WorldWideScience

Sample records for system safety efficacy

  1. Efficacy and Safety of Methotrexate in Articular and Cutaneous Manifestations of systemic Lupus Erythematosus

    NARCIS (Netherlands)

    Islam, Nazrul; Hossain, Mohsin; Haq, Syed A.; Alam, Mohammad N.; ten Klooster, Peter M.; Rasker, Johannes J.

    2012-01-01

    Aim:  A prospective open-label study comparing the efficacy and safety of methotrexate (MTX) and chloroquine (CQ) in articular and cutaneous manifestations of systemic lupus erythematosus (SLE). Methods:  Consecutive SLE patients were randomly assigned to either 10 mg MTX weekly or 150 mg CQ daily

  2. Efficacy and safety of biological agents for systemic juvenile idiopathic arthritis

    DEFF Research Database (Denmark)

    Tarp, Simon; Amarilyo, Gil; Foeldvari, Ivan

    2016-01-01

    OBJECTIVE: To define the optimal biologic agent for systemic JIA (sJIA) based on safety and efficacy data from a randomized controlled trial (RCT). METHODS: Through a systematic literature search, sJIA RCTs evaluating biologic agents were identified. The primary efficacy outcome was defined as a 30......, this meta-analysis of short-term RCTs presents empirical evidence that canakinumab and tocilizumab are more effective than rilonacept. Biologic agents in sJIA seem safe and comparable with respect to SAE risk in the short term....

  3. 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.

  4. 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

  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. 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,

  7. Efficacy and Safety of the Doxazosin Gastrointestinal Therapeutic System for the Treatment of Benign Prostate Hyperplasia

    Directory of Open Access Journals (Sweden)

    Guang-Huan Sun

    2010-10-01

    Full Text Available This study was carried out to obtain information on the efficacy and safety of the controlled release formulation of the doxazosin Gastrointestinal Therapeutic System (GITS in Taiwanese subjects with benign prostatic hyperplasia (BPH. Studies of doxazosin in Asian populations for this indication have lacked data particularly from Taiwan. This was an 8-week, post-marketing, open-label, non-comparative study. Eighty male subjects (mean age=64 years with BPH received doxazosin GITS 4 mg once daily. At week 4, subjects who achieved an increase in maximum urinary flow rate (Qmax of >3 mL/s and a >30% reduction in the total International Prostate Symptom Score (IPSS continued on doxazosin GITS 4 mg for the remaining 4 weeks; all other subjects were up-titrated to 8mg once daily. Change from baseline at weeks 4 and 8 (primary endpoint in IPSS and Qmax was evaluated using two-sided paired t tests for the intent-to-treat population. Safety was assessed throughout the study. A total of 53 (66.3% subjects completed the study. Baseline Qmax and IPSS were 10.7+3.4 mL/s and 20.6+5.4, respectively. At week 8, a significant increase from baseline in Qmax of 3.3+4.6 mL/s (95% confidence interval = 2.2-4.4, p< 0.001 and a significant decrease in total IPSS of −8.9 + 7.0 (95% confidence interval=−10.5 to −7.3, p< 0.001 was observed. The most common treatment-related adverse event was dizziness. Doxazosin GITS 4 mg per day (with an 8-mg titration step effectively improved symptoms of BPH. The results from this study provide further information for clinicians on the use of doxazosin GITS for the treatment of BPH, particularly in Taiwanese patients.

  8. Introduction of a closed-system cell processor for red blood cell washing: postimplementation monitoring of safety and efficacy.

    Science.gov (United States)

    Acker, Jason P; Hansen, Adele L; Yi, Qi-Long; Sondi, Nayana; Cserti-Gazdewich, Christine; Pendergrast, Jacob; Hannach, Barbara

    2016-01-01

    After introduction of a closed-system cell processor, the effect of this product change on safety, efficacy, and utilization of washed red blood cells (RBCs) was assessed. This study was a pre-/postimplementation observational study. Efficacy data were collected from sequentially transfused washed RBCs received as prophylactic therapy by β-thalassemia patients during a 3-month period before and after implementation of the Haemonetics ACP 215 closed-system processor. Before implementation, an open system (TerumoBCT COBE 2991) was used to wash RBCs. The primary endpoint for efficacy was a change in hemoglobin (Hb) concentration corrected for the duration between transfusions. The primary endpoint for safety was the frequency of adverse transfusion reactions (ATRs) in all washed RBCs provided by Canadian Blood Services to the transfusion service for 12 months before and after implementation. Data were analyzed from more than 300 RBCs transfused to 31 recipients before implementation and 29 recipients after implementation. The number of units transfused per episode reduced significantly after implementation, from a mean of 3.5 units to a mean of 3.1 units (p processor. The ACP 215 allowed for an extended expiry time, improving inventory management and overall utilization of washed RBCs. Transfusion of fewer RBCs per episode reduced exposure of recipients to allogeneic blood products while maintaining efficacy. © 2015 AABB.

  9. 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.)

  10. Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus.

    Science.gov (United States)

    Suzuki, Katsuya; Kameda, Hideto; Amano, Koichi; Nagasawa, Hayato; Takei, Hirofumi; Nishi, Eiko; Okuyama, Ayumi; Tsuzaka, Kensei; Takeuchi, Tsutomu

    2011-06-01

    The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus (TAC) in various manifestations of systemic lupus erythematosus (SLE) patients in daily clinical practice. Each of the 21 TAC-treated patients with SLE in our care over 2 years was enrolled in this open-label trial. Patients were administered TAC at a dosage of 1-6 mg once daily, followed up for 24 weeks. Efficacy and safety were evaluated utilizing clinical and laboratory findings. As treatment targets, TAC was preferentially used with oral corticosteroid administration for mild active manifestations such as arthritis, skin eruptions, or asymptomatic nephritis. In efficacy, the mean value of the SLE disease activity index was significantly reduced to 4.1, 2.7, 1.8, and 1.2 (N=21, 20, 16 and 13) at 0, 4, 12, and 24 weeks, respectively. In eight cases, treatment was discontinued within 24 weeks due to insufficient effects (6 cases) and side effects (2 cases). Non-serious side effects were observed in only five cases (23.8%) over 24 weeks. TAC can be considered both effective and safe for the treatment of various manifestations of SLE.

  11. Short-term safety and efficacy of the Trans-oral Endoscopic Restrictive Implant System for the treatment of obesity

    NARCIS (Netherlands)

    de Jong, Koen; Mathus-Vliegen, Elisabeth M. H.; Veldhuyzen, Elisabeth A. M. L.; Eshuis, Jan H.; Fockens, Paul

    2010-01-01

    Background: Medical treatment of obesity often fails, and surgical treatment, although successful, is aggressive. Objective: To evaluate the short-term safety and efficacy of an endoscopic restrictive implant procedure in the treatment of obesity. Design: Prospective, observational study. Setting:

  12. The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System.

    Science.gov (United States)

    Philpott, Jonathan M; Zemlin, Christian W; Cox, James L; Stirling, Mack; Mack, Michael; Hooker, Robert L; Morris, Allen; Heimansohn, David A; Longoria, James; Gandhi, Divyakant B; McCarthy, Patrick M

    2015-11-01

    The Cox Maze-IV procedure (CMP-IV) has replaced the Cox Maze-III procedure as the most common approach for the surgical treatment of atrial fibrillation (AF). The Food and Drug Administration-regulated AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE) trial sought to demonstrate the safety and efficacy of the CMP-IV performed with the Synergy ablation system (AtriCure, Inc, Cincinnati, OH). Fifty-five patients (aged 70.5 ± 9.3 years), 92.7% of whom had nonparoxysmal AF, underwent CMP-IV to terminate AF during a concomitant cardiac surgical procedure. Lesions were created using the AtriCure Synergy bipolar radiofrequency ablation system. All patients were seen for follow-up visits after 30 days, 3 months, and 6 months, with 24-hour Holter monitoring at 6 months. Late evaluation was performed by 48-hour Holter monitoring at an average of 21 months. The primary efficacy endpoint, absence of AF (30 seconds or less) at 6-month follow-up off antiarrhythmic medications (Heart Rhythm Society definition), indicated 76% (38 of 50) were AF free (95% confidence interval: 62.6% to 85.7%). The primary safety endpoint, the rate of major adverse events within 30 days, was 9.1% (5 of 55; 95% confidence interval: 3.9% to 19.6%), with 3.6% mortality (2 of 55). Secondary efficacy endpoints included being AF free with antiarrhythmic drugs (6 months, 84%; 21 months, 75%), successful pulmonary vein isolation (100%), and AF burden at 6 and 21 months. The results, together with those for the secondary safety endpoint (6-month major adverse events), demonstrated that the Synergy system performs comparably to the cut-and-sew Cox Maze-III procedure. The CMP-IV using the AtriCure Synergy system was safe and effective for cardiac surgical patients who had persistent and longstanding persistent AF. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Directory of Open Access Journals (Sweden)

    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.

    Science.gov (United States)

    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 anti-CD20 antibody rituximab for patients with refractory systemic lupus erythematosus.

    Science.gov (United States)

    Iwata, S; Saito, K; Hirata, S; Ohkubo, N; Nakayamada, S; Nakano, K; Hanami, K; Kubo, S; Miyagawa, I; Yoshikawa, M; Miyazaki, Y; Yoshinari, H; Tanaka, Y

    2018-04-01

    Objective We examined the efficacy and safety of rituximab in patients with refractory systemic lupus erythematosus (SLE). Methods The study enrolled 63 SLE patients who were treated with rituximab between 2002 and 2015. The participants underwent a battery of tests before treatment and at one year. Treatment ranged from two to four times at 500 or 1000 mg. Results Baseline characteristics were males:females = 6:57, age 33.9 years, and disease duration 87.2 months. The primary endpoint: The rate of major clinical response (MCR) was 60% while the partial clinical response (PCR) was 25%. Thirty of 36 (83%) patients with lupus nephritis (WHO II: 2, III: 5, IV: 22, V: 4, IV+V: 2, not assessed: 1) and 22 of 24 patients (92%) with neuropsychiatric SLE, who could be followed at one year, showed changes from BILAG A or B score to C or D score at one year. Multivariate analysis identified high anti-dsDNA antibody and shorter disease duration as significant determinants of MCR at one year. Repeat examination was conducted at five years. Primary failure was recorded in 8.8% and secondary failure in 32.4% (time to relapse: 24.4 months). Rituximab was well tolerated although 65 adverse events, mostly infections, were recorded within one year. Conclusion Rituximab is potentially efficacious for the treatment of patients with refractory SLE.

  17. The LINX (R) reflux management system: confirmed safety and efficacy now at 4 years

    NARCIS (Netherlands)

    Lipham, John C.; DeMeester, Tom R.; Ganz, Robert A.; Bonavina, Luigi; Saino, Greta; Dunn, Daniel H.; Fockens, Paul; Bemelman, Willem

    2012-01-01

    Sphincter augmentation with the LINXA (R) Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years. In a

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

    Directory of Open Access Journals (Sweden)

    Megan N Beatty

    2009-07-01

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

  19. Efficacy And Safety Of Systemic Antifungal Agents In Chronic Dermatophytosis -An Open Trial

    Directory of Open Access Journals (Sweden)

    Nirmala S

    2000-01-01

    Full Text Available Forty patients comprising of 20 males and 20 females suffering from dermatophytosis for more than one year and who were not on any topical or systemic medication 3 months prior to the institution of therapy, were divided into 4 groups, each comprising of 5 males and 5 females, were given oral griseofulvin 250 mg twice daily for 8 weeks for group A, oral ketoconzole 200mg daily for group B, oral fluconazole 150 mg twice weekly for group C and oral itraconazole and fluconazole were most effective drugs. Griseofulvin and itraconazole were found less effective. All the four drugs did not give rise to any side effect.

  20. LigaSure vessel sealing system in vaginal hysterectomy: safety, efficacy and limitations.

    Science.gov (United States)

    Gizzo, Salvatore; Burul, Giorgia; Di Gangi, Stefania; Lamparelli, Laura; Saccardi, Carlo; Nardelli, Giovanni Battista; D'Antona, Donato

    2013-11-01

    The aim of this study is to compare vaginal hysterectomy performed with standard technique versus the one performed with LigaSure. Observational-longitudinal-cohort study on 42 women candidates to vaginal hysterectomy because of benign uterine pathology. Outcome variables, methods of analysis, inclusion and exclusion criteria were determined prospectively. Eligible patients were subdivided in Group-A (LigaSure-21 patients), or in Group-B (classical-21 patients). Group-A was divided into Subgroup-A1 (10 patients) and Subgroup-A2 (11 patients), depending on the point where the stump of the uterosacral-ligament was transfixed: Subgroup-A1 at cervical portion, Subgroup-A2 at intermediate portion. For all patients were reported: pre-post surgery haemoglobin and hematocrit, number of sutures, duration of intervention and blood loss, NRS-score on first/third post-operative days. All patients underwent gynaecological examination 30 and 180 days after surgery. General characteristics did not show significant differences between the two groups. Statistically significant differences emerged from the comparison between Group-A versus Group-B in terms of: intraoperative bleeding, post-operative value of haemoglobin, Δ-Hb, number of sutures, surgical time, pain at first and third post-operative day. The 180 days follow-up demonstrated four cases of vaginal vault prolapse, only in the Subgroup-A1 related to thermal damage of the uterosacral ligament. LigaSure vessel sealing system is a safe alternative for securing pedicles in vaginal hysterectomy with significant improvement in patients outcome. Following vaginal vault prolapse, we determined the optimal fixation-site to perform the colposuspension in the intermediate portion of the uterosacral-ligament, especially if the cervical portion received a thermal damage, as occurs during the LigaSure use.

  1. 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…

  2. Comparison of efficacy and safety between transconjunctival 23-gauge and conventional 20-gauge vitrectomy systems in macular surgery.

    Science.gov (United States)

    Goncu, Tugba; Gurelik, Gokhan; Hasanreisoglu, Berati

    2012-10-01

    To compare the efficacy and safety of 23-gauge transconjunctival vitrectomy with the conventional 20-gauge method in idiopathic epiretinal membrane and macular hole surgery. Sixty-one consecutive patients undergoing vitrectomy for idiopathic epiretinal membrane and macular hole were recruited to either 20- or 23-gauge vitrectomy groups and prospectively evaluated. Surgical success rates, operating time, surgery-related complications, long-term visual outcomes, and postoperative ocular surface problems are compared in the two groups. There were 31 eyes in the 20-gauge group and 33 eyes in the 23-gauge group. The macular hole closure rate after the first surgery was 83% and 90.9% in the 20-gauge and 23-gauge groups, respectively, with no significant difference between groups (p = 0.59). The success rate for idiopathic epiretinal membranes cases was 100% in both groups. There was no statistically significant difference between overall surgical times (p = 0.90). None of the patients in either group experienced postoperative complications of severe postoperative hypotony, vitreous hemorrhage or endophthalmitis, except one eye in the 20-gauge group, which was found to have retinal detachment. In both groups, statistically significant improvement in visual acuity was achieved 1-month postoperatively (p = 0.002) and thereafter at all postoperative visits (p gauge group at all postoperative visits compared with the 20-gauge group scores (p = 0.001). Transconjunctival 23-gauge vitrectomy appears to be as effective and safe as conventional 20-gauge vitrectomy in idiopathic epiretinal membrane and macular hole surgeries.

  3. Foam treatment for varicose veins; efficacy and safety | Kotb ...

    African Journals Online (AJOL)

    Introduction: Lower extremity varicose vein is a common disease. Sclerotherapy can be used to treat truncal varices of the superficial venous system. This involves injecting a sclerosant intraluminally in order to cause fibrosis and eventual obliteration of the vein. Objective: To demonstrate the efficacy and safety of foam ...

  4. Safety and efficacy of biosimilars in oncology.

    Science.gov (United States)

    Schellekens, Huub; Smolen, Josef S; Dicato, Mario; Rifkin, Robert M

    2016-11-01

    Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment, and its imminent introduction is expected to expand affordability worldwide. However, biosimilar monoclonal antibodies provide many challenges compared with first-generation biosimilars, growth factors, and hormones, because they have shown only a modest clinical effect, and are often used in combination with other more toxic therapies, making it difficult to design studies that allow appropriate efficacy and safety assessments compared with the original products. The value of comparative clinical trials for showing clinical equivalence of biosimilars that demonstrate a high degree of similarity in physical, chemical, structural, and biological characteristics with the original product is increasingly being questioned, and advances in analytical methods that provide robust non-clinical data might reduce the need for extensive clinical comparisons. In this Series paper, the third of three papers on drug safety in oncology, we review the safety and efficacy of biosimilars in oncology, assessing biosimilar monoclonal antibodies in relation to first-generation biosimilars, the issues surrounding interchangeability and extrapolation of biosimilars to other disease and patient indications, and reassessing the safety approval pathway in light of 10 years worth of biosimilar experience. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. 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.

  6. Long-term safety and efficacy of belimumab in patients with systemic lupus erythematosus: a continuation of the Phase 3 United States BLISS-76 trial.

    Science.gov (United States)

    Furie, Richard A; Wallace, Daniel J; Aranow, Cynthia; Fettiplace, James; Wilson, Barbara; Mistry, Prafull; Roth, David A; Gordon, D

    2018-02-06

    This US multicenter continuation study (GSK Study BEL112233; NCT00724867) assessed long-term safety and efficacy of belimumab in patients with SLE who completed BLISS-76 (NCT00410384). Patients continued to receive the same belimumab dose plus standard of care; patients previously receiving placebo received belimumab 10 mg/kg. Primary outcome measures included long-term safety (AE frequency and damage assessed by Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI] evaluated every 48 weeks [study year]). Other assessments included SLE Responder Index (SRI), flare rates (modified SLE Flare Index [SFI]), prednisone use and B cell levels. Of 268 patients, 140 completed and 128 withdrew. Mean (SD) baseline Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA-SLEDAI) score was 7.8 (3.86); SDI score was 1.2 (1.51). Overall incidence of treatment-related and serious AEs remained stable or declined through study Year 7; mean (SD) SDI score increased by 0.4 (0.68) from baseline. An SRI response was achieved by 41.9% and 75.6% of patients at study Year 1 and 7 midpoints, respectively. At study Year 7 midpoint, relative to baseline, 78.2% achieved a ≥4-point SELENA-SLEDAI score reduction, 98.4% had no new British Isles Lupus Assessment Group 1A/2B organ domain scores, 93.7% had no worsening in Physician's Global Assessment, 20.6% experienced ≥1 severe SFI flare, mean decrease in prednisone dose was 31.4% and median change in CD20+ B cells was -83.2%. These long-term exposure results confirm the previously observed safety and efficacy profiles of belimumab in patients with SLE. This article is protected by copyright. All rights reserved.

  7. 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.

  8. Safety and efficacy of different systemic treatment modalities for acute pain of herpes zoster: A pilot study

    Directory of Open Access Journals (Sweden)

    Sanjiv Choudhary

    2018-01-01

    Full Text Available Background: Herpes zoster is a viral infection of skin caused by Varicella Zoster virus. The most important symptom for which the patient seeks medical advice is pain, which is perceived before the development of rash and lasts even after its resolution. The pain during the first 30 days after onset of herpes zoster is known as acute herpetic neuralgia. The aim of this study was to compare the efficacy and side-effects of different systemic treatment modalities for acute herpes zoster neuralgia. Materials and Methods: This was a randomized, single-blind, parallel control study. Forty-five patients of herpes zoster within 72 hours of onset were enrolled after considering various inclusion and exclusion criteria over a duration of 1 year. Pain severity was assessed after sequential distribution and allotment of patients in three groups using verbal rating scale (VRS. Patients in Group A (control group, were treated with Tab.valacyclovir (1 g tds × 7 days, Group B–Tab.valacyclovir (1 g tds × 7 days + Cap. Pregabalin (75 mg bd × 1 month, and Group C –Tab.valacyclovir (1 g tds × 7 days +Cap. Pregabalin (75 mg bd × 1 month + Tab.methylprednisolone (0.64 mg/kg body weight in two divided doses × 7 days. Patients were followed up at 1, 4, 6 weeks. Complete resolution of acute pain and side-effects were noted. Results: At the end of 4 weeks, reduction in acute pain was statistically significant (P < 0.05 in all the three groups individually compared to the baseline value. At the end of 6 weeks, percentage of patients with persistence of pain was more in Group A and B compared to Group C, which was statistically significant (P = 0.0001. In group A, postherpetic neuralgia was observed in more patients compared to group B and C. No significant side-effects were observed in any group except vomiting, somnolence, and dizziness. Limitations: Sample size of this study was limited. Further studies with large sample size are required to further validate

  9. Efficacy and safety of multitarget therapy with mizoribine and tacrolimus for systemic lupus erythematosus with or without active nephritis.

    Science.gov (United States)

    Nomura, A; Shimizu, H; Kishimoto, M; Suyama, Y; Rokutanda, R; Ohara, Y; Yamaguchi, K; Okada, M

    2012-11-01

    The prognosis of lupus nephritis (LN) has improved since the introduction of immunosuppressant therapies, but the safety and effectiveness of treatments can also be improved. We retrospectively assessed the treatment courses of 12 patients with systemic lupus erythematosus who were treated with glucocorticoid, mizoribine (MZR) and tacrolimus. This regimen was used as initial therapy for active LN in six patients (mean glucocorticoid dose, 66.6 mg); four of these six patients also received pulse methylprednisolone therapy. The starting doses of MZR and tacrolimus were 150 and 3 mg, respectively, and they were titrated as required. Five of six patients achieved complete remission and one achieved partial remission at 6 months. Five patients who completed 12-month analysis achieved complete remission. Another six patients were given the combination regimen for treating minor flares or for steroid sparing. The mean prednisolone doses were reduced from 11.0 mg at baseline to 6.6 mg at 12 months. Six patients experienced minor adverse events, including three minor infections. One patient stopped tacrolimus because of suspected toxicity. All 12 patients were successfully treated, and none experienced severe adverse events. Multitarget therapy combining glucocorticoid, MZR and tacrolimus may have the potential to become a treatment option which is effective and safe.

  10. 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...... with the most complete dataset were included for quality appraisal and data extraction. All 12 studies were prospective observational studies. Immediate procedural success ranged from 72-100%; 30 day mortality ranged from 0-7.8%. There was a significant improvement in haemodynamic profile and functional status...

  11. 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

  12. 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

  13. [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.

  14. Efficacy and safety of 120-W GreenLight High-Performance System laser photo vaporization of the prostate: 3-year results with specific considerations

    Directory of Open Access Journals (Sweden)

    Yong Sun Choi

    2013-12-01

    Conclusions: Laser resection of the prostate is safe and effective. The results of HPS laser PVP were not influenced by prostate size, the use of anticoagulants, the intake of 5-ARI for BPH management, a history of AUR, a history of TURP, or other factors. Thus, this study was able to reconfirm the efficacy and safety of laser resection of the prostate.

  15. Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial.

    Science.gov (United States)

    Schmitz, Michael L; Zempsky, William T; Meyer, James M

    2015-08-01

    The goal of this study was to determine if a lidocaine hydrochloride monohydrate powder intradermal system designed to provide cutaneous analgesia is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. COMFORT-004, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects, was a single-dose, parallel group study of children undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of the hand. Included were subjects (3-18 years) in 3 age groups: 3-7, 8-12, and 13-18 years. Excluded were those with recent similar procedures or with implantable devices or skin pathologies at the anatomical site, insufficient cognitive skills, or allergies to local anesthetics or adhesives. Subjects were randomized to receive the needle-free powder lidocaine delivery system (active system, 0.5 mg of lidocaine/21 ± 1 bar of pressure [n = 269]) or sham placebo (n = 266) 1-3 minutes before venipuncture or peripheral venous cannulation. Analgesic efficacy was assessed patient self-report of venous access pain (Wong-Baker FACES Pain Rating Scale [3-18 years] and visual analog scale [VAS; 8-18 years]) and parental observational VAS. Safety assessments included adverse events (AEs) and relationship to study treatment. Skin signs and symptoms were graded numerically. Wong-Baker FACES scores, VAS, and parental VAS were analyzed by using an ANOVA model. Responder ratings and success rates were compared by using a Cochran-Mantel-Haenszel test stratified according to center, age group, and body site. The active system group had significantly (P = 0.0022) less pain compared with the sham placebo in all age groups combined according to the modified Wong-Baker FACES scale. Secondary efficacy analyses found that the active system resulted in less pain as assessed by subjects' VAS pain assessments aged 8-18 years (P = 0.1856), responder analysis (P

  16. [Outpatient monitoring of oesophageal pH with a catheter-free pH-meter (Bravo System). A Study of tolerance, safety and efficacy].

    Science.gov (United States)

    Martínez de Haro, Luisa F; Munitiz, Vicente; Ortiz, Angeles; Ruiz de Angulo, David; Navarro, M Dolores; Parrilla, Pascual

    2008-10-01

    A new catheter-free outpatient oesophageal pH-meter system (Bravo) has recently been developed. The objective of this study is to test the tolerance, safety and efficacy of the system in the measurement of gastric-oesophageal reflux by comparing it with a conventional pH system. The study was performed on a control group consisting of 10 healthy volunteers (group 1) and in a group of 40 patients with symptoms of gastric-oesophageal reflux disease (groups 2 and 3). An upper digestive system endoscopy, oesophageal manometry and oesophageal pH measurements with a conventional system and/or with the Bravo catheter-free system, was performed on all patients. All patients who had both tests done (groups 1 and 2) filled in a questionnaire on any physical problems and changes in their daily activity. The test tolerance was higher with the Bravo system in the 9 parameters studied. In the group of healthy volunteers (group 1), the median (range) of the total percentage of pH pH and 1.7% (0-3.4) with the Bravo. When comparing the patients with symptoms of gastric-oesophageal reflux disease (group 2) with those who had only one type of pH measurement made, the acid reflux was significantly higher in patients with Barrett's oesophagus than in the rest of the groups, with conventional pH as well as with the Bravo. If we analyse the patient group with disease due to gastric-oesophageal reflux with those on whom both techniques were used (group 3), 7 of the 10 patients had a pathological reflux that only showed up on measuring pH with the Bravo system. Catheter-free pH measurements (Bravo) is better tolerated and with better satisfaction for the healthy volunteers and patients than with conventional PH, even, on occasions being more efficient for studying acid reflux due to the lower incidence of negative results.

  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.; Kublanck, A.; Warnack, W.; Markov, M.; Jörger, W.; Mertins, B.; Köttig, T.; Fischer, H. P.; Benusch, T.; Böhm, M.; Szymula, S.; Willgerodt, J.; Eckert, R.; Schneider, J.; Wicht, A.; Indig, M.; Tenke, P.; Nagy, J.; Katona, F.; Szabo, A.; Klucsai, R.; Nagy, G.; Rosta, G.; Cicalese, V.; Pagliarulo, A.; Vavassori, I.; Motta, M.; Damiano, R.; Nicita, G.; Vaccarella, G.; Risi, O.; de la Rosette, J.; IJzerman, W.; Taubert, E. W. J.; Vrijhof, H. J. E. J.; Kristensen, E.; van der Beek, C.; Roos, E. P. M.; Kil, P. J. M.; Bruins, J.; Stepnik, D.; Wolski, Z.; Maciukiewicz, P.; Ciechan, J.; Bryczkowski, M.; Borkowski, A.; Alayev, Y.; Avdoshin, V.; Al-Shukri, S. H.; Gomberg, V.; Petrov, S.; Brezovsky, M.; Gajdos, M.; Zahorjan, D.; Marencak, J.; Sokol, R.; Mikulas, J.; Sarmiento, R.; Drake, M.; Persad, R.; Thomas, H.; Hassanin, H.; Crawford, G.; Ellahbadi, R.; Abdulhakim, E. E. A.; Pavel-Knox, I.; Savani, N.; Malone, P.; Shaw, H.; Chapple, C.; Speakman, M. J.; MacDermott, 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 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.

  19. 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 ...

  20. Safety and efficacy of catheter-directed thrombolysis

    DEFF Research Database (Denmark)

    Bækgaard, N; Klitfod, Lotte; Broholm, R

    2012-01-01

    To describe the background for--and mechanism of--catheter-directed thrombolysis (CDT) for iliofemoral deep venous thrombosis (DVT) accessed via the popliteal vein. Focus is on safety and efficacy.......To describe the background for--and mechanism of--catheter-directed thrombolysis (CDT) for iliofemoral deep venous thrombosis (DVT) accessed via the popliteal vein. Focus is on safety and efficacy....

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

    African Journals Online (AJOL)

    Most herbal products developed by local herbalists and sold to the public are not standardized and lack efficacy and safety data to support use. Objective: To formulate from two Ugandan medicinal plants a herbal product for wound management and test its preclinical safety and efficacy using rat models. Methods: Thirty ...

  2. 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.

  3. Safety and efficacy of ureteroscopic pneumatic lithotripsy.

    Science.gov (United States)

    Khan, Adeel Ahmed; Hussain, Syed Alamdar; Khan, Naqeeb-Ullah; Kamran Majeed, Syed Muhammad; Sulaiman, Muhammad

    2011-10-01

    To determine the safety and efficacy of ureteroscopic pneumatic lithotripsy (PL) for the clearance of ureteral calculi (UC). Experimental study. Department of Urology, KRL Hospital, Islamabad, from March 2006 till December 2008. Ureteroscopic PL was performed on 104 patients with ureteric calculus measuring > 6 mm; using Swiss Lithoclast through a 9.5 French semi-rigid ureteroscope. At the end of the procedure, a DJ stent was inserted. Complications were noted. Stone clearance was assessed through X-ray KUB. DJ stent was removed within 3 - 6 weeks after the procedure. Sixty-eight patients (65.4%) were males and 36 (34.6%) females. The average hospital stay was 2.6 + 2.8 days; 72 (69.6%) patients were discharged on the first post-procedure day. Complete stone clearance was achieved in 98 (94.2%) patients, at 3-6 weeks. Four patients (26.7% of upper ureteral stones) had stone retropulsion. The only major complication was perforation occurring in 2 (1.9%) distal ureters. One case was successfully managed by endoscopic DJ stent placement, the other required open repair. Ureteroscopic PL is effective in clearing majority of middle and distal UC. Patients with proximal stones may have stone retropulsion. Ureteric perforation is an uncommon complication.

  4. 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

    BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also......)-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.......2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27...

  5. 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

  6. 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.

  7. Efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus and lupus nephritis who are refractory to conventional therapy.

    Science.gov (United States)

    Tanaka, Yoshiya; Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Sumida, Takayuki; Mimori, Tsuneyo; Koike, Takao; Endo, Kazuhiro; Mashino, Naomi; Yamamoto, Kazuhiko

    2016-01-01

    To evaluate the efficacy and safety of rituximab in Japanese patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN) who are refractory to conventional immunosuppressive therapy. Eligible patients received rituximab at a dose of 1,000 mg at days 1, 15, 169, and 183, and were followed for 53 weeks after the first dose of rituximab. Overall disease activity was assessed monthly using a British Isles Lupus Assessment Group activity index. Patients with LN (Upr/Ucr ≥ 1.0 at study entry) were identified and their renal responses were evaluated according to the criteria proposed by the American College of Rheumatology (ACR) and the Lupus Nephritis Assessment with Rituximab (LUNAR) study. A total of 34 patients were enrolled and received at least one dose of rituximab. Decrease in disease activity was achieved in 16 (76.5%) out of 34 patients. In 17 patients with LN, response rates of 58.8% and 52.9% by ACR and LUNAR criteria, respectively, were seen. Successful steroid tapering was achieved in association with disease remission. Rituximab was well tolerated, and most adverse drug reactions were grade 1-2 in severity. Rituximab is effective for treatment of Japanese patients with SLE and LN refractory to conventional therapy.

  8. Efficacy, safety, and trends in assisted reproductive technology in Japan-analysis of four-year data from the national registry system.

    Science.gov (United States)

    Takeshima, Kazumi; Saito, Hidekazu; Nakaza, Aritoshi; Kuwahara, Akira; Ishihara, Osamu; Irahara, Minoru; Hirahara, Humiki; Yoshimura, Yasunori; Sakumoto, Tetsuro

    2014-04-01

    This study aimed to evaluate the efficacy, safety, and trends in assisted reproductive technology (ART) in Japan. Data pertaining to treatment cycles, pregnancy rate, live birth rate, age distribution, single embryo transfer rate, and multiple pregnancy rate were analyzed for patients registered in the national ART registry system of Japan from 2007 to 2010. The total number of treatment cycles was 161,164, 190,613, 213,800, and 242,161 in 2007, 2008, 2009, and 2010, respectively. The number of ART treatments administered to patients aged ≥40 years was 31.2 %, 32.1 %, 33.4 %, and 35.7 %, respectively, showing an increasing trend from 2007 to 2010. In each of these years, the total pregnancy rate per embryo transfer was 24.4 %, 21.9 %, 22.3 %, and 21.9 % for fresh cycles, respectively, and 32.0 %, 32.1 %, 32.5 %, and 33.7 % for frozen cycles, respectively. The single embryo transfer rate was 49.9 %, 63.6 %, 70.6 %, and 73.0 %, respectively, showing an increasing trend, while the multiple pregnancy rate was 11.5 %, 6.8 %, 5.3 %, and 4.8 %, respectively, showing a decreasing trend. From 2007 to 2010 in Japan, the number of ART treatment cycles, number of elderly patients treated, and the single embryo transfer rate increased, while the multiple pregnancy rate decreased. However, the overall pregnancy rate remained stable during the study period.

  9. Reply: Pauling, et al., Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis.

    Science.gov (United States)

    Denton, Christopher P; Herrick, Ariane L

    2018-03-07

    Pauling et al highlight some of the limitations of using the Raynaud's Condition Score (RCS) in clinical trials of Raynaud's phenomenon and the need for better patient reported outcome measures. They have explored this in a survey of patients with systemic sclerosis who completed the RCS and although the number of cases in the survey is small, and possibly not representative of a clinical trial population, the points raised are interesting.We acknowledge the difficulties of undertaking clinical trials in Raynaud's phenomenon. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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

  17. Bioactive compounds: Safety and efficacy (Consensus Meeting - Part II)

    NARCIS (Netherlands)

    Biesalski, H.K.; Dragsted, L.O.; Elmadfa, I.; Grossklaus, R.; Müller, M.R.; Schrenk, D.; Walter, P.; Weber, P.

    2009-01-01

    The efficacy and safety of bioactive compounds depend on a few known and unknown parameters. What is a physiologic dose and how can that dose be defined in cases of bioactive compounds with a poor knowledge of supply and distribution? What safety sets are needed? How can individual aspects such as

  18. 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.......4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results....

  19. 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...

  20. 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

  1. 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.

  2. Efficacy and safety of intraocular implants: a Meta-analysis

    Directory of Open Access Journals (Sweden)

    Ren-Liang Huang

    2016-07-01

    Full Text Available AIM: To systemically evaluate the clinical efficacy and safety of intraocular implants for vitreous retinal surgery. METHODS: We performed a comprehensive search for studies reporting vitreous surgery with intraocular implants randomized controlled and a retrospective controlled clinical trials from China Hownet(CNKI, Wanfang database, and VIP literature database. Studies obtained from those database were filtered according to the criteria, and data were retrieved from eligible studies for further analysis. Then we performed a meta-analysis to evaluate the efficacy and safety of intraocular implants using comprehensive Meta-analysis software version 2(Biostat, Englewood, NJ.RESULTS: In total 36 studies were recruited for our Meta-analysis, including 5 092 cases. Meta analysis showed: 1regarding the efficacy of repairing the retinal detachment, silicone oil was a better intraocular implants than C3F8(OR=1.76; 95% CI: 1.19-2.60, P=0.0047and SF6(OR= 4.68; 95% CI: 1.48-14.81, P=0.0087; 2regarding the risk of postoperative cataract, silicone oil showed significant higher risk than BBS(OR=3.24; 95% CI: 2.10-4.99, P=1.09 e-7, and C3F8(OR=3.03; 95% CI: 1.50-6.10, P=0.0019; 3regarding the risk of postoperative intraocular pressure, silicone oil showed significant higher risk than BBS(OR=6.74; 95% CI: 3.38-13.41, P=5.67 e-08, and C3F8 also showed a higher risk than BBS(OR=4.79; 95% CI: 2.37-9.68, P=1.29 e-05. In addition, silicone oil showed significant lower risk as compared with heavy silicone oil(OR=0.16; 95% CI: 0.08-0.53, P=0.0026. CONCLUSION: The intraocular implants for the treatment of retinal detachment in vitreous retinal surgery are mainly divided into two major categories, liquid and gas implants. The silicone oil, a major liquid implant, shows higher efficacy in terms of treating retinal detachment than the gas implants. However, the silicone oil is associated with a higher risk of postoperative cataract and intraocular pressure as compared

  3. 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.)

  4. 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

  5. Efficacy and safety of sublingual immunotherapy in Asian children.

    Science.gov (United States)

    Park, Il-Ho; Hong, Sung-Moon; Lee, Heung-Man

    2012-12-01

    Sublingual immunotherapy is currently accepted as a suitable alternative to subcutaneous immunotherapy because of its easy and painless administration and improved safety. Many clinical trials have demonstrated that sublingual immunotherapy is an effective and safe treatment for pollen or mite allergic rhinitis. However, there have been very few studies overall on children with allergic rhinitis who are sensitized to house-dust mites in Asia. The purpose of the present study was to investigate the efficacy and safety of sublingual immunotherapy in children with allergic rhinitis to house-dust mites. A total of 112 patients under the age of 15 who had allergic rhinitis to Dermatophagoides pteronyssinus and Dermatophagoides farinae were included. All patients were treated with sublingual immunotherapy (Staloral(®)). Symptom scores and quality of life were evaluated by questionnaires until one year after sublingual immunotherapy. The medication score was assessed monthly using a diary medication card and serologic tests were evaluated before and 6 and 12 months after treatment. Adverse effects and compliance were also investigated. All nasal and non-nasal symptoms and quality of life were significantly improved after treatment. The total medication score was decreased significantly after sublingual immunotherapy. There was no significant change in serologic tests. Some minor adverse effects were reported, however there were no systemic reactions. The drop-out rate was 21%. Sublingual immunotherapy is a valuable therapy for the treatment of allergic rhinitis in Asian children sensitized to house-dust mites. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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

    African Journals Online (AJOL)

    Background: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. Study design: A double blind clinical trial comparing the safety and efficacy of ...

  7. 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 ...

  8. Safety, Efficacy and Acceptabilty of Norplant R Implants in Jos ...

    African Journals Online (AJOL)

    Conclusion: NorplantR subdermal implant was an effective safe and acceptable method of contraception amongst the acceptors, despite its minimal side effects. Key Words: NorplantR Implants, Safety, Efficacy and Acceptability NorplantR is a registered trademark of The Population Council for levonorgestrel subdermal ...

  9. 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 ...

  10. 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 ...

  11. 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.

  12. Original Articles Efficacy and Safety of Doxazosin (CARDURA TM ...

    African Journals Online (AJOL)

    Objective To assess the efficacy and safety of the selective á -blocker doxazosin in black men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia. Patients and Methods An open-label study involving consecutive patients with benign prostatic hyperplasia. They were asked to complete the ...

  13. ORIGINAL ARTICLES Safety and efficacy of procedural sedation ...

    African Journals Online (AJOL)

    subsequent development of chronic pain.1-3. Considerable research has proved the safety and efficacy of PSA when administered by emergency ... False Bay Hospital is situated in Fish Hoek in the southern suburbs of the Cape Town Metro Health District. It is attended by a diverse patient population, including those from a ...

  14. Long-term efficacy and safety of bronchial thermoplasty in patients with moderate-to-severe persistent asthma: a systemic review and meta-analysis.

    Science.gov (United States)

    Zhou, Jian Ping; Feng, Yun; Wang, Qiong; Zhou, Li Na; Wan, Huan Ying; Li, Qing Yun

    2016-01-01

    To evaluate the long-term efficacy and safety of bronchial thermoplasty (BT) in the treatment of patients with moderate-to-severe persistent asthma. We therefore performed a systematic literature review of peer-reviewed studies focusing on BT intervention in asthma control published between January 2000 and June 2014. Three randomized controlled studies and extension studies met the inclusion criteria (n = 6). Outcomes assessed after BT included spirometric data, adverse respiratory events, emergency room (ER) visits and hospitalization for respiratory illness. One-year and 5-year follow-up data were defined as V1 and V5, respectively. There were 249 BT-treated subjects in total who had a 1-year follow-up (V1), whereas 216 of them finished a 5-year follow-up (V5). No evidence of significant decline was found in pre-bronchodilator FEV1 (% predicted) (WMD = 0.75; 95% CI: 3.36 to 1.85; p = 0.57), or in post-bronchodilator FEV1 (% predicted) (WMD = 0.62; 95% CI: 3.32 to 2.08; p = 0.65) between V1 and V5. In addition, the frequency of respiratory adverse events was reduced significantly during the follow-up (RR = 3.41, 95% CI: 2.96-3.93, p < 0.00001). The number of ER visits for adverse respiratory events remained unchanged (RR = 1.06, 95% CI: 0.77-1.46, p = 0.71) after BT treatment. There was no statistically significant increase in the incidence of hospitalization for respiratory adverse events (V5 vs. V1, RR = 1.47, 95% CI: 0.69-3.12, p = 0.32). These data demonstrate long-term benefits of BT with regard to both asthma control and safety for moderate-to-severe asthmatic patients.

  15. New Treatment Options for Chronic Constipation: Mechanisms, Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Michael Camilleri

    2011-01-01

    Full Text Available The present review has several objectives, the first of which is to review the pharmacology and selectivity of serotonergic agents to contrast the older serotonergic agents (which were withdrawn because of cardiac or vascular adverse effects with the newer generation serotonin receptor subtype 4 agonists. Second, the chloride ion secretagogues that act through the guanylate cyclase C receptor are appraised and their pharmacology is compared with the approved medication, lubiprostone. Third, the efficacy and safety of the application of bile acid modulation to treat constipation are addressed. The long-term studies of surgically induced excess bile acid delivery to the colon are reviewed to ascertain the safety of this therapeutic approach. Finally, the new drugs for opiate-induced constipation are introduced. Assuming these drugs are approved, practitioners will have a choice; however, patient responsiveness will be based on trial and error. Nevertheless, the spectrum of mechanisms and demonstrated efficacy and safety augur well for satisfactory treatment outcomes.

  16. 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.

  17. 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

  18. Vancomycin treatment: analysis of efficacy and safety

    Directory of Open Access Journals (Sweden)

    Brigita Mavsar-Najdenov

    2007-11-01

    vancomycin was in vestigated.Results: Among the covariates tested significant effect of creatinine clearance calculated by the Cockroft-Gault equation on vancomycin clearance was determined. Plasma levels of vancomycin for a chosen dosing regimen can be predicted a priori in each patient on the basis of developed model and estimates of creatinine clearance.Conclusions: Pharmacokinetic analysis enables the design of individual dosing regimen for patients with impaired renal function. With patient individualised dosing regimen of vancomycin, nephrotoxicity can be prevented and an increase in efficacy can be achieved. Moreover, reduced risk of antimicrobial resistance by the proper use of vancomycin is expected.

  19. 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)

  20. 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)

    S A Savelyeva

    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

  1. The efficacy, safety, and practicality of treatments for adolescents with attention-deficit/hyperactivity disorder (ADHD).

    Science.gov (United States)

    Smith, B H; Waschbusch, D A; Willoughby, M T; Evans, S

    2000-12-01

    Studies examining interventions for adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) were reviewed to evaluate their efficacy. These efficacy findings were supplemented with a preliminary system for judging safety and practicality. Results suggest that the stimulant drug methylphenidate (MPH) is safe and well-established empirically, but has some problems with inconvenience and noncompliance. Preliminary research supports the efficacy, safety, and practicality of some psychotherapeutic interventions, including behavioral classroom interventions, note-taking training, and family therapy. Treatment with tricyclic antidepressants was judged to have minimal empirical support and debatable safety. Very little is known about long-term effectiveness of treatments, long-term compliance, or multimodal treatments for adolescents such as stimulants plus behavior therapy.

  2. Safety and Efficacy of a Pharmacoinvasive Strategy in ST-Segment Elevation Myocardial Infarction: A Patient Population Study Comparing a Pharmacoinvasive Strategy With a Primary Percutaneous Coronary Intervention Strategy Within a Regional System.

    Science.gov (United States)

    Rashid, Mohammed K; Guron, Nita; Bernick, Jordan; Wells, George A; Blondeau, Melissa; Chong, Aun-Yeong; Dick, Alexander; Froeschl, Michael P V; Glover, Chris A; Hibbert, Benjamin; Labinaz, Marino; Marquis, Jean-François; Osborne, Christina; So, Derek Y; Le May, Michel R

    2016-10-10

    This study investigated the safety and efficacy of a pharmacoinvasive strategy compared with a primary percutaneous coronary intervention (PCI) strategy for ST-segment elevation myocardial infarction (STEMI) in the context of a real-world system. Primary PCI continues to be the optimal reperfusion therapy; however, in areas where PCI centers are not readily available, a pharmacoinvasive strategy has been proposed. The University of Ottawa Heart Institute regional STEMI system provides a primary PCI strategy for patients presenting within a 90-km radius from the PCI center, and a pharmacoinvasive strategy for patients outside this limit. We included all confirmed STEMI patients between April 2009 and May 2011. The primary efficacy outcome was a composite of mortality, reinfarction, or stroke and the primary safety outcome was major bleeding. We identified 236 and 980 consecutive patients enrolled in pharmacoinvasive and primary PCI strategies, respectively. The median door-to-needle time was 31 min in the pharmacoinvasive group and the median door-to-balloon time was 95 min in the primary PCI group. In a multivariable model, there was no significant difference in the primary efficacy outcome (odds ratio: 1.54; p = 0.21); however, the propensity for more bleeding with a pharmacoinvasive strategy approached statistical significance (odds ratio: 2.02; p = 0.08). Within the context of a STEMI system, a pharmacoinvasive strategy was associated with similar rates of the composite of mortality, reinfarction, or stroke as compared with a primary PCI strategy; however, there was a propensity for more bleeding with a pharmacoinvasive strategy. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. ANTIHISTAMINE MEDICATIONS: EFFICACY AND SAFETY OF USING IN PEDIATRIC PRACTICE

    Directory of Open Access Journals (Sweden)

    L.R. Giniyatova

    2010-01-01

    Full Text Available Therapy of allergic and many other diseases using antihistamine medications is the pressing topic in modern medicine. Since the first antihistamine medications were created, knowledge of effects from these drugs have expanded and changed. The article discusses approaches to classification, pharmacological properties, side effects of antihistamine medications, and provides literature review of information about justification for administering and safety of using antihistamine drugs in pediatric practice from the standpoint of evidence-based medicine. Key words: antihistamine medications, efficacy, safety, pharmacoepidemiology, children. (Pediatric Pharmacology. – 2010; 7(3:71-77

  4. Long-term safety and efficacy of teriflunomide

    DEFF Research Database (Denmark)

    O'Connor, Paul; Comi, Giancarlo; Freedman, Mark S

    2016-01-01

    OBJECTIVE: To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). METHODS: A total of 742 patients entered the extension. Teriflunomide....... Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48). CONCLUSIONS: In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving...

  5. 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?

  6. New glaucoma medications in the geriatric population: efficacy and safety.

    Science.gov (United States)

    Novack, Gary D; O'Donnell, Martin J; Molloy, D William

    2002-05-01

    Glaucoma can be considered a disease of the aging eye. Most medications used to treat glaucoma are in topical eyedrop form and may cause numerous untoward systemic effects in older persons. In recent years, several new ocular hypotensive medications have become available. These medications are being used more commonly because there is a growing trend by ophthalmologists to aggressively lower intraocular pressure. Therefore, geriatricians require a comprehensive knowledge of medications used to treat glaucoma, in addition to an understanding of their mechanism of action profiles of untoward effects and possible interactions with other diseases or medications. Therefore, we performed a review of the medications recently introduced into clinical practice. We selected drugs approved by the U.S. Food and Drug Administration between 1996 and September 2001. The safety profiles of these agents and their untoward side effects were reviewed by class: topical carbonic anhydrase inhibitors (brinzolamide: ocular tolerance, taste perversion), beta-adrenoceptor antagonists (timolol: bradycardia and bronchospasm), alpha-adrenergic agonists (brimonidine: oral dryness, headache, and fatigue), and prostaglandin analogs (latanoprost, bimatoprost, travoprost, and unoprostone isopropyl: ocular hyperemia, iris color changes). The function of this review is to make geriatricians more aware of the efficacy and untoward effects of medications recently introduced into clinical practice. We recommend that geriatricians perform a medication review on all medications their patients use, including eye drops.

  7. 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

  8. Pharmacovigilance: Boon for the safety and efficacy of ayuvedic formulations

    Directory of Open Access Journals (Sweden)

    Anand Chaudhary

    2010-01-01

    Full Text Available 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.

  9. Allergen immunotherapy: routes, safety,efficacy, and mode of action

    Directory of Open Access Journals (Sweden)

    Hochfelder JL

    2013-07-01

    Full Text Available Jillian Leigh Hochfelder, Punita PondaDivision of Allergy and Immunology, North Shore–Long Island Jewish Health System, New Hyde Park, NY, USAAbstract: Allergic rhinitis, allergic conjunctivitis, and allergic asthma have been steadily increasing in prevalence in recent years. These allergic diseases have a major impact on quality of life and are a major economic burden in the US. Although allergen avoidance and pharmacotherapy are currently the mainstays of therapy, they are not always successful in treating patients’ symptoms effectively. If a patient fails allergen avoidance and medical therapy, immunotherapy may be indicated. Furthermore, immunotherapy is the only therapy that may change the course of the disease and induce long-term remission. Though subcutaneous administration has been the standard route for immunotherapy for many decades, there are several other routes of administration that have been and are currently being studied. The goal of utilizing alternative routes of immunotherapy is to improve safety without decreasing the efficacy of treatment. This paper will review the novel routes of immunotherapy, including sublingual, oral, local nasal, epicutaneous, and intralymphatic.Keywords: immunotherapy, allergic rhinitis, allergic asthma, sublingual, intralymphatic

  10. Efficacy and safety of blonanserin versus other antipsychotics: a review

    OpenAIRE

    Anant D. Patil

    2013-01-01

    Although many atypical antipsychotics are available, there is a need of an atypical antipsychotic effective in all symptom domains of schizophrenia and well tolerated especially for side effects like extrapyramidal side effects, weight gain and blood prolactin elevation. Blonanserin is an atypical antipsychotic which blocks dopamine D2 and serotonin 5HT2A receptors. Its efficacy and safety has been studied in patients with schizophrenia and delirium. Blonanserin is found to be effective and w...

  11. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms

    DEFF Research Database (Denmark)

    Vrijlandt, Elianne J L E; El Azzi, Georges; Vandewalker, Mark

    2018-01-01

    BACKGROUND: Few studies have assessed the safety and efficacy of potential asthma medications in children younger than 5 years. We descriptively assessed the safety and efficacy of tiotropium, a long-acting anticholinergic drug, in children aged 1-5 years with persistent asthmatic symptoms. METHO...... are needed to further assess the safety and efficacy of tiotropium in young children. FUNDING: Boehringer Ingelheim....

  12. 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.

  13. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

    Science.gov (United States)

    Li, Dianyou; Zhang, Chencheng; Gault, Judith; Wang, Wei; Liu, Jianmin; Shao, Ming; Zhao, Yanyan; Zeljic, Kristina; Gao, Guodong; Sun, Bomin

    2017-01-01

    Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function. © 2017 S. Karger AG, Basel.

  14. [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.

  15. The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trial.

    Science.gov (United States)

    Koo, Ja-Won; Chang, Mun Young; Yun, Sung-Cheol; Kim, Tae Su; Kong, Soo-Keun; Chung, Jong Woo; Goh, Eui-Kyung

    2016-09-01

    Steroids are currently the most frequently accepted agents for idiopathic sudden sensorineural hearing loss (ISSNHL). However, the therapeutic effect of steroids is not always satisfactory. In this pilot study, we evaluated whether systemic treatment with Ginkgo biloba extract (EGb761) has an additive therapeutic effect in patients receiving a systemic steroid due to ISSNHL. A multicenter, randomized, double-blind clinical trial was performed. Fifty-six patients with ISSNHL were allocated to either EGb761 or placebo. In both groups, methylprednisolone was administered for 14 days. EGb761 was infused intravenously for 5 days in the EGb761 group, while the same amount of normal saline was infused in the placebo group. For the efficacy evaluation, pure-tone audiometry, speech audiometry, tinnitus handicap inventory (THI) and short form-36 health (SF-36) survey outcomes were obtained before administration and on days 3, 5, 14 and 28 of administration. Twenty-four patients in each group completed the study protocol. There was no difference in hearing loss between the two groups before treatment. At day 28, air conduction threshold values in the placebo and EGb761 groups were 34.63 ± 28.90 and 23.84 ± 25.42 dB, respectively (p = 0.082). Speech discrimination scores in the placebo and EGb761 groups were 69.17 ± 40.89 and 87.48 ± 28.65 %, respectively (p = 0.050). THI and SF-36 scores in the placebo and EGb761 groups were similar. Although a combination of steroid and EGb761 for initial treatment did not show better pure tone threshold, compared with steroid alone, speech discrimination was significantly improved in combination therapy. Further studies will be needed to know if addition of EGb761 actually improves the outcome of ISSNHL 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. 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.

  18. Plant and safety system model

    International Nuclear Information System (INIS)

    Beltracchi, Leo

    1999-01-01

    The design and development of a digital computer-based safety system for a nuclear power plant is a complex process. The process of design and product development must result in a final product free of critical errors; operational safety of nuclear power plants must not be compromised. This paper focuses on the development of a safety system model to assist designers, developers, and regulators in establishing and evaluating requirements for a digital computer-based safety system. The model addresses hardware, software, and human elements for use in the requirements definition process. The purpose of the safety system model is to assist and serve as a guide to humans in the cognitive reasoning process of establishing requirements. The goals in the use of the model are to: (1) enhance the completeness of the requirements and (2) reduce the number of errors associated with the requirements definition phase of a project

  19. 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

  20. 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.

  1. Efficacy and safety of vernakalant in patients with atrial flutter

    DEFF Research Database (Denmark)

    Camm, A John; Toft, Egon; Torp-Pedersen, Christian

    2012-01-01

    AIMS: Vernakalant is a novel, relatively atrial-selective antiarrhythmic agent for conversion of atrial fibrillation (AF) to sinus rhythm. This study examined the safety and efficacy of vernakalant in converting atrial flutter (AFL) to sinus rhythm. METHODS AND RESULTS: This was a phase 2....... The primary efficacy outcome was the proportion of patients who had treatment-induced conversion of AFL to sinus rhythm for a minimum duration of 1 min within 90 min after the start of the first infusion. No patient in the placebo group met the primary outcome. Only one patient receiving vernakalant (1 of 39......, 3%) converted to sinus rhythm. A reduced mean absolute ventricular response rate occurred within 50 min in patients receiving vernakalant (mean change from baseline -8.2 b.p.m.) vs. patients receiving placebo (-0.2 b.p.m.) (P = 0.037). A post-hoc analysis revealed that vernakalant increased AFL...

  2. 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.

  3. Efficacy and safety of ginger in osteoarthritis patients

    DEFF Research Database (Denmark)

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

    2015-01-01

    oral ginger treatment with placebo in OA patients aged >18 years. Outcomes were reduction in pain and reduction in disability. Harm was assessed as withdrawals due to adverse events. The efficacy effect size was estimated using Hedges' standardized mean difference (SMD), and safety by risk ratio (RR......). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). Out of 122 retrieved references, 117 were discarded, leaving five trials (593 patients) for meta-analyses. The majority reported relevant randomization procedures and blinding, but an inadequate.......04)]; P = 0.01; I(2) = 0%]) were seen, both in favor of ginger. Patients given ginger were more than twice as likely to discontinue treatment compared to placebo ([RR = 2.33; 95% CI: (1.04, 5.22)]; P = 0.04; I(2) = 0%]). Ginger was modestly efficacious and reasonably safe for treatment of OA. We judged...

  4. Etanercept therapy in rheumatoid arthritis: Efficacy and safety

    Directory of Open Access Journals (Sweden)

    Ilić Tatjana

    2013-01-01

    Full Text Available Introduction. Etanercept, tumor necrosis factor (TNFα antagonist, lowers the disease activity level in patients with rheumatoid arthritis (RA, reduces joint destruction saving physical functions and improving life quality. Objective. The aim of this study was to establish efficacy and safety of etanercept in combination with disease modifying antirheumatic drugs (DMARDs in the treatment of RA. Methods. To patients with active RA, who were on therapy with DMARD, etanercept was introduced in weekly doses of 50 mg, with continuation of DMARD. Efficacy of this form of treatment was evaluated in the 12th week. Maintenance of the effect of treatment was also evaluated during 24, 48 and 96 weeks. Long term evaluation of etanercept safety was assessed by registering all unwanted events during a two year period. Results. After 12 weeks of treatment with etanercept, 80% of patients had ACR20 response, while 85% showed clinically significant decrease of DAS28 index. We achieved remission in five patients (12.5% and low activity of RA in 17 patients (42.5%. During a 96week of followup period, achieved therapy effects were maintained. In four patients (10% etanercept therapy was interrupted after 24 weeks because of inadequate response. In one of them (2.5% we recorded a cardiovascular incident. Acute infections were registered in 47 cases. Four of those were severe infections. Neither cases of malignancy development were noted, nor were there any lethal disease outcomes. Conclusion. Etanercept in combination with DMARD shows a high level of efficacy in the treatment of RA. The safety profile of the drug is satisfactory.

  5. 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.

  6. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study.

    Science.gov (United States)

    Denton, Christopher P; Hachulla, Éric; Riemekasten, Gabriela; Schwarting, Andreas; Frenoux, Jean-Marie; Frey, Aline; Le Brun, Franck-Olivier; Herrick, Ariane L

    2017-12-01

    To determine the effect of selexipag, an oral, selective IP prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (RP) in patients with systemic sclerosis (SSc). Patients with SSc-related RP were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 μg twice daily) during a 3-week titration period. The primary end point was the weekly average number of RP attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of RP attacks. Other outcome measures included Raynaud's Condition Score (RCS), RP attack duration, and treatment-emergent adverse events (AEs). Baseline characteristics were comparable between treatment groups. For 83.3% of patients, the individualized maintenance dosage of selexipag was ≤800 μg twice daily. No significant difference was observed between placebo and selexipag in weekly average number of electronic diary (eDiary)-recorded RP attacks during the maintenance period (14.2 attacks during the maintenance period and 21.5 attacks during the baseline week in the placebo group [n = 32] versus 18.0 attacks during the maintenance period and 22.4 attacks during the baseline week in the selexipag group [n = 27]; adjusted mean treatment difference of 3.4 in favor of placebo). No significant treatment effect was observed on RCS or RP attack duration. In the double-blind period, 86.8% of placebo-treated patients and 100% of selexipag-treated patients reported ≥1 AE; 55.3% and 91.7%, respectively, reported ≥1 prostacyclin-associated AE. Treatment with selexipag did not reduce the number of RP attacks compared with placebo. The safety profile of selexipag was similar to that previously reported. This study provides important information about the feasibility of eDiary reporting of RP attacks in clinical trials. © 2017, American College of Rheumatology.

  7. 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.

  8. 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.

  9. 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.

  10. Linagliptin: farmacology, efficacy and safety in type 2 diabetes treatment.

    Science.gov (United States)

    Guedes, Erika Paniago; Hohl, Alexandre; de Melo, Thais Gomes; Lauand, Felipe

    2013-05-22

    Type 2 diabetes mellitus (T2DM) has a high prevalence and incidence around the world. The complex pathophysiology mechanism is among the barriers for diabetes treatment. Type 2 diabetes patients have dysfunction in incretin hormones (as glucagon-like peptide-1 or GLP-1, and glucose-dependent insulinotropic polypeptide or GIP). By inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme, it is possible to slow the inactivation of GLP-1 and GIP, promoting blood glucose level reduction in a glucose-dependent manner. Linagliptin is a highly specific and potent inhibitor of DPP-4 that is currently indicated for the treatment of type 2 diabetes. Clinical studies with linagliptin demonstrated efficacy in reducing glycated hemoglobin (HbA1c) levels in type 2 diabetes patients, while maintaining a placebo-like safety and tolerability profile. Linagliptin has an interesting pharmacokinetic profile in terms of its predominantly non-renal elimination and the main implication of this characteristic is that no dose adjustment is necessary in patients with renal disease. Also, no dose adjustment is required in patients with hepatic insufficiency, as well in elderly or obese patients. This article will review the pharmacokinetic profile, efficacy data and safety aspects of linagliptin in type 2 diabetes patients.

  11. 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.

  12. 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

  13. The efficacy and safety of cilomilast in COPD.

    Science.gov (United States)

    Rennard, Stephen; Knobil, Katharine; Rabe, Klaus F; Morris, Andrea; Schachter, Neil; Locantore, Nicholas; Canonica, Walter G; Zhu, Yuanjue; Barnhart, Frank

    2008-01-01

    The aim of this review is to present the clinical data on the efficacy and safety of cilomilast in patients with chronic obstructive pulmonary disease (COPD). Over 6000 COPD patients received cilomilast during an extensive clinical development programme performed by GlaxoSmithKline (GSK).Five phase III randomized, double-blind, placebo-controlled, parallel-group pivotal studies were conducted in poorly reversible patients (salbutamol). Patients were randomized to receive oral cilomilast 15 mg (n = 2088) or placebo (n = 1408) twice daily for 24 weeks. The co-primary efficacy variables were changes from baseline in trough (predose) FEV(1) and in total score of the St George's Respiratory Questionnaire (SGRQ).Additional studies were performed to investigate the anti-inflammatory actions of cilomilast by measuring inflammatory cells and mediators in biopsies and induced sputum; to assess the long-term effects of cilomilast; to assess the cardiac safety of cilomilast; and to assess the efficacy of cilomilast on hyperinflation. Results from one of the phase III and from one supportive study have been previously published.In the phase III pivotal studies, when averaged over 24 weeks, the mean change from baseline in FEV(1) in the cilomilast group showed improvement compared with placebo in all studies (range 24-44 mL treatment difference). When averaged over 24 weeks, there was a similar improvement in the mean total SGRQ score in both treatment groups with a decrease ranging from -1.8 to -4.2 units in the cilomilast group and 0.4 to -4.9 units in the placebo group. Only one study, however, showed both a statistically and clinically meaningful difference between the two treatment groups (treatment difference -4.1 units; p mechanism of action. However, subsequent phase III studies failed to definitively confirm the earlier programme results, which led to termination of the development of cilomilast.

  14. Efficacy and safety of dopamine agonists in restless legs syndrome.

    Science.gov (United States)

    Hornyak, Magdolna; Trenkwalder, Claudia; Kohnen, Ralf; Scholz, Hanna

    2012-03-01

    Restless legs syndrome (RLS) is a common neurological disorder causing considerable impairment to daily living. This article is an overview of a comprehensive Cochrane meta-analysis on the efficacy and safety of dopamine agonists (DAs), the first-line treatment of RLS. CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL databases were searched for double-blind randomized controlled trials (RCTs) of DAs vs placebo. Thirty-five placebo-controlled RCTs (total number of patients=6954) were eligible. The likelihood of bias was considered to be low. The mean treatment duration of the RCTs was 10.3 (standard deviation 7.3) weeks, with treatment durations up to seven months. Overall, DAs showed a moderate improvement in the International RLS Severity Scale score (mean difference -5.7 points [95% confidence interval, CI, -6.7 to -4.7; PImpression-Improvement response (risk ratio 1.44 [95% CI 1.34-1.54; P<0.00001]) compared with placebo. Periodic limb movements decreased by -22.38/h (95% CI -27.8 to -16.9; P<0.00001) for DAs compared with placebo. Sleep quality and disease-specific quality of life increased slightly to moderately. Safety data confirmed the established safety characteristics of DAs. Augmentation, a specific side-effect of dopaminergic treatment of RLS, was not assessed adequately. This meta-analysis showed that DAs have moderate efficacy in the treatment of RLS. Actively controlled and long-term studies are still lacking. Large-scale comparative studies are needed to identify the most efficient treatments for this chronic disorder. Copyright © 2011 Elsevier B.V. All rights reserved.

  15. 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.

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

    OpenAIRE

    A.-M. Beer; A. Neff

    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...

  17. Optimization of nuclear safety systems

    International Nuclear Information System (INIS)

    Beninson, D.; Gonzalez, A.J.

    1981-01-01

    The paper presents an approach for selecting the level of ambition of nuclear safety by a process of optimization based on cost-benefit considerations. Optimization has been incorporated as a requirement for radiation protection, to keep doses ''as low as reasonably achievable''. In radiation protection, optimization takes account of the costs of protection and the costs of the detriment, minimizing the sum of both. Optimization of a nuclear safety system could conceptually treat similarly the cost of potential damages from nuclear accidents and the cost associated with achieving a given level of safety. Within the above framework a method of optimizing the design of nuclear safety systems is presented, and a simple case of redundancy by output voting techniques is given. (author)

  18. 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.

  19. 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....... Secondary outcomes included the number of patients with reduction in pain intensity during transport (NRS ≥ 2), the number of patients with NRS > 3 at hospital arrival, and potential fentanyl-related side effects. RESULTS: Fentanyl reduced pain from before treatment (8, IQR 7-9) to hospital arrival (4, IQR...

  20. Intracameral lidocaine in trabeculectomy. A preliminary safety and efficacy study

    Directory of Open Access Journals (Sweden)

    Lai Jimmy

    2002-01-01

    Full Text Available Purpose: To study the safety and efficacy of intracameral lidocaine as anaesthesia in trabeculectomy for primary open-angle glaucoma. Methods: Trabeculectomy under intracameral anaesthesia using 1% preservative-free lidocaine was performed in 10 patients with primary open-angle glaucoma. Intraoperative pain score, postoperative intraocular pressure (IOP and endothelial cell count at 3 months were recorded. Results: The mean pain score was 1.70 ± 1.34. The mean IOP was lowered from 24.60 ± 8.28 mmHg preoperatively to 14.1 ± 3.11 mm Hg postoperatively. There was no significant decrease in the mean endothelial cell count 3 months after the surgery (P = 0.375. Conclusion: Intracameral lidocaine may be a safe and effective alternative anaesthesia method in trabeculectomy for uncomplicated primary open-angle glaucoma.

  1. 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

    participants and all study staff, including the central readers, were masked to treatment assignment apart from the pharmacist responsible for preparing the study treatments and the pharmacy monitor at each site. The primary endpoint was remyelination at 24 weeks, measured as recovery of affected optic nerve......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, double......-blind, placebo-controlled, phase 2 study (RENEW) was done at 33 sites in Australia, Canada, and Europe in participants (aged 18-55 years) with a first unilateral acute optic neuritis episode within 28 days from study baseline. After treatment with high-dose methylprednisolone (1 g/day, intravenously, for 3...

  2. Safety and efficacy of pegfilgrastim in patients receiving myelosuppressive chemotherapy.

    Science.gov (United States)

    Crawford, Jeffrey

    2003-08-01

    The major dose-limiting toxicity associated with myelosuppressive chemotherapy is neutropenia, which can be ameliorated with proactive administration of granulocyte colony-stimulating factor (G-CSF). Pegfilgrastim is a long-acting G-CSF, recently approved by the Food and Drug Administration. The efficacy and safety of pegfilgrastim administered once/chemotherapy cycle have been evaluated in clinical trials involving patients treated with myelosuppressive chemotherapy for breast cancer, lung cancer, non-Hodgkin's lymphoma, and Hodgkin's disease. Two pivotal phase III trials in patients with breast cancer showed that pegfilgrastim is as effective as filgrastim regarding the primary efficacy end point, which was duration of grade 4 (severe) neutropenia in cycle 1 of myelosuppressive chemotherapy. Secondary end points were the frequency of fever with neutropenia (febrile neutropenia), duration of neutropenia in cycles 2-4, depth of the absolute neutrophil count (ANC) nadir, and time to ANC recovery in cycles 1-4. Once/cycle pegfilgrastim 100 microg/kg or 6 mg was as safe and effective as daily filgrastim 5 microg/kg in reducing the frequency and duration of severe neutropenia. A trend toward a greater reduction in the overall frequency of febrile neutropenia with pegfilgrastim was observed. The availability of pegfilgrastim simplifies the use of prophylactic G-CSF, with the potential to increase patient convenience and adherence in management of chemotherapy-induced neutropenia.

  3. 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

  4. 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.

  5. Safety and efficacy of Bixa orellana (achiote, annatto) leaf extracts.

    Science.gov (United States)

    Stohs, Sidney J

    2014-07-01

    Bixa orellana leaf preparations have been used for many years by indigenous people for a variety of medicinal applications. Published research studies in animals indicate that various extracts of Bixa leaves exhibit antioxidant, broad antimicrobial (antibacterial and antifungal), anti-inflammatory, analgesic, hypoglycemic, and antidiarrheal activities. No studies have specifically assessed the ability of leaf extracts to inhibit urogenital infections although Bixa products have been used in folkloric medicine to treat gonorrhea and other infections. Few human studies have been conducted and published using Bixa leaf preparations. Many more studies have been conducted and published involving Bixa seed (annatto) extracts than with leaf extracts. No subchronic safety (toxicity) studies have been conducted in animals. A 6 month study in humans given 750 mg of leaf powder per day demonstrated no significant or serious adverse effects. Bixa leaf extracts appear to be safe when given under current conditions of use. However, additional human and animal controlled safety and efficacy studies are needed. In addition, detailed chemical analyses are required to establish structure-function relationships. Copyright © 2013 John Wiley & Sons, Ltd.

  6. 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.

  7. Oxycodone combined with opioid receptor antagonists: efficacy and safety.

    Science.gov (United States)

    Davis, Mellar; Goforth, Harold W; Gamier, Pam

    2013-05-01

    A mu receptor antagonist combined with oxycodone (OXY) may improve pain control, reduce physical tolerance and withdrawal, minimizing opioid-related bowel dysfunction and act as an abuse deterrent. The authors cover the use of OXY plus ultra-low-dose naltrexone for analgesia and the use of sustained-release OXY plus sustained-release naloxone to reduce the opioid bowel syndrome. The authors briefly describe the use of sustained-release OXY and naltrexone pellets as a drug abuse deterrent formulation. Combinations of ultra-low-dose naltrexone plus OXY have been in separate trials involved in patients with chronic pain from osteoarthritis and idiopathic low back pain. High attrition and marginal differences between ultra-low-dose naltrexone plus OXY and OXY led to discontinuation of development. Prolonged-release (PR) naloxone combined with PR OXY demonstrates a consistent reduction in opioid-related bowel dysfunction in multiple randomized controlled trials. However, gastrointestinal side effects, including diarrhea, were increased in several trials with the combination compared with PR OXY alone. Analgesia appeared to be maintained although non-inferiority to PR OXY is not formally established. There were flaws to trial design and safety monitoring. Naltrexone has been combined with OXY in individual pellets encased in a capsule. This combination has been reported in a Phase II trial and is presently undergoing Phase III studies. Due to the lack of efficacy the combination of altered low-dose naltrexone with oxycodone should cease in development. The combination of sustained release oxycodone plus naloxone reduces constipation with a consistent benefit. Safety has been suboptimally evaluated which is a concern. Although the drug is commercially available in several countries, ongoing safety monitoring particularly high doses would be important.

  8. 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.

  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. 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.

  11. 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

  12. 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...

  13. System Safety in Aircraft Acquisition

    Science.gov (United States)

    1984-01-01

    Factors Engineering, Master Plan, FY83" (for research) realizes that "Potential hazards in the area of human performance and behavior must also be... aggresive system safety programs -- i.e., the contractor would be exempt from strict liability if, assuming certain other conditions are obtained, he

  14. 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...

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. Oseltamivir efficacy, side effects, and safety in children with influenza

    Directory of Open Access Journals (Sweden)

    Eun Sun Seo

    2010-01-01

    Full Text Available Purpose : Although oseltamivir is widely used for treatment of influenza, few clinical studies of its efficacy and resistance have been performed in Korea. We evaluated the safety, side effects, and efficacy of oseltamivir treatment in Korean pediatric patients. Methods : We analyzed 321 children diagnosed with influenza at Busan St. Mary's Medical Center, Korea, between January 2008 and June 2008 (first study period and November 2008 and January 2009 (second study period. Patients were divided into two groups: those receiving oseltamivir treatment for 5 days and those receiving only symptomatic treatment. We investigated clinical symptoms, side effects, and resistance to oseltamivir. We also identified influenza strains and evaluated resistance to oseltamivir using an influenza virus culture. Results : One hundred eighty-six patients were assigned to the treatment group, and 135 were assigned to the control group. The treatment group showed shorter admission duration (4.4 days compared with controls (5.0 days (P=0.000 and had fewer lower respiratory tract complications compared with controls (P&lt;0.05. No significant statistical difference in the virus antigenic type was observed between the groups. In the first study period, virus culture showed influenza B (41.7% vs. 49.6%, A/H3N2 (7.9% vs. 8.4%, and A/H1N1 (9.4% vs. 6.5%. In the second study period, only A/H1N1 (55.3% vs. 50.0% was isolated, except for one case of A (H3N2 in the treatment group. No differences in short- and long-term side effects, including neuropsychologic side effects, were noted between groups. There was no resistance to oseltamivir before or after treatment in the first study period. Conclusion : Based on our results, we suggest that osetalmivir therapy in pediatric patients is effective.

  20. 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.

  1. Albendazole: a review of anthelmintic efficacy and safety in humans.

    Science.gov (United States)

    Horton, J

    2000-01-01

    This comprehensive review briefly describes the history and pharmacology of albendazole as an anthelminthic drug and presents detailed summaries of the efficacy and safety of albendazole's use as an anthelminthic in humans. Cure rates and 0% egg reduction rates are presented from studies published through March 1998 both for the recommended single dose of 400 mg for hookworm (separately for Necator americanus and Ancylostoma duodenale when possible), Ascaris lumbricoides, Trichuris trichiura, and Enterobius vermicularis and, in separate tables, for doses other than a single dose of 400 mg. Overall cure rates are also presented separately for studies involving only children 2-15 years. Similar tables are also provided for the recommended dose of 400 mg per day for 3 days in Strongyloides stercoralis, Taenia spp. and Hymenolepis nana infections and separately for other dose regimens. The remarkable safety record involving more than several hundred million patient exposures over a 20 year period is also documented, both with data on adverse experiences occurring in clinical trials and with those in the published literature and/or spontaneously reported to the company. The incidence of side effects reported in the published literature is very low, with only gastrointestinal side effects occurring with an overall frequency of just >1% . Albendazole's unique broad-spectrum activity is exemplified in the overall cure rates calculated from studies employing the recommended doses for hookworm (78% in 68 studies: 92%, for A. duodenale in 23 studies and 75% for N. americanus in 30 studies), A. lumbricoides (95% in 64 studies), T. trichiura (48% in 57 studies), E. vermicularis (98% in 27 studies), S. stercoralis (62% in 19 studies), H. nana (68% in 11 studies), and Taenia spp. (85% in 7 studies). The facts that albendazole is safe and easy to administer, both in treatment of individuals and in treatment of whole communities where it has been given by paramedical and nonmedical

  2. Efficacy and safety of midostaurin in patients with advanced systemic mastocytosis: 10-year median follow-up of a phase II trial.

    Science.gov (United States)

    DeAngelo, D J; George, T I; Linder, A; Langford, C; Perkins, C; Ma, J; Westervelt, P; Merker, J D; Berube, C; Coutre, S; Liedtke, M; Medeiros, B; Sternberg, D; Dutreix, C; Ruffie, P-A; Corless, C; Graubert, T J; Gotlib, J

    2018-02-01

    Patients with advanced systemic mastocytosis (SM) (e.g. aggressive SM (ASM), SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL)) have limited treatment options and exhibit reduced survival. Midostaurin is an oral multikinase inhibitor that inhibits D816V-mutated KIT, a primary driver of SM pathogenesis. We conducted a phase II trial of midostaurin 100 mg twice daily, administered as 28-day cycles, in 26 patients (ASM, n=3; SM-AHN, n= 17; MCL, n=6) with at least one sign of organ damage. During the first 12 cycles, the overall response rate was 69% (major/partial response: 50/19%) with clinical benefit in all advanced SM variants. With ongoing therapy, 2 patients achieved a complete remission of their SM. Midostaurin produced a ⩾50% reduction in bone marrow mast cell burden and serum tryptase level in 68% and 46% of patients, respectively. Median overall survival for the entire cohort was 40 months, and 18.5 months for MCL patients. Low-grade gastrointestinal side effects were common and manageable with antiemetics. The most frequent grade 3/4 nonhematologic and hematologic toxicities were asymptomatic hyperlipasemia (15%) and anemia (12%). With median follow-up of 10 years, no unexpected toxicities emerged. These data establish the durable activity and tolerability of midostaurin in advanced SM.

  3. 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

  4. 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

  5. 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.

  6. Transbrachial selective carotid DSA in outpatients: safety and efficacy

    International Nuclear Information System (INIS)

    Rosen, T.; Poretti, F.; Vorwerk, D.; Krawczynski, H.

    2003-01-01

    Purpose: To describe safety and efficacy of transbrachial selective carotid digital subtraction angiography (DSA) in outpatients. Materials and Methods: From July 1999 to November 2001, selective carotid angiography was performed in 141 outpatients preferably using a left brachial arterial approach. The average age of the patients was 68 years (range: 39-89 years). After flush aortography through a 4F-pigtail catheter, bilateral selective common carotid artery (CCA) catheterization was performed with 4F-Sidewinder-1 or Sidewinder-2 catheters. In 49 patients, Doppler-sonography was performed before or after arteriography. A total of 41 patients underwent carotid surgery. Results: Selective catheterization of the CCA was successful in 96% of the cases. The diagnostic quality of the opacified aortra and CCA images was good to excellent. The overall complication rate did not exceed 2.1%, and severe complications were not observed. One patient showed transient neurological symptoms and another mild nausea and agitation, probably as toxic reaction to the contrast medium. A single local hematoma developed after unsuccessful puncture of the brachial artery. Conclusion: Transbrachial selective carotid DSA is safe, reliable and well-tolerated in outpatients and achieves a superimposition-free CCA visualization. (orig.) [de

  7. Efficacy and safety of topical tazarotene: a review.

    Science.gov (United States)

    Talpur, Rakhashandra; Cox, Katherine; Duvic, Madeleine

    2009-02-01

    Tazarotene (Tazorac, Avage, Allergan, Inc., Irvine, CA, USA) is a synthetic retinoic acid receptor- betagamma topical retinoid approved for the treatment of plaque psoriasis and acne vulgaris. To review a decade of experience using tazarotene as a monotherapy or as combination therapy for approved and other indications: acne, psoriasis, photoaging, basal cell carcinomas and various keratinization disorders. We reviewed the published literature available on PubMed for safety and efficacy of topical tazarotene gel or cream preparations. Tazarotene, in both gel and cream formulations, has been used both as monotherapy and as an adjuvant therapy. For psoriasis it has been combined with steroids, calcipotriene and phototherapy, and for acne, with antibiotics. Tazarotene has been shown to upregulate the tumor suppressor, tazarotene induced gene 3, which is overexpressed in psoriasis and skin cancer. Adverse effects are limited to mild to moderate local irritation and erythema as seen with the 'retinization period' of other topical retinoid therapies. Daily application of tazarotene is effective with sustained benefits and limited local side effects.

  8. 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

  9. Efficacy and safety of sublingual immunotherapy in children.

    Science.gov (United States)

    Arasi, Stefania; Passalacqua, Giovanni; Caminiti, Lucia; Crisafulli, Giuseppe; Fiamingo, Chiara; Pajno, Giovanni Battista

    2016-01-01

    Allergen immunotherapy (AIT) is currently the only available disease-modifying and aetiological treatment of IgE-mediated diseases. Sublingual allergen immunotherapy (SLIT) constitutes the preferred route of administration of AIT for respiratory allergies in Europe. Recently it has also been approved in the US. Further applications are currently under evaluation, such as IgE-mediated food allergy and IgE-mediated atopic dermatitis. The SLIT safety profile is overall favourable, although local adverse events, usually mild, are described. Most of the meta-analyses confirmed the efficacy of SLIT in reducing symptoms and medication intake in children with allergic diseases. AIT, as an immune-modulating treatment, can modify the natural history of the allergic diseases: reduction of the risk of development of asthma and bronchial hyperreactivity in patients with allergic rhinitis, and reduction of the onset of new sensitizations. A great interest is now devoted to the preventive effects of AIT and, consequently, to the optimal time of initiation.

  10. Analysis of the evidence of efficacy and safety of over-the-counter cough medications registered in Brazil

    OpenAIRE

    Reis,Adriano Max Moreira; Figueras,Albert

    2010-01-01

    The objective of this study was to analyze the level of evidence regarding the efficacy, effectiveness and safety of over-the-counter (OTC) cough medications registered in Brazil. The National Health Surveillance Agency database was used to identify the drugs. Clinical trials, systematic reviews, meta-analyses, and studies on safety were searched on the Medline baseline, the Cochrane Library and SIETES (System of Essential Information in Therapeutics and Health; database in Spanish). Most dru...

  11. 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.

  12. 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

  13. 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...

  14. 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.

  15. Efficacy and safety of diacerein in patients with knee osteoarthritis

    Directory of Open Access Journals (Sweden)

    L. I. Alekseeva

    2017-01-01

    Full Text Available Diacerein (D belongs to a class of symptomatic slow-acting agents, has an original mechanism of action, and is widely used as a diseasemodifying antirheumatic drug to treat osteoarthritis (OA in Russia and many countries of the world. The ability of the drug to affect the main symptoms and progression of OA has been shown in a number of well-organized clinical trials.Objective: to evaluate the efficacy and safety of D in patients with knee OA.Patients and methods. An open-label trial evaluating the efficacy and safety of D (diaflex in patients with knee OA was conducted in accordance with the multicenter program «Osteoarthrosis: Assessment of Progression in Real Clinical Practice». The trial included 80 patients of both sexes with Stage II–III knee OA; mean age, 60.8±6.8 years (47–75 years; mean body mass index, 31.8±5.9 kg/m2; disease duration, 10.3±5.7 years (2–30 years. The duration of the trial was 9 months (6 months of therapy and 3 months of follow-up.Results. There was a statistically significant reduction in visual analog scale pain on walking just 1 month after therapy initiation (57.1±9.7 and 44.7±13.9 mm; p<0.0001 and a further significant improvement throughout the 6-month therapy. Pain did not increase after the drug was discontinued (the follow-up period was 3 months. The same pattern was observed in the assessment of the WOMAC index (pain during early therapy, 243.8±73.9; pain at the end of therapy, 137.5±78.9; stiffness, 97.8±41.1 and 57.7±38.6; functional failure, 875.8±250.4 and 525±305.7 respectively; p<0.0001. Statistically significantly improved quality of life indicators measured by EQ-5D were noted throughout the follow-up period: 0.43±0.23 at the beginning of therapy, 0.61±0.14 at its end, and 0.63±0.11 at 3 months following treatment completion (p<0.0001. By the time of therapy completion, 71.3% of the patients completely refused to take nonsteroidal anti-inflammatory drugs (NSAIDs. Both

  16. Efficacy and safety of garenoxacin tablets on clinically diagnosed atypical pneumonia: postmarketing surveillance in Japan.

    Science.gov (United States)

    Izumikawa, Koichi; Watanabe, Akira; Miyashita, Naoyuki; Ishida, Tadashi; Hosono, Hiroaki; Kushimoto, Satoru; Kohno, Shigeru

    2014-09-01

    We performed a postmarketing surveillance study to determine the efficacy and safety of the oral quinolone antibacterial agent garenoxacin (Geninax(®) Tablets 200 mg) against atypical pneumonia. Between October 2009 and July 2011, patients with community-acquired pneumonia visited 26 facilities in Japan; we collected survey forms from 105 of these patients who were suspected of having atypical pneumonia based on the Japanese Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults. We examined the safety in 105 patients and the efficacy in 71 patients. 1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients) and 92.3% (12/13 patients), respectively. The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain). 2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively. In conclusion, garenoxacin showed an efficacy rate of greater than 90% for suspected atypical pneumonia and confirmed atypical pneumonia. Garenoxacin is considered to be useful in daily practice. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  17. Efficacy and safety of herbal medicines in treating gastric ulcer: A review

    Science.gov (United States)

    Bi, Wei-Ping; Man, Hui-Bin; Man, Mao-Qiang

    2014-01-01

    Gastric ulcer is a common disorder of the digestive system. Current therapeutic regimens largely rely on Western medicine. However, numerous studies have demonstrated that herbal medicines can effectively treat gastric ulcer in humans and various animal models via divergent mechanisms. This review updates the efficacy and safety of herbal medicines in treating gastric ulcer, and the mechanisms of their action in humans and animal models. Studies have demonstrated that the efficacy of herbal medicines is comparable or superior to that of drugs such as omeprazole or cimetidine in humans and animal models, and herbal medicines display fewer adverse effects. The mechanisms by which herbal medicines benefit gastric ulcer include stimulation of mucous cell proliferation, anti-oxidation, and inhibition of gastric acid secretion and H(+)/K(+)-ATPase activity. Some herbal medicines also exhibit antimicrobial properties. Utilization of herbal medicines could be a valuable alternative to treat gastric ulcer in humans effectively, with few adverse effects. PMID:25493014

  18. Efficacy and safety of bazedoxifene for postmenopausal osteoporosis

    Science.gov (United States)

    Kawate, Hisaya; Takayanagi, Ryoichi

    2011-01-01

    Bazedoxifene, a novel selective estrogen receptor modulator, has been developed to have favorable effects on bone and the lipid profile while minimizing stimulation of uterine or breast tissues. Two large Phase III clinical trials showed that bazedoxifene, as well as raloxifene, increased bone mineral density, decreased levels of bone turnover markers, and significantly reduced the risk of new vertebral fractures in postmenopausal women compared with placebo. Although the incidence of nonvertebral fractures with bazedoxifene or raloxifene did not differ significantly from that with placebo, a post hoc analysis of a subgroup of women at higher fracture risk revealed that bazedoxifene significantly reduced the nonvertebral fracture risk relative to placebo and raloxifene. Bazedoxifene also improved the lipid profile by reducing the serum concentrations of total cholesterol and low-density lipoprotein cholesterol, with an increase in the serum level of high-density lipoprotein cholesterol. The incidences of vasodilatation (hot flushes), leg cramps, and venous thromboembolic events were significantly higher with bazedoxifene and raloxifene compared with placebo. There was no evidence of endometrial and breast stimulation with bazedoxifene. Taking advantage of the favorable effects of bazedoxifene on the breast and endometrium, the pairing of bazedoxifene with conjugated estrogens is under investigation for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis. A Phase III trial showed that combination therapy of bazedoxifene and conjugated estrogens significantly increased bone mineral density and decreased bone turnover markers, with relief of hot flushes and improvement of vaginal atrophy. This article reviews the clinical efficacy and safety of bazedoxifene in the treatment of postmenopausal osteoporosis. PMID:21753870

  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 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.

  1. Efficacy and safety of ingredients found in preworkout supplements.

    Science.gov (United States)

    Eudy, Anne E; Gordon, Lindsay L; Hockaday, Brandon C; Lee, Daniel A; Lee, Vivianne; Luu, Daniel; Martinez, Carlos A; Ambrose, Peter J

    2013-04-01

    Published evidence on common ingredients of "energy drinks" and other dietary supplements widely used by consumers in hopes of enhancing athletic performance is reviewed. Preworkout products- unregulated dietary supplements- typically contain "proprietary blends" of multiple ingredients, including caffeine, dimethylamylamine, creatine, arginine, β-alanine, taurine, and phosphates. While some dietary supplement labels instruct consumers to seek the advice of a health care professional before using the products, the labels usually do not disclose all ingredients or their precise amounts, and evidence to support the purported performance-enhancing benefits is generally lacking. There is limited evidence to support the use of some preworkout supplement ingredients. For example, in one small placebo-controlled study (n = 12), the use of the energy drink Red Bull (containing caffeine and taurine) 40 minutes before a simulated cycling time trial appeared to provide a meaningful ergogenic benefit; in another small study (n = 12), the use of a similar caffeine-containing product (Redline) by strength-trained athletes was found to improve reaction time, energy, and mental focus relative to placebo use. However, published evidence on the use of the other ingredients listed above is scant, inconclusive, or conflicting. Adverse effects reported in association with preworkout supplements include gastrointestinal symptoms, cardiac arrhythmia, blood pressure increases, and potential effects on lipids and blood glucose. Although evidence exists to support the performance-enhancement efficacy of some preworkout ingredients as standalone agents, published data on combination products are scant, inconclusive, or conflicting. The safety of these products may be compromised if users consume larger-than-recommended amounts or use more than one product.

  2. Efficacy and safety of instrumentation in caries spine

    Directory of Open Access Journals (Sweden)

    Basu Saumyajit

    2006-01-01

    Full Text Available Background: Spinal instrumentation may be used in tuberculosis of spine for prevention or correction of deformity. Methods: Thirty eight patients of caries spine underwent surgery with spinal instrumentation in the last 3 years. Out of these patients, 30 cases have completed a minimum follow-up of 9 months (Range 9 to 39 months, mean 12.8 months. The regional distribution was 1 in the craniocervical junction, 7 in the subaxial cervical spine, 3 in the cervicothoracic junction, 3 in the thoracic region, 4 in the thoracolumbar junction and 8 in the lumbar region and 1 in the lumbosacral junction. All the cases had anterior lesions except one, which had both anterior and posterior lesions. All of them had decompression, debridement of the lesion and instrumented fusion. Indication of surgery was caries spine with neurodeficit and /or osseous destruction and deformity, which was not responding to conservative treatment of one month. Results: Results were analyzed keeping in mind the clinical and radiological criteria. The former included recovery of pain, and neural deficit with a feeling of general well being. The latter included correction of deformity and evidence of fusion. There was no case which had wound healing/infection related problems. Complications included one case of implant failure and one case of transient neurological deterioration. Results were excellent in 20, good in 5, fair in one and poor in one patient. Majority of the patients were very satisfied with the surgery and all the patients had full anti-tubercular chemotherapy for one year. Conclusions: In properly selected patients, spinal instrumentation is justified because of its safety and efficacy in achieving deformity correction and solid fusion.

  3. 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. PMID:24062793

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

    Directory of Open Access Journals (Sweden)

    A.-M. Beer

    2013-01-01

    Full Text Available 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. 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....... Bevacizumab and triamcinolone were excluded. OUTCOME MEASURES: Efficacy outcomes were mean change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study scale) and the percentage of patients gaining ≥ 15 letters. Safety outcome was the percentage of patients with increased intraocular...

  6. Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

    Directory of Open Access Journals (Sweden)

    Iborra M

    2014-02-01

    Full Text Available Marisa Iborra,1 Diego Álvarez-Sotomayor,2 Pilar Nos1 1Gastroenterology Unit, Department of Digestive Disease, Centro de investigación biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD, La Fe University and Polytechnic Hospital, Valencia, Spain; 2Gastroenterology Unit, Department of Digestive Disease, La Fe University and Polytechnic Hospital, Valencia, Spain Abstract: Ulcerative colitis (UC is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon. Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide's usefulness in treating active mild to moderate ileocecal Crohn's disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide's efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide's long-term safety and efficacy in treating UC. Keywords: budesonide, ulcerative colitis, Crohn's disease, safety

  7. 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.

  8. 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.

  9. 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.

  10. 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 ...

  11. 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...

  12. 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...

  13. 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.

  14. Simultaneous bilateral laser in situ keratomileusis: safety and efficacy.

    Science.gov (United States)

    Gimbel, H V; van Westenbrugge, J A; Penno, E E; Ferensowicz, M; Feinerman, G A; Chen, R

    1999-08-01

    To compare the safety and efficacy of simultaneous bilateral to sequential bilateral laser in situ keratomileusis (LASIK) surgery for the correction of myopia. Retrospective, nonrandomized, comparative trial. A total of 2142 consecutive simultaneous and sequential bilateral myopic LASIK surgery eyes operated from March 1996 through June 1998 for the correction of myopia were reviewed. Two surgeons (HVG and JAV) performed myopic LASIK using the Nidek EC-5000 excimer laser and either the Chiron Automated Corneal Shaper or the Bausch & Lomb Hansatome microkeratome. The incidence of intra- or perioperative complications for sequential and simultaneous bilateral LASIK for myopia was recorded. Refractive and visual outcomes at 3 to 6 months postoperative were analyzed. Deviations from targeted spherical equivalent (SE), uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and retreatment rates are reported. Laser in situ keratomileusis was performed on the first eye of 1853 patients scheduled for simultaneous bilateral myopic LASIK. Of these, 28 (1.5%) first eyes had intraoperative or perioperative complications. The second eye surgery was cancelled in 11 cases, and 1842 second eyes completed simultaneous surgery; 13 (0.7%) intraoperative or perioperative complications occurred. Of these 41 complications in simultaneous cases, 1 eye lost 1 line of BCVA at 6 months follow-up. Two hundred eighty-nine patients were scheduled for sequential bilateral myopic LASIK. Five (1.8%) first eyes of the sequential cases had intraoperative complications compared with four (1.4%) sequential second eyes. There was no loss of BCVA in any sequential bilateral case with complications at a minimum at 6 months follow-up. There was no statistically significant difference between intra- and perioperative complication rates comparing simultaneous to sequential bilateral LASIK. Three to 6 months postoperative visual and refractive data were reviewed; except when comparing

  15. Sub system and component level safety classification evaluation and identification for tank farm safety systems

    International Nuclear Information System (INIS)

    JANICEK, G.P.

    2001-01-01

    This document provides the safety classification, and classification rationale, for all elements of (some) Tank Farm Safety Systems identified in the Tank Farms Final Safety Analyses. It also contains the official Safety Equipment List (SEL) for the safety systems evaluated. The initial issue of this document does not address all Tank Farm safety systems. The remainder will be addressed, and incorporated in this document, in subsequent revisions

  16. 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)

  17. 76 FR 14592 - Safety Management System; Withdrawal

    Science.gov (United States)

    2011-03-17

    ...-06A] RIN 2120-AJ15 Safety Management System; Withdrawal AGENCY: Federal Aviation Administration (FAA... (``product/ service providers'') to develop a Safety Management System (SMS). The FAA is withdrawing the... management with a set of robust decision-making tools to use to improve safety. The FAA received 89 comments...

  18. 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

  19. 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...

  20. 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

  1. System Design and the Safety Basis

    Energy Technology Data Exchange (ETDEWEB)

    Ellingson, Darrel

    2008-05-06

    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 & decommissioning (D&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.

  2. 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

  3. Safety System for a Towed Array

    Science.gov (United States)

    2017-09-25

    300196 1 of 13 SAFETY SYSTEM FOR A TOWED SOURCE STATEMENT OF GOVERNMENT INTEREST [0001] The invention described herein may be manufactured...invention is a towed array safety system and method of use that prevents the loss of a towed array cable and towed array handling system in the event of a...tension surge while retaining required safety features of the towed array handling system . (2) Description of the Prior Art [0004] There have

  4. 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)

  5. 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

  6. INTEGRATED SAFETY MANAGEMENT SYSTEM SAFETY CULTURE IMPROVEMENT INITIATIVE

    Energy Technology Data Exchange (ETDEWEB)

    MCDONALD JA JR

    2009-01-16

    In 2007, the Department of Energy (DOE) identified safety culture as one of their top Integrated Safety Management System (ISMS) related priorities. A team was formed to address this issue. The team identified a consensus set of safety culture principles, along with implementation practices that could be used by DOE, NNSA, and their contractors. Documented improvement tools were identified and communicated to contractors participating in a year long pilot project. After a year, lessons learned will be collected and a path forward determined. The goal of this effort was to achieve improved safety and mission performance through ISMS continuous improvement. The focus of ISMS improvement was safety culture improvement building on operating experience from similar industries such as the domestic and international commercial nuclear and chemical industry.

  7. Safety and Efficacy of Cyclosporine in the Treatment of Chronic Dry Eye

    Directory of Open Access Journals (Sweden)

    Clyde Schultz

    2014-01-01

    Full Text Available Dry-eye syndrome (DES is a multifactorial disease affecting millions of individuals worldwide. Various factors, including age, hormonal status, genetics, sex, immune status, innervation status, nutrition, pathogens, and environmental stress, can alter the cellular and molecular structure or function of components of the ocular surface system. The resulting imbalance increases susceptibility to desiccation and epithelial damage, leading to a vicious circle in which inflammation amplifies and sustains further damage by chronic deregulation of the system. Lubricating agents and steroids have been used as treatment options. However, as the causes of the disease become better elucidated, the more chemically complex cyclosporine A has become an increasingly useful treatment option and in the United States is currently the only Food and Drug Administration (FDA-approved prescription drug for the treatment of dry eye. The safety and efficacy of cyclosporine have been shown in numerous studies.

  8. Resolute Integrity drug eluting stent safety and efficacy for the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Burgos JD

    2013-02-01

    Full Text Available Jose D Burgos, Safa Farrag, Debabrata Mukherjee Department of Internal Medicine, Paul L Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, TX, USA Abstract: The need to develop a local antirestenotic mechanism to prevent in-stent thrombosis has driven the development of new generation stents. The Resolute Integrity® stent is a zotarolimus-eluting system with a new BioLinx™ polymer that allows a slower drug elution. Recently available data has shown the clinical efficacy and safety of this stent in randomized and observational studies. The Resolute Integrity stent system has demonstrated noninferiority when compared with other stents and holds the promise to treat more complex coronary lesions. Keywords: zotarolimus, BioLinx, coronary stenosis, stents, restensosis, stent thrombosis

  9. 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....

  10. Safety-Critical Java for Embedded Systems

    DEFF Research Database (Denmark)

    Rios Rivas, Juan Ricardo

    Safety-critical systems are real-time systems whose failure can have severe or catastrophic consequences, possibly endangering human life. Many safety-critical systems incorporate embedded computers used to control different tasks. Software running on safety-critical systems needs to be certified...... before its deployment and the most time-consuming step of this process is the testing and verification phase. Due to the increasing complexity in safety-critical systems there is a need for new technologies that can facilitate testing and verification activities. The safety-critical specification...... for Java aims at providing a reduced set of the Java programming language that can be used for systems that need to be certified at the highest levels of criticality. Safety-critical Java (SCJ) restricts how a developer can structure an application by providing a specific programming model...

  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. 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

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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

  18. 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.

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

    African Journals Online (AJOL)

    Most believed that spiritual remedies are safe during pregnancy (94.2%) and in labour and pueperium (97.9%); and herbs are safe during labour and pueperium (91.0%). Conclusion: Health authorities in Nigeria should institutionalize structures for censoring, training, regulation of TM practice and safety of remedies used.

  20. Fingolimod Real World Experience: Efficacy and Safety in Clinical Practice

    OpenAIRE

    Fonseca, Joaquim

    2015-01-01

    Fingolimod is a multiple sclerosis treatment licensed in Europe since 2011. Its efficacy has been demonstrated in three large phase III trials, used in the regulatory submissions throughout the world. As usual, in these trials the inclusion and exclusion criteria were designed to obtain a homogeneous population, with interchangeable characteristics in the different treatment arms. Although this is the best strategy to achieve a robust answer to the investigation question, it does not guaranty...

  1. 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.

  2. 77 FR 70409 - System Safety Program

    Science.gov (United States)

    2012-11-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Railroad Administration 49 CFR Part 270 2130-AC31 System Safety Program AGENCY: Federal Railroad... commuter and intercity passenger railroads to develop and implement a system safety program (SSP) to...

  3. 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

  4. Opportunistic Sensing in Train Safety Systems

    NARCIS (Netherlands)

    Scholten, Johan; Bakker, Pascal

    2011-01-01

    Train safety systems are complex and expensive, and changing them requires huge investments. Changes are evolutionary and small. Current developments, like faster - high speed - trains and a higher train density on the railway network, have initiated research on safety systems that can cope with the

  5. Safety and efficacy of a novel cannabinoid chemotherapeutic, KM-233, for the treatment of high-grade glioma.

    Science.gov (United States)

    Duntsch, Christopher; Divi, Murali Krishna; Jones, Terreia; Zhou, Qihong; Krishnamurthy, Mathangi; Boehm, Peter; Wood, George; Sills, Allen; Moore, Bob M

    2006-04-01

    To test in vitro and in vivo the safety and efficacy of a novel chemotherapeutic agent, KM-233, for the treatment of glioma. In vitro cell cytotoxicity assays were used to measure and compare the cytotoxic effects of KM-233, Delta(8)-tetrahydrocannabinol (THC), and bis-chloroethyl-nitrosurea (BCNU) against human U87 glioma cells. An organotypic brain slice culture model was used for safety and toxicity studies. A human glioma-SCID mouse side-pocket tumor model was used to test in vivo the safety and efficacy of KM-233 with intratumoral and intra-peritoneal administration. KM-233 is a classical cannabinoid with good blood brain barrier penetration that possesses a selective affinity for the CB2 receptors relative to THC. KM-233 was as efficacious in its cytotoxicity against human U87 glioma as Delta(8)-tetrahydrocannabinol, and superior to the commonly used anti-glioma chemotherapeutic agent, BCNU. The cytotoxic effects of KM-233 against human glioma cells in vitro occur as early as two hours after administration, and dosing of KM-233 can be cycled without compromising cytotoxic efficacy and while improving safety. Cyclical dosing of KM-233 to treat U87 glioma in a SCID mouse xenograft side pocket model was effective at reducing the tumor burden with both systemic and intratumoral administration. These studies provide both in vitro and in vivo evidence that KM-233 shows promising efficacy against human glioma cell lines in both in vitro and in vivo studies, minimal toxicity to healthy cultured brain tissue, and should be considered for definitive preclinical development in animal models of glioma.

  6. 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...

  7. Computer system reliability safety and usability

    CERN Document Server

    Dhillon, BS

    2013-01-01

    Computer systems have become an important element of the world economy, with billions of dollars spent each year on development, manufacture, operation, and maintenance. Combining coverage of computer system reliability, safety, usability, and other related topics into a single volume, Computer System Reliability: Safety and Usability eliminates the need to consult many different and diverse sources in the hunt for the information required to design better computer systems.After presenting introductory aspects of computer system reliability such as safety, usability-related facts and figures,

  8. Recommendations for the LHC safety alarm system

    CERN Document Server

    Laeger, H

    1999-01-01

    A working group was set up to define the LHC safety alarm system, also known as Alarm-of-Level-3-System (AL3S). The mandate asked for recommendations to be elaborated on four items: the overall concept of the AL3S for machine and experiments, the transmission and display of safety alarms, the AL3S during civil engineering construction, and the transition from the present LEP to the final LHC safety alarm system. The members of the working group represented a wide range of interest and experience including the CERN Fire Brigade, safety officers from experiments and machines, and specialists for safety and control systems. The recommendations highlight the need for a clear definition of responsibilities and procedures, well-engineered homogeneous systems across CERN, and they point to several important issues outside the mandate of the working group. These recommendations were presented, discussed and accepted by several CERN and LHC committees.

  9. ANTIHISTAMINE MEDICATIONS: EFFICACY AND SAFETY OF USING IN PEDIATRIC PRACTICE

    OpenAIRE

    L.R. Giniyatova; O.I. Pikuza; L.Е. Ziganshina

    2010-01-01

    Therapy of allergic and many other diseases using antihistamine medications is the pressing topic in modern medicine. Since the first antihistamine medications were created, knowledge of effects from these drugs have expanded and changed. The article discusses approaches to classification, pharmacological properties, side effects of antihistamine medications, and provides literature review of information about justification for administering and safety of using antihistamine drugs in pediatri...

  10. 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...

  11. Efficacy and safety of carotid artery stenting for stroke prevention

    OpenAIRE

    Elserwi, Ahmed; Amer, Talal; Soliman, Nermin; Gaballa, Ghada M.; Elmokadem, Ali H.

    2016-01-01

    Background: Extracranial carotid artery stenosis is a leading cause of ischemic stroke. Carotid endarterectomy (CEA) is the gold-standard management for secondary stroke prevention yet carotid artery stenting (CAS) has emerged in the last decade as an alternative for high surgical risk patients. Purpose: To assess the effectiveness, safety and outcomes of CAS in extra-cranial carotid artery stenosis patients in terms of stroke prevention. Methodology: Twenty patients with symptomatic an...

  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. Safety and efficacy of incobotulinumtoxinA as a potential treatment for poststroke spasticity

    Science.gov (United States)

    Santamato, Andrea

    2016-01-01

    Spasticity is a common disabling symptom for several neurological conditions. Botulinum toxin type A injection represents the gold standard treatment for focal spasticity after stroke showing efficacy, reversibility, and low prevalence of complications. In recent years, incobotulinumtoxinA, a new Botulinum toxin type A free of complexing proteins, has been used for treating several movement disorders with safety and efficacy. IncobotulinumtoxinA is currently approved for treating spasticity of the upper limb in stroke survivors, even if several studies described the use also in lower limb muscles. In the present review article, we examine the safety and effectiveness of incobotulinumtoxinA for the treatment of spasticity after stroke. PMID:26869793

  14. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

    DEFF Research Database (Denmark)

    Goldstein, S R; Bachmann, G A; Koninckx, P R

    2014-01-01

    6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from...... resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed...

  15. 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...

  16. 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.)

  17. 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. 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.

  18. Safety, Efficacy, and Mechanistic Studies Regarding Citrus aurantium (Bitter Orange) Extract and p‐Synephrine

    OpenAIRE

    Stohs, Sidney J.

    2017-01-01

    Citrus aurantium L. (bitter orange) extracts that contain p‐synephrine as the primary protoalkaloid are widely used for weight loss/weight management, sports performance, appetite control, energy, and mental focus and cognition. Questions have been raised about the safety of p‐synephrine because it has some structural similarity to ephedrine. This review focuses on current human, animal, in vitro, and mechanistic studies that address the safety, efficacy, and mechanisms of action of bitter or...

  19. Efficacy and safety of the PPARγ partial agonist balaglitazone compared with pioglitazone and placebo

    DEFF Research Database (Denmark)

    Henriksen, Kim; Byrjalsen, Inger; Qvist, Per

    2011-01-01

    Treatment of patients with perioxisome proliferator-activated receptor-¿ full agonists are associated with weight gain, heart failure, peripheral oedema, and bone loss. However, the safety of partial perioxisome proliferator-activated receptor-¿ agonists has not been established in a clinical tri....... The BALaglitazone glucose Lowering Efficacy Trial aimed to establish the glucose-lowering effects and safety parameters of the perioxisome proliferator-activated receptor-¿ partial agonist balaglitazone in diabetic patients on stable insulin therapy....

  20. 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.

  1. 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.

  2. Safety and efficacy of colchicine therapy in the prevention of recurrent pericarditis.

    Science.gov (United States)

    Eun, Judy; Smith, Andrew

    2014-08-01

    A review of published data on the safety and efficacy of colchicine therapy for primary and secondary prevention of pericarditis is presented. Colchicine has been used effectively as an antiinflammatory agent for gout and has shown promise as a treatment for acute and recurrent pericarditis. Several small studies have indicated that colchicine can decrease pericarditis symptom persistence at 72 hours and pericarditis recurrence rates at 18 months compared with conventional therapy (corticosteroids and aspirin or ibuprofen). A review of pooled data from four prospective randomized trials concluded that colchicine is safe and efficacious for the management of acute and recurrent pericarditis, with the results indicating lower rates of the respective primary and secondary endpoints of recurrent disease and symptom persistence in colchicine-treated patients. A separate meta-analysis of five studies found a reduced risk of pericarditis with colchicine use, suggesting that the drug may have clinical utility in both primary and secondary prevention. The accumulated evidence suggests that treatment with colchicine in the context of pericarditis is safe and well tolerated, with gastrointestinal intolerance being the most common adverse event documented in the clinical trials to date. Based on a review of the literature, prevention of recurrent pericarditis with colchicine can be considered a safe and effective option, though some patients have experienced gastrointestinal intolerance. Due to evidence that corticosteroids may potentially exacerbate the risk of relapse, colchicine may be a safer and preferable option. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  3. Automated process safety parameters monitoring system

    International Nuclear Information System (INIS)

    Iyudina, O.S.; Solov'eva, A.G.; Syrov, A.A.

    2015-01-01

    Basing on the expertise in upgrading and creation of control systems for NPP process equipment, “Diakont” has developed the automated process safety parameters monitoring system project. The monitoring system is a set of hardware, software and data analysis tools based on a dynamic logical-and-probabilistic model of process safety. The proposed monitoring system can be used for safety monitoring and analysis of the following processes: reactor core reloading; spent nuclear fuel transfer; startup, loading, on-load operation and shutdown of an NPP turbine [ru

  4. System safety management: A new discipline

    Science.gov (United States)

    Pope, W. C.

    1971-01-01

    The systems theory is discussed in relation to safety management. It is suggested that systems safety management, as a new discipline, holds great promise for reducing operating errors, conserving labor resources, avoiding operating costs due to mistakes, and for improving managerial techniques. It is pointed out that managerial failures or system breakdowns are the basic reasons for human errors and condition defects. In this respect, a recommendation is made that safety engineers stop visualizing the problem only with the individual (supervisor or employee) and see the problem from the systems point of view.

  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. 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.

  7. 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

  8. 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.

  9. Safety features of subcritical fluid fueled systems

    International Nuclear Information System (INIS)

    Bell, Charles 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. 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.

  12. Effect of a Low-Dose Contraceptive Patch on Efficacy, Bleeding Pattern, and Safety

    Science.gov (United States)

    Wiegratz, Inka; Bassol, Susana; Weisberg, Edith; Mellinger, Uwe

    2014-01-01

    This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD. Participants were women aged 18 to 35 years, all of whom received the EE/GSD patch for 13 cycles each of 21 treatment days (one patch per week for 3 weeks) followed by a 7-day, patch-free interval. The primary efficacy variable was the occurrence of unintended pregnancies during the study period as assessed by life table analysis and the Pearl Index. Secondary efficacy variables were days with bleeding during four 90-day reference periods and during 1 treatment year, bleeding pattern, and cycle control. The Kaplan-Meier probability of contraceptive protection after 364 treatment days was 98.8% and the adjusted Pearl Index was 0.81. The percentage of participants with intracyclic bleeding/spotting decreased over time, from 11.4% to 6.8% in cycles 1 and 12, respectively. Almost all participants (range: 90.8%-97.6%) experienced withdrawal bleeding across the study period. Compliance was very high (mean: 97.9%; median: 100%). The most frequent adverse events were headache (9.5%) and application site reaction (8.5%); no clinically significant safety concerns were observed. Results suggest the EE/GSD patch is highly effective in preventing pregnancy. Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population. The patch was well tolerated and treatment compliance was high. PMID:24784719

  13. 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

  14. 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...

  15. 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

  16. 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.

  17. Prestandardisation Activities for Computer Based Safety Systems

    DEFF Research Database (Denmark)

    Taylor, J. R.; Bologna, S.; Ehrenberger, W.

    1981-01-01

    Questions of technical safety become more and more important. Due to the higher complexity of their functions computer based safety systems have special problems. Researchers, producers, licensing personnel and customers have met on a European basis to exchange knowledge and formulate positions...

  18. 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....... 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...

  19. 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.

  20. Diagnostic yield, safety, and efficacy of push enteroscopy in pediatrics.

    Science.gov (United States)

    Darbari, Anil; Kalloo, Anthony N; Cuffari, Carmen

    2006-08-01

    Push enteroscopy has not been compared to standard endoscopy in children. The aim of this study was to determine the feasibility of push enteroscopy in children with suspected proximal small bowel disease, and to compare its diagnostic yield and safety with standard endoscopy. Database review. A database analysis was performed on all children who underwent push enteroscopy at The Johns Hopkins Children's Center from 2001 to 2005. Patient demographics, clinical history, and indication for push enteroscopy were all recorded. Clinical utility was qualified based on the influence of PE on therapy. Diagnostic yield and safety of push enteroscopy in children. Push enteroscopy was performed on 44 children (27 M; 17 F) with a median age (range) of 10 (2-18) years. The most common indications for push enteroscopy were suspected proximal small bowel disease based on radiological criteria (21), and bleeding (9). Push enteroscopy confirmed the diagnosis of proximal small bowel Crohn's disease (CD) in 23, polyps in 5, eosinophilic gastroenteritis in 4, celiac disease in 1, microvillous inclusion disease in 1, and lymphoproliferative disease in 1 patient. An isolated non-Crohn's related gastric (1) and jejunal ulcer (1) was also identified. Just 9 of these identifiable lesions were within reach by esophagogastroduodenoscopy (EGD). Seven patients had a normal push enteroscopy. The clinical management was modified in 34 patients. Push enteroscopy was not shown to significantly alter the time of procedure when compared to EGD. Push enteroscopy is a safe diagnostic tool with proven clinical utility in children with suspected proximal small bowel disease. Larger studies are needed to establish the widespread application of push enteroscopy in pediatrics.

  1. 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)

  2. Safety and efficacy of a Labisia pumila var alata water extract on ...

    African Journals Online (AJOL)

    This randomized double-blind, placebo-controlled study investigated the safety and efficacy of Labisia pumila (LP) water extract on sexual health, lipid profile and inflammatory markers in 36 healthy pre-and post-menopausal North American women. Participants were randomized to either LP (200 mg) or placebo for 12 ...

  3. 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

  4. Estradiol gel : review of the pharmacology, pharmacokinetics, efficacy, and safety in menopausal women

    NARCIS (Netherlands)

    Naunton, M.; Al Hadithy, A.F.Y.; Brouwers, J.R.B.J.; Archer, D.F.

    2006-01-01

    Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of a gel containing estradiol that is applied to the skin. Design: MEDLINE and EMBASE searches were conducted from 1966 to March 2005. Additional references were identified from bibliographies from selected studies in

  5. 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...

  6. 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

  7. 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

  8. Safety and efficacy of granulocyte colony-stimulating factor in kidney and liver transplant recipients

    NARCIS (Netherlands)

    Turgeon, N.; Hovingh, G. K.; Fishman, J. A.; Basgoz, N.; Tolkoff-Rubin, N. E.; Doran, M.; Cosimi, A. B.; Rubin, R. H.

    2000-01-01

    Leukopenia is not infrequently encountered following solid organ transplantation, most often in the setting of cytomegalovirus (CMV) disease and/or its treatment with ganciclovir. The present study was undertaken to determine the safety and efficacy of granulocyte colony-stimulating factor (G-CSF)

  9. 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

  10. 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

  11. Safety and Efficacy of Repeated-Dose Intravenous Ketamine for Treatment-Resistant Depression

    NARCIS (Netherlands)

    aan het Rot, Marije; Collins, Katherine A.; Murrough, James W.; Perez, Andrew M.; Reich, David L.; Charney, Dennis S.; Mathew, Sanjay J.

    2010-01-01

    Background: A single subanesthetic (intravenous) IV dose of ketamine might have rapid but transient antidepressant effects in patients with treatment-resistant depression (TRD). Here we tested the tolerability, safety, and efficacy of repeated-dose open-label IV ketamine (six infusions over 12 days)

  12. Efficacy and safety of medical cannabinoids in older subjects: A systematic review

    NARCIS (Netherlands)

    Elsen, G.A.H. van den; Ahmed, A.I.A.; Lammers, M.; Kramers, C.; Verkes, R.J.; Marck, M.A. van der; Olde Rikkert, M.G.M.

    2014-01-01

    This systematic review aims to integrate the evidence on indications, efficacy, safety and pharmacokinetics of medical cannabinoids in older subjects. The literature search was conducted using PubMed, EMBASE, CINAHL and Cochrane Library. We selected controlled trials including solely older subjects

  13. Leadership Styles and Self-Efficacy in Determining Transfer Intentions of Safety Training

    Science.gov (United States)

    Vignoli, Michela; Mariani, Marco Giovanni; Guglielmi, Dina; Violante, Francesco Saverio

    2018-01-01

    Purpose: This study aims to investigate the factors that can influence the transfer process of training in open skills, i.e. non-technical skills (NTS). Specifically, according to the model of the transfer process, the aim of this paper is to analyse the effects of both personal (e.g. self-efficacy) and work environment (e.g. safety leadership…

  14. Safety and efficacy of drug eluting stents in patients with spontaneous coronary artery dissection

    NARCIS (Netherlands)

    Conrotto, Federico; D'Ascenzo, Fabrizio; Cerrato, Enrico; Fernández-Ortiz, Antonio; Gonzalo, Nieves; Macaya, Fernando; Tamburino, Corrado; Barbanti, Marco; van Lavieren, Martijn; Piek, Jan J.; Applegate, Robert J.; Latib, Azeem; Spinnler, Maria Teresa; Marzullo, Raffaella; Iannaccone, Mario; Pavani, Marco; Crimi, Gabriele; Fattori, Rossella; Chinaglia, Alessandra; Presbitero, Patrizia; Varbella, Ferdinando; Gaita, Fiorenzo; Escaned, Javier

    2017-01-01

    Aims: Given the different pathogenesis, use of drug eluting stent (DES) in patients with Spontaneous Coronary Artery Dissection SCAD may delay the healing of the dissected vessel. Aim of our studywas to compare the safety and the efficacy of DES vs. bare metal stent (BMS) in a cohort of patients who

  15. 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.

  16. The safety and efficacy of trans-vesical prostatectomy done at a ...

    African Journals Online (AJOL)

    ... incontinence and sexual dysfunction. to investigate the safety and efficacy of trans-vesical prostatectomy donein a primary general hospital setting with limited facilities in Ethiopia. Methods: This was a prospective cross sectional hospital based non-randomized study with a mean follow up of three months after operation.

  17. 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...

  18. 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

  19. 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

  20. Tiagabine: efficacy and safety in partial seizures – current status

    Directory of Open Access Journals (Sweden)

    Jürgen Bauer

    2008-09-01

    Full Text Available Jürgen Bauer, Déirdre Cooper-MahkornDepartment of Epileptology, Bonn University Hospital, GermanyAbstract: Tiagabine hydrochloride (TGB is a selective gamma-aminobutyric acid (GABA reuptake inhibitor. TGB is effective as an add-on medication in adults and children 12 years and older in the treatment of partial seizures. Results of nonrandomized add-on trials with TGB show treatment success with seizure reduction of at least 50% in 33% to 46% of patients. In newly diagnosed patients with partial epilepsy, TGB monotherapy was as effective as carbamazepine. Comedication with TGB elevates the risk of nonconvulsive status (7.8% vs 2.7% without TGB. The most common side effects include dizziness/lightheadedness, asthenia/lack of energy and somnolence. TGB has no negative effects on cognition; it does not increase the risk of fractures or rash. TGB may interfere with color perception. TGB presents an intermediate risk for depression in patients with epilepsy (approximately 4%. Regarding the risk of overdose, 96–680 mg TGB (mean 224 mg caused seizures or coma. TGB is an antiepileptic drug exhibiting a specific anticonvulsive mechanism of action, the efficacy of which is relatively low when used in comedication. Critical side effects, such as the induction of nonconvulsive status epilepticus, further limit its use.Keywords: epilepsy, tiagabine, antiepileptic drugs, status epilepticus, pharmacotherapy

  1. 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.

  2. 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 ocular symptoms, use of rescue medication, satisfaction with treatment and compliance. Children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis were included in a multinational, randomized, double-blind, placebo-controlled study and received either a 300IR five......-grass pollen tablet or placebo daily in a pre- (4 months) and co-seasonal protocol. The severity of six symptoms (sneezing, rhinorrhoea, nasal congestion, nasal and ocular pruritis, and tearing) was scored, and rescue medication use was recorded daily during the pollen season. Patient satisfaction was recorded...

  3. 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

  4. Clinical impact, safety, and efficacy of single- versus Dual-Coil ICD leads in MADIT-CRT

    DEFF Research Database (Denmark)

    Kutyifa, Valentina; Huth Ruwald, Anne Christine; Aktas, Mehmet K.

    2013-01-01

    Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory.......Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory....

  5. Efficacy and Safety of Daclatasvir in Hepatitis C: An Overview.

    Science.gov (United States)

    Gamal, Nesrine; Gitto, Stefano; Andreone, Pietro

    2016-12-28

    Hepatitis C virus (HCV) infection is a growing public health concern, with 184 million people infected worldwide. During the past decade, interferon has been the backbone of HCV treatment, even though it remains far from ideal. The latest development of the new direct antivirals has drastically changed the treatment approach for chronic hepatitis C (CHC). Inhibitors of the HCV NS5A region have garnered remarkable interest among treating physicians, due to their high potency and favourable safety profile. In particular, treatment with daclatasvir (DCV) has yielded high rates of vriologic response in patients infected with genotype (Gt) 1 and Gt 3, when used in combination with other antivirals of a different class, such as sofosbuvir. Although few data are available for DCV treatment of the other Gts, the results in patients with Gt 2 and Gt 4 infection appear promising, as do those for unique patient populations. NS5A-resistant viral variants can pre-exist or emerge after treatment failure for the HCV NS5A inhibitors. Nonetheless, DCV-resistant viral variants continue to be sensitive to interferon and other classes of antivirals such as NS3/4A and NS5B inhibitors. Herein, we aimed to provide an overview of the current knowledge about DCV in the treatment of CHC.

  6. Safety and efficacy of erenumab for preventive treatment of chronic migraine

    DEFF Research Database (Denmark)

    Tepper, Stewart; Ashina, Messoud; Reuter, Uwe

    2017-01-01

    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......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...... 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...

  7. Efficacy and safety of PPC-5650 on experimental rectal pain in patients with irritable bowel syndrome

    DEFF Research Database (Denmark)

    Nielsen, Lecia Møller; Olesen, Anne Estrup; Andresen, Trine

    2015-01-01

    areas (all p > 0.05). No significant or clinically relevant treatment-related differences were seen for the laboratory safety variables or any other reported adverse event. In conclusion, in patients with IBS on rectal sensitivity to multi-modal stimulations, PPC-5650 did not produce efficacy relative...... bowel syndrome (IBS). In patients with IBS, the aims of the study were: (1) to assess the efficacy of a single bolus of PPC-5650 locally applied in the rectum using multi-modal stimulations of the recto sigmoid and (2) to assess the safety profile of PPC-5650. The study was a randomized, double...... to placebo. The overall safety and tolerability of PPC-5650 was acceptable....

  8. 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)

  9. CDC STATE System Tobacco Legislation - Fire Safety

    Data.gov (United States)

    U.S. Department of Health & Human Services — 1995-2017. Centers for Disease Control and Prevention (CDC). State Tobacco Activities Tracking and Evaluation (STATE) System. Legislation – Fire-Safety. The STATE...

  10. CDC STATE System Tobacco Legislation - Fire Safety

    Data.gov (United States)

    U.S. Department of Health & Human Services — 1995-2018. Centers for Disease Control and Prevention (CDC). State Tobacco Activities Tracking and Evaluation (STATE) System. Legislation – Fire-Safety. The STATE...

  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. Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

    Science.gov (United States)

    Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

    2017-11-01

    Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the

  13. 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

  14. 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

  15. 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

  16. Efficacy and Safety of Ephedra and Ephedrine for Weight Loss and Athletic Performance: A Meta-analysis

    OpenAIRE

    Shekelle, Paul G.; Hardy, Mary; Morton, Sally C.; Maglione, Margaret; Mojica, Walter A.; Suttorp, Marika J.; Rhodes, Shannon L.; Jungvig, Lara; Gagné, James

    2003-01-01

    CONTEXT: Ephedra and ephedrine sometimes are used for weight loss or enhanced athletic performance, but the efficacy and safety of these compounds are uncertain. OBJECTIVE: To assess the efficacy and safety of ephedra and ephedrine used for weight loss and enhanced athletic performance. DATA SOURCES: We searched 9 databases using the terms ephedra, ephedrine, adverse effect, side effect, efficacy, effective, and toxic. We included unpublished trials and non-English-language doc...

  17. 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.

  18. 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,

  19. The Laryngeal Mask Airway Supreme™: safety and efficacy during ...

    African Journals Online (AJOL)

    2011-11-29

    Nov 29, 2011 ... a handheld manometer (Ambu, Ballerup, Denmark) to achieve 60 cmH2O. The number of insertion attempts was recorded. Three attempts were allowed before insertion was considered to be a failure. A circle anaesthesia breathing system was connected (inspired tidal volume 8 ml/kg, respiratory rate of 12 ...

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. Efficacy, safety, and applicability of outpatient treatment for diverticulitis

    Directory of Open Access Journals (Sweden)

    Tursi A

    2014-03-01

    Full Text Available Antonio TursiGastroenterology Service, ASL BAT, Andria BT, ItalyAbstract: Acute diverticulitis of the colon represents a significant burden for national health systems, in terms of direct and indirect costs. Although current guidelines recommend use of antibiotics for the outpatient treatment of acute uncomplicated diverticulitis, evidence for this is still lacking. Hence, significant effort is now being made to identify the appropriate therapeutic approach to treat and prevent relapses of diverticulitis. Outpatient treatment has been identified as a safe and effective therapeutic approach in up to 90% of patients with uncomplicated diverticulitis. It allows important costs saving to health systems without a negative influence on quality of life for patients with uncomplicated diverticulitis, and reduces health care costs by more than 60%.Keywords: diverticulitis, 5-aminosalycilic acid, antibiotics, probiotics, outpatient treatment

  5. Efficacy, safety, and applicability of outpatient treatment for diverticulitis

    Science.gov (United States)

    Tursi, Antonio

    2014-01-01

    Acute diverticulitis of the colon represents a significant burden for national health systems, in terms of direct and indirect costs. Although current guidelines recommend use of antibiotics for the outpatient treatment of acute uncomplicated diverticulitis, evidence for this is still lacking. Hence, significant effort is now being made to identify the appropriate therapeutic approach to treat and prevent relapses of diverticulitis. Outpatient treatment has been identified as a safe and effective therapeutic approach in up to 90% of patients with uncomplicated diverticulitis. It allows important costs saving to health systems without a negative influence on quality of life for patients with uncomplicated diverticulitis, and reduces health care costs by more than 60%. PMID:24729730

  6. Safety systems (AL3) and systems relevant to Safety

    CERN Document Server

    Hutchins, S

    2009-01-01

    The AL3 systems are basic life protection and are especially important during the shutdown; there should be no point in the LHC underground areas in which a person is not or cannot be informed of the dangers around him when they exist and so take appropriate action. The implantation of the different detection and alarm systems will be reviewed and their performance and reliability examined. The need for fire doors to control released Helium will also be considered, which may have consequences for the ventilation and access systems.

  7. 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.

  8. Efficacy and safety of an oral device to reduce food intake and promote weight loss.

    Science.gov (United States)

    Ryan, D H; Parkin, C G; Longley, W; Dixon, J; Apovian, C; Bode, B

    2018-02-01

    Minimal risk weight loss tools are needed. This study's objective was to confirm Food and Drug Administration submissions of the SmartByte ™ System's safety and efficacy. This 16-week, prospective, single-arm, four-centre, observational study assessed the oral device in combination with a video-delivered lifestyle programme in adults aged 18-49 years with body mass index 27 to loss, 16 (40%) achieved ≥4% and 21 (52.5%) achieved ≥3%. Week 16 mean loss for the PP population was 2.93%, and among 36 participants who did not meet PP criteria, it was 1.45%. Among 76 intent-to-treat subjects, two subjects reported three mild to moderate device-related adverse events, resolving spontaneously (one hard palate abrasion and two tongue lacerations). The System, a minimal risk tool, can help individuals achieve meaningful weight loss, when used with a lifestyle video. More frequent device use was associated with more weight loss, on average, and greater chance of achieving ≥4% or ≥5% weight loss.

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

    Science.gov (United States)

    Elalouf, Ofir; Elkayam, Ori

    2015-01-01

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

  10. 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

  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. 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.

  13. 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.

  14. 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)

  15. 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)

  16. Efficacy and Safety of 2% and 4% Articaine for Lower Third Molar Surgery.

    Science.gov (United States)

    Senes, A M; Calvo, A M; Colombini-Ishikiriama, B L; Gonçalves, P Z; Dionísio, T J; Sant'ana, E; Brozoski, D T; Lauris, J R P; Faria, F A C; Santos, C F

    2015-09-01

    This double-blind crossover randomized clinical trial compared the efficacy of 2 concentrations of articaine, 2% (A2) and 4% (A4), with 1:200,000 epinephrine, for lower third molar removal. During 2 separate appointments with either A2 or A4, both similarly positioned lower third molars in 46 volunteers were extracted. The following were evaluated: onset and duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative analgesia, and mouth opening and wound healing during the 7th postoperative day, along with the incidence, type, and severity of adverse reactions. Nearly identical volumes of both anesthetic solutions were used for each appointment: 3.4 ± 0.9 mL ≈ 68 mg of articaine (A2) and 3.3 ± 0.8 mL ≈ 132 mg of articaine (A4). Statistical analysis indicated no differences in onset or duration of anesthetic action on soft tissues or duration of postoperative analgesia evoked by A2 and A4 anesthetic solutions (P > 0.05). The surgeon's rating of intraoperative bleeding was considered minimal throughout all surgery with both anesthetic solutions. While transient changes in blood pressure, heart rate, and oxygen saturation were observed, these factors were clinically insignificant and were uninfluenced by articaine concentration (P > 0.05). No systemic or local adverse reactions were observed in the preoperative and postoperative periods due to A2 or A4, but 1 case of bilateral paresthesia was observed. There were no significant differences between preoperative and postoperative (7th day) values of mouth opening and wound healing whether volunteers received A2 or A4 (P > 0.05). In conclusion, both A2 and A4, administered in equal volumes, were effective and safe during lower third molar surgery, and no significant differences were found between their efficacy and safety (ClinicalTrials.gov NCT02457325). © International & American Associations for Dental Research.

  17. 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. 

  18. Efficacy and safety of transdermal buprenorphine in the management of children with cancer-related pain.

    Science.gov (United States)

    Ruggiero, Antonio; Coccia, Paola; Arena, Roberta; Maurizi, Palma; Battista, Andrea; Ridola, Vita; Attinà, Giorgio; Riccardi, Riccardo

    2013-03-01

    The current study investigated the efficacy, safety, tolerability, and compliance of a transdermal buprenorphine delivery system for the management of chronic cancer pain in the pediatric population. Sixteen pediatric patients with moderate to severe cancer-related pain not satisfactorily controlled with previous non-opioid therapies were enrolled. Transdermal buprenorphine was administered following a 72 hour schedule and rescue medication (tramadol) was allowed for breakthrough pain. Pain intensity was assessed using the Wong-Baker faces pain rating scale (WBS) and other parameters related to the global quality of life were evaluated. Children's evaluations of efficacy, compliance, and tolerability were recorded using numerical scales. Adverse events were monitored during the study and the medications needed to control opioid-related nausea and constipation were recorded. Eleven patients (68.75%) responded to transdermal buprenorphine after 2 weeks of treatment. Pain intensity measured with WBS decreased from 6.25 at baseline to 1.38 at Day +60 (P alimentation, play and activity, speech, and crying) significantly improved over the 60-day study period. Children's evaluations of compliance and tolerability of the drug were always positive over the entire period of treatment. No severe adverse events were recorded. Opioid-related nausea was well controlled with medication on request, and the need for laxative therapy was greater at the end of the second month of treatment. Transdermal buprenorphine was found to represent an efficient, safe and well tolerated approach to the management of children's chronic cancer pain. Copyright © 2012 Wiley Periodicals, Inc.

  19. Efficacy and safety of sublingual immunotherapy for two seasons in patients with Japanese cedar pollinosis.

    Science.gov (United States)

    Okamoto, Yoshitaka; Okubo, Kimihiro; Yonekura, Syuji; Hashiguchi, Kazuhiro; Goto, Minoru; Otsuka, Takashi; Murata, Tadayuki; Nakao, Yuji; Kanazawa, Chigiri; Nagakura, Hitoshi; Okawa, Toru; Nakano, Koichi; Hisamitsu, Minako; Kaneko, Shinya; Konno, Akiyoshi

    2015-01-01

    Japanese cedar (JC) pollinosis is the most common seasonal allergic rhinitis in Japan. Standardized JC pollen extract is available for subcutaneous immunotherapy, but this treatment is limited by potentially serious side effects. The aim of this double-blind, randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation (CEDARTOLEN®, Torii Pharmaceutical Co., Ltd., Tokyo, Japan) for sublingual immunotherapy (SLIT) for JC pollinosis. A total of 531 subjects with JC pollinosis were randomized into 2 groups at a ratio of 1:1 to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of 2,000 Japanese allergy units (JAU) or placebo for 2 consecutive pollen seasons. The efficacy was evaluated using the total nasal symptom and medication score (TNSMS) as the primary end point. Secondary end points included the total ocular symptom and medication score (TOSMS) and scores for individual symptoms and medication. The TNSMS was significantly lower (p < 0.0001) in the SLIT group than in the placebo group in the peak symptom period by 18 and 30% in the first and second seasons, respectively. All secondary end points were also significantly lower in the SLIT group in both seasons. No systemic anaphylaxis occurred. SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication. The JC pollen extract was well tolerated with only local adverse events. © 2015 S. Karger AG, Basel.

  20. 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?

  1. 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

  2. Safety and Efficacy of Vaccination Against Influenza in Patients With Rheumatoid Arthritis

    Directory of Open Access Journals (Sweden)

    Ori Elkayam

    2006-01-01

    Full Text Available Vaccination against influenza is currently recommended for patients with rheumatoid arthritis (RA. The safety and efficacy of vaccination in patients suffering from rheumatic diseases is still a matter of debate. This review summarizes the studies performed on the safety and immunogenicity of influenza vaccination in patients with RA as well as the rheumatic complications of the vaccine in otherwise healthy persons. Several trials have shown that the vaccine induces an adequate humoral response and does not induce clinical exacerbation of RA. Rheumatic complications (mainly vasculitis following influenza vaccination in the general population are scarce.

  3. 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.

  4. Safety and efficacy of the multitargeted receptor kinase inhibitor pazopanib in the treatment of corneal neovascularization.

    Science.gov (United States)

    Amparo, Francisco; Sadrai, Zahra; Jin, Yiping; Alfonso-Bartolozzi, Belen; Wang, Haobing; Shikari, Hasanain; Ciolino, Joseph B; Chodosh, James; Jurkunas, Ula; Schaumberg, Debra A; Dana, Reza

    2013-01-17

    To evaluate the safety and efficacy of topical pazopanib in the treatment of corneal neovascularization (CNV). Twenty eyes of 20 patients with stable CNV were enrolled in a prospective, open label, noncomparative study and treated with topical pazopanib 0.5% for 3 weeks, and followed for 12 weeks. The primary endpoint was to determine the tolerability and safety of topical pazopanib in the treatment of CNV defined by the occurrence of ocular and systemic adverse events during the study. The secondary endpoint was to evaluate the effect of topical pazopanib on the reduction of (1) neovascular area (NA), defined as the area of the corneal vessels themselves, (2) invasion area (IA), defined as the fraction of the total cornea into which the vessels extend, (3) vessel length (VL), defined as the mean measurement of the extent of vessels from end to end, and (4) vessel caliber (VC), defined as the mean diameter of the corneal vessels. There were no severe adverse events following the use of topical pazopanib. Compared with the baseline visit, NA and VL showed a statistically significant decrease at week 3 (P = 0.02 and 0.01, respectively); and NA, IA, and VL statistically significantly decreased at week 12 (P = 0.03, 0.04, and <0.01, respectively). Visual acuity maintained without changes after the 12 week follow-up. This preliminary study suggests that topical treatment with pazopanib 0.5% is safe, well tolerated, and may have a role as an alternative for the treatment of CNV (ClinicalTrials.gov number, NCT01257750).

  5. Efficacy and Safety of Intracameral Bevacizumab for Treatment of Neovascular Glaucoma.

    Science.gov (United States)

    Ha, Jun Young; Lee, Tae Hee; Sung, Mi Sun; Park, Sang Woo

    2017-12-01

    To evaluate the long-term efficacy and safety of intracameral bevacizumab in patients with neovascular glaucoma. This retrospective study included 26 eyes of 26 neovascular glaucoma patients who received intracameral bevacizumab injection between January 2013 and May 2015, and were followed-up for at least 1 year. All patients were treated with topical and/or systemic intraocular pressure (IOP)-lowering medications, intracameral bevacizumab, and panretinal photocoagulation (PRP). The main outcome measures were changes in visual acuity, IOP, and neovascularization of the iris (NVI) and the anterior chamber angle (NVA). To assess the safety of intracameral bevacizumab, corneal endothelial changes were also determined using specular microscopy. Patients whose IOP was uncontrolled received IOP-lowering surgery. Clinical factors associated with IOP-lowering surgery were also investigated. In all patients, intracameral bevacizumab resulted in a rapid and marked reduction of IOP, NVI, and NVA within 1 week. At 12 months after initial injection, 19 of 26 eyes (73%) underwent IOP-lowering surgery. The average interval between initial injection and surgical treatment was 33.6 ± 26.9 days. Baseline IOP (p = 0.018), NVA grade (p = 0.029), and incomplete PRP (p = 0.005) were identified as predictive factors for IOP-lowering surgery. During the follow-up period, there were no statistically significant corneal endothelial changes after intracameral bevacizumab injection. During 1 year of follow-up after intracameral bevacizumab, the procedure was found to be safe for the corneal endothelium. However, the IOP-lowering effect was transient, and 73% of patients eventually required IOP-lowering surgery. Predictive factors for IOP-lowering surgery were high baseline IOP and NVA grade, and incomplete PRP. © 2017 The Korean Ophthalmological Society

  6. Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis

    NARCIS (Netherlands)

    D'Haens, G. R.; Kovács, A.; Vergauwe, P.; Nagy, F.; Molnár, T.; Bouhnik, Y.; Weiss, W.; Brunner, H.; Lavergne-Slove, A.; Binelli, D.; Di Stefano, A. F. D.; Marteau, P.

    2010-01-01

    Ulcerative colitis (UC) is a chronic inflammatory disease with relapses. Many patients need systemic corticosteroids to induce clinical remission. Efficacy and safety of Budesonide-MMX® 9 mg tablets, a new oral, extended-release formulation, were evaluated in patients suffering from active,

  7. 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.

  8. Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy.

    Science.gov (United States)

    Moradi, Amir; Palm, Melanie

    2015-09-01

    Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles). Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits. Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment

  9. Subcutaneous methotrexate for symptomatic control of severe recalcitrant psoriasis: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Manalo IF

    2015-05-01

    Full Text Available Iviensan F Manalo,1 Kathleen E Gilbert,2 Jashin J Wu3 1Medical College of Georgia, Georgia Regents University, Augusta, GA, 2Indiana University School of Medicine, Indianapolis, IN, 3Department of Dermatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA Background: Although oral methotrexate is an effective first-line traditional systemic therapy for psoriasis, the use of the subcutaneous form of methotrexate for the treatment of psoriasis has not been fully established. Objective: This study is a literature review of the research related to the safety, efficacy, and patient acceptability of subcutaneous methotrexate for its application in the treatment of severe recalcitrant psoriasis. Methods: Systematic literature searches were conducted of the PubMed, Ovid, and ClinicalTrials.gov databases. Results: Only three relevant sources of literature were found studying subcutaneous methotrexate specifically in the context of psoriasis. Of these, only one clinical trial was found to directly study the use of subcutaneous methotrexate in psoriasis patients; however, results of this study have not been published. The other two literature sources involved a cost-effectiveness analysis and a literature review for subcutaneous methotrexate. Otrexup™ and Rasuvo™ are two particular single-use auto-injector modalities of subcutaneous methotrexate that are approved by the US Food and Drug Administration. The equivalents of Rasuvo available in countries outside of the USA are advertised as Metoject® or Metex®. Much more research has been conducted on the use of subcutaneous methotrexate in rheumatoid arthritis patients. Conclusion: There is a lack of original evidence-based studies evaluating the use of subcutaneous methotrexate specifically for the treatment of psoriasis. Based on the more extensively researched data on the safety, efficacy, and patient acceptability of subcutaneous methotrexate in rheumatoid arthritis patients

  10. Integrated safety management system verification: Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    Christensen, R.F.

    1998-08-10

    Department of Energy (DOE) Policy (P) 450.4, Safety Management System Policy, commits to institutionalization of an Integrated Safety Management System (ISMS) throughout the DOE complex. The DOE Acquisition Regulations (DEAR, 48 CFR 970) requires contractors to manage and perform work in accordance with a documented Integrated Safety Management System (ISMS). Guidance and expectations have been provided to PNNL by incorporation into the operating contract (Contract DE-ACM-76FL0 1830) and by letter. The contract requires that the contractor submit a description of their ISMS for approval by DOE. PNNL submitted their proposed Safety Management System Description for approval on November 25,1997. RL tentatively approved acceptance of the description pursuant to a favorable recommendation from this review. The Integrated Safety Management System Verification is a review of the adequacy of the ISMS description in fulfilling the requirements of the DEAR and the DOE Policy. The purpose of this review is to provide the Richland Operations Office Manager with a recommendation for approval of the ISMS description of the Pacific Northwest Laboratory based upon compliance with the requirements of 49 CFR 970.5204(-2 and -78); and to verify the extent and maturity of ISMS implementation within the Laboratory. Further the review will provide a model for other DOE laboratories managed by the Office of Assistant Secretary for Energy Research.

  11. 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

  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. Traffic safety effects of navigation systems

    NARCIS (Netherlands)

    Feenstra, P.J.; Hogema, J.H.; Vonk, T.

    2007-01-01

    Abstract— To investigate effects of navigation systems on traffic safety, a literature search, a damages database analysis, a user survey and an instrumented car study were conducted. This paper presents the instrumented car study to investigate the effects of a navigation system on driving behavior

  14. Clinical efficacy and safety of imatinib in the management of Ph+ chronic myeloid or acute lymphoblastic leukemia in Chinese patients

    Science.gov (United States)

    Zhu, Yu; Qian, Si-Xuan

    2014-01-01

    Imatinib mesylate is considered the standard first-line systemic treatment for patients with chronic myeloid leukemia (CML) and functions by targeting BCR-ABL tyrosine kinases. Imatinib has substantially changed the clinical management and improved the prognosis of CML and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL). Here, we review the pharmacology, mode of action, and pharmacokinetics of imatinib; Chinese efficacy studies in CML and Ph+ ALL; safety and tolerability; patient-focused perspectives, such as quality of life, patient satisfaction, acceptability, and adherence; and uptake of imatinib. PMID:24623982

  15. 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

  16. 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.

  17. The efficacy and safety of rituximab in treating childhood nephrotic syndrome: an Italian perspective.

    Science.gov (United States)

    Maratea, Dario; Bettio, Monica; Corti, Maria Grazia; Montini, Giovanni; Venturini, Francesca

    2016-07-12

    Nephrotic syndrome is a disorder characterized by proteinuria, hypoalbuminemia and dyslipidemia. Low-dose alternate-day steroid regimen is the standard of care. In case of relapse or significant adverse events, steroid-sparing agents may be used. This analysis was aimed at assessing the efficacy and safety of rituximab for the treatment of children with nephrotic syndrome. Four studies were included in the final meta-analysis. The end-point of our analysis was the percentage of patients in remission at 6 months. Pooled data from the four studies favours the use of rituximab (RR 5.25, 95 % CI: 3.05-9.06; p nephrotic syndrome: 1. favourable clinical efficacy and safety data; 2. no available alternatives; 3. outcome data collecting by AIFA through prescribers. In conclusion, our results report a significant incremental benefit of adding rituximab to corticosteroid and/or calcineurin inhibitors for the treatment of nephrotic syndrome.

  18. 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.

  19. 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

  20. 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

  1. Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhea: a double blind randomised controlled trial.

    Science.gov (United States)

    Riaz, Musheer; Alam, Seema; Malik, Abida; Ali, S Manazir

    2012-04-01

    To see the efficacy and safety of 250 mg of Saccharomyces boulardii twice daily for 5 d in acute childhood diarrhea. Children aged between 3 mo and 59 mo with acute onset diarrhea (of less than 48 h) admitted in DTTU (diarrhea treatment and training unit) were included and those with clinical evidence of severe malnutrition, systemic infection, encephalopathy and/or convulsion, electrolyte imbalance, invasive diarrhea or previous use of any probiotics were excluded from the study. Those included randomly were given either a placebo or Saccharomyces boullardi (SB) in identical packets mixed with puffed rice powder. Mean post intervention duration of diarrhea was significantly (95% CI = -28.13 to -5.43) shorter in SB group (52.08 ± 24.57 h) as compared to placebo group (64.04 ± 30.43 h). The time of appearance of first semi formed stool in SB group (39.48 ± 23.09 h) was significantly (95% CI -25.4 to -3.87) shorter than the placebo group (54.13 ± 28.21 h). No statistically significant difference was found in rest of the parameters. There is initial evidence available that SB may have a therapeutic role in the management of acute childhood diarrhea.

  2. Duloxetine: A Review of its Safety and Efficacy in the Management of Fibromyalgia Syndrome

    Directory of Open Access Journals (Sweden)

    Howard S. Smith

    2010-01-01

    Full Text Available Fibromyalgia (FM is a chronic disorder characterized by widespread pain and other associated symptoms including fatigue, insomnia, cognitive/memory problems, and even psychological distress. Duloxetine is one of three FDA approved medications (the other two being milnacipran and pregabalin for the treatment of FM. It has been demonstrated that FM patients possess low central nervous system levels of serotonin and norepinephrine. Duloxetine, which is classified pharmacologically as a serotonin-norepinephrine reuptake inhibitor (SNRI, may be beneficial for FM patients by increasing these levels. This review will touch briefly upon the pathophysiology of FM, diagnostic tools, currently available therapeutic options (both pharmacologic and non-pharmacologic, as well as the pharmacokinetic/pharmacodynamic properties of duloxetine. In addition, the efficacy and safety/tolerability of duloxetine exclusively in FM will be assessed through examination of 5 randomized controlled trials, as well as pooled analyses of current data. Suggestions for a therapeutic niche for duloxetine in FM are discussed based on a presentation of the characteristics of duloxetine.

  3. The Clinical Efficacy and Safety of Tulsi in Humans: A Systematic Review of the Literature

    Directory of Open Access Journals (Sweden)

    Negar Jamshidi

    2017-01-01

    Full Text Available Tulsi, also known as holy basil, is indigenous to the Indian continent and highly revered for its medicinal uses within the Ayurvedic and Siddha medical systems. Many in vitro, animal and human studies attest to tulsi having multiple therapeutic actions including adaptogenic, antimicrobial, anti-inflammatory, cardioprotective, and immunomodulatory effects, yet to date there are no systematic reviews of human research on tulsi’s clinical efficacy and safety. We conducted a comprehensive literature review of human studies that reported on a clinical outcome after ingestion of tulsi. We searched for studies published in books, theses, conference proceedings, and electronic databases including Cochrane Library, Google Scholar, Embase, Medline, PubMed, Science Direct, and Indian Medical databases. A total of 24 studies were identified that reported therapeutic effects on metabolic disorders, cardiovascular disease, immunity, and neurocognition. All studies reported favourable clinical outcomes with no studies reporting any significant adverse events. The reviewed studies reinforce traditional uses and suggest tulsi is an effective treatment for lifestyle-related chronic diseases including diabetes, metabolic syndrome, and psychological stress. Further studies are required to explore mechanisms of action, clarify the dosage and dose form, and determine the populations most likely to benefit from tulsi’s therapeutic effects.

  4. 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

  5. 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.

  6. Long-Term Safety and Efficacy of Empagliflozin, Sitagliptin, and Metformin

    OpenAIRE

    Ferrannini, Ele; Berk, Andreas; Hantel, Stefan; Pinnetti, Sabine; Hach, Thomas; Woerle, Hans J.; Broedl, Uli C.

    2013-01-01

    OBJECTIVE To investigate the long-term safety and efficacy of empagliflozin, a sodium glucose cotransporter 2 inhibitor; sitagliptin; and metformin in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS In this randomized, open-label, 78-week extension study of two 12-week, blinded, dose-finding studies of empagliflozin (monotherapy and add-on to metformin) with open-label comparators, 272 patients received 10 mg empagliflozin (166 as add-on to metformin), 275 received 25 mg empagliflo...

  7. An open labeled study to evaluate efficacy and safety of ampucare in patients with bedsore

    OpenAIRE

    Janardhan Singh; Sukhbir Singh Sangwan; Jarnail Singh; Ram Chandar Siwach; Govind Shukla

    2013-01-01

    Background: To evaluate efficacy and safety of ampucare, a polyherbal product, in patients with bedsore. Methods: One hundred patients, either sex, more than 18 years of age, with bedsore were divided in to two groups of 50 each. Group-I- Served as control- povidone iodine solution was applied locally on the bedsore, once daily. Group- II- Treatment group- ampucare lotion was applied locally, once daily. Primary end point was time to wound healing and secondary end point included reduction in...

  8. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy.

    Science.gov (United States)

    Volovat, Constantin; Gladkov, Oleg A; Bondarenko, Igor M; Barash, Steve; Buchner, Anton; Bias, Peter; Adar, Liat; Avisar, Noa

    2014-04-01

    Recombinant granulocyte colony-stimulating factors (G-CSFs) reduce the incidence and duration of chemotherapy-induced neutropenia and febrile neutropenia when given as adjunct therapy to patients receiving myelosuppressive chemotherapy. Balugrastim is a long-acting G-CSF composed of a genetic fusion between recombinant human serum albumin and G-CSF. We compared the efficacy and safety of balugrastim and pegfilgrastim, a long-acting pegylated recombinant G-CSF, in patients with breast cancer who were scheduled to receive chemotherapy. In this double-blind randomized phase III trial, patients with ≥ 1.5 × 10(9) neutrophils/L were randomly assigned to subcutaneous injections of balugrastim 40 mg (n = 153) or pegfilgrastim 6 mg (n = 151). The primary efficacy end point was the duration of severe neutropenia (DSN) (days with an absolute neutrophil count [ANC] < 0.5 × 10(9) cells/L) during cycle 1. Efficacy analyses were performed in the per-protocol (PP) population. In a separate open-label single-arm study, newly recruited patients (n = 77) received balugrastim 40 mg and were included in the safety analysis. The mean DSN in cycle 1 was 1.1 days in the balugrastim group and 1.0 days in the pegfilgrastim group (95% confidence interval [CI], -0.13-0.37). Two and 4 patients, respectively, had febrile neutropenia during cycle 1. Twenty percent of patients in the balugrastim group and 19% in the pegfilgrastim group had adverse events (AEs) considered to be related to study medication; 3.9% and 4.7% of patients, respectively, experienced serious AEs. This study demonstrates the comparable safety and efficacy profile of balugrastim and pegfilgrastim and the noninferiority of balugrastim for reduction in DSN. There were no unexpected safety events. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Efficacy and Safety of Clonidine versus Placebo for Anxiety in Odontology

    OpenAIRE

    Bermúdez-Reyes, Patricia; Támara-Eraso, Ana Karina; Vargas, Jorge William

    2013-01-01

    Introduction: There are different strategies for anxiety control in dentistry. The objective of this study was to determine the efficacy and safety of clonidine medication versus placebo to decrease anxiety and pain in third-molar extraction. Methods: a placebo controlled clinical trial, randomized, triple-blind, parallel group design, included 40 healthy patients aged 14 to 40, who would be undergoing third molar surgery, with a score ≥ 13, in accordance with the Modified Dental Anxiety Scal...

  10. Resistance training among young athletes: safety, efficacy and injury prevention effects

    OpenAIRE

    Faigenbaum, A D; Myer, G D

    2009-01-01

    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 power-lifting 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 trainin...

  11. 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

    for all drugs except for adalimumab and secukinumab. Adverse events (predominantly infections) were most frequent for secukinumab and showed an increased (albeit low) incidence of cardiovascular events compared with the other agents. CONCLUSIONS: Ustekinumab was associated with the highest drug survival......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...

  12. Deferasirox: appraisal of safety and efficacy in long-term therapy

    OpenAIRE

    Chaudhary, Preeti; Pullarkat, Vinod

    2013-01-01

    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 &b...

  13. 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.

  14. 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.

  15. 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

  16. Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis.

    Science.gov (United States)

    Jahn, Franziska; Jordan, Karin; Behlendorf, Timo; Globig, Cordula; Schmoll, Hans-Joachim; Müller-Tidow, Carsten; Jordan, Berit

    2015-01-01

    Although rare, neoplastic meningitis (NM) has been increasingly observed in patients with cancer due to the prolonged course of the disease. Intrathecal chemotherapy with methotrexate or cytarabine with repeating injection schedules of 2-3 times per week is currently the mainstay of treatment. An efficacious and comfortable treatment alternative might be represented by liposomal cytarabine. In this retrospective study, we reviewed all patients with NM due to solid tumors or hematological malignancies treated with liposomal cytarabine at our institution between March 2004 and September 2011. The primary endpoint was treatment response, which was defined as improvement in neurological symptoms and/or conversion of the initial cerebrospinal fluid cytology and/or response in the radiological findings. The main secondary endpoint was safety. Fifty-one adult patients were evaluable for safety and 44 patients for efficacy. In 36 patients (81.8%), a treatment response was achieved. The median overall survival after diagnosis of NM was 11 months (95% confidence interval 8.8-13.2). Adverse events grade 1-4 occurred in 31 patients (60.8%), whereas grade 3-4 occurred in 18 patients (35.3%). The encouraging efficacy and safety data obtained in our analysis and the convenient administration schedule make intrathecal liposomal cytarabine a favorable treatment option for NM patients.

  17. Comparative Efficacy and Safety of Phosphate Binders in Hyperphosphatemia Patients With Chronic Kidney Disease.

    Science.gov (United States)

    Yang, Xiuqin; Bai, Qingning; Li, Yanguo; Liu, Haijun; Guo, Haiying; Zhang, Xiaolei

    2017-08-01

    In this study, we coordinated a network meta-analysis to establish the efficacy and safety of different agents used in the treatment of hyperphosphatemia patients with chronic kidney disease. PubMed, CNKI, and Embase were systematically searched to retrieve relevant studies. Outcomes were presented by mean differences, odds ratios, and corresponding 95% credible intervals for continuous outcomes and binary outcomes, respectively. Each therapy was ranked according to the value of surface under the cumulative ranking curve. Consistencies between direct and indirect comparisons were assessed with a node-splitting plot. In terms of efficacy end points (including levels of serum phosphate, serum calcium, serum intact parathyroid hormone, and serum calcium × phosphorus product), all 7 kinds of agents outperformed or performed at least equally to placebo, with iron-based phosphate-binding agents being potentially the most effective. As for safety end points (including mortality, adverse events, and all-cause discontinuation), almost all agents were equivalent in term of mortality and all-cause discontinuation except in the comparison between iron-based phosphate-binding agents and placebo. Meanwhile, iron-based phosphate-binding agents colestilan and nicotinic acid performed poorly compared with placebo in terms of adverse events. Furthermore, iron-based phosphate-binding agents were potentially the safest agents followed sequentially by calcium-based phosphate-binding agents and placebo. Iron-based phosphate-binding agents were the preferable agents when considering efficacy and safety simultaneously.

  18. Efficacy and safety of venous thromboembolism prophylaxis with fondaparinux in women at risk after cesarean section.

    Science.gov (United States)

    Kawaguchi, Ryuji; Haruta, Shoji; Kobayashi, Hiroshi

    2017-11-01

    Cesarean section is associated with an increased risk for venous thromboembolism (VTE). The safety and efficacy of primary prophylaxis of fondaparinux, a synthetic sulfated pentasaccharide heparin analog, in women at risk after cesarean section is uncertain. This was a retrospective study of 295 cases of pregnant women presenting to a tertiary referral center of Nara, Japan, to evaluate the usefulness of thromboprophylaxis with fondaparinux after cesarean delivery between 2011 and 2012. Patients were initially received unfractionated heparin (once 5,000 IU subcutaneously, twice a day), starting 6 hours after cesarean section for 24 hours, and then treated with fondaparinux (once 2.5 mg daily, subcutaneously) for 5 days. The primary efficacy end-point was an improvement in the incidence of symptomatic VTE or fatal post-cesarean pulmonary thromboembolism. The primary safety end-point was major bleeding during treatment. There were neither any episodes of symptomatic VTE cases nor maternal deaths. A total of 10 patients had a bleeding event. Major bleeding complication was observed in 2 (0.68%) of 295 patients receiving fondaparinux. Non-major bleeding into critical sites was observed in 8 patients, often at surgical sites, and recovery was not delayed. This study demonstrates the safety and efficacy of fondaparinux in women at high risk of VTE after cesarean section. Large phase trials comparing clinical outcomes with fondaparinux across a wide spectrum of patients are needed to confirm these observations.

  19. Analysis of the efficacy, safety, and regulatory status of novel forms of creatine.

    Science.gov (United States)

    Jäger, Ralf; Purpura, Martin; Shao, Andrew; Inoue, Toshitada; Kreider, Richard B

    2011-05-01

    Creatine has become one of the most popular dietary supplements in the sports nutrition market. The form of creatine that has been most extensively studied and commonly used in dietary supplements is creatine monohydrate (CM). Studies have consistently indicated that CM supplementation increases muscle creatine and phosphocreatine concentrations by approximately 15-40%, enhances anaerobic exercise capacity, and increases training volume leading to greater gains in strength, power, and muscle mass. A number of potential therapeutic benefits have also been suggested in various clinical populations. Studies have indicated that CM is not degraded during normal digestion and that nearly 99% of orally ingested CM is either taken up by muscle or excreted in urine. Further, no medically significant side effects have been reported in literature. Nevertheless, supplement manufacturers have continually introduced newer forms of creatine into the marketplace. These newer forms have been purported to have better physical and chemical properties, bioavailability, efficacy, and/or safety profiles than CM. However, there is little to no evidence that any of the newer forms of creatine are more effective and/or safer than CM whether ingested alone and/or in combination with other nutrients. In addition, whereas the safety, efficacy, and regulatory status of CM is clearly defined in almost all global markets; the safety, efficacy, and regulatory status of other forms of creatine present in today's marketplace as a dietary or food supplement is less clear.

  20. Comprehensive Safety Analysis 2010 Safety Measurement System (SMS) Methodology, Version 2.1 Revised December 2010

    Science.gov (United States)

    2010-12-01

    This report documents the Safety Measurement System (SMS) methodology developed to support the Comprehensive Safety Analysis 2010 (CSA 2010) Initiative for the Federal Motor Carrier Safety Administration (FMCSA). The SMS is one of the major tools for...

  1. Modelling safety of multistate systems with ageing components

    Science.gov (United States)

    Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna

    2016-06-01

    An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics of the consecutive "m out of n: F" is presented as well.

  2. Reliability assessment of redundant safety systems with degradation

    NARCIS (Netherlands)

    Rogova, E.S.

    2017-01-01

    Reliability of transport equipment plays a crucial role in providing safety for passengers. Safety systems of transport equipment perform safety functions with assigned safety integrity levels (SIL). If the reliability of a safety system is not sufficient, it has to be improved till the required

  3. Prestandardisation Activities for Computer Based Safety Systems

    DEFF Research Database (Denmark)

    Taylor, J. R.; Bologna, S.; Ehrenberger, W.

    1981-01-01

    Questions of technical safety become more and more important. Due to the higher complexity of their functions computer based safety systems have special problems. Researchers, producers, licensing personnel and customers have met on a European basis to exchange knowledge and formulate positions....... The Commission of the european Community supports the work. Major topics comprise hardware configuration and self supervision, software design, verification and testing, documentation, system specification and concurrent processing. Preliminary results have been used for the draft of an IEC standard and for some...

  4. 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.

  5. Safety of high speed magnetic levitation transportation systems. Preliminary safety review of the transrapid maglev system

    Science.gov (United States)

    Dorer, R. M.; Hathaway, W. T.

    1990-11-01

    The safety of various magnetically levitated trains under development for possible implementation in the United States is of direct concern to the Federal Railroad Administration. Safety issues are addressed related to a specific maglev technology. The Transrapid maglev system was under development by the German Government over the last 10 to 15 years and was evolved into the current system with the TR-07 vehicle. A technically based safety review was under way over the last year by the U.S. Department of Transportation. The initial results of the review are presented to identify and assess potential maglev safety issues.

  6. 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

  7. A method for optimizing dosage regimens in oncology by visualizing the safety and efficacy response surface: analysis of inotuzumab ozogamicin.

    Science.gov (United States)

    Luu, Kenneth T; Boni, Joseph

    2016-10-01

    The aim of this investigation was to develop a quantitative method to optimize inotuzumab ozogamicin (InO) dosage regimen in patients with indolent non-Hodgkin lymphoma (NHL) by simultaneously balancing safety and efficacy. Pharmacokinetics (PK), safety and efficacy data were obtained from a phase 2 trial of InO administered intravenously to patients (n = 81) with indolent NHL. The PK was described by a two-compartment model which was linked to: (1) an exponential tumor growth model to describe tumor size time course (efficacy determinant expressed as objective response rate) and (2) a precursor-dependent platelet inhibition model to describe platelet time course (safety determinant expressed as thrombocytopenia grade). The model was used to simulate virtual trials to construct safety and efficacy response surfaces. Using the simulated safety and efficacy contours, a clinical utility index (CUI) contour was then constructed, from which optimal InO regimens were then selected. The model-simulated efficacy response surface indicated near-optimal efficacy of InO at the dosage regimen used in the trial (1.8 mg/m(2) every 4 weeks). The model-simulated safety response surface indicated that modifying the dosage regimen resulted in modest improvements in safety with little compromise in efficacy. The CUI contour identified 2 mg/m(2) every 10, 11, or 12 weeks as the "sweet spot" for optimal InO dosage regimen in patients with indolent NHL. An approach to dosage regimen optimization was developed for simultaneously balancing safety and efficacy. This approach allows objective identification of optimal dosage regimens from early trial information and thus has broad utility across oncology trials.

  8. 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

    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......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...

  9. 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

  10. 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

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

    Science.gov (United States)

    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; Hannan, Raquibul

    2017-05-01

    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. 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. 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; Pradiation 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 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. SAbR demonstrated excellent LC of metastatic renal cell carcinoma with a favorable safety profile when an adequate dose and coverage were applied. Multimodality treatment with surgery should be considered for reirradiation or vertebral metastasis. A higher radiation dose may be required in patients who received previous systemic therapies. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Integrated safety management system verification: Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Christensen, R.F.

    1998-08-12

    Department of Energy (DOE) Policy (P) 450.4, Safety Management System Policy, commits to institutionalizing an Integrated Safety Management System (ISMS) throughout the DOE complex. The DOE Acquisition Regulations (DEAR 48 CFR 970) requires contractors to manage and perform work in accordance with a documented Integrated Safety Management System. The Manager, Richland Operations Office (RL), initiated a combined Phase 1 and Phase 2 Integrated Safety Management Verification review to confirm that PNNL had successfully submitted a description of their ISMS and had implemented ISMS within the laboratory facilities and processes. A combined review was directed by the Manager, RL, based upon the progress PNNL had made in the implementation of ISM. This report documents the results of the review conducted to verify: (1) that the PNNL integrated safety management system description and enabling documents and processes conform to the guidance provided by the Manager, RL; (2) that corporate policy is implemented by line managers; (3) that PNNL has provided tailored direction to the facility management; and (4) the Manager, RL, has documented processes that integrate their safety activities and oversight with those of PNNL. The general conduct of the review was consistent with the direction provided by the Under Secretary`s Draft Safety Management System Review and Approval Protocol. The purpose of this review was to provide the Manager, RL, with a recommendation to the adequacy of the ISMS description of the Pacific Northwest Laboratory based upon compliance with the requirements of 49 CFR 970.5204(-2 and -78); and, to provide an evaluation of the extent and maturity of ISMS implementation within the Laboratory. Further, this review was intended to provide a model for other DOE Laboratories. In an effort to reduce the time and travel costs associated with ISM verification the team agreed to conduct preliminary training and orientation electronically and by phone. These

  13. The efficacy and safety of cefovecin in the treatment of feline abscesses and infected wounds.

    Science.gov (United States)

    Stegemann, M R; Sherington, J; Passmore, C

    2007-12-01

    To determine the efficacy and safety of cefovecin for the treatment of bacterial abscesses and wounds in cats at clinics in Germany, France, Spain and the UK. Cats with abscesses or wounds were enrolled. Cats (217) were randomised to treatment with either cefovecin administered by subcutaneous injection at 14 day intervals or amoxicillin/clavulanic acid as twice-daily oral tablets for 14 days. Treatment courses were repeated at 14 day intervals, when deemed necessary. Clinicians assessing lesions were masked to treatment allocation. Only animals with a confirmed pretreatment bacterial pathogen were included in the efficacy analysis. Cases were evaluated 28 days after initiation of the final course of treatment. Cefovecin was as efficacious as amoxicillin/clavulanic acid, and efficacy was 100 per cent for both treatments. Cefovecin, administered as a single subcutaneous injection repeated at 14 day intervals as required, was shown to be as efficacious as oral amoxicillin/clavulanic acid in the treatment of abscesses/wounds in cats.

  14. 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

  15. 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

  16. 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)

  17. 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.

  18. 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.

  19. Information systems in food safety management

    NARCIS (Netherlands)

    McMeekin, T.A.; Baranyi, J.; Bowman, J.; Dalgaard, P.; Kirk, M.; Ross, T.; Schmid, S.; Zwietering, M.H.

    2006-01-01

    Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with

  20. 77 FR 55371 - System Safety Program

    Science.gov (United States)

    2012-09-07

    ... (AASHTO); American Chemistry Council; American Petroleum Institute; American Public Transportation... group in June 2008 in Baltimore, MD. Additional meetings were held on December 2-4, 2008 in Cambridge... Washington, DC, February 1-2, 2012 in Cambridge, MA, and March 8, 2012 by teleconference. The System Safety...

  1. 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...

  2. 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.

  3. Safety and efficacy of atrial antitachycardia pacing in congenital heart disease.

    Science.gov (United States)

    Kramer, Collin C; Maldonado, Jennifer; Olson, Mark; Gingerich, Jean C; Ochoa, Luis; Law, Ian H

    2017-12-12

    Intra-atrial reentrant tachycardia (IART) is a common sequela in the congenital heart disease (CHD) population, and it significantly increases morbidity and mortality. Atrial antitachycardia devices (ATDs) capable of atrial antitachycardia pacing (ATP) therapy have been used to manage IART in the CHD population, but there are limited data on their safety and efficacy. To determine whether ATD implantation was associated with reduced direct current (DC) cardioversions and to compare ATP success between different CHD diagnoses and ATP programs. A single-center retrospective chart review was performed on CHD patients with ATDs. Demographic data were collected in addition to the number of DC cardioversions required before and after ATD implantation; data on ATP efficacy and the specific ATP program utilized; and adverse events related to ATD implantation or subsequent ATP treatments. ATD implantation in 91 CHD patients was associated with a significant reduction in DC cardioversions (P < .01). Overall, 72% of IART episodes were successfully terminated by ATP. Patients with levo-transposition of the great arteries experienced lower rates of ATP success than the remainder of the cohort (P < .01). There was no evidence of degeneration to ventricular arrhythmia or death directly attributed to ATP. ATD implantation was associated with reduced DC cardioversion burden. Patients with levo-transposition of the great arteries may experience lower ATP efficacy than patients with other CHDs; however, a larger patient population is required to better determine subgroup efficacy. These results support the safety and efficacy of ATP in the CHD population. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  4. Safety Aspects of Big Cryogenic Systems Design

    Science.gov (United States)

    Chorowski, M.; Fydrych, J.; Poliński, J.

    2010-04-01

    Superconductivity and helium cryogenics are key technologies in the construction of large scientific instruments, like accelerators, fusion reactors or free electron lasers. Such cryogenic systems may contain more than hundred tons of helium, mostly in cold and high-density phases. In spite of the high reliability of the systems, accidental loss of the insulation vacuum, pipe rupture or rapid energy dissipation in the cold helium can not be overlooked. To avoid the danger of over-design pressure rise in the cryostats, they need to be equipped with a helium relief system. Such a system is comprised of safety valves, bursting disks and optionally cold or warm quench lines, collectors and storage tanks. Proper design of the helium safety relief system requires a good understanding of worst case scenarios. Such scenarios will be discussed, taking into account different possible failures of the cryogenic system. In any case it is necessary to estimate heat transfer through degraded vacuum superinsulation and mass flow through the valves and safety disks. Even if the design of the helium relief system does not foresee direct helium venting into the environment, an occasional emergency helium spill may happen. Helium propagation in the atmosphere and the origins of oxygen-deficiency hazards will be discussed.

  5. Safety, Efficacy, and Bioavailability of Fixed-Dose Combinations in Type 2 Diabetes Mellitus: A Systematic Updated Review

    Directory of Open Access Journals (Sweden)

    Thangavel Mahalingam Vijayakumar, M.Pharm, PhD

    2017-01-01

    Implications: From this updated review, it was found that metformin was the most widely used component of FDCs with other OHAs. Studies on the safety and efficacy of newly approved OHAs such as sodium glucose cotransporter inhibitors were limited. An increasing number of randomized trials on the safety and efficacy of newly emerging FDCs suggests that they would be better treatment options for T2DM patients.

  6. 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...

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. The safety and efficacy of palbociclib in the treatment of metastatic breast cancer.

    Science.gov (United States)

    Ettl, Johannes; Harbeck, Nadia

    2017-08-01

    Palbociclib (Ibrance®) is the first-in-class CDK4/6 inhibitor which has been introduced into clinical practice for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). It is an orally administered drug, which acts by selectively inhibiting cyclin-dependant kinases CDK4 and CDK6. Given together with anti-estrogens like letrozole and fulvestrant it enhances the antiproliferative effect of these drugs without compromising the favorable toxicity profile of endocrine therapy. Areas covered: This review gives a concise overview of the current available preclinical and clinical data about pabociclib including its chemistry, mechanism of action, pharmacokinetics and evidence of its substantial anti-tumor efficacy and safety profile when combined with endocrine therapy Expert commentary: Palbociclib doubles treatment efficacy of letrozole and fulvestrant with a restricted and well manageable toxicity profile. Efficacy as well as safety results from the three registration trials are remarkably consistent. Patients' quality of life is maintained on palbociclib treatment. The treatment landscape in ER+ HER2- MBC will be highly influenced by this compound and development of two other CDK4/6 inhibitors.

  12. Scalp Cooling: A Literature Review of Efficacy, Safety, and Tolerability for Chemotherapy-Induced Alopecia
.

    Science.gov (United States)

    Ross, Mikel; Fischer-Cartlidge, Erica

    2017-04-01

    More than 75% of patients with cancer cite alopecia as the most feared side effect of treatment, with as many as 10% considering treatment refusal. Despite wide acceptance in other countries, scalp cooling to reduce chemotherapy-induced alopecia (CIA) has been uncommon in the United States because of longstanding concerns of scalp metastases and a lack of reliable efficacy data. 
. This article reviews 40 years of efficacy, safety, and tolerability literature on scalp cooling to prevent CIA. 
. A systematic review was performed in PubMed and CINAHL®. Forty articles were reviewed, with 12 articles demonstrating high levels of evidence and meeting inclusion criteria. Comparative trials, systematic reviews, and one large single-arm trial were included. 
. Scalp cooling efficacy is dependent on many factors but demonstrates better hair preservation than no cooling. No increase in scalp metastases or statistically significant difference in overall survival was seen in retrospective safety data when cooling was used. Few patients discontinue cooling early because of adverse experiences.

  13. Effect of renal function on antihypertensive drug safety and efficacy in children.

    Science.gov (United States)

    Watt, Kevin M; Avant, Debbie; Sherwin, Jennifer; Benjamin, Daniel K; Hornik, Christoph; Benjamin, Daniel K; Li, Jennifer S; Smith, P Brian

    2018-01-01

    Hypertension and chronic kidney disease (CKD) are common comorbidities. Guidelines recommend treating hypertension in children with CKD because it is a modifiable risk factor for subsequent cardiovascular disease. Children with CKD are frequently excluded from antihypertensive drug trials. Consequently, safety and efficacy data for antihypertensive drugs are lacking in children with CKD. We determined the incidence of adverse events in 10 pediatric antihypertensive trials to determine the effect of renal function on antihypertensive safety and efficacy in children. These trials were submitted to the US Food and Drug Administration from 1998 to 2005. We determined the number and type of adverse events reported during the trials and compared these numbers in participants with normal renal function and those with decreased function (defined as an estimated glomerular filtration rate [eGFR] children in the 10 studies, 315 had decreased renal function. We observed no difference between the two cohorts in the incidence of adverse events or adverse drug reactions related to study drug. Only 5 participants, all with decreased renal function, experienced a serious adverse event; none was recorded by investigators to be study drug-related. Among treated participants, children with decreased renal function who received a high dose of study drug had a significantly larger drop in diastolic blood pressure compared with children with normal renal function. These data show that antihypertensive treatment in children with renal dysfunction can be safe and efficacious, and consideration should be given to their inclusion in selected drug development programs.

  14. Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.

    Science.gov (United States)

    Sanders, Mary Ellen; Klaenhammer, Todd R; Ouwehand, Arthur C; Pot, Bruno; Johansen, Eric; Heimbach, James T; Marco, Maria L; Tennilä, Julia; Ross, R Paul; Franz, Charles; Pagé, Nicolas; Pridmore, R David; Leyer, Greg; Salminen, Seppo; Charbonneau, Duane; Call, Emma; Lenoir-Wijnkoop, Irene

    2014-02-01

    Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy. © 2014 New York Academy of Sciences.

  15. 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

  16. 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

  17. Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing

    DEFF Research Database (Denmark)

    Bisgaard, Hans; Allen, David; Milanowski, Janusz

    2004-01-01

    OBJECTIVE: Our aim was to compare the 12-month safety and efficacy of fluticasone propionate (FP) and sodium cromoglycate (SCG) in children aged 1 to 3 years with mild to moderate recurrent wheeze. METHODS: The study was a randomized, parallel-group, open-label multicenter study of 625 children...... clinically important side effects but is more efficacious than SCG....

  18. Efficacy and safety of dose escalation of infliximab therapy in Japanese patients with psoriasis: Results of the SPREAD study.

    Science.gov (United States)

    Torii, Hideshi; Nakano, Masayuki; Yano, Toshiro; Kondo, Kazuoki; Nakagawa, Hidemi

    2017-05-01

    Although infliximab is approved for psoriasis, its efficacy is reduced over time in some patients. The aim of this phase III trial is to evaluate efficacy and safety of infliximab dose escalation in Japanese psoriasis patients with loss of efficacy to standard-dose therapy. Patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis or psoriatic erythroderma who showed loss of efficacy to standard-dose therapy received infliximab dose escalation (10 mg/kg every 8 weeks) from weeks 0 to 32. Loss of efficacy was defined as not maintaining 50% reduction in the Psoriasis Area and Severity Index (PASI 50) after achieving PASI 75. Efficacy and safety were evaluated up to week 40. Fifty-one patients received dose escalation and 43 completed the study. PASI 75 and median improvement rate of PASI score at week 40 were 44% and 70.0%, respectively, showing efficacy in skin symptoms. Efficacies in quality of life, nail psoriasis and joint pain were also obtained. Median serum infliximab level increased from less than 0.1 to 1.1 μg/mL from weeks 0 to 40, showing positive correlation between efficacy and serum infliximab level at week 40. Favorable efficacy was observed in patients with detectable serum infliximab levels (≥0.1 μg/mL) at baseline. Incidences of adverse events, serious adverse events, serious infections and serious infusion reactions were 92%, 10%, 4% and 0%, respectively. No marked difference was observed in both efficacy and safety among psoriasis types. No new safety concerns were observed. Infliximab dose escalation was effective and well-tolerated in psoriasis patients with loss of efficacy to standard-dose therapy, suggesting that dose escalation may be a useful therapeutic option for these patients. © 2016 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  19. Clinical efficacy and safety of a water-soluble micellar paclitaxel (Paccal Vet) in canine mastocytomas.

    Science.gov (United States)

    Rivera, P; Akerlund-Denneberg, N; Bergvall, K; Kessler, M; Rowe, A; Willmann, M; Persson, G; Kastengren Fröberg, G; Westberg, S; von Euler, H

    2013-01-01

    To determine the clinical efficacy and safety of a cremophor-free formulation of paclitaxel (Paccal Vet, Oasmia Pharmaceuticals) in dogs with mast cell tumours. Paccal Vet was administered at a median dose of 145 (range, 135 to 150) mg/m(2) intravenously once every 21 days for three cycles to 29 dogs with macroscopic grade 2 or 3 mast cell tumour. Efficacy was assessed by tumour response (Response Evaluation Criteria in Solid Tumours version 1.0) and performance status score. Progression-free survival, quality of life and safety/adverse events were also evaluated. Clinical safety was assessed by clinicopathological analyses and recording of adverse events. Complete or partial response was observed in 59% of dogs. Performance status score remained constant or improved for 20 dogs and decreased by one grade for 9 dogs. Median time to progression was 247 (range, 42 to 268) days. Expected, transient frequently subclinical adverse events (primarily grade 3/4 neutropenia and grade 1/2 leukopenia) were observed in the majority of dogs. Nine dogs were euthanased and one dog died due to disease progression. Paccal Vet appears to be a clinically safe and effective treatment for canine mast cell tumours. Further controlled confirmatory investigation is warranted. © 2012 British Small Animal Veterinary Association.

  20. Review of the efficacy and safety of over-the-counter medicine

    Directory of Open Access Journals (Sweden)

    Gerusa Clazer Halila

    2015-06-01

    Full Text Available Over-the-counter medicines are available without prescription because of their safety and effectiveness, to treat minor ailments and symptoms. The objective of the study was to analyze the availability and quality of systematic reviews published about nonprescription medicines, identifying the groups for which there are gaps in evidence. We identified published articles through the Cochrane Database of Systematic Review and MEDLINE, from the start of the database until May 2012, using the search terms "nonprescription drugs," "over the counter," and "OTC." We searched for articles that describe systematic reviews addressing the efficacy and safety of drugs dispensed without a prescription, according to the lists published by the Association of the European Self-Medication Industry and in Brazil, in the clinical conditions listed in Groups and Specified Therapeutic Indications. We included 49 articles, 18 articles were of moderate quality and 31 of high quality. Of the studies, 74.5% demonstrated efficacy in favor of the use of drugs evaluated. Of the 24 studies that evaluated safety, 21% showed evidence unfavorable to the drug. Overall, the evidence found in the studies included in the overview is favorable to the use of the drugs evaluated. However, there are gaps in evidence for some therapy groups.

  1. 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.

  2. Efficacy and safety of immunotherapy for allergies to Alternaria alternata in children.

    Science.gov (United States)

    Kuna, Piotr; Kaczmarek, Jadwiga; Kupczyk, Maciej

    2011-02-01

    The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents. We evaluated the efficacy and safety of specific immunotherapy with a standardized allergen extract in a randomized, double-blind, placebo-controlled, 3-year prospective study of patients who were allergic to only Alternaria alternata. Fifty children and adolescents (25 girls; 5-18 years of age) with A alternata-induced seasonal allergic rhinoconjunctivitis and/or bronchial asthma were randomly assigned to groups given treatment (Novo-Helisen Depot, A alternata 100%) or placebo. The primary end point was the combined symptom medication score. Secondary end points included safety, quality of life, and sensitivity to allergen-specific nasal challenge. Forty-five children completed the 3-year study. Although there was no significant change in year 1, the combined symptom medication score decreased in years 2 and 3 of the study (by 38.7% and 63.5%, respectively; P children and adolescents without serious side effects. Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  3. 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.

  4. Safety and efficacy of dual-axis rotational coronary angiography vs. standard coronary angiography.

    Science.gov (United States)

    Klein, Andrew J; Garcia, Joel A; Hudson, Paul A; Kim, Michael S; Messenger, John C; Casserly, Ivan P; Wink, Onno; Hattler, Brack; Tsai, Thomas T; Chen, S Y James; Hansgen, Adam; Carroll, John D

    2011-05-01

    To determine the safety and efficacy of dual-axis rotational coronary angiography (DARCA) by directly comparing it to standard coronary angiography (SA). Standard coronary angiography (SA) requires numerous fixed static images of the coronary tree and has multiple well-documented limitations. Dual-axis rotational coronary angiography (DARCA) is a new rotational acquisition technique that entails simultaneous LAO/RAO and cranial/caudal gantry movement. This technological advancement obtains numerous unique images of the left or right coronary tree with a single coronary injection. We sought to assess the safety and efficacy of DARCA as well as determine DARCA's adequacy for CAD screening and assessment. Thirty patients underwent SA following by DARCA. Contrast volume, radiation dose (DAP) and procedural time were recorded for each method to assess safety. For DARCA acquisitions, blood pressure (BP), heart rate (HR), symptoms and any arrhythmias were recorded. All angiograms were reviewed for CAD screening adequacy by two independent invasive cardiologists. Compared to SA, use of DARCA was associated with a 51% reduction in contrast, 35% less radiation exposure, and 18% shorter procedural time. Both independent reviewers noted DARCA to be at least equivalent to SA with respect to the ability to screen for CAD. DARCA represents a new angiographic technique which is equivalent in terms of image quality and is associated with less contrast use, radiation exposure, and procedural time than SA. Copyright © 2011 Wiley-Liss, Inc.

  5. Porcine reproductive and respiratory syndrome virus vaccines: Immunogenicity, efficacy and safety aspects

    Science.gov (United States)

    Charerntantanakul, Wasin

    2012-01-01

    Porcine reproductive and respiratory syndrome virus (PRRSV) infection is the leading cause of economic casualty in swine industry worldwide. The virus can cause reproductive failure, respiratory disease, and growth retardation in the pigs. This review deals with current status of commercial PRRS vaccines presently used to control PRRS. The review focuses on the immunogenicity, protective efficacy and safety aspects of the vaccines. Commercial PRRS modified-live virus (MLV) vaccine elicits delayed humoral and cell-mediated immune responses following vaccination. The vaccine confers late but effective protection against genetically homologous PRRSV, and partial protection against genetically heterologous virus. The MLV vaccine is of concern for its safety as the vaccine virus can revert to virulence and cause diseases. PRRS killed virus (KV) vaccine, on the other hand, is safe but confers limited protection against either homologous or heterologous virus. The KV vaccine yet helps reduce disease severity when administered to the PRRSV-infected pigs. Although efforts have been made to improve the immunogenicity, efficacy and safety of PRRS vaccines, a better vaccine is still needed in order to protect against PRRSV. PMID:24175208

  6. 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.

  7. 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

  8. Unavailability analysis of redundant safety systems

    International Nuclear Information System (INIS)

    Vaurio, J.K.; Sciaudone, D.

    1980-01-01

    Analytical equations have been obtained for the unavailabilities of redundant standby safety systems with components tested periodically. Test and repair contributions, hardware failures, human testing and repair errors as well as failures due to true demands have been taken into account. Equations have been derived for m-out-of-n systems (1 less than or equal to m less than or equal to n less than or equal to 4) with uniformly staggered, consecutive and random testing schemes. The equations have been used in a computer code, ICARUS, and applied to practical safety systems. The results are useful for optimizing the redundancy and testing and they illustrate the importance of human/testing errors and falures associated with true demands

  9. Efficacy and safety of rituximab in the treatment of refractory pemfigus vulgaris

    Directory of Open Access Journals (Sweden)

    Aslı Bilgiç Temel

    2015-06-01

    Full Text Available Background and Design: Pemphigus vulgaris (PV is a severe, chronic, potentially life-threatening autoimmune blistering disease that affects the skin and mucous membranes, associated with the loss of cell-cell adhesion and blister formation. Systemic steroids in combination with immunosuppressive agents are the mainstay of therapy in pemphigus. Rituximab is a chimeric monoclonal anti- CD20 antibody, has been tried increasingly for the treatment of PV. Objective: We sought to test the efficacy and safety of rituximab as an adjuvant therapy by retrospective analysis of clinical and immunological data of patients. Method: A retrospective analysis is presented of 13 patients with refractory pemphigus vulgaris who were treated with rituximab at Akdeniz University Hospital, Dermatology and Venereology Department, Bullous Disease Unit. We evaluated clinical and immunological data with last treatments. Results: Patients were treated with one cycle of two biweekly infusions of rituximab at a dose of 1000 mg on days 1 and 15, except one received four doses of 375 mg / m2 intravenously weekly. The mean follow-up time was 18.5 months. All patients had a decrease in antibody titers or antibodies were completely undetected after treatment. Rituximab use resulted in a significant reduction in steroid dosage during follow-up. At the end of the follow-up period, 7 patients achieved complete disease remission without therapy, 1 patient achieved partial disease remission without therapy, 2 patients achieved complete remission on minimal therapy, 1 patient achieved complete remission on therapy, 1 patient achieved partial remission on minimal therapy, and one patient had no follow-up. Rituximab was well tolerated by all patients. Clinical relapse had seen 53.8% by the mean period of 13.8 months. Relapses have been managed with additional infusions of rituximab. Conclusion: Rituximab is beneficial in the management of refractory PV, induces prolonged clinical

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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 ...

  15. 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

  16. Efficacy and safety of antidepressant augmentation of continued antipsychotic treatment in patients with schizophrenia

    DEFF Research Database (Denmark)

    Galling, B; Vernon, J A; Pagsberg, A K

    2018-01-01

    OBJECTIVE: To evaluate the efficacy and safety of antidepressant augmentation of antipsychotics in schizophrenia. METHODS: Systematic literature search (PubMed/MEDLINE/PsycINFO/Cochrane Library) from database inception until 10/10/2017 for randomized, double-blind, efficacy-focused trials comparing...... adjunctive antidepressants vs. placebo in schizophrenia. RESULTS: In a random-effects meta-analysis (studies = 42, n = 1934, duration = 10.1 ± 8.1 weeks), antidepressant augmentation outperformed placebo regarding total symptom reduction [standardized mean difference (SMD) = -0.37, 95% confidence interval.......77, -0.09, P = 0.012). Antidepressants did not improve depressive symptoms more than placebo (P = 0.185). Except for more dry mouth [risk ratio (RR) = 1.57, 95% CI = 1.04-2.36, P = 0.03], antidepressant augmentation was not associated with more adverse events or all-cause/specific-cause discontinuation...

  17. Efficacy and safety of the trastuzumab biosimilar candidate CT-P6.

    Science.gov (United States)

    Esteva, Francisco J; Saeki, Toshiaki; Kim, HoUng; Stebbing, Justin

    2018-02-27

    Trastuzumab is an anti-HER2 monoclonal antibody indicated for the treatment of HER2-overexpressing breast and gastric cancers. Despite its clinical efficacy, access to the biological drug can be limited due to its relatively high price, especially in low-income countries. CT-P6 (Herzuma ® ) is a biosimilar candidate of originator or 'reference' trastuzumab, which may offer an alternative, more cost-effective treatment option. This article reviews the unmet needs of patients eligible to receive reference trastuzumab and the potential place of a trastuzumab biosimilar within the market. The review also summarizes the available clinical evidence supporting the biosimilarity of CT-P6 and reference trastuzumab with respect to pharmacokinetics, efficacy, safety and immunogenicity.

  18. Efficacy and safety of modified-release prednisone in patients with rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Krasselt M

    2016-03-01

    Full Text Available Marco Krasselt, Christoph Baerwald Rheumatology Unit, Clinic for Gastroenterology and Rheumatology, Department of Internal Medicine, Neurology and Dermatology, University of Leipzig, Leipzig, Germany Abstract: The introduction of modified-release (MR prednisone adds a drug with encouraging potential to the armamentarium of the rheumatologist. In particular, for patients experiencing a reduced quality of life due to prolonged morning stiffness, it is a promising therapeutic approach. Two clinical trials and one open-label observational study investigated the effectiveness of MR prednisone in reducing rheumatoid arthritis-related morning stiffness for both new and current users of corticosteroids. The efficacy and safety of MR prednisone use in rheumatoid arthritis patients are reviewed in this article. This includes pivotal trials as well as pathophysiological considerations and clinical implications. Keywords: modified-release prednisone, rheumatoid arthritis, efficacy, chronotherapy, HPA axis, side effects, low-dose prednisone 

  19. The Efficacy and Safety of Rituximab in a Patient with Rheumatoid Spondylitis

    Directory of Open Access Journals (Sweden)

    Şenol Kobak

    2013-01-01

    Full Text Available Rheumatoid arthritis (RA is considered as a connective tissue disease while ankylosing spondylitis (AS is a prototype of spondyloarthritis. These diseases are seen concomitantly only very rarely. Also, rituximab has proven efficacy in the treatment of RA while its role in the treatment of AS is unclear. In this presentation, the concomitant presence of RA and AS in a 43-year-old male patient as well as the efficacy and safety of rituximab is discussed. Rituximab was given due to lack of response to treatment with anti-TNF-alpha. Evaluations made at the 6th and 12th months of treatment showed complete response for RA and partial response for AS.

  20. 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,

  1. 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...

  2. The efficacy and safety of bronchial thermoplasty in severe persistent asthma on extended follow-up.

    Science.gov (United States)

    O'Reilly, A; Browne, I; Watchorn, D; Egan, J J; Lane, S

    2018-03-01

    Asthma is a common condition and there remains a subset of patients who are poorly controlled on maximal therapy. Bronchial thermoplasty (BT) is a bronchoscopic therapy using radiofrequency energy to reduce airway smooth muscle, which has been shown to improve asthma control although further evidence regarding long-term efficacy and safety is required. We aimed to demonstrate safety and efficacy of BT on extended follow-up. Our initial experience with this group was previously reported in 2016, where patients were shown to have a significant improvement in asthma control test (ACT) scores 1-year post-treatment. We carried out a retrospective observational study of seven patients who underwent BT between 2012 and 2013 in an Irish severe asthma centre. The primary endpoint was change in ACT scores from baseline to present. Seven patients underwent BT at a tertiary referral centre in Ireland. ACT scores and data on hospital admissions, exacerbations, maintenance corticosteroid requirements, rescue bronchodilator use and forced expiratory volume for 1 s (FEV1) prior to the procedure and on extended follow-up were collected. Mean follow-up was 49.42 months. A trend towards improvement was seen in median hospitalisations (respective values for median over 12 months 3, 1 P = 0.059) and ACT scores, from 9 to 13 (P = 0.249). Mean FEV1 was 1.68 l prior to treatment and 1.46 l 4 years post-treatment (P = 0.237). There was no mortality among the group. These data support the safety of BT and suggest extended efficacy. © The Author 2017. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  3. Safety and efficacy of NEPA, an oral fixed combination of netupitant and palonosetron, in older patients.

    Science.gov (United States)

    Aapro, Matti; Jordan, Karin; Gralla, Richard J; Rizzi, Giada; Rossi, Giorgia; Palmas, Marco; Alyasova, Anna V; Lisyanskaya, Alla S; Bošnjak, Snežana M; Hesketh, Paul J

    2017-01-01

    Prevention of chemotherapy-induced nausea and vomiting is critical in older patients with cancer. NEPA is an oral fixed combination of netupitant 300mg, a new NK 1 receptor antagonist (RA), and palonosetron 0.5mg, a pharmacologically distinct 5-HT 3 RA. This retrospective analysis evaluated the efficacy and safety of NEPA in older patients. Patients aged ≥65 and ≥70years from one phase II and two phase III trials were considered. Chemotherapy-naive patients with malignant tumors were treated with anthracycline-cyclophosphamide (AC), non-AC-based moderately emetogenic chemotherapy (non-AC MEC), or highly emetogenic chemotherapy (HEC). Following single-dose NEPA, patients received oral dexamethasone on day 1 (AC and non-AC MEC) or days 1-4 (HEC). Efficacy was evaluated through complete response (CR) in cycle 1. Safety was evaluated by AEs and ECGs. Data were summarized by descriptive statistics. Overall, 214 patients were ≥65years and 80 were ≥70years. A higher CR was observed in older patients versus the total population; in the acute phase >90% of patients ≥65years experienced CR. Efficacy was maintained over multiple cycles of chemotherapy. No significant nausea rates were generally higher in the older patients versus total population. Similar rates of AEs in the first treatment cycle were reported for patients ≥65years, ≥70years, and total population (72.9% vs 67.5% vs 70.0%, respectively). No cardiac safety concerns were raised. NEPA is highly effective in older patients receiving MEC or HEC regimens. NEPA is also well tolerated, demonstrating suitability for use in older patients who may have comorbidities. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. 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.

  5. Clinical evaluation of the efficacy and safety of fractional bipolar radiofrequency for the treatment of moderate to severe acne scars.

    Science.gov (United States)

    Verner, Ines

    2016-01-01

    Several treatment modalities are used for the treatment of acne scars with variable results. Recent studies showed that fractional radiofrequency may be an effective treatment modality for acne scars. The objective of this study was to assess the efficacy, safety, tolerability and patient satisfaction of fractional bipolar radiofrequency (RF), the eTwo™ system (Syneron Candela Ltd., Yokneam, Israel) for treating acne scars. Twelve patients with moderate to severe acne scars received 3-5 treatments with the Sublative fractionated bipolar RF applicator of the eTwo device at 1-month intervals. Patients were evaluated clinically and photographically at each visit and 3 months after the final treatment. Very good improvement (at least one scale) was seen after completing the five treatments. The patient satisfaction survey (Global Aesthetic Improvement Scale scores) revealed that half (6 out of 12) of the patients reported to be satisfied with treatment results, while the other half reported to be very satisfied. Beyond the expected erythema and minimal scab formation in the treated areas, which was mild and transient, none of the participants reported any adverse events. The data presented here support the high efficacy and safety of fractionated bipolar RF for the aesthetic improvement of moderate to severe acne scars. © 2015 Wiley Periodicals, Inc.

  6. Efficacy and safety of subcutaneous allergen-specific immunotherapy with depigmented polymerized mite extract in atopic dermatitis.

    Science.gov (United States)

    Novak, Natalija; Bieber, Thomas; Hoffmann, Matthias; Fölster-Holst, Regina; Homey, Bernhard; Werfel, Thomas; Sager, Angelika; Zuberbier, Torsten

    2012-10-01

    Exposure to house dust mites (HDMs) aggravates the course of atopic dermatitis (AD) in patients sensitized to HDMs. This study investigated the efficacy and safety of subcutaneous allergen-specific immunotherapy with the use of depigmented polymerized mite extract as an add-on therapy to basic (ie, topical and, as necessary, systemic) medication. Patients (n = 168) were recruited in a randomized, double-blind, placebo-controlled parallel group phase III study conducted in Germany (21 sites), in adult patients with AD aggravated by HDMs. The primary end points of the study were the assessments of the area under the curves of the total Severity Scoring Atopic Dermatitis (SCORAD) score and of the use of basic medication during the 18-month treatment period. Post hoc subgroup analyses were also performed. Overall efficacy analysis of the intention-to-treat and per-protocol study populations showed no statistically significant differences between the active treatment and placebo groups. However, the subgroup of patients with severe AD (SCORAD > 50) showed a statistically significant reduction of the median total SCORAD by 18% (P = .02) compared with placebo. The frequency of adverse reactions was similar in both groups, suggesting the safety of the active treatment. Although subcutaneous allergen-specific immunotherapy showed no statistically significant difference in the overall population of patients with AD, statistically significant reduction of the total SCORAD could be achieved in a subgroup of patients with severe AD. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  7. 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

  8. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

    Science.gov (United States)

    Senabre-Gallego, José Miguel; Santos-Ramírez, Carlos; Santos-Soler, Gregorio; Salas-Heredia, Esteban; Sánchez-Barrioluengo, Mabel; Barber, Xavier; Rosas, José

    2013-01-01

    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 hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, hematologic disorders like aplastic anemia and pancytopenia, vasculitis, immunogenicity, and exacerbation or induction of psoriasis are class effects of all the anti-TNF drugs, and have been seen in patients with ankylosing spondylitis. However, etanercept is less likely to induce reactivation of tuberculosis than the other anti-TNF drugs and it has been suggested that etanercept might be less immunogenic, especially in ankylosing spondylitis. Acute uveitis, Crohn’s disease, and sarcoidosis are other adverse events that have been rarely associated with etanercept

  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 BSG group (P BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  10. [Efficacy and safety of linezolid among patients withmethicillin-resistant Staphylococcus aureusbacteremia].

    Science.gov (United States)

    Chen, S L; Zhu, C Y; Zhou, H; Yang, Q; Shen, Y H; Zhou, J Y

    2017-04-11

    Objective: To study the efficacy and safety of linezolid for the treatment of patients with bacteremia caused by methicillin - resistant Staphylococcus aureus (MRSA). Methods: Totally 52 cases of MRSA bacteremia patients, from January 2010 to April 2014 in the First Affiliated Hospital, School of Medicine, Zhejiang University, were retrospectively analyzed. They were classified into two groups based on linezolid therapeutic regimen: primary treatment with linezolid (19 cases) and alternated to linezolid (33 cases). The following data were collected and compared: clinical characteristics, lasting time of fever, bacterial clearance rate, clinical efficacy, fatality rate, and adverse events. Results: Forty three of the 52 patients (82.7%) suffered complicated MRSA bacteremia. The most common clinical feature was fever[86.5%(45/52)]. Linezolid was initiatively used mostly because of renal insufficiency[68.4%(13/19)]. In the other 33 patient, glycopeptides were initiatively used, then alternated to linezolid because of persistent fever[69.7%(23/33)]; damage of kidney function during treatment period of glycopeptides[12.1%(4/33)]; occurrence of new infectious site related to MRSA[18.2%(6/33)]. The clinical efficacy were 78.9%(15/19) in the group of primary treatment with linezolid and 81.8% (27/33) in the group of alternated to linezolid, persistent time of fever were 4(3, 15) d and 12(5, 24) d, mortality during 28 d period were 15.8% (3/19) and 9.1% (3/33), adverse rate were 15.8% (3/19) and 12.1% (4/33) in these two groups, respectively (all P >0.05). Conclusion: Linezolid is an option with high clinical efficacy and good safety for MRSA bacteremia patients.

  11. 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.

  12. 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

  13. 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.

  14. 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.

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

    Directory of Open Access Journals (Sweden)

    Pacha O

    2012-05-01

    Full Text Available Omar Pacha, Adelaide A HebertDepartment of Dermatology, University of Texas Health Science Center, Houston, TX, USAAbstract: Advances in current understanding of the pathophysiology of atopic dermatitis have led to improved targeting of the structural deficiencies in atopic skin. Ceramide deficiency appears to be one of the major alterations in atopic dermatitis and the replenishment of this epidermal component through topically applied ceramide based emollients appears to be safe, well tolerated, and effective. Recently a ceramide hyaluronic acid foam has become commercially available and increasing evidence supports its safety and efficacy in patients who suffer from atopic dermatitis.Keywords: atopic dermatitis, ceramide, Hylatopic, eczema, non-steroidal, dermatology

  16. 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 ... in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P

  17. 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.

  18. 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.

  19. 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...... 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...... 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...

  20. 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.

  1. 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.

  2. Efficacy and safety results of long-term growth hormone treatment of idiopathic short stature.

    Science.gov (United States)

    Kemp, Stephen F; Kuntze, Joyce; Attie, Kenneth M; Maneatis, Thomas; Butler, S; Frane, James; Lippe, Barbara

    2005-09-01

    Small clinical trials of GH treatment of idiopathic short stature (ISS) show variable efficacy. The study was an analysis of a large GH registry for efficacy and safety of GH treatment of ISS. There was also a comparison with a specific clinical trial. Up to 7 yr of GH treatment of ISS was evaluated for efficacy and safety in the National Cooperative Growth Study (NCGS). The NCGS study was conducted at Genentech, Inc. and included 47,226 patients. The ISS group included maximum stimulated GH 10 ng/ml or more and/or a report of ISS by investigator (n = 8018; all included for safety). Cohort 1 (n = 2520) was similar to the clinical trial, cohort 2 (n = 283) included subjects younger than 5 yr of age, and cohort 3 (n = 940) was pubertal at GH start. GH, approximately 0.30 mg/kg.wk, was given. These included growth velocities and height sd (HtSDS). Mean first-year growth velocities in cohorts 1, 2, and 3 increased 4.6, 3.9, and 4.4 cm/yr over pretreatment, respectively. Measures included: baseline mean HtSDS, -2.9, -3.2, and -2.8; mean HtSDS at 1 yr, -2.4, -2.3, and -2.3, respectively. Mean HtSDS after 7 yr in cohorts 1 (n = 303) and 2 (n = 85) and 5 yr in cohort 3 (n = 58) were: -1.2, -1.0, and -1.5, respectively. Cohort 3 shorter treatment time was due to advanced baseline age (mean 13.8 yr) and puberty. Mean HtSDS gain in cohort 1 was comparable with the clinical trial. No new safety signals specific to the NCGS ISS population were observed. ISS patients in the GH registry demonstrate a significant increase in HtSDS with the safety profile similar to GH-deficient patients. RESULTS were similar to the clinical trial.

  3. Safety characteristics of decay heat removal systems

    International Nuclear Information System (INIS)

    Hofmann, F.

    1991-01-01

    Safety features of the decay heat removal systems including power sunply and final heat sink are described. A rather high reliability and an utmost degree of independence from energy supply are goals to be attained in the design of the European Fast Reactor (EFR) decay heat removal scheme. Natural circulation is an ambitious design goal for EFR. All the considerations are performed within the frame of risk minimization

  4. System of its indicator economic safety

    OpenAIRE

    Alexandrova, A.

    2010-01-01

    The thesis is devoted to the scientific and methodological decision of problem of formulation peculiarity economic safety’s guarantying of Ukraine in regional aspect. The scientific ground of optimization economic safety’s management are design. This work describes the bases of research economic safety, define the structure of this category, system of its indicators. Regional features of social and economical development are determined. Various between social and economical development of reg...

  5. Listerine® Products: An Update on the Efficacy and Safety.

    Science.gov (United States)

    Vlachojannis, C; Al-Ahmad, A; Hellwig, E; Chrubasik, S

    2016-03-01

    In the 19th century, the mouthwash Listerine® was formulated from four essential oils. Later, the oils were replaced by their marker substances. To keep them in solution, 24-27% ethanol was added as a vehicle. This is an update of our previous review on the efficacy and safety of Listerine®. PubMed was searched for clinical studies on the therapeutic benefits and safety of Listerine® from the end of 2011 to the end of October 2015. Sixteen studies were found and extracted. Three of the four 6-month studies were of sound confirmatory design. Two of these investigated Listerine® and one Listerine Zero®. The evidence of effectiveness for Listerine®, based on the bulk of three confirmatory studies and numerous exploratory studies carried out so far, is strong, but only moderate for Listerine® Zero and poor for Listerine® Cool Blue. In the three safety studies identified, we found methodological flaws that biased the results. Evidence is accumulating that Listerine® is effective in improving oral health, but the absence of systematic toxicological studies means that an accurate safety assessment cannot be made. Copyright © 2016 John Wiley & Sons, Ltd.

  6. 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)

  7. 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)

  8. Safety analysis of tritium recycling system

    International Nuclear Information System (INIS)

    Yang Yong; Zhang Dong; Xing Shixiong

    2009-04-01

    Safety of a tritium recycling system is analysed according to the structure of the system. The method of accident tree is used to analyse the leakage probability of the system. The result show that the leakage probability of the system failure is 1.1 x 10 -3 and the leakage probability of human fault is 7.2 x 10 -3 , which is are in safe limit. But the leakage probability of human fault is higher than system failure. The MCA will occur because of tritium waste emission cell breakage or misplay, in this case, all tritium in the system will leak, which is about 5.84 TBq. The maximal effective individual dose is 1.24 x 10 -3 mSv, the maximal effective close of the collectivity is 15.33 Person·mSv. (authors)

  9. 46 CFR 62.25-15 - Safety control systems.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Safety control systems. 62.25-15 Section 62.25-15... AUTOMATION General Requirements for All Automated Vital Systems § 62.25-15 Safety control systems. (a) Minimum safety trip controls required for specific types of automated vital systems are listed in Table 62...

  10. Safety and efficacy of a novel European vaccine for porcine reproductive and respiratory virus in bred gilts.

    Science.gov (United States)

    Piontkowski, Michael D; Kroll, Jeremy; Orveillon, Francois-Xavier; Kraft, Christian; Coll, Teresa

    2016-10-01

    Porcine reproductive and respiratory syndrome virus (PRRSV) can be devastating to commercial breeding operations. The objective of this study was to evaluate a novel European PRRSV vaccinal strain for safety and efficacy in bred gilts. In 2 experiments, 110 gilts were vaccinated intramuscularly and the vaccine was evaluated for safety and efficacy. Gilts in Experiment 1 were evaluated for local and systemic reactions and gilts in both experiments were observed for clinical signs of disease through farrow. In both experiments, piglet clinical observations, piglet average daily weight gain (ADWG), gilt serology [determined by enzyme-linked immunosorbent assay (ELISA)], gilt and piglet viremia [determined by quantitative real-time polymerase chain reaction (qPCR)], as well as piglet lung lesion scores and PRRS virus in lung tissue (qPCR) were determined. The vaccine was shown to be safe as there were no significant differences among groups in either experiment. Efficacy was established in Experiment 2 as both vaccinated groups were associated with desirable significant differences in percentage of gilts with abnormal clinical findings; gilt viral load post-challenge [day 125, day of farrowing (DOF), and DOF + 13]; percentages of alive, healthy live, weak live, and mummified piglets per litter at farrowing and weaning; percentage of piglets per gilt that were positive for viremia; percentage of piglets per gilt with clinical disease; and piglet viral load on DOF. It was concluded that a vaccine formulated from the PRRSV modified live virus (MLV) strain 94881 is a safe and effective method of protection against the detrimental effects of virulent PRRSV infection in breeding female pigs.

  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...... Haviland's theorem allows an infinite dimensional optimization problem on measures to be formulated as a polynomial optimization problem. Subsequently, the moment sequence is truncated (relaxed) to obtain a finite dimensional polynomial optimization problem. Finally, we provide an illustrative example...

  12. ESSAA: Embedded system safety analysis assistant

    Science.gov (United States)

    Wallace, Peter; Holzer, Joseph; Guarro, Sergio; Hyatt, Larry

    1987-01-01

    The Embedded System Safety Analysis Assistant (ESSAA) is a knowledge-based tool that can assist in identifying disaster scenarios. Imbedded software issues hazardous control commands to the surrounding hardware. ESSAA is intended to work from outputs to inputs, as a complement to simulation and verification methods. Rather than treating the software in isolation, it examines the context in which the software is to be deployed. Given a specified disasterous outcome, ESSAA works from a qualitative, abstract model of the complete system to infer sets of environmental conditions and/or failures that could cause a disasterous outcome. The scenarios can then be examined in depth for plausibility using existing techniques.

  13. 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

  14. Safety, efficacy and immunogenicity evaluation of the SAG2 oral rabies vaccine in Formosan ferret badgers.

    Science.gov (United States)

    Hsu, Ai-Ping; Tseng, Chun-Hsien; Barrat, Jacques; Lee, Shu-Hwae; Shih, Yu-Hua; Wasniewski, Marine; Mähl, Philippe; Chang, Chia-Chia; Lin, Chun-Ta; Chen, Re-Shang; Tu, Wen-Jane; Cliquet, Florence; Tsai, Hsiang-Jung

    2017-01-01

    Since 2013, rabies cases have been reported among Formosan ferret badgers in Taiwan, and they have been shown to be the major reservoirs for Taiwanese enzootics. To control and eradicate rabies, the authorities plan to implement a vaccination programme. Before distributing live vaccines in the field, this study assessed the safety, efficacy, and immunogenicity of SAG2 vaccine on ferret badgers by direct oral instillation. After application of 109 TCID50/dose, no virus was excreted into the oral cavity 1-7 days post-application, and safety was also satisfactorily verified over a 266-day period. Moreover, despite the low level of rabies virus neutralising antibodies induced after vaccination of a 108 TCID50/dose, the efficacy assessment revealed a 100% survival rate (15/15) of vaccinees and an 87.5% fatality rate (7/8) in control animals after a challenge on the 198th day post-vaccination. The immunisation and protection rates obtained more than 6 months after a single vaccination dose demonstrated that SAG2 is an ideal vaccine candidate to protect Formosan ferret badgers against rabies in Taiwan.

  15. Safety and efficacy of acarbose in the treatment of diabetes in Chinese patients

    Directory of Open Access Journals (Sweden)

    He K

    2014-06-01

    Full Text Available Ke He*, Jun-Cheng Shi*, Xiao-Ming Mao Department of Endocrinology, Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, People's Republic of China *These authors contributed equally to this work Abstract: Acarbose is an α-glucosidase inhibitor that is commonly used to control postprandial blood glucose. It functions as a competitive and reversible inhibitor of small intestinal brush border glucosidase, blocks the degradation of starch and sucrose, and delays the absorption of glucose and fructose in the alimentary tract. The starch content of a diet might alter the hypoglycemic effects of acarbose because of its mechanism of action. Chinese individuals consume a typical Eastern diet, which is characterized by a high intake of whole grains, legumes, vegetables, fruits, and fish. These dietary habits allow acarbose to be used extensively in the People's Republic of China. Several Chinese-based studies have demonstrated that the use of acarbose as a monotherapy had similar effects on other anti-diabetes agents in decreasing glycosylated hemoglobin (HbA1c and blood glucose levels, and acarbose in combination with other anti-diabetic drugs could further reduce blood glucose and decrease the mean amplitude of glycemic excursions. Importantly, acarbose is safe and well tolerated, with a low incidence of adverse effects. This article provides a comprehensive review of the safety and efficacy of acarbose for the treatment of diabetes in Chinese patients. Keywords: acarbose, α-glucosidase inhibitor, efficacy, safety

  16. 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

  17. 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.

  18. Efficacy and safety of daikenchuto (TJ-100) in pregnant women with constipation.

    Science.gov (United States)

    Tsuda, Hiroyuki; Kotani, Tomomi; Sumigama, Seiji; Mano, Yukio; Hayakawa, Hiromi; Kikkawa, Fumitaka

    2016-02-01

    Constipation is common and a significant problem in pregnant women. The purpose of this study was to examine the efficacy and the safety of daikenchuto in pregnant women with constipation. This was a prospective study, and a total of 20 patients were registered between February 2010 and August 2012. The patients received 7.5 g/d of daikenchuto for 28 days from the day of registration. All enrolled patients were asked to complete the constipation assessment scale (CAS) every day. In addition, we measured the aspartate transaminase, alanine transaminase, blood urea nitrogen, and creatinine levels to assess the adverse effects of daikenchuto. The CAS scores were significantly lower at 28 days after daikenchuto treatment (p = 0.019), with a significant effect achieved on Day 1. The impact of the therapy was greatest in the second trimester (p = 0.043). No significant adverse effects of daikenchuto were observed, and the rates of preterm birth and pregnancy-induced hypertension were 10% and 5%, respectively, which are similar to previously reported values. We herein demonstrated the efficacy and safety of daikenchuto in pregnant women with constipation. We hope that our findings will aid in the management of constipation in pregnant women. Copyright © 2016. Published by Elsevier B.V.

  19. Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy.

    Science.gov (United States)

    Koke, Stephanie C; Brown, Eileen B; Miner, Cherri M

    2002-09-01

    Because many women who receive pharmacologic therapy with antidepressants are also prescribed oral contraceptives, it is important to assess the risk of clinically significant drug interactions. We reviewed the United States fluoxetine clinical trial database, specifically analyzing women ages 18 to 45 years, for differences in safety, antidepressant efficacy, and unplanned pregnancies that were associated with oral contraceptive use. Data from 17 double-blind, placebo-controlled clinical trials in 1698 women were analyzed retrospectively. A subgroup of women with oral contraceptive use was compared with a subgroup of women with no oral contraceptive use. Differences in treatment-emergent adverse events, unplanned pregnancies, and 17-item Hamilton Depression Scale (HAMD-17) scores were analyzed. The only treatment-emergent adverse events that showed a statistically significantly different odds ratio for oral contraceptive use versus no oral contraceptive use were headache, asthenia, and pain. There was not a statistically significant interaction in the incidence of unintended pregnancies (P =.111) or in the changes from baseline in HAMDD-17 scores. There is no clinical evidence that concomitant use of oral contraceptives and fluoxetine affects the safety or efficacy of either agent.

  20. Safety, efficacy and immunogenicity evaluation of the SAG2 oral rabies vaccine in Formosan ferret badgers.

    Directory of Open Access Journals (Sweden)

    Ai-Ping Hsu

    Full Text Available Since 2013, rabies cases have been reported among Formosan ferret badgers in Taiwan, and they have been shown to be the major reservoirs for Taiwanese enzootics. To control and eradicate rabies, the authorities plan to implement a vaccination programme. Before distributing live vaccines in the field, this study assessed the safety, efficacy, and immunogenicity of SAG2 vaccine on ferret badgers by direct oral instillation. After application of 109 TCID50/dose, no virus was excreted into the oral cavity 1-7 days post-application, and safety was also satisfactorily verified over a 266-day period. Moreover, despite the low level of rabies virus neutralising antibodies induced after vaccination of a 108 TCID50/dose, the efficacy assessment revealed a 100% survival rate (15/15 of vaccinees and an 87.5% fatality rate (7/8 in control animals after a challenge on the 198th day post-vaccination. The immunisation and protection rates obtained more than 6 months after a single vaccination dose demonstrated that SAG2 is an ideal vaccine candidate to protect Formosan ferret badgers against rabies in Taiwan.

  1. 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.

  2. The efficacy and safety of rituximab in treating childhood refractory nephrotic syndrome: a meta-analysis.

    Science.gov (United States)

    Zhao, Zhihong; Liao, Guixiang; Li, Yongqiang; Zhou, Shulu; Zou, Hequn

    2015-02-03

    Rituximab is considered to be a promising drug for treating childhood refractory nephrotic syndrome. However, the efficacy and safety of rituximab in treating childhood refractory nephrotic syndrome remain inconclusive. This meta-analysis aimed to investigate the efficacy and safety of rituximab treatment compared with other immunosuppressive agents in children with refractory nephrotic syndrome. Three randomized controlled trials and two comparative control studies were included in our analysis. The included studies were of moderately high quality. Compared with other immunotherapies, rituximab therapy significantly improved relapse-free survival (hazard ratio = 0.49, 95% confidence interval [CI], 0.26-0.92, P = 0.03). Rituximab also achieved a higher rate of complete remission (risk ratio,1.62; 95% CI, 0.92 to 2.84, P = 0.09) and reduced the occurrence of proteinuria (mean difference = -0.25, 95% CI = -0.29 to -0.21, P childhood refractory nephrotic syndrome; however, the long-term effects and cost-effectiveness of rituximab treatment were not fully assessed, and there were limited studies that evaluated the clinical benefits of a concurrent infusion of rituximab plus a steroid compared with an infusion of rituximab only. Additional studies are required to address these issues.

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

    Science.gov (United States)

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

    2017-03-01

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

  4. An observational study on safety and efficacy of povidone-iodine for pleurodesis in cancer patients

    Directory of Open Access Journals (Sweden)

    Ayush Makkar

    2017-01-01

    Full Text Available Introduction: Pleurodesis is a time-honored procedure for malignant effusion as one of the palliative procedures to treat recurrent effusions. Various agents have been used in the past such as tetracycline, talc, bleomycin, and povidone-iodine. This paper aims at evaluating safety and efficacy of povidone-iodine for the procedure. Materials and Methods: One hundred and four patients underwent of pleurodesis with povidone-iodine done at our center for malignant effusion between June 2008 and August 2015. The safety and efficacy of the procedure was analyzed. Results: One hundred and four patients of malignant effusion with mean age of 53 years and a mean follow-up of 7.8 months were evaluated. A total of 79% patients did not show any reaccumulation of fluid in their follow-up. There was no periprocedural mortality. Eight patients had severe pain; eleven patients had fever, while one patient had arrhythmia.Conclusion: Povidone-iodine is a simple, cheap, and effective method of pleurodesis with no major complication and a high success rate.

  5. Efficacy and safety of infliximab in psoriatic patients over the age of 65.

    Science.gov (United States)

    Chiricozzi, Andrea; Pavlidis, Athanasios; Dattola, Annunziata; Bianchi, Luca; Chimenti, Maria Sole; Fida, Monika; Saraceno, Rosita

    2016-11-01

    Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. This was a retrospective study conducted at the Department of Dermatology of the University of Rome Tor Vergata. Clinical data were reported at week 12, 52, 104, 208. 151 charts were evaluated. A total of 27 patients were included. Range of the age was between 65 and 85 years; mean age was 73 years ±5.4; female to male ratio was 1:2; mean age of onset of psoriasis was 43 years±17. The average of treatment duration was 39 months ±27 (range 1-100). Fourteen patients suffered from plaque type psoriasis and 13 from psoriatic arthritis. At the baseline the mean PASI score was 15.6 ± 10.2. At week 12, 52, 104, and 208 the mean PASI was 2, 2.3, 1.9 and 1.8 respectively. A reduction in the mean PASI was maintained in the long-term treatment in 12 patients (p infliximab is effective and safe in patients over 65 years old and that IV therapy is also associated with a high compliance.

  6. 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

  7. Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

    Science.gov (United States)

    Hill, Janice; Victor, Daniel

    2008-01-01

    When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

  8. 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

  9. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.

    Science.gov (United States)

    Pavel, Marianne; Gross, David J; Benavent, Marta; Perros, Petros; Srirajaskanthan, Raj; Warner, Richard R P; Kulke, Matthew H; Anthony, Lowell B; Kunz, Pamela L; Hörsch, Dieter; Weickert, Martin O; Lapuerta, Pablo; Jiang, Wenjun; Kassler-Taub, Kenneth; Wason, Suman; Fleming, Rosanna; Fleming, Douglas; Garcia-Carbonero, Rocio

    2018-03-01

    Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients ( N  = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. Through week 12, TEAEs were generally mild to moderate in severity; 5 (placebo), 1 (telotristat ethyl 250 mg) and 3 (telotristat ethyl 500 mg) patients experienced serious events, and the rate of TEAEs in the OLE was comparable. At week 12, significant reductions in u5-HIAA from baseline were observed, with Hodges-Lehmann estimators of median treatment differences from placebo of -54.0% (95% confidence limits, -85.0%, -25.1%, P  < 0.001) and -89.7% (95% confidence limits, -113.1%, -63.9%, P  < 0.001) for telotristat ethyl 250 mg and 500 mg. These results support the safety and efficacy of telotristat ethyl when added to SSAs in patients with CS diarrhea (ClinicalTrials.gov identifier: Nbib2063659). © 2018 The authors.

  10. Total Quality Management and the System Safety Secretary

    Science.gov (United States)

    Elliott, Suzan E.

    1993-01-01

    The system safety secretary is a valuable member of the system safety team. As downsizing occurs to meet economic constraints, the Total Quality Management (TQM) approach is frequently adopted as a formula for success and, in some cases, for survival.

  11. Integrated environment, safety, and health management system description

    International Nuclear Information System (INIS)

    Zoghbi, J. G.

    2000-01-01

    The Integrated Environment, Safety, and Health Management System Description that is presented in this document describes the approach and management systems used to address integrated safety management within the Richland Environmental Restoration Project

  12. Development of Safety Assessment Information System (SAIS)

    International Nuclear Information System (INIS)

    Park, Byung Shik; Lee, Kyung Jin; Lee, Byung Chul; Song, Tae Young; Lee, Chang Ho

    2007-01-01

    Many reports and documents about nuclear power plant safety analysis like a Periodic Safe Review (PSR), Periodic Safety Analysis (PSA) and Severe Accident Management Guideline (SAMG) come to be drawn up from KHNP. Since these are not arranged easy to look up, the systematic arrangement of data was necessary. The solution against hereupon is to store database, and it was developed with the name, SAIS, by FNC Tech. Co. together with NETEC KHNP. In this web program it is easy to manage (registration, search and statistics) data. And the authorized user can approach this system. This was developed, and was verified under the development environment of; - Web Server : Apache 2.2.5 - Program Language : PHP 5.2 - DBMS : Oracle 10g

  13. 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

  14. Efficacy and safety of acupuncture in children: an overview of systematic reviews.

    Science.gov (United States)

    Yang, Chunsong; Hao, Zilong; Zhang, Ling-Li; Guo, Qin

    2015-08-01

    In recent years, acupuncture has increasingly being integrated into pediatric health care. It was used on ~150,000 children (0.2%). We aim to update the evidence for the efficacy and safety of acupuncture for children and evaluate the methodological qualities of these studies to improve future research in this area. We included 24 systematic reviews, comprising 142 randomized controlled trials (RCTs) with 12,787 participants. Only 25% (6/24) reviews were considered to be high quality (10.00 ± 0.63). High-quality systematic reviews and Cochrane systematic reviews tend to yield neutral or negative results (P = 0.052, 0.009 respectively). The efficacy of acupuncture for five diseases (Cerebral Palsy (CP), nocturnal enuresis, tic disorders, amblyopia, and pain reduction) is promising. It was unclear for hypoxic ischemic encephalopathy, attention deficit hyperactivity disorder, mumps, autism spectrum disorder (ASD), asthma, nausea/vomiting, and myopia. Acupuncture is not effective for epilepsy. Only six reviews reported adverse events (AEs) and no fatal side effects were reported. The efficacy of acupuncture for some diseases is promising and there have been no fatal side effects reported. Further high-quality studies are justified, with five diseases in particular as research priorities.

  15. 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.

  16. 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.

  17. A systematic review on the efficacy and safety of Infliximab in patients with psoriasis

    Science.gov (United States)

    Wang, Jin; Zhan, Qingxia; Zhang, Litao

    2016-01-01

    ABSTRACT Objective: To assess the efficacy and safety of infliximab for the treatment of psoriasis in a meta-analysis framework. Methods: Data were extracted by searching the EMBASE (1974–2014), PubMed(1966–2014) and the Cochrane library2013.4th databases. Only randomized and placebo-controlled studies were selected in this study. Results: Statistically significant differences in efficacy were found for the infliximab (3 or 5 mg/kg) group compared with the control group which received placebo in the treatment of psoriasis vulgaris [OR 13.55, 95%CI (11.14,16.48)]or[OR85.45, 95%CI (39.13,186.58)]. There were also significant differences in efficacy between the infliximab (5 mg/kg) group and the placebo control group during treatment of psoriasis arthritis (PsA) [OR8.36, 95%CI (5.63, 12.40)]. A controlled trial used infliximab (5 mg/kg) in the treatment of palmoplantar psoriasis. This study showed that the effective rate of the infliximab group was 33.3% (4/12) when compared to the placebo control group, which was 8.3% (1/12). Conclusion: Infliximab is significantly associated with symptom relief, skin lesion improvement, and an increase in the quality of life of psoriasis patients. The most common drug-induced adverse events were pain, hepatic dysfunction, and infusion reaction. PMID:26528924

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. Sublingual or subcutaneous immunotherapy for seasonal allergic rhinitis: an indirect analysis of efficacy, safety and cost.

    Science.gov (United States)

    Dranitsaris, George; Ellis, Anne K

    2014-06-01

    The standard of preventive care for poorly controlled seasonal allergic rhinitis (AR) is subcutaneous immunotherapy (SCIT) with allergen extracts, administered in a physician's office. As an alternative to SCIT, sublingual immunotherapy (SLIT) is now an option for patients with seasonal AR. Oralair, a SLIT tablet containing freeze-dried allergen extracts of five grasses [cocksfoot (Dactylis glomerata), meadow grass (Poa pratensis), rye grass (Lolium perenne), sweet vernal grass (Anthoxanthum odoratum) and timothy grass (Phleum pratense)], and Grazax, a SLIT tablet containing a standardized extract of grass pollen allergen from timothy grass (P pratenase), are two such agents currently available in many countries. However, head-to-head comparative data are not available. In this study, an indirect comparison on efficacy, safety and cost was undertaken between Oralair, Grazax and SCIT. A systematic review was conducted for double-blind placebo-controlled randomized trials evaluating Oralair, Grazax or SCIT in patients with grass-induced seasonal AR. Using placebo as the common control, an indirect statistical comparison between treatments was performed using meta regression analysis with active drug as the primary independent variable. An economic analysis, which included both direct and indirect costs for the Canadian setting, was also undertaken. Overall, 20 placebo-controlled trials met the study inclusion criteria. The indirect analysis suggested improved efficacy with Oralair over SCIT [standardized mean difference (SMD) in AR symptom control = -0.21; P = 0.007] and Grazax (SMD = -0.18; P = 0.018). In addition, there were no significant differences in the risk of discontinuation due to adverse events between therapies. Oralair was associated with cost savings against year-round SCIT ($2471), seasonal SCIT ($948) and Grazax ($1168) during the first year of therapy. Oralair has at least non-inferior efficacy and comparable safety against SCIT and

  4. 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.

  5. Safety Implications Concerning Usage of Tools in Complex System

    OpenAIRE

    Augusto, Rafael; Silva, Nuno

    2016-01-01

    International audience; Integration of tools and configuration data is nowadays present in all railway systems and plays a central role in functionality, flexibility and the safety of railway systems. This paper aims to present the challenges and the importance of tools, the configuration data integrity and the toolchain definition in the design of railway systems safety. We focus on the relevant implications on the safety analysis and safety assurance of such systems. Two examples of the usa...

  6. [Efficacy and safety of endotracheal intubation performed in moving vs motionless environments].

    Science.gov (United States)

    Castejón de la Encina, M ª Elena; Sanjuán Quiles, Ángela; Del Moral Vicente-Mazariegos, Ignacio; García Aracil, Noelia; José Alcaide, Lourdes; Richart Martínez, Miguel

    2017-02-01

    To compare the efficacy and safety of endotracheal intubation (ETI) in a simulated clinical environment in motion vs a motionless one. Clinical simulation trial of ETI with 3 endotracheal tubes (Airtraq, Fast-trach, Macintosh laryngoscope) in mannequins with realistic physiological responses (MetiMan) in 2 scenarios: an environment in motion vs a motionless one. Thirty-six physicians expert in prehospital ETI participated. Outcome variables were successful intubation, effective intubation, number of attempts, maximum apnea time, and total maneuver time. The safety variables were the presence of bradycardia, tachycardia, or high or low systolic blood pressures (ie, 20% variation from baseline); hypoxemia (decrease in oxygen saturation to <90% or 10% below baseline), tube placement in the esophagus or main bronchus, and dental trauma. No statistically significant differences between the 2 scenarios were found in the numbers of successful ETI (motionless, 71 [65.7%]; in motion, 67 [62.0%]; P=.277) or effective ETI (motionless, 104 [96.3%]; in motion, 105 [97.2%]; P=.108). Likewise, the number of attempts were similar (motionless, 91 [84.2%]; in motion, 90 [83.3%]; P=.305). Nor did we see differences in the mean (SD) maximum apnea times (motionless, 14.0 [5.6] seconds; in motion, 14.9 [8.1] seconds; P=.570) or mean total maneuver times (motionless, 236.7 [73.4] seconds; in motion, 210.3 [77.9] seconds; P=.164). The prevalences of bradycardia, tachycardia, high or low systolic blood pressure, hypoxemia, placements in the esophagus or bronchus, and dental trauma also did not differ significantly between the 2 scenarios. Neither efficacy nor safety variables differed significantly when ETI was performed in mannequins in a motionless environment vs one simulating ambulances in motion.

  7. Efficacy and safety of a new power toothbrush in a population with mild to moderate gingivitis.

    Science.gov (United States)

    Goyal, C Ram; Qaqish, Jimmy G; Galustians, Jack; Ortbald, Katherine

    2007-01-01

    To evaluate the efficacy and safety of a novel ultrasound power toothbrush over a 30-day period in a population with mild to moderate gingivitis. A 30-day, randomized, examiner-blind, parallel-arm study was conducted to evaluate the safety and efficacy of a ultrasound novel power toothbrush (Ultreo - ULT) as compared to a control manual toothbrush (Oral-B 35-MTB). Fifty-three subjects (n = 26 ULT, n = 27 MTB) with a minimum of 18 natural teeth and a Löe and Silness Gingival Index of > or = 1.5 were enrolled. An intraoral examination (oral soft and hard tissues, restorations) was performed, and Löe and Silness Gingival Index scores were recorded at baseline and 30 days. Subjects were instructed to brush at home twice per day with their assigned toothbrush and study toothpaste. A product evaluation questionnaire was also completed at the 30-day study visit. Oral examinations indicated normal findings at all time points for both groups, and no adverse events were reported during the study. There were no significant differences in gingivitis scores at baseline between the toothbrush groups (p > 0.05). From baseline, each treatment group demonstrated a significant reduction in gingivitis over the 30-day period (p toothbrush (p = 0.010). Results from the questionnaire, on average, indicated subjects in the ULT group scored their device higher with respect to the clean feeling after brushing and perceived improvements in gingival health. The novel Ultreo ultrasound power toothbrush significantly reduced gingivitis over the 30-day study, and resulted in a significantly greater reduction in gingivitis than a manual toothbrush. No adverse events or safety concerns were identified with either the power or manual toothbrush.

  8. Safety Analysis for Power Reactor Protection System

    International Nuclear Information System (INIS)

    Eisawy, E.A.; Sallam, H.

    2012-01-01

    The main function of a Reactor Protection System (RPS) is to safely shutdown the reactor and prevents the release of radioactive materials. The purpose of this paper is to present a technique and its application for used in the analysis of safety system of the Nuclear Power Plant (NPP). A more advanced technique has been presented to accurately study such problems as the plant availability assessments and Technical Specifications evaluations that are becoming increasingly important. The paper provides the Markov model for the Reactor Protection System of the NPP and presents results of model evaluations for two testing policies in technical specifications. The quantification of the Markov model provides the probability values that the system will occupy each of the possible states as a function of time.

  9. Development of Network Protocol for the Integrated Safety System

    International Nuclear Information System (INIS)

    Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M.

    2007-06-01

    Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants

  10. Development of Network Protocol for the Integrated Safety System

    Energy Technology Data Exchange (ETDEWEB)

    Park, S. W.; Baek, J. I.; Lee, S. H.; Park, C. S.; Park, K. H.; Shin, J. M. [Hannam Univ., Daejeon (Korea, Republic of)

    2007-06-15

    Communication devices in the safety system of nuclear power plants are distinguished from those developed for commercial purposes in terms of a strict requirement of safety. The concept of safety covers the determinability, the reliability, and the separation/isolation to prevent the undesirable interactions among devices. The safety also requires that these properties be never proof less. Most of the current commercialized communication products rarely have the safety properties. Moreover, they can be neither verified nor validated to satisfy the safety property of implementation process. This research proposes the novel architecture and protocol of a data communication network for the safety system in nuclear power plants.

  11. Safety systems and safety analysis of the Qinshan phase III CANDU nuclear power plant

    International Nuclear Information System (INIS)

    Cai Jianping; Shen Sen; Barkman, N.

    1999-01-01

    The author introduces the Canadian nuclear reactor safety philosophy and the Qinshan Phase III CANDU NPP safety systems and safety analysis, which are designed and performed according to this philosophy. The concept of 'defence-in-depth' is a key element of the Canadian nuclear reactor safety philosophy. The design concepts of redundancy, diversity, separation, equipment qualification, quality assurance, and use of appropriate design codes and standards are adopted in the design. Four special safety systems as well as a set of reliable safety support systems are incorporated in the design of Qinshan phase III CANDU for accident mitigation. The assessment results for safety systems performance show that the fundamental safety criteria for public dose, and integrity of fuel, channels and the reactor building, are satisfied

  12. NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

    Science.gov (United States)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

    2011-01-01

    System safety assessment is defined in NPR 8715.3C, NASA General Safety Program Requirements as a disciplined, systematic approach to the analysis of risks resulting from hazards that can affect humans, the environment, and mission assets. Achievement of the highest practicable degree of system safety is one of NASA's highest priorities. Traditionally, system safety assessment at NASA and elsewhere has focused on the application of a set of safety analysis tools to identify safety risks and formulate effective controls.1 Familiar tools used for this purpose include various forms of hazard analyses, failure modes and effects analyses, and probabilistic safety assessment (commonly also referred to as probabilistic risk assessment (PRA)). In the past, it has been assumed that to show that a system is safe, it is sufficient to provide assurance that the process for identifying the hazards has been as comprehensive as possible and that each identified hazard has one or more associated controls. The NASA Aerospace Safety Advisory Panel (ASAP) has made several statements in its annual reports supporting a more holistic approach. In 2006, it recommended that "... a comprehensive risk assessment, communication and acceptance process be implemented to ensure that overall launch risk is considered in an integrated and consistent manner." In 2009, it advocated for "... a process for using a risk-informed design approach to produce a design that is optimally and sufficiently safe." As a rationale for the latter advocacy, it stated that "... the ASAP applauds switching to a performance-based approach because it emphasizes early risk identification to guide designs, thus enabling creative design approaches that might be more efficient, safer, or both." For purposes of this preface, it is worth mentioning three areas where the handbook emphasizes a more holistic type of thinking. First, the handbook takes the position that it is important to not just focus on risk on an individual

  13. Safety Evaluation of Fail-Safe Fieldbus in Safety Related Control System

    Science.gov (United States)

    Franeková, Mária; Rástočný, Karol

    2010-11-01

    The paper deals with the problem of modelling safety features of the safety Fieldbus transmission system used within safety related control systems. The basic principles of the modelling failures effect upon the safety of closed transmission system and standards used in the process of safety evaluation are summarized in the paper. The practical part is oriented to a description of a realized Markov model for determination of the random failures effect on the safety of a closed transmission system. The model reflects the safety analysis of failures effect caused by electromagnetic interference in the communication channel and random HW failures of the transmission system. In the paper the results of simulation of parameters of the transmission system are discussed, such as the probability of an undetected corrupted message.

  14. Safety and efficacy of vismodegib in patients aged ≥65 years with advanced basal cell carcinoma.

    Science.gov (United States)

    Chang, Anne Lynn S; Lewis, Karl D; Arron, Sarah T; Migden, Michael R; Solomon, James A; Yoo, Simon; Day, Bann-Mo; McKenna, Edward F; Sekulic, Aleksandar

    2016-11-15

    Because many patients with unresectable basal cell carcinoma (BCC) are aged ≥65 years, this study explores the efficacy and safety of vismodegib in these patients with locally advanced (la) or metastatic (m) basal cell carcinoma (BCC) in the ERIVANCE BCC trial and the expanded access study (EAS).We compared patients aged ≥65 years to patients aged <65 years taking vismodegib 150 mg/day, using descriptive statistics for response and safety. Patients aged ≥65 years (laBCC/mBCC) were enrolled in ERIVANCE BCC (33/14) and EAS (27/26). Investigator-assessed best overall response rate in patients ≥65 and <65 years was 46.7%/35.7% and 72.7%/52.6% (laBCC/mBCC), respectively, in ERIVANCE BCC and 45.8%/33.3% and 46.9%/28.6%, respectively, in EAS. These differences were not clinically meaningful. Safety was similar in both groups, although those aged ≥65 years had a higher percentage of grade 3-5 adverse events than those aged <65 years. Vismodegib demonstrated similar clinical activity and adverse events regardless of age.

  15. Long-term efficacy and safety of lamotrigine for all types of bipolar disorder.

    Science.gov (United States)

    Watanabe, Yoshinori; Hongo, Seiji

    2017-01-01

    We investigated whether the long-term efficacy and safety of lamotrigine (LTG) for bipolar disorder (BP) differs between disease types (BP-I, BP-II, or BP not otherwise specified [BP-NOS]), and the efficacy of the concomitant use of antidepressants (ADs). For >1 year, we observed 445 outpatients with BP (diagnosed by DSM-IV criteria) who initiated LTG treatment between July 1 and October 31, 2011, using the Himorogi Self-rating Depression (HSDS) and Anxiety Scales and the Clinical Global Impression-Improvement scale and also recorded adverse events. Treatment efficacy was observed at week 4, with the improved HSDS scores sustained until week 52 for all types of BP; 50% of the patients with any type of BP could be treated with LTG for 1 year, whereas ~40% could be treated for >1.5 years. However, 25% of the patients were withdrawn within the first 4 weeks. The overall incidence of adverse events was 22.9% (104/455): 34.1% (14/41) for BP-I, 22.7% (15/66) for BP-II, and 22.2% (75/338) for BP-NOS. The most common adverse event was skin rash: 22.0% for BP-I, 16.7% for BP-II, and 12.1% for BP-NOS. There was no control group. Data were collected retrospectively. With careful and adequate titration, long-term treatment with LTG is possible for any type of BP, with BP-NOS patients, the largest population in clinical practice, responding particularly well. Symptoms can improve with or without ADs. Large-scale prospective studies of the efficacy of ADs in bipolar treatment are warranted.

  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. Signaling Рathway Blockers: Action Mechanism, Efficacy, Safety of Therapy for Patients with Psoriasis and Psoriatic Arthritis

    Directory of Open Access Journals (Sweden)

    A. A. Bakulev

    2017-01-01

    Full Text Available In the literature review, contemporary data on immune pathogenesis of psoriasis and the emergence of comorbid states against the background of systemic chronic inflammation among patients is discussed. On the example of the apremilast medical preparation, the information on a new class of therapeutic agents for the treatment of psoriasis and psoriatic arthritis – “small molecules” is given, including their physicochemical properties and action mechanism, as well as on the key differences from immune-suppressive and genetically engineered biological preparations. Data on large-scale international randomised clinical trials of the efficacy and safety of the PDE4 inhibitor of apremilast among patients with moderate to severe psoriasis and psoriatic arthritis is presented. The published international clinical recommendations on the use of apremilast among patients with psoriasis and psoriatic arthritis, the criteria for evaluating the response to therapy, as well as the potential profile of patients for the use of apremilast in real clinical practice are discussed.

  18. 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

  19. 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

  20. Safety and efficacy of high fluence CO2 laser skin resurfacing with a single pass.

    Science.gov (United States)

    Khosh, M M; Larrabee, W F; Smoller, B

    1999-01-01

    Carbon dioxide (CO2) laser skin resurfacing has nearly replaced more traditional methods of superficial skin rejuvenation. Post-treatment erythema is the most common side effect of this method of skin resurfacing. Sublethal thermal damage to the dermis has been proposed as an etiology for post laser erythema. Recent developments in laser resurfacing technology have aimed at minimizing thermal damage to the dermis. To determine depth of skin ablation, extent of thermal injury, and ideal laser parameters for the FeatherTouch laser system. To assess the safety and efficacy of laser resurfacing at high energy fluences with a single pass. Laser resurfacing was performed in the preauricular skin of five patients undergoing rhytidectomy. A total of 60 sites were tested with fluences of 7 to 17 Joules/cm2. Histologic evaluation of excised skin showed maximal thermal injury to be restricted to 60 microns in the papillary dermis. The reticular dermis showed no evidence of injury. Based on these findings, laser resurfacing at 17 J/cm2 (70 watts) was performed on 30 patients (in the periorbital area, a maximum of 9 J/cm2 or 36 watts was used). Follow up ranged between 12 and 18 months. Based on histologic comparison of average and high fluence laser resurfacing, high fluence laser resurfacing did not cause added thermal damage to the reticular dermis. In the clinical group, no major complications such as scarring, scleral show, infection or ectropion were encountered. Transient hyperpigmentation was noted in three patients. Overall patient satisfaction was good to excellent. Post-treatment erythema lasted an average of 4 weeks. We conclude that CO2 laser resurfacing of the face (excluding the periorbital region) can be performed safely and effectively, with the FeatherTouch laser, at 17 J/cm2 with one pass. In our group of patients, laser resurfacing with a single pass at 17 J/cm2 caused less post-operative erythema than two or more passes at 9 J/cm2.

  1. Information systems in food safety management.

    Science.gov (United States)

    McMeekin, T A; Baranyi, J; Bowman, J; Dalgaard, P; Kirk, M; Ross, T; Schmid, S; Zwietering, M H

    2006-12-01

    Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in: Identifying pathogens in food at the genus or species level using applied systematics in automated ways. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as the genesis of an international web based searchable database (ComBase). Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting "pattern match" indicating problems that may arise from changes in product formulation or processing conditions. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices. In addition there are many other uses of information systems that benefit food safety more globally, including: Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents. Active surveillance networks allowing rapid dissemination

  2. ISO 22000 FOOD SAFETY MANAGEMENT SYSTEM

    OpenAIRE

    Başaran, Burhan

    2015-01-01

    The increase in the level of welfare of the countriesand the awareness of the consumers have forced the firms in the food sector toseek for new pursuits. In this re­gard, ISO 22000 is the most commonlypreferred food safety system. This study aims to contribute the share­holdersand the researchers studying this topic by in­terpreting the lateststudies in this field and determine the critical relationships inorder to picture an effective and productive implementation ofISO22000 which is one of ...

  3. The WIPP transportation system: Dedicated to safety

    International Nuclear Information System (INIS)

    Ward, T.; McFadden, M.

    1993-01-01

    When developing a transportation system to transport transuranic (TRU) waste from ten widely-dispersed generator sites, the Department of Energy (DOE) recognized and addressed many challenges. Shipments of waste to the Waste Isolation Pilot Plant (WIPP) were to cover a twenty-five year period and utilize routes covering over twelve thousand miles in twenty-three states. Enhancing public safety by maximizing the payload, thus reducing the number of shipments, was the primary objective. To preclude the requirement for overweight permits, the DOE started with a total shipment weight limit of 80,000 pounds and developed an integrated transportation system consisting of a Type ''B'' package to transport the material, a lightweight tractor and trailer, stringent driver requirements, and a shipment tracking system referred to as ''TRANSCOM''

  4. Software for computer based systems important to safety in nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    Computer based systems are of increasing importance to safety in nuclear power plants as their use in both new and older plants is rapidly increasing. They are used both in safety related applications, such as some functions of the process control and monitoring systems, as well as in safety critical applications, such as reactor protection or actuation of safety features. The dependability of computer based systems important to safety is therefore of prime interest and should be ensured. With current technology, it is possible in principle to develop computer based instrumentation and control systems for systems important to safety that have the potential for improving the level of safety and reliability with sufficient dependability. However, their dependability can be predicted and demonstrated only if a systematic, fully documented and reviewable engineering process is followed. Although a number of national and international standards dealing with quality assurance for computer based systems important to safety have been or are being prepared, internationally agreed criteria for demonstrating the safety of such systems are not generally available. It is recognized that there may be other ways of providing the necessary safety demonstration than those recommended here. The basic requirements for the design of safety systems for nuclear power plants are provided in the Requirements for Design issued in the IAEA Safety Standards Series.The IAEA has issued a Technical Report to assist Member States in ensuring that computer based systems important to safety in nuclear power plants are safe and properly licensed. The report provides information on current software engineering practices and, together with relevant standards, forms a technical basis for this Safety Guide. The objective of this Safety Guide is to provide guidance on the collection of evidence and preparation of documentation to be used in the safety demonstration for the software for computer based

  5. Software for computer based systems important to safety in nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    Computer based systems are of increasing importance to safety in nuclear power plants as their use in both new and older plants is rapidly increasing. They are used both in safety related applications, such as some functions of the process control and monitoring systems, as well as in safety critical applications, such as reactor protection or actuation of safety features. The dependability of computer based systems important to safety is therefore of prime interest and should be ensured. With current technology, it is possible in principle to develop computer based instrumentation and control systems for systems important to safety that have the potential for improving the level of safety and reliability with sufficient dependability. However, their dependability can be predicted and demonstrated only if a systematic, fully documented and reviewable engineering process is followed. Although a number of national and international standards dealing with quality assurance for computer based systems important to safety have been or are being prepared, internationally agreed criteria for demonstrating the safety of such systems are not generally available. It is recognized that there may be other ways of providing the necessary safety demonstration than those recommended here. The basic requirements for the design of safety systems for nuclear power plants are provided in the Requirements for Design issued in the IAEA Safety Standards Series.The IAEA has issued a Technical Report to assist Member States in ensuring that computer based systems important to safety in nuclear power plants are safe and properly licensed. The report provides information on current software engineering practices and, together with relevant standards, forms a technical basis for this Safety Guide. The objective of this Safety Guide is to provide guidance on the collection of evidence and preparation of documentation to be used in the safety demonstration for the software for computer based

  6. Software for computer based systems important to safety in nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2000-01-01

    Computer based systems are of increasing importance to safety in nuclear power plants as their use in both new and older plants is rapidly increasing. They are used both in safety related applications, such as some functions of the process control and monitoring systems, as well as in safety critical applications, such as reactor protection or actuation of safety features. The dependability of computer based systems important to safety is therefore of prime interest and should be ensured. With current technology, it is possible in principle to develop computer based instrumentation and control systems for systems important to safety that have the potential for improving the level of safety and reliability with sufficient dependability. However, their dependability can be predicted and demonstrated only if a systematic, fully documented and reviewable engineering process is followed. Although a number of national and international standards dealing with quality assurance for computer based systems important to safety have been or are being prepared, internationally agreed criteria for demonstrating the safety of such systems are not generally available. It is recognized that there may be other ways of providing the necessary safety demonstration than those recommended here. The basic requirements for the design of safety systems for nuclear power plants are provided in the Requirements for Design issued in the IAEA Safety Standards Series.The IAEA has issued a Technical Report to assist Member States in ensuring that computer based systems important to safety in nuclear power plants are safe and properly licensed. The report provides information on current software engineering practices and, together with relevant standards, forms a technical basis for this Safety Guide. The objective of this Safety Guide is to provide guidance on the collection of evidence and preparation of documentation to be used in the safety demonstration for the software for computer based

  7. Remote mobile communication in safety support system

    International Nuclear Information System (INIS)

    Inagaki, Kanji; Kobayashi, Hiroyuki; Hatanaka, Takahiro; Sakuma, Akira; Fukumoto, Akira; Ikeda, Jun

    1999-01-01

    Safety Support System (SSS) is a computerized operator support system for nuclear power plants, which is now under development. The concept of SSS covers 1) earlier detection of failure symptom and prediction of its influence to the plant operation, 2) improved transparency and robustness of plant control systems, 3) advanced human-machine interface and communication. The authors have been working on the third concept and proposed a remote mobile communication system called Plant Communication System (PCS). PCS aims to realize convenient communication between main control room and other areas such as plant local areas and site offices, using Personal Handyphone System (PHS) and wireless LAN (Local Area Network). PCS can transmit not only data but also graphic displays and dynamic video displays between the main control room and plant local areas. MPEG4 (Moving Picture Experts Group 4) technology is utilized in video data compression and decompression. The authors have developed the special multiplexing unit that connects PHS Cell Stations (CSs) and exiting coaxial cables. Voice recognition and announcement capability is also realized in the system, which enables verbal retrieval of information in the computer systems in the main control room from local areas. (author)

  8. The efficacy and safety of a novel posterior scleral reinforcement device in rabbits

    International Nuclear Information System (INIS)

    Yuan, Yongguang; Zong, Yao; Zheng, Qishan; Qian, Garrett; Qian, Xiaobin; Li, Yujie; Shao, Wanwen; Gao, Qianying

    2016-01-01

    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

  9. 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

  10. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease.

    Science.gov (United States)

    Webb, Nicholas J A; Lerner, Gary; Warady, Bradley A; Dell, Katherine M; Greenbaum, Larry A; Ariceta, Gema; Hoppe, Bernd; Linde, Peter; Lee, Ho-Jin; Eldred, Ann; Dufek, Matthew B

    2017-07-01

    Elevated intact parathyroid hormone (iPTH) levels can contribute to morbidity and mortality in children with chronic kidney disease (CKD). We evaluated the pharmacokinetics, efficacy, and safety of oral paricalcitol in reducing iPTH levels in children with stages 3-5 CKD. Children aged 10-16 years with stages 3-5 CKD were enrolled in two phase 3 studies. The stage 3/4 CKD study characterized paricalcitol pharmacokinetics and compared the efficacy and safety of paricalcitol with placebo followed by an open-label period. The stage 5 CKD study evaluated the efficacy and safety of paricalcitol (no comparator) in children with stage 5 CKD undergoing dialysis. In the stage 3/4 CKD study, mean peak plasma concentration and area under the time curve from zero to infinity were 0.13 ng/mL and 2.87 ng•h/((or ng×h/))mL, respectively, for 12 children who received 3 μg paricalcitol. Thirty-six children were randomized to paricalcitol or placebo; 27.8% of the paricalcitol group achieved two consecutive iPTH reductions of ≥30% from baseline versus none of the placebo group (P = 0.045). Adverse events were higher in children who received placebo than in those administered paricalcitol during the double-blind treatment (88.9 vs. 38.9%; P = 0.005). In the stage 5 CKD study, eight children (61.5%) had two consecutive iPTH reductions of ≥30% from baseline, and five (38.5%) had two consecutive iPTH values of between 150 and 300 pg/mL. Clinically meaningful hypercalcemia occurred in 21% of children. Oral paricalcitol in children aged 10-16 years with stages 3-5 CKD reduced iPTH levels and the treatment was well tolerated. Results support an initiating dose of 1 μg paricalcitol 3 times weekly in children aged 10-16 years.

  11. Modelling safety of multistate systems with ageing components

    Energy Technology Data Exchange (ETDEWEB)

    Kołowrocki, Krzysztof; Soszyńska-Budny, Joanna [Gdynia Maritime University, Department of Mathematics ul. Morska 81-87, Gdynia 81-225 Poland (Poland)

    2016-06-08

    An innovative approach to safety analysis of multistate ageing systems is presented. Basic notions of the ageing multistate systems safety analysis are introduced. The system components and the system multistate safety functions are defined. The mean values and variances of the multistate systems lifetimes in the safety state subsets and the mean values of their lifetimes in the particular safety states are defined. The multi-state system risk function and the moment of exceeding by the system the critical safety state are introduced. Applications of the proposed multistate system safety models to the evaluation and prediction of the safty characteristics of the consecutive “m out of n: F” is presented as well.

  12. An Approach to Modeling Software Safety in Safety-Critical Systems

    OpenAIRE

    Ben S. Medikonda; Seetha R. Panchumarthy

    2009-01-01

    Software for safety-critical systems has to deal with the hazards identified by safety analysis in order to make the system safe, risk-free and fail-safe. Software safety is a composite of many factors. Problem statement: Existing software quality models like McCalls and Boehms and ISO 9126 were inadequate in addressing the software safety issues of real time safety-critical embedded systems. At present there does not exist any standard framework that comprehensively addresses the Factors, Cr...

  13. 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.)

  14. 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.

  15. 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.)

  16. Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj in rheumatoid arthritis patients: a pilot prospective study.

    Directory of Open Access Journals (Sweden)

    Gajendra Kumar

    2015-01-01

    Full Text Available Background & objectives: In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj in patients with rheumatoid arthritis. Methods: One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT, aspartate aminotransferase (AST, alkaline phosphatase (ALP, bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL tests and urine mercury level. Results: The study was completed by 90.7 per cent (78/86 patients. Patients with moderate and high disease activity were 57.7 per cent (45/78 and 42.3 per cent (33/78, respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were

  17. 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...

  18. Feasibility, Safety, and Efficacy of the Combination of -Serine and Computerized Cognitive Retraining in Schizophrenia: An International Collaborative Pilot Study

    OpenAIRE

    D'Souza, Deepak C; Radhakrishnan, Rajiv; Perry, Edward; Bhakta, Savita; Singh, Nagendra M; Yadav, Richa; Abi-Saab, Danielle; Pittman, Brian; Chaturvedi, Santosh K; Sharma, Mahendra P; Bell, Morris; Andrade, Chittaranjan

    2012-01-01

    The combination of pharmacotherapy and cognitive retraining (CRT) for the cognitive deficits of schizophrenia may be more efficacious than either approach alone, but this has not yet been tested. This study evaluated the feasibility, safety, tolerability, and efficacy of 12 weeks of -serine, combined with CRT in the treatment of cognitive deficits in schizophrenia at two academic sites in parallel, in India and the United States. In a randomized, partial double-blind, placebo-controlled, par...

  19. Design for safety: theoretical framework of the safety aspect of BIM system to determine the safety index

    Directory of Open Access Journals (Sweden)

    Ai Lin Evelyn Teo

    2016-12-01

    Full Text Available Despite the safety improvement drive that has been implemented in the construction industry in Singapore for many years, the industry continues to report the highest number of workplace fatalities, compared to other industries. The purpose of this paper is to discuss the theoretical framework of the safety aspect of a proposed BIM System to determine a Safety Index. An online questionnaire survey was conducted to ascertain the current workplace safety and health situation in the construction industry and explore how BIM can be used to improve safety performance in the industry. A safety hazard library was developed based on the main contributors to fatal accidents in the construction industry, determined from the formal records and existing literature, and a series of discussions with representatives from the Workplace Safety and Health Institute (WSH Institute in Singapore. The results from the survey suggested that the majority of the firms have implemented the necessary policies, programmes and procedures on Workplace Safety and Health (WSH practices. However, BIM is still not widely applied or explored beyond the mandatory requirement that building plans should be submitted to the authorities for approval in BIM format. This paper presents a discussion of the safety aspect of the Intelligent Productivity and Safety System (IPASS developed in the study. IPASS is an intelligent system incorporating the buildable design concept, theory on the detection, prevention and control of hazards, and the Construction Safety Audit Scoring System (ConSASS. The system is based on the premise that safety should be considered at the design stage, and BIM can be an effective tool to facilitate the efforts to enhance safety performance. IPASS allows users to analyse and monitor key aspects of the safety performance of the project before the project starts and as the project progresses.

  20. Study of efficacy and safety of pharmacological stress tests in nuclear cardiology

    Directory of Open Access Journals (Sweden)

    Baškot Branislav

    2009-01-01

    %, respectively improved safety and patients tolerance, improved target-to-background ratios because of less subdiaphragmal activity, and earlier acquisition time. Because of producing a lot of arrhythmias (in 49% of patients dobutamin was considered a last choice for pharmacological stress testing. Conclusion. Safety and efficacy of vasodilatators (adenosine, dipyridamole pharmacological stress tests are good, but with concomitant exercise even better. The safety and efficacy of adenosin are better than those of dipyridamole. AdenoEX protocol provides good safety and patients tolerance. In light of these benefits we recommend AdenoEX whenever possible. Dobutamine is the last pharmacological toll for MPS.