficiently stable for disposal (site selection). Design and installation of the engineered barrier system in a stable geological environment (engineering measures). Confirmation of the safety of the constructed geological disposal system (safety assessment). For site selection, particular consideration is given to the long-term stability of the geological environment taking into account the fact

  6. RSAS: a Reactor Safety Assessment System

    International Nuclear Information System (INIS)

    Sebo, D.E.; Dixon, B.W.; Bray, M.A.

    1985-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (NRC). RSAS is being developed for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system generates situation assessments for the NRC Reactor Safety Team based on a limited number of plant parameters, known operator actions, and plant status data. The RSAS rule base currently covers one reactor type. The extension of the rule base to other reactor types is also discussed

  7. Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome

    Directory of Open Access Journals (Sweden)

    Yang YM

    2015-09-01

    Full Text Available Young-Mo Yang, Eun Joo Choi College of Pharmacy, Chosun University, Gwangju, South Korea Background: Polycystic ovary syndrome (PCOS is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles.Methods: A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS.  Results: Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported.  Conclusion: The clinical trials suggest that metformin or oral

  8. Food safety performance indicators to benchmark food safety output of food safety management systems.

    Science.gov (United States)

    Jacxsens, L; Uyttendaele, M; Devlieghere, F; Rovira, J; Gomez, S Oses; Luning, P A

    2010-07-31

    There is a need to measure the food safety performance in the agri-food chain without performing actual microbiological analysis. A food safety performance diagnosis, based on seven indicators and corresponding assessment grids have been developed and validated in nine European food businesses. Validation was conducted on the basis of an extensive microbiological assessment scheme (MAS). The assumption behind the food safety performance diagnosis is that food businesses which evaluate the performance of their food safety management system in a more structured way and according to very strict and specific criteria will have a better insight in their actual microbiological food safety performance, because food safety problems will be more systematically detected. The diagnosis can be a useful tool to have a first indication about the microbiological performance of a food safety management system present in a food business. Moreover, the diagnosis can be used in quantitative studies to get insight in the effect of interventions on sector or governmental level. Copyright 2010 Elsevier B.V. All rights reserved.

  9. Expert systems and nuclear safety

    International Nuclear Information System (INIS)

    Beltracchi, L.

    1990-01-01

    The US Nuclear Regulatory Commission (NRC) and the Electric Power Research Institute have initiated a broad-based exploration of means to evaluate the potential applications of expert systems in the nuclear industry. This exploratory effort will assess the use of expert systems to augment the diagnostic and decision-making capabilities of personnel with the goal of enhancing productivity, reliability, and performance. The initial research effort is the development and documentation of guidelines for verifying and validating (V and V) expert systems. An initial application of expert systems in the nuclear industry is to aid operations and maintenance personnel in decision-making tasks. The scope of the decision aiding covers all types of cognitive behavior consisting of skill, rule, and knowledge-based behavior. For example, procedure trackers were designed and tested to support rule-based behavior. Further, these systems automate many of the tedious, error-prone human monitoring tasks, thereby reducing the potential for human error. The paper version of the procedure contains the knowledge base and the rules and thus serves as the basis of the design verification of the procedure tracker. Person-in-the-loop tests serve as the basis for the validation of a procedure tracker. When conducting validation tests, it is important to ascertain that the human retains the locus of control in the use of the expert system

  10. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis

    NARCIS (Netherlands)

    Bergmann, Karl-Christian; Demoly, Pascal; Worm, Margitta; Fokkens, Wytske J.; Carrillo, Teresa; Tabar, Ana I.; Nguyen, Hélène; Montagut, Armelle; Zeldin, Robert K.

    2014-01-01

    Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite (HDM) extracts in adults with allergic rhinitis. We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year. Adults with

  11. Safety Analysis of Stochastic Dynamical Systems

    DEFF Research Database (Denmark)

    Sloth, Christoffer; Wisniewski, Rafael

    2015-01-01

    This paper presents a method for verifying the safety of a stochastic system. In particular, we show how to compute the largest set of initial conditions such that a given stochastic system is safe with probability p. To compute the set of initial conditions we rely on the moment method that via...... that shows how the p-safe initial set is computed numerically....

  12. Safety analysis of accident localization system

    International Nuclear Information System (INIS)

    1999-01-01

    A complex safety analysis of accident localization system of Ignalina NPP was performed. Calculation results obtained, results of non-destruct ing testing and experimental data of reinforced concrete testing of buildings does not revealed deficiencies of buildings of accident localization system at unit 1 of Ignalina NPP. Calculations were performed using codes NEPTUNE, ALGOR, CONTAIN

  13. Safety parameter display system: an operator support system for enhancement of safety in Indian PHWRs

    International Nuclear Information System (INIS)

    Subramaniam, K.; Biswas, T.

    1994-01-01

    Ensuring operational safety in nuclear power plants is important as operator errors are observed to contribute significantly to the occurrence of accidents. Computerized operator support systems, which process and structure information, can help operators during both normal and transient conditions, and thereby enhance safety and aid effective response to emergency conditions. An important operator aid being developed and described in this paper, is the safety parameter display system (SPDS). The SPDS is an event-independent, symptom-based operator aid for safety monitoring. Knowledge-based systems can provide operators with an improved quality of information. An information processing model of a knowledge based operator support system (KBOSS) developed for emergency conditions using an expert system shell is also presented. The paper concludes with a discussion of the design issues involved in the use of a knowledge based systems for real time safety monitoring and fault diagnosis. (author). 8 refs., 4 figs., 1 tab

  14. Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices.

    Science.gov (United States)

    Elder, Alexander; Paterson, Caron

    2006-12-01

    To review the literature on sharps injuries and occupational bloodborne virus transmission in health care in the UK and the worldwide evidence for injury prevention of sharps safety devices. Literature review by online database and Internet resource search. Twenty-four relevant publications were identified regarding UK reported sharps injury rates. UK studies showed as much as a 10-fold difference between injuries reported through standard reporting systems (0.78-5.15 per 100 person-years) and rates estimated from retrospective questionnaires of clinical populations (30-284 per 100 person-years). National surveillance data from England, Wales and Northern Ireland gives a rate of 1.43 known hepatitis C virus or human immunodeficiency virus (HIV) transmissions to health care workers per annum. When extrapolated, this suggests an approximate rate of 0.009 such viral transmissions per 1000 hospital beds per annum. Risk of infection from sources with no risk factors is extremely small (less than one in one million for HIV transmission based on Scottish data). Thirty-one studies on the efficacy of sharps safety devices showed evidence of a reduction in injuries, with the greatest reductions achieved by blunt suture needles and safety cannulae. Although injuries remain common, confirmed viral transmission in the UK has been relatively rare. The degree of under-reporting of sharps injuries may be as much as 10-fold. Safety-engineered devices are likely to be effective at injury reduction.

  15. Efficacy and safety of intravenous secukinumab in noninfectious uveitis requiring steroid-sparing immunosuppressive therapy.

    Science.gov (United States)

    Letko, Erik; Yeh, Steven; Foster, C Stephen; Pleyer, Uwe; Brigell, Mitchell; Grosskreutz, Cynthia L

    2015-05-01

    Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibited promising activity in a proof-of-concept study when administered in intravenous (IV) doses to patients with active, chronic, noninfectious uveitis. This study compared the efficacy and safety of different IV and subcutaneous (SC) doses of secukinumab in patients with noninfectious uveitis. Multicenter, randomized, double-masked, dose-ranging, phase 2 clinical trial. Thirty-seven patients with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis who required corticosteroid-sparing immunosuppressive therapy. Patients were randomized to secukinumab 300 mg SC every 2 weeks for 4 doses, secukinumab 10 mg/kg IV every 2 weeks for 4 doses, or secukinumab 30 mg/kg IV every 4 weeks for 2 doses. Intravenous or SC saline was administered to maintain masking. Efficacy was assessed on day 57 (2-4 weeks after last dose). Percentage of patients with treatment response, defined as (1) at least a 2-grade reduction in vitreous haze score or trace or absent vitreous haze in the study eye without an increase in corticosteroid dose and without uveitis worsening or (2) reduction in corticosteroid dosages to prespecified levels without uveitis worsening. Percentage of patients with remission, defined as anterior chamber cell and vitreous haze scores of 0 or 0.5+ in both eyes without corticosteroid therapy or uveitis worsening. Secukinumab 30 mg/kg IV and 10 mg/kg IV, compared with the 300 mg SC dose, produced higher responder rates (72.7% and 61.5% vs. 33.3%, respectively) and remission rates (27.3% and 38.5% vs. 16.7%, respectively). Statistical and clinical superiority for the 30 mg/kg IV dose compared with the 300 mg SC dose was established in a Bayesian probability model. Other measures, including time to response onset, change in visual acuity, and change in vitreous haze score, showed numeric trends favoring IV dosing. Secukinumab, administered in IV or SC formulations, appeared

  16. Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs

    Directory of Open Access Journals (Sweden)

    Denilson C. Albuquerque

    2005-08-01

    Full Text Available OBJECTIVE: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. MATERIALS AND METHODS: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity. During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. RESULTS: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively. In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001. The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%, vasodilation (11.4% and dyspepsia (6.5%. There were no significant changes in blood pressure measurements in both groups. CONCLUSION: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.

  17. Safety and anti-hyperglycemic efficacy of various tea types in mice

    Science.gov (United States)

    Han, Manman; Zhao, Guangshan; Wang, Yijun; Wang, Dongxu; Sun, Feng; Ning, Jingming; Wan, Xiachun; Zhang, Jinsong

    2016-01-01

    Tea, a beverage consumed worldwide, has proven anti-hyperglycemic effects in animal models. Better efficacies of tea beverages are frequently associated with high-dose levels, whose safety attracts considerable attention. Based on the inherent nature of tea catechin oxidation, fresh tea leaves are manufactured into diverse tea types by modulating the oxidation degree of catechins. The present study aimed to assess various tea types for their safety properties and anti-hyperglycemic effects. Mice were allowed free access to tea infusion (1:30, w/v) for one week, and the rare smoked tea caused salient adverse reactions, including hepatic and gastrointestinal toxicities; meanwhile, the widely-consumed green and black teas, unlike the rare yellow tea, suppressed growth in fast-growing healthy mice. When mice were fed a high-fat diet and allowed free access to tea infusion (1:30, w/v) for 25 days, only yellow tea significantly reduced blood glucose. Therefore, various teas showed different safety profiles as well as anti-hyperglycemic efficacy strengths. To achieve an effective and safe anti-hyperglycemic outcome, yellow tea, which effectively suppressed high-fat diet-induced early elevation of hepatic thioredoxin-interacting protein, is an optimal choice. PMID:27531374

  18. EFFICACY OF DEPURATION ON SAFETY OF MEDITERRANEAN MUSSELS (Mytilus galloprovincialis REARED IN THE OLBIA GULF

    Directory of Open Access Journals (Sweden)

    R. Mazzette

    2013-02-01

    Full Text Available The aim of the present study was to investigate the effect of depuration on the safety of Mediterranean mussels harvested in the Olbia gulf and to evaluate the efficacy of E.coli and Salmonella spp. as indicators of the presence of naturally occurring Vibrios and other pathogens (viruses causing hepatitis, L.monocytogenes and S.aureus. Samples of mussels belonging to 5 batches of products, from 2 Depuration Centers, were collected before depuration (T0, after 4h (T4 and at the end of depuration (T8. Results showed an overall efficacy of the depuration in respect to E.coli moderate counts. A depuration for ~8 hours led to a rapid decline in the concentration, complying to the Food Safety Criteria of the Reg. (EC 2073/2005. The decline in numbers of E.coli, does not correlate with the presence of naturally occurring Vibrios, which decline at an even slower rate. The adoption of shorter treatments times for mussels with high initial counts of Vibrios could lead to a reduction unfitted to guarantee the safety of consumers.

  19. In vitro and in vivo evaluation of efficacy and safety of photoprotective formulations containing antioxidant extracts

    Directory of Open Access Journals (Sweden)

    Maria Cristina P.P. Reis Mansur

    Full Text Available ABSTRACT Chronic exposure to solar radiation could contribute to premature skin aging and skin cancer. Skin presents its own antioxidant defense, however when defenses are out of balance, reactive oxygen species could damage biological structures. In the present work, an oil-in-water photoprotective emulsion was developed and Bauhinia microstachya var. massambabensis Vaz, Fabaceae, extracts at 1% (obtained by extraction with different solvents were added to this emulsion. In vitro and in vivo efficacy and safety of the formulations were evaluated. Spectrophotometric methods and in vivo Colipa test were performed to evaluated efficacy of the formulations, through sun protection factor (SPF determination and UVA protection factor assessment. To the in vitro safety assessment HET-CAM, CAM-TBS and Red Blood Cell tests were performed. Results showed that both extracts contributed to a higher in vivo photoprotection (SPF 18 when compared to the formulation without extract (SPF 13, this result could be attributed to the antioxidant activity of the plant extracts that act by capturing reactive oxygen species. Concerning safety, all formulations were considered non-irritant according to in vitro tests. Formulations containing extracts could be considered efficient and safe for cosmetic use since they presented higher sun protection factor and passed the toxicity tests.

  20. From Safe Systems to Patient Safety

    DEFF Research Database (Denmark)

    Aarts, J.; Nøhr, C.

    2010-01-01

    for the third conference with the theme: The ability to design, implement and evaluate safe, useable and effective systems within complex health care organizations. The theme for this conference was "Designing and Implementing Health IT: from safe systems to patient safety". The contributions have reflected...... and implementation of safe systems and thus contribute to the agenda of patient safety? The contributions demonstrate how the health informatics community has contributed to the performance of significant research and to translating research findings to develop health care delivery and improve patient safety......This volume presents the papers from the fourth International Conference on Information Technology in Health Care: Socio-technical Approaches held in Aalborg, Denmark in June 2010. In 2001 the first conference was held in Rotterdam, The Netherlands with the theme: Sociotechnical' approaches...

  1. Recent advances in systems safety and security

    CERN Document Server

    Stamatescu, Grigore

    2016-01-01

    This book represents a timely overview of advances in systems safety and security, based on selected, revised and extended contributions from the 2nd and 3rd editions of the International Workshop on Systems Safety and Security – IWSSS, held in 2014 and 2015, respectively, in Bucharest, Romania. It includes 14 chapters, co-authored by 34 researchers from 7 countries. The book provides an useful reference from both theoretical and applied perspectives in what concerns recent progress in this area of critical interest. Contributions, broadly grouped by core topic, address challenges related to information theoretic methods for assuring systems safety and security, cloud-based solutions, image processing approaches, distributed sensor networks and legal or risk analysis viewpoints. These are mostly accompanied by associated case studies providing additional practical value and underlying the broad relevance and impact of the field.

  2. Safety and Efficacy of Human Wharton's Jelly-Derived Mesenchymal Stem Cells Therapy for Retinal Degeneration.

    Directory of Open Access Journals (Sweden)

    S N Leow

    Full Text Available To investigate the safety and efficacy of subretinal injection of human Wharton's Jelly-derived mesenchymal stem cells (hWJ-MSCs on retinal structure and function in Royal College of Surgeons (RCS rats.RCS rats were divided into 2 groups: hWJ-MSCs treated group (n = 8 and placebo control group (n = 8. In the treatment group, hWJ-MSCs from healthy donors were injected into the subretinal space in one eye of each rat at day 21. Control group received saline injection of the same volume. Additional 3 animals were injected with nanogold-labelled stem cells for in vivo tracking of cells localisation using a micro-computed tomography (microCT. Retinal function was assessed by electroretinography (ERG 3 days before the injection and repeated at days 15, 30 and 70 after the injection. Eyes were collected at day 70 for histology, cellular and molecular studies.No retinal tumor formation was detected by histology during the study period. MicroCT scans showed that hWJ-MSCs stayed localised in the eye with no systemic migration. Transmission electron microscopy showed that nanogold-labelled cells were located within the subretinal space. Histology showed preservation of the outer nuclear layer (ONL in the treated group but not in the control group. However, there were no significant differences in the ERG responses between the groups. Confocal microscopy showed evidence of hWJ-MSCs expressing markers for photoreceptor, Müller cells and bipolar cells.Subretinal injection of hWJ-MSCs delay the loss of the ONL in RCS rats. hWJ-MSCs appears to be safe and has potential to differentiate into retinal-like cells. The potential of this cell-based therapy for the treatment of retinal dystrophies warrants further studies.

  3. Efficacy and safety of nanohybrids comprising silver nanoparticles and silicate clay for controlling Salmonella infection

    Directory of Open Access Journals (Sweden)

    Bau IJ

    2012-05-01

    Full Text Available Shu-Her Chiao,1* Siou-Hong Lin,1* Ching-I Shen,2* Jiunn-Wang Liao,3 I-Jiuan Bau,1 Jiun-Chiou Wei,4 Li-Ping Tseng,1 Shan-hui Hsu,4 Ping-Shan Lai,2 Shinn-Zong Lin,5–7 Jiang-Jen Lin,4 Hong-Lin Su,1,8 1Department of Life Sciences, Agricultural Biotechnology Center, National Chung Hsing University, 2Department of Chemistry, Agricultural Biotechnology Center, National Chung Hsing University, 3Graduate Institute of Veterinary Pathobiology, Agricultural Biotechnology Center, National Chung Hsing University, Taichung, Taiwan; 4Institute of Polymer Science and Engineering, National Taiwan University, Taipei, Taiwan; 5Center for Neuropsychiatry, China Medical University and Hospital, Taichung, Taiwan; 6Department of Neurosurgery, China Medical University Beigan Hospital, Yunlin, Taiwan; 7Graduate Institute of Immunology, China Medical University, Taichung, Taiwan; 8Department of Physical Therapy, China Medical University, Taichung, Taiwan*These three authors contributed equallyAbstract: Developing effective and safe drugs is imperative for replacing antibiotics and controlling multidrug-resistant microbes. Nanoscale silicate platelet (NSP and its nanohybrid, silver nanoparticle/NSP (AgNP/NSP, have been developed, and the nanohybrids show a strong and general antibacterial activity in vitro. Here, their efficacy for protecting Salmonella-infected chicks from fatality and septicemia was evaluated. Both orally administrated NSP and AgNP/NSP, but not AgNPs alone, effectively reduced the systemic Salmonella infection and mortality. In addition, quantitative Ag analyses demonstrated that Ag deposition from AgNP/NSP in the intestines was less than that from conventional AgNPs, indicating that the presence of NSP for immobilizing AgNPs reduced Ag accumulation in tissue and improved the safety of AgNPs. These in vivo results illustrated that both NSP and AgNP/NSP nanohybrid represent potential agents for controlling enteric bacterial infections.Keywords: silver

  4. Tranexamic acid for the treatment of heavy menstrual bleeding: efficacy and safety

    Science.gov (United States)

    Leminen, Henri; Hurskainen, Ritva

    2012-01-01

    Tranexamic acid has proven to be an effective treatment for heavy menstrual bleeding (HMB). It reduces menstrual blood loss (MBL) by 26%–60% and is significantly more effective than placebo, nonsteroidal anti-inflammatory drugs, oral cyclical luteal phase progestins, or oral etamsylate, while the levonorgestrel-releasing intrauterine system reduces MBL more than tranexamic acid. Other treatments used for HMB are oral contraceptives, danazol, and surgical interventions (endometrial ablation and hysterectomy). Medical therapy is usually considered a first-line treatment for idiopathic HMB. Tranexamic acid significantly improves the quality of life of women treated for HMB. The recommended oral dosage is 3.9–4 g/day for 4–5 days starting from the first day of the menstrual cycle. Adverse effects are few and mainly mild. No evidence exists of an increase in the incidence of thrombotic events associated with its use. An active thromboembolic disease is a contraindication. In the US, a history of thrombosis or thromboembolism, or an intrinsic risk for thrombosis or thromboembolism are considered contraindications as well. This review focuses on the efficacy and safety of tranexamic acid in the treatment of idiopathic HMB. We searched for medical literature published in English on tranexamic acid from Ovid Medline, PubMed, and Cinahl. Additional references were identified from the reference lists of articles. Ovid Medline, PubMed, and Cinahl search terms were “tranexamic acid” and “menorrhagia” or “heavy menstrual bleeding.” Searches were last updated on March 25, 2012. Studies with women receiving tranexamic acid for HMB were included; randomized controlled studies with a description of appropriate statistical methodology were preferred. Relevant data on the physiology of menstruation and the pharmacodynamics and pharmacokinetics of tranexamic acid are also included. PMID:22956886

  5. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients.

    Science.gov (United States)

    Busse, William W; Wenzel, Sally E; Meltzer, Eli O; Kerwin, Edward M; Liu, Mark C; Zhang, Nan; Chon, Yun; Budelsky, Alison L; Lin, Joseph; Lin, Shao-Lee

    2013-02-01

    The D-prostanoid receptor and the chemoattractant receptor homologous molecule expressed on T(H)2 cells (CRTH2) are implicated in asthma pathogenesis. AMG 853 is a potent, selective, orally bioavailable, small-molecule dual antagonist of human D-prostanoid and CRTH2. We sought to determine the efficacy and safety of AMG 853 compared with placebo in patients with inadequately controlled asthma. Adults with moderate-to-severe asthma were randomized to placebo; 5, 25, or 100 mg of oral AMG 853 twice daily; or 200 mg of AMG 853 once daily for 12 weeks. All patients continued their inhaled corticosteroids. Long-acting β-agonists were not allowed during the treatment period. Allowed concomitant medications included short-acting β-agonists and a systemic corticosteroid burst for asthma exacerbation. The primary end point was change in total Asthma Control Questionnaire score from baseline to week 12. Secondary and exploratory end points included FEV(1), symptom scores, rescue short-acting β-agonist use, and exacerbations. Among treated patients, no effect over placebo (n = 79) was observed in mean changes in Asthma Control Questionnaire scores at 12 weeks (placebo, -0.492; range for AMG 853 groups [n = 317], -0.444 to -0.555). No significant differences between the active and placebo groups were observed for secondary end points. The most commonly reported adverse events were asthma, upper respiratory tract infection, and headache; 9 patients experienced serious adverse events, all of which were deemed unrelated to study treatment by the investigator. AMG 853 as an add-on to inhaled corticosteroid therapy demonstrated no associated risks but was not effective at improving asthma symptoms or lung function in patients with inadequately controlled moderate-to-severe asthma. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  6. Safety and Efficacy of Human Wharton's Jelly-Derived Mesenchymal Stem Cells Therapy for Retinal Degeneration.

    Science.gov (United States)

    Leow, S N; Luu, Chi D; Hairul Nizam, M H; Mok, P L; Ruhaslizan, R; Wong, H S; Wan Abdul Halim, Wan Haslina; Ng, M H; Ruszymah, B H I; Chowdhury, S R; Bastion, M L C; Then, K Y

    2015-01-01

    To investigate the safety and efficacy of subretinal injection of human Wharton's Jelly-derived mesenchymal stem cells (hWJ-MSCs) on retinal structure and function in Royal College of Surgeons (RCS) rats. RCS rats were divided into 2 groups: hWJ-MSCs treated group (n = 8) and placebo control group (n = 8). In the treatment group, hWJ-MSCs from healthy donors were injected into the subretinal space in one eye of each rat at day 21. Control group received saline injection of the same volume. Additional 3 animals were injected with nanogold-labelled stem cells for in vivo tracking of cells localisation using a micro-computed tomography (microCT). Retinal function was assessed by electroretinography (ERG) 3 days before the injection and repeated at days 15, 30 and 70 after the injection. Eyes were collected at day 70 for histology, cellular and molecular studies. No retinal tumor formation was detected by histology during the study period. MicroCT scans showed that hWJ-MSCs stayed localised in the eye with no systemic migration. Transmission electron microscopy showed that nanogold-labelled cells were located within the subretinal space. Histology showed preservation of the outer nuclear layer (ONL) in the treated group but not in the control group. However, there were no significant differences in the ERG responses between the groups. Confocal microscopy showed evidence of hWJ-MSCs expressing markers for photoreceptor, Müller cells and bipolar cells. Subretinal injection of hWJ-MSCs delay the loss of the ONL in RCS rats. hWJ-MSCs appears to be safe and has potential to differentiate into retinal-like cells. The potential of this cell-based therapy for the treatment of retinal dystrophies warrants further studies.

  7. Efficacy and safety evaluation of icotinib in patients with advanced non-small cell lung cancer.

    Science.gov (United States)

    Gu, Aiqin; Shi, Chunlei; Xiong, Liwen; Chu, Tianqing; Pei, Jun; Han, Baohui

    2013-02-01

    To evaluate the efficacy and safety of icotinib hydrochloride in patients with advanced non-small cell lung cancer (NSCLC). A total of 89 patients with stage IIIB or IV NSCLC received icotinib at a dose of 125 mg administered 3 times a day. Icotinib treatment was continued until disease progression or development of unacceptable toxicity. A total of 89 patients were assessable. In patients treated with icotinib, the overall response rate (RR) was 36.0% (32/89), and the disease control rate (DCR) was 69.7% (62/89). RR and DCR were significantly improved in patients with adenocarcinoma versus non-adenocarcinoma (Picotinib hydrochloride in the treatment of advanced NSCLC is efficacious and safe, and its toxic effects are tolerable.

  8. Population analyses of efficacy and safety of ABT-594 in subjects with diabetic peripheral neuropathic pain.

    Science.gov (United States)

    Dutta, Sandeep; Hosmane, Balakrishna S; Awni, Walid M

    2012-06-01

    ABT-594, a neuronal nicotinic acetylcholine receptor ligand, is 30- to 100-fold more potent than morphine in animal models of nociceptive and neuropathic pain. Efficacy and safety of ABT-594 in subjects with painful diabetic polyneuropathy was evaluated in a phase 2 study. The objective of this work was to use a nonlinear mixed effects model-based approach for characterizing the relationship between dose and response (efficacy and safety) of ABT-594. Subjects (N = 266) were randomized into four groups in a double-blind, placebo-controlled, 7-week study to receive twice daily regimens of placebo or 150, 225, and 300 μg of ABT-594. The primary efficacy variable, pain score (11-point Likert scale), was assessed on five occasions. The probability of change from baseline pain score of ≥1, ≥2, and ≥3 was modeled using cumulative logistic regression with dose and days of treatment as explanatory variables. The incidence of five most frequently occurring adverse events (AEs) was modeled using linear logistic regression. ABT-594 ED(50) values (improvement in 50% of subjects) for improvement in pain scores of ≥1, ≥2, and ≥3 were 50, 215, and 340 μg, respectively, for the average number of days (33) on treatment. The rank order of ED(50) values for AEs was nausea, vomiting, dizziness, headache, and abnormal dreams; nicotine users were less sensitive to AEs. Population pharmacodynamic models developed to characterize the improvement in pain score and incidence of adverse events indicate an approximately twofold separation between the ED(50) values for efficacy and AEs.

  9. Safety and efficacy of subretinal visual implants in humans: methodological aspects.

    Science.gov (United States)

    Stingl, Katarina; Bach, Michael; Bartz-Schmidt, Karl-Ulrich; Braun, Angelika; Bruckmann, Anna; Gekeler, Florian; Greppmaier, Udo; Hörtdörfer, Gernot; Kusnyerik, Akos; Peters, Tobias; Wilhelm, Barbara; Wilke, Robert; Zrenner, Eberhart

    2013-01-01

    Replacing the function of visual pathway neurons by electronic implants is a novel approach presently explored by various groups in basic research and clinical trials. The novelty raises unexplored methodological aspects of clinical trial design that may require adaptation and validation. We present procedures of efficacy and safety testing for subretinal visual implants in humans, as developed during our pilot trial 2005 to 2009 and multi-centre clinical trial since 2010. Planning such a trial requires appropriate inclusion and exclusion criteria. For subretinal electronic visual implants, patients with photoreceptor degeneration are the target patient group, whereas presence of additional diseases affecting clear optic media or the visual pathway must be excluded. Because sham surgery is not possible, a masked study design with implant power ON versus OFF is necessary. Prior to the efficacy testing by psychophysical tests, the implant's technical characteristics have to be controlled via electroretinography (ERG). Moreover the testing methods require adaptation to the particular technology. We recommend standardised tasks first to determine the light perception thresholds, light localisation and movement detection, followed by grating acuity and vision acuity test via Landolt C rings. A laboratory setup for assessing essential activities of daily living is presented. Subjective visual experiences with the implant in a natural environment, as well as questionnaires and psychological counselling are further important aspects. A clinical trial protocol for artificial vision in humans, which leads a patient from blindness to the state of very low vision is a challenge and cannot be defined completely prior to the study. Available tests of visual function may not be sufficiently suited for efficacy testing of artificial vision devices. A protocol based on experience with subretinal visual implants in 22 patients is presented that has been found adequate to monitor

  10. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

    Directory of Open Access Journals (Sweden)

    J.B. Calixto

    2000-02-01

    Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  11. Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

    Science.gov (United States)

    Reeves, Fairleigh; Batty, Lachlan; Pitt, Veronica; Chau, Marisa; Pattuwage, Loyal; Gruen, Russell L

    2013-10-01

    Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future

  12. 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.

  13. 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.

  14. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery

    NARCIS (Netherlands)

    Dahl, Vegard; Pendeville, Philippe E.; Hollmann, Markus W.; Heier, Tom; Abels, Esther Am; Blobner, Manfred

    2009-01-01

    Background and objective The present randomized, safety-assessor blinded, placebo-controlled trial was designed to assess safety and efficacy of sugammadex, a novel selective relaxant-binding agent, in patients with underlying cardiovascular disease undergoing noncardiac surgery. Methods Overall,

  15. Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial

    DEFF Research Database (Denmark)

    Dahl, Ronald; Calverley, Peter M A; Anzueto, Antonio

    2015-01-01

    OBJECTIVES: This post hoc analysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) evaluated safety and exacerbation efficacy in patients with stable (≥2 months) use of tiotropium HandiHaler 18 µg (HH18) prior to study entry, to evaluate whether there was a difference in risk for patie...

  16. Feasibility, safety, acceptability, and preliminary efficacy of measurement-based care depression treatment for HIV patients in Bamenda, Cameroon.

    Science.gov (United States)

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

    2014-06-01

    Depression affects 18-30 % of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. We enrolled 55 participants; all started amitriptyline 25-50 mg daily at baseline. By 12 weeks, most remained at 50 mg daily (range 25-125 mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87 % achieved depression remission (PHQ-9 feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting.

  17. Plant air systems safety study: Portsmouth Gaseous Diffusion Plant

    International Nuclear Information System (INIS)

    1982-05-01

    The Portsmouth Gaseous Diffusion Plant Air System facilities and operations are reviewed for potential safety problems not covered by standard industrial safety procedures. Information is presented under the following section headings: facility and process description (general); air plant equipment; air distribution system; safety systems; accident analysis; plant air system safety overview; and conclusion

  18. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Senabre-Gallego JM

    2013-09-01

    Full Text Available José Miguel Senabre-Gallego,1 Carlos Santos-Ramirez,2 Gregorio Santos-Soler,1 Esteban Salas-Heredia,1 Mabel Sánchez-Barrioluengo,3 Xavier Barber,4 José Rosas1 On behalf of the AIRE-MB group 1Rheumatology, Hospital Marina Baixa, Villajoyosa, 2Rheumatology, Hospital Marina Salud, Denia, 3INGENIO (Instituto de Gestión de la Inovación y del Conocimiento (CSIC [Consejo Superior de Investigaciones Científicas]-UPV [Universidad Politécnica de Valencia], Universitat Politècnica de València, Valencia, 4CIO (Centro de Investigación Operativa-UMH (Universidad Miguel Hernández, Universidad Miguel Henández, Elche, Spain Abstract: To date, anti-tumor necrosis factor alfa (anti-TNF-α therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of

  19. Efficacy, safety, and patient preference of monoamine oxidase B inhibitors in the treatment of Parkinson's disease.

    Science.gov (United States)

    Robottom, Bradley J

    2011-01-20

    Parkinson's disease (PD) is the second most common neurodegenerative disease and the most treatable. Treatment of PD is symptomatic and generally focuses on the replacement or augmentation of levodopa. A number of options are available for treatment, both in monotherapy of early PD and to treat complications of advanced PD. This review focuses on rasagiline and selegiline, two medications that belong to a class of antiparkinsonian drugs called monoamine oxidase B (MAO-B) inhibitors. Topics covered in the review include mechanism of action, efficacy in early and advanced PD, effects on disability, the controversy regarding disease modification, safety, and patient preference for MAO-B inhibitors.

  20. Safety and efficacy of a low-cost glaucoma drainage device for refractory childhood glaucoma.

    Science.gov (United States)

    Kaushik, Sushmita; Kataria, Pankaj; Raj, Srishti; Pandav, Surinder Singh; Ram, Jagat

    2017-12-01

    To evaluate the safety and efficacy of a low-cost glaucoma drainage device (GDD), Aurolab aqueous drainage implant (AADI), similar in design to the Baerveldt glaucoma implant (BGI), in refractory childhood glaucoma. This prospective interventional study was conducted in a tertiary care postgraduate teaching institute. Children aged glaucoma valve implant in children. © 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.

  1. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.

    Science.gov (United States)

    Hübner, N-O; Kramer, A

    2010-01-01

    Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications. Copyright © 2010 S. Karger AG, Basel.

  2. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults

    DEFF Research Database (Denmark)

    Hristovska, Ana-Marija; Duch, Patricia; Allingstrup, Mikkel

    2017-01-01

    , and undesirable autonomic responses. Sugammadex is a selective relaxant-binding agent specifically developed for rapid reversal of non-depolarizing neuromuscular blockade induced by rocuronium. Its potential clinical benefits include fast and predictable reversal of any degree of block, increased patient safety......, reduced incidence of residual block on recovery, and more efficient use of healthcare resources. OBJECTIVES: The main objective of this review was to compare the efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade caused by non-depolarizing neuromuscular agents......-depolarizing neuromuscular blocking agents for an elective in-patient or day-case surgical procedure. We included all trials comparing sugammadex versus neostigmine that reported recovery times or adverse events. We included any dose of sugammadex and neostigmine and any time point of study drug administration. DATA...

  3. Resistance training among young athletes: safety, efficacy and injury prevention effects.

    Science.gov (United States)

    Faigenbaum, A D; Myer, G D

    2010-01-01

    A literature review was employed to evaluate the current epidemiology of injury related to the safety and efficacy of youth resistance training. Several case study reports and retrospective questionnaires regarding resistance exercise and the competitive sports of weightlifting and powerlifting reveal that injuries have occurred in young lifters, although a majority can be classified as accidental. Lack of qualified instruction that underlies poor exercise technique and inappropriate training loads could explain, at least partly, some of the reported injuries. Current research indicates that resistance training can be a safe, effective and worthwhile activity for children and adolescents provided that qualified professionals supervise all training sessions and provide age-appropriate instruction on proper lifting procedures and safe training guidelines. Regular participation in a multifaceted resistance training programme that begins during the preseason and includes instruction on movement biomechanics may reduce the risk of sports-related injuries in young athletes. Strategies for enhancing the safety of youth resistance training are discussed.

  4. 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...

  5. Modern Therapy for Gout through the Prism of Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    I.Yu. Golovach

    2015-04-01

    Full Text Available The modern data on the treatment of such common condition as gout were presented in this article. Gout management covers and unites two directions: firstly, adequate treatment of acute gout episodes and, secondly, a steady decline in serum urate level below 360 µmol/l (6 mg/dl or lower in some cases to prevent recurrences and to promote resorption of tophi. The therapeutic possibilities in acute gout episode include nonsteroidal anti-inflammatory drugs, colchicine and glucocorticoids; in the treatment of chronic gout, allopurinol is widely used. The efficacy and safety of innovative drugs in the treatment of gout — febuxostat and interleukin-1 inhibitors were shown. It is underlined that the main problems of gout treatment are related to long-term safety and comorbidities.

  6. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy.

    Science.gov (United States)

    Polydefkis, Michael; Arezzo, Joseph; Nash, Marshall; Bril, Vera; Shaibani, Aziz; Gordon, Robert J; Bradshaw, Kate L; Junor, Roderick W J

    2015-12-01

    We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy (DSPN). Patients (18-75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double-blind, phase II/III study (ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1 : 1 : 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265 : 264 : 271). Change in peroneal motor nerve conduction velocity (PMNCV) from baseline to 24 months was the primary endpoint with a goal improvement vs. placebo ≥1.2 m/s. Other endpoints included symptoms, quality-of-life, and safety. Six hundred thirty-three patients completed the study. The PMNCV difference from placebo was significant at 6, 12, and 18 months in both ranirestat groups, but diabetes. © 2015 Peripheral Nerve Society.

  7. Generalized Safety and Efficacy of Simplified Intravenous Thrombolysis Treatment (SMART) Criteria in Acute Ischemic Stroke

    DEFF Research Database (Denmark)

    Sørensen, Sigrid B; Barazangi, Nobl; Chen, Charlene

    2016-01-01

    BACKGROUND: Common intravenous recombinant tissue plasminogen activator (IV rt-PA) exclusion criteria may substantially limit the use of thrombolysis. Preliminary data have shown that the SMART (Simplified Management of Acute stroke using Revised Treatment) criteria greatly expand patient...... eligibility by reducing thrombolysis exclusions, but they have not been assessed on a large scale. We evaluated the safety and efficacy of general adoption of SMART thrombolysis criteria to a large regional stroke network. METHODS: Retrospective analysis of consecutive patients who received IV thrombolysis...... within a regional stroke network was performed. Patients were divided into those receiving thrombolysis locally versus at an outside hospital. The primary outcome was modified Rankin Scale score (≤1) at discharge and the main safety outcome was symptomatic intracranial hemorrhage (sICH) rate. RESULTS...

  8. DESIGN PACKAGE 1E SYSTEM SAFETY ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    M. Salem

    1995-06-23

    The purpose of this analysis is to systematically identify and evaluate hazards related to the Yucca Mountain Project Exploratory Studies Facility (ESF) Design Package 1E, Surface Facilities, (for a list of design items included in the package 1E system safety analysis see section 3). This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the Design Package 1E structures/systems/components(S/S/Cs) in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the structure/system/component design, (2) add safety devices and capabilities to the designs that reduce risk, (3) provide devices that detect and warn personnel of hazardous conditions, and (4) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions.

  9. Development of the Digital Reactor Safety System

    International Nuclear Information System (INIS)

    Lee, Dong Young; Lee, C. K.; Hwang, I. K.

    2008-04-01

    Objectives of Project - Development of Digital Safety Grade PLC and Licensing - Development of Safety System(RPS) and Licensing - Development of Safety System(ESF-CCS) and Licensing Content and Result of Project - POSAFE-Q PLC : Development of PLC platform for Shin-UCN unit 1 and 2 ·Development Scope : Processor module, Power module, 3 kinds of Communication module, Bus extension module(Master and Slave), 16 kinds of Input and Output module ·PLC application software development tool(pSET) - IDiPS RPS and IDiPS ESF-CCS : Development of PPS for Sin-UCN 1 and 2 ·Development Scope - 4-channels RPS with the KNICS inherent architecture - A part of 1-channels ESF-CCS with the KNICS inherent architecture - Licensing ·optical Report Submitted and Expected to finish the licensing process until Aug. 2008

  10. Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

    Directory of Open Access Journals (Sweden)

    Michael R. Kohn

    2012-01-01

    Full Text Available Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD. Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication.

  11. Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

    Science.gov (United States)

    Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

    2012-01-01

    Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

  12. GOLIMUMAB — A NEW TNF α-BLOCKER. THE REVIEW OF THE EFFICACY AND SAFETY EVALUATION RESULTS

    Directory of Open Access Journals (Sweden)

    R. V. Denisova

    2012-01-01

    Full Text Available The article represents the results of efficacy and safety evaluation of the human monoclonal antibodies — golimumab, according to the data of international multicenter randomized double-blind placebo-controlled trials, including patients with active stage of rheumatoid arthritis. It was shown, that golimumab was reliably more effective than placebo both when administered hypodermic and intravenous. The safety profile of golimumab is comparable to that of the other tumor necrosis factor alpha blockers. The review also contains information on the 3d phase of golimumab efficacy and safety research in patients with juvenile idiopathic arthritis.

  13. Role of computers in CANDU safety systems

    International Nuclear Information System (INIS)

    Hepburn, G.A.; Gilbert, R.S.; Ichiyen, N.M.

    1985-01-01

    Small digital computers are playing an expanding role in the safety systems of CANDU nuclear generating stations, both as active components in the trip logic, and as monitoring and testing systems. The paper describes three recent applications: (i) A programmable controller was retro-fitted to Bruce ''A'' Nuclear Generating Station to handle trip setpoint modification as a function of booster rod insertion. (ii) A centralized monitoring computer to monitor both shutdown systems and the Emergency Coolant Injection system, is currently being retro-fitted to Bruce ''A''. (iii) The implementation of process trips on the CANDU 600 design using microcomputers. While not truly a retrofit, this feature was added very late in the design cycle to increase the margin against spurious trips, and has now seen about 4 unit-years of service at three separate sites. Committed future applications of computers in special safety systems are also described. (author)

  14. Safety system for reactor container

    International Nuclear Information System (INIS)

    Shimizu, Miwako; Seki, Osamu; Mano, Takio.

    1995-01-01

    A slanted structure is formed below a reactor core where there is a possibility that molten reactor core materials are dropped, and above a water level of a pool which is formed by coolants flown from a reactor recycling system and accumulated on the inner bottom of the reactor container, to prevent molten fuels from dropping at once in the form of a large amount of lump. The molten materials are provisionally received on the structure, gradually formed into small pieces and then dropped. Further, the molten materials are dropped and received provisionally on a group of coolant-flowing pipelines below the structure, to lower the temperature of the molten materials, and then the reactor core molten materials are gradually formed into small pieces and dropped into the pool water. Since they are not dropped directly into the pool water but dropped gradually into the pool water as small droplets, occurrence of steam explosion can be reduced. The occurrence of steam explosion due to dropped molten reactor core material and pool water is suppressed, and the molten materials are kept in the pool water, thereby enabling to maintain the integrity of the reactor container more effectively. (N.H.)

  15. Analysis and design on airport safety information management system

    Directory of Open Access Journals (Sweden)

    Yan Lin

    2017-01-01

    Full Text Available Airport safety information management system is the foundation of implementing safety operation, risk control, safety performance monitor, and safety management decision for the airport. The paper puts forward the architecture of airport safety information management system based on B/S model, focuses on safety information processing flow, designs the functional modules and proposes the supporting conditions for system operation. The system construction is helpful to perfecting the long effect mechanism driven by safety information, continually increasing airport safety management level and control proficiency.

  16. Advanced reactor systems: safety and regulatory aspects

    International Nuclear Information System (INIS)

    Gopalakrishnan, A.

    1994-01-01

    Safety features which are desirable in futuristic reactor systems have been the subject of several studies over the past decade by different expert groups. When one discusses this subject, therefore, in a somewhat non-specific and qualitative manner, it is best to make use of the already available collective wisdom and literature on the matter. (author). 3 refs

  17. 76 FR 14592 - Safety Management System; Withdrawal

    Science.gov (United States)

    2011-03-17

    ...), Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 494...). The FAA also chartered the Safety Management System Aviation Rulemaking Committee (ARC) (Order No..., including the ANPRM. On March 31, 2010, the ARC submitted its report to the FAA. As a result of the...

  18. Maintenance of radiation safety information system

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Ho Sun [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of); Park, Moon Il; Chung, Chong Kyu; Lim, Bock Soo; Kim, Hyung Uk; Chang, Kwang Il; Nam, Kwan Hyun; Cho, Hye Ryan [AD center incubation LAB, Taejon (Korea, Republic of)

    2001-12-15

    The objectives of radiation safety information system maintenance are to maintain the requirement of users, change of job process and upgrade of the system performance stably and effectively while system maintenance. We conduct the code of conduct recommended by IAEA, management of radioisotope inventory database systematically using analysis for the state of inventory database integrated in this system. This system and database will be support the regulatory guidance, rule making and information to the MOST, KINS, other regulatory related organization and general public optimizationally.

  19. 77 FR 11120 - Patient Safety Organizations: Voluntary Relinquishment From UAB Health System Patient Safety...

    Science.gov (United States)

    2012-02-24

    ... Organizations: Voluntary Relinquishment From UAB Health System Patient Safety Organization AGENCY: Agency for... notification of voluntary relinquishment from the UAB Health System Patient Safety Organization of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005...

  20. Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial.

    Science.gov (United States)

    Misawa, Sonoko; Kuwabara, Satoshi; Sato, Yasunori; Yamaguchi, Nobuko; Nagashima, Kengo; Katayama, Kanako; Sekiguchi, Yukari; Iwai, Yuta; Amino, Hiroshi; Suichi, Tomoki; Yokota, Takanori; Nishida, Yoichiro; Kanouchi, Tadashi; Kohara, Nobuo; Kawamoto, Michi; Ishii, Junko; Kuwahara, Motoi; Suzuki, Hidekazu; Hirata, Koichi; Kokubun, Norito; Masuda, Ray; Kaneko, Juntaro; Yabe, Ichiro; Sasaki, Hidenao; Kaida, Ken-Ichi; Takazaki, Hiroshi; Suzuki, Norihiro; Suzuki, Shigeaki; Nodera, Hiroyuki; Matsui, Naoko; Tsuji, Shoji; Koike, Haruki; Yamasaki, Ryo; Kusunoki, Susumu

    2018-06-01

    Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome. This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3-5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via a computer-generated process and web response system with minimisation for functional grade and age. The study had a parallel non-comparative single-arm outcome measure. The primary outcomes were efficacy (the proportion of patients with restored ability to walk independently [functional grade ≤2] at week 4) in the eculizumab group and safety in the full analysis set. For the efficacy endpoint, we predefined a response rate threshold of the lower 90% CI boundary exceeding 50%. This trial is registered with ClinicalTrials.gov, number, NCT02493725. Between Aug 10, 2015, and April 21, 2016, 34 patients were assigned to receive either eculizumab (n=23) or placebo (n=11). At week 4, the proportion of the patients able to walk independently (functional grade ≤2) was 61% (90% CI 42-78; n=14) in the eculizumab group, and 45% (20-73; n=5) in the placebo group. Adverse events occurred in all 34 patients. Three patients had serious adverse events: two in the eculizumab group (anaphylaxis in one patient and intracranial haemorrhage and abscess in another patient) and one in the placebo group (depression

  1. INTEGRATED SAFETY MANAGEMENT SYSTEM IN AIR TRAFFIC SERVICES

    Directory of Open Access Journals (Sweden)

    Volodymyr Kharchenko

    2014-06-01

    Full Text Available The article deals with the analysis of the researches conducted in the field of safety management systems.Safety management system framework, methods and tools for safety analysis in Air Traffic Control have been reviewed.Principles of development of Integrated safety management system in Air Traffic Services have been proposed.

  2. The efficacy and safety of external cephalic version after a previous caesarean delivery.

    Science.gov (United States)

    Weill, Yishay; Pollack, Raphael N

    2017-06-01

    External cephalic version (ECV) in the presence of a uterine scar is still considered a relative contraindication despite encouraging studies of the efficacy and safety of this procedure. We present our experience with this patient population, which is the largest cohort published to date. To evaluate the efficacy and safety of ECV in the setting of a prior caesarean delivery. A total of 158 patients with a fetus presenting as breech, who had an unscarred uterus, had an ECV performed. Similarly, 158 patients with a fetus presenting as breech, and who had undergone a prior caesarean delivery also underwent an ECV. Outcomes were compared. ECV was successfully performed in 136/158 (86.1%) patients in the control group. Of these patients, 6/136 (4.4%) delivered by caesarean delivery. In the study group, 117/158 (74.1%) patients had a successful ECV performed. Of these patients, 12/117 (10.3%) delivered by caesarean delivery. There were no significant complications in either of the groups. ECV may be successfully performed in patients with a previous caesarean delivery. It is associated with a high success rate, and is not associated with an increase in complications. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  3. Silodosin for the treatment of clinical benign prostatic hyperplasia: safety, efficacy, and patient acceptability.

    Science.gov (United States)

    Cho, Hee Ju; Yoo, Tag Keun

    2014-01-01

    α1-Adrenergic receptor antagonists are commonly used to treat male lower urinary tract symptoms and benign prostatic hyperplasia (BPH). We performed a literature search using PubMed, Medline via Ovid, Embase, and the Cochrane Library databases to identify studies on the treatment of BPH by silodosin. Silodosin is a novel α1-adrenergic receptor antagonist whose affinity for the α1A-adrenergic receptor is greater than that for the α1B-adrenergic receptor. Therefore, silodosin does not increase the incidence of blood pressure-related side effects, which may result from the inhibition of the α1B-adrenergic receptor. Patients receiving silodosin at a daily dose of 8 mg showed a significant improvement in the International Prostate Symptom Score and maximum urinary flow rate compared with those receiving a placebo. Silodosin also improved both storage and voiding symptoms, indicating that silodosin is effective, even during early phases of BPH treatment. Follow-up extension studies performed in the United States, Europe, and Asia demonstrated its long-term safety and efficacy. In the European study, silodosin significantly reduced nocturia compared to the placebo. Although retrograde or abnormal ejaculation was the most commonly reported symptom in these studies, only a few patients discontinued treatment. The incidence of adverse cardiovascular events was also very low. Evidence showing solid efficacy and cardiovascular safety profiles of silodosin will provide a good solution for the treatment of lower urinary tract symptoms associated with BPH in an increasingly aging society.

  4. The Safety and Efficacy of Cryolipolysis: A Systematic Review of Available Literature.

    Science.gov (United States)

    Derrick, Chase D; Shridharani, Sachin M; Broyles, Justin M

    2015-09-01

    In the past decade, the practice of body contouring using cryolipolysis has increased tremendously. While numerous anecdotal reports extol the efficacy of this product, the majority of these studies are small, retrospective case-series that lack control groups. The authors aim to systematically review available literature to better illustrate the efficacy and safety of this new procedure. A systematic literature review performed using MEDLINE, Embase, PubMed, and Cochrane databases identified all published studies evaluating cryolipolysis for body contouring. A total of 34 articles up to February 2015 were identified. Nineteen articles matched the selection criteria and were included in the analysis. Sixteen were evaluated in the final analysis. A total of 1445 patients had reportable data for analysis of the safety profile. Twelve patients (0.82%) reported complications with the most common being diminished sensation lasting greater than 4 weeks. An aggregate total of 295 patients had objective data for evaluation of tissue reduction. The mean time from procedure to objective outcome evaluation was 3.83 months. The mean reduction of subcutaneous tissue was 19.55% with respect to a designated control site. Selective cryolipolysis appears, at short-term follow-up, to reliably decrease subcutaneous tissue deposits. Reported complications are uncommon and appear to resolve without intervention. Future studies should aim to optimize patient selection and treatment characteristics while obtaining long-term follow-up data. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  5. Deferasirox: appraisal of safety and efficacy in long-term therapy

    Directory of Open Access Journals (Sweden)

    Chaudhary P

    2013-08-01

    Full Text Available Preeti Chaudhary, Vinod PullarkatJane Ann Nohl Division of Hematology, University of Southern California Keck School of Medicine, Los Angeles, CA, USAAbstract: Deferasirox is a once-daily, oral iron chelator that is widely used in the management of patients with transfusional hemosiderosis. Several Phase II trials along with their respective extension studies as well as a Phase III trial have established the efficacy and safety of this novel agent in transfusion-dependent patients with β-thalassemia, sickle-cell disease and bone marrow-failure syndromes, including myelodysplastic syndrome and aplastic anemia. Data from various clinical trials show that a deferasirox dose of 20 mg/kg/day stabilizes serum ferritin levels and liver iron concentration, while a dose of 30–40 mg/kg/day reduces these parameters and achieves negative iron balance in red cell transfusion-dependent patients with iron overload. Across various pivotal clinical trials, deferasirox was well tolerated, with the most common adverse events being gastrointestinal disturbances, skin rash, nonprogressive increases in serum creatinine, and elevations in liver enzyme levels. Longer-term extension studies have also confirmed the efficacy and safety of deferasirox. However, it is essential that patients on deferasirox therapy are monitored regularly to ensure timely management for any adverse events that may occur with long-term therapy.Keywords: deferasirox, iron overload, thalassemia, sickle-cell disease, myelodysplastic syndrome

  6. Efficacy and safety of miconazole for oral candidiasis: a systematic review and meta-analysis.

    Science.gov (United States)

    Zhang, L-W; Fu, J-Y; Hua, H; Yan, Z-M

    2016-04-01

    The objective of this study is to assess the efficacy and safety of miconazole for treating oral candidiasis. Twelve electronic databases were searched for randomized controlled trials evaluating treatments for oral candidiasis and complemented by hand searching. The clinical and mycological outcomes, as well as adverse effects, were set as the primary outcome criteria. Seventeen trials were included in this review. Most studies were considered to have a high or moderate level of bias. Miconazole was more effective than nystatin for thrush. For HIV-infected patients, there was no significant difference in the efficacy between miconazole and other antifungals. For denture wearers, microwave therapy was significantly better than miconazole. No significant difference was found in the safety evaluation between miconazole and other treatments. The relapse rate of miconazole oral gel may be lower than that of other formulations. This systematic review and meta-analysis indicated that miconazole may be an optional choice for thrush. Microwave therapy could be an effective adjunct treatment for denture stomatitis. Miconazole oral gel may be more effective than other formulations with regard to long-term results. However, future studies that are adequately powered, large-scale, and well-designed are needed to provide higher-quality evidence for the management of oral candidiasis. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Pan CY

    2013-05-01

    Full Text Available CY Pan,1 XL Wang21Chinese PLA General Hospital, Beijing, People's Republic of China; 2Medical Affairs Department, Beijing Novartis Pharma Co, Ltd, Beijing, People's Republic of ChinaAbstract: Vildagliptin is a selective and potent dipeptidyl peptidase-4 inhibitor that improves glycemic control by inhibiting the degradation of both endogenous glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. This article is a comprehensive review of the safety and efficacy of vildagliptin in patients with type 2 diabetes. Clinical evidence has proven that it effectively decreases hemoglobin A1c with a low risk of hypoglycemia and is weight neutral. The addition of vildagliptin to metformin improves glucose control and significantly reduces gastrointestinal adverse events, particularly in patients inadequately controlled with metformin monotherapy. Its long-term advantages include preservation of β-cell function, reduction in total cholesterol, decrease in fasting lipolysis in adipose tissue, and triglyceride storage in non-fat tissues. Vildagliptin is well tolerated with a low incidence of AEs, and it does not increase the risk of cardiovascular/cerebrovascular (CCV events. It can be taken before or after meals, and has little drug interaction, thus it will be well accepted.Keywords: dipeptidyl peptidase-4, incretin hormones, vildagliptin, efficacy, safety, patient acceptability

  8. Efficacy and safety of small intestinal submucosa in dural defect repair in a canine model

    Energy Technology Data Exchange (ETDEWEB)

    He, Shu-kun [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Guo, Jin-hai [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Department of Orthopedics, The Third People' s Hospital of Chengdu, Chengdu, Sichuan 610031 (China); Wang, Zhu-le [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Zhang, Yi [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Tu, Yun-hu [Department of Neurosurgery, Chengdu Military General Hospital, Chengdu, Sichuan 610083 (China); Wu, Shi-zhou [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China); Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Huang, Fu-guo [Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041 (China); Xie, Hui-qi, E-mail: xiehuiqi@scu.edu.cn [Laboratory of Stem Cell and Tissue Engineering, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041 (China)

    2017-04-01

    Dural defects are a common problem, and inadequate dural closure can lead to complications. Several types of dural substitute materials have recently been discarded or modified owing to poor biocompatibility or mechanical properties and adverse reactions. The small intestinal submucosa (SIS) is a promising material used in a variety of applications. Based on the limitations of previous studies, we conducted an animal study to evaluate the efficacy and safety of the SIS in preclinical trials. Twenty-four male beagle dogs were subjected to surgical resection to produce dural defects. SIS or autologous dural mater was patched on the dural defect. Gross and histological evaluations were carried out to evaluate the efficacy and safety of the therapy. Our findings demonstrated that the SIS, which stimulated connective and epithelial tissue responses for dural regeneration and functional recovery without immunological rejection, could provide prolonged defect repair and prevent complications. The mechanical properties of the SIS could be adjusted by application of multiple layers, and the biocompatibility of the material was appropriate. Thus, our data suggested that this material may represent an alternative option for clinical treatment of dural defects. - Highlights: • SIS stimulates dura regeneration without immunological rejection. • SIS has adjustable mechanical properties and appropriate biocompatibility. • SIS may be an effective alternative option for clinical treatment of dural defects.

  9. Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Gajofatto A

    2015-12-01

    Full Text Available Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS, a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management. Keywords: multiple sclerosis, fingolimod, safety, tolerability, efficacy

  10. Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

    International Nuclear Information System (INIS)

    Kulkarni, R.D.; Gopal, N.G.S.

    1975-01-01

    Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

  11. Efficacy and safety of topical Trikatu preparation in, relieving mosquito bite reactions: a randomized controlled trial.

    Science.gov (United States)

    Maenthaisong, Ratree; Chaiyakunapruk, Nathorn; Tiyaboonchai, Waree; Tawatsin, Apiwat; Rojanawiwat, Archawin; Thavara, Usavadee

    2014-02-01

    Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. There were no significant differences between treatment and reference arms on any outcome at any time of measurement. Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Managing blood pressure control in Asian patients: safety and efficacy of losartan.

    Science.gov (United States)

    Cheung, Tommy Tsang; Cheung, Bernard Man Yung

    2014-01-01

    Hypertension is common in Asian populations and is a major cause of cardiovascular diseases. The prevalence of hypertension is increasing in many Asian countries. The overall prevalence of hypertension in India and the People's Republic of China has been estimated to be 20.6% in men and 22.6% in women. However, the rates of detection, treatment, and control of hypertension remain low in Asia. This reflects a low level of literacy and education, as well as a low level of access to medical care. To overcome these obstacles, strategies targeted at education, promotion, and optimization of medical care, are crucial to achieve target blood pressure control. Angiotensin receptor blockers are one of the first-line treatments for essential hypertension because they confer better cardiovascular outcomes. Losartan has been widely evaluated for the management of hypertension. Although some studies suggested that the blood pressure-lowering effect of losartan is perhaps lower than for other angiotensin receptor blockers, losartan has been demonstrated to be beneficial in terms of renal protection in patients with diabetes, heart failure resulting from either systolic or diastolic dysfunction, and diuretic-induced hyperuricemia. However, most of these data were obtained from Caucasian populations. The efficacy and safety of losartan in Asian populations may be different because of genetic and ethnic variations. Therefore, the efficacy and safety of losartan in Asian patients with hypertension warrant further study.

  13. Efficacy and safety of small intestinal submucosa in dural defect repair in a canine model

    International Nuclear Information System (INIS)

    He, Shu-kun; Guo, Jin-hai; Wang, Zhu-le; Zhang, Yi; Tu, Yun-hu; Wu, Shi-zhou; Huang, Fu-guo; Xie, Hui-qi

    2017-01-01

    Dural defects are a common problem, and inadequate dural closure can lead to complications. Several types of dural substitute materials have recently been discarded or modified owing to poor biocompatibility or mechanical properties and adverse reactions. The small intestinal submucosa (SIS) is a promising material used in a variety of applications. Based on the limitations of previous studies, we conducted an animal study to evaluate the efficacy and safety of the SIS in preclinical trials. Twenty-four male beagle dogs were subjected to surgical resection to produce dural defects. SIS or autologous dural mater was patched on the dural defect. Gross and histological evaluations were carried out to evaluate the efficacy and safety of the therapy. Our findings demonstrated that the SIS, which stimulated connective and epithelial tissue responses for dural regeneration and functional recovery without immunological rejection, could provide prolonged defect repair and prevent complications. The mechanical properties of the SIS could be adjusted by application of multiple layers, and the biocompatibility of the material was appropriate. Thus, our data suggested that this material may represent an alternative option for clinical treatment of dural defects. - Highlights: • SIS stimulates dura regeneration without immunological rejection. • SIS has adjustable mechanical properties and appropriate biocompatibility. • SIS may be an effective alternative option for clinical treatment of dural defects.

  14. Efficacy and safety of tofacitinib in older and younger patients with rheumatoid arthritis.

    Science.gov (United States)

    Curtis, Jeffrey R; Schulze-Koops, Hendrik; Takiya, Liza; Mebus, Charles A; Terry, Ketti K; Biswas, Pinaki; Jones, Thomas V

    2017-01-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the efficacy and safety of tofacitinib 5 or 10 mg twice daily (BID), in patients with moderate to severe RA, aged ≥65 and tofacitinib, or placebo (Phase 3 only), with/without conventional synthetic DMARDs (mainly methotrexate). Clinical efficacy outcomes from Phase 3 studies were evaluated at Month 3. Safety evaluations using pooled Phase 3 data (Month 12) and pooled LTE data (Month 24) compared exposure-adjusted incidence rates (IRs; with 95% confidence intervals [CIs]), in older versus younger patients. In Phase 3 and LTE studies, 15.3% (475/3111) and 16.1% (661/4102) of patients, respectively, were aged ≥65 years. Consequently, exposure to tofacitinib was lower in older versus younger patients in Phase 3 (259.2 vs. 1554.9 patient years [pt-yrs]) and LTE (962.1 vs. 5071.7 pt-yrs) studies. Probability ratios for ACR responses and HAQ-DI improvement from baseline ≥0.22 (Month 3) favoured tofacitinib and were similar in older and younger patients, with overlapping CIs. IRs for SAEs and discontinuations due to AEs were generally numerically higher in older versus younger patients, irrespective of treatment. Older patients receiving tofacitinib 5 or 10 mg BID had a similar probability of ACR20 or ACR50 response and, due to comorbidities, a numerically higher risk of SAEs and discontinuations due to AEs compared with younger patients.

  15. The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

    Science.gov (United States)

    Meier, Brian P; Lappas, Courtney M

    2016-11-01

    Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

  16. Security for safety critical space borne systems

    Science.gov (United States)

    Legrand, Sue

    1987-01-01

    The Space Station contains safety critical computer software components in systems that can affect life and vital property. These components require a multilevel secure system that provides dynamic access control of the data and processes involved. A study is under way to define requirements for a security model providing access control through level B3 of the Orange Book. The model will be prototyped at NASA-Johnson Space Center.

  17. National and foreign research of Anaferon Kid: efficacy, safety and experience of application (review

    Directory of Open Access Journals (Sweden)

    Yu. V. Lobzin

    2015-01-01

    Full Text Available Interest in acute respiratory viral infections (ARVI in children does not tend to decrease and is determined by their high prevalence, relatedness to «uncontrollable infections» in most cases and presence of age limits in the use of antiviral drugs. Presently, focus on the use of national drugs is made in the RF clinical practice. An innovative drug Anaferon for children was developed by the Russian pharmaceutical company OOO «NPF «Materia Medica Holding» and registered in Russia in 2002.The summary purpose is to classify and analyze national and international publications on the results of non-clinical and clinical investigation of Anaferon for children efficacy and safety in ARVI and other viral infections.Study method: exploratory and analytical.Results: the summary presents the data of non-clinical studies justifying the drug mechanism of action at molecular level ensuring its combined antiviral and immunomodulating efficacy. The results obtained in the experiment were verified by clinical studies and are reflected in numerous scientific publications including international ones. The summary contains analysis of the results of clinical studies of the drug in children with ARVI including influenza. Anaferon for children was found to reduce duration of the main clinical symptoms of ARVI and influenza, incidence of bacterial complications, it is well-tolerated and has high safety profile. The open-label randomized comparative study of Anaferon for children efficacy and safety vs. Oseltamivir in influenza demonstrated clinical efficacy of these drugs. Numerous publications evidence that Anaferon for children exerts antiviral effect against most viruses causing acute respiratory viral infections as well as herpes viruses, viruses causing intestinal infections and tick-borne encephalitis. The list of scientific publications on the drug consists of approximately 800 references including more than 50 articles in

  18. Safety and efficacy of extracorporeal shock wave myocardial revascularization therapy for refractory angina pectoris.

    Science.gov (United States)

    Cassar, Andrew; Prasad, Megha; Rodriguez-Porcel, Martin; Reeder, Guy S; Karia, Darshak; DeMaria, Anthony N; Lerman, Amir

    2014-03-01

    To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires. Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10). In this multicenter feasibility

  19. Using system dynamics simulation for assessment of hydropower system safety

    Science.gov (United States)

    King, L. M.; Simonovic, S. P.; Hartford, D. N. D.

    2017-08-01

    Hydropower infrastructure systems are complex, high consequence structures which must be operated safely to avoid catastrophic impacts to human life, the environment, and the economy. Dam safety practitioners must have an in-depth understanding of how these systems function under various operating conditions in order to ensure the appropriate measures are taken to reduce system vulnerability. Simulation of system operating conditions allows modelers to investigate system performance from the beginning of an undesirable event to full system recovery. System dynamics simulation facilitates the modeling of dynamic interactions among complex arrangements of system components, providing outputs of system performance that can be used to quantify safety. This paper presents the framework for a modeling approach that can be used to simulate a range of potential operating conditions for a hydropower infrastructure system. Details of the generic hydropower infrastructure system simulation model are provided. A case study is used to evaluate system outcomes in response to a particular earthquake scenario, with two system safety performance measures shown. Results indicate that the simulation model is able to estimate potential measures of system safety which relate to flow conveyance and flow retention. A comparison of operational and upgrade strategies is shown to demonstrate the utility of the model for comparing various operational response strategies, capital upgrade alternatives, and maintenance regimes. Results show that seismic upgrades to the spillway gates provide the largest improvement in system performance for the system and scenario of interest.

  20. Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Geng H

    2017-03-01

    Full Text Available Hua Geng, Chengzhong Wang Department of Pediatrics, Maternal and Child Health Hospital of Yancheng, Yancheng City, People’s Republic of China Background: To assess the efficacy and safety of oxcarbazepine (OXC in the treatment of children with epilepsy.Methods: Randomized controlled trials (RCTs published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China, and Chinese National Knowledge Infrastructure (China database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR with 95% confidence intervals (95% CIs was calculated using fixed-effects or random-effects model.Results: Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo, OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P=0.366 and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P=0.310; for 50%–75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P=0.301; for <50% reduction: RR =0.79, 95% CI: 0.56, 1.12; P=0.179. Moreover, patients treated with OXC had a comparable incidence of adverse events compared with those treated with other antiepileptic drugs (RR =1.01, 95% CI: 0.92, 1.11; P=0.760.Conclusion: OXC showed similar effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings. Keywords: epilepsy, children, oxcarbazepine, meta-analysis

  1. The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing

    Directory of Open Access Journals (Sweden)

    Romil Parikh

    2016-09-01

    Full Text Available BackgroundSome of the relatively newer, more efficacious, and potent topical wound dressing solutions include tetrachlorodecaoxide and super-oxidised solution. This study compares the efficacy and safety of these two drugs.MethodsThis is a block-randomised, double blind, parallel-arm, post-marketing study. One hundred fifty patients with ulcers (75 blocks uniform for sex, ulcer aetiology, diabetes mellitus, and wound area score were randomised into the two treatment arms. Patients were observed for eight weeks with weekly assessments. One hundred and twenty patients completed the study. Wound healing was objectively assessed by measurement of wound area, scoring of wound exudation and tissue type, and using the pressure ulcer scale of healing Tool (validated for multiple wound aetiologies. Subjective improvement in pain was noted using a visual analogue scale. Both groups were compared using Mann–Whitney U test on all indicators.ResultsDifference in change in wound tissue type in the two groups was significant (α=0.05 by intention-to-treat (ITT and per-protocol (PP analysis at the end of week two (ITT and PP, P0.05. No study-related adverse events were observed.ConclusionsBoth drugs are efficacious. Tetrachlorodecaoxide yields healthy granulation tissue earlier. Both drugs appear to be safe for application.

  2. Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients

    International Nuclear Information System (INIS)

    Ming-Lin Ho; Chih-Yuan Chung

    2010-01-01

    We evaluated the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablet, for the treatment of breakthrough pain in cancer patients. This study was conducted at Changhua Christian Hospital, Changhua, Taiwan from January 2006 to February 2007. The single-center and open-label study enrolled 59 opioid-treated cancer patients with at least moderate breakthrough pain (visual analog scale [VAS] score >/=40mm on a 100-mm scale). The efficacy measures included VAS scores and adverse effect assessment 10, 30, and 60 minutes after the administration of tramadol/acetaminophen. Visual analog scale score at time of pain relief was reported. The mean VAS score when the breakthrough pain episode began (0 minute) was 77.8. Analysis showed significant better mean pain VAS scores at 10, 30, and 60 minutes after the administration of tramadol/acetaminophen (p Tramadol/acetaminophen might be efficacious and safe in the treatment of breakthrough pain in cancer (Author).

  3. Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients.

    Science.gov (United States)

    Ho, Ming-Lin; Chung, Chih-Yuan; Wang, Chuan-Cheng; Lin, Hsuan-Yu; Hsu, Nicholas C; Chang, Cheng-Shyong

    2010-12-01

    We evaluated the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablet, for the treatment of breakthrough pain in cancer patients. This study was conducted at Changhua Christian Hospital, Changhua, Taiwan from January 2006 to February 2007. The single-center and open-label study enrolled 59 opioid-treated cancer patients with at least moderate breakthrough pain (visual analog scale [VAS] score ≥40mm on a 100-mm scale). The efficacy measures included VAS scores and adverse effect assessment 10, 30, and 60 minutes after the administration of tramadol/acetaminophen. Visual analog scale score at time of pain relief was reported. The mean VAS score when the breakthrough pain episode began (0 minute) was 77.8. Analysis showed significant better mean pain VAS scores at 10, 30, and 60 minutes after the administration of tramadol/acetaminophen (p≤0.001 versus 0 min for all 3 time points). The mean time to pain relief was 597.2 seconds and the mean VAS score at time of relief was 43.4. The effective rates, defined by more than 30% reduction of the VAS score, after 10 minutes of administration was 74.6%, 30 minutes 86.4%, and one hour 94.9% (p≤0.001 versus 0 minute for all 3 time points). Two cases of drowsiness were reported. Tramadol/acetaminophen might be efficacious and safe in the treatment of breakthrough pain in cancer.

  4. American rural women's exercise self-efficacy and awareness of exercise benefits and safety during pregnancy.

    Science.gov (United States)

    Melton, Bridget; Marshall, Elaine; Bland, Helen; Schmidt, Michael; Guion, W Kent

    2013-12-01

    Though the positive link between physical activity and maternal health is well documented, physical activity declines during pregnancy and, internationally, rural mothers are less likely than urban mothers to engage in physical activity. Some evidence suggests that self-efficacy is related to sustained engagement in physical activity. The purpose of this study was to examine self-efficacy, perceived benefits, and knowledge of safe exercise among 88 rural pregnant women in a southeastern region of the United States. Exercise self-efficacy was significantly related to maternal age and gestation. Women over age 26 years, and those in the second and third trimesters, scored significantly higher than younger women or those in the first trimester. Fifty-two percent (n = 46) of participants perceived that activity would decrease energy levels, 37.5% (n = 33) did not know that exercise can decrease the risk of gestational diabetes, and 47.6% (n = 41) were unaware that a mother who is overweight is more likely to have an overweight child. Results confirm a need for education to improve women's knowledge about health benefits and safety information related to physical activity during pregnancy. © 2013 Wiley Publishing Asia Pty Ltd.

  5. Systematic Review on the Efficacy and Safety of Herbal Medicines for Vascular Dementia

    Directory of Open Access Journals (Sweden)

    Sui Cheung Man

    2012-01-01

    Full Text Available We present a systematic review of existing research that aims to assess the efficacy and safety of herbal medications (HM, as either monotherapy or adjunct to orthodox medications (OM, mainly comprised of cholinesterase inhibitors, for vascular dementia (VaD. We included 47 studies conducted in mainland China, each testing different HM. Of 43 HM monotherapy studies, 37 reported HM to be significantly better than OM or placebo; six reported similar efficacy between HM and OM. All four HM adjuvant studies reported significant efficacy. No major adverse events for HM were reported. Heterogeneity in diagnostic criteria, interventions and outcome measures hindered comprehensive data analysis. Studies suggested that HM can be a safe and effective treatment for VaD, either alone or in conjunction with OM. However, methodological flaws in the design of the studies limited the extent to which the results could be interpreted. Thirty most commonly used herbal constituents, including Rhizoma Chuanxiong (Chuanxiong in Chinese, Radix Polygoni Multiflori (Heshouwu in Chinese and Radix Astragali (Huangqi in Chinese. were ranked. Further multi-center trials with large sample sizes, high methodological quality and standardized HM ingredients are necessary for clinical recommendations to be made.

  6. Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

    Science.gov (United States)

    Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

    2017-10-01

    Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65

  7. Instrumentation and control systems important to safety in nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    This Safety Guide was prepared under the IAEA programme for establishing safety standards for nuclear power plants. It supplements Safety Standards Series No. NS-R-1: Safety of Nuclear Power Plants: Design (the Requirements for Design), which establishes the design requirements for ensuring the safety of nuclear power plants. This Safety Guide describes how the requirements should be met for instrumentation and control (I and C) systems important to safety. This publication is a revision and combination of two previous Safety Guides: Safety Series Nos 50-SG-D3 and 50-SG-D8, which are superseded by this new Safety Guide. The revision takes account of developments in I and C systems important to safety since the earlier Safety Guides were published in 1980 and 1984, respectively. The objective of this Safety Guide is to provide guidance on the design of I and C systems important to safety in nuclear power plants, including all I and C components, from the sensors allocated to the mechanical systems to the actuated equipment, operator interfaces and auxiliary equipment. This Safety Guide deals mainly with design requirements for those I and C systems that are important to safety. It expands on paragraphs of Ref in the area of I and C systems important to safety. This publication is intended for use primarily by designers of nuclear power plants and also by owners and/or operators and regulators of nuclear power plants. This Safety Guide provides general guidance on I and C systems important to safety which is broadly applicable to many nuclear power plants. More detailed requirements and limitations for safe operation specific to a particular plant type should be established as part of the design process. The present guidance is focused on the design principles for systems important to safety that warrant particular attention, and should be applied to both the design of new I and C systems and the modernization of existing systems. Guidance is provided on how design

  8. Nebulized formoterol: a review of clinical efficacy and safety in COPD

    Directory of Open Access Journals (Sweden)

    Nicholas J Gross

    2010-06-01

    Full Text Available Nicholas J Gross1, James F Donohue21Hines VA Hospital, Stritch Loyola School of Medicine, Hines, IL, USA; 2University of North Carolina School of Medicine, Chapel Hill, NC, USAAbstract: A nebulized formulation of formoterol, Perforomist®, 20 μg/2 ml, has been available since 2007 for the maintenance treatment of chronic obstructive pulmonary disease (COPD. We review the safety and efficacy data obtained during its development. In a dose-finding study, formoterol inhalation solution (FFIS was similar to the formoterol originator, Foradil® 12 μg DPI (FA in patients with COPD. In a 12-week efficacy study, FFIS manifested a rapid onset of action and FEV1 peak, AUC0–12, and trough levels similar to FA. No loss of efficacy, tachyphylaxis, was observed over 12 weeks of regular administration. In placebo-controlled studies in COPD patients receiving maintenance tiotropium, the addition of FFIS significantly augmented bronchodilation over the 6-week treatment duration, signifying that nebulized formoterol can further improve lung function in patients who are receiving tiotropium without an observed increase in adverse reactions. The safety profile of FFIS during 12-week and 1-year studies revealed adverse events that were similar to those of placebo and FA. Cardiac rhythm studies, including frequent ECGs and Holter monitoring, did not indicate any increase in rate or rhythm disturbances greater than placebo or FA. We conclude that maintenance use of Perforomist® is appropriate for patients with COPD who require or prefer a nebulizer for management of their disease.Keywords: long-acting bronchodilator, β-agonist, chronic bronchitis, pulmonary emphysema, Perforomist®, chronic obstructive pulmonary disease

  9. Exposure-safety and efficacy response relationships and population pharmacokinetics of eslicarbazepine acetate.

    Science.gov (United States)

    Gidal, B E; Jacobson, M P; Ben-Menachem, E; Carreño, M; Blum, D; Soares-da-Silva, P; Falcão, A; Rocha, F; Moreira, J; Grinnell, T; Ludwig, E; Fiedler-Kelly, J; Passarell, J; Sunkaraneni, S

    2018-05-06

    Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) for focal-onset seizures (FOS). Pharmacokinetic (PK) and pharmacodynamic (PD) models were developed to assess dose selection, identify significant AED drug interactions, and quantitate relationships between exposure and safety and efficacy outcomes from Phase 3 trials of adjunctive ESL. Eslicarbazepine (the primary active metabolite of ESL) population PK was evaluated using data from 1351 subjects enrolled in 14 studies (11 Phase 1 and three Phase 3 studies) after multiple oral doses ranging from 400 to 1200 mg. Population PK and PD models related individual eslicarbazepine exposures to safety outcomes and efficacy responses. Eslicarbazepine PK was described by a one-compartment model with linear absorption and elimination. The probability of a treatment-emergent adverse event (TEAE; dizziness, headache, or somnolence) was higher with an initial dose of ESL 800 mg than with an initial dose of ESL 400 mg QD. Body weight, sex, region, and baseline use of carbamazepine (CBZ) or lamotrigine were also found to influence the probability of TEAEs. Eslicarbazepine exposure influenced serum sodium concentration, standardized seizure frequency, and probability of response; better efficacy outcomes were predicted in patients not from Western Europe (WE; vs WE patients) and those not taking CBZ (vs taking CBZ) at baseline. Pharmacokinetic and PK/PD modeling were implemented during the development of ESL for adjunctive treatment of FOS in adults. This quantitative approach supported decision-making during the development of ESL, and contributed to dosing recommendations and labeling information related to drug interactions. © 2018 The Authors. Acta Neurologica Scandinavica Published by John Wiley & Sons Ltd.

  10. Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.

    Science.gov (United States)

    Upadhyaya, Himanshu; Kratochvil, Christopher; Ghuman, Jaswinder; Camporeale, Angelo; Lipsius, Sarah; D'Souza, Deborah; Tanaka, Yoko

    2015-12-01

    This extrapolation analysis qualitatively compared the efficacy and safety profile of atomoxetine from Lilly clinical trial data in 6-7-year-old patients with attention-deficit/hyperactivity disorder (ADHD) with that of published literature in 4-5-year-old patients with ADHD (two open-label [4-5-year-old patients] and one placebo-controlled study [5-year-old patients]). The main efficacy analyses included placebo-controlled Lilly data and the placebo-controlled external study (5-year-old patients) data. The primary efficacy variables used in these studies were the ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent:Inv) total score, or the Swanson, Nolan and Pelham (SNAP-IV) scale score. Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs. Descriptive statistics (means, percentages) are presented. Acute atomoxetine treatment improved core ADHD symptoms in both 6-7-year-old patients (n=565) and 5-year-old patients (n=37) (treatment effect: -10.16 and -7.42). In an analysis of placebo-controlled groups, the mean duration of exposure to atomoxetine was ∼ 7 weeks for 6-7-year-old patients and 9 weeks for 5-year-old patients. Decreased appetite was the most common TEAE in atomoxetine-treated patients. The TEAEs observed at a higher rate in 5-year-old versus 6-7-year-old patients were irritability (36.8% vs. 3.6%) and other mood-related events (6.9% each vs. atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients.

  11. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    LENUS (Irish Health Repository)

    Ní Ainle, Fionnuala

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU\\/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU\\/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered

  12. Efficacy and safety of CPAP in low- and middle-income countries.

    Science.gov (United States)

    Thukral, A; Sankar, M J; Chandrasekaran, A; Agarwal, R; Paul, V K

    2016-05-01

    We conducted a systematic review to evaluate the (1) feasibility and efficacy and (2) safety and cost effectiveness of continuous positive airway pressure (CPAP) therapy in low- and middle-income countries (LMIC). We searched the following electronic bibliographic databases-MEDLINE, Cochrane CENTRAL, CINAHL, EMBASE and WHOLIS-up to December 2014 and included all studies that enrolled neonates requiring CPAP therapy for any indication. We did not find any randomized trials from LMICs that have evaluated the efficacy of CPAP therapy. Pooled analysis of four observational studies showed 66% reduction in in-hospital mortality following CPAP in preterm neonates (odds ratio 0.34, 95% confidence interval (CI) 0.14 to 0.82). One study reported 50% reduction in the need for mechanical ventilation following the introduction of bubble CPAP (relative risk 0.5, 95% CI 0.37 to 0.66). The proportion of neonates who failed CPAP and required mechanical ventilation varied from 20 to 40% (eight studies). The incidence of air leaks varied from 0 to 7.2% (nine studies). One study reported a significant reduction in the cost of surfactant usage with the introduction of CPAP. Available evidence suggests that CPAP is a safe and effective mode of therapy in preterm neonates with respiratory distress in LMICs. It reduces the in-hospital mortality and the need for ventilation thereby minimizing the need for up-transfer to a referral hospital. But given the overall paucity of studies and the low quality evidence underscores the need for large high-quality studies on the safety, efficacy and cost effectiveness of CPAP therapy in these settings.

  13. Field study on the safety and efficacy of intradermal versus intramuscular vaccination against Mycoplasma hyopneumoniae.

    Science.gov (United States)

    Beffort, Lisa; Weiß, Christine; Fiebig, Kerstin; Jolie, Rika; Ritzmann, Mathias; Eddicks, Matthias

    2017-09-30

    The present study compares the safety and efficacy of a needle-free, intradermal Mycoplasma hyopneumoniae vaccine to an intramuscular one. 420 piglets (21+3 days of age) were randomly assigned to two vaccination groups (intradermal vaccination V1 (n=138), intramuscular vaccination V2 (n=144)) and one unvaccinated control group (CG, n=138). As safety parameters clinical observations, local injection site reactions (ISR) and rectal temperatures were assessed. Average daily weight gain (ADWG) and pneumonic lung lesions (LL) were measured as efficacy parameters. ISRs were minor in V1. After both vaccinations, no adverse impact on appetite was observed and mean rectal temperatures remained within physiological range. ADWG during the fattening period was significantly higher in vaccinated groups (V1: 913.4 g, V2: 924.5 g) compared with CG (875.6 g). No differences in ADWG were observed between V1 and V2. Vaccinated pigs had a significantly reduced mean extent of LL compared with CG. V1 was superior in reducing the extent and prevalence of LL compared with V2. These results reveal that a needle-free intradermal vaccination is safe and efficacious in reducing both the prevalence and extent of lung lesions, as well as in improving performance parameters, in a farrow-to-finish farm with a late onset of M hyopneumonia e infection. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin.

    Science.gov (United States)

    Dabrowski, Edward; Bonikowski, Marcin; Gormley, Mark; Volteau, Magali; Picaut, Philippe; Delgado, Mauricio R

    2018-05-01

    The effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous injections has remained largely unexplored. We present subgroup analyses of a phase III study conducted in ambulatory children (aged two to 17) with spastic equinus foot. Patients were randomized to single doses of abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injected into the gastrocnemius-soleus complex (one or both legs). The first analysis was prespecified to review the effect of abobotulinumtoxinA in children previously treated with botulinum toxin versus those children new to the treatment; a second post hoc analysis evaluated the effect of abobotulinumtoxinA in children who changed botulinum toxin formulation. Of the 241 randomized patients, 113 had previously received botulinum toxin, including 86 who had been treated with another formulation. In both analyses, muscle tone (Modified Ashworth Scale) and the Physicians Global Assessment, at week 4, improved with abobotulinumtoxinA treatment versus placebo, regardless of baseline botulinum toxin status. Placebo responses in patients new to treatment were consistently higher than in the previously treated group. These results demonstrate similar abobotulinumtoxinA efficacy and safety profiles in children with spasticity who are new to botulinum toxin treatment and those children who were previously treated. The efficacy and safety of abobotulinumtoxinA treatment in these previously treated patients were comparable with the overall trial population, indicating that doses of 10 and 15 U/kg/leg are suitable starting doses for children with spasticity regardless of the previous botulinum toxin preparation used. Copyright © 2018 Elsevier Inc. All rights reserved.

  15. Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis.

    Science.gov (United States)

    Mei, Changlin; Chen, Nan; Ding, Xiaoqiang; Yu, Xueqing; Wang, Li; Qian, Jiaqi; Wang, Mei; Jiang, Gengru; Li, Xuemei; Hou, Fanfan; Zuo, Li; Wang, Niansong; Liu, Hong

    2016-10-01

    Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels. © 2016 International Society for Hemodialysis.

  16. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery.

    Science.gov (United States)

    Lin, Zilan X; Woolf, Shane K

    2016-01-01

    Perioperative bleeding and postsurgical hemorrhage are common in invasive surgical procedures, including orthopedic surgery. Tranexamic acid (TXA) is a pharmacologic agent that acts through an antifibrinolytic mechanism to stabilize formed clots and reduce active bleeding. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in total hip and knee arthroplasty and spine surgery. Numerous research studies have reported favorable safety and efficacy in orthopedic cases, although there is no universal standard on its administration and its use has not yet become the standard of practice. Reported administration methods often depend on the surgeon's preference, with both topical and intravenous routes showing efficacy. The type and anatomic site of the surgery seem to influence the decision making but also result in conflicting opinions. Reported complication rates with TXA use are low. The incidence of both arterial and venous thromboembolic events, particularly deep venous thrombosis and pulmonary embolism, has not been found to be significantly different with TXA use for healthy patients. The route of administration and dosage do not appear to affect complication rates either. However, data on patients with higher-risk conditions are deficient. In addition, TXA has shown potential to reduce blood loss, transfusion rates and volumes, perioperative hemoglobin change, and hospital-related costs at various degrees among the published studies. Conservation of blood products, reduced laboratory costs, and shorter hospital stays are likely the major factors driving the cost savings associated with TXA use. This article reviews current data supporting the safety, efficacy, and cost-effectiveness of TXA in orthopedic surgery. Copyright 2016, SLACK Incorporated.

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

    Directory of Open Access Journals (Sweden)

    Moataz Alhaj

    2016-01-01

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

  18. Safety of the medical gas pipeline system

    Directory of Open Access Journals (Sweden)

    Sushmita Sarangi

    2018-01-01

    Full Text Available Medical gases are nowadays being used for a number of diverse clinical applications and its piped delivery is a landmark achievement in the field of patient care. Patient safety is of paramount importance in the design, installation, commissioning, and operation of medical gas pipeline systems (MGPS. The system has to be operational round the clock, with practically zero downtime and its failure can be fatal if not restored at the earliest. There is a lack of awareness among the clinicians regarding the medico-legal aspect involved with the MGPS. It is a highly technical field; hence, an in-depth knowledge is a must to ensure safety with the system.

  19. ACP Facility Safety Surveillance System Installation

    International Nuclear Information System (INIS)

    You, Gil Sung; Kook, D. H.; Choung, W. M.; Ku, J. H.; Cho, I. J.; You, G. S.; Kwon, K. C.; Lee, W. K.; Lee, E. P.

    2006-10-01

    The Advanced spent fuel Conditioning Process is under development for effective management of spent fuel by converting UO 2 into U-metal. For demonstration of this process, α-γ type new hotcell was built in the IMEF basement. All facilities which treat radioactive materials must manage CCTV system which is under control of Health Physics department. Three main points (including hotcell rear door area) have each camera, but operators who are in charge of facility management need to check the safety of the facility immediately through the network in his office. This needs introduce additional network cameras installation and this new surveillance system is expected to update the whole safety control ability with existing system

  20. Reactor safety: the Nova computer system

    International Nuclear Information System (INIS)

    Eisgruber, H.; Stadelmann, W.

    1991-01-01

    After instances of maloperation, the causes of defects, the effectiveness of the measures taken to control the situation, and possibilities to avoid future recurrences need to be investigated above all before the plant is restarted. The most important aspect in all these efforts is to check the sequence in time, and the completeness, of the control measures initiated automatically. For this verification, a computer system is used instead of time-consuming manual analytical techniques, which produces the necessary information almost in real time. The results are available within minutes after completion of the measures initiated automatically. As all short-term safety functions are initiated by automatic systems, their consistent and comprehensive verification results in a clearly higher level of safety. The report covers the development of the computer system, and its implementation, in the Gundremmingen nuclear power station. Similar plans are being pursued in Biblis and Muelheim-Kaerlich. (orig.) [de

  1. The NASA Aviation Safety Reporting System

    Science.gov (United States)

    1983-01-01

    This is the fourteenth in a series of reports based on safety-related incidents submitted to the NASA Aviation Safety Reporting System by pilots, controllers, and, occasionally, other participants in the National Aviation System (refs. 1-13). ASRS operates under a memorandum of agreement between the National Aviation and Space Administration and the Federal Aviation Administration. The report contains, first, a special study prepared by the ASRS Office Staff, of pilot- and controller-submitted reports related to the perceived operation of the ATC system since the 1981 walkout of the controllers' labor organization. Next is a research paper analyzing incidents occurring while single-pilot crews were conducting IFR flights. A third section presents a selection of Alert Bulletins issued by ASRS, with the responses they have elicited from FAA and others concerned. Finally, the report contains a list of publications produced by ASRS with instructions for obtaining them.

  2. A randomized trial of telemedicine efficacy and safety for nonacute headaches.

    Science.gov (United States)

    Müller, Kai I; Alstadhaug, Karl B; Bekkelund, Svein I

    2017-07-11

    To evaluate long-term treatment efficacy and safety of one-time telemedicine consultations for nonacute headaches. We randomized, allocated, and consulted nonacute headache patients via telemedicine (n = 200) or in a traditional manner (n = 202) in a noninferiority trial. Efficacy endpoints, assessed by questionnaires at 3 and 12 months, included change from baseline in Headache Impact Test-6 (HIT-6) (primary endpoint) and pain intensity (visual analogue scale [VAS]) (secondary endpoint). The primary safety endpoint, assessed via patient records, was presence of secondary headache within 12 months after consultation. We found no differences between telemedicine and traditional consultations in HIT-6 ( p = 0.84) or VAS ( p = 0.64) over 3 periods. The absolute difference in HIT-6 from baseline was 0.3 (95% confidence interval [CI] -1.26 to 1.82, p = 0.72) at 3 months and 0.2 (95% CI -1.98 to 1.58, p = 0.83) at 12 months. The absolute change in VAS was 0.4 (95% CI -0.93 to 0.22, p = 0.23) after 3 months and 0.3 (95% CI -0.94 to 0.29, p = 0.30) at 12 months. We found one secondary headache in each group at 12 months. The estimated number of consultations needed to miss one secondary headache with the use of telemedicine was 20,200. Telemedicine consultation for nonacute headache is as efficient and safe as a traditional consultation. NCT02270177. This study provides Class III evidence that a one-time telemedicine consultation for nonacute headache is noninferior to a one-time traditional consultation regarding long-term treatment outcome and safety. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  3. Passive safety systems for integral reactors

    International Nuclear Information System (INIS)

    Kuul, V.S.; Samoilov, O.B.

    1996-01-01

    In this paper, a wide range of passive safety systems intended for use on integral reactors is considered. The operation of these systems relies on natural processes and does not require external power supplies. Using these systems, there is the possibility of preventing serious consequences for all classes of accidents including reactivity, loss-of-coolant and loss of heat sink as well as severe accidents. Enhancement of safety system reliability has been achieved through the use of self-actuating devices, capable of providing passive initiation of protective and isolation systems, which respond immediately to variations in the physical parameters of the fluid in the reactor or in a guard vessel. For beyond design base accidents accompanied by complete loss of heat removal capability, autonomous self-actuated ERHR trains have been proposed. These trains are completely independent of the secondary loops and need no action to isolate them from the steam turbine plant. Passive safety principles have been consistently implemented in AST-500, ATETS-200 and VPBER 600 which are new generation NPPs developed by OKBM. Their main characteristic is enhanced stability over a wide range of internal and external emergency initiators. (author). 10 figs

  4. Passive safety systems for integral reactors

    Energy Technology Data Exchange (ETDEWEB)

    Kuul, V S; Samoilov, O B [OKB Mechanical Engineering (Russian Federation)

    1996-12-01

    In this paper, a wide range of passive safety systems intended for use on integral reactors is considered. The operation of these systems relies on natural processes and does not require external power supplies. Using these systems, there is the possibility of preventing serious consequences for all classes of accidents including reactivity, loss-of-coolant and loss of heat sink as well as severe accidents. Enhancement of safety system reliability has been achieved through the use of self-actuating devices, capable of providing passive initiation of protective and isolation systems, which respond immediately to variations in the physical parameters of the fluid in the reactor or in a guard vessel. For beyond design base accidents accompanied by complete loss of heat removal capability, autonomous self-actuated ERHR trains have been proposed. These trains are completely independent of the secondary loops and need no action to isolate them from the steam turbine plant. Passive safety principles have been consistently implemented in AST-500, ATETS-200 and VPBER 600 which are new generation NPPs developed by OKBM. Their main characteristic is enhanced stability over a wide range of internal and external emergency initiators. (author). 10 figs.

  5. Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.

    Science.gov (United States)

    Phua, Kong Boo; Lim, Fong Seng; Quak, Seng Hock; Lee, Bee Wah; Teoh, Yee Leong; Suryakiran, Pemmaraju V; Han, Htay Htay; Bock, Hans L

    2016-02-01

    This was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life. Healthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed. Of 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups. Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.

  6. A Methodological Framework for Software Safety in Safety Critical Computer Systems

    OpenAIRE

    P. V. Srinivas Acharyulu; P. Seetharamaiah

    2012-01-01

    Software safety must deal with the principles of safety management, safety engineering and software engineering for developing safety-critical computer systems, with the target of making the system safe, risk-free and fail-safe in addition to provide a clarified differentaition for assessing and evaluating the risk, with the principles of software risk management. Problem statement: Prevailing software quality models, standards were not subsisting in adequately addressing the software safety ...

  7. Industrial Personal Computer based Display for Nuclear Safety System

    International Nuclear Information System (INIS)

    Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min

    2014-01-01

    The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view

  8. Industrial Personal Computer based Display for Nuclear Safety System

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Ji Hyeon; Kim, Aram; Jo, Jung Hee; Kim, Ki Beom; Cheon, Sung Hyun; Cho, Joo Hyun; Sohn, Se Do; Baek, Seung Min [KEPCO, Youngin (Korea, Republic of)

    2014-08-15

    The safety display of nuclear system has been classified as important to safety (SIL:Safety Integrity Level 3). These days the regulatory agencies are imposing more strict safety requirements for digital safety display system. To satisfy these requirements, it is necessary to develop a safety-critical (SIL 4) grade safety display system. This paper proposes industrial personal computer based safety display system with safety grade operating system and safety grade display methods. The description consists of three parts, the background, the safety requirements and the proposed safety display system design. The hardware platform is designed using commercially available off-the-shelf processor board with back plane bus. The operating system is customized for nuclear safety display application. The display unit is designed adopting two improvement features, i.e., one is to provide two separate processors for main computer and display device using serial communication, and the other is to use Digital Visual Interface between main computer and display device. In this case the main computer uses minimized graphic functions for safety display. The display design is at the conceptual phase, and there are several open areas to be concreted for a solid system. The main purpose of this paper is to describe and suggest a methodology to develop a safety-critical display system and the descriptions are focused on the safety requirement point of view.

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

    Science.gov (United States)

    Lousberg, Laurence; Jerusalem, Guy

    2016-01-01

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

  10. Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

    OpenAIRE

    Ueda, Takeshi; Uemura, Hirotsugu; Tomita, Yoshihiko; Tsukamoto, Taiji; Kanayama, Hiroomi; Shinohara, Nobuo; Tarazi, Jamal; Chen, Connie; Kim, Sinil; Ozono, Seiichiro; Naito, Seiji; Akaza, Hideyuki

    2013-01-01

    Objective Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated. Methods A subgroup analysis was conducted in Japanese patients enrolled in the randomized Phase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma. Results Twenty-five (of 361) and 29 (o...

  11. Does the concept of safety culture help or hinder systems thinking in safety?

    Science.gov (United States)

    Reiman, Teemu; Rollenhagen, Carl

    2014-07-01

    The concept of safety culture has become established in safety management applications in all major safety-critical domains. The idea that safety culture somehow represents a "systemic view" on safety is seldom explicitly spoken out, but nevertheless seem to linger behind many safety culture discourses. However, in this paper we argue that the "new" contribution to safety management from safety culture never really became integrated with classical engineering principles and concepts. This integration would have been necessary for the development of a more genuine systems-oriented view on safety; e.g. a conception of safety in which human, technological, organisational and cultural factors are understood as mutually interacting elements. Without of this integration, researchers and the users of the various tools and methods associated with safety culture have sometimes fostered a belief that "safety culture" in fact represents such a systemic view about safety. This belief is, however, not backed up by theoretical or empirical evidence. It is true that safety culture, at least in some sense, represents a holistic term-a totality of factors that include human, organisational and technological aspects. However, the departure for such safety culture models is still human and organisational factors rather than technology (or safety) itself. The aim of this paper is to critically review the various uses of the concept of safety culture as representing a systemic view on safety. The article will take a look at the concepts of culture and safety culture based on previous studies, and outlines in more detail the theoretical challenges in safety culture as a systems concept. The paper also presents recommendations on how to make safety culture more systemic. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety management of radiation workers in medical institutions

    International Nuclear Information System (INIS)

    Han, Eun Ok

    2007-01-01

    Radiation safety managements in medical institutions are needed to protect certain radiation damages as a part of National Coalition. This study investigates the characteristics of self-efficacy that become the major factor on the knowledge, attitude, and behavior on the radiation safety management of radiation workers as an approach of educational aspects and analyzes the relationship between such factors to provide basic materials for improving the activity level of radiation safety managements. In order to implement the goal of this study, a survey was performed for 1,200 workers who were engaged in radiation treatments in medical centers, such as general hospital, university hospital, private hospital, and public health center for 42 days from July 23, 2006. Then, the results of the analysis can be summarized as follows: 1. Average scores on knowledge, attitude, and behavior in the radiation safety management were presented as 75.76±11.20, 90.55±8.59, 80.58±11.70, respectively. Also, the average score of self-efficacy was recorded as 73.55±9.82. 2. Knowledge levels in the radiation safety management showed significant differences according to the sex, age, marriage, education, and experience. Also, males of married, older, highly educated, and largely experienced represented high knowledge levels. Attitude levels in the radiation safety management showed certain significant differences according to the type of medical centers in which private hospitals showed a relatively low level compared to that of high levels in university hospitals. Behavior levels in the radiation safety management also represented significant differences according to the age, marriage, education, experience, and types of medical centers. Factors in married, general hospital, older, highly educated, and largely experienced showed high behavior levels. In addition, the self-efficacy showed certain differences according to the marriage and types of medical centers. Factors in married

  13. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety management of radiation workers in medical institutions

    Energy Technology Data Exchange (ETDEWEB)

    Han, Eun Ok [Daegu Health College, Daegu (Korea, Republic of)

    2007-06-15

    Radiation safety managements in medical institutions are needed to protect certain radiation damages as a part of National Coalition. This study investigates the characteristics of self-efficacy that become the major factor on the knowledge, attitude, and behavior on the radiation safety management of radiation workers as an approach of educational aspects and analyzes the relationship between such factors to provide basic materials for improving the activity level of radiation safety managements. In order to implement the goal of this study, a survey was performed for 1,200 workers who were engaged in radiation treatments in medical centers, such as general hospital, university hospital, private hospital, and public health center for 42 days from July 23, 2006. Then, the results of the analysis can be summarized as follows: 1. Average scores on knowledge, attitude, and behavior in the radiation safety management were presented as 75.76{+-}11.20, 90.55{+-}8.59, 80.58{+-}11.70, respectively. Also, the average score of self-efficacy was recorded as 73.55{+-}9.82. 2. Knowledge levels in the radiation safety management showed significant differences according to the sex, age, marriage, education, and experience. Also, males of married, older, highly educated, and largely experienced represented high knowledge levels. Attitude levels in the radiation safety management showed certain significant differences according to the type of medical centers in which private hospitals showed a relatively low level compared to that of high levels in university hospitals. Behavior levels in the radiation safety management also represented significant differences according to the age, marriage, education, experience, and types of medical centers. Factors in married, general hospital, older, highly educated, and largely experienced showed high behavior levels. In addition, the self-efficacy showed certain differences according to the marriage and types of medical centers. Factors in

  14. System analysis of vehicle active safety problem

    Science.gov (United States)

    Buznikov, S. E.

    2018-02-01

    The problem of the road transport safety affects the vital interests of the most of the population and is characterized by a global level of significance. The system analysis of problem of creation of competitive active vehicle safety systems is presented as an interrelated complex of tasks of multi-criterion optimization and dynamic stabilization of the state variables of a controlled object. Solving them requires generation of all possible variants of technical solutions within the software and hardware domains and synthesis of the control, which is close to optimum. For implementing the task of the system analysis the Zwicky “morphological box” method is used. Creation of comprehensive active safety systems involves solution of the problem of preventing typical collisions. For solving it, a structured set of collisions is introduced with its elements being generated also using the Zwicky “morphological box” method. The obstacle speed, the longitudinal acceleration of the controlled object and the unpredictable changes in its movement direction due to certain faults, the road surface condition and the control errors are taken as structure variables that characterize the conditions of collisions. The conditions for preventing typical collisions are presented as inequalities for physical variables that define the state vector of the object and its dynamic limits.

  15. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN)

    DEFF Research Database (Denmark)

    Howard, James F; Utsugisawa, Kimiaki; Benatar, Michael

    2017-01-01

    BACKGROUND: Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients...... with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. METHODS: We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76...... hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II-IV disease...

  16. Safety and efficacy of using the Viabahn endoprosthesis for percutaneous treatment of vascular access complications after transfemoral aortic valve implantation

    DEFF Research Database (Denmark)

    De Backer, Ole; Arnous, Samer; Sandholt, Benjamin

    2015-01-01

    Vascular access complications (VACs) remain one of the biggest challenges when performing transcatheter aortic valve implantation (TAVI). This study aimed to investigate the short- and medium-term safety and efficacy of the Viabahn endoprosthesis (Gore, Flagstaff, AZ) when used to treat TAVI......-induced vascular injury. Over a 40-month period, 354 patients underwent true percutaneous transfemoral (TF)-TAVI using a CoreValve and Prostar-XL closure system; this was our study population. A VAC leading to acute intervention occurred in 72 patients (20.3%) - of these, 18 were managed by balloon angioplasty, 48...... were treated by Viabahn stenting (technical success rate 98%), and 6 needed surgical intervention. Overall, this approach resulted in a major VAC rate of 3.1% (n = 11) in our study cohort. Length of hospitalization and 30-day mortality rates were comparable in patients with a VAC treated by Viabahn...

  17. Monitoring System For Improving Radiation Safety Management

    International Nuclear Information System (INIS)

    Osovizky, A.; Paran, J.; Tal, N.; Ankry, N.; Ashkenazi, B.; Tirosh, D.; Marziano, R.; Chisin, R.

    1999-01-01

    Medi SMARTS (Medical Survey Mapping Automatic Radiation Tracing System), a gamma radiation monitoring system, was installed in a nuclear medicine department. In this paper the evaluation of the system's ability to improve radiation safety management is presented. The system is based on a state of the art software that continuously collects on line radiation measurements for display, analysis and logging. Radiation is measured by GM tubes; the signal is transferred to a data processing unit and then via an RS-485 communication line to a computer. The system automatically identifies the detector type and its calibration factor, thus providing compatibility, maintainability and versatility when changing detectors. Radiation levels are displayed on the nuclear medicine department map at six locations. The system has been operating continuously for more than one year, documenting abnormal events caused by routine operation or failure incidents. In cases where abnormal working conditions were encountered, an alarm message was sent automatically to the supervisor via his tele-pager. An interesting issue observed during the system evaluation, was the inability to distinguish between high radiation levels caused by proper routine operation and those caused by safety failure incidents. The solution included examination of two parameters, radiation levels as well as their duration period. A careful analysis of the historical data, applying the appropriated combined parameters determined for each location, verified that such a system can identify abnormal events, provide alarms to warn in case of incidents and improve standard operating procedures

  18. Analgesic efficacy and safety of epidural oxycodone in patients undergoing total hip arthroplasty: a pilot study

    Directory of Open Access Journals (Sweden)

    Olczak B

    2017-09-01

    Full Text Available Bogumił Olczak,1 Grzegorz Kowalski,1,2 Wojciech Leppert,2 Agnieszka Bienert,3 Artur Teżyk,4 Michał Adamski,1 Stanisław Rzymski,1 Katarzyna Wieczorowska-Tobis2 1Department of Anaesthesiology, Józef Struś Multiprofile Municipal Hospital, Poznań, 2Department of Palliative Medicine, 3Department of Clinical Pharmacy and Biopharmacy, 4Department of Forensic Medicine, Poznan University of Medical Sciences, Poznań, Poland Background and objectives: Oxycodone is poorly studied as an adjuvant to central blockades. The aim of this pilot study was to assess the efficacy and safety of oxycodone hydrochloride in epidural blockade among patients undergoing total hip arthroplasty (THA.Patients and methods: In 11 patients (American Society of Anesthesiologists physical status classification system II/III, age range: 59–82 years, THA was conducted with an epidural blockade using 15 mL 0.25% bupivacaine (37.5 mg with 5 mg oxycodone hydrochloride and sedation with propofol infusion at a dose of 3–5 mg/kg/h. After the surgery, patients received ketoprofen at a dose of 100 mg twice daily. In the first 24 hours postoperative period, pain was assessed by numerical rating scale at rest and on movement; adverse effects (AEs were recorded; and plasma concentrations of oxycodone, noroxycodone, and bupivacaine were measured.Results: The administration of epidural oxycodone at a dose of 5 mg in patients undergoing THA provided analgesia for a mean time of 10.3±4.89 h. In one patient, mild pruritus was observed. Oxycodone did not evoke other AEs. Plasma concentrations of oxycodone while preserving analgesia were >2.9 ng/mL. Noroxycodone concentrations in plasma did not guarantee analgesic effect.Conclusion: The administration of epidural oxycodone at a dose of 5 mg prolongs the analgesia period to ~10 hours in patients after THA. Oxycodone may evoke pruritus. A 5 mg dose of oxycodone hydrochloride used in an epidural blockade seems to be a safe drug in patients

  19. Safety and Efficacy of Advanced Bipolar Vessel Sealing in Vaginal Hysterectomy: 1000 Cases.

    Science.gov (United States)

    Clavé, Henri; Clavé, Arnaud

    2017-02-01

    To determine the safety and efficacy of advanced electrothermal bipolar vessel sealing (EBVS) during vaginal hysterectomy by evaluating urinary complications, overall complications, and reoperation rate. A retrospective cohort (Canadian Task Force classification III). High-volume gynecologic surgeon practice, private hospital. One thousand consecutive patients who have undergone vaginal hysterectomy for benign conditions carried out with EBVS between January 2002 and December 2012. Vaginal hysterectomy performed using an EBVS device. One thousand consecutive patients underwent vaginal hysterectomy with advanced EBVS between January 2002 and December 2012 with an average age of 51.4 ± 8.9 years (range, 31-88) and mean weight and body mass index of 57.4 ± 7.2 kg (range, 42-105) and 25.8 ± 4.2 kg/m 2 (range, 19.1-38.9), respectively. Eighty-five percent of patients (852/1000) were healthy without any severe systemic disease. A single experienced surgeon performed all vaginal hysterectomies with EBVS, specifically by not applying traction during thermofusion to avoid hemorrhage, amputating the cervix to transform the uterus to an apple shape to facilitate a vaginal approach and rotation of the uterus, and placing bi-clamp forceps on the edge of the uterus and not at a 45- or 90-degree angle. Wound closure was completed with a continuous suture. Eleven urinary complications (1.1%) were recorded (10 bladder mechanical injuries and 1 vesicovaginal fistula). This was not statistically different from the rate of .64% previously reported in the FINHYST study (p = .15). The overall rate of complications was 5.3%, and 20 patients (2.0%) required reoperation. The presence of uterine scar tissue (odds ratio, 5.5; 95% confidence interval, 1.6-19.2) and larger uterus size (odds ratio, 2.5; 95% confidence interval, 1.01-19.2) were associated with a higher risk of urinary complications. The use of EBVS during vaginal hysterectomy results in urinary and overall

  20. Qualitative safety analysis in accelerator based systems

    International Nuclear Information System (INIS)

    Sarkar, P.K.; Chowdhury, Lekha M.

    2006-01-01

    In recent developments connected to high energy and high current accelerators, the accelerator driven systems (ADS) and the Radioactive Ion Beam (RIB) facilities come in the forefront of application. For medical and industrial applications high current accelerators often need to be located in populated areas. These facilities pose significant radiological hazard during their operation and accidental situations. We have done a qualitative evaluation of radiological safety analysis using the probabilistic safety analysis (PSA) methods for accelerator-based systems. The major contribution to hazard comes from a target rupture scenario in both ADS and RIB facilities. Other significant contributors to hazard in the facilities are also discussed using fault tree and event tree methodologies. (author)

  1. The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

    Energy Technology Data Exchange (ETDEWEB)

    Yuan, Yongguang; Zong, Yao; Zheng, Qishan [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Qian, Garrett [University of New South Wales (Australia); Qian, Xiaobin; Li, Yujie; Shao, Wanwen [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China); Gao, Qianying, E-mail: gaoqy@mail.sysu.edu.cn [State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou (China)

    2016-05-01

    Purpose: To evaluate the efficacy and safety of posterior scleral reinforcement (PSR) device for myopia suppression in rabbits' eyes. Methods: PSR surgery was performed on the normal 12 8-week-old New Zealand white rabbits' right eyes. To determine efficacy of the device, ophthalmic examination would be taken at pre-operation and post-operation (1 week, 1 month, 3 months, 6 months, and 1 year), such as A-ultrasound, diopter and B-ultrasound. Evaluation of safety were based on the following indicators: intraocular pressure (IOP), slit lamp, fundus photography, fundus fluorescein angiography and pathological examination after surgery. The efficacy and safety of PSR device were evaluated by comparison (treated eyes and contralateral eyes) of pre and post-operation. Results: The novel PSR device could significantly shorten axial length (preoperative axial length: 16.36 ± 0.14 mm, postoperative 1 week, 1 month, 3 months, 6 months and 1 year axial lengths: 15.03 ± 0.28 mm, 15.23 ± 0.32 mm, 15.39 ± 0.31 mm, 15.45 ± 0.22 mm and 15.45 ± 0.22 mm; P = 0.00037 < 0.001) in the treated eyes (right eyes) after surgery. At different postoperative time points, the B-ultrasound images showed that the PSR located in appropriate position and supported the posterior sclera very well. At the same time, IOP of treated eyes kept a relatively stable level (preoperative IOP: 12.56 ± 2.01 mmHg, postoperative IOP: ranging from 11.33 ± 1.23 mmHg to 13.44 ± 2.19 mmHg, P > 0.05) post-operation 1 year. During observation period, there was no significant inflammatory reaction and complications such as anterior chamber flare, empyema, endophthalmitis, vitreous hemorrhage, retina detachment and retinal choroid neovascularization by slit lamp, fundus photography and fundus fluorescein angiography. In addition, there were no pathologic changes be found by comparison treated eyes group and contralateral group eyes based on pathological examinations. Conclusions: In vivo study

  2. Optimized Evaluation System to Athletic Food Safety

    OpenAIRE

    Shanshan Li

    2015-01-01

    This study presented a new method of optimizing evaluation function in athletic food safety information programming by particle swarm optimization. The process of food information evaluation function is to automatically adjust these parameters in the evaluation function by self-optimizing method accomplished through competition, which is a food information system plays against itself with different evaluation functions. The results show that the particle swarm optimization is successfully app...

  3. Autonomous Highway Systems Safety and Security

    OpenAIRE

    Sajjad, Imran

    2017-01-01

    Automated vehicles are getting closer each day to large-scale deployment. It is expected that self-driving cars will be able to alleviate traffic congestion by safely operating at distances closer than human drivers are capable of and will overall improve traffic throughput. In these conditions, passenger safety and security is of utmost importance. When multiple autonomous cars follow each other on a highway, they will form what is known as a cyber-physical system. In a general setting, t...

  4. Safer Systems: A NextGen Aviation Safety Strategic Goal

    Science.gov (United States)

    Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

    2008-01-01

    The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

  5. Occupational Safety and Health Management System (OSHMS)

    International Nuclear Information System (INIS)

    Shyen, A.K.S.; Mohd Khairul Hakimin; Manisah Saedon

    2011-01-01

    Safe work environment has always been one of the major concerns at workplace. For this, Occupational Safety and Health Act 1994 has been promulgated for all workplaces to ensure the Safety, Health and Welfare of its employees and any person at workplaces. Malaysian Nuclear Agency therefore has started the initiative to review and improve the current Occupational Safety and Health Management System (OSHMS) by going for OHSAS 18001:2007 and MS 1722 standards certification. This would also help in our preparation to bid as the TSO (Technical Support Organization) for the NPP (Nuclear Power Plant) when it is established. With a developed and well maintained OSHMS, it helps to create a safe working condition and thus enhancing the productivity, quality and good morale. Ultimately, this will lead to a greater organization profit. However, successful OSHMS requires full commitment and support from all level of the organization to work hand in hand in implementing the safety and health policy. Therefore it is essential for all to acknowledge the progress of the implementation and be part of it. (author)

  6. Progress report: 1996 Radiation Safety Systems Division

    International Nuclear Information System (INIS)

    Bhagwat, A.M.; Sharma, D.N.; Abani, M.C.; Mehta, S.K.

    1997-01-01

    The activities of Radiation Safety Systems Division include (i) development of specialised monitoring systems and radiation safety information network, (ii) radiation hazards control at the nuclear fuel cycle facilities, the radioisotope programmes at Bhabha Atomic Research Centre (BARC) and for the accelerators programme at BARC and Centre for Advanced Technology (CAT), Indore. The systems on which development and upgradation work was carried out during the year included aerial gamma spectrometer, automated environment monitor using railway network, radioisotope package monitor and air monitors for tritium and alpha active aerosols. Other R and D efforts at the division included assessment of risk for radiation exposures and evaluation of ICRP 60 recommendations in the Indian context, shielding evaluation and dosimetry for the new upcoming accelerator facilities and solid state nuclear track detector techniques for neutron measurements. The expertise of the divisional members was provided for 36 safety committees of BARC and Atomic Energy Regulatory Board (AERB). Twenty three publications were brought out during the year 1996. (author)

  7. Efficacy and safety of SOX chemotherapy with or without surgery in AFP-producing advanced gastric cancer

    OpenAIRE

    Li, Zhu; Hou, Xu; Chen, Juan; Sun, Huidong; Mi, Yuetang; Sui, Yongling; Li, Yuhong; Xie, Jiaping; Qiao, Yingli; Lei, Xiaofeng; Che, Xiaoshuang; Liu, Jun

    2017-01-01

    The present study investigated the clinical efficacy of S-1 plus oxaliplatin (SOX) regimen, with or without surgery in ?-fetoprotein-producing gastric cancer (APGC) with liver metastasis. A total of 24 patients with APGC treated at the Liaocheng People's Hospital between January 2011 and December 2013 were retrospectively reviewed. Clinical efficacy and patient safety were compared between the two groups. The median progression-free survival (PFS) and overall survival (OS) in the SOX group we...

  8. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    OpenAIRE

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    AIM: To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). METHODS: In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS...

  9. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  10. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  11. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  12. Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

    Science.gov (United States)

    Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

    2013-01-01

    Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine