Science.gov

Sample records for long-term safety evaluation

  1. Total disc replacement in the cervical spine: a systematic review evaluating long-term safety

    PubMed Central

    Anderson, Paul A.; Hashimoto, Robin

    2012-01-01

    Study design: Systematic review. Clinical questions: What are the rates and causes of subsequent surgeries? What is the long-term complication rates following cervical artificial disc replacement (C-ADR)? How do these rates change over time? Methods: A systematic review was undertaken for articles published up to October 2011. Electronic databases and reference lists of key articles were searched to identify comparative and non-comparative studies reporting long-term (≥ 48 months) complications of C-ADR. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus. Results: Two RCTs reporting outcomes following C-ADR (Bryan disc, Prestige disc) versus anterior cervical discectomy and fusion (ACDF) at follow-ups of 4 to 5 years were found; five case series reporting outcomes following C-ADR at follow-ups of 4 to 8 years were identified. Secondary surgery rates were similar or slightly lower following C-ADR compared with fusion at 4 to 5 years postoperatively. In one small subset of an RCT, rates of adjacent disc heterotopic ossification were lower in C-ADR patients than in those treated with fusion. Rates of other adverse events were similar between treatment groups. Conclusions: There is low evidence on the long-term safety outcomes following C-ADR. Additional comparative studies with follow-up of at least 4 years are needed to fully understand the long-term safety outcomes of C-ADR compared with fusion. PMID:23236309

  2. Evaluating the Long-Term Safety of a Repository at Yucca Mountain 

    SciTech Connect

    Van Luik, Abe

    2009-07-17

    Regulations require that the repository be evaluated for its health and safety effects for 10,000 years for the Site Recommendation process. Regulations also require potential impacts to be evaluated for up to a million years in an Environmental Impact Statement. The Yucca Mountain Project is in the midst of the Site Recommendation process. The Total System Performance Assessment (TSPA) that supports the Site Recommendation evaluated safety for these required periods of time. Results showed it likely that a repository at this site could meet the licensing requirements promulgated by the Nuclear Regulatory Commission. The TSPA is the tool that integrates the results of many years of scientific investigations with design information to allow evaluations of potential far-future impacts of building a Yucca Mountain repository. Knowledge created in several branches of physics is part of the scientific basis of the TSPA that supports the Site Recommendation process.

  3. A security/safety survey of long term care facilities.

    PubMed

    Acorn, Jonathan R

    2010-01-01

    What are the major security/safety problems of long term care facilities? What steps are being taken by some facilities to mitigate such problems? Answers to these questions can be found in a survey of IAHSS members involved in long term care security conducted for the IAHSS Long Term Care Security Task Force. The survey, the author points out, focuses primarily on long term care facilities operated by hospitals and health systems. However, he believes, it does accurately reflect the security problems most long term facilities face, and presents valuable information on security systems and practices which should be also considered by independent and chain operated facilities.

  4. Long-term safety and efficacy of stereotactic radiosurgery for vestibular schwannomas: evaluation of 440 patients more than 10 years after treatment with Gamma Knife surgery.

    PubMed

    Hasegawa, Toshinori; Kida, Yoshihisa; Kato, Takenori; Iizuka, Hiroshi; Kuramitsu, Shunichiro; Yamamoto, Takashi

    2013-03-01

    Object Little is known about long-term outcomes, including tumor control and adverse radiation effects, in patients harboring vestibular schwannomas (VSs) treated with stereotactic radiosurgery > 10 years previously. The aim of this study was to confirm whether Gamma Knife surgery (GKS) for VSs continues to be safe and effective > 10 years after treatment. Methods A total of 440 patients with VS (including neurofibromatosis Type 2) treated with GKS between May 1991 and December 2000 were evaluable. Of these, 347 patients (79%) underwent GKS as an initial treatment and 93 (21%) had undergone prior resection. Three hundred fifty-eight patients (81%) had a solid tumor and 82 (19%) had a cystic tumor. The median tumor volume was 2.8 cm(3) and the median marginal dose was 12.8 Gy. Results The median follow-up period was 12.5 years. The actuarial 5- and ≥ 10-year progression-free survival was 93% and 92%, respectively. No patient developed treatment failure > 10 years after treatment. According to multivariate analysis, significant factors related to worse progression-free survival included brainstem compression with a deviation of the fourth ventricle (p < 0.0001), marginal dose ≤ 13 Gy (p = 0.01), prior treatment (p = 0.02), and female sex (p = 0.02). Of 287 patients treated at a recent optimum dose of ≤ 13 Gy, 3 (1%) developed facial palsy, including 2 with transient palsy and 1 with persistent palsy after a second GKS, and 3 (1%) developed facial numbness, including 2 with transient and 1 with persistent facial numbness. The actuarial 10-year facial nerve preservation rate was 97% in the high marginal dose group (> 13 Gy) and 100% in the low marginal dose group (≤ 13 Gy). Ten patients (2.3%) developed delayed cyst formation. One patient alone developed malignant transformation, indicating an incidence of 0.3%. Conclusions In this study GKS was a safe and effective treatment for the majority of patients followed > 10 years after treatment. Special attention

  5. Evaluating Long-Term Care Through the Humanbecoming Lens.

    PubMed

    Hart, Judith D

    2015-10-01

    The author describes evaluating long-term care from the humanbecoming perspective. Three core ideas are presented related to dignity and living quality, and how the humanbecoming perspective can be incorporated into long-term care evaluations that make a difference to the residents, caregivers, management, and to the outcomes of long-term care. This approach from the humanbecoming perspective can enrich evaluative information, influence long-term care outcomes, and ensure human dignity for all concerned.

  6. Evaluating Long-Term Disability Insurance Plans.

    ERIC Educational Resources Information Center

    Powell, Jan

    1992-01-01

    This report analyzes the factors involved in reviewing benefits and services of employer-sponsored group long-term disability plans for higher education institutions. Opening sections describe the evolution of disability insurance and its shape today. Further sections looks at the complex nature of "value" within a plan, relationship…

  7. Long-term safety concerns with proton pump inhibitors.

    PubMed

    Ali, Tauseef; Roberts, David Neil; Tierney, William M

    2009-10-01

    Proton pump inhibitors (PPIs) are among the most widely prescribed medications worldwide. Their use has resulted in dramatic improvements in treatment of peptic ulcer disease and gastroesophageal reflux disease. Despite an acceptable safety profile, mounting data demonstrate concerns about the long-term use of PPIs. To provide a comprehensive review regarding the concerns of long-term PPI use, a literature search was performed to identify pertinent original and review articles. Despite study shortcomings, the collective body of information overwhelmingly suggests an increased risk of infectious complications and nutritional deficiencies. Data regarding any increased risk in gastric or colon malignancy are less convincing. PPIs have revolutionized the management and complications of acid-related disorders with a high margin of safety; however, with the data available, efforts to reduce the dosing of or discontinue the use of PPIs must be reassessed frequently.

  8. Modelling study to evaluate two variants for accessing a deep geological repository from the point of view of long-term safety

    SciTech Connect

    Poller, Andreas; Zuidema, Piet; Schneider, Jurg W.; Smith, Paul; Mayer, Gerhard; Hayek, Mohamed

    2013-07-01

    Siting a deep geological repository for radioactive waste essentially involves two interrelated steps: deciding on an appropriate geological environment for the underground facilities and selecting a suitable location for the associated surface facility. An acceptable solution is more easily achieved if some flexibility exists for siting the surface facility, irrespective of the exact position of the underground facilities. Such flexibility is available if a ramp is used as the main access route from the surface facility to the underground facilities. Another option is to use a combination of shafts and (sub)horizontal tunnels as the main access route. Both variants include shafts for ventilation, etc. In this paper, the two variants (i) main access via ramp and (ii) main access via shaft are compared in terms of long-term safety. To this end, the entire network of underground tunnels of a deep geological repository is implemented in an analytical resistor network flow model. Radionuclide release through the tunnel system and the host rock is then calculated with a numerical network transport model, using as input the results from the flow model. The results clearly indicate that, even in case of hypothetically deficient horizontal and sub-horizontal sealing elements, the choice between ramp and shaft as the main access route is irrelevant to long-term safety. (authors)

  9. Long term follow-up study to evaluate immunogenicity and safety of a single dose of live attenuated hepatitis a vaccine in children.

    PubMed

    Mitra, Monjori; Shah, Nitin; Faridi, Mma; Ghosh, Apurba; Sankaranarayanan, V S; Aggarwal, Anju; Chatterjee, Suparna; Bhattacharyya, Nisha; Kadhe, Ganesh; Vishnoi, Gaurav; Mane, Amey

    2015-01-01

    Worldwide, viral hepatitis continues to be a cause of considerable morbidity and mortality. Mass immunization with a single dose of live attenuated HAV has been shown to significantly reduce disease burden in the community. This was a phase IV, 5-year follow up study carried out at 4 centers (Kolkata, Delhi, Mumbai and Chennai) across India. The subjects with antibody titer <20 mIU/mL at baseline were evaluated for long term immunogenicity. Of the 503 subjects enrolled, 349 subjects were baseline seronegative with an anti-HAV antibody titer <20 mIU/mL. Overall, 343 subjects could be followed up at some point of time during this 5 y post vaccination period. In the last year (60 months) of follow-up, 108 subjects (97.3%) of 111 subjects (who came for follow-up at the end of 5 y) had a protective antibody titer (anti-HAV antibody titer >20 mIU/mL). The seroconversion rates considering seroprotection levels of anti-HAV antibody titer >20 mIU/mL, following vaccination starting from 6 weeks, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months were 95.1%, 97.9%, 98.3%, 96.2%, 97.8%, 92.6% and 97.3%, respectively. The geometric mean concentration (GMC) over the years increased from 64.9 mIU/mL at 6 weeks to 38.1 mIU/mL and 135.2 mIU/mL at 6 months and 12 months, respectively and was maintained at 127.1 mIU/mL at 60 months. In conclusion, the result of this 5-year follow up study showed that the single dose of live attenuated vaccine is well tolerated and provides long-term immunogenicity in healthy Indian children.

  10. Demonstrating the Safety of Long-Term Dry Storage - 13468

    SciTech Connect

    McCullum, Rod; Brookmire, Tom; Kessler, John; Leblang, Suzanne; Levin, Adam; Martin, Zita; Nesbit, Steve; Nichol, Marc; Pickens, Terry

    2013-07-01

    Commercial nuclear plants in the United States were originally designed with the expectation that used nuclear fuel would be moved directly from the reactor pools and transported off site for either reprocessing or direct geologic disposal. However, Federal programs intended to meet this expectation were never able to develop the capability to remove used fuel from reactor sites - and these programs remain stalled to this day. Therefore, in the 1980's, with reactor pools reaching capacity limits, industry began developing dry cask storage technology to provide for additional on-site storage. Use of this technology has expanded significantly since then, and has today become a standard part of plant operations at most US nuclear sites. As this expansion was underway, Federal programs remained stalled, and it became evident that dry cask systems would be in use longer than originally envisioned. In response to this challenge, a strong technical basis supporting the long term dry storage safety has been developed. However, this is not a static situation. The technical basis must be able to address future challenges. Industry is responding to one such challenge - the increasing prevalence of high burnup (HBU) used fuel and the need to provide long term storage assurance for these fuels equivalent to that which has existed for lower burnup fuels over the past 25 years. This response includes a confirmatory demonstration program designed to address the aging characteristics of HBU fuel and set a precedent for a learning approach to aging management that will have broad applicability across the used fuel storage landscape. (authors)

  11. Medical care evaluation studies in long-term care facilities.

    PubMed

    Zimmer, J G

    1979-02-01

    This report describes the selection, design, conduct, analysis, and application of medical care evaluation studies in long-term care facilities (skilled nursing homes) in a regional program in the Rochester region of upstate New York. Eight examples are presented to highlight methodologic approaches and problems. They are classified under four general headings: Administration Audits, Diagnosis-specific Studies, Care Modality-specific Studies, and General Outcome Indicators. The implementation of results and recommendations from the studies is discussed and an application of "tracer" methodology for assessing the components of care activities in long-term facilities is described. Problems and challenges in long-term quality care are outlined.

  12. Acute And Long-Term Bioeffects And Lamp Safety

    NASA Astrophysics Data System (ADS)

    Andersen, F. Alan

    1980-10-01

    Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

  13. The long-term efficacy and safety profile of barnidipine.

    PubMed

    Smilde, J G

    2000-11-01

    Two multicentre trials have investigated the efficacy and tolerability of treatment with once-daily barnidipine, in patients with mild to moderate essential hypertension. The long-term efficacy and safety of barnidipine were demonstrated in a long-term, multicentre, open-label study. In total, 106, 79 and 32 patients were followed for the first, second and third year, respectively. Patients received barnidipine at a dose titrated to achieve a sitting DBP > or = 90 mmHg or a decrease in sitting BDP > or = 10 mmHg. If necessary, another antihypertensive agent was added to achieve normalisation of blood pressure. In the first year, normalisation of blood pressure was achieved in 91% of patients. This was maintained in 91% and 81% of patients in the second and third years, respectively. At the end of treatment in both years, over 60% of patients remained on barnidipine monotherapy (10 or 20 mg/day). A low incidence of adverse events possibly or probably related to barnidipine (10 or 20 mg/day) monotherapy was reported in the first and second years with headache, peripheral oedema and palpitations the most commonly reported. In the third year of follow-up, only one adverse event, an ECG abnormality, was considered to be possibly related to the study medication. The effective 24 hour control of blood pressure with barnidipine monotherapy was confirmed in a randomised, double-blind, placebo-controlled, cross-over study of 20 patients. These patients were given 6 week regimens of both barnidipine (20 mg/day) and placebo. Office and 24 hour ambulatory blood pressures were recorded at the end of each treatment phase. Barnidipine lowered blood pressure to a significantly greater extent than placebo both at night and during the day. Adverse events were classified as mild or moderate and fewer adverse events were reported with barnidipine treatment compared with placebo. Barnidipine monotherapy (20 mg/day) is safe and effective in providing 24 hour control of blood pressure

  14. Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

    PubMed

    Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-02-02

    An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris.

  15. Storability Investigations of Water Long-Term Storage Evaluation

    DTIC Science & Technology

    1974-12-01

    previously for the other tankage and then descaled in a pickling solution of 33.2% HN03 , 1.6% HF, and 65.2% water at 140°F for 3 minutes. The titanium...AD/A-004 462 STORABILITY INVESTIGATIONS OF WATER LONG-TERM STORAGE EVALUATION E. M. Vander Wall, et al I Aerojet Liquid Rocket Company Prc pared for...Investigations of Water , Long-Term ,Annual Storage Evaluation 6. PERFORMING ORG. REPORT NUMBER 7. AU THOR(s) 0. CONTRACT OR GRANT NUMPEIR(.) Vander Wall, E. M

  16. Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children.

    PubMed

    Watanaveeradej, Veerachai; Simasathien, Sriluck; Mammen, Mammen P; Nisalak, Ananda; Tournay, Elodie; Kerdpanich, Phirangkul; Samakoses, Rudiwilai; Putnak, Robert J; Gibbons, Robert V; Yoon, In-Kyu; Jarman, Richard G; De La Barrera, Rafael; Moris, Philippe; Eckels, Kenneth H; Thomas, Stephen J; Innis, Bruce L

    2016-06-01

    We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1-4 waned during the 1-3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response.

  17. Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

    2009-01-01

    Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

  18. PLUME-SCALER-EVALUATING LONG-TERM MONITORING WELL NETWORKS

    EPA Science Inventory

    EPA's Subsurface Protection and Remediation Division is developing a new computer application called PLUME-SCALER to evaluate long term monitoring well networks using typically available historical site water level data. PLUME-SCALER can be used to determine if there are enough ...

  19. Evaluation of Long Term Performance of Continuously Running Atomic Fountains

    DTIC Science & Technology

    2014-05-28

    DISTRIBUTION/AVAILABILITY STATEMENT Approved for public release; distribution unlimited 13. SUPPLEMENTARY NOTES Metrologia 51 (2014) 263?269 14...Std Z39-18 | Bureau International des Poids et Mesures Metrologia Metrologia 51 (2014) 263–269 doi:10.1088/0026-1394/51/3/263 Evaluation of long term...utilizes data from hundreds of these clocks, 0026-1394/14/030263+07$33.00 263 © 2014 BIPM & IOP Publishing Ltd Printed in the UK Metrologia 51 (2014) 263 S

  20. Long-term safety and efficacy profile of simvastatin.

    PubMed

    Boccuzzi, S J; Bocanegra, T S; Walker, J F; Shapiro, D R; Keegan, M E

    1991-11-01

    Simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, has been administered to approximately 2,400 patients with primary hypercholesterolemia with a mean follow-up of 1 year in controlled clinical studies and their open extensions. Approximately 10% of this population received simvastatin for a period of greater than or equal to 2 years. The population on whom this safety analysis is based had a mean age of 50 years; 62% were men and approximately 27% had preexisting coronary artery disease. Simvastatin was titrated to the maximal daily dose of 40 mg each evening in 56% of the study population (last recorded dose). The most frequently reported drug-related clinical adverse experiences were constipation (2.5%), abdominal pain (2.2%), flatulence (2.0%) and headaches (1%). Persistent elevations of serum transaminase levels greater than 3 times the upper limit of normal were observed in only 1% of this cohort with only 0.1% of the total population requiring discontinuation of therapy. There were no clinically apparent episodes of hepatitis. Discontinuation of therapy due to myopathy was extremely rare (0.08%). Only minimal increases in the frequency of lens opacities (1%) were observed from baseline to the last lens examination during follow-up, consistent with the expected increase in lens opacity development due to normal aging. Patients who were greater than or equal to 65 years old had a clinical and laboratory safety profile comparable to the nonelderly population.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain.

    PubMed

    Gimbel, Joseph S; Kivitz, Alan J; Bramson, Candace; Nemeth, Mary Anne; Keller, David S; Brown, Mark T; West, Christine R; Verburg, Kenneth M

    2014-09-01

    A noncontrolled, randomized, multicenter study (NCT00924664) evaluated long-term safety and effectiveness of tanezumab in patients with chronic low back pain following a randomized placebo- and active-controlled parent study that evaluated analgesic efficacy. Patients were randomized to tanezumab 10mg (n=321) or 20mg (n=527) administered at 8-week intervals via 3 intravenous injections followed by 4 subcutaneous injections. Effectiveness analyses included change from parent study baseline in Brief Pain Inventory Short Form, Roland Morris Disability Questionnaire, and Patient's Global Assessment of low back pain. Safety assessments included adverse event documentation, physical/neurological examinations, and laboratory tests. Mean treatment duration during the extension study was 194 and 202 days with tanezumab 10 and 20mg, respectively. Both tanezumab doses provided similar and sustained improvements in all effectiveness outcomes. The most frequently reported adverse events were arthralgia, paresthesia, and hypoesthesia. Adverse events initially described as osteonecrosis were reported in 6 patients (tanezumab 10mg, n=2; tanezumab 20mg, n=4); 9 additional patients (tanezumab 10mg, n=7; tanezumab 20mg, n=2) underwent total joint replacement (TJR). A blinded, independent adjudication committee reviewed all 6 patients with reported osteonecrosis and 4 of the 9 patients undergoing TJR. Adjudication outcomes were osteonecrosis (n=0), worsening osteoarthritis (n=5; 1 rapidly progressive), and another diagnosis or indeterminate (n=5). Tanezumab 10mg had better tolerability than tanezumab 20mg, and may represent an effective long-term treatment for chronic low back pain.

  2. Improving patient safety in a UK dental hospital: long-term use of clinical audit.

    PubMed

    Ashley, M P; Pemberton, M N; Saksena, A; Shaw, A; Dickson, S

    2014-10-01

    The improvement of patient safety has been a long-term aim of healthcare organisations and following recent negative events within the UK, the focus on safety has rightly increased. For over twenty years, clinical audit has been the tool most frequently used to measure safety-related aspects of healthcare and when done so correctly, can lead to sustained improvements. This paper explains how clinical audit is used as a safety improvement tool in an English dental hospital and gives several examples of projects that have resulted in long-term improvements in secondary dental care.

  3. Long-term safety of mepolizumab for the treatment of hypereosinophilic syndromes

    PubMed Central

    Roufosse, Florence E; Kahn, Jean-Emmanuel; Gleich, Gerald J; Schwartz, Lawrence B; Singh, Anish D; Rosenwasser, Lanny J; Denburg, Judah A; Ring, Johannes; Rothenberg, Marc E; Sheikh, Javed; Haig, Ann E; Mallett, Stephen A; Templeton, Deborah N; Ortega, Hector G; Klion, Amy D

    2012-01-01

    Background Hypereosinophilic syndromes (HES) are chronic disorders that require long-term therapy to suppress eosinophilia and clinical manifestations. Corticosteroids are usually effective, yet many patients become corticosteroid-refractory or develop corticosteroid toxicity. Mepolizumab, a humanised monoclonal anti-interleukin-5 antibody, demonstrated corticosteroid-sparing effects in a double-blind, placebo-controlled study of FIP1L1/PDGFRA-negative, corticosteroid-responsive subjects with HES. Objective To evaluate long-term safety and efficacy of mepolizumab (750 mg) in HES. Methods MHE100901 is an open-label extension study. The primary endpoint was the frequency of adverse events (AEs). Optimal dosing frequency, corticosteroid-sparing effect of mepolizumab, and development of anti-mepolizumab antibodies were also explored. Results Seventy-eight subjects received 1–66 mepolizumab infusions each (including mepolizumab infusions received in the placebo-controlled trial). Mean exposure was 251 weeks (range 4–302). The most common dosing interval was 9–12 weeks. The incidence of AEs was 932 events per 100 subject-years in the first year, declining to 461 events per 100 subject-years after 48 months. Serious AEs, including one death, were reported by the investigator as possibly due to mepolizumab in three subjects. The median daily prednisone dose decreased from 20.0 to 0 mg in the first 24 weeks. The median average daily dose for all subjects over the course of the study was 1.8 mg. Sixty-two percent of subjects were prednisone-free without other HES medications for ≥12 consecutive weeks. No neutralizing antibodies were detected. Twenty-four subjects withdrew prior to study completion for death (n=4), lack of efficacy (n=6), or other reasons. Conclusion Mepolizumab was well tolerated and effective as a long-term corticosteroid-sparing agent in PDGFRA-negative HES. PMID:23040887

  4. SULFURIC ACID REMOVAL PROCESS EVALUATION: LONG-TERM RESULTS

    SciTech Connect

    Gary M. Blythe; Richard McMillan

    2002-07-03

    longer-term (approximately 25-day) full-scale tests on two different units. The longer-term tests were conducted to confirm the effectiveness of the sorbents tested over extended operation on two different boilers, and to determine balance-of-plant impacts. The first long-term test was conducted on FirstEnergy's BMP, Unit 3, and the second test was conducted on AEP's Gavin Plant, Unit 1. The Gavin Plant testing provided an opportunity to evaluate the effects of sorbent injected into the furnace on SO{sub 3} formed across an operating SCR reactor. This report presents the results from those long-term tests. The tests determined the effectiveness of injecting commercially available magnesium hydroxide slurry (Gavin Plant) and byproduct magnesium hydroxide slurry (both Gavin Plant and BMP) for sulfuric acid control. The results show that injecting either slurry could achieve up to 70 to 75% overall sulfuric acid removal. At BMP, this overall removal was limited by the need to maintain acceptable electrostatic precipitator (ESP) particulate control performance. At Gavin Plant, the overall sulfuric acid removal was limited because the furnace injected sorbent was less effective at removing SO{sub 3} formed across the SCR system installed on the unit for NOX control than at removing SO{sub 3} formed in the furnace. The long-term tests also determined balance-of-plant impacts from slurry injection during the two tests. These include impacts on boiler back-end temperatures and pressure drops, SCR catalyst properties, ESP performance, removal of other flue gas species, and flue gas opacity. For the most part the balance-of-plant impacts were neutral to positive, although adverse effects on ESP performance became an issue during the BMP test.

  5. Safety, Tolerability, and Compliance with Long-Term Antimalarial Chemoprophylaxis in American Soldiers in Afghanistan

    PubMed Central

    Saunders, David L.; Garges, Eric; Manning, Jessica E.; Bennett, Kent; Schaffer, Sarah; Kosmowski, Andrew J.; Magill, Alan J.

    2015-01-01

    Long-term antimalarial chemoprophylaxis is currently used by deployed U.S. military personnel. Previous small, short-term efficacy studies have shown variable rates of side effects among patients taking various forms of chemoprophylaxis, though reliable safety and tolerability data on long-term use are limited. We conducted a survey of troops returning to Fort Drum, NY following a 12-month deployment to Operation Enduring Freedom, Afghanistan from 2006 to 2007. Of the 2,351 respondents, 95% reported taking at least one form of prophylaxis during their deployment, and 90% were deployed for > 10 months. Compliance with daily doxycycline was poor (60%) compared with 80% with weekly mefloquine (MQ). Adverse events (AEs) were reported by approximately 30% with both MQ and doxycycline, with 10% discontinuing doxycycline compared with 4% of MQ users. Only 6% and 31% of soldiers reported use of bed nets and skin repellents, respectively. Compliance with long-term malaria prophylaxis was poor, and there were substantial tolerability issues based on these anonymous survey results, though fewer with MQ than doxycycline. Given few long-term antimalarial chemoprophylaxis options, there is an unmet medical need for new antimalarials safe for long-term use. PMID:26123954

  6. Safety, Tolerability, and Compliance with Long-Term Antimalarial Chemoprophylaxis in American Soldiers in Afghanistan.

    PubMed

    Saunders, David L; Garges, Eric; Manning, Jessica E; Bennett, Kent; Schaffer, Sarah; Kosmowski, Andrew J; Magill, Alan J

    2015-09-01

    Long-term antimalarial chemoprophylaxis is currently used by deployed U.S. military personnel. Previous small, short-term efficacy studies have shown variable rates of side effects among patients taking various forms of chemoprophylaxis, though reliable safety and tolerability data on long-term use are limited. We conducted a survey of troops returning to Fort Drum, NY following a 12-month deployment to Operation Enduring Freedom, Afghanistan from 2006 to 2007. Of the 2,351 respondents, 95% reported taking at least one form of prophylaxis during their deployment, and 90% were deployed for > 10 months. Compliance with daily doxycycline was poor (60%) compared with 80% with weekly mefloquine (MQ). Adverse events (AEs) were reported by approximately 30% with both MQ and doxycycline, with 10% discontinuing doxycycline compared with 4% of MQ users. Only 6% and 31% of soldiers reported use of bed nets and skin repellents, respectively. Compliance with long-term malaria prophylaxis was poor, and there were substantial tolerability issues based on these anonymous survey results, though fewer with MQ than doxycycline. Given few long-term antimalarial chemoprophylaxis options, there is an unmet medical need for new antimalarials safe for long-term use.

  7. Resilience Engineering in Critical Long Term Aerospace Software Systems: A New Approach to Spacecraft Software Safety

    NASA Astrophysics Data System (ADS)

    Dulo, D. A.

    Safety critical software systems permeate spacecraft, and in a long term venture like a starship would be pervasive in every system of the spacecraft. Yet software failure today continues to plague both the systems and the organizations that develop them resulting in the loss of life, time, money, and valuable system platforms. A starship cannot afford this type of software failure in long journeys away from home. A single software failure could have catastrophic results for the spaceship and the crew onboard. This paper will offer a new approach to developing safe reliable software systems through focusing not on the traditional safety/reliability engineering paradigms but rather by focusing on a new paradigm: Resilience and Failure Obviation Engineering. The foremost objective of this approach is the obviation of failure, coupled with the ability of a software system to prevent or adapt to complex changing conditions in real time as a safety valve should failure occur to ensure safe system continuity. Through this approach, safety is ensured through foresight to anticipate failure and to adapt to risk in real time before failure occurs. In a starship, this type of software engineering is vital. Through software developed in a resilient manner, a starship would have reduced or eliminated software failure, and would have the ability to rapidly adapt should a software system become unstable or unsafe. As a result, long term software safety, reliability, and resilience would be present for a successful long term starship mission.

  8. Evaluation of long term performance of continuously running atomic fountains

    NASA Astrophysics Data System (ADS)

    Peil, Steven; Hanssen, James L.; Swanson, Thomas B.; Taylor, Jennifer; Ekstrom, Christopher R.

    2014-06-01

    An ensemble of rubidium atomic fountain clocks has been put into operation at the US Naval Observatory (USNO). These fountains are used as continuous clocks in the manner of commercial caesium beams and hydrogen masers for the purpose of improved timing applications. Four fountains have been in operation for more than two years and are included in the ensemble used to generate the USNO master clock. Individual fountain performance is characterized by a white-frequency noise level below 2 × 10-13 and fractional-frequency stability routinely reaching the low 10-16 s. The highest performing pair of fountains exhibits stability consistent with each fountain integrating as white frequency noise, with Allan deviation surpassing 6 × 10-17 at 107 s, and with no relative drift between the fountains at the level of 7.5 × 10-19/day. As an ensemble, the fountains generate a timescale with white-frequency noise level of 1 × 10-13 and long-term frequency stability consistent with zero drift relative to the world's primary standards at 1 × 10-18/day. The rubidium fountains are reported to the BIPM as continuously running clocks, as opposed to secondary standards, the only cold-atom clocks so reported. Here we further characterize the performance of the individual fountains and the ensemble during the first two years in an operational environment, presenting the first look at long-term continuous behavior of fountain clocks.

  9. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy

    PubMed Central

    Witt, Thomas; Worth, Robert; Henry, Thomas R.; Gross, Robert E.; Nazzaro, Jules M.; Labar, Douglas; Sperling, Michael R.; Sharan, Ashwini; Sandok, Evan; Handforth, Adrian; Stern, John M.; Chung, Steve; Henderson, Jaimie M.; French, Jacqueline; Baltuch, Gordon; Rosenfeld, William E.; Garcia, Paul; Barbaro, Nicholas M.; Fountain, Nathan B.; Elias, W. Jeffrey; Goodman, Robert R.; Pollard, John R.; Tröster, Alexander I.; Irwin, Christopher P.; Lambrecht, Kristin; Graves, Nina; Fisher, Robert

    2015-01-01

    Objective: To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related epilepsy. Methods: This long-term follow-up is a continuation of a previously reported trial of 5- vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators' discretion. Seizure frequency was determined using daily seizure diaries. Results: The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001). Conclusion: Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population. Classification of evidence: This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years. PMID:25663221

  10. Long-term efficacy and safety of botulinum toxin injections in dystonia.

    PubMed

    Ramirez-Castaneda, Juan; Jankovic, Joseph

    2013-02-04

    Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurological and non-neurological disorders. Despite almost 30 years of therapeutic use, there are only few studies of patients treated with BoNT injections over long period of time. These published data clearly support the conclusion that BoNT not only provides safe and effective symptomatic relief of dystonia but also long-term benefit and possibly even favorably modifying the natural history of this disease. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. With the chronic use of BoNT and an expanding list of therapeutic indications, there is a need to carefully examine the existing data on the long-term efficacy and safety of BoNT. In this review we will highlight some of the aspects of long-term effects of BoNT, including efficacy, safety, and immunogenicity.

  11. Long-term safety assessment of live attenuated tetravalent dengue vaccines: deliberations from a WHO technical consultation.

    PubMed

    Bentsi-Enchill, Adwoa D; Schmitz, Julia; Edelman, Robert; Durbin, Anna; Roehrig, John T; Smith, Peter G; Hombach, Joachim; Farrar, Jeremy

    2013-05-28

    Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.

  12. Open-Label, Long-Term Safety Study of Cevimeline in the Treatment of Postirradiation Xerostomia

    SciTech Connect

    Chambers, Mark S. Jones, Christopher Uwe; Biel, Merrill A.; Weber, Randal S.; Hodge, Kenneth M.; Chen, Y.; Holland, John M.; Ship, Jonathan; Vitti, Robert; Armstrong, Ingrid; Garden, Adam S.; Haddad, Robert

    2007-12-01

    Purpose: To assess the safety of long-term cevimeline treatment of radiation-induced xerostomia in patients with head-and-neck cancer; and to assess the efficacy of cevimeline in these patients. Methods and Materials: A total of 255 adults with head-and-neck cancer who had received more than 40 Gy of radiation 4 months or more before entry and had clinically significant salivary gland dysfunction received cevimeline hydrochloride 45 mg t.i.d. orally for 52 weeks. Adverse events (AEs), their severity, and their relationship to the study medication were assessed by each investigator. The efficacy assessment was based on subjects' global evaluation of oral dryness on a scale of 0 (none) to 3 (severe). Results: Overall, 175 subjects (68.6%) experienced expected treatment-related AEs, most mild to moderate. The most frequent was increased sweating (47.5%), followed by dyspepsia (9.4%), nausea (8.2%), and diarrhea (6.3%). Fifteen subjects (5.9%) experienced Grade 3 treatment-related AEs, of which the most frequent was increased sweating. Eighteen subjects (7.1%) reported at least one serious AE, and 45 subjects (17.6%) discontinued study medication because of an AE. The global efficacy evaluation at the last study visit showed that cevimeline improved dry mouth in most subjects (59.2%). Significant improvement was seen at each study visit in the mean change from baseline of the numeric global evaluation score (p < 0.0001). Conclusions: Cevimeline 45 mg t.i.d. was generally well tolerated over a period of 52 weeks in subjects with xerostomia secondary to radiotherapy for cancer in the head-and-neck region.

  13. Long-term safety and efficacy of oral phentolamine mesylate (Vasomax) in men with mild to moderate erectile dysfunction.

    PubMed

    Padma-Nathan, H; Goldstein, I; Klimberg, I; Coogan, C; Auerbach, S; Lammers, P

    2002-08-01

    The objectives of this study were to evaluate long-term safety and efficacy of phentolamine mesylate, an orally active, rapid-acting alpha-adrenergic receptor antagonist, for the treatment of men suffering from erectile dysfunction (ED). It was an open-label study involving more than 2000 patients. Men received phentolamine mesylate 40 mg or 80 mg (10 tablets/month) as needed for up to 13 months and self-assessed erectile performance using two validated questionnaires. Treatment with phentolamine mesylate was associated with increases in Erectile Function Domain score of the IIEF, successful vaginal penetrations, and in overall satisfaction. Most adverse events were mild or moderate in severity and consistent with the known pharmacodynamic properties of phentolamine. In conclusion, phentolamine mesylate is safe and effective in the long-term treatment of men with mild to moderate ED.

  14. The long term storage of radioactive waste and spent fuel: safety and policy considerations

    SciTech Connect

    Rowat, J.; Metcalf, P.

    2007-07-01

    Storage is a necessary step in the overall management of radioactive waste. In recent years, due to the unavailability of disposal facilities, storage facilities intended originally as temporary, have had their lifetimes extended and consideration has been given, in some countries, to the use of long term storage (LTS) as a management option. In 2003, the IAEA published a position paper titled 'The Long Term Storage of Radioactive Waste: Safety and Sustainability'. The position paper, which written for a non-specialist audience, focused on seven key factors for safety and sustainability of LTS, namely: safety, maintenance/institutional control, retrieval, security, costs, community attitudes and retention of information. The Agency is preparing a follow-up report to the position paper that elaborates in a more technical manner upon the issues raised in the position paper and issues important for implementation of LTS. It also provides some discussion of the reasons for implementing a LTS option and contrasts LTS with aspects of other management options. The present paper provides an overview of the draft follow-up report. (authors)

  15. Long-Term Safety and Efficacy of Lowering Low-Density Lipoprotein Cholesterol With Statin Therapy

    PubMed Central

    Ford, Ian; Murray, Heather; Packard, Chris J.

    2016-01-01

    Background— Extended follow-up of statin-based low-density lipoprotein cholesterol lowering trials improves the understanding of statin safety and efficacy. Examining cumulative cardiovascular events (total burden of disease) gives a better appreciation of the clinical value of statins. This article evaluates the long-term impact of therapy on mortality and cumulative morbidity in a high-risk cohort of men. Methods and Results— The West of Scotland Coronary Prevention Study was a primary prevention trial in 45- to 64-year-old men with high low-density lipoprotein cholesterol. A total of 6595 men were randomized to receive pravastatin 40 mg once daily or placebo for an average of 4.9 years. Subsequent linkage to electronic health records permitted analysis of major incident events over 20 years. Post trial statin use was recorded for 5 years after the trial but not for the last 10 years. Men allocated to pravastatin had reduced all-cause mortality (hazard ratio, 0.87; 95% confidence interval, 0.80–0.94; P=0.0007), attributable mainly to a 21% decrease in cardiovascular death (hazard ratio, 0.79; 95% confidence interval, 0.69–0.90; P=0.0004). There was no difference in noncardiovascular or cancer death rates between groups. Cumulative hospitalization event rates were lower in the statin-treated arm: by 18% for any coronary event (P=0.002), by 24% for myocardial infarction (P=0.01), and by 35% for heart failure (P=0.002). There were no significant differences between groups in hospitalization for noncardiovascular causes. Conclusion— Statin treatment for 5 years was associated with a legacy benefit, with improved survival and a substantial reduction in cardiovascular disease outcomes over a 20-year period, supporting the wider adoption of primary prevention strategies. PMID:26864092

  16. Growth Hormone and Treatment Controversy; Long Term Safety of rGH

    PubMed Central

    DiVall, Sara A.; Radovick, Sally

    2013-01-01

    The availability of recombinant human growth hormone (rGH) for treatment of growth disorders has provided an unlimited supply for replacement in patients with growth hormone insufficiency but also for short stature due to Turner syndrome, renal failure, Prader-Willi syndrome, small for gestational age and idiopathic short stature. Considering the potential for side effects in the use of a growth promoting agent, the community of physicians and pharmaceutical manufacturers developed systematic methods to survey for short and long term effects. Recently published data from the National Cooperative Growth Study (NCGS), managed by Genentech, concluded that GH has a ‘favorable profile’. In 2012, results from the European Union’s Safety and Appropriateness of GH treatment in Europe (EU SAGhE) study about the long term mortality in GH treated patients were published in two separate manuscripts. This review will examine the issue of safety of rGH in order that practitioners are informed as they consider initiation of therapy with patients. PMID:23772352

  17. Effects of an active accelerator pedal on driver behaviour and traffic safety after long-term use in urban areas.

    PubMed

    Várhelyi, András; Hjälmdahl, Magnus; Hydén, Christer; Draskóczy, Magda

    2004-09-01

    The long-term effects of the active accelerator pedal (AAP) were evaluated in the city of Lund in 2000 and 2001. The system, installed in 284 vehicles, produced a counterforce in the accelerator pedal at the speed limit. It could, however be overridden by pressing the accelerator pedal harder. The results showed that test drivers' compliance with the speed limits improved considerably. Reduction in average speeds and less speed variation by the test vehicles indicate a great traffic-safety potential. Travel times were unaffected, while emission volumes decreased significantly.

  18. Safety of long-term use of linezolid: results of an open-label study

    PubMed Central

    Vazquez, Jose A; Arnold, Anthony C; Swanson, Robert N; Biswas, Pinaki; Bassetti, Matteo

    2016-01-01

    Objective The objective of this study was to assess the long-term safety of linezolid in patients with chronic infections requiring treatment for ≥6 weeks. Enhanced monitoring for optic neuropathy was included to characterize the early development of this side effect and to identify ophthalmologic tests that might be valuable in early detection of this event. Methods This was a multicenter, open-label, pilot study of patients aged ≥18 years on long-term linezolid therapy. Matched control patients were included for baseline assessment comparison. Patients were assessed at study entry, monthly while on treatment, at the end of treatment, and 30 days following the last dose. Aggregate ocular safety data were reviewed. Response to treatment was reported. Results The study was terminated owing to slow enrollment. Twenty-four patients received linezolid; nine patients were included as matched controls. Linezolid was prescribed for a median of 80.5 days (range, 50–254 days). In patients with a reported clinical outcome, the majority were considered improved or cured. Common treatment-related adverse events (AEs) included anemia, peripheral neuropathy, polyneuropathy, vomiting, and asthenia, and were consistent with the known safety profile. Most AEs resolved or stabilized with discontinuation of treatment. Results of ophthalmologic tests in the one case adjudicated as probable linezolid-associated optic neuropathy revealed abnormal color vision, characteristic changes in the optic disk, and central scotomas in each eye. Conclusion In our small population, linezolid was generally well tolerated and AEs were consistent with the known safety profile. Extensive ophthalmologic testing of all 24 linezolid-treated patients identified one case adjudicated as probable, linezolid-associated optic neuropathy. PMID:27621644

  19. Acute injury with intravenous iron and concerns regarding long-term safety.

    PubMed

    Bishu, Kalkidan; Agarwal, Rajiv

    2006-09-01

    Intravenous iron is widely used to maintain adequate iron stores and prevent iron deficiency anemia in patients with chronic kidney disease, yet concerns remain about its long-term safety with respect to oxidative stress, kidney injury, and accelerated atherosclerosis, which are the subjects of this review. Three parenteral iron formulations are available for use in the United States: Iron dextran, iron gluconate, and iron sucrose. Iron dextran, especially the high molecular form, has been linked with anaphylactoid and anaphylactic reactions, and its use has been declining. A portion of intravenous iron preparations is redox-active, labile iron available for direct donation to transferrin. In vitro tests show that commonly available intravenous iron formulations have differing capacities to saturate transferrin directly: Iron gluconate > iron sucrose > iron dextran. Intravenous iron treatment produces oxidative stress, as demonstrated by increases in plasma levels of lipid peroxidation products (malondialdehyde), at a point that is much earlier than the time to peak concentration of catalytically active iron, suggesting a direct effect of iron sucrose on oxidative stress. Furthermore, iron sucrose infusion produces endothelial dysfunction that seems to peak earlier than the serum level of free iron. Intravenous iron sucrose infusion also has been shown to produce acute renal injury and inflammation as demonstrated by increased urinary albumin, enzyme (N-acetyl-beta-glucosaminidase), and cytokine (chemokine monocyte chemoattractant protein-1) excretions. Although the long-term dangers of intravenous iron are unproved, these data call for examination of effects of intravenous iron on the potential for long-term harm in patients with chronic kidney disease.

  20. Long-term Evaluation of Cosmetic Appearance of Repaired Lacerations: Validation of Telephone Assessment.

    PubMed

    Hollander, Judd E; Valentine, Sharon M; McCuskey, Charles F; Turque, Theo; Singer, Adam J

    1998-01-01

    See editorial Objective: Patients with lacerations are most concerned about the ultimate cosmetic appearance of their wound. We evaluated methods to assess the long-term cosmetic appearance by telephone survey.

  1. Long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety?

    PubMed Central

    Kissin, Igor

    2013-01-01

    Background For the past 30 years, opioids have been used to treat chronic nonmalignant pain. This study tests the following hypotheses: (1) there is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective; and (2) the main problem associated with the safety of such treatment – assessment of the risk of addiction – has been neglected. Methods Scientometric analysis of the articles representing clinical research in this area was performed to assess (1) the quality of presented evidence (type of study); and (2) the duration of the treatment phase. The sufficiency of representation of addiction was assessed by counting the number of articles that represent (1) editorials; (2) articles in the top specialty journals; and (3) articles with titles clearly indicating that the addiction-related safety is involved (topic-in-title articles). Results Not a single randomized controlled trial with opioid treatment lasting >3 months was found. All studies with a duration of opioid treatment ≥6 months (n = 16) were conducted without a proper control group. Such studies cannot provide the consistent good-quality evidence necessary for a strong clinical recommendation. There were profound differences in the number of addiction articles related specifically to chronic nonmalignant pain patients and to opioid addiction in general. An inadequate number of chronic pain-related publications were observed with all three types of counted articles: editorials, articles in the top specialty journals, and topic-in-title articles. Conclusion There is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective. The above identified signs indicating neglect of addiction associated with the opioid treatment of chronic nonmalignant pain were present. PMID:23874119

  2. Rodent model for assessing the long term safety and performance of peripheral nerve recording electrodes

    NASA Astrophysics Data System (ADS)

    Vasudevan, Srikanth; Patel, Kunal; Welle, Cristin

    2017-02-01

    Objective. In the US alone, there are approximately 185 000 cases of limb amputation annually, which can reduce the quality of life for those individuals. Current prosthesis technology could be improved by access to signals from the nervous system for intuitive prosthesis control. After amputation, residual peripheral nerves continue to convey motor signals and electrical stimulation of these nerves can elicit sensory percepts. However, current technology for extracting information directly from peripheral nerves has limited chronic reliability, and novel approaches must be vetted to ensure safe long-term use. The present study aims to optimize methods to establish a test platform using rodent model to assess the long term safety and performance of electrode interfaces implanted in the peripheral nerves. Approach. Floating Microelectrode Arrays (FMA, Microprobes for Life Sciences) were implanted into the rodent sciatic nerve. Weekly in vivo recordings and impedance measurements were performed in animals to assess performance and physical integrity of electrodes. Motor (walking track analysis) and sensory (Von Frey) function tests were used to assess change in nerve function due to the implant. Following the terminal recording session, the nerve was explanted and the health of axons, myelin and surrounding tissues were assessed using immunohistochemistry (IHC). The explanted electrodes were visualized under high magnification using scanning electrode microscopy (SEM) to observe any physical damage. Main results. Recordings of axonal action potentials demonstrated notable session-to-session variability. Impedance of the electrodes increased upon implantation and displayed relative stability until electrode failure. Initial deficits in motor function recovered by 2 weeks, while sensory deficits persisted through 6 weeks of assessment. The primary cause of failure was identified as lead wire breakage in all of animals. IHC indicated myelinated and unmyelinated axons

  3. State policies for the residency of offenders in long-term care facilities: balancing right to care with safety.

    PubMed

    Cohen, Donna; Hays, Teresa; Molinari, Victor

    2011-09-01

    The presence of residents in long-term care facilities who are registered sex offenders, other predatory offenders, parolees, or inmates transferred by correctional authorities is controversial and has raised concerns about how to care for this potentially dangerous population who may jeopardize the safety of others. Although the present offender population appears to be small, it is likely that demographic and economic pressures will increase its size. Since 2004, 14 states have passed legislation about placement of sex and other offenders in facilities and 5 have implemented non-law policies. Because legislation is relatively recent, it is not possible to evaluate best practices at this time. Research should be a priority to determine best policies and practices to balance the right to care with safety.

  4. Long-term efficacy and safety of internal neurolysis for trigeminal neuralgia without neurovascular compression.

    PubMed

    Ko, Andrew L; Ozpinar, Alp; Lee, Albert; Raslan, Ahmed M; McCartney, Shirley; Burchiel, Kim J

    2015-05-01

    OBJECT Trigeminal neuralgia (TN) occurs and recurs in the absence of neurovascular compression (NVC). While microvascular decompression (MVD) is the most effective treatment for TN, it is not possible when NVC is not present. Therefore, the authors sought to evaluate the safety, efficacy, and durability of internal neurolysis (IN), or "nerve combing," as a treatment for TN without NVC. METHODS This was a retrospective review of all cases of Type 1 TN involving all patients 18 years of age or older who underwent evaluation (and surgery when appropriate) at Oregon Health & Science University between July 2006 and February 2013. Chart reviews and telephone interviews were conducted to assess patient outcomes. Pain intensity was evaluated with the Barrow Neurological Institute (BNI) Pain Intensity scale, and the Brief Pain Inventory-Facial (BPI-Facial) was used to assess general and face-specific activity. Pain-free survival and durability of successful pain relief (BNI pain scores of 1 or 2) were statistically evaluated with Kaplan-Meier analysis. Prognostic factors were identified and analyzed using Cox proportional hazards regression. RESULTS A total of 177 patients with Type 1 TN were identified. A subgroup of 27 was found to have no NVC on high-resolution MRI/MR angiography or at surgery. These patients were significantly younger than patients with classic Type 1 TN. Long-term follow-up was available for 26 of 27 patients, and 23 responded to the telephone survey. The median follow-up duration was 43.4 months. Immediate postoperative results were comparable to MVD, with 85% of patients pain free and 96% of patients with successful pain relief. At 1 year and 5 years, the rate of pain-free survival was 58% and 47%, respectively. Successful pain relief at those intervals was maintained in 77% and 72% of patients. Almost all patients experienced some degree of numbness or hypesthesia (96%), but in patients with successful pain relief, this numbness did not

  5. Self-contained self-rescuer long term field evaluation: combined eighth and ninth phase results

    SciTech Connect

    2006-10-15

    The National Institute for Occupational Safety and Health (NIOSH) National Personal Protective Technology Laboratory (NPPTL) and the Mine Safety and Health Administration (MSHA) conduct a Long Term Field Evaluation (LTFE) program to evaluate deployed self-contained self rescuers (SCSRs). The objective of the program is to evaluate how well SCSRs endure the underground coal mining environment with regard to both physical damage and aging when they are deployed in accordance with Federal regulations (30 CFR 75.1714). This report presents findings of the combined eighth and ninth phases of the LTFE. For these phases, over four hundred SCSRs were evaluated. The units tested include the CSE SR-100, Draeger Oxy K-Plus, MSA Life-saver 60, and the OCENCO EBA 6.5. The OCENCO 20 was evaluated only in Phase 9. Testing was performed between December 2000 and April 2004. Results of the evaluation indicate that all SCSRs experience some performance degradation due to the mining environment. Observed degradation varies from elevated levels of carbon dioxide, high breathing resistance, and reduced capacity. Mechanical degradation to the SCSR components included breathing hoses, chemical beds, outer cases and seals. The LTFE tests discussed in this report are different from tests performed for SCSR certification to the requirements of 42 Code of Federal Regulations, Part 84 (42 CFR, Part 84). LTFE tests reported here are conducted to an end point, oxygen depletion, to enable comparison of the duration of new and deployed SCSRs. The method for obtaining deployed SCSRs for this evaluation was not a random selection from the deployed population of SCSRs. Although the results of these tests are useful for observing performance of the tested SCSRs, they are not representative of all deployed SCSRs. 9 refs., 10 figs., 9 tabs., 3 apps.

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

    PubMed Central

    Watanabe, Yoshinori; Hongo, Seiji

    2017-01-01

    Background 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). Methods 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. Results 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. Limitations There was no control group. Data were collected retrospectively. Conclusion 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. PMID:28360522

  7. Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease

    PubMed Central

    Dubinsky, Marla; Ruemmele, Frank M.; Escher, Johanna; Rosh, Joel; Hyams, Jeffrey S.; Eichner, Samantha; Li, Yao; Reilly, Nattanan; Thakkar, Roopal B.; Robinson, Anne M.; Lazar, Andreas

    2017-01-01

    Background: IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Methods: Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Results: Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Conclusions: Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials. PMID:28129288

  8. Long-Term Safety of Topical Bacteriophage Application to the Frontal Sinus Region

    PubMed Central

    Drilling, Amanda J.; Ooi, Mian L.; Miljkovic, Dijana; James, Craig; Speck, Peter; Vreugde, Sarah; Clark, Jason; Wormald, Peter-John

    2017-01-01

    Background: Staphylococcus aureus biofilms contribute negatively to a number of chronic conditions, including chronic rhinosinusitis (CRS). With the inherent tolerance of biofilm-bound bacteria to antibiotics and the global problem of bacterial antibiotic resistance, the need to develop novel therapeutics is paramount. Phage therapy has previously shown promise in treating sinonasal S. aureus biofilms. Methods: This study investigates the long term (20 days) safety of topical sinonasal flushes with bacteriophage suspensions. The bacteriophage cocktail NOV012 against S. aureus selected for this work contains two highly characterized and different phages, P68 and K710. Host range was assessed against S. aureus strains isolated from CRS patients using agar spot tests. NOV012 was applied topically to the frontal sinus region of sheep, twice daily for 20 days. General sheep wellbeing, mucosal structural changes and inflammatory load were assessed to determine safety of NOV012 application. Results: NOV012 could lyse 52/61 (85%) of a panel of locally derived CRS clinical isolates. Application of NOV012 to the frontal sinuses of sheep for 20 days was found to be safe, with no observed inflammatory infiltration or tissue damage within the sinus mucosa. Conclusion: NOV012 cocktail appears safe to apply for extended periods to sheep sinuses and it could infect and lyse a wide range of S. aureus CRS clinical isolates. This indicates that phage therapy has strong potential as a treatment for chronic bacterial rhinosinusitis. PMID:28286740

  9. Long-term evaluation of a phase 1 study of AADC gene therapy for Parkinson's disease.

    PubMed

    Mittermeyer, Gabriele; Christine, Chadwick W; Rosenbluth, Kathryn H; Baker, Suzanne L; Starr, Philip; Larson, Paul; Kaplan, Paul L; Forsayeth, John; Aminoff, Michael J; Bankiewicz, Krystof S

    2012-04-01

    We report the results of a long-term follow-up of subjects in a phase 1 study of AAV2-hAADC (adeno-associated virus type 2-human aromatic L-amino acid decarboxylase) gene therapy for the treatment of Parkinson's disease (PD). Ten patients with moderately advanced PD received bilateral putaminal infusions of either a low or a high dose of AAV2-hAADC vector. An annual positron emission tomography (PET) imaging with [(18)F]fluoro-L-m-tyrosine tracer was used for evaluation of AADC expression, and a standard clinical rating scale [Unified Parkinson's Disease Rating Scale (UPDRS)] was used to assess effect. Our previous analysis of the 6-month data suggested that this treatment was acutely safe and well tolerated. We found that the elevated PET signal observed in the first 12 months persisted over 4 years in both dose groups. A significantly increased PET value compared with the presurgery baseline was maintained over the 4-year monitoring period. The UPDRS in all patients off medication for 12 hr improved in the first 12 months, but displayed a slow deterioration in subsequent years. This analysis demonstrates that apparent efficacy continues through later years with an acceptable safety profile. These data indicate stable transgene expression over 4 years after vector delivery and continued safety, but emphasize the need for a controlled efficacy trial and the use of a higher vector dose.

  10. Safety and effectiveness profile of raloxifene in long-term, prospective, postmarketing surveillance.

    PubMed

    Iikuni, Noriko; Hamaya, Etsuro; Nihojima, Shigeru; Yokoyama, Shunji; Goto, Wakana; Taketsuna, Masanori; Miyauchi, Akimitsu; Sowa, Hideaki

    2012-11-01

    This large-scale postmarketing surveillance of raloxifene (60 mg/day) was conducted to assess the safety and effectiveness of raloxifene for long-term use in postmenopausal Japanese women with osteoporosis. The baseline examination included 6,967 women (mean age, 70.4 years). Participants completed observation after 6, 12, 24, and 36 months of therapy. Adverse drug reactions (ADR) were reported in 776 participants (11.14 %), with a total of 87 serious ADR cases occurring in 76 participants (1.09 %). The most frequently reported ADRs were edema peripheral (45/6,967, 0.65 %) and venous thromboembolism (11/6,967, 0.16 %). Of the 6,967 participants, 2,784 were included in the effectiveness analysis. Lumbar spine bone mineral density (BMD) increased significantly (p < 0.001, paired t test) compared with baseline at 6, 12, 24, and 36 months (2.51 %, 2.85 %, 4.76 %, and 3.51 %, respectively). Significant decreases in serum and urinary cross-linked amino-terminal telopeptide of type I collagen (NTX) and urinary deoxypyridinoline levels from baseline were observed at 3 months, followed by a significant decrease of serum bone alkaline phosphatase at 6 months [p < 0.001 for all comparisons except serum NTX (p = 0.011), Wilcoxon signed-rank test]. Early reductions in the biochemical markers of bone turnover (BTM) observed at 3 months with raloxifene treatment correlated negatively with subsequent increases in lumbar spine BMD at 1 year (r = -0.347, p = 0.008). The incidence of any new clinical fractures within 3 years was 1.18 % (82/6,967 participants). In summary, no new signals in safety were observed in the daily use of raloxifene. Moreover, the effectiveness profile of raloxifene was confirmed in practical use by this large-scale, long-term, postmarketing surveillance.

  11. Long-term efficacy and safety of ramosetron in the treatment of diarrhea-predominant irritable bowel syndrome

    PubMed Central

    Chiba, Toshimi; Yamamoto, Kazunari; Sato, Shoko; Suzuki, Kazuyuki

    2013-01-01

    Irritable bowel syndrome (IBS) is a functional disease with persisting gastrointestinal symptoms that has been classified into four subtypes. Serotonin (5-hydroxytryptamine [5-HT]) plays important physiological roles in the contraction and relaxation of smooth muscle. Intraluminal distension of the intestine is known to stimulate the release of endogenous 5-HT from enterochromaffin cells, activating 5-HT3 receptors located on primary afferent neurons and leading to increases in intestinal secretions and peristaltic activity. Ramosetron, a potent and selective 5-HT3-receptor antagonist, has been in development for use in patients suffering from diarrhea-predominant IBS. In a double-blind, placebo-controlled, parallel-group study of 418 patients with diarrhea-predominant IBS-D, once-daily 5 μg and 10 μg doses of ramosetron increased the monthly responder rates of IBS symptoms compared to placebo. In a 12-week randomized controlled trial of 539 patients, a positive response to treatment was reported by 47% of a once-daily 5 μg dose of ramosetron-treated individuals compared to 27% of patients receiving placebo (P<0.001). Furthermore, the responder rate was increased in the oral administration of 5 μg of ramosetron for at least 28 weeks (up to 52 weeks), and long-term efficacy for overall improvement of IBS symptoms was also demonstrated. The rate was further increased subsequently. Adverse events were reported by 7% in ramosetron treatment. No serious adverse events, eg, severe constipation or ischemic colitis, were reported for long-term treatment with ramosetron. In conclusion, further studies to evaluate the long-term efficacy and safety of ramosetron are warranted in the form of randomized controlled trials. PMID:23922505

  12. Evaluation and prediction of long-term environmental effects on nonmetallic materials

    NASA Technical Reports Server (NTRS)

    1982-01-01

    Changes in functional properties of a broad spectrum of nonmetallic materials as a function of environment and exposure time were evaluated. Models for predicting long-term material performance are discussed. A literature search on specific materials in the space and simulated space environment was carried out and evaluated.

  13. Long-Term Marine Traffic Monitoring for Environmental Safety in the Aegean Sea

    NASA Astrophysics Data System (ADS)

    Giannakopoulos, T.; Gyftakis, S.; Charou, E.; Perantonis, S.; Nivolianitou, Z.; Koromila, I.; Makrygiorgos, A.

    2015-04-01

    The Aegean Sea is characterized by an extremely high marine safety risk, mainly due to the significant increase of the traffic of tankers from and to the Black Sea that pass through narrow straits formed by the 1600 Greek islands. Reducing the risk of a ship accident is therefore vital to all socio-economic and environmental sectors. This paper presents an online long-term marine traffic monitoring work-flow that focuses on extracting aggregated vessel risks using spatiotemporal analysis of multilayer information: vessel trajectories, vessel data, meteorological data, bathymetric / hydrographic data as well as information regarding environmentally important areas (e.g. protected high-risk areas, etc.). A web interface that enables user-friendly spatiotemporal queries is implemented at the frontend, while a series of data mining functionalities extracts aggregated statistics regarding: (a) marine risks and accident probabilities for particular areas (b) trajectories clustering information (c) general marine statistics (cargo types, etc.) and (d) correlation between spatial environmental importance and marine traffic risk. Towards this end, a set of data clustering and probabilistic graphical modelling techniques has been adopted.

  14. Improving Service Quality in Long-term Care Hospitals: National Evaluation on Long-term Care Hospitals and Employees Perception of Quality Dimensions

    PubMed Central

    Kim, Jinkyung; Han, Woosok

    2012-01-01

    Objectives To investigate predictors for specific dimensions of service quality perceived by hospital employees in long-term care hospitals. Methods Data collected from a survey of 298 hospital employees in 18 long-term care hospitals were analysed. Multivariate ordinary least squares regression analysis with hospital fixed effects was used to determine the predictors of service quality using respondents’ and organizational characteristics. Results The most significant predictors of employee-perceived service quality were job satisfaction and degree of consent on national evaluation criteria. National evaluation results on long-term care hospitals and work environment also had positive effects on service quality. Conclusion The findings of the study show that organizational characteristics are significant determinants of service quality in long-term care hospitals. Assessment of the extent to which hospitals address factors related to employeeperceived quality of services could be the first step in quality improvement activities. Results have implications for efforts to improve service quality in longterm care hospitals and designing more comprehensive national evaluation criteria. PMID:24159497

  15. Monitoring the Long-Term Effectiveness of Integrated Safety Management System (ISMS) Implementation Through Use of a Performance Dashboard Process

    SciTech Connect

    Michael D. Kinney and William D. Barrick

    2008-09-01

    This session will examine a method developed by Federal and Contractor personnel at the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) to examine long-term maintenance of DOE Integrated Safety Management System (ISMS) criteria, including safety culture attributes, as well as identification of process improvement opportunities. This process was initially developed in the summer of 2000 and has since been expanded to recognize the importance of safety culture attributes, and associated safety culture elements, as defined in DOE M 450.4-1, “Integrated Safety Management System Manual.” This process has proven to significantly enhance collective awareness of the importance of long-term ISMS implementation as well as support commitments by NNSA/NSO personnel to examine the continued effectiveness of ISMS processes.

  16. Evaluation of the Long-Term Stability and Temperature Coefficient of Dew-Point Hygrometers

    NASA Astrophysics Data System (ADS)

    Benyon, R.; Vicente, T.; Hernández, P.; De Rivas, L.; Conde, F.

    2012-09-01

    The continuous quest for improved specifications of optical dew-point hygrometers has raised customer expectations on the performance of these devices. In the absence of a long calibration history, users with a limited prior experience in the measurement of humidity, place reliance on manufacturer specifications to estimate long-term stability. While this might be reasonable in the case of measurement of electrical quantities, in humidity it can lead to optimistic estimations of uncertainty. This article reports a study of the long-term stability of some hygrometers and the analysis of their performance as monitored through regular calibration. The results of the investigations provide some typical, realistic uncertainties associated with the long-term stability of instruments used in calibration and testing laboratories. Together, these uncertainties can help in establishing initial contributions in uncertainty budgets, as well as in setting the minimum calibration requirements, based on the evaluation of dominant influence quantities.

  17. Methodological Considerations in Evaluating Long-Term Systems Change: A Case Study From Eastern Nepal

    ERIC Educational Resources Information Center

    Koleros, Andrew; Jupp, Dee; Kirwan, Sean; Pradhan, Meeta S.; Pradhan, Pushkar K.; Seddon, David; Tumbahangfe, Ansu

    2016-01-01

    This article presents discussion and recommendations on approaches to retrospectively evaluating development interventions in the long term through a systems lens. It is based on experiences from the implementation of an 18-month study to investigate the impact of development interventions on economic and social change over a 40-year period in the…

  18. Evaluating the Long-Term Impacts of AmeriCorps Service on Participants. PRGS Dissertation

    ERIC Educational Resources Information Center

    Epstein, Diana

    2009-01-01

    Since 1993, over 500,000 people have served in AmeriCorps national service programs. This dissertation evaluates the long-term impacts of AmeriCorps service on participants, particularly in the areas of civic engagement, future volunteerism, appreciation of diversity, and a number of other job and life skills. It fills a gap by using both…

  19. Computer simulation of microgravity long-term effects and risk evaluation

    NASA Astrophysics Data System (ADS)

    Perez-Poch, Antoni

    The objective of this work is to analyse and simulate possible long-term effects of microgravity on the human pulmonary function. It is also studied the efficacy of long-term regular exercise on relevant cardiovascular parameters when the human body is also exposed to microgravity. Little is known today about what long-term effects microgravity may cause on pulmonary function. It does not exist a complete explanation of the possible risks involved, although some experiments are under way on the ISS in order to evaluate them. Computer simulations are an important tool which may be used to predict and analyse these possible effects, and compare them with in-flight experiments. We based our study on a previous computer model (NELME: Numerical Evaluation of Long-term Microgravity Effects) which was developed in our laboratory and validated with the available data, focusing on the cardiovascular parameters affected by changes in gravity exposure. In this previous work we simulated part of the cardiovascular systems and we applied it to evaluate risks of blood-forming organs malfunction. NELME is based on an electrical-like control system model of the physiological changes, that may occur when gravity changes are applied. The computer implementation has a modular architecture. Hence, different output parameters, potential effects, organs and countermeasures can be easily implemented and evaluated. In this work we added a module to the system to analyse the pulmonary function with a gravity input parameter, as well as exposure time. We then conducted a battery of simulations when different values of g are applied for long-term exposures. We found no significant evidence of changes and no risks were foreseen. We also carried out an EVA simulation as a perturbation in the system (intense exercise, changes in breathed air) and studied the acute response. This is of great importance as current mission requirements do not allow data collection immediately following real EVAs

  20. Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia.

    PubMed

    Fleischhacker, W Wolfgang; Sanchez, Raymond; Johnson, Brian; Jin, Na; Forbes, Robert A; McQuade, Robert; Baker, Ross A; Carson, William; Kane, John M

    2013-07-01

    The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia. This long-term, pivotal study had four phases: oral conversion (phase 1, 4-6 weeks); oral stabilization (phase 2, 4-12 weeks); ARI-OM stabilization with coadministration of oral aripiprazole in the first 2 weeks (phase 3, 12-36 weeks); and a 52-week, randomized [phase 4, ARI-OM vs. placebo (2 : 1)], double-blind, maintenance phase. Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight. Patient enrollment was phase 1=633; phase 2=710, of whom 210 entered phase 2 directly; phase 3=576; and phase 4=403 (ARI-OM, n=269; placebo, n=134). Adverse events (>5%) in any phase were insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, and tremor. Headache, somnolence, and nausea had a peak first onset within 4 weeks of treatment initiation. The incidence of extrapyramidal symptoms was similar in all phases. There were no unexpected changes in weight or shifts in fasting metabolic parameters across all study phases. ARI-OM had a safety and tolerability profile comparable with oral aripiprazole in maintenance treatment of schizophrenia.

  1. Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation.

    PubMed

    Tretti Clementoni, Matteo; Galimberti, Michela; Tourlaki, Athanasia; Catenacci, Maximilian; Lavagno, Rosalia; Bencini, Pier Luca

    2013-02-01

    Although numerous papers have recently been published on ablative fractional resurfacing, there is a lack of information in literature on very long-term results. The aim of this retrospective study is to evaluate the efficacy, adverse side effects, and long-term results of a random fractional ultrapulsed CO2 laser on a large population with photodamaged facial skin. Three hundred twelve patients with facial photodamaged skin were enrolled and underwent a single full-face treatment. Six aspects of photodamaged skin were recorded using a 5 point scale at 3, 6, and 24 months after the treatment. The results were compared with a non-parametric statistical test, the Wilcoxon's exact test. Three hundred one patients completed the study. All analyzed features showed a significant statistical improvement 3 months after the procedure. Three months later all features, except for pigmentations, once again showed a significant statistical improvement. Results after 24 months were similar to those assessed 18 months before. No long-term or other serious complications were observed. From the significant number of patients analyzed, long-term results demonstrate not only how fractional ultrapulsed CO2 resurfacing can achieve good results on photodamaged facial skin but also how these results can be considered stable 2 years after the procedure.

  2. Radioembolization for Neuroendocrine Liver Metastases: Safety, Imaging, and Long-Term Outcomes

    SciTech Connect

    Memon, Khairuddin; Lewandowski, Robert J.; Mulcahy, Mary F.; Riaz, Ahsun; Ryu, Robert K.; Sato, Kent T.; Gupta, Ramona; Nikolaidis, Paul; Miller, Frank H.; Yaghmai, Vahid; Gates, Vanessa L.; Atassi, Bassel; Newman, Steven; Omary, Reed A.; Benson, Al B.; Salem, Riad

    2012-07-01

    Purpose: To present long-term outcomes on the safety and efficacy of Yttrium-90 radioembolization in the treatment of unresectable hepatic neuroendocrine metastases refractory to standard-of-care therapy. Methods and Materials: This study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Forty patients with hepatic neuroendocrine metastases were treated with {sup 90}Y radioembolization at a single center. Toxicity was assessed using National Cancer Institute Common Terminology Criteria v3.0. Response to therapy was assessed by World Health Organization (WHO) guidelines for size and European Association for the Study of the Liver disease (EASL) guidelines for necrosis. Time to response and overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed. Results: The median dose was 113 Gy (29-299 Gy). Clinical toxicities included fatigue (63%), nausea/vomiting (40%), abdominal pain (18%), fever (8%), diarrhea and weight loss (5%); Grade 3 and 4 bilirubin toxicities were experienced by 2 patients and 1 patient, respectively. Different responses were noted by WHO (complete response, 1.2%; partial response, 62.7%) and EASL (complete response, 20.5%; partial response, 43.4%). Median time to response was 4 and 4.9 months by lesion and patient, respectively. The 1-, 2-, and 3-year overall survival rates were 72.5%, 62.5%, and 45%, respectively. Eastern Cooperative Oncology Group (ECOG) performance score 0 (p < 0.0001), tumor burden {<=}25% (p = 0.0019), albumin {>=}3.5 g/dL (p = 0.017), and bilirubin {<=}1.2 mg/dL (p = 0.002) prognosticated survival on univariate analysis; only ECOG performance score 0 and bilirubin {<=}1.2 mg/dL prognosticated better survival outcome on multivariate analysis (p = 0.0001 and p = 0.02). Conclusion: Yttrium-90 therapy for hepatic neuroendocrine metastases leads to satisfactory tumor response and patient survival

  3. Model-based prediction of the acute and long-term safety profile of naproxen in rats

    PubMed Central

    Sahota, Tarjinder; Sanderson, Ian; Danhof, Meindert; Della Pasqua, Oscar

    2015-01-01

    Background and Purpose Despite the increasing importance of biomarkers as predictors of drug effects, toxicology protocols continue to rely on the experimental evidence of adverse events (AEs) as a basis for establishing the link between indicators of safety and drug exposure. Furthermore, biomarkers may facilitate the translation of findings from animals to humans. Combined with a model-based approach, biomarker data have the potential to predict long-term effects arising from prolonged drug exposure. Here, we used naproxen as a paradigm to explore the feasibility of a biomarker-guided approach for the prediction of long-term AEs in humans. Experimental Approach An experimental toxicology protocol was set up for evaluating the effects of naproxen in rats, in which four active doses were tested (7.5, 15, 40 and 80 mg·kg−1). In addition to AE monitoring and histology, a few blood samples were also collected for the assessment of drug exposure, TXB2 and PGE2 levels. Non-linear mixed effects modelling was used to analyse the data and identify covariate factors on the incidence and severity of AEs. Key Results Modelling results showed that besides drug exposure, maximum PGE2 inhibition and treatment duration were also predictors of gastrointestinal ulceration. Although PGE2 levels were clearly linked to the incidence rates, it appeared that ulceration severity is better predicted by measures of drug exposure. Conclusions and Implications These results show that the use of a model-based approach provides the opportunity to integrate pharmacokinetics, pharmacodynamics and toxicity data, enabling optimization of the design, analysis and interpretation of toxicology experiments. PMID:25884765

  4. Hydrodynamic evaluation of long term impacts of climate change and coastal effluents in the Arabian Gulf.

    PubMed

    Elhakeem, Abubaker; Elshorbagy, Walid

    2015-12-30

    A comprehensive basin wide hydrodynamic evaluation has been carried out to assess the long term impacts of climate change and coastal effluents on the salinity and seawater temperature of the Arabian Gulf (AG) using Delft3D-Flow model. The long term impacts of climate change scenarios A2 and B1 of the IPCC-AR4 on the AG hydrodynamics were evaluated. Using the current capacity and production rates of coastal desalination, power, and refinery plants, two projection scenarios until the year 2080 with 30 year intervals were developed namely the realistic and the optimistic discharge scenarios. Simulations of the individual climate change scenarios ascertained overall increase of the AG salinity and temperature and decrease of precipitation. The changes varied spatially with different scenarios as per the depth, proximity to exchange with ocean water, flushing, vertical mixing, and flow restriction. The individual tested scenarios of coastal projected discharges showed significant effects but within 10-20 km from the outfalls.

  5. Female long term survivors after allo-HSCT: evaluation and management

    PubMed Central

    Shanis, Dana; Merideth, Melissa; Pulanic, Tajana Klepac; Savani, Bipin N; Battiwalla, Minoo; Stratton, Pamela

    2011-01-01

    Female long term survivors of allogeneic hematopoietic stem cell transplantation incur a significant burden of late effects. Genital GVHD, HPV reactivation, ovarian failure and infertility, sexual dysfunction and osteoporosis are concerns that can significantly impact quality of life. This review examines the risk, pathogenesis, clinical presentation and implications of these common complications. Recommendations are provided for evaluation and management of these late effects, and other obstetric and gynecologic issues that may arise in this patient population. PMID:22221788

  6. Evaluation of the measurement uncertainty in automated long-term sampling of PCDD/PCDFs.

    PubMed

    Vicaretti, M; D'Emilia, G; Mosca, S; Guerriero, E; Rotatori, M

    2013-12-01

    Since the publication of the first version of European standard EN-1948 in 1996, long-term sampling equipment has been improved to a high standard for the sampling and analysis of polychlorodibenzo-p-dioxin (PCDD)/polychlorodibenzofuran (PCDF) emissions from industrial sources. The current automated PCDD/PCDF sampling systems enable to extend the measurement time from 6-8 h to 15-30 days in order to have data values better representative of the real pollutant emission of the plant in the long period. EN-1948:2006 is still the European technical reference standard for the determination of PCDD/PCDF from stationary source emissions. In this paper, a methodology to estimate the measurement uncertainty of long-term automated sampling is presented. The methodology has been tested on a set of high concentration sampling data resulting from a specific experience; it is proposed with the intent that it is to be applied on further similar studies and generalized. A comparison between short-term sampling data resulting from manual and automated parallel measurements has been considered also in order to verify the feasibility and usefulness of automated systems and to establish correlations between results of the two methods to use a manual method for calibration of automatic long-term one. The uncertainty components of the manual method are analyzed, following the requirements of EN-1948-3:2006, allowing to have a preliminary evaluation of the corresponding uncertainty components of the automated system. Then, a comparison between experimental data coming from parallel sampling campaigns carried out in short- and long-term sampling periods is realized. Long-term sampling is more reliable to monitor PCDD/PCDF emissions than occasional short-term sampling. Automated sampling systems can assure very useful emission data both in short and long sampling periods. Despite this, due to the different application of the long-term sampling systems, the automated results could not be

  7. Servoregulation of centrifugal pumps. A new technical approach to improve patient safety during long-term extracorporeal life support.

    PubMed

    Müller, E; Münch, K

    1996-01-01

    The objective of this study was to evaluate the principle technical requirements to servoregulate a centrifugal pump (Bio-Pump) and to discuss the potential risks and benefits of the potential use of such a device during long-term extra-corporeal support in an experimental laboratory study. A pressure control module (PCM) for the Bio-Pump was developed and a pressure measurement chamber to indirectly measure pressure in the venous limb of an extracorporeal circuit was constructed. The performance of the PCM combined with the pressure measurement chamber was evaluated in an experimental test circuit by recording pressure changes after sudden clamping of the venous line with and without servoregulation. Without the PCM pressure dropped from baseline to approximately -200 mm Hg after clamping and remained at that level. With the PCM active the pump speed was automatically and immediately reduced and the preclamping pressure level (+/- 10 percent) was restored within 500 msec. In this laboratory setting the Bio-Pump could effectively and rapidly be servoregulated with a conventional controller and an indirect pressure monitoring system. A potential clinical use of this system could help to improve the safety without imposing additional risks such as air embolism or backflow.

  8. Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

    PubMed Central

    Lemoine, Patrick; Garfinkel, Doron; Laudon, Moshe; Nir, Tali; Zisapel, Nava

    2011-01-01

    Background Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation. Objective To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment. Methods Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary), adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]). Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM. Results Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as “good” or “very good” was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production. Conclusion Results support the efficacy and safety of PRM in primary insomnia patients aged 20–80 throughout 6–12 months of continuous therapy. PRM discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production. PMID:21845053

  9. Evaluation of Long-Term Migration Testing from Can Coatings into Food Simulants: Polyester Coatings.

    PubMed

    Paseiro-Cerrato, Rafael; Noonan, Gregory O; Begley, Timothy H

    2016-03-23

    FDA guidance for food contact substances recommends that for food packaging intended for use at sterilized, high temperature processed, or retorted conditions, a migration test with a retort step at 121 °C for 2 h followed by a 10 day migration test at 40 °C should be performed. These conditions are in intended to simulate processing and long-term storage. However, can coatings may be in contact with food for years, and there are very few data evaluating if this short-term testing accurately simulates migration over extended time periods. A long-term migration test at 40 °C with retorted and non-retorted polyester cans using several food simulants (water, 3% acetic acid, 10% ethanol, 50% ethanol, and isooctane) was conducted to verify whether traditional migration testing protocols accurately predict migration from food contact materials used for extended time periods. Time points were from 1 day to 515 days. HPLC-MS/MS was used to analyze polyester monomers, and oligomer migration was monitored using HPLC-DAD/CAD and HPLC-MS. Concentrations of monomers and oligomers increased during the migration experiments, especially in ethanol food simulants. The data suggest that current FDA migration protocols may need to be modified to address changes in migrants as a result of long-term storage conditions.

  10. Evaluation of a Baccalaureate External Degree Program in Health Services Administration with a Major in Long Term Care Administration.

    ERIC Educational Resources Information Center

    Kleppick, Annabelle L.; And Others

    The development and evaluation of a nontraditional program with a major in Long Term Care Administration is presented. Part 1 presents an evaluation of the impact of the program on students, faculty, the curricula for long term care administration, and in the field of practice. Student characteristics are established and the performance of the…

  11. Evaluation of a seven state criminal history screening pilot program for long-term care workers.

    PubMed

    Radcliff, Tiffany A; White, Alan; West, David R; Hurd, Donna; Côté, Murray J

    2013-01-01

    This article summarizes results from an evaluation of a federally sponsored criminal history screening (CHS) pilot program to improve screening for workers in long-term care settings. The evaluation addressed eight key issues specified through enabling legislation, including efficiency, costs, and outcomes of screening procedures. Of the 204,339 completed screenings, 3.7% were disqualified due to criminal history, and 18.8% were withdrawn prior to completion for reasons that may include relevant criminal history. Lessons learned from the pilot program experiences may inform a new national background check demonstration program.

  12. Long-term safety of antiresorptive treatment: bone material, matrix and mineralization aspects

    PubMed Central

    Misof, Barbara M; Fratzl-Zelman, Nadja; Paschalis, Eleftherios P; Roschger, Paul; Klaushofer, Klaus

    2015-01-01

    It is well established that long-term antiresorptive use is effective in the reduction of fracture risk in high bone turnover osteoporosis. Nevertheless, during recent years, concerns emerged that longer bone turnover reduction might favor the occurrence of fatigue fractures. However, the underlying mechanisms for both beneficial and suspected adverse effects are not fully understood yet. There is some evidence that their effects on the bone material characteristics have an important role. In principle, the composition and nanostructure of bone material, for example, collagen cross-links and mineral content and crystallinity, is highly dependent on tissue age. Bone turnover determines the age distribution of the bone structural units (BSUs) present in bone, which in turn is decisive for its intrinsic material properties. It is noteworthy that the effects of bone turnover reduction on bone material were observed to be dependent on the duration of the antiresorptive therapy. During the first 2–3 years, significant decreases in the heterogeneity of material properties such as mineralization of the BSUs have been observed. In the long term (5–10 years), the mineralization pattern reverts towards normal heterogeneity and degree of mineralization, with no signs of hypermineralization in the bone matrix. Nevertheless, it has been hypothesized that the occurrence of fatigue fractures (such as atypical femoral fractures) might be linked to a reduced ability of microdamage repair under antiresorptive therapy. The present article examines results from clinical studies after antiresorptive, in particular long-term, therapy with the aforementioned potentially positive or negative effects on bone material. PMID:25709811

  13. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients

    PubMed Central

    Son, Seung Yeon; Jang, Hye Ryoun; Lee, Jung Eun; Yoo, Heejin; Kim, Kyunga; Park, Jae Berm; Kim, Sung Joo; Oh, Ha Young; Huh, Wooseong

    2017-01-01

    This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR]<1.2) for TCB compared to PGF (HR: 0.58; 95% CI: 0–1.14). The 5-year patient survival rate was 96% for patients in the PGF group and 97% for patients in the TCB group. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval limit of the HR<2.0) for TCB compared to PGF (HR: 0.83; 95% CI: 0–1.95). The 5-year acute rejection-free graft survival rate was not significantly different between the groups (TCB 67%, PGF 68.8%; P=0.6286). The incidence of adverse events including adverse cardiovascular or cerebrovascular events, malignancies, new-onset diabetes after transplantation, and infection events did not differ significantly between the two groups. We conclude that TCB is a comparable alternative to the original tacrolimus as a first-line immunosuppressive drug. Producers of generics should support further study of their products after approval to assure physicians of their efficacy and safety. PMID:28138224

  14. Long-term cardiac safety and tolerability of fingolimod in multiple sclerosis: A postmarketing study.

    PubMed

    Paolicelli, Damiano; Manni, Alessia; Direnzo, Vita; D'Onghia, Mariangela; Tortorella, Carla; Zoccolella, Stefano; Trojano, Maria

    2015-10-01

    Fingolimod is the first oral disease-modifying therapy approved for multiple sclerosis (MS). The risks associated with the use of fingolimod include cardiovascular adverse events (AEs). First-dose observation (FDO) is required for all patients for at least 6 hours. We describe FDO data and long-term cardiac tolerability in a cohort of fingolimod-treated relapsing MS patients. Two hundred and twelve patients started fingolimod 0.5 mg once daily. Before the first administration, all subjects had an electrocardiogram (ECG) with cardiologist interpretation. Following administration they were monitored for 6 hours and underwent a cardiac monitoring every 3 months. In this cohort, there was a heart rate reduction at the VI hour of 9.6 ± 8 beats per minute (P < .001). Fifty-four individuals (25.5%) presented an abnormal ECG during the 6 hours. We experienced 1 case (0.22%) of symptomatic second-degree atrioventricular block. The mean follow-up period was 1.5 ± 0.7 years. During this period, 1 patient showed atrial fibrillation that needed to be treated. We also observed 5 cases of persistent increase in blood pressure. This postmarketing study shows that fingolimod is well tolerated and tha tcardiologic AEs are generally self-limited in the long term.

  15. Long-Term Benefits of Prompts to Use Safety Belts among Drivers Exiting Senior Communities

    ERIC Educational Resources Information Center

    Cox, Cory D.; Cox, Brian S.; Cox, Daniel J.

    2005-01-01

    Senior drivers are vulnerable to automobile crashes and subsequent injury and death. Safety belts reduce health risks associated with auto crashes. Therefore, it is important to encourage senior drivers to wear safety belts while driving. Using a repeated baseline design (AAB), we previously reported that motivating signs boosted safety belt usage…

  16. Polysomnographic and long-term video electroencephalographic evaluation of cases presenting with parasomnias.

    PubMed

    Yiş, Uluç; Kurul, Semra Hiz; Öztura, Ibrahim; Ecevit, Mustafa Cenk; Dirik, Eray

    2013-09-01

    The aim of this study is to evaluate the clinical, electroencephalographic and polysomnographic features of patients presenting with parasomnias. Cases who were admitted for differentiating parasomnias from epilepsy were included in the study. Clinical features of cases were recorded and routine sleep electroencephalography was obtained from all cases. Cases whose symptoms strongly suggested nocturnal seizure underwent all night video electroencephalography monitoring. Polysomnography was obtained to evaluate the quality of breathing from patients whose symptoms suggested obstructive sleep apnea. Twenty-three patients with no neurological disorder were included in the study. The mean age of the patients was 11.7 ± 2.8 [7-17] years. Twelve patients (52 %) presented with sleep terrors and 11 patients (48 %) presented with sleep walking. All of the patients underwent a routine sleep electroencephalographic study and 15 patients (65 %) whose symptoms strongly suggested nocturnal epilepsy underwent long-term video electroencephalographic evaluation. Ten patients (43 %) underwent polysomnographic study. Three patients (20 %) who underwent long-term video electroencephalographic evaluation were diagnosed to have nocturnal frontal lobe epilepsy and two patients (20 %) who underwent polysomnography had pathological sleep apnea. Eleven patients (48 %) had a psychiatric disorder like major depression, anxiety disorder, hyperactivity disorder and obsessive-compulsive disorder. Childhood cases presenting with parasomnias should be searched for nocturnal epileptic disorders, sleep disordered breathing and psychiatric disorders.

  17. New tools for detecting latent tuberculosis infection: evaluation of RD1-specific long-term response

    PubMed Central

    2009-01-01

    Background Interferon-gamma (IFN-γ) release assays (IGRAs) were designed to detect latent tuberculosis infection (LTBI). However, discrepancies were found between the tuberculin skin test (TST) and IGRAs results that cannot be attributed to prior Bacille Calmètte Guerin vaccinations. The aim of this study was to evaluate tools for improving LTBI diagnosis by analyzing the IFN-γ response to RD1 proteins in prolonged (long-term response) whole blood tests in those subjects resulting negative to assays such as QuantiFERON-TB Gold In tube (QFT-IT). Methods The study population included 106 healthy TST+ individuals with suspected LTBI (recent contact of smear-positive TB and homeless) consecutively enrolled. As controls, 13 healthy subjects unexposed to M. tuberculosis (TST-, QFT-IT-) and 29 subjects with cured pulmonary TB were enrolled. IFN-γ whole blood response to RD1 proteins and QFT-IT were evaluated at day 1 post-culture. A prolonged test evaluating long-term IFN-γ response (7-day) to RD1 proteins in diluted whole blood was performed. Results Among the enrolled TST+ subjects with suspected LTBI, 70/106 (66.0%) responded to QFT-IT and 64/106 (60.3%) to RD1 proteins at day 1. To evaluate whether a prolonged test could improve the detection of LTBI, we set up the test using cured TB patients (with a microbiologically diagnosed past pulmonary disease) who resulted QFT-IT-negative and healthy controls as comparator groups. Using this assay, a statistically significant difference was found between IFN-γ levels in cured TB patients compared to healthy controls (p < 0.006). Based on these data, we constructed a receiver operating characteristic (ROC) curve and we calculated a cut-off. Based on the cut-off value, we found that among the 36 enrolled TST+ subjects with suspected LTBI not responding to QFT-IT, a long term response to RD1 proteins was detected in 11 subjects (30.6%). Conclusion These results indicate that IFN-γ long-term response to M. tuberculosis RD1

  18. Long-term efficacy and safety of exemestane in the treatment of breast cancer

    PubMed Central

    Walker, GA; Xenophontos, M; Chen, LC; Cheung, KL

    2013-01-01

    Exemestane, a steroidal aromatase inhibitor, is licensed for postmenopausal patients with estrogen receptor (ER)-positive breast cancer as second-line therapy in metastatic disease following antiestrogen failure and as part of sequential adjuvant therapy following initial tamoxifen. This study is a systematic literature review, evaluating exemestane in different clinical settings. The Ovid Medline (1948–2012), Embase (1980–2012), and Web of Science (1899–2012) databases were searched. Forty-two relevant articles covering randomized controlled trials were reviewed for efficacy and safety, and three for adherence. With regard to efficacy in metastatic disease, exemestane is superior to megestrol acetate after progression on tamoxifen. There is evidence for noninferiority to fulvestrant (following a prior aromatase inhibitor) and to nonsteroidal aromatase inhibitors in the first-line setting. Combined use with everolimus is shown to be more efficacious than exemestane alone following previous aromatase inhibitor use. In the adjuvant setting, a switch to exemestane after 2–3 years of tamoxifen is superior to 5 years of tamoxifen. Exemestane is noninferior to 5 years of tamoxifen as upfront therapy, and may have a role as an extended adjuvant therapy. Used as neoadjuvant therapy, increased breast conservation is achievable. As chemoprevention, exemestane significantly reduces the incidence of breast cancer in “at-risk” postmenopausal women. Exemestane is associated with myalgias and arthralgias, as well as reduced bone mineral density and increased risk of fracture, which do not appear to persist at follow-up, with subsequent return to pretreatment values. Compared with tamoxifen, there is a reduced incidence of endometrial changes, thromboembolic events, and hot flashes. Limited evidence shows nonadherence in 23%–32% of patients. Evidence is growing in support of exemestane in all clinical settings. It is generally more efficacious and has a better safety

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

    PubMed

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

    2016-11-17

    Sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor-neprilysin inhibitor, demonstrated significant reductions in office and 24 h ambulatory blood pressure (BP) over 8 weeks in Asian patients with hypertension. This 52-week extension to the 8-week core study was aimed at evaluating the long-term safety, tolerability and efficacy of sacubitril/valsartan. Patients who completed an 8-week randomized study (the core study) were enrolled in this 52-week open-label study and received sacubitril/valsartan 200 mg QD. The sacubitril/valsartan dose was uptitrated to 400 mg QD if BP was uncontrolled (>140/90 mm Hg) after 4 weeks. Subsequently, in patients with uncontrolled BP, treatment was intensified every 4 weeks with amlodipine 5-10 mg followed by hydrochlorothiazide 6.25-25 mg. Of the 341 patients enrolled, 7 (2.1%) discontinued the study drug due to adverse events (AEs). The incidence of AEs and serious AEs were 63.9 and 3.8%, respectively, and no deaths were reported in this study. The most frequent AEs were nasopharyngitis (18.2%) and dizziness (8.8%). Events that were potentially indicative of low BP were infrequent. One patient reported mild transient angioedema (lasting 2.5 h) that resolved without treatment but led to study drug discontinuation. The sacubitril/valsartan-based regimen provided clinically significant mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) reductions from baseline (-24.7/-16.2 mm Hg). The overall BP control, msSBP and msDBP response rates were 75.3, 90.6 and 87.6%, respectively. Long-term use of sacubitril/valsartan was generally safe and well-tolerated in patients with hypertension and provided significant BP reductions from baseline.Hypertension Research advance online publication, 17 November 2016; doi:10.1038/hr.2016.151.

  20. Long-term effectiveness and safety of interleukin-1 receptor antagonist (anakinra) in Schnitzler's syndrome: a French multicenter study.

    PubMed

    Néel, Antoine; Henry, Benoit; Barbarot, Sebastien; Masseau, Agathe; Perrin, François; Bernier, Claire; Kyndt, Xavier; Puechal, Xavier; Weiller, Pierre-Jean; Decaux, Olivier; Ninet, Jacques; Hot, Arnaud; Aouba, Achille; Astudillo, Leonardo; Berthelot, Jean-Marie; Bonnet, Fabrice; Brisseau, Jean-Marie; Cador, Bérangère; Closs-Prophette, Fabienne; Dejoie, Thomas; de Korwin, Jean-Dominique; Dhote, Robin; Fior, Renato; Grosbois, Bernard; Hachulla, Eric; Hatron, Pierre-Yves; Jardel, Henry; Launay, David; Lorleac'h, Adrien; Pottier, Pierre; Moulis, Guillaume; Serratrice, Jacques; Smail, Amar; Hamidou, Mohamed

    2014-10-01

    The aim of this study is to assess the long-term effectiveness and safety of IL1Ra in Schnitzler syndrome (SchS). Between 2010 and 2012, we performed a nationwide survey among French internal medicine departments to identify SchS patients. We retrospectively analyzed the long-term efficacy and safety of IL1Ra and the outcome of patients that did not receive this treatment. Forty-two patients were included in the study, 29 of whom received IL1Ra. The mean age at disease onset was 59.9years. Disease manifestations included urticaria (100%), fever (76%), bone/joint pain (86%), bone lesions (76%), anemia (67%), and weight loss (60%). The monoclonal gammopathy was overwhelmingly IgM kappa (83%). The mean follow-up was 9.5years (range: 1.6-35). Two patients developed Waldenström's macroglobulinemia and one developed AA amyloidosis. All of the 29 patients who received IL1Ra responded dramatically. After a median follow-up of 36months (range: 2-79), the effectiveness remained unchanged. All patients remained on anti-IL-1 therapy. Twenty-four patients (83%) went into complete remission and five (17%) into partial remission. Three patients experienced grade 3-4 neutropenia. Six patients developed severe infections. No lymphoproliferative diseases occurred while on IL1Ra. When last seen, all patients without anakinra had an active disease with variable impact on their quality of life. Their median corticosteroids dosage was 6mg/d (range: 5-25). IL1Ra is effective in SchS, with a sharp corticosteroid-sparing effect. Treatment failures should lead to reconsider the diagnosis. Long-term follow-up revealed no loss of effectiveness and a favorable tolerance profile. The long-term effects on the risk of hemopathy remain unknown.

  1. Evaluation of different validation strategies and long term effects in NIR calibration models.

    PubMed

    Sileoni, Valeria; Marconi, Ombretta; Perretti, Giuseppe; Fantozzi, Paolo

    2013-12-01

    Stable and reliable NIR calibration models for the barley malt quality assessment were developed and exhaustively evaluated. The measured parameters are: fine extract, fermentability, pH, soluble nitrogen, viscosity, friability and free-amino nitrogen. The reliability of the developed calibration models was evaluated comparing the classic leave-one-out internal validation with a more challenging one exploiting re-sampling scheme. The long-term effects, intended as possible alterations of the NIR method predictive power, due to the variation between samples collected in different years, were evaluated through an external validation which demonstrated the stability of the developed calibration models. Finally, the accuracy and the precision of the developed calibration models were evaluated in comparison with the reference methods. This exhaustive evaluation offers a realistic idea of the developed NIR methods predictive power for future unknown samples and their application in the beer industry.

  2. Detecting long-term growth trends using tree rings: a critical evaluation of methods.

    PubMed

    Peters, Richard L; Groenendijk, Peter; Vlam, Mart; Zuidema, Pieter A

    2015-05-01

    Tree-ring analysis is often used to assess long-term trends in tree growth. A variety of growth-trend detection methods (GDMs) exist to disentangle age/size trends in growth from long-term growth changes. However, these detrending methods strongly differ in approach, with possible implications for their output. Here, we critically evaluate the consistency, sensitivity, reliability and accuracy of four most widely used GDMs: conservative detrending (CD) applies mathematical functions to correct for decreasing ring widths with age; basal area correction (BAC) transforms diameter into basal area growth; regional curve standardization (RCS) detrends individual tree-ring series using average age/size trends; and size class isolation (SCI) calculates growth trends within separate size classes. First, we evaluated whether these GDMs produce consistent results applied to an empirical tree-ring data set of Melia azedarach, a tropical tree species from Thailand. Three GDMs yielded similar results - a growth decline over time - but the widely used CD method did not detect any change. Second, we assessed the sensitivity (probability of correct growth-trend detection), reliability (100% minus probability of detecting false trends) and accuracy (whether the strength of imposed trends is correctly detected) of these GDMs, by applying them to simulated growth trajectories with different imposed trends: no trend, strong trends (-6% and +6% change per decade) and weak trends (-2%, +2%). All methods except CD, showed high sensitivity, reliability and accuracy to detect strong imposed trends. However, these were considerably lower in the weak or no-trend scenarios. BAC showed good sensitivity and accuracy, but low reliability, indicating uncertainty of trend detection using this method. Our study reveals that the choice of GDM influences results of growth-trend studies. We recommend applying multiple methods when analysing trends and encourage performing sensitivity and reliability

  3. Long-term evaluation of a liquid crystal polymer (LCP)-based retinal prosthesis

    NASA Astrophysics Data System (ADS)

    Jeong, Joonsoo; Bae, So Hyun; Seo, Jong-Mo; Chung, Hum; Kim, Sung June

    2016-04-01

    Objective. The aim of this study is to evaluate the long-term reliability of a recently presented liquid crystal polymer (LCP) -based retinal prosthesis in vitro as well as in vivo. Because an all-polymer implant introduces another intrinsic leak type due to gas permeation, for which the traditional helium leak test for metallic packages was not designed to quantify, a new method to investigate its durability is required. Approach. We designed and carried out a series of reliability tests specifically for all-polymer implants by quantitatively investigating moisture ingress through various pathways of the polymer surface, and the polymer-polymer and polymer-metal adhesions. Moisture permeation through the bulk material was estimated by analytic calculation, while water ingress through the adhesively sealed LCP-LCP and LCP-metal interfaces was investigated using the separate parts of an electrode array and a package in an accelerated aging condition. In vivo tests were done in rabbits to examine the long-term biocompatibility and implantation stability by fundus observation and optical coherence tomography (OCT) imaging. Main results. The analytic calculation estimated good barrier properties of the LCP. Samples of the LCP-based electrode array failed after 114 days in 87 °C saline as a result of water penetration through the LCP-metal interface. An eye-conformable LCP package survived for 87 days in an accelerated condition at 87 °C. The in vivo results confirmed that no adverse effects were observed around the retina 2.5 years after the implantation of the device. Significance. These long-term evaluation results show the potential for the chronic use of LCP-based biomedical implants to provide an alternative to traditional metallic packages.

  4. Long Term Stability Evaluation of Prostacyclin Released from Biomedical Device Through Turbiscan Lab Expert

    PubMed Central

    Celia, Christian; Locatelli, Marcello; Cilurzo, Felisa; Cosco, Donato; Gentile, Emanuela; Scalise, Daniela; Carafa, Maria; Ventura, Cinzia Anna; Fleury, Mathias; Tisserand, Christelle; Barbacane, Renato C.; Fresta, Massimo; Marzio, Luisa Di; Paolino, Donatella

    2015-01-01

    Therapeutic guidelines indicate prostacyclin as the first line of treatment in inflammation and vascular diseases. Prostacyclins prevent formation of the platelet plug involved in primary hemostasis by inhibiting platelet activation and, combined with thromboxane, are effective vasodilators in vascular damage. Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II guidelines indicates prostacyclins; in particular, Iloprost, as the first therapeutic option for treating peripheral arterial disease. However, therapeutic efficacy of Iloprost has witnessed several drawbacks that have occurred in patients receiving repeated weekly administration of the drug by intravenous infusions. Adverse reactions arose under perfusion with Iloprost for 6 h and patient compliance was drastically decreased. Biomedical devices could provide a suitable alternative to overcome these drawbacks. In particular, elastomeric pumps, filled with Iloprost isotonic solution, could slowly release the drug, thus decreasing its side effects, representing a valid alternative to hospitalization of patients affected by peripheral arterial disease. However, the home therapy treatment of patients requires long-term stability of Iloprost in solution-loaded elastomeric pumps. The aim of this work was to investigate the long-term stability of Iloprost isotonic solution in biomedical devices using Turbiscan technology. Turbiscan Lab Expert (L’Union, France) predicts the long-term stability of suspensions, emulsions and colloidal formulations by measuring backscattering and transmission of particulates dispersed in solution. The formulations were evaluated by measuring the variation of physical-chemical properties of colloids and suspensions as a function of backscattering and transmission modifications. In addition, the release profile of Iloprost isotonic solution from the biomedical device was evaluated. PMID:25381994

  5. Long-term safety of polypropylene knots under scleral flaps for transsclerally sutured posterior chamber lenses.

    PubMed Central

    Van Meter, W S

    1997-01-01

    PURPOSE: To evaluate the safety of polypropylene knots used in TS-SPCL combined with PK and AV over time. METHOD: A retrospective review of 26 consecutive cases of TS-SPCL by one surgeon (WSVM) with at least 12 months follow-up (mean 26, range 12-62). All patients had a double strand polypropylene knot buried under partial thickness scleral flaps at 2 and 8 o'clock. Knots were rotated into the globe (R) in 10 cases, and could not be buried (N) in 13 cases, and in 3 cases 1 knot was buried. RESULTS: No cases of suture erosion occurred in R or N. One or more polypropylene sutures were visible in 17 patients (8 R, 9 T) at last exam. Twenty-three of 52 knots were rotated into the globe, and 70% of rotated knots were not even visible at the slit lamp at final visit. There was no evidence of conjunctival erosion in any patient. There was no lens dislocation and no endophthalmitis. CONCLUSION: The combination of partial thickness scleral flaps with double strand polypropylene knots reduces the incidence of suture erosion through the conjunctive if knots cannot be rotated into the globe. Images FIGURE 1 FIGURE 2 FIGURE 3 PMID:9440177

  6. Safety and long term efficacy of porfimer sodium photodynamic therapy in locally advanced biliary tract carcinoma

    PubMed Central

    Pereira, Stephen P; Aithal, Guruprasad P; Ragunath, Krish; Devlin, John; Owen, Faye; Meadows, Helen

    2012-01-01

    Background In patients with unresectable cholangiocarcinoma, photodynamic therapy (PDT) with porfimer sodium promotes biliary drainage and may improve survival and quality of life. Aim To prospectively evaluate the safety and efficacy of PDT in patients with locally advanced biliary tract carcinoma. Methods Eligible patients had unresectable, histologically confirmed disease, a Karnofsky performance status of ≥30% and life expectancy >12 weeks. Patients received 2mg/kg i.v. of porfimer sodium, followed by endobiliary laser activation and stent replacement 48 hrs later. Patients were assessed clinically and radiologically before treatment and on day 28, and followed up thereafter at three-monthly intervals until death. Results 36 patients were entered over an 18 months period: 14 males, 22 females, with a median age of 65 (30-79) yr and performance status of 80 (50-100). PDT was technically successful in all cases and was generally well tolerated; there was no grade 4 toxicity and no treatment-associated mortality. The median survival was 12 (1-84) months. Conclusions Porfimer sodium PDT can be delivered safely to patients with biliary tract cancer and is suitable for testing in phase III studies (UKCRN ID 1218). PMID:23200007

  7. A long-term evaluation of biopsy darts and DNA to estimate cougar density

    USGS Publications Warehouse

    Beausoleil, Richard A.; Clark, Joseph D.; Maletzke, Benjamin T.

    2016-01-01

    Accurately estimating cougar (Puma concolor) density is usually based on long-term research consisting of intensive capture and Global Positioning System collaring efforts and may cost hundreds of thousands of dollars annually. Because wildlife agency budgets rarely accommodate this approach, most infer cougar density from published literature, rely on short-term studies, or use hunter harvest data as a surrogate in their jurisdictions; all of which may limit accuracy and increase risk of management actions. In an effort to develop a more cost-effective long-term strategy, we evaluated a research approach using citizen scientists with trained hounds to tree cougars and collect tissue samples with biopsy darts. We then used the DNA to individually identify cougars and employed spatially explicit capture–recapture models to estimate cougar densities. Overall, 240 tissue samples were collected in northeastern Washington, USA, producing 166 genotypes (including recaptures and excluding dependent kittens) of 133 different cougars (8-25/yr) from 2003 to 2011. Mark–recapture analyses revealed a mean density of 2.2 cougars/100 km2 (95% CI=1.1-4.3) and stable to decreasing population trends (β=-0.048, 95% CI=-0.106–0.011) over the 9 years of study, with an average annual harvest rate of 14% (range=7-21%). The average annual cost per year for field sampling and genotyping was US$11,265 ($422.24/sample or $610.73/successfully genotyped sample). Our results demonstrated that long-term biopsy sampling using citizen scientists can increase capture success and provide reliable cougar-density information at a reasonable cost.

  8. Long-term evaluation of donor site morbidity after free fibula transfer.

    PubMed

    Sieg, Peter; Taner, Ceylan; Hakim, Samer George; Jacobsen, Hans-Christian

    2010-06-01

    Our aim was to evaluate the long-term morbidity at the donor site after harvest of free fibular flaps. From a total of 165 patients, we were able to examine (not randomly) 62 donor regions in 57 patients (33 men and 24 women) 2-167 months (mean 45 months) after fibular transfer. Patients' individual risk factors and any disturbances of healing, and dysfunction of the toes, were recorded. The Kitaoka ankle-hindfoot score was used for evaluation of functional impairment. Thirteen donor regions displayed prolonged wound healing, eight of which needed revision of the wounds. Eight (14%) had abnormalities of gait. The median Kitaoka ankle-hindfoot score was 93 (range: 14-100). In 17 patients (27%) after a follow-up period of 4 months, hammer and claw toes and deficits in dorsal extension of the hallux were assessed. Thirty patients (48%) had sensory deficits of the calf and toes. Neither the risk factors recorded nor the factors that indicated disturbance of wound healing or deformities of the toe were significantly associated with the development of functional impairment. In more than three-quarters of the cases healing was uneventful, but in a small number the morbidity at the donor site was severe, forcing the patient to use walking aids. We were not able to identify any risk factors for the development of long-term malfunction.

  9. Evaluation of Rifapentine in Long-Term Treatment Regimens for Tuberculosis in Mice

    PubMed Central

    Lenaerts, Anne M. J. A.; Chase, Sharon E.; Chmielewski, Alex J.; Cynamon, Michael H.

    1999-01-01

    Besides direct bactericidal activity, long-term effectiveness is one of the most important features to consider when developing new drugs for chemotherapy. In this study, we evaluated the ability of rifapentine (RFP), in monotherapy and combination therapy, to completely eradicate a Mycobacterium tuberculosis infection and to prevent relapse posttreatment in a Swiss mouse model. The combination of RFP, isoniazid (INH), and pyrazinamide (PZA) administered daily resulted in an apparent clearance of M. tuberculosis organisms in the lungs and spleens of infected mice after 10 weeks of treatment. However, 3 months after the cessation of therapy, bacterial regrowth occurred in mice treated for a 12-week period, indicating a relapse of infection. In intermittent treatment regimens of RFP in combination with INH and PZA, sterilization was achieved when mice were treated two to five times per week for 9 weeks. Bacterial growth was still observed in the once-weekly treatment group. Our results show that mouse models can predict important parameters for new drugs. We stress the necessity for long-term posttreatment observation in animal models for the routine evaluation of new drugs for antituberculosis chemotherapy. PMID:10508006

  10. Automated analysis of phantom images for the evaluation of long-term reproducibility in digital mammography

    NASA Astrophysics Data System (ADS)

    Gennaro, G.; Ferro, F.; Contento, G.; Fornasin, F.; di Maggio, C.

    2007-03-01

    The performance of an automatic software package was evaluated with phantom images acquired by a full-field digital mammography unit. After the validation, the software was used, together with a Leeds TORMAS test object, to model the image acquisition process. Process modelling results were used to evaluate the sensitivity of the method in detecting changes of exposure parameters from routine image quality measurements in digital mammography, which is the ultimate purpose of long-term reproducibility tests. Image quality indices measured by the software included the mean pixel value and standard deviation of circular details and surrounding background, contrast-to-noise ratio and relative contrast; detail counts were also collected. The validation procedure demonstrated that the software localizes the phantom details correctly and the difference between automatic and manual measurements was within few grey levels. Quantitative analysis showed sufficient sensitivity to relate fluctuations in exposure parameters (kVp or mAs) to variations in image quality indices. In comparison, detail counts were found less sensitive in detecting image quality changes, even when limitations due to observer subjectivity were overcome by automatic analysis. In conclusion, long-term reproducibility tests provided by the Leeds TORMAS phantom with quantitative analysis of multiple IQ indices have been demonstrated to be effective in predicting causes of deviation from standard operating conditions and can be used to monitor stability in full-field digital mammography.

  11. Evaluation of effects of long term exposure on lethal toxicity with mammals.

    PubMed

    Verma, Vibha; Yu, Qiming J; Connell, Des W

    2014-02-01

    The relationship between exposure time (LT50) and lethal exposure concentration (LC50) has been evaluated over relatively long exposure times using a novel parameter, Normal Life Expectancy (NLT), as a long term toxicity point. The model equation, ln(LT50) = aLC50(ν) + b, where a, b and ν are constants, was evaluated by plotting lnLT50 against LC50 using available toxicity data based on inhalation exposure from 7 species of mammals. With each specific toxicant a single consistent relationship was observed for all mammals with ν always <1. Use of NLT as a long term toxicity point provided a valuable limiting point for long exposure times. With organic compounds, the Kow can be used to calculate the model constants a and v where these are unknown. The model can be used to characterise toxicity to specific mammals and then be extended to estimate toxicity at any exposure time with other mammals.

  12. Long-term effects of St. John's wort (Hypericum perforatum) treatment: a 1-year safety study in mild to moderate depression.

    PubMed

    Brattström, Axel

    2009-04-01

    Long-term safety and the effects of a St. John's wort (SJW) extract Ze 117 (Hypericum perforatum) were evaluated in the treatment of patients with depression. An open multicentre safety study with 440 out-patients suffering from mild to moderate depression according to ICD-10 was conducted. Patients were treated for up to 1 year with 500 mg St. John's wort extract per day (Ze 117). Evaluation criteria were safety (adverse event frequency) and influence on depression (HAM-D, CGI). Two hundred and seventeen (49%) patients reported 504 adverse events, 30 (6%) of which were possibly or probably related to the treatment. Gastrointestinal and skin complaints were the most common events associated with treatment. No age-related difference in the safety of the applied medication was found. The long-term intake of up to 1 year of the study medication did not result in any changes in clinical chemistry and electrocardiogram recordings. Body mass index (BMI) did not change either. Mean HAM-D scores decreased steadily from 20.58 at baseline to 12.07 at week 26 and to 11.18 at week 52. Mean CGI scores decreased from 3.99 to 2.20 at week 26 and 2.19 at week 52. Therefore, St. John's wort extract ZE 117 is a safe and effective way to treat mild to moderate depression over long periods of time, and therefore seems especially suitable for a relapse prevention.

  13. Sustainable development and next generation's health: a long-term perspective about the consequences of today's activities for food safety.

    PubMed

    Frazzoli, Chiara; Petrini, Carlo; Mantovani, Alberto

    2009-01-01

    Development is defined sustainable when it meets the needs of the present without compromising the ability of future generations to meet their own needs. Pivoting on social, environmental and economic aspects of food chain sustainability, this paper presents the concept of sustainable food safety based on the prevention of risks and burden of poor health for generations to come. Under this respect, the assessment of long-term, transgenerational risks is still hampered by serious scientific uncertainties. Critical issues to the development of a sustainable food safety framework may include: endocrine disrupters as emerging contaminants that specifically target developing organisms; toxicological risks assessment in Countries at the turning point of development; translating knowledge into toxicity indexes to support risk management approaches, such as hazard analysis and critical control points (HACCP); the interplay between chemical hazards and social determinants. Efforts towards the comprehensive knowledge and management of key factors of sustainable food safety appear critical to the effectiveness of the overall sustainability policies.

  14. Evaluation of the long-term efficacy and safety of an imidacloprid 10%/flumethrin 4.5% polymer matrix collar (Seresto®) in dogs and cats naturally infested with fleas and/or ticks in multicentre clinical field studies in Europe

    PubMed Central

    2012-01-01

    Background The objective of these two GCP multicentre European clinical field studies was to evaluate the long-term efficacy and safety of a new imidacloprid/flumethrin collar (Seresto®, Bayer AnimalHealth, Investigational Veterinary Product(IVP)) in dogs and cats naturally infested with fleas and/or ticks in comparison to a dimpylat collar ("Ungezieferband fuer Hunde/fuer Katzen", Beaphar, Control Product (CP)). Methods 232 (IVP) and 81 (CP) cats and 271(IVP) and 129 (CP) dogs were treated with either product according to label claims and formed the safety population. Flea and tick counts were conducted in monthly intervals for up to 8 months in the efficacy subpopulation consisting of 118 (IVP) + 47 (CP) cats and 197 (IVP) + 94 (CP) dogs. Efficacy was calculated as reduction of infestation rate within the same treatment group and statistically compared between the two treatment groups. Results Preventive efficacy against fleas in cats/dogs varied in the IVP group between 97.4%/94.1% and 100%/100% (overall mean: 98.3%/96.7%) throughout the 8 month period and in the CP group between 57.1%/28.2% and 96.1%/67.8% (overall mean: 79.3%/57.9%). Preventive efficacy against ticks in cats/dogs varied in the IVP group between 94.0%/91.2% and 100%/100% (overall mean: 98.4%/94.7%) throughout the 8 month period and in the CP group between 90.7%/79.9% and 100%/88.0% (overall mean: 96.9%/85.6%). The IVP group was statistically non-inferior to the CP group, and on various assessment days, statistical superiority was proven for flea and tick count reduction in dogs and cats. Both treatments proved to be safe in dogs and cats with mainly minor local observations at the application site. There was moreover, no incidence of any mechanical problem with the collar in dogs and cats during the entire study period. Conclusions The imidacloprid/flumethrin collar proved to reduce tick counts by at least 90% and flea counts by at least 95% for a period of at least 7-8 months in cats and dogs

  15. Long-term safety and analgesic efficacy of buprenorphine buccal film in patients with moderate-to-severe chronic pain requiring around-the-clock opioids

    PubMed Central

    Hale, Martin; Urdaneta, Veronica; Kirby, M Todd; Xiang, Qinfang; Rauck, Richard

    2017-01-01

    Background This open-label, single-arm study was conducted to evaluate the long-term safety and efficacy of a novel buprenorphine formulation, buprenorphine buccal film, in the treatment of moderate-to-severe chronic pain requiring around-the-clock opioids. Methods The primary purpose of this study was to evaluate the long-term safety and tolerability of buprenorphine buccal film. Five hundred and six patients who completed previous studies with buprenorphine buccal film (n=445; rollover patients) or were recruited de novo for this study (n=61) were enrolled in this study. All patients underwent a dose titration period of ≤6 weeks, during which doses of buprenorphine buccal film were adjusted to a maximum 900 µg every 12 hours, depending on tolerability and the need for rescue medication. An optimal dose was defined as the dose that the patient found satisfactory for both pain relief and tolerability, without the need for rescue medication or with ≤2 tablets of rescue medication per day. Once the optimal dose was reached, treatment was continued for ≤48 weeks. Pain intensity was measured throughout the study using a 0–10 numerical rating scale. Results Of 435 patients achieving an optimal dose of buprenorphine buccal film who commenced long-term treatment, 158 (36.3%) completed 48 weeks of treatment. Treatment-related adverse events occurred in 116 patients (22.9%) during the titration phase and 61 patients (14.0%) during the long-term treatment phase, and adverse events leading to discontinuation of treatment occurred in 14 (2.8%) and 14 (3.2%) patients, respectively. The most common adverse events were those typically associated with opioids, such as nausea, constipation, and headache. In both rollover and de novo patients, pain intensity scores remained constant at approximately 3–4 during long-term treatment, and the dose of buprenorphine buccal film remained unchanged in 86.2% of patients. Conclusion In appropriate patients, buprenorphine buccal

  16. Service improvement system to enhance the safety of patients admitted on long-term warfarin

    PubMed Central

    Warcel, Dana; Johnson, Daniel; Shah, Neeraj; shreeve, Norman

    2014-01-01

    It is common for hospital inpatients on warfarin to suffer from fluctuations in their INR (international normalised ratio). Raised INRs are potentially very dangerous and may result in acute life-threatening haemorrhages. Conversely, low INRs may increase the risk for the development of venous thromboembolism. Having observed many deranged INRs among hospital inpatients, we decided to focus our project on identifying the contributing factors to deranged INRs and ways to address this problem. We analysed the warfarin prescriptions on all drug charts and surveyed the junior doctor staff. Our results revealed poor knowledge and confidence levels on warfarin prescribing among junior doctor staff. This is likely to be reflected in the poor completion rate of warfarin prescriptions. We instituted practical changes to resolve the issue: most importantly, a change to the warfarin administration time from 6 pm to 2 pm, supported by a poster campaign to increase awareness of the problem. The objective of these changes was to reduce prescribing errors by reducing warfarin prescriptions out-of-hours, by the on-call doctors. We repeated the audit cycle twice. Although our interventions were successfully introduced as shown in our second audit cycle, the changes that were implemented were not sustained as shown in the third audit cycle. We identified a need for annual intervention to educate new junior doctor staff to ensure that the positive outcomes achieved are maintained in the long term. PMID:26734259

  17. Long-Term Evaluation of Continuous Epidural Anesthesia in an Improved Canine Model

    PubMed Central

    Sasauchi, Kyoko; Sunada, Katsuhisa; Nakamura, Tatsuo

    2016-01-01

    Background Continuous epidural analgesia with catheterization is a useful technique, because it has a wide adaptation range and provides prolonged analgesia. Problems that may arise from long-term epidural analgesia are changes in the analgesic area, duration of analgesia and catheter-related problems. Few articles have evaluated gradual changes of long-term epidural analgesia. In the animal models used in those studies, the catheter was inserted by an invasive surgical procedure. In the present study, we evaluated changes in a canine model in which the catheter was inserted by a minimally invasive procedure. Objectives To evaluate long-term changes in the efficacy of epidural analgesia in an improved canine model in which the epidural catheter was inserted and fixed for 5 weeks using a minimally invasive procedure. Materials and Methods Six beagles underwent epidural catheterization under general anaesthesia. The catheter tip was located in the sixth lumbar region; the catheter peripheral end was passed subcutaneously through the neck. Physiological saline was continuously infused (1.0 mL/h) via the catheter throughout the study. The efficacy of epidural analgesia was assessed weekly with 2% lidocaine once a week in 5 weeks. Peripheral blood analysis including interleukin-6 (IL-6) level in the cerebrospinal fluid (CSF), histological evaluations and epidurography were performed to evaluate the mechanisms underlying the changes. Results No dog died and the catheters were kept in place. The efficacy of analgesia was well maintained until 4 weeks; at 5th week, the efficacy decreased by half. The spread of injected medium was not observed in the cranial direction at 5th week and the tip of catheter was capped with granulation tissue. Throughout the study period, white blood cell counts and C-reactive protein levels were slightly high for catheterization and the IL-6 level in CSF was below detectable limits. Conclusions This was the longest study period with continuous

  18. Long-term evaluation of the controlled pressure method for assessment of the vapor intrusion pathway.

    PubMed

    Holton, Chase; Guo, Yuanming; Luo, Hong; Dahlen, Paul; Gorder, Kyle; Dettenmaier, Erik; Johnson, Paul C

    2015-02-17

    Vapor intrusion (VI) investigations often require sampling of indoor air for evaluating occupant risks, but can be confounded by temporal variability and the presence of indoor sources. Controlled pressure methods (CPM) have been proposed as an alternative, but temporal variability of CPM results and whether they are indicative of impacts under natural conditions have not been rigorously investigated. This study is the first involving a long-term CPM test at a house having a multiyear high temporal resolution indoor air data set under natural conditions. Key observations include (a) CPM results exhibited low temporal variability, (b) false-negative results were not obtained, (c) the indoor air concentrations were similar to the maximum concentrations under natural conditions, and (d) results exceeded long-term average concentrations and emission rates under natural conditions by 1-2 orders of magnitude. Thus, the CPM results were a reliable indicator of VI occurrence and worst-case exposure regardless of day or time of year of the CPM test.

  19. Evaluating multimodel variability of humidity over Europe using long term GPS network and ground base datasets

    NASA Astrophysics Data System (ADS)

    Bastin, Sophie; Bock, Olivier; Parracho, Ana

    2016-04-01

    Thanks to efforts made to reanalyse observed data to produce long-term homogenized datasets of new parameters or multi-parameters in recent years, we can better characterize, evaluate and analyse the water cycle in models at different scales. In this paper, a few MED-CORDEX simulations covering the ERA-interim period are evaluated against reprocessed IWV from GPS datasets over the European domain, from 1995 to 2008. The humidity is an important component of the water cycle, and models often have difficulties representing it. The high quality, consistent, long-term IWV dataset recently produced from GPS at more than 100 stations over Europe, with about half of the stations having nearly 15 years of data over the period from 1995 to 2010 is therefore used to evaluate the simulated IWV at seasonal, interannual and possibly diurnal time scales. Regional features are then identified, corresponding to different climate regimes. Other datasets, such as reanalysis of multi-parameters observed at one site (SIRTA, Palaiseau, France) over more than 10 years, or more regional networks are used to explain the dispersion of IWV among the different models and their biases against observations. The relationship between IWV and surface temperature is also evaluated locally to assess how much the sources of humidity from advection or surface fluxes are enough to reach the total capacity of the atmosphere in humidity when temperature increases. Over arid areas, this relation can depart from the Clausius-Clapeyron relation when temperature becomes too high. The ability of models to reproduce this relation during present climate is of high importance to estimate future climate.

  20. Long-term care: nursing home quality and safety--2005. End of Year Issue Brief.

    PubMed

    Tanner, Rachel; Bercaw, Lawren

    2005-12-31

    In 2002, the Government Accountability Office reported that more than 1.7 million senior citizens resided in over 17,000 nursing homes across the United States. A 2003 Administration on Aging report predicted that number would increase dramatically as the "baby-boom" generation ages. Accordingly, legislators and nursing home administrators have striven to develop facilities that provide safe, high-quality eldercare to the nations' growing senior population. The Health Policy Tracking Service (HPTS) published a study in January--2005 Health Care Priorities Report--that depicts state lawmakers' concern for nursing home quality and safety. To policymakers, nursing home quality and safety is a very high priority, second only to Medicaid. The HPTS survey also indicated that 38 states planned to address senior facility safety in 2005 by adopting more stringent employee background checks, higher staffing standards and strict licensure requirements

  1. Peer Tutoring to Prevent Firearm Play: Acquisition, Generalization, and Long-term Maintenance of Safety Skills

    PubMed Central

    Jostad, Candice M; Miltenberger, Raymond G; Kelso, Pamela; Knudson, Peter

    2008-01-01

    Hundreds of accidental injuries and deaths to children occur annually in the United States as a result of firearm play. Behavioral skills training (BST) and in situ training have been found to be effective in teaching children the skills to use if they find a firearm, but training requires substantial time and effort. The current study examined the use of peers as tutors as a potential way to decrease the time and resources needed to teach these safety skills to youngsters. Peer trainers conducted BST and in situ training with other children. Children taught by the peer trainers acquired the safety skills and demonstrated them in naturalistic situations in which the skills were needed. Furthermore, all of the peer trainers acquired and maintained the skills. These results support the use of peer tutoring for teaching safety skills to other children. PMID:18468285

  2. Climate considerations in long-term safety assessments for nuclear waste repositories.

    PubMed

    Näslund, Jens-Ove; Brandefelt, Jenny; Liljedahl, Lillemor Claesson

    2013-05-01

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  3. Long-Term PEG-J Tube Safety in Patients With Advanced Parkinson's Disease

    PubMed Central

    Epstein, Michael; Johnson, David A; Hawes, Robert; Schmulewitz, Nathan; Vanagunas, Arvydas D; Gossen, E Roderich; Robieson, Weining Z; Eaton, Susan; Dubow, Jordan; Chatamra, Krai; Benesh, Janet

    2016-01-01

    OBJECTIVES: The objectives of this study were to present procedure- and device-associated adverse events (AEs) identified with long-term drug delivery via percutaneous endoscopic gastrojejunostomy (PEG-J). Levodopa-carbidopa intestinal gel (LCIG, also known in US as carbidopa-levodopa enteral suspension, CLES) is continuously infused directly to the proximal small intestine via PEG-J in patients with advanced Parkinson's disease (PD) to overcome slow and erratic gastric emptying and treat motor fluctuations that are not adequately controlled by oral or other pharmacological therapy. METHODS: An independent adjudication committee of three experienced (>25 years each) gastroenterologists reviewed gastrointestinal procedure- and device-associated AEs reported for PD patients (total n=395) enrolled in phase 3 LCIG studies. The rate, clinical significance, and causality of the procedure/device events were determined. RESULTS: The patient median exposure to PEG-J at the data cutoff was 480 days. Procedure- and device-associated serious AEs (SAEs) occurred in 67 (17%) patients. A total of 42% of SAEs occurred during the first 4 weeks following PEG-J placement. SAEs of major clinical significance with the highest procedural incidence were peritonitis (1.5%), pneumonia (1.5%), and abdominal pain (1.3%). The most common non-serious procedure- and device-associated AEs were abdominal pain (31%), post-operative wound infection (20%), and procedural pain (23%). In all, 17 (4.3%) patients discontinued treatment owing to an AE. CONCLUSIONS: In conclusion, incidences of PEG-J AEs with the LCIG delivery system and PEG-J longevity were compared favorably with ranges described in the PEG/PEG-J literature. A low discontinuation rate in this study suggests acceptable procedural outcomes and AE rates in PD patients treated with this PEG-J drug delivery system. PMID:27030949

  4. Comparison of Long-Term Safety and Efficacy Outcomes after Drug-Eluting and Bare-Metal Stent Use across Racial Groups: insights from NHLBI Dynamic Registry

    PubMed Central

    Olafiranye, Oladipupo; Vlachos, Helen; Mulukutla, Suresh R.; Marroquin, Oscar; Selzer, Faith; Kelsey, Sheryl F.; Williams, David O.; Strollo, Patrick J.; Reis, Steven E.; Lee, Joon S.; Smith, AJ. Conrad

    2015-01-01

    Background Long-term data on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) and bare-metal stent (BMS) across racial groups are limited, and minorities are under-represented in existing clinical trials. Whether DES has better long-term clinical outcomes compared to BMS across racial groups remains to be established. Accordingly, we assessed whether longer-term clinical outcomes are better with DES compared to BMS across racial groups. Methods Using the multicenter National Heart, Lung, and Blood Institute (NHLBI)-sponsored Dynamic Registry, 2-year safety (death, MI) and efficacy (repeat revascularization) outcomes of 3,326 patients who underwent PCI with DES versus BMS were evaluated. Results With propensity-score adjusted analysis, the use of DES, compared to BMS, was associated with a lower risk for death or MI at 2 years for both blacks (adjusted Hazard Ratio (aHR)=0.41, 95% CI 0.25–0.69, p<0.001) and whites (aHR=0.67, 95% CI 0.51–0.90, p=0.007). DES use was associated with a significant 24% lower risk of repeat revascularization in whites (aHR=0.76, 95% CI 0.60–0.97, p=0.03) and with nominal 34% lower risk in blacks (aHR=0.66, 95% CI 0.39–1.13, p=0.13). Conclusion Use of DES in PCI was associated with better long-term safety outcomes across racial groups. Compared to BMS, DES was more effective in reducing repeat revascularization in whites and blacks, but this benefit was attenuated after statistical adjustment in blacks. These findings indicate that DES is superior to BMS in all patients regardless of race. Further studies are needed to determine long-term outcomes across racial groups with newer generation stents. PMID:25697874

  5. Congenital adrenal hyperplasia: long-term evaluation of feminizing genitoplasty and psychosocial aspects.

    PubMed

    Gupta, D K; Shilpa, Sharma; Amini, A C; Gupta, M; Aggarwal, Gautam; Deepika, Gupta; Kamlesh, Khatri

    2006-11-01

    Analyzing the long-term outcome in females with congenital adrenal hyperplasia (CAH) is crucial to evaluate effectiveness of treatment strategies. The aim of the study was to evaluate the long-term results in patients with CAH after feminizing surgery from the pediatric intersex clinic. Of 163 patients of CAH being followed (1980-2005), 50 responded for review. The patients had undergone feminizing genitoplasty and hormonal therapy. Evaluation included filling a detailed questionnaire along with physical examination and a structured interview in privacy. Assessment was performed for cosmetic results (50), psychosocial adjustment (42) above 5-year age, and functional outcome in 19 cases above 14-year age. Mean age at clitoroplasty was 3.6 years (1-16 years) and at time of the study was 14.6 years (4-23 years), with a mean post-op follow up of 6 years after the final surgery (6 months-17 years). The cosmetic outcome of clitoroplasty was excellent in 37, satisfactory in 10, and poor in 3. Gender identity was female, male, and mixed in 45, 4, and 1, respectively. The attitude to self and life was positive in 36 and negative in 6. The functional outcome of vaginoplasty was satisfactory, unsatisfactory, and undetermined in 11, 4, and 4, respectively. Endocrine control was satisfactory in 36/50. A novel assessment system has been adopted for analyzing the results of clitoroplasty and vaginoplasty. Endocrine control and surgical treatment are complimentary to each other to achieve satisfactory results in majority of CAH patients.

  6. Criteria for the evaluation and certification of long-term digital archives in the earth sciences

    NASA Astrophysics Data System (ADS)

    Klump, Jens

    2010-05-01

    Digital information has become an indispensable part of our cultural and scientific heritage. Scientific findings, historical documents and cultural achievements are to a rapidly increasing extent being presented in electronic form - in many cases exclusively so. However, besides the invaluable advantages offered by this form, it also carries a serious disadvantage: users need to invest a great deal of technical effort in accessing the information. Also, the underlying technology is still undergoing further development at an exceptionally fast pace. The rapid obsolescence of the technology required to read the information combined with the frequently imperceptible physical decay of the media themselves represents a serious threat to preservation of the information content. Many data sets in earth science research are from observations that cannot be repeated. This makes these digital assets particularly valuable. Therefore, these data should be kept and made available for re-use long after the end of the project from which they originated. Since research projects only run for a relatively short period of time, it is advisable to shift the burden of responsibility for long-term data curation from the individual researcher to a trusted data repository or archive. But what makes a trusted data repository? Each trusted digital repository has its own targets and specifications. The trustworthiness of digital repositories can be tested and assessed on the basis of a criteria catalogue. This is the main focus of the work of the nestor working group "Trusted repositories - Certification". It identifies criteria which permit the trustworthiness of a digital repository to be evaluated, both at the organisational and technical levels. The criteria are defined in close collaboration with a wide range of different memory organisations, producers of information, experts and other interested parties. This open approach ensures a high degree of universal validity, suitability for

  7. Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease.

    PubMed

    Makumi, Clare W; Asgharian, Afsaneh; Ellis, Jeffrey; Shaikh, Soraya; Jimenez, Teri; VanMeter, Susan

    2016-01-01

    Long-term safety of once-daily ropinirole extended/prolonged release (ropinirole XL/PR) was evaluated in subjects with early and advanced Parkinson's disease (PD) in this study, 101468/248. Subjects (n = 419) who completed one of three prior studies evaluating ropinirole XL/PR for the treatment of PD were enrolled in this open-label, multicenter, extension study, and were to be followed for up to 73 months. Ropinirole XL/PR was titrated/continued, and adjusted as appropriate during the maintenance phase (maximum 24 mg/d). Levodopa (L-dopa) and other nondopamine agonist PD medications were permitted. Safety outcomes that were investigated included frequency of adverse events (AEs). Subjects' preference regarding once daily versus three times daily study medication regimens was also investigated in a subset of the study population. The median duration of ropinirole XL/PR exposure was 1275 d. Most subjects (87%) reported at least one AE, with the most common (≥ 10%) AEs being, back pain (14%), hallucinations (13%), somnolence (11%) and peripheral edema (11%). Twenty-five percent of subjects discontinued the study prematurely due to an AE during the treatment period. Long-term treatment with ropinirole XL/PR was not associated with any new or unexpected safety concerns in patients with early and advanced PD, and a majority of subjects preferred the once-daily dosing regimen.

  8. Clinical Nursing Leadership Education in Long-Term Care: Intervention Design and Evaluation.

    PubMed

    Fiset, Valerie; Luciani, Tracy; Hurtubise, Alyssa; Grant, Theresa L

    2017-04-01

    The main objective of the current case study was to investigate the perceived leadership learning needs and feasibility of delivering leadership education to registered staff involved in direct care in long-term care (LTC) homes. The study was conducted in Ontario, Canada, and participants included RNs, registered practical nurses, and nursing administrators. Phase 1 bilingual web-based survey and bilingual focus group needs assessment data supported a preference for external training along with in-house mentoring to support sustainability. An intervention designed using insights gained from Phase 1 data was delivered via a 2-day, in-person workshop. Phases 2 and 3 evaluation survey data identified aspects of leadership training for LTC that require ongoing refinement. Findings suggest that communication skills and managing day-to-day nursing demands in the context of regulatory frameworks were areas of particular interest for leadership training in the LTC setting. [Journal of Gerontological Nursing, 43(4), 49-56.].

  9. Gasbuggy, New Mexico Long-Term Hydrologic Monitoring Program Evaluation Report

    SciTech Connect

    2009-06-01

    This report summarizes an evaluation of the Long-Term Hydrologic Monitoring Program (LTHMP) that has been conducted since 1972 at the Gasbuggy, New Mexico underground nuclear detonation site. The nuclear testing was conducted by the U.S. Atomic Energy Commission under the Plowshare program, which is discussed in greater detail in Appendix A. The detonation at Gasbuggy took place in 1967, 4,240 feet below ground surface, and was designed to fracture the host rock of a low-permeability natural gas-bearing formation in an effort to improve gas production. The site has historically been managed under the Nevada Offsites Project. These underground nuclear detonation sites are within the United States but outside of the Nevada Test Site where most of the experimental nuclear detonations conducted by the U.S. Government took place. Gasbuggy is managed by the U.S. Department of Energy (DOE) Office of Legacy Management (LM ).

  10. Evaluation of Mand-Reinforcer Relations Following Long-Term Functional Communication Training

    PubMed Central

    Wacker, David P.; Harding, Jay W.; Berg, Wendy K.

    2008-01-01

    The investigators evaluated the relation between mands and positive reinforcement in the form of parent attention following long-term in-home treatment with functional communication training (FCT) for destructive behavior. Participants were 3 five-year-old children (2 boys, 1 girl) with developmental disabilities who manded to obtain different levels of parent attention (Phase 1). To determine whether the children's rate of manding would vary based on the amount of reinforcement received, the investigators adjusted the duration of parent attention (12 s vs. 30 s) provided to each child for manding on an FR1 schedule (Phase 2) using a reversal design. All 3 children changed their rates of manding so that each child maintained consistent levels of reinforcement across Phase 2 conditions. PMID:19043601

  11. Evaluation of long-term quality of life after reoperative coronary artery surgery: preliminary results

    PubMed Central

    Noyez, L.; Schultz, A.; van der Heide, S.M.; van Eck, F.M.; Brouwer, R.M.H.J.

    2003-01-01

    Objective The risks of reoperative coronary artery bypass surgery (RECABG) still exceed those of a primary revascularisation and late results are not very favourable either. The subject of the present study is an evaluation of the long-term quality of life after RECABG. Methods We studied the outcome of 541 patients who underwent a RECABG from January 1987 to December 1998. The endpoint of the study was December 2002, or the patient's death. Quality of life, using the EuroQol registration, was evaluated. Results Hospital mortality was 6.7%. Follow-up was 95.6% complete, mean 7.7 years. There were 177 late deaths. The cumulative survival rates were 83.8, 76.9, and 60.6%, and cardiac survival rates were 84.8, 78.5, and 66.5%, at the one-year, five-year and ten-year follow-up, respectively. For 255 patients (89%), NYHA and EuroQol information was complete. In total 23% of the patients were in NYHA class I, 51% in class II, 21% in class III and 5% were in class IV. In the EuroQol registration, 54% of the patients declared they had no mobility problems, 85% no problems with self-care, and 65% no problems with usual activities. However, 60% suffered from moderate pain or discomfort, and 33% from anxiety or depression. On the visual analogue scale (mean 63.5), 13% of the patients scored >90, 68% between 50 and 90, and 19% of the patients <50. Conclusion The long-term results of cumulative survival and cardiac survival, and NYHA class in our patient population who underwent RECABG are comparable with other studies. Quality of life is acceptable regarding the high risk of a RECABG. PMID:25696170

  12. Development and evaluation of a global long-term passive microwave vegetation product

    NASA Astrophysics Data System (ADS)

    Liu, Y. Y.; Van Dijk, A. I. J. M.; de Jeu, R. A. M.; McCabe, M. F.; Evans, J. P.

    2012-04-01

    Vegetation optical depth (VOD) retrievals from three satellite-based passive microwave instruments were merged to produce the first long-term global microwave-based vegetation product, spanning from 1988 through 2008. The resulting VOD product shows seasonal cycles and inter-annual variations that generally correspond with those observed in the Advanced Very High Resolution Radiometer (AVHRR) Normalized Difference Vegetation Index (NDVI). Some notable differences exist in the long-term trends: the NDVI, operating in the optical regime, is sensitive to chlorophyll abundance and photosynthetically active biomass of the leaves, whereas the microwave-based VOD is an indicator of the vegetation water content in total above-ground biomass, i.e. including wood and leaf components. A global analysis is undertaken to evaluate global VOD trends over 1988-2008. We conduct Mann-Kendall linear trend tests on annual average VOD to identify regions of significant change. Patterns for these regions were evaluated against independent datasets to diagnose the underlying cause of the observed trends. Results indicate that: (1) VOD patterns correspond strongly to temporal precipitation patterns over water limited regions; (2) over croplands, annual average VOD shows a similar temporal pattern with reported crop production; (3) over forest, the spatial pattern of VOD decline agrees well with patterns of deforestation, fires and clear cutting. We conclude that VOD can be used to estimate and interpret global changes in total above ground vegetation. We expect that this new observation source will be of considerable interest to hydrological, agricultural, climate change and carbon cycle studies, and provide new insights into these and related process investigations.

  13. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis

    PubMed Central

    Burmester, Gerd R; Landewé, Robert; Genovese, Mark C; Friedman, Alan W; Pfeifer, Nathan D; Varothai, Nupun A; Lacerda, Ana P

    2017-01-01

    Background Adalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications. Objective To update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA. Methods This analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry. Results Serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women. Conclusions This analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced. Trial registration numbers NCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301. PMID:27338778

  14. Evaluation of focused multipolar stimulation for cochlear implants in long-term deafened cats

    NASA Astrophysics Data System (ADS)

    George, Shefin S.; Wise, Andrew K.; Fallon, James B.; Shepherd, Robert K.

    2015-06-01

    Objective. Focused multipolar (FMP) stimulation has been shown to produce restricted neural activation using intracochlear stimulation in animals with a normal population of spiral ganglion neurons (SGNs). However, in a clinical setting, the widespread loss of SGNs and peripheral fibres following deafness is expected to influence the effectiveness of FMP. Approach. We compared the efficacy of FMP stimulation to both monopolar (MP) and tripolar (TP) stimulation in long-term deafened cat cochleae (n = 8). Unlike our previous study, these cochleae contained <10% of the normal SGN population adjacent to the electrode array. We also evaluated the effect of electrode position on stimulation modes by using either modiolar facing or lateral wall facing half-band electrodes. The spread of neural activity across the inferior colliculus, a major nucleus within the central auditory pathway, was used as a measure of spatial selectivity. Main results. In cochleae with significant SGN degeneration, we observed that FMP and TP stimulation resulted in greater spatial selectivity than MP stimulation (p < 0.001). However, thresholds were significantly higher for FMP and TP stimulation compared to MP stimulation (p < 0.001). No difference between FMP and TP stimulation was found in any measures. The high threshold levels for FMP stimulation was significantly reduced without compromising spatial selectivity by varying the degree of current focusing (referred as ‘partial-FMP’ stimulation). Spatial selectivity of all stimulation modes was unaffected by the electrode position. Finally, spatial selectivity in long-term deafened cochleae was significantly less than that of cochleae with normal SGN population (George S S et al 2014 J. Neural Eng. 11 065003). Significance. The present results indicate that the greater spatial selectivity of FMP and TP stimulation over MP stimulation is maintained in cochleae with significant neural degeneration and is not adversely affected by electrode

  15. Long-term efficacy and safety of interferon-alpha-2B in patients with mumps orchitis.

    PubMed

    Yapanoglu, Turgut; Kocaturk, Huseyin; Aksoy, Yilmaz; Alper, Fatih; Ozbey, Isa

    2010-12-01

    The aim of this study was to determine long-term efficacy and safety subcutaneous injection of interferon-alpha-2B in patients with mumps orchitis in terms of testicular volume and other testicular functions. Mumps orchitis was evaluated in 37 patients. Patients were hospitalized and administered 1 × 3,000,000 IU subcutaneous injection of interferon-alpha-2B daily for 7 days. The testicular volumes of all the patients were measured by ultrasonography in the 18th month following treatment termination. The testes volumes were evaluated by descriptive statistics as percentages. Patients were divided into three groups according to testes volumes and differences between the involved and non-involved testicles. Group I included patients with normal testes volume (> 12 ml) and a difference between testes of less than 2 ml or 20%; Group II (atrophic groups) included patients with testes volume of less than 12 ml; and Group III (hypotrophic groups) included patients with testes volume of greater than 12 ml and a difference between testes of more than 2 ml or 20%. Groups were compared in terms of results of semen analysis and serum follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels. Patients' ages ranged between 17 and 41 years (mean: 28.3 years). A total of nine atrophy cases were identified. Sixteen patients were determined to have hypotrophic testes with a difference of 2-10 ml or 20% between the involved and non-involved testicles, despite the absence of testicular atrophy. A comparison of groups revealed that sperm density, total sperm count, total motile sperm count, and motility percentage were significantly higher in Group I than in the other groups, while serum FSH and LH levels were lower in Group I than in the other groups. Although the use of interferon-alpha-2B appears to prevent testicular atrophy and protect testicular function, it leads to a considerable difference in the volume between testicles and a significant loss of testicular

  16. Evaluation of the long-term performance of six alternative disposal methods for LLRW

    SciTech Connect

    Kossik, R.; Sharp, G.; Chau, T.

    1995-12-31

    The State of New York has carried out a comparison of six alternative disposal methods for low-level radioactive waste (LLRW). An important part of these evaluations involved quantitatively analyzing the long-term (10,000 yr) performance of the methods with respect to dose to humans, radionuclide concentrations in the environment, and cumulative release from the facility. Four near-surface methods (covered above-grade vault, uncovered above-grade vault, below-grade vault, augered holes) and two mine methods (vertical shaft mine and drift mine) were evaluated. Each method was analyzed for several generic site conditions applicable for the state. The evaluations were carried out using RIP (Repository Integration Program), an integrated, total system performance assessment computer code which has been applied to radioactive waste disposal facilities both in the U.S. (Yucca Mountain, WIPP) and worldwide. The evaluations indicate that mines in intact low-permeability rock and near-surface facilities with engineered covers generally have a high potential to perform well (within regulatory limits). Uncovered above-grade vaults and mines in highly fractured crystalline rock, however, have a high potential to perform poorly, exceeding regulatory limits.

  17. Long-term efficacy, safety and tolerability of Remoxy for the management of chronic pain.

    PubMed

    Pergolizzi, Joseph V; Zampogna, Gianpietro; Taylor, Robert; Raffa, Robert B

    2015-03-01

    Historically, chronic pain generally went under-treated for a variety of objective and subjective reasons, including difficulty to objectively diagnose and manage over a long period of time, potential serious adverse effects of commonly available medications, and patient, healthcare and societal concerns over opioid medications. More recently, in an effort to redress the under-treatment of pain, the number of prescriptions of opioid analgesics has risen dramatically. However, paralleling the increased legitimate use has been a concomitant increase in opioid abuse, misuse and diversion. Pharmaceutical companies have responded by developing a variety of opioid formulations designed to deter abuse by making the products more difficult to tamper with. One such product is Remoxy(®), an extended-release formulation of the strong opioid oxycodone. We review the efficacy, safety and tolerability of this formulation based on the available published literature.

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

    PubMed Central

    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

  19. Safety of real-time convection-enhanced delivery of liposomes to primate brain: a long-term retrospective

    PubMed Central

    Krauze, Michal T.; Vandenberg, Scott R.; Yamashita, Yoji; Saito, Ryuta; Forsayeth, John; Noble, Charles; Park, John; Bankiewicz, Krystof S.

    2008-01-01

    Convection-enhanced delivery (CED) is gaining popularity in direct brain infusions. Our group has pioneered the use of liposomes loaded with the MRI contrast reagent as a means to track and quantitate CED in the primate brain through real-time MRI. When co-infused with therapeutic nanoparticles, these tracking liposomes provide us with unprecedented precision in the management of infusions into discrete brain regions. In order to translate real-time CED into clinical application, several important parameters must be defined. In this study, we have analyzed all our cumulative animal data to answer a number of questions as to whether real-time CED in primates depends on concentration of infusate, is reproducible, allows prediction of distribution in a given anatomic structure, and whether it has long term pathological consequences. Our retrospective analysis indicates that real-time CED is highly predictable; repeated procedures yielded identical results, and no long-term brain pathologies were found. We conclude that introduction of our technique to clinical application would enhance accuracy and patient safety when compared to current non-monitored delivery trials. PMID:18295759

  20. Safety of real-time convection-enhanced delivery of liposomes to primate brain: a long-term retrospective.

    PubMed

    Krauze, Michal T; Vandenberg, Scott R; Yamashita, Yoji; Saito, Ryuta; Forsayeth, John; Noble, Charles; Park, John; Bankiewicz, Krystof S

    2008-04-01

    Convection-enhanced delivery (CED) is gaining popularity in direct brain infusions. Our group has pioneered the use of liposomes loaded with the MRI contrast reagent as a means to track and quantitate CED in the primate brain through real-time MRI. When co-infused with therapeutic nanoparticles, these tracking liposomes provide us with unprecedented precision in the management of infusions into discrete brain regions. In order to translate real-time CED into clinical application, several important parameters must be defined. In this study, we have analyzed all our cumulative animal data to answer a number of questions as to whether real-time CED in primates depends on concentration of infusate, is reproducible, allows prediction of distribution in a given anatomic structure, and whether it has long term pathological consequences. Our retrospective analysis indicates that real-time CED is highly predictable; repeated procedures yielded identical results, and no long-term brain pathologies were found. We conclude that introduction of our technique to clinical application would enhance accuracy and patient safety when compared to current non-monitored delivery trials.

  1. Safety and Long-Term Performance of Lithium-ion Pouch Cells

    NASA Technical Reports Server (NTRS)

    Jeevarajan, Judith

    2012-01-01

    Lithium-ion batteries have the highest energy density of the batteries available in the commercial market today. Although most lithium-ion cell designs use a metal can design, this has changed significantly in recent years. Cell designs are offered in the pouch format as they offer better volumetric and gravimetric energy densities and in some cases, higher tolerance to abuse or off-nominal conditions. In the past decade, several state-of-the-art lithium-ion pouch cell designs have been tested. The pouch cell designs have become more robust in the past two years but there are still a few issues that need to be looked into for optimization. The pouch cells seem to have a tendency to swell when left in storage under ambient conditions. The cells also swell under overvoltage and undervoltage conditions. A significant issue that has been observed is the swelling of the cells under a vacuum condition which could lead to deformation of the cell pouch after this exposure. This last factor would be very critical in the use of these cell designs for space applications as vacuum exposure is used to check for cell and battery leaks before it is flown into space. In rare cases, corrosion of the aluminum layer of the pouches has been observed in stored cells. Pouch material analysis has been carried out in an effort to understand the strength of the pouches and determine if this is a factor in the corrosion as well as unsafe condition of the cells as deformation of the inner layers of the pouch could occur when the cells swell under the various conditions described above. Pouch materials are typically aluminized plastic, made up of a layer of Al sandwiched between one or more layers of polymeric material. Deformations or cell manufacturing processes could lead to a compromise of the inner polymeric layer/s of the pouch leading to the corrosion of the Al layer in the aluminized pouch material. The safety of the pouch cell designs has been determined for cells from various

  2. Long-term analysis of the impact of longitudinal barriers on motorway safety.

    PubMed

    Martin, Jean-Louis; Mintsa-Eya, Colette; Goubel, Clément

    2013-10-01

    The objective of this study was to assess the influence of longitudinal barriers located on the median strips and hard shoulders of toll motorways on crash severity in vehicles running off the roadway. The study was based on crashes involving injury and property damage only, recorded from 1996 to 2010 on a French toll motorway network of about 2000 km. In run-off from the roadway onto the hard shoulder, injury risk was halved by a longitudinal barrier. A specific one-sided W-beam guardrail ("GS4") appeared to be the best solution for cars, and even for LUVs and trucks. This does not affect the advisability of specific guardrails for bridges or of concrete barriers, when narrow working widths are required. In run-off onto median strips, a specific guardrail ("GS2") appeared to be the most efficient, followed by the three other metal guardrails currently installed. Concrete barriers, however, are much more effective in preventing complete crossing of the median, which is uncommon and mainly involves trucks, but often with very serious consequences. Longitudinal barriers make an important contribution to highway-user safety, providing a "forgiving" infrastructure in the event of a vehicle going off the road, provided that there are very few motorized two-wheel vehicles using the roadway.

  3. Efficacy and safety of an intravenous C1-inhibitor concentrate for long-term prophylaxis in hereditary angioedema

    PubMed Central

    Craig, Timothy; Shapiro, Ralph; Vegh, Arthur; Baker, James W.; Bernstein, Jonathan A.; Busse, Paula; Magerl, Markus; Martinez-Saguer, Inmaculada; Riedl, Marc A.; Lumry, William; Williams-Herman, Debora; Edelman, Jonathan; Feuersenger, Henrike; Machnig, Thomas

    2017-01-01

    Background: The plasma-derived, pasteurized, nanofiltered C1-inhibitor concentrate (pnfC1-INH) is approved in the United States as an intravenous (IV) on-demand treatment for hereditary angioedema (HAE) attacks, and, in Europe, as on demand and short-term prophylaxis. Objective: This analysis evaluated Berinert Patient Registry data regarding IV pnfC1-INH used as long-term prophylaxis (LTP). Methods: The international registry (2010–2014) collected prospective and retrospective usage, dosing, and safety data on individuals who used pnfC1-INH for any reason. Results: The registry included data on 47 subjects (80.9% female subjects; mean age, 44.8 years), which reflected 4082 infusions categorized as LTP and a total of 430.2 months of LTP administration. The median absolute dose of pnfC1-INH given for LTP was 1000 IU (range, 500–3000 IU), with a median time interval between infusion and a subsequent pnfC1-INH–treated attack of 72.0 hours (range, 0.0–166.4 hours). Fifteen subjects (31.9%) had no pnfC1-INH–treated HAE attacks within 7 days after pnfC1-INH infusion for LTP; 32 subjects (68.1%) experienced 246 attacks, with rates of 0.06 attacks per infusion and 0.57 attacks per month. A total of 81 adverse events were reported in 16 subjects (34.0%) (0.02 events per infusion; 0.19 events per month); only 3 adverse events were considered related to pnfC1-INH (noncardiac chest pain, postinfusion headache, deep vein thrombosis in a subject with an IV port). Conclusion: In this international registry, IV pnf-C1-INH given as LTP for HAE was safe and efficacious, with a low rate of attacks that required pnfC1-INH treatment, particularly within the first several days after LTP administration. PMID:28381322

  4. Evaluating the clinical and physiological effects of long term ultraviolet B radiation on guinea pigs (Cavia porcellus).

    PubMed

    Watson, Megan K; Stern, Adam W; Labelle, Amber L; Joslyn, Stephen; Fan, Timothy M; Leister, Katie; Kohles, Micah; Marshall, Kemba; Mitchell, Mark A

    2014-01-01

    Vitamin D is an important hormone in vertebrates. Most animals acquire this hormone through their diet, secondary to exposure to ultraviolet B (UVB) radiation, or a combination thereof. The objectives for this research were to evaluate the clinical and physiologic effects of artificial UVB light supplementation on guinea pigs (Cavia porcellus) and to evaluate the long-term safety of artificial UVB light supplementation over the course of six months. Twelve juvenile acromelanic Hartley guinea pigs were randomly assigned to one of two treatment groups: Group A was exposed to 12 hours of artificial UVB radiation daily and Group B received only ambient fluorescent light for 12 hours daily. Animals in both groups were offered the same diet and housed under the same conditions. Blood samples were collected every three weeks to measure blood chemistry values, parathyroid hormone, ionized calcium, and serum 25-hydroxyvitamin D3 (25-OHD3) levels. Serial ophthalmologic examinations, computed tomography scans, and dual energy x-ray absorptiometry scans were performed during the course of the study. At the end of the study the animals were euthanized and necropsied. Mean ± SD serum 25-OHD3 concentrations differed significantly in the guinea pigs (p<0.0001) between the UVB supplementation group (101.49±21.81 nmol/L) and the control group (36.33±24.42 nmol/L). An increased corneal thickness in both eyes was also found in the UVB supplementation compared to the control group (right eye [OD]: p<0.0001; left eye [OS]: p<0.0001). There were no apparent negative clinical or pathologic side effects noted between the groups. This study found that exposing guinea pigs to UVB radiation long term significantly increased their circulating serum 25-OHD3 levels, and that this increase was sustainable over time. Providing guinea pigs exposure to UVB may be an important husbandry consideration that is not currently recommended.

  5. Evaluating the Clinical and Physiological Effects of Long Term Ultraviolet B Radiation on Guinea Pigs (Cavia porcellus)

    PubMed Central

    Watson, Megan K.; Stern, Adam W.; Labelle, Amber L.; Joslyn, Stephen; Fan, Timothy M.; Leister, Katie; Kohles, Micah; Marshall, Kemba; Mitchell, Mark A.

    2014-01-01

    Vitamin D is an important hormone in vertebrates. Most animals acquire this hormone through their diet, secondary to exposure to ultraviolet B (UVB) radiation, or a combination thereof. The objectives for this research were to evaluate the clinical and physiologic effects of artificial UVB light supplementation on guinea pigs (Cavia porcellus) and to evaluate the long-term safety of artificial UVB light supplementation over the course of six months. Twelve juvenile acromelanic Hartley guinea pigs were randomly assigned to one of two treatment groups: Group A was exposed to 12 hours of artificial UVB radiation daily and Group B received only ambient fluorescent light for 12 hours daily. Animals in both groups were offered the same diet and housed under the same conditions. Blood samples were collected every three weeks to measure blood chemistry values, parathyroid hormone, ionized calcium, and serum 25-hydroxyvitamin D3 (25-OHD3) levels. Serial ophthalmologic examinations, computed tomography scans, and dual energy x-ray absorptiometry scans were performed during the course of the study. At the end of the study the animals were euthanized and necropsied. Mean ± SD serum 25-OHD3 concentrations differed significantly in the guinea pigs (p<0.0001) between the UVB supplementation group (101.49±21.81 nmol/L) and the control group (36.33±24.42 nmol/L). An increased corneal thickness in both eyes was also found in the UVB supplementation compared to the control group (right eye [OD]: p<0.0001; left eye [OS]: p<0.0001). There were no apparent negative clinical or pathologic side effects noted between the groups. This study found that exposing guinea pigs to UVB radiation long term significantly increased their circulating serum 25-OHD3 levels, and that this increase was sustainable over time. Providing guinea pigs exposure to UVB may be an important husbandry consideration that is not currently recommended. PMID:25517408

  6. Mathematical models as tools for probing long-term safety of CO2 storage

    SciTech Connect

    Pruess, Karsten; Birkholzer, Jens; Zhou, Quanlin

    2009-02-01

    Subsurface reservoirs being considered for storing CO{sub 2} include saline aquifers, oil and gas reservoirs, and unmineable coal seams (Baines and Worden, 2004; IPCC, 2005). By far the greatest storage capacity is in saline aquifers (Dooley et al., 2004), and our discussion will focus primarily on CO{sub 2} storage in saline formations. Most issues for safety and security of CO{sub 2} storage arise from the fact that, at typical temperature and pressure conditions encountered in terrestrial crust, CO{sub 2} is less dense than aqueous fluids. Accordingly, CO{sub 2} will experience an upward buoyancy force in most subsurface environments, and will tend to migrate upwards whenever (sub-)vertical permeable pathways are available, such as fracture zones, faults, or improperly abandoned wells (Bachu, 2008; Pruess, 2008a, b; Tsang et al., 2008). CO{sub 2} injection will increase fluid pressures in the target formation, thereby altering effective stress distributions, and potentially triggering movement along fractures and faults that could increase their permeability and reduce the effectiveness of a caprock in containing CO{sub 2} (Rutqvist et al., 2008; Chiaramonte et al., 2008). Induced seismicity as a consequence of fluid injection is also a concern (Healy et al., 1968; Raleigh et al., 1976; Majer et al., 2007). Dissolution of CO{sub 2} in the aqueous phase generates carbonic acid, which may induce chemical corrosion (dissolution) of minerals with associated increase in formation porosity and permeability, and may also mediate sequestration of CO{sub 2} as solid carbonate (Gaus et al., 2008). Chemical dissolution of caprock minerals could promote leakage of CO{sub 2} from a storage reservoir (Gherardi et al., 2007). Chemical dissolution and geomechanical effects could reinforce one another in compromising CO{sub 2} containment. Additional issues arise from the potential of CO{sub 2} to mobilize hazardous chemical species (Kharaka et al., 2006), and from migration of

  7. Long-term performance evaluation of wood fibre fills. Final report

    SciTech Connect

    Kilian, A.P.; Ferry, C.D.

    1992-08-01

    The paper presents the results of a research project to determine the long-term performance of wood fiber embankments, that were constructed by the Washington State Department of Transportation (WSDOT) beginning in 1972. At the time of their construction, concern existed that wood fiber fills would only provide a 15 to 20 year service life. Performance of existing wood fiber fills was evaluated based on the quality of the wood fiber material, quality of the effluent, and condition of the pavement. A visual classification system rating the wood fiber from fresh to completely decomposed was developed and used in order to establish a criteria from which all wood fiber material could be rated. Visual examination in conjunction with laboratory tests were used as determining aspects for the effluent quality. The WSDOT Pavement Management System was used to evaluate relative pavement performance. Site descriptions are presented giving specific characteristics and properties of the fills inventoried. An analysis of this information was done to determine the effectiveness of the fills. Over half the wood fiber samples were found to be nearly fresh or fresh and none were found to be completely decomposed. In all but one case, the pavement quality over the wood fiber fills surpassed the comparative highway segment rating indicating the wood fill's performance exceeded that of the surrounding area.

  8. Long-term environmental impacts of building composites containing waste materials: Evaluation of the leaching protocols.

    PubMed

    Drinčić, Ana; Nikolić, Irena; Zuliani, Tea; Milačič, Radmila; Ščančar, Janez

    2017-01-01

    The NEN 7375 test has been proposed for evaluating the long-term environmental impacts caused by the release of contaminants from monolithic building and waste materials. Over a period of 64days, at specific points in time, the leaching solution (demineralised water) is replenished. By applying the NEN 7375 test, leaching of contaminants that is based mainly on diffusion is followed. In the present work, the results from modified leaching protocols were evaluated against those obtained by NEN 7375 test. In modified protocols, synthetic sea, surface and MilliQ water were used for the leaching of selected elements and chromate, molybdate and vanadate from compact and ground building composites (98% mixture of fly ash (80%) and cement (20%), and 2% of electric arc furnace (EAF) dust) over 6months. The leaching solutions were not replenished, imitating both the diffusion and the dissolution of contaminants. The data revealed larger extent of leaching when the leaching solution was not replenished. More extensive was also leaching from ground composites, which simulated the disintegration of the material over time. The composition of the leaching solution influenced the release of the matrix constituents from the composites and, consequently, the amount of elements and their chemical species. Synthetic sea and surface water used as leaching solutions, without replenishing, were found to be suitable to simulate the conditions when the building material is immersed in stagnant environmental waters.

  9. Evaluating Clouds in Long-Term Cloud-Resolving Model Simulations with Observational Data

    NASA Technical Reports Server (NTRS)

    Zeng, Xiping; Tao, Wei-Kuo; Zhang, Minghua; Peters-Lidard, Christa; Lang, Stephen; Simpson, Joanne; Kumar, Sujay; Xie, Shaocheng; Eastman, Joseph L.; Shie, Chung-Lin; Geiger, James V.

    2006-01-01

    Two 20-day, continental midlatitude cases are simulated with a three-dimensional (3D) cloud-resolving model (CRM) and compared to Atmospheric Radiation Measurement (ARM) data. This evaluation of long-term cloud-resolving model simulations focuses on the evaluation of clouds and surface fluxes. All numerical experiments, as compared to observations, simulate surface precipitation well but over-predict clouds, especially in the upper troposphere. The sensitivity of cloud properties to dimensionality and other factors is studied to isolate the origins of the over prediction of clouds. Due to the difference in buoyancy damping between 2D and 3D models, surface precipitation fluctuates rapidly with time, and spurious dehumidification occurs near the tropopause in the 2D CRM. Surface fluxes from a land data assimilation system are compared with ARM observations. They are used in place of the ARM surface fluxes to test the sensitivity of simulated clouds to surface fluxes. Summertime simulations show that surface fluxes from the assimilation system bring about a better simulation of diurnal cloud variation in the lower troposphere.

  10. Interlaboratory evaluation of Hyalella azteca and Chironomus tentans short-term and long-term sediment toxicity tests

    USGS Publications Warehouse

    Norberg-King, T. J.; Sibley, P.K.; Burton, G.A.; Ingersoll, C.G.; Kemble, N.E.; Ireland, S.; Mount, D.R.; Rowland, C.D.

    2006-01-01

    Methods for assessing the long-term toxicity of sediments to Hyalella azteca and Chironomus tentans can significantly enhance the capacity to assess sublethal effects of contaminated sediments through multiple endpoints. Sublethal tests allow us to begin to understand the relationship between short-term and long-term effects for toxic sediments. We present an interlaboratory evaluation with long-term and 10-d tests using control and contaminated sediments in which we assess whether proposed and existing performance criteria (test acceptability criteria [TAC]) could be achieved. Laboratories became familiar with newly developed, long-term protocols by testing two control sediments in phase 1. In phase 2, the 10-d and long-term tests were examined with several sediments. Laboratories met the TACs, but results varied depending on the test organism, test duration, and endpoints. For the long-term tests in phase 1, 66 to 100% of the laboratories consistently met the TACs for survival, growth, or reproduction using H. azteca, and 70 to 100% of the laboratories met the TACs for survival and growth, emergence, reproduction, and hatchability using C. tentans. In phase 2, fewer laboratories participated in long-term tests: 71 to 88% of the laboratories met the TAC for H. azteca, whereas 50 to 67% met the TAC for C. tentans. In the 10-d tests with H. azteca and C. tentans, 82 and 88% of the laboratories met the TAC for survival, respectively, and 80% met the TAC for C. tentans growth. For the 10-d and long-term tests, laboratories predicted similar toxicity. Overall, the interlaboratory evaluation showed good precision of the methods, appropriate endpoints were incorporated into the test protocols, and tests effectively predicted the toxicity of sediments. ?? 2006 SETAC.

  11. Long-term evaluation of home-based pulmonary rehabilitation in patients with COPD

    PubMed Central

    Grosbois, Jean Marie; Gicquello, Alice; Langlois, Carole; Le Rouzic, Olivier; Bart, Frédéric; Wallaert, Benoit; Chenivesse, Cécile

    2015-01-01

    Introduction Personalized, global pulmonary rehabilitation (PR) management of patients with COPD is effective, regardless of the place in which this rehabilitation is provided. The objective of this retrospective observational study was to study the long-term outcome of exercise capacity and quality of life during management of patients with COPD treated by home-based PR. Methods Home-based PR was administered to 211 patients with COPD (mean age, 62.3±11.1 years; mean forced expiratory volume in 1 second, 41.5%±17.7%). Home-based PR was chosen because of the distance of the patient’s home from the PR center and the patient’s preference. Each patient was individually managed by a team member once a week for 8 weeks with unsupervised continuation of physical exercises on the other days of the week according to an individual action plan. Exercise conditioning, therapeutic patient education, and self-management were included in the PR program. The home assessment comprised evaluation of the patient’s exercise capacity by a 6-minute stepper test, Timed Up and Go test, ten times sit-to-stand test, Hospital Anxiety and Depression score, and quality of life (Visual Simplified Respiratory Questionnaire, VQ11, Maugeri Respiratory Failure 28). Results No incidents or accidents were observed during the course of home-based PR. The 6-minute stepper test was significantly improved after completion of the program, at 6 months and 12 months, whereas the Timed Up and Go and ten times sit-to-stand test were improved after PR and at 6 months but not at 12 months. Hospital Anxiety and Depression and quality of life scores improved after PR, and this improvement persisted at 6 months and 12 months. Conclusion Home-based PR for unselected patients with COPD is effective in the short term, and this effectiveness is maintained in the medium term (6 months) and long term (12 months). Home-based PR is an alternative to outpatient management provided all activities, such as exercise

  12. An evaluation of persistence of treatment effects during long-term treatment of destructive behavior.

    PubMed

    Wacker, David P; Harding, Jay W; Berg, Wendy K; Lee, John F; Schieltz, Kelly M; Padilla, Yaniz C; Nevin, John A; Shahan, Timothy A

    2011-09-01

    Eight young children who displayed destructive behavior maintained, at least in part, by negative reinforcement received long-term functional communication training (FCT). During FCT, the children completed a portion of a task and then touched a communication card attached to a microswitch to obtain brief breaks. Prior to and intermittently throughout FCT, extinction probes were conducted within a withdrawal design in which task completion, manding, and destructive behavior were placed on extinction to evaluate the relative persistence of appropriate and destructive behavior over the course of treatment. FCT continued until appropriate behavior persisted and destructive behavior failed to recur at baseline levels during extinction probes. The completion of FCT was followed by four challenges to the persistence of treatment effects conducted within mixed- or multiple-schedule designs: (a) extended extinction sessions (from 5 to 15 min), (b) introduction of a novel task, (c) removal of the microswitch and communication card, and (d) a mixed schedule of reinforcement in which both appropriate and destructive behavior produced reinforcement. The results showed that although FCT often resulted in quick reductions in destructive behavior and increases in appropriate behavior, destructive behavior often recurred during the extinction probes conducted during the initial treatment. When the effects of treatment persisted during the extinction probes, the remaining challenges to treatment effects resulted in only mild to moderate disruptions in behavior. These results are consistent with the quantitative predictions of behavioral momentum theory and may provide an alternative definition of maintenance as constituting behavioral persistence.

  13. Evaluation of the long-term oral consequences of equine exodontia in 50 horses.

    PubMed

    Townsend, Neil B; Dixon, Padraic M; Barakzai, Safia Z

    2008-12-01

    The aims of this study were to objectively evaluate and quantify the process of post-extraction cheek teeth (CT) dental drift in horses, and to report on associated disorders of CT wear and long-term periodontal health. Fifty horses that had CT oral extraction because of apical infection were prospectively re-examined and a full oral examination, including measurements of some dental parameters, was performed. Narrowing of the extraction space was noted in all cases with complete closure occurring in 18% of horses. The rate of dental drift was calculated as 15.7% of extraction space/year (range 4-50%) and was not associated with the age at extraction (P=0.78) or frequency of dental care since extraction (P=0.48). There was a significant negative relationship between the rate of dental drift and the duration of time since extraction (P=0.008). Overgrowths were present on the opposite CT row in 98% of horses, including opposite the extracted CT and on the Triadan 06s and 11s. No significant difference was noted in either the number of diastemata (P=0.9) or periodontal disease score (P=0.8) between the extraction and the contralateral cheek tooth rows.

  14. Long-term evaluation of direct repair of traumatic isthmic aortic transection.

    PubMed

    Fernandez, G; Fontan, F; Deville, C; Madonna, F; Thibaud, D

    1989-01-01

    Direct repair of traumatic aortic isthmic transection eliminates the late complications of prosthetic graft repair. This study evaluates the long-term fate of direct aortic repair to which little attention has been paid. Among 32 patients operated upon from 1965 to 1987, 27 (84%) underwent direct repair. The tear was circumferential in 15 patients and partial in 12. Multiple traumatic lesions were present in 26 patients, including intracranial injury in 19. Partial cardiopulmonary bypass was used in 15 patients and simple aortic cross-clamping in 12. No paraplegia was observed. There were 4 deaths from associated lesions among the 14 patients operated upon for acute traumatic isthmic transection and no deaths in the others. Among the 23 survivors, 4 were lost to follow-up; the other 19 patients have excellent clinical results. Intravenous digital aortic angiography performed in 14 patients at a mean delay of 5 years 3 months showed excellent aortic reconstruction in all cases. Technically more demanding and faster than a graft interposition, direct repair is recommended as the procedure of choice in the surgical treatment of traumatic isthmic transection, particularly in young patients, the group most at risk from this lesion.

  15. Preventing child obesity: a long-term evaluation of the HENRY approach.

    PubMed

    Brown, Rebecca E; Willis, Thomas A; Aspinall, Nichola; Candida, Hunt; George, Jackie; Rudolf, Mary C J

    2013-07-01

    Childhood obesity has reached epidemic levels, yet many health professionals lack confidence in working with parents around lifestyle change. HENRY (Health Exercise Nutrition for the Really Young) aims to tackle this through training practitioners to work more effectively with parents of preschoolers around obesity and lifestyle issues.We evaluated the long-term impact of HENRY training on health professionals' knowledge, skills and confidence in tackling obesity prevention. All practitioners trained 2007-11 (n = 1601) were invited to complete an online survey. 237 emails (14.8%) were undeliverable; 354 (26.0%) of the remainder completed the survey. A majority (67%) reported using knowledge and skills gained on a regular basis in their professional lives. Sessions on the importance of empathy and key parenting skills were considered particularly useful, with 78% and 74% respectively reporting regular use of these skills. Effects on respondents' personal lives were also reported: 61% applied the knowledge and skills at home, identifying for example, more shared family mealtimes and reduced portion sizes. The impact endures, with 71% of those undergoing training > 12 months ago, stating that they continued to use concepts in their professional lives. The findings suggest that brief training can have a sustained impact on practitioners' professional and personal lives.

  16. Transition of municipal sludge anaerobic digestion from mesophilic to thermophilic and long-term performance evaluation.

    PubMed

    Tezel, Ulas; Tandukar, Madan; Hajaya, Malek G; Pavlostathis, Spyros G

    2014-10-01

    Strategies for the transition of municipal sludge anaerobic digestion from mesophilic to thermophilic were assessed and the long-term stability and performance of thermophilic digesters operated at a solids retention time of 30days were evaluated. Transition from 36°C to 53.3°C at a rate of 3°C/day resulted in fluctuation of the daily gas and volatile fatty acids (VFAs) production. Steady-state was reached within 35days from the onset of temperature increase. Transitions from either 36 or 53.3°C to 60°C resulted in relatively stable daily gas production, but VFAs remained at very high levels (in excess of 5000mg COD/L) and methane production was lower than that of the mesophilic reactor. It was concluded that in order to achieve high VS and COD destruction and methane production, the temperature of continuous-flow, suspended growth digesters fed with mixed municipal sludge should be kept below 60°C.

  17. An Evaluation of Persistence of Treatment Effects During Long-Term Treatment of Destructive Behavior

    PubMed Central

    Wacker, David P; Harding, Jay W; Berg, Wendy K; Lee, John F; Schieltz, Kelly M; Padilla, Yaniz C; Nevin, John A; Shahan, Timothy A

    2011-01-01

    Eight young children who displayed destructive behavior maintained, at least in part, by negative reinforcement received long-term functional communication training (FCT). During FCT, the children completed a portion of a task and then touched a communication card attached to a microswitch to obtain brief breaks. Prior to and intermittently throughout FCT, extinction probes were conducted within a withdrawal design in which task completion, manding, and destructive behavior were placed on extinction to evaluate the relative persistence of appropriate and destructive behavior over the course of treatment. FCT continued until appropriate behavior persisted and destructive behavior failed to recur at baseline levels during extinction probes. The completion of FCT was followed by four challenges to the persistence of treatment effects conducted within mixed- or multiple-schedule designs: (a) extended extinction sessions (from 5 to 15 min), (b) introduction of a novel task, (c) removal of the microswitch and communication card, and (d) a mixed schedule of reinforcement in which both appropriate and destructive behavior produced reinforcement. The results showed that although FCT often resulted in quick reductions in destructive behavior and increases in appropriate behavior, destructive behavior often recurred during the extinction probes conducted during the initial treatment. When the effects of treatment persisted during the extinction probes, the remaining challenges to treatment effects resulted in only mild to moderate disruptions in behavior. These results are consistent with the quantitative predictions of behavioral momentum theory and may provide an alternative definition of maintenance as constituting behavioral persistence. PMID:21909168

  18. Long-Term Impact of Community-Based Information, Education and Communication Activities on Food Hygiene and Food Safety Behaviors in Vietnam: A Longitudinal Study

    PubMed Central

    Takanashi, Kumiko; Quyen, Dao To; Le Hoa, Nguyen Thi; Khan, Nguyen Cong; Yasuoka, Junko; Jimba, Masamine

    2013-01-01

    Background Ingestion of contaminated water or food is a major contributor to childhood diarrhea in developing countries. In Vietnam, the use of community-based information, education and communication (IEC) activities could be a sustainable strategy to improve food hygiene and food safety behaviors. This study thus examined the long-term impact of community-based IEC activities on food hygiene and food safety behaviors. Methods In this longitudinal study, we interviewed caregivers of children aged between six months and four years in suburban Hanoi. Baseline data were collected in January 2006 (n = 125). After conducting IEC interventions, we collected a 1st set of evaluation data in January 2007 (n = 132). To examine the long-term impact of the interventions, we then collected a 2nd set of evaluation data in January 2008 (n = 185). Changes in childhood diarrhea prevalence, IEC coverage, and food hygiene and food safety behaviors were assessed over a two-year period using bivariate and logistic regression analyses. Effective IEC channels were determined through multiple linear regression analysis. Results Childhood diarrhea was significantly reduced from 21.6% at baseline to 7.6% at the 1st post-intervention evaluation (P = 0.002), and to 5.9% at the 2nd evaluation. Among 17 food hygiene and food safety behaviors measured, a total of 11 behaviors were improved or maintained by the 2nd evaluation. Handwashing after toilet use was significantly improved at both evaluation points. Overall, 3 food safety behaviors and 7 food hygiene behaviors were found to have significantly improved at the 1st and at the 2nd evaluations, respectively. Flip chart communication administered by community groups was identified to be the most effective IEC channel for effecting behavior change (P = 0.018). Conclusions Flip chart communication administered by community groups is effective for improving multiple food hygiene and food safety behaviors in sustainable ways

  19. Longitudinal study to assess the safety and efficacy of a live-attenuated SHIV vaccine in long term immunized rhesus macaques

    SciTech Connect

    Yankee, Thomas M. Sheffer, Darlene; Liu Zhengian; Dhillon, Sukhbir; Jia Fenglan; Chebloune, Yahia; Stephens, Edward B.; Narayan, Opendra

    2009-01-05

    Live-attenuated viruses derived from SIV and SHIV have provided the most consistent protection against challenge with pathogenic viruses, but concerns regarding their long-term safety and efficacy have hampered their clinical usefulness. We report a longitudinal study in which we evaluated the long-term safety and efficacy of {delta}vpuSHIV{sub PPC}, a live virus vaccine derived from SHIV{sub PPC}. Macaques were administered two inoculations of {delta}vpuSHIV{sub PPC}, three years apart, and followed for eight years. None of the five vaccinated macaques developed an AIDS-like disease from the vaccine. At eight years, macaques were challenged with pathogenic SIV and SHIV. None of the four macaques with detectable cellular-mediated immunity prior to challenge had detectable viral RNA in the plasma. This study demonstrates that multiple inoculations of a live vaccine virus can be used safely and can significantly extend the efficacy of the vaccine, as compared to a single inoculation, which is efficacious for approximately three years.

  20. Evaluation of the antipsychotic medication review process at four long-term facilities in Alberta

    PubMed Central

    Birney, Arden; Charland, Paola; Cole, Mollie; Aslam Arain, Mubashir

    2016-01-01

    Purpose The goal of this evaluation was to understand how four long-term care (LTC) facilities in Alberta have implemented medication reviews for the Appropriate Use of Antipsychotics (AUA) initiative. We aimed to determine how interprofessional (IP) collaboration was incorporated in the antipsychotic medication reviews and how the reviews had been sustained. Methods Four LTC facilities in Alberta participated in this evaluation. We conducted semistructured interviews with 18 facility staff and observed one antipsychotic medication review at each facility. We analyzed data according to the following key components that we identified as relevant to the antipsychotic medication reviews: the structure of the reviews, IP interactions between the staff members, and strategies for sustaining the reviews. Results The duration of antipsychotic medication reviews ranged from 1 to 1.5 hours. The number of professions in attendance ranged from 3 to 9; a pharmacist led the review at two sites, while a registered nurse led the review at one site and a nurse practitioner at the remaining site. The number of residents discussed during the review ranged from 6 to 20. The process at some facilities was highly IP, demonstrating each of the six IP competencies. Other facilities conducted the review in a less IP manner due to challenges of physician involvement and staff workload, particularly of health care aides. Facilities that had an nurse practitioner on site were more efficient with the process of implementing recommendations resulting from the medication reviews. Conclusion The LTC facilities were successful in implementing the medication review process and the process seemed to be sustainable. A few challenges were observed in the implementation process at two facilities. IP practice moved forward the goals of the AUA initiative to reduce the inappropriate use of antipsychotics. PMID:27785044

  1. Evaluating and ranking threats to the long-term persistence of polar bears

    USGS Publications Warehouse

    Atwood, Todd C.; Marcot, Bruce G.; Douglas, David C.; Amstrup, Steven C.; Rode, Karyn D.; Durner, George M.; Bromaghin, Jeffrey F.

    2015-01-01

    The polar bear (Ursus maritimus) was listed as a globally threatened species under the U.S. Endangered Species Act (ESA) in 2008, mostly due to the significant threat to their future population viability from rapidly declining Arctic sea ice. A core mandate of the ESA is the development of a recovery plan that identifies steps to maintain viable populations of a listed species. A substantive evaluation of the relative influence of putative threats to population persistence is helpful to recovery planning. Because management actions must often be taken in the face of substantial information gaps, a formalized evaluation hypothesizing potential stressors and their relationships with population persistence can improve identification of relevant conservation actions. To this end, we updated a Bayesian network model previously used to forecast the future status of polar bears worldwide. We used new information on actual and predicted sea ice loss and polar bear responses to evaluate the relative influence of plausible threats and their mitigation through management actions on the persistence of polar bears in four ecoregions. We found that polar bear outcomes worsened over time through the end of the century under both stabilized and unabated greenhouse gas (GHG) emission pathways. Under the unabated pathway (i.e., RCP 8.5), the time it took for polar bear populations in two of four ecoregions to reach a dominant probability of greatly decreased was hastened by about 25 years. Under the stabilized GHG emission pathway (i.e., RCP 4.5), where GHG emissions peak around the year 2040, the polar bear population in the Archipelago Ecoregion of High Arctic Canada never reached a dominant probability of greatly decreased, reinforcing earlier suggestions of this ecoregion’s potential to serve as a long-term refugium. The most influential drivers of adverse polar bear outcomes were declines to overall sea ice conditions and to the marine prey base. Improved sea ice conditions

  2. Evaluating Methods of Updating Training Data in Long-Term Genomewide Selection.

    PubMed

    Neyhart, Jeffrey L; Tiede, Tyler; Lorenz, Aaron J; Smith, Kevin P

    2017-03-17

    Genomewide selection is hailed for its ability to facilitate greater genetic gains per unit time. Over breeding cycles, the requisite linkage disequilibrium (LD) between quantitative trait loci (QTL) and markers is expected to change as a result of recombination, selection, and drift, leading to a decay in prediction accuracy. Previous research has identified the need to update the training population using data that may capture new LD generated over breeding cycles, however optimal methods of updating have not been explored. In a barley (Hordeum vulgare L.) breeding simulation experiment, we examined prediction accuracy and response to selection when updating the training population each cycle with the best predicted lines, the worst predicted lines, both the best and worst predicted lines, random lines, criterion-selected lines, or no lines. In the short-term, we found that updating with the best predicted lines or the best and worst predicted lines resulted in high prediction accuracy and genetic gain, but in the long-term, all methods (besides not updating) performed similarly. We also examined the impact of including all data in the training population or only the most recent data. Though patterns among update methods were similar, using a smaller, but more recent training population provided a slight advantage in prediction accuracy and genetic gain. In an actual breeding program, a breeder might desire to gather phenotypic data on lines predicted to be the best, perhaps to evaluate possible cultivars. Therefore, our results suggest that an optimal method of updating the training population is also very practical.

  3. Long-term geochemical evaluation of the coastal Chicot aquifer system, Louisiana, USA

    NASA Astrophysics Data System (ADS)

    Borrok, David M.; Broussard, Whitney P.

    2016-02-01

    Groundwater is increasingly being overdrafted in the Gulf and Atlantic Coastal regions of the United States. Geochemical data associated with groundwater in these aquifers can provide important information on changes in salinity, recharge, and reaction pathways that can be used to improve water management strategies. Here we evaluated long-term geochemical changes associated with the 23,000 km2 Chicot aquifer system in Louisiana, USA. The Chicot aquifer is currently being overdrafted by about 1,320,000 m3 per day. We compiled selected bulk geochemical data from samples collected from 20 wells in the Chicot aquifer from 1993 to 2015. Oxygen and hydrogen isotope measurements were additionally completed for the 2014 samples. We identified three zones of groundwater with distinctive geochemical character; (1) A groundwater recharge zone in the northern part of the study area with low pH, low salinity, and low temperature relative to other groundwater samples, (2) a groundwater recharge zone in the southeastern part of the study area with low temperature, high alkalinity, and higher Ca and Mg concentrations compared to the other groundwater samples, and (3) groundwater in the southwestern part of the aquifer system with high salinity, high temperature, and a ∼1:1 Na/Cl ratio. The geochemistry of these regions has been relatively stable over the last ∼20 years. However, in the drought year of 2011, the estimated extent of zones with elevated salinity increased substantially. Geochemical evidence suggests that there was increased infiltration of deeper, more salt-rich waters into the shallower Chicot aquifer.

  4. Long-term results of radiotherapy for periarthritis of the shoulder: a retrospective evaluation

    PubMed Central

    Niewald, Marcus; Fleckenstein, Jochen; Naumann, Susanne; Ruebe, Christian

    2007-01-01

    Background To evaluate retrospectively the results of radiotherapy for periarthritis of the shoulder Methods In 1983–2004, 141 patients were treated, all had attended at least one follow-up examination. 19% had had pain for several weeks, 66% for months and 14% for years. Shoulder motility was impaired in 137/140 patients. Nearly all patients had taken oral analgesics, 81% had undergone physiotherapy, five patients had been operated on, and six had been irradiated. Radiotherapy was applied using regular anterior-posterior opposing portals and Co-60 gamma rays or 4 MV photons. 89% of the patients received a total dose of 6 Gy (dose/fraction of 1 Gy twice weekly, the others had total doses ranging from 4 to 8 Gy. The patients and the referring doctors were given written questionnaires in order to obtain long-term results. The mean duration of follow-up was 6.9 years [0–20 years]. Results During the first follow-up examination at the end of radiotherapy 56% of the patients reported pain relief and improvement of motility. After in median 4.5 months the values were 69 and 89%, after 3.9 years 73% and 73%, respectively. There were virtually no side effects. In the questionnaires, 69% of the patients reported pain relief directly after radiotherapy, 31% up to 12 weeks after radiotherapy. 56% of the patients stated that pain relief had lasted for "years", in further 12% at least for "months". Conclusion Low-dose radiotherapy for periarthropathy of the shoulder was highly effective and yielded long-lasting improvement of pain and motility without side effects. PMID:17868446

  5. Development and evaluation of a modis vegetation index compositing algorithm for long-term climate studies

    NASA Astrophysics Data System (ADS)

    Solano Barajas, Ramon

    radiometers. Lastly, we evaluated the performance of the proposed algorithm for detecting inter-annual VI anomalies from long-term time series, as compared with current MODIS VI C5. For this, we analyzed the EVI anomalies from a densely vegetated evergreen region, for the period July--September (2000--2010). Results showed a high general similarity between results from both algorithms, but also systematic differences, suggesting that proposed algorithm towards C6 may represent an advance in the reduction of uncertainties for the MODIS VI product.

  6. DEVELOMENT AND EVALUATION OF A MODEL FOR ESTIMATING LONG-TERM AVERAGE OZONE EXPOSURES TO CHILDREN

    EPA Science Inventory

    Long-term average exposures of school-age children can be modelled using longitudinal measurements collected during the Harvard Southern California Chronic Ozone Exposure Study over a 12-month period: June, 1995-May, 1996. The data base contains over 200 young children with perso...

  7. Long-Term Evaluation of a Life Skills Approach for Alcohol and Drug Abuse Prevention.

    ERIC Educational Resources Information Center

    Brochu, Serge; Souliere, Michelle

    1988-01-01

    Three-day life skills re-education program, embedded in 10-week new employee basic training had no long-term effects on alcohol and drug knowledge and attitudes. Findings suggest that primary prevention program targeting adults may be too late to affect alcohol and drug habits, life skills approach may work best in secondary prevention efforts,…

  8. Evaluation of long-term bedload virtual velocity in gravel-bed rivers (Ardenne, Belgium)

    NASA Astrophysics Data System (ADS)

    Houbrechts, Geoffrey; Levecq, Yannick; Peeters, Alexandre; Hallot, Eric; Van Campenhout, Jean; Denis, Anne-Cécile; Petit, François

    2015-12-01

    In many gravel-bed rivers, bed material transfer has been interrupted or perturbed by anthropogenic activities. Currently, restoration projects are being conducted in many countries in order to re-establish bedload continuity. However, until now, few studies have provided indications of the velocity of bed material over the long-term (at least decade to century time-scale). In the context of river restoration projects (e.g. weir removal, addition of spawning gravel), these data are nevertheless crucial to predict the downstream propagation of the geomorphological and biological benefits (e.g. supply-transport equilibrium, morphological and substratum diversity). In our study, PIT-tag tracers were used in eight medium-sized gravel-bed rivers (Ardenne Region, Belgium) to propose a flow competence relationship based on specific stream power, on the one hand, and to determine the long-term virtual velocity of the bed material corresponding to the median diameter (D50) of the surface layer of riffles, on the other hand. After each flow event that exceeded the threshold for sediment entrainment, tagged particles were sought and located, even when they were buried in the subsurface layer. Afterwards, all of the data were used to estimate the virtual velocity of the bed material over the long-term using three approaches. Finally, the results were compared with long-term transport estimations based on iron slag dispersed by the rivers since the end of the middle ages.

  9. An Evaluation of Persistence of Treatment Effects during Long-Term Treatment of Destructive Behavior

    ERIC Educational Resources Information Center

    Wacker, David P.; Harding, Jay W.; Berg, Wendy K.; Lee, John F.; Schieltz, Kelly M.; Padilla, Yaniz C.; Nevin, John A.; Shahan, Timothy A.

    2011-01-01

    Eight young children who displayed destructive behavior maintained, at least in part, by negative reinforcement received long-term functional communication training (FCT). During FCT, the children completed a portion of a task and then touched a communication card attached to a microswitch to obtain brief breaks. Prior to and intermittently…

  10. Evaluating the Impact of Supplemental Instruction on Short- and Long-Term Retention of Course Content

    ERIC Educational Resources Information Center

    Price, Jodi; Lumpkin, Amber G.; Seemann, Eric A.; Bell, Diana Calhoun

    2012-01-01

    Findings from prior research in various content domains have indicated that Peer Assisted Study Sessions (PASS) attendees earned higher final grades than non-attendees. However, what makes PASS effective remains unknown; for example, PASS could improve short-term retention but hinder long-term maintenance of course content given that some methods…

  11. Evaluation of long term solar activity effects on GPS derived TEC

    NASA Astrophysics Data System (ADS)

    Mansoori, Azad A.; Khan, Parvaiz A.; Ahmad, Rafi; Atulkar, Roshni; M, Aslam A.; Bhardwaj, Shivangi; Malvi, Bhupendra; Purohit, P. K.; Gwal, A. K.

    2016-10-01

    The solar activity hence the solar radiance follows a long term periodic variability with eleven years periodicity, known as solar cycle. This drives the long term variability of the ionosphere. In the present problem we investigate the long term behaviour of the ionosphere with the eleven year cyclic solar activity. Under the present study we characterize the ionospheric variability by Total Electron Content (TEC) using measurements made by Global Positioning System (GPS) and solar cycle variability by various solar activity indices. We make use of five solar activity indices viz. sunspot number (Rz), solar radio Flux (F10.7 cm), EUV Flux (26-34 nm), flare index and CME occurrences. The long term variability of these solar activity indices were then compared and correlated with the variability of ionospheric TEC, at a mid latitude station, Usuda (36.13N, 138.36E), of Japan, during the solar cycle 23 and ascending phase of cycle 24. From our study, we found that long term changes in the ionospheric TEC vary synchronously with corresponding changes in the solar activity indices. The correlation analysis shows that all the solar activity indices exhibit a very strong correlation with TEC (R =0.76 -0.99). Moreover the correlation between the two is stronger in the descending phase of the solar cycle. The correlation is found to be remarkably strongest during the deep minimum of the solar cycle 24 i.e. between 2007- 2009. Also we noticed a hysteresis effect exists with solar radio flux (F10.7 cm) and solar EUV flux (26-34 nm). This effect is absent with other parameters.

  12. Evaluation of long-term water-level declines in basalt aquifers near Mosier, Oregon

    USGS Publications Warehouse

    Burns, Erick R.; Morgan, David S.; Lee, Karl K.; Haynes, Jonathan V.; Conlon, Terrence D.

    2012-01-01

    are not sustainable, (2) well construction practices that have resulted in leakage from aquifers into springs and streams, and (3) reduction in aquifer recharge resulting from long-term climate variations. Historical well construction practices, specifically open, unlined, uncased boreholes that result in cross-connecting (or commingling) multiple aquifers, allow water to flow between these aquifers. Water flowing along the path of least resistance, through commingled boreholes, allows the drainage of aquifers that previously stored water more efficiently. The study area is in the eastern foothills of the Cascade Range in north central Oregon in a transitional zone between the High Cascades to the west and the Columbia Plateau to the east. The 78-square mile (mi2) area is defined by the drainages of three streams - Mosier Creek (51.8 mi2), Rock Creek (13.9 mi2), and Rowena Creek (6.9 mi2) - plus a small area that drains directly to the Columbia River.The three major components of the study are: (1) a 2-year intensive data collection period to augment previous streamflow and groundwater-level measurements, (2) precipitation-runoff modeling of the watersheds to determine the amount of recharge to the aquifer system, and (3) groundwater-flow modeling and analysis to evaluate the cause of groundwater-level declines and to evaluate possible water resource management strategies. Data collection included the following: 1. Water-level measurements were made in 37 wells. Bi-monthly or quarterly measurements were made in 30 wells, and continuous water-level monitoring instruments were installed in 7 wells. The measurements principally were made to capture the seasonal patterns in the groundwater system, and to augment the available long-term record. 2. Groundwater pumping was measured, reported, or estimated from irrigation, municipal and domestic wells. Flowmeters were installed on 74 percent of all high-capacity irrigation wells in the study area. 3. Borehole geophysical data

  13. Evaluation of Long Term Effect of RV Apical Pacing on Global LV Function by Echocardiography

    PubMed Central

    Tilkar, Mahendra; Jain, Siddhant; Mondal, Subrata; Sarkar, Piyabi; Modi, Nitin

    2016-01-01

    Introduction We very often face pacemaker implanted patients during follow-up with shortness of breath and effort intolerance inspite of normal clinical parameters. Aim The aim of our study is to evaluate the cause of effort intolerance and probable cause of sub-clinical Congestive Cardiac Failure (CCF) in a case of long term Right Ventricular (RV) apical pacing on global Left Ventricular (LV) function non- invasively by echocardiography. Materials and Methods We studied 54 patients (Male 42, Female 12) of complete heart block (CHB) with RV apical pacing (40 VVI and 14 DCP). Mean duration of pacing was 58+4 months. All patients underwent 24 hours Holter monitoring to determine the percentage of ventricular pacing beats. 2-D Echocardiography was done to assess the regional wall motion of abnormality and global LV ejection fraction by modified Simpson’s rule. These methods were coupled with the Doppler derived Myocardial Performance Index (MPI), tissue Doppler imaging, and mechanical regional dyssynchrony with 3-D Echocardiography. Data were analysed from 54 RV- apical paced patients and compared with age and body surface area of 60 controlled subjects (Male 46, Female 14). Results Evaluation of LV function in 54 patients demonstrated regional wall motion abnormality and Doppler study revealed both LV systolic and diastolic dysfunction compare with control subjects (regional wall motion abnormality 80±6% vs 30±3% with p-value<0.0001) which is proportional to the percentage of ventricular pacing beats (mean paced beat 78%). Global LVEF 50±4% vs 60±2% (p-valve <0.0001) and MPI 0.46 ±0.12 v/s 0.36±0.09 (p-value <0.0001). Conclusion RV–apical pacing induces iatrogenic electrical dyssynchrony which leads to remodeling of LV and produces mechanical dyssynchrony which is responsible for LV dysfunction. Alternate site of RV pacing and/or biventricular pacing should be done to maintain biventricular electrical synchrony which will preserve the LV function. PMID

  14. Evaluation of Late Adverse Events in Long-Term Wilms' Tumor Survivors

    SciTech Connect

    Dijk, Irma van; Oldenburger, Foppe; Cardous-Ubbink, Mathilde C.; Geenen, Maud M.

    2010-10-01

    Purpose: To evaluate the prevalence and severity of adverse events (AEs) and treatment-related risk factors in long-term Wilms' tumor (WT) survivors, with special attention to radiotherapy. Methods and Materials: The single-center study cohort consisted of 185 WT survivors treated between 1966 and 1996, who survived at least 5 years after diagnosis. All survivors were invited to a late-effects clinic for medical assessment of AEs. AEs were graded for severity in a standardized manner. Detailed radiotherapy data enabled us to calculate the equivalent dose in 2 Gy fractions (EQD{sub 2}) to compare radiation doses in a uniform way. Risk factors were evaluated with multivariate logistic regression analysis. Results: Medical follow-up was complete for 98% of survivors (median follow-up, 18.9 years; median attained age, 22.9 years); 123 survivors had 462 AEs, of which 392 had Grade 1 or 2 events. Radiotherapy to flank/abdomen increased the risk of any AE (OR, 1.08 Gy{sup -1} [CI, 1.04-1.13]). Furthermore, radiotherapy to flank/abdomen was associated with orthopedic events (OR, 1.09 Gy{sup -1} [CI, 1.05-1.13]) and second tumors (OR, 1.11 Gy{sup -1} [CI, 1.03-1.19]). Chest irradiation increased the risk of pulmonary events (OR, 1.14 Gy{sup -1} [CI, 1.06-1.21]). Both flank/abdominal and chest irradiation were associated with cardiovascular events (OR, 1.05 Gy{sup -1} [CI, 1.00-1.10], OR, 1.06 Gy{sup -1} [CI, 1.01-1.12]) and tissue hypoplasia (OR, 1.17 Gy{sup -1} [CI, 1.10-1.24], OR 1.10 Gy{sup -1} [CI, 1.03-1.18]). Conclusion: The majority of AEs, overall as well as in irradiated survivors, were mild to moderate. Nevertheless, the large amount of AEs emphasizes the importance of follow-up programs for WT survivors.

  15. Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension

    PubMed Central

    Santos, Raul D.; Duell, P. Barton; East, Cara; Guyton, John R.; Moriarty, Patrick M.; Chin, Wai; Mittleman, Robert S.

    2015-01-01

    Aims To evaluate the efficacy and safety of extended dosing with mipomersen in patients with familial hypercholesterolaemia (HC) taking maximally tolerated lipid-lowering therapy. Methods and results A planned interim analysis of an ongoing, open-label extension trial in patients (n = 141) with familial HC receiving a subcutaneous injection of 200 mg mipomersen weekly plus maximally tolerated lipid-lowering therapy for up to 104 weeks. The mean changes in low-density lipoprotein cholesterol (LDL-C) from baseline to weeks 26 (n = 130), 52 (n = 111), 76 (n = 66), and 104 (n = 53) were −28, −27, −27, and −28%; and in apolipoprotein B −29, −28, −30, and −31%, respectively. Reductions in total cholesterol, non-high-density lipoprotein-cholesterol, and lipoprotein(a) were comparable with decreases in LDL-C and apolipoprotein B levels. Mean high-density lipoprotein cholesterol increased from baseline by 7 and 6% at weeks 26 and 52, respectively. The long-term safety profile of mipomersen was similar to that reported in the associated randomized placebo-controlled Phase 3 trials. Adverse events included injection site reactions and flu-like symptoms. There was an incremental increase in the median liver fat during the initial 6–12 months that appeared to diminish with continued mipomersen exposure beyond 1 year and returned towards baseline 24 weeks after last drug dose suggestive of adaptation. The median alanine aminotransferase level showed a similar trend over time. Conclusion Long-term treatment with mipomersen for up to 104 weeks provided sustained reductions in all atherosclerotic lipoproteins measured and a safety profile consistent with prior controlled trials in these high-risk patient populations. Clinicaltrials.gov NCT00694109. PMID:24366918

  16. Long-Term Safety and Adverse Events of Risperidone in Children, Adolescents, and Adults with Pervasive Developmental Disorders

    ERIC Educational Resources Information Center

    Hellings, Jessica A.; Cardona, Alicia M.; Schroeder, Stephen R.

    2010-01-01

    The objective of this study was to examine long-term adverse events of risperidone in 19 children, adolescents, and adults with Pervasive Developmental Disorders and intellectual disability, continuing risperidone for a mean of 186.5 weeks, following a 46-week risperidone study. Nineteen individuals continued long-term follow-up after our…

  17. The transplantation of human fetal neuroretinal cells in advanced retinitis pigmentosa patients: results of a long-term safety study.

    PubMed

    Das, T; del Cerro, M; Jalali, S; Rao, V S; Gullapalli, V K; Little, C; Loreto, D A; Sharma, S; Sreedharan, A; del Cerro, C; Rao, G N

    1999-05-01

    The purpose of this study was to determine the long-term safety of transplanting human fetal neuroretinal cells (14 to 18 week gestational age) into a series of patients with advanced retinitis pigmentosa (RP). After obtaining informed consent, both hosts and mothers of donors were screened for transmissible diseases. Pre- and postoperative clinical exams, visual acuity, electroretinograms, and fluorescein angiograms were performed and visual field testing was attempted in each case. Surgically, an anterior approach through pars plana ciliaris was used. A retinotomy was performed in the paramacular area and a two-function cannula was introduced into the subretinal space to deliver a suspension of donor cells. The cell suspension carried approximately 4000 cells/microl; the volume injected did not exceed 150 microl. The patients were examined for periods ranging from 12 to 40 months posttransplantation. To date, no evidence of inflammation, infection, or overt rejection of the graft was noted in the host eye, neither was any change observed in the contralateral, unoperated eye. In conclusion, neuroretinal cells were injected into the subretinal space of 14 patients with advanced RP with no clinical appearance of detrimental effects at the time of surgery or up to 40 months postinjection except in 1 patient who developed retinal detachment. This sets the stage for a phase II clinical trial to determine the possible beneficial effects of this procedure in patients blinded by degenerative retinal disease.

  18. Long-Term Effects of Outpatient Geriatric Evaluation and Management on Health Care Utilization, Cost, and Survival

    ERIC Educational Resources Information Center

    Engelhardt, Joseph B.; Toseland, Ronald W.; Gao, Jian; Banks, Steven

    2006-01-01

    Purpose: The long-term effectiveness and efficiency of an outpatient geriatric evaluation and management (GEM) program was compared to usual primary care (UPC). Design and Method: A randomized controlled group design was used. Health care utilization, cost of care, and survival were assessed during a 48-month period among a sample of 160 male…

  19. A Primary Nursing Model in Long-Term Care Facilities: Evaluation of Impact on Affect, Behavior, and Socialization.

    ERIC Educational Resources Information Center

    Teresi, Jeanne; And Others

    1993-01-01

    Implemented and evaluated primary care model of delivery of nursing aide care in small, rural nursing home and large, urban facility. Findings suggest that primary care nursing as applied to nursing attendants in long-term care was beneficial to residents in terms of decreasing disturbed behavior and improved affect. (Author/NB)

  20. Evaluating Indicator-Based Methods of "Measuring Long-Term Impacts of a Science Center on Its Community"

    ERIC Educational Resources Information Center

    Jensen, Eric Allen

    2016-01-01

    This article addresses some of the challenges faced when attempting to evaluate the long-term impact of informal science learning interventions. To contribute to the methodological development of informal science learning research, we critically examine (Falk and Needham (2011) "Journal of Research in Science Teaching," 48: 1-12.) study…

  1. Long-term efficacy and safety of atazanavir with stavudine and lamivudine in patients previously treated with nelfinavir or atazanavir.

    PubMed

    Wood, Robin; Phanuphak, Praphan; Cahn, Pedro; Pokrovskiy, Vadim; Rozenbaum, Willy; Pantaleo, Giuseppe; Sension, Michael; Murphy, Robert; Mancini, Marco; Kelleher, Thomas; Giordano, Michael

    2004-06-01

    The purpose of the study was to determine long-term efficacy, safety, and tolerability of atazanavir plus stavudine/lamivudine in 346 HIV-infected patients previously treated with atazanavir or nelfinavir. BMS AI424-044 is an ongoing, multicenter, international, open-label, rollover/switch study initiated in June 2001. Patients completing >or=48 weeks in trial BMS AI424-008 with a plasma HIV RNA viral load <10,000 copies/mL were eligible to continue on atazanavir (400 or 600 mg) or to switch from nelfinavir to atazanavir (400 mg) once daily. Antiviral efficacy, change in CD4 cell counts, and effect on lipid parameters were measured. After 24 weeks of atazanavir use in BMS AI424-044, 83%, 85%, and 87% of the atazanavir 400-mg, atazanavir 600-mg, and nelfinavir-to-atazanavir-switched patients, respectively, had HIV RNA levels <400 copies/mL compared with 76%, 76%, and 63%, respectively, at week 48 of BMS AI424-008. Atazanavir-treated patients showed minimal changes in lipid levels compared with baseline. Patients switched from nelfinavir to atazanavir showed significant mean percent decreases in total cholesterol (-16%), fasting low-density lipoprotein cholesterol (-21%), and fasting triglycerides (-28%) (P<0.0001) by week 12 of atazanavir treatment. No new safety issues were identified, and the overall incidence of treatment-emergent adverse events during BMS AI424-044 was comparable across treatment groups. Atazanavir was safe, tolerable, and effective during extended use and in patients switched from nelfinavir. Extended atazanavir use resulted in continued viral suppression and lipid changes that were not clinically relevant. In virologically suppressed nelfinavir-treated patients switched to atazanavir, virologic improvement continued, whereas nelfinavir-induced lipid elevations were reversed within 12 weeks, approaching pretreatment values.

  2. Comprehensive evaluation of long-term hydrological data sets: Constraints of the Budyko framework

    NASA Astrophysics Data System (ADS)

    Greve, Peter; Orlowsky, Boris; Seneviratne, Sonia I.

    2013-04-01

    An accurate estimate of the climatological land water balance is essential for a wide range of socio-economical issues. Despite the simplicity of the underlying water balance equation, its individual variables are of complex nature. Global estimates, either derived from observations or from models, of precipitation (P ) and especially evapotranspiration (ET) are characterized by high uncertainties. This leads to inconsistent results in determining conditions related to the land water balance and its components. In this study, we consider the Budyko framework as a constraint to evaluate long-term hydrological data sets within the period from 1984 to 2005. The Budyko framework is a well established empirically based relationsship between ET-P and Ep-P , with Ep being the potential evaporation. We use estimates of ET associated with the LandFlux-EVAL initiative (Mueller et. al., 2012), either derived from observations, CMIP5 models or land-surface models (LSMs) driven with observation-based forcing or atmospheric reanalyses. Data sets of P comprise all commonly used global observation-based estimates. Ep is determined by methods of differing complexity with recent global temperature and radiation data sets. Based on this comprehensive synthesis of data sets and methods to determine Ep, more than 2000 possible combinations for ET-P in conjunction with Ep-P are created. All combinations are validated against the Budyko curve and against physical limits within the Budyko phase space. For this purpose we develop an error measure based on the root mean square error which combines both constraints. We find that uncertainties are mainly induced by the ET data sets. In particular, reanalysis and CMIP5 data sets are characterized by low realism. The realism of LSMs is further not primarily controlled by the forcing, as different LSMs driven with the same forcing show significantly different error measures. Our comprehensive approach is thus suitable to detect uncertainties

  3. RHEUMATOID ARTHRITIS—An Evaluation of Long-Term Treatment with Cortisone

    PubMed Central

    Engleman, Ephraim P.; Krupp, Marcus A.; Saunders, William W.; Wilson, Lloyd E.; Fredell, Erling W.

    1954-01-01

    Fifty-six patients with rheumatoid arthritis were treated continuously with cortisone for periods ranging between 4 and 38 months, in daily doses of 15 to 100 mg. Concomitant therapy included periods of rest, physical therapy, and salicylates. The incidence of subjective improvement exceeded that of objective improvement. The incidence of objective improvement was higher in females; also, in those patients whose disease was in an early stage and of short duration at the time therapy was begun, and who required relatively smaller maintenance doses of cortisone. Therapeutic results were not affected by the age of the patient or by the presence of spondylitis. Despite precautions, the long-term administration of cortisone was, in some patients, productive of serious undesirable side-effects. Although cortisone usually suppressed the symptoms and signs of rheumatoid arthritis, progression of the disease was frequently noted during its long-term administration. ImagesFigure 1 PMID:13150213

  4. The long-term efficacy and safety of a testosterone mucoadhesive buccal tablet in testosterone-deficient men.

    PubMed

    Dinsmore, Wallace W; Wyllie, Michael G

    2012-07-01

    What's known on the subject? and What does the study add? Striant® SR is the only available buccal delivery system for testosterone replacement therapy. Previous pharmacokinetic studies have shown that Striant SR effectively produces physiological serum testosterone levels in hypogonadal men. Efficacy and safety data from previously unpublished studies over 2 years of continuous use indicate that Striant SR is effective long term in maintaining serum testosterone within a physiological range, is well tolerated and has a high level of patient acceptance. Striant® sustained-release (SR) is a mucoadhesive buccal tablet (30 mg testosterone, The Urology Company) that adheres to the gum surface in the mouth providing controlled- and sustained-release of testosterone over a 12-h dosing period, offering a unique and rational method of testosterone delivery. Striant SR is indicated for testosterone-replacement therapy (TRT) for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Pharmacokinetic studies have shown that testosterone is released from Striant SR in a manner similar to the normal daily rhythm of endogenous testosterone secretion, with serum levels rising rapidly after insertion and peak levels reached by the second 12-hourly dose with no accumulation over time. In clinical trials involving hypogonadal men receiving Striant SR for up to 2 years, mean serum testosterone levels have always remained within the normal range. Striant SR is well tolerated, with gum-related disorders (such as irritation, inflammation and gingivitis) and taste perversion being the most commonly reported adverse events, reported by 5.6-16.3% and 3.0-4.1% of patients, respectively. Once patients have become accustomed to it, Striant SR has a high level of patient acceptance. In a long-term study, 90% of patients rated the twice-daily dosing as acceptable, just under half preferred it to other forms of TRT that they have used and

  5. Retrospective Curriculum Evaluation: An Approach to Evaluation of Long Term Effects.

    ERIC Educational Resources Information Center

    Tamir, Pinchas; Amir, Ruth

    This study attempted to measure the functional availability of knowledge and skills acquired in high school biology as they affect the achievement of students in a first year university course. The study, referred to as retrospective curriculum evaluation, uses a self-assessment instrument, the Knowledge and Prior Study Inventory (KPSI). An…

  6. Evaluating the Long-Term Performance of Geosynethic Clay Liners Exposed to Freeze-Thaw

    SciTech Connect

    Robert K. Podgorney; Jesse E. Bennett

    2006-02-01

    Geosynethic clay liners have become an increasingly common component in landfill liner and cover systems since their introduction in the early 1980’s. An important consideration for landfills and covers constructed in the frost zone of cold climates is the possible deterioration in performance due to freeze-thaw cycling over the design life of the liner or cover system, which can be up to 1,000 years. The literature contains several examples showing that geosynethic clay liners can withstand a limited number of freeze-thaw events, but data on long-term performance are lacking The objective of this study was to examine the long-term performance of geosynethic clay liners exposed to repeated freeze-thaw cycles, encompassing their application as a final cover as well as a bottom liner. Laboratory analysis of hydraulic conductivity was performed after as many as 150 freeze-thaw cycles, with no appreciable changes observed. Based upon an analytical heat transfer analysis, this equates to [at least] 150 years of field service for placement depths greater then approximately 30 cm below the surface of the liner. The long-term insusceptibility of GCLs to increased hydraulic conductivity as a response to repeated freeze-thaw cycling is largely due to the self-healing characteristics of the sodium bentonite used in their construction. GCLs perform well and maintain efficiency as a barrier to flow after 150 freeze-thaw cycles. Other factors, such as permeant chemistry, physical disturbance, desiccation, etc., may be much more important factors to consider when planning for the long-term performance of GCLs.

  7. Evaluation of the Macroinvertebrate Component of the Long Term Resource Monitoring Program

    DTIC Science & Technology

    2005-12-01

    3 Data Management and Delivery ......................................................................... 5 Workshop Overview and Survey...models. The work stems from the management focus of the Workshop Overview and Survey Results LTRMP. Resource managers are concemed with the abundance of... Overview . Department of Commerce. McDonald L., T. McDonald, and D. Robertson. 55 pp. 1998. Review of the Denali National Park and Preserve (DENA) Long-Term

  8. Evaluating satellite-derived long-term historical precipitation datasets for drought monitoring in Chile

    NASA Astrophysics Data System (ADS)

    Zambrano, Francisco; Wardlow, Brian; Tadesse, Tsegaye; Lillo-Saavedra, Mario; Lagos, Octavio

    2017-04-01

    Precipitation is a key parameter for the study of climate change and variability and the detection and monitoring of natural disaster such as drought. Precipitation datasets that accurately capture the amount and spatial variability of rainfall is critical for drought monitoring and a wide range of other climate applications. This is challenging in many parts of the world, which often have a limited number of weather stations and/or historical data records. Satellite-derived precipitation products offer a viable alternative with several remotely sensed precipitation datasets now available with long historical data records (+30years), which include the Climate Hazards Group InfraRed Precipitation with Station (CHIRPS) and Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks-Climate Data Record (PERSIANN-CDR) datasets. This study presents a comparative analysis of three historical satellite-based precipitation datasets that include Tropical Rainfall Measuring Mission (TRMM) Multi-satellite Precipitation Analysis (TMPA) 3B43 version 7 (1998-2015), PERSIANN-CDR (1983-2015) and CHIRPS 2.0 (1981-2015) over Chile to assess their performance across the country and for the case of the two long-term products the applicability for agricultural drought were evaluated when used in the calculation of commonly used drought indicator as the Standardized Precipitation Index (SPI). In this analysis, 278 weather stations of in situ rainfall measurements across Chile were initially compared to the satellite data. The study area (Chile) was divided into five latitudinal zones: North, North-Central, Central, South-Central and South to determine if there were a regional difference among these satellite products, and nine statistics were used to evaluate their performance to estimate the amount and spatial distribution of historical rainfall across Chile. Hierarchical cluster analysis, k-means and singular value decomposition were used to analyze

  9. Medicare and Medicaid programs; fire safety requirements for long term care facilities, automatic sprinkler systems. Final rule.

    PubMed

    2008-08-13

    This final rule requires all long term care facilities to be equipped with sprinkler systems by August 13, 2013. Additionally, this final rule requires affected facilities to maintain their automatic sprinkler systems once they are installed.

  10. Evaluation of long-term gas hydrate production testing locations on the Alaska North Slope

    USGS Publications Warehouse

    Collett, Timothy S.; Boswell, Ray; Lee, Myung W.; Anderson, Brian J.; Rose, Kelly K.; Lewis, Kristen A.

    2012-01-01

    The results of short-duration formation tests in northern Alaska and Canada have further documented the energy-resource potential of gas hydrates and have justified the need for long-term gas-hydrate-production testing. Additional data acquisition and long-term production testing could improve the understanding of the response of naturally occurring gas hydrate to depressurization-induced or thermal-, chemical-, or mechanical-stimulated dissociation of gas hydrate into producible gas. The Eileen gashydrate accumulation located in the Greater Prudhoe Bay area in northern Alaska has become a focal point for gas-hydrate geologic and production studies. BP Exploration (Alaska) Incorporated and ConocoPhillips have each established research partnerships with the US Department of Energy to assess the production potential of gas hydrates in northern Alaska. A critical goal of these efforts is to identify the most suitable site for production testing. A total of seven potential locations in the Prudhoe Bay, Kuparuk River, and Milne Point production units were identified and assessed relative to their suitability as a long-term gas-hydrate-production test sites. The test-site-assessment criteria included the analysis of the geologic risk associated with encountering reservoirs for gas-hydrate testing. The site-selection process also dealt with the assessment of the operational/logistical risk associated with each of the potential test sites. From this review, a site in the Prudhoe Bay production unit was determined to be the best location for extended gas-hydrate-production testing. The work presented in this report identifies the key features of the potential test site in the Greater Prudhoe Bay area and provides new information on the nature of gas-hydrate occurrence and the potential impact of production testing on existing infrastructure at the most favorable sites. These data were obtained from well-log analysis, geological correlation and mapping, and numerical

  11. Evaluation of long-term gas hydrate production testing locations on the Alaska north slope

    USGS Publications Warehouse

    Collett, T.S.; Boswell, R.; Lee, M.W.; Anderson, B.J.; Rose, K.; Lewis, K.A.

    2011-01-01

    The results of short duration formation tests in northern Alaska and Canada have further documented the energy resource potential of gas hydrates and justified the need for long-term gas hydrate production testing. Additional data acquisition and long-term production testing could improve the understanding of the response of naturally-occurring gas hydrate to depressurization-induced or thermal-, chemical-, and/or mechanical-stimulated dissociation of gas hydrate into producible gas. The Eileen gas hydrate accumulation located in the Greater Prudhoe Bay area in northern Alaska has become a focal point for gas hydrate geologic and production studies. BP Exploration (Alaska) Incorporated and ConocoPhillips have each established research partnerships with U.S. Department of Energy to assess the production potential of gas hydrates in northern Alaska. A critical goal of these efforts is to identify the most suitable site for production testing. A total of seven potential locations in the Prudhoe Bay, Kuparuk, and Milne Point production units were identified and assessed relative to their suitability as a long-term gas hydrate production test site. The test site assessment criteria included the analysis of the geologic risk associated with encountering reservoirs for gas hydrate testing. The site selection process also dealt with the assessment of the operational/logistical risk associated with each of the potential test sites. From this review, a site in the Prudhoe Bay production unit was determined to be the best location for extended gas hydrate production testing. The work presented in this report identifies the key features of the potential test site in the Greater Prudhoe Bay area, and provides new information on the nature of gas hydrate occurrence and potential impact of production testing on existing infrastructure at the most favorable sites. These data were obtained from well log analysis, geological correlation and mapping, and numerical simulation

  12. Evaluation of long-term gas hydrate production testing locations on the Alaska North Slope

    USGS Publications Warehouse

    Collett, Timothy; Boswell, Ray; Lee, Myung W.; Anderson, Brian J.; Rose, Kelly K.; Lewis, Kristen A.

    2011-01-01

    The results of short duration formation tests in northern Alaska and Canada have further documented the energy resource potential of gas hydrates and justified the need for long-term gas hydrate production testing. Additional data acquisition and long-term production testing could improve the understanding of the response of naturally-occurring gas hydrate to depressurization-induced or thermal-, chemical-, and/or mechanical-stimulated dissociation of gas hydrate into producible gas. The Eileen gas hydrate accumulation located in the Greater Prudhoe Bay area in northern Alaska has become a focal point for gas hydrate geologic and production studies. BP Exploration (Alaska) Incorporated and ConocoPhillips have each established research partnerships with U.S. Department of Energy to assess the production potential of gas hydrates in northern Alaska. A critical goal of these efforts is to identify the most suitable site for production testing. A total of seven potential locations in the Prudhoe Bay, Kuparuk, and Milne Point production units were identified and assessed relative to their suitability as a long-term gas hydrate production test site. The test site assessment criteria included the analysis of the geologic risk associated with encountering reservoirs for gas hydrate testing. The site selection process also dealt with the assessment of the operational/logistical risk associated with each of the potential test sites. From this review, a site in the Prudhoe Bay production unit was determined to be the best location for extended gas hydrate production testing. The work presented in this report identifies the key features of the potential test site in the Greater Prudhoe Bay area, and provides new information on the nature of gas hydrate occurrence and potential impact of production testing on existing infrastructure at the most favorable sites. These data were obtained from well log analysis, geological correlation and mapping, and numerical simulation.

  13. Ophthalmic evaluation of long-term survivors of childhood acute lymphoblastic leukemia

    SciTech Connect

    Weaver, R.G. Jr.; Chauvenet, A.R.; Smith, T.J.; Schwartz, A.C.

    1986-08-15

    Thirty-four long-term survivors of childhood acute lymphoblastic leukemia (ALL) underwent comprehensive ophthalmic examinations to detect retinopathy or other ocular sequelae. Sixteen of the 34 patients received whole brain radiation (greater than or equal to 2400 rad). All 18 patients in the non-radiated group had normal eye examinations, while 4 of 16 in the radiated group had ocular abnormalities. None of the ocular abnormalities could be definitely attributed to radiation and all patients had normal visual acuity. No radiation retinopathy was found in either group.

  14. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care

    PubMed Central

    Urowitz, M; van Vollenhoven, R; Aranow, C; Fettiplace, J; Oldham, M; Wilson, B; Molta, C; Roth, D; Gordon, D

    2016-01-01

    Objective To examine long-term organ damage and safety following treatment with belimumab plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE). Methods Pooled data were examined from two ongoing open-label studies that enrolled patients who completed BLISS-52 or BLISS-76. Patients received belimumab every four weeks plus SoC. SLICC Damage Index (SDI) values were assessed every 48 weeks (study years) following belimumab initiation (baseline). The primary endpoint was change in SDI from baseline at study years 5–6. Incidences of adverse events (AEs) were reported for the entire study period. Results The modified intent-to-treat (MITT) population comprised 998 patients. At baseline, 940 (94.2%) were female, mean (SD) age was 38.7 (11.49) years, and disease duration was 6.7 (6.24) years. The mean (SD) SELENA-SLEDAI and SDI scores were 8.2 (4.18) and 0.7 (1.19), respectively; 411 (41.2%) patients had organ damage (SDI = 1: 235 (23.5%); SDI ≥ 2: 176 (17.6%)) prior to belimumab. A total of 427 (42.8%) patients withdrew overall; the most common reasons were patient request (16.8%) and AEs (8.5%). The mean (SD) change in SDI was +0.2 (0.48) at study years 5–6 (n = 403); 343 (85.1%) patients had no change from baseline in SDI score (SDI +1: 46 (11.4%), SDI +2: 13 (3.2%), SDI +3: 1 (0.2%)). Of patients without organ damage at baseline, 211/241 (87.6%) had no change in SDI and the mean change (SD) in SDI was +0.2 (0.44). Of patients with organ damage at baseline, 132/162 (81.5%) had no change in SDI and the mean (SD) change in SDI was +0.2 (0.53). The probability of not having a worsening in SDI score was 0.88 (95% CI: 0.85, 0.91) and 0.75 (0.67, 0.81) in those without and with baseline damage, respectively (post hoc analysis). Drug-related AEs were reported for 433 (43.4%) patients; infections/infestations (282, 28.3%) and gastrointestinal disorders (139, 13.9%) were the most common. Conclusion Patients with SLE treated with long-term

  15. Safety of long-term exposure to abiraterone acetate in patients with castration-resistant prostate cancer and concomitant cardiovascular risk factors

    PubMed Central

    Verzoni, Elena; Grassi, Paolo; Ratta, Raffaele; Niger, Monica; De Braud, Filippo; Valdagni, Riccardo; Procopio, Giuseppe

    2016-01-01

    Background: We aimed to evaluate the long-term safety profile of abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) with controlled cardiovascular comorbidities or risk factors. Methods: We retrospectively analysed the clinical charts of consecutive mCRPC patients with cardiac disorders/risk factors who had been treated with abiraterone 1000 mg once daily plus prednisone 5 mg twice daily for a median duration of 16 months at an oncology referral centre between April 2011 and July 2015. Patients underwent an electrocardiogram (ECG) and echocardiographic assessments, including measurement of left ventricular ejection fraction (LVEF) at baseline and at the end of treatment. Blood pressure (BP) was measured daily at home. During follow up (median 24 months), all adverse events were recorded. Cardiac events (CEs) were defined, according to Common Terminology Criteria for Adverse Events version 4.0, as the appearance of a symptomatic CE that required medical intervention. Results: A total of 51 patients (median age 71 years) were evaluated. Pre-existing cardiovascular conditions included hypertension (41%), cardiac ischaemia (12%), stroke (9%), dyslipidaemia (18%) and type 2 diabetes mellitus (12%). No CEs were recorded and no changes in LVEF were observed. The most frequently reported adverse events were Grade 1–2 fluid retention (18%), hypertension (16%) and asthenia (16%). No patients permanently discontinued abiraterone due to cardiac events. Conclusions: Long-term abiraterone treatment was well tolerated in mCRPC patients with controlled cardiovascular comorbidities/risk factors, with no apparent worsening of cardiovascular conditions from baseline over an extended observation period. PMID:27583024

  16. Incremental validity of neuropsychological evaluations to computed tomography in predicting long-term outcomes after traumatic brain injury.

    PubMed

    Williams, Michael W; Rapport, Lisa J; Hanks, Robin A; Millis, Scott R; Greene, Hillary A

    2013-01-01

    This study evaluated the incremental utility of neuropsychological tests to computed tomography (CT) in predicting long-term outcomes of adults with moderate to severe traumatic brain injury (TBI). Participants were 288 adults with mild complicated, moderate, and severe TBI. Longitudinal data were evaluated during inpatient status in an urban rehabilitation hospital with a TBI Model System, as well as 1 and 2 years post injury. Predictors including demographic characteristics, injury severity, CT characteristics, and neuropsychological evaluations were regressed to outcomes of disability, life satisfaction, and employment at 1 and 2 years post injury. Prediction of life satisfaction was not improved with the use of CT characteristics or neuropsychological tests, but prediction of return to work was improved by these variables at 2 years post injury. Neuropsychological evaluations uniquely contributed to outcome predictions of functional disability, even after considering demographic and injury severity characteristics, including information from CT. In contrast, CT characteristics were not predictive of long-term functional disability at 1 or 2 years post TBI. Taken together, the findings indicate that neuropsychological tests add unique predictive information for long-term functional outcomes after TBI.

  17. Long term storage of dilute acid pretreated corn stover feedstock and ethanol fermentability evaluation.

    PubMed

    Zhang, Jian; Shao, Shuai; Bao, Jie

    2016-02-01

    This study reported a new solution of lignocellulose feedstock storage based on the distributed pretreatment concept. The dry dilute sulfuric acid pretreatment (DDAP) was conducted on corn stover feedstock, instead of ammonia fiber explosion pretreatment. Then the dry dilute acid pretreated corn stover was stored for three months during summer season with high temperature and humidity. No negative aspects were found on the physical property, composition, hydrolysis yield and ethanol fermentability of the long term stored pretreated corn stover, plus the additional merits including no chemicals recovery operation, anti-microbial contaminant environment from stronger acid and inhibitor contents, as well as the mild and slow hydrolysis in the storage. The new pretreatment method expanded the distributed pretreatment concept of feedstock storage with potential for practical application.

  18. Long-Term Follow-Up of a Revascularized Immature Necrotic Tooth Evaluated by CBCT

    PubMed Central

    She, C. M. L.; Cheung, G. S. P.; Zhang, C. F.

    2016-01-01

    This case study reports the successful treatment of an immature upper premolar with periapical pathosis and sinus tract using revascularization technique. Clinical and radiographic examination demonstrated the recovery of vitality, continued root development, and periapical healing at the 7-month follow-up. In addition, severe calcification of the canal was noted at the 36-month follow-up. At the 66-month follow-up, cone-beam computed tomography (CBCT) revealed complete periapical healing, apical closure, increase in root length and thickness of dentin, and severe calcification of the root canal. Even though the nature of tissue within the root canal is unknown, revascularization appears to give good clinical and radiographic success. This case report highlights that severe calcification of the canal is one of the long-term outcomes of revascularized root canals. PMID:26949550

  19. Evaluating long-term performance of in situ vitrified waste forms: Methodology and results

    SciTech Connect

    McGrail, B.P.; Olson, K.M.

    1992-11-01

    In situ vitrification (ISV) is an emerging technology for the remediation of hazardous and radioactive waste sites. The concept relies on the principle of Joule heating to raise the temperature of a soil between an array of electrodes above the melting temperature. After cooling, the melt solidifies into a massive glass and crystalline block similar to naturally occurring obsidian. Determining the long-term performance of ISV products in a changing regulatory environment requires a fundamental understanding of the mechanisms controlling the dissolution behavior of the material. A series of experiments was performed to determine the dissolution behavior of samples produced from the ISV processing of typical soils from the Idaho National Engineering Laboratory subsurface disposal area. Dissolution rate constant measurements were completed at 90{degrees}C over the pH range 2 to 11 for one sample obtained from a field test of the ISV process.

  20. Evaluating long-term performance of in situ vitrified waste forms: Methodology and results

    SciTech Connect

    McGrail, B.P.; Olson, K.M.

    1992-11-01

    In situ vitrification (ISV) is an emerging technology for the remediation of hazardous and radioactive waste sites. The concept relies on the principle of Joule heating to raise the temperature of a soil between an array of electrodes above the melting temperature. After cooling, the melt solidifies into a massive glass and crystalline block similar to naturally occurring obsidian. Determining the long-term performance of ISV products in a changing regulatory environment requires a fundamental understanding of the mechanisms controlling the dissolution behavior of the material. A series of experiments was performed to determine the dissolution behavior of samples produced from the ISV processing of typical soils from the Idaho National Engineering Laboratory subsurface disposal area. Dissolution rate constant measurements were completed at 90[degrees]C over the pH range 2 to 11 for one sample obtained from a field test of the ISV process.

  1. Experimental evaluation of stable long term operation of semiconductor magnetic sensors at ITER relevant environment

    NASA Astrophysics Data System (ADS)

    Bolshakova, I.; Belyaev, S.; Bulavin, M.; Brudnyi, V.; Chekanov, V.; Coccorese, V.; Duran, I.; Gerasimov, S.; Holyaka, R.; Kargin, N.; Konopleva, R.; Kost, Ya.; Kuech, T.; Kulikov, S.; Makido, O.; Moreau, Ph; Murari, A.; Quercia, A.; Shurygin, F.; Strikhanov, M.; Timoshyn, S.; Vasil'evskii, I.; Vinichenko, A.

    2015-08-01

    The paper deals with radiation resistant sensors and their associated measuring instrumentation developed in the course of R and D activities carried out in the framework of an international collaboration. The first trial tests of three-dimensional (3D) probes with Hall sensors have been performed in European tokamaks TORE SUPRA (2004) and JET (2005). Later in 2009 six sets of 3D probes were installed in JET and now continue to operate. The statistical analysis performed in 2014 on the basis of the JET database have demonstrated stable long term operation of all 18 sensors of 3D probes. The results of measurements conducted at the neutron fluxes of nuclear reactors have demonstrated the operability of the sensors up to high neutron fluences of F  >  1018n • cm-2 that exceeds the maximum one for the locations of steady state sensors in ITER over its total lifetime.

  2. Long-term environmental effects and flight service evaluation of composite materials

    NASA Technical Reports Server (NTRS)

    Dexter, H. Benson

    1987-01-01

    Results of a NASA-Langley sponsored research program to establish the long term effects of realistic flight environments and ground based exposure on advanced composite materials are presented. The effects of moisture, ultraviolet radiation, aircraft fuels and fluids, sustained stress, and fatigue loading are reported. Residual strength and stiffness as a function of exposure time and exposure location are reported for seven different material systems after 10 years of worldwide outdoor exposure. Flight service results of over 300 composite components installed on rotorcraft and transport aircraft are included. Over 4 million total component flight hours were accumulated on various aircraft since initiation of flight service in 1973. Service performance, maintenance characteristics, and residual strength of numerous composite components installed on commercial and military aircraft are reported as a function of flight hours and years in service. Residual strength test results of graphite/epoxy spoilers with 10 years of worldwide service and over 28,000 flight hours are reported.

  3. Transplantation of a horseshoe kidney from a living donor: Case report, long term outcome and donor safety

    PubMed Central

    Justo-Janeiro, Jaime Manuel; Orozco, Eduardo Prado; Reyes, Francisco J.Roberto Enríquez; de la Rosa Paredes, René; de Lara Cisneros, Luis G.Vázquez; Espinosa, Alfonso Lozano; Naylor, Jesús Mier

    2015-01-01

    Introduction The use of a horseshoe kidney in renal transplant remains controversial, when it is found in the evaluation of a living donor, anatomical, surgical and ethical issues are involved. Presentation of Case An uncomplicated horseshoe kidney was detected in a 51-year-old woman who was the only suitable donor for her 30-year-old son. Kidneys were fused in the inferior pole and no vascular or urinary abnormalities were detected during imaging evaluation. The surgical procedure was approved by the hospital transplant committee. A laparotomy was performed by means of a medial upper incision. The isthmus of the kidney was divided using a harmonic scalpel and the left segment was used; it had 2 arteries too distant to create a common one, thus anastomosed separately. The renal vein was side-to-side anastomosed to the right external iliac vein and a Lich-Gregoir ureteral implant was made. There were no intraoperative or postoperative complications in the donor who currently remains asymptomatic. Recipient developed a delayed graft function (DGF), and was discharged on the 12th day after surgery. After 24 months of surgery, renal function has remained stable with a serum creatinine of 128 μmol/L (1.45 mg/dL). Discussion There are 7 reports of a horseshoe kidney from living donors in 8 patients without morbidity and a good long term outcome of all recipients. Conclusion If we anticipate a low operative risk and there is a suitable anatomy, we may consider the use of horseshoe kidneys from living donors a viable alternative. PMID:26299249

  4. Robustness-based evaluation of long-term river basin planning under climate change

    NASA Astrophysics Data System (ADS)

    Taner, M. U.; Ray, P. A.; Brown, C. M.

    2015-12-01

    This work develops a bottom-up, multi-stage planning framework for the sustainable development of river basin systems under deep climate uncertainty. The research focuses on whether and when it is desirable to invest for costly water infrastructure projects, and how to select among a set of project alternatives in order achieve the desired economic benefits with a relatively low level of risk. The proposed framework begins with identifying a set of climate conditions to represent the future vulnerability domain of the system using simulation analysis. The conditions identified in the simulation analysis are then used to develop a scenario-tree, to represent the manner in which the uncertainties may evolve over the course of the planning period. Next, optimal decisions are repeatedly explored through a multi-stage optimization model, by varying the probability weights employed in the scenario-tree. The resulting vector of optimal decisions are post-processed to identify robust choices that are least sensitive to the scenario probabilities. The proposed planning framework is illustrated for the Niger Basin, over a 45-year planning period from 2015 to 2060. The Niger Basin is a transboundary system facing a series of challenges including endemic poverty, inadequate infrastructure and weak adaptive capacity to climate variability and change. The case study assesses long-term economic benefits from four new dam projects, and from a range of expansions across the eleven irrigation zones. The climate scenarios are obtained by first generating new climate variability realizations from a stochastic weather generator, and then placing climate change factors on the generated climate realizations. Basin runoff response to climate scenarios are simulated by a series of monthly, two-compartment water balance models. Long-term economic benefits are estimated from the sectors of irrigated agriculture, hydropower, navigation, fishing, and environmental protection, using a mixed

  5. Evaluation of low-dosage environmental mutagens with a long-term, cultured epithelial cell line

    SciTech Connect

    Li, C.S.; Lin, R.H.

    1996-12-31

    Polycyclic or polynuclear aromatic hydrocarbons (PAHs) are a group of compounds consisting of at least two fused aromatic rings and are common environmental contaminants in soil, water, and air. Additionally, some PAHs are considered to be mutagenic, carcinogenic, and cytotoxic compounds. BaA (Benz(a)anthracene) and BaP (Benzo(a)pyrene) are the two major unsubstituted PAHs identified by the USEPA as priority pollutants. BaA is suspected to be a human carcinogen by the US Department of Health and Human Services, whereas BaP is regarded as an animal carcinogen. It is estimated that the emission concentrations of BaA and BaP from mainstream cigarette smoke are 20-70 ng per g cigarette and 20-40 ng per g cigarette, respectively, with an average sidestream to mainstream weight ratio of 3. In addition, BaA and BaP are also the main emissions from diesel particulate extracts with mean concentrations of 500 ppm and 40 ppm, respectively. From a recent report concerning PAHs in urban areas all over the world, the airborne concentration of BaP was typically found to be in the range of 1-20 ng/m{sup 3} in Europe and 1 ng/m{sup 3} in the U.S.A. For BaA, the concentrations commonly ranged from I to 50 ng/m{sup 3} in Europe and from 0.1 to 1 ng/m{sup 3} in the U.S.A. Therefore, the long term exposure to these two compounds may cause health effects. This study examines long-term cultured epithelial cell lines exposed to BaP or BaA, in vitro, and the frequency of HGPRT mutants. 19 refs., 3 figs.

  6. Life Outcomes of Anterior Temporal Lobectomy: Serial Long-term Follow-up Evaluations

    PubMed Central

    Jones, Jana E.; Blocher, Jacquelyn B.; Jackson, Daren C.

    2014-01-01

    Background At three time points, this study examined long-term psychosocial life outcomes of individuals who underwent anterior temporal lobectomy (ATL) compared to individuals with temporal lobe epilepsy that were medically managed. Objective Participants were on average 17 years post-surgery. Seizure frequency, employment, driving, independent living, financial independence, mental health, and quality of life were examined at each follow-up assessment, and predictors of outcomes were examined. Methods All participants were diagnosed with medically intractable complex partial seizures of temporal lobe origin with or without secondary generalization. A structured clinical interview was utilized at all three time points. Information was obtained regarding seizure frequency, anti-epilepsy medications, employment, driving status, financial assistance, and independent living. Additionally, questions regarding quality of life, satisfaction with surgery, and presence of depression or anxiety were included. Results Surgery resulted in significantly improved and sustained seizure outcomes. At the first, second, and third follow-ups 67%, 72%, and 67% of participants in the surgery group remained seizure free in the year prior to follow-up interview. At each follow-up, 97%, 84%, and 84% reported that they would undergo surgery again. Seizure freedom predicted driving outcomes at all three time points, but was not a significant predictor for employment, independent living or financial independence. Psychosocial life outcomes in the surgical group were improved and maintained over time when compared to the medically managed group. Conclusion This systematic long-term investigation provides strong support for the positive impact of ATL on psychosocial life outcomes including driving, employment, independent living, and financial independence. PMID:24056319

  7. Smile esthetics: Evaluation of long-term changes in the transverse dimension

    PubMed Central

    Misner, Kenner; English, Jeryl D.; Alexander, Wick G.; Alexander, J. Moody; Gallerano, Ron

    2017-01-01

    Objective To analyze the long-term changes in maxillary arch widths and buccal corridor ratios in orthodontic patients treated with and without premolar extractions. Methods The study included 53 patients who were divided into the extraction (n = 28) and nonextraction (n = 25) groups. These patients had complete orthodontic records from the pretreatment (T1), posttreatment (T2), and postretention (T3) periods. Their mean retention and postretention times were 4 years 2 months and 17 years 8 months, respectively. Dental models and smiling photographs from all three periods were digitized to compare the changes in three dental arch width measurements and three buccal corridor ratios over time between the extraction and nonextraction groups. Data were analyzed using analysis of variance tests. Post-hoc multiple comparisons were made using Bonferroni correction. Results Soft-tissue extension during smiling increased with age in both groups. The maximum dental width to smile width ratio (MDW/SW) also showed a favorable increase with treatment in both groups (p < 0.05), and remained virtually stable at T3 (p > 0.05). According to the MDW/SW ratio, the mean difference in the buccal corridor space of the two groups was 2.4 ± 0.2% at T3. Additionally, no significant group × time interaction was found for any of the buccal corridor ratios studied. Conclusions Premolar extractions did not negatively affect transverse maxillary arch widths and buccal corridor ratios. The long-term outcome of orthodontic treatment was comparable between the study groups. PMID:28337419

  8. Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study.

    PubMed Central

    Dobbie, Fiona; Hiscock, Rosemary; Leonardi-Bee, Jo; Murray, Susan; Shahab, Lion; Aveyard, Paul; Coleman, Tim; McEwen, Andy; McRobbie, Hayden; Purves, Richard; Bauld, Linda

    2015-01-01

    BACKGROUND NHS Stop Smoking Services (SSSs) provide free at the point of use treatment for smokers who would like to stop. Since their inception in 1999 they have evolved to offer a variety of support options. Given the changes that have happened in the provision of services and the ongoing need for evidence on effectiveness, the Evaluating Long-term Outcomes for NHS Stop Smoking Services (ELONS) study was commissioned. OBJECTIVES The main aim of the study was to explore the factors that determine longer-term abstinence from smoking following intervention by SSSs. There were also a number of additional objectives. DESIGN The ELONS study was an observational study with two main stages: secondary analysis of routine data collected by SSSs and a prospective cohort study of service clients. The prospective study had additional elements on client satisfaction, well-being and longer-term nicotine replacement therapy (NRT) use. SETTING The setting for the study was SSSs in England. For the secondary analysis, routine data from 49 services were obtained. For the prospective study and its added elements, nine services were involved. The target population was clients of these services. PARTICIPANTS There were 202,804 cases included in secondary analysis and 3075 in the prospective study. INTERVENTIONS A combination of behavioural support and stop smoking medication delivered by SSS practitioners. MAIN OUTCOME MEASURES Abstinence from smoking at 4 and 52 weeks after setting a quit date, validated by a carbon monoxide (CO) breath test. RESULTS Just over 4 in 10 smokers (41%) recruited to the prospective study were biochemically validated as abstinent from smoking at 4 weeks (which was broadly comparable with findings from the secondary analysis of routine service data, where self-reported 4-week quit rates were 48%, falling to 34% when biochemical validation had occurred). At the 1-year follow-up, 8% of prospective study clients were CO validated as abstinent from smoking

  9. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years.

    PubMed

    Rosenfeld, William; Fountain, Nathan B; Kaubrys, Gintaras; Ben-Menachem, Elinor; McShea, Cindy; Isojarvi, Jouko; Doty, Pamela

    2014-12-01

    Long-term (up to 8 years of exposure) safety and efficacy of the antiepileptic drug lacosamide was evaluated in this open-label extension trial (SP615 [ClinicalTrials.gov identifier: NCT00552305]). Patients were enrolled following participation in a double-blind trial or one of two open-label trials of adjunctive lacosamide for partial-onset seizures. Dosage adjustments of lacosamide (100-800 mg/day) and/or concomitant antiepileptic drugs were allowed to optimize tolerability and seizure reduction. Of the 370 enrolled patients, 77%, 51%, and 39% had >1, >3, or >5 years of lacosamide exposure, respectively. Median lacosamide modal dose was 400mg/day. Common treatment-emergent adverse events (TEAEs) were dizziness (39.7%), headache (20.8%), nausea (17.3%), diplopia (17.0%), fatigue (16.5%), upper respiratory tract infection (16.5%), nasopharyngitis (16.2%), and contusion (15.4%). Dizziness (2.2%) was the only TEAE that led to discontinuation in >2% of patients. Ranges for median percent reductions in seizure frequency were 47-65%, and those for ≥ 50% responder rates were 49-63% for 1-, 3-, and 5-year completer cohorts. Exposure to lacosamide for up to 8 years was generally well tolerated, with a safety profile similar to previous double-blind trials, and efficacy was maintained.

  10. Evaluation of an intervention for staff in a long-term care facility using a retrospective pretest design.

    PubMed

    Hyman, R B

    1993-06-01

    It has been previously established that human service workers often suffer from emotional exhaustion, which has been conceptualized by Maslach and Jackson as burnout. Burnout may be a particularly great risk in workers providing long-term geriatric care. The current study evaluated the effects of a series of three 3-hour sessions designed to address team building, communication skills, self-esteem, and stress management on a random sample of 51 of the 188 long-term care staff who participated. Using a retrospective pretest design, a statistically significant improvement from "then" to "today" was found for the three components of burnout: Depersonalization, Emotional Exhaustion, and Personal Accomplishment. Responses to an open-ended question about workshop effects corroborated the quantitative data, and effects noted were highly related to the defined objectives of the workshops.

  11. Accelerated forgetting? An evaluation on the use of long-term forgetting rates in patients with memory problems.

    PubMed

    Geurts, Sofie; van der Werf, Sieberen P; Kessels, Roy P C

    2015-01-01

    The main focus of this review was to evaluate whether long-term forgetting rates (delayed tests, days, to weeks, after initial learning) are more sensitive measures than standard delayed recall measures to detect memory problems in various patient groups. It has been suggested that accelerated forgetting might be characteristic for epilepsy patients, but little research has been performed in other populations. Here, we identified eleven studies in a wide range of brain injured patient groups, whose long-term forgetting patterns were compared to those of healthy controls. Signs of accelerated forgetting were found in three studies. The results of eight studies showed normal forgetting over time for the patient groups. However, most of the studies used only a recognition procedure, after optimizing initial learning. Based on these results, we recommend the use of a combined recall and recognition procedure to examine accelerated forgetting and we discuss the relevance of standard and optimized learning procedures in clinical practice.

  12. Accelerated forgetting? An evaluation on the use of long-term forgetting rates in patients with memory problems

    PubMed Central

    Geurts, Sofie; van der Werf, Sieberen P.; Kessels, Roy P. C.

    2015-01-01

    The main focus of this review was to evaluate whether long-term forgetting rates (delayed tests, days, to weeks, after initial learning) are more sensitive measures than standard delayed recall measures to detect memory problems in various patient groups. It has been suggested that accelerated forgetting might be characteristic for epilepsy patients, but little research has been performed in other populations. Here, we identified eleven studies in a wide range of brain injured patient groups, whose long-term forgetting patterns were compared to those of healthy controls. Signs of accelerated forgetting were found in three studies. The results of eight studies showed normal forgetting over time for the patient groups. However, most of the studies used only a recognition procedure, after optimizing initial learning. Based on these results, we recommend the use of a combined recall and recognition procedure to examine accelerated forgetting and we discuss the relevance of standard and optimized learning procedures in clinical practice. PMID:26106343

  13. Evaluating long-term annual sediment yield estimating potential of GIS interfaced MUSLE model on two micro-watersheds.

    PubMed

    Arekhi, Saleh

    2008-01-15

    Use of an event scale MUSLE model for obtaining accurate long-term annual sediment yield estimates from micro-watersheds was evaluated. Such estimates are extremely important for designing appropriate soil/water conserving measures. For easy extraction and inputting of model input parameters, the proposed model was interfaced to an Arc-View/Spatial Analyst geographic information system. Application of this GIS interfaced MUSLE model on two gauged (pine and oak forest) hilly micro-watersheds viz., Salla Rautella (0.47 km2) and Naula (0.42 km2), in Almora district of Uttaranchal, India showed that it could estimate annual sediment yields with absolute mean relative errors ranging between 12-14%. Even long-term average sediment yields for Salla Rautella (observed: 9.58 tons and estimated: 10.92 tons) and Naula: (Observed: 23.89 tons and estimated: 26.61 tons) micro-watersheds could be quite realistically simulated by the proposed model.

  14. An evaluation of two incontinence skin care protocols in a long-term care setting.

    PubMed

    Lewis-Byers, Kari; Thayer, Debra

    2002-12-01

    Caring for the skin of patients with incontinence is an essential activity in long-term care. A prospective descriptive study to compare the effect of two skin care protocols on skin condition, pain, and caregiver time was conducted. Thirty-two (32) skilled nursing facility residents with incontinence participated in the 3-week study. Patients were randomly assigned to a standard care regimen (soap and water cleansing after each incontinence episode, followed by application of a moisturizing lotion) or study care protocol (no-rinse skin cleanser after each episode and application of a barrier cream with durable properties after the first incontinence episode of each shift). Number and type of incontinence episodes, skin condition, pain, and caregiver time spent were assessed. Skin integrity was maintained in the majority of control (69%) and study group (72%) patients and improvement occurred in 8% of control and 17% of the study group (NS). Study protocol procedures took less time to complete than control procedures (a savings of 79 minutes/patient/day). A positive correlation between pain intensity and level of skin impairment was observed (r = 0.88). The results of this study suggest that at this facility, use of soap, water, and a moisturizer may be less effective and more time-consuming than using a no-rinse cleanser and a durable barrier product.

  15. Long-term biocompatibility evaluation of 0.5 % zinc containing hydroxyapatite in rabbits.

    PubMed

    Resende, Rodrigo F B; Fernandes, Gustavo V O; Santos, Sílvia R A; Rossi, Alexandre M; Lima, Inayá; Granjeiro, José M; Calasans-Maia, Mônica D

    2013-06-01

    This study investigates the long-term biocompatibility of 0.5 % zinc-containing hydroxyapatite compared with hydroxyapatite. Spheres (425 < ∅ < 550) of both materials were produced by extrusion of ceramic slurry in calcium chloride and characterized by FTIR, XRD, XRF and SEM. Fifteen White New Zealand rabbits were submitted to general anesthesia, and an perforation (2 mm), was made in each tibia, one for zinc-containing hydroxyapatite sphere implantation and one for hydroxyapatite sphere implantation. After 26, 52 and 78 weeks, the animals were euthanized, and the fragment containing the biomaterial was harvested. A 30-50 μm section was obtained for histological analysis in bright field and polarized light. SEM images revealed similar morphologies between the tested biomaterials. Histological analysis showed that there was no difference between the test groups. The morphometric analysis, however, indicates that there was a greater absorption. The materials are biocompatible, promote osteogenesis and that the zinc-containing hydroxyapatite microspheres were absorbed more quickly.

  16. Evaluating the feasibility of biological waste processing for long term space missions.

    PubMed

    Garland, J L; Alazraki, M P; Atkinson, C F; Finger, B W

    1998-01-01

    Recycling waste products during orbital (e.g., International Space Station) and planetary missions (e.g., lunar base, Mars transit mission, Martian base) will reduce storage and resupply costs. Wastes streams on the space station will include human hygiene water, urine, faeces, and trash. Longer term missions will contain human waste and inedible plant material from plant growth systems used for atmospheric regeneration, food production, and water recycling. The feasibility of biological and physical-chemical waste recycling is being investigated as part of National Aeronautics and Space Administration's (NASA) Advanced Life Support (ALS) Program. In-vessel composting has lower manpower requirements, lower water and volume requirements, and greater potential for sanitization of human waste compared to alternative bioreactor designs such as continuously stirred tank reactors (CSTR). Residual solids from the process (i.e. compost) could be used a biological air filter, a plant nutrient source, and a carbon sink. Potential in-vessel composting designs for both near- and long-term space missions are presented and discussed with respect to the unique aspects of space-based systems.

  17. Evaluating the feasibility of biological waste processing for long term space missions

    NASA Technical Reports Server (NTRS)

    Garland, J. L.; Alazraki, M. P.; Atkinson, C. F.; Finger, B. W.; Sager, J. C. (Principal Investigator)

    1998-01-01

    Recycling waste products during orbital (e.g., International Space Station) and planetary missions (e.g., lunar base, Mars transit mission, Martian base) will reduce storage and resupply costs. Wastes streams on the space station will include human hygiene water, urine, faeces, and trash. Longer term missions will contain human waste and inedible plant material from plant growth systems used for atmospheric regeneration, food production, and water recycling. The feasibility of biological and physical-chemical waste recycling is being investigated as part of National Aeronautics and Space Administration's (NASA) Advanced Life Support (ALS) Program. In-vessel composting has lower manpower requirements, lower water and volume requirements, and greater potential for sanitization of human waste compared to alternative bioreactor designs such as continuously stirred tank reactors (CSTR). Residual solids from the process (i.e. compost) could be used a biological air filter, a plant nutrient source, and a carbon sink. Potential in-vessel composting designs for both near- and long-term space missions are presented and discussed with respect to the unique aspects of space-based systems.

  18. Statistical evaluation of mortality in long-term carcinogenicity bioassays using a Williams-type procedure.

    PubMed

    Herberich, Esther; Hothorn, Ludwig A

    2012-10-01

    Several doses and a control group can be compared under order restriction using the Williams procedure for normally distributed endpoints assuming variance homogeneity. Comparison of the survival functions represents a secondary endpoint in long-term in vivo bioassays of carcinogenicity. Therefore, a Williams-type procedure for the comparison of survival functions is proposed for the assumption of the Cox proportional hazards model or the general frailty Cox model to allow a joint analysis over sex and strains. Interpretation according to both statistical significance and biological relevance is possible with simultaneous confidence intervals for hazard ratios. Related survival data can be analyzed using the R packages survival, coxme, and multcomp. Together with the R packages MCPAN and nparcomp, Dunnett- or Williams-type procedures are now available for the statistical analysis of the following endpoint types in toxicology: (i) normally distributed, (ii) non-normally distributed, (iii) score (ordered categorical) data, (iv) crude proportions, (v) survival functions, and (vi) time-to-tumor data with and without cause-of-death information.

  19. Long-term tracking of budding yeast cells in brightfield microscopy: CellStar and the Evaluation Platform

    PubMed Central

    Versari, Cristian; Stoma, Szymon; Batmanov, Kirill; Llamosi, Artémis; Mroz, Filip; Kaczmarek, Adam; Deyell, Matt

    2017-01-01

    With the continuous expansion of single cell biology, the observation of the behaviour of individual cells over extended durations and with high accuracy has become a problem of central importance. Surprisingly, even for yeast cells that have relatively regular shapes, no solution has been proposed that reaches the high quality required for long-term experiments for segmentation and tracking (S&T) based on brightfield images. Here, we present CellStar, a tool chain designed to achieve good performance in long-term experiments. The key features are the use of a new variant of parametrized active rays for segmentation, a neighbourhood-preserving criterion for tracking, and the use of an iterative approach that incrementally improves S&T quality. A graphical user interface enables manual corrections of S&T errors and their use for the automated correction of other, related errors and for parameter learning. We created a benchmark dataset with manually analysed images and compared CellStar with six other tools, showing its high performance, notably in long-term tracking. As a community effort, we set up a website, the Yeast Image Toolkit, with the benchmark and the Evaluation Platform to gather this and additional information provided by others. PMID:28179544

  20. Long-term tracking of budding yeast cells in brightfield microscopy: CellStar and the Evaluation Platform.

    PubMed

    Versari, Cristian; Stoma, Szymon; Batmanov, Kirill; Llamosi, Artémis; Mroz, Filip; Kaczmarek, Adam; Deyell, Matt; Lhoussaine, Cédric; Hersen, Pascal; Batt, Gregory

    2017-02-01

    With the continuous expansion of single cell biology, the observation of the behaviour of individual cells over extended durations and with high accuracy has become a problem of central importance. Surprisingly, even for yeast cells that have relatively regular shapes, no solution has been proposed that reaches the high quality required for long-term experiments for segmentation and tracking (S&T) based on brightfield images. Here, we present CellStar, a tool chain designed to achieve good performance in long-term experiments. The key features are the use of a new variant of parametrized active rays for segmentation, a neighbourhood-preserving criterion for tracking, and the use of an iterative approach that incrementally improves S&T quality. A graphical user interface enables manual corrections of S&T errors and their use for the automated correction of other, related errors and for parameter learning. We created a benchmark dataset with manually analysed images and compared CellStar with six other tools, showing its high performance, notably in long-term tracking. As a community effort, we set up a website, the Yeast Image Toolkit, with the benchmark and the Evaluation Platform to gather this and additional information provided by others.

  1. Evaluation of urinary bladder fibrogenesis in a mouse model of long-term ketamine injection

    PubMed Central

    Shen, Cheng-Huang; Wang, Shou-Chieh; Wang, Shou-Tsung; Lin, Shu-Mei; Wu, Jiann-Der; Lin, Chang-Te; Liu, Yi-Wen

    2016-01-01

    Long-term ketamine abuse has been shown to affect the lower urinary tract and result in interstitial cystitis-like syndrome. However, the causative mechanism of ketamine-induced dysfunction remains unclear. The present study aimed to investigate the physiological, histological and molecular changes on ketamine-associated cystitis (KC) in a mouse model. Both male and female Balb/c mice were separately distributed into the control group (normal saline) and ketamine group, which received ketamine hydrochloride (100 mg/kg/day) daily by intraperitoneal injection for a total period of 20 weeks. In each group, the urine was analyzed by gas chromatography-mass spectrometry to measure the concentration of ketamine and its metabolites. Urinary frequency and urine volume were examined to investigate the urinary voiding functions. Mice bladders were excised for cDNA microarray and hematoxylin and eosin (HE) staining. The ketamine and metabolites were detected only in ketamine-treated mice urine. The voiding interval was reduced in the male mice group after 20 week ketamine administration. Additionally, the result of cDNA array analysis revealed a number of gene expression levels involved in chronic wound healing response and collagen accumulation, which were closely associated with fibrosis progression in the connective tissue. In HE staining of the bladder tissue, the ketamine-injected mice exhibited prominently denser blood vessel distribution in the submucosal layer. Based on the evidence in the present study, a mechanism that delineates fibrosis formation of urinary bladder induced by the pathogenesis of ketamine abuse can be constructed. PMID:27431428

  2. Long-term Evaluation of Radiation-Induced Optic Neuropathy After Single-Fraction Stereotactic Radiosurgery

    SciTech Connect

    Leavitt, Jacqueline A.; Stafford, Scott L.; Link, Michael J.; Pollock, Bruce E.

    2013-11-01

    Purpose: To determine the long-term risk of radiation-induced optic neuropathy (RION) in patients having single-fraction stereotactic radiosurgery (SRS) for benign skull base tumors. Methods and Materials: Retrospective review of 222 patients having Gamma Knife radiosurgery for benign tumors adjacent to the anterior visual pathway (AVP) between 1991 and 1999. Excluded were patients with prior or concurrent external beam radiation therapy or SRS. One hundred twenty-nine patients (58%) had undergone previous surgery. Tumor types included confirmed World Health Organization grade 1 or presumed cavernous sinus meningioma (n=143), pituitary adenoma (n=72), and craniopharyngioma (n=7). The maximum dose to the AVP was ≤8.0 Gy (n=126), 8.1-10.0 Gy (n=39), 10.1-12.0 Gy (n=47), and >12 Gy (n=10). Results: The mean clinical and imaging follow-up periods were 83 and 123 months, respectively. One patient (0.5%) who received a maximum radiation dose of 12.8 Gy to the AVP developed unilateral blindness 18 months after SRS. The chance of RION according to the maximum radiation dose received by the AVP was 0 (95% confidence interval [CI] 0-3.6%), 0 (95% CI 0-10.7%), 0 (95% CI 0-9.0%), and 10% (95% CI 0-43.0%) for patients receiving ≤8 Gy, 8.1-10.0 Gy, 10.1-12.0 Gy, and >12 Gy, respectively. The overall risk of RION in patients receiving >8 Gy to the AVP was 1.0% (95% CI 0-6.2%). Conclusions: The risk of RION after single-fraction SRS in patients with benign skull base tumors who have no prior radiation exposure is very low if the maximum dose to the AVP is ≤12 Gy. Physicians performing single-fraction SRS should remain cautious when treating lesions adjacent to the AVP, especially when the maximum dose exceeds 10 Gy.

  3. Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials

    PubMed Central

    Goodman, Andrew D; Bethoux, Francois; Brown, Theodore R; Schapiro, Randall T; Cohen, Ron; Marinucci, Lawrence N; Henney, Herbert R

    2015-01-01

    Background: In Phase 3 double-blind trials (MS-F203 and MS-F204), dalfampridine extended release tablets 10 mg twice daily (dalfampridine-ER; prolonged-release fampridine in Europe; fampridine modified or sustained release elsewhere) improved walking speed relative to placebo in patients with multiple sclerosis (MS). Objectives: Evaluation of long-term safety and efficacy of dalfampridine-ER in open-label extensions (MS-F203EXT, MS-F204EXT). Methods: Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months. Subjects were categorized as dalfampridine-ER responders or non-responders, based on their treatment response in the double-blind parent trials that assessed T25FW. Results: We had 269 patients enter MS-F203EXT and 154 patients complete it; for a maximum exposure of 5 years. We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years. No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase. Improvements in walking speed were lost after dalfampridine-ER was discontinued in the parent trial, but returned by the 2-week assessment after re-initiation of the drug. Throughout the extensions, mean improvement in walking speed declined, but remained improved, among the double-blind responders as compared with non-responders. Conclusions: The dalfamipridine-ER safety profile was consistent with the parent trials. Although walking speed decreased over time, dalfampridine-ER responders continued to show improved walking speed, which was sustained compared with non-responders. PMID:25583832

  4. Long-term efficacy and safety of once-daily mesalazine granules for the treatment of active ulcerative colitis

    PubMed Central

    Böhm, Stephan Karl; Kruis, Wolfgang

    2014-01-01

    demonstrated that OD administration of 5-ASA is as effective as conventional dosing in mild to moderate active UC. The three 5-ASA products MMX, Salofalk®, and Pentasa® employed in those studies so far have not shown differences in efficacy between OD and conventional dosing. No differences regarding safety outcomes have been detected between OD and conventional dosing, including incidence of adverse events, serious adverse events, or withdrawal from treatment due to an adverse event. Although the majority of patients prefer OD dosing to conventional dosing, it was not possible to detect differences in adherence between OD and multiple dose regimens in the clinical trial setting. Well-designed and controlled large-scale community-based studies are necessary to further investigate and prove the point of improved long-term adherence and treatment efficacy in OD dosing. PMID:25285021

  5. Efficacy and safety of long-term prophylaxis in severe hemophilia A dogs following liver gene therapy using AAV vectors.

    PubMed

    Sabatino, Denise E; Lange, Amy M; Altynova, Ekaterina S; Sarkar, Rita; Zhou, Shangzhen; Merricks, Elizabeth P; Franck, Helen G; Nichols, Timothy C; Arruda, Valder R; Kazazian, Haig H

    2011-03-01

    Developing adeno-associated viral (AAV)-mediated gene therapy for hemophilia A (HA) has been challenging due to the large size of the factor VIII (FVIII) complementary DNA and the concern for the development of inhibitory antibodies to FVIII in HA patients. Here, we perform a systematic study in HA dogs by delivering a canine FVIII (cFVIII) transgene either as a single chain or two chains in an AAV vector. An optimized cFVIII single chain delivered using AAV serotype 8 (AAV8) by peripheral vein injection resulted in a dose-response with sustained expression of FVIII up to 7% (n = 4). Five HA dogs administered two-chain delivery using either AAV8 or AAV9 via the portal vein expressed long-term, vector dose-dependent levels of FVIII activity (up to 10%). In the two-chain approach, circulating cFVIII antigen levels were more than fivefold higher than activity. Notably, no long-term immune response to FVIII was observed in any of the dogs (1/9 dogs had a transient inhibitor). Long-term follow-up of the dogs showed a remarkable reduction (>90%) of bleeding episodes in a combined total of 24 years of observation. These data demonstrate that both approaches are safe and achieve dose-dependent therapeutic levels of FVIII expression, which supports translational studies of AAV-mediated delivery for HA.

  6. Evaluating the adequacy of climate change information to support long-term water resource planning

    NASA Astrophysics Data System (ADS)

    Brekke, L. D.; Clark, M. P.; Gutmann, E. D.; Pruitt, T.; Mizukami, N.; Mendoza, P. A.; Rasmussen, R.; Arnold, J.; Raff, D. A.; Rajagopalan, B.

    2013-12-01

    The National Center for Atmospheric Research (NCAR), the Department of Interior's Bureau of Reclamation (Reclamation) and the U.S. Army Corps of Engineers (USACE) are partnering to understand appropriate applications of downscaling methods and hydrologic analysis used to produce projections of hydroclimate impacts used in long-term water resources planning and management. The overall objectives of this project are to determine the extent to which the portrayal of hydroclimate impacts depends on methodological choices, understand why different methods produce different results, and provide guidance on the suitability of different methods to provide state-of-the-art intelligence for water resources planning and management. Research questions include: (1) How does the portrayal of hydrologic impacts under climate change depend on the chosen downscaling method and resolution (i.e. dynamical downscaling using regional climate models versus non-dynamical downscaling using statistical or empirical methods)? (2) How does the portrayal of hydrologic impacts under climate change depend on the choice/configuration of hydrologic model(s) used for impact assessment and the parameter estimation strategy? This presentation provides a synthesis of methods and key findings. Main results are (i) high-resolution dynamic downscaling using a model such as the Weather Research and Forecasting model (WRF) is required to properly capture precipitation processes over complex terrain in the Colorado Headwaters region, and climate change scenarios from the 4-km WRF simulations are very different from current guidance being provided to water managers; (ii) WRF simulations at 12-km and 36-km have poor correspondence to observations, and very different change signals to the 4-km WRF simulations; (iii) the statistical downscaling methods examined struggle to adequately capture daily precipitation characteristics that are important to hydrologic impacts, such as wet-day frequency and spatial

  7. Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults

    PubMed Central

    2009-01-01

    Background: Obstructive sleep apnea (OSA) is a common chronic disorder that often requires lifelong care. Available practice parameters provide evidence-based recommendations for addressing aspects of care. Objective: This guideline is designed to assist primary care providers as well as sleep medicine specialists, surgeons, and dentists who care for patients with OSA by providing a comprehensive strategy for the evaluation, management and long-term care of adult patients with OSA. Methods: The Adult OSA Task Force of the American Academy of Sleep Medicine (AASM) was assembled to produce a clinical guideline from a review of existing practice parameters and available literature. All existing evidence-based AASM practice parameters relevant to the evaluation and management of OSA in adults were incorporated into this guideline. For areas not covered by the practice parameters, the task force performed a literature review and made consensus recommendations using a modified nominal group technique. Recommendations: Questions regarding OSA should be incorporated into routine health evaluations. Suspicion of OSA should trigger a comprehensive sleep evaluation. The diagnostic strategy includes a sleep-oriented history and physical examination, objective testing, and education of the patient. The presence or absence and severity of OSA must be determined before initiating treatment in order to identify those patients at risk of developing the complications of sleep apnea, guide selection of appropriate treatment, and to provide a baseline to establish the effectiveness of subsequent treatment. Once the diagnosis is established, the patient should be included in deciding an appropriate treatment strategy that may include positive airway pressure devices, oral appliances, behavioral treatments, surgery, and/or adjunctive treatments. OSA should be approached as a chronic disease requiring long-term, multidisciplinary management. For each treatment option, appropriate outcome

  8. Long-Term Care

    MedlinePlus

    ... this page please turn Javascript on. Long-Term Care What Is Long-Term Care? Long-term care involves a variety of services ... the Escape (Esc) button on your keyboard.) Most Care Provided at Home Long-term care is provided ...

  9. Long-term evaluation of 'BARC 68Ge/68Ga generator' based on the nanoceria-polyacrylonitrile composite sorbent.

    PubMed

    Chakravarty, Rubel; Chakraborty, Sudipta; Ram, Ramu; Dash, Ashutosh; Pillai, M R A

    2013-10-01

    This article describes the long-term evaluation of a nanoceria-polyacrylonitrile (CeO2-PAN) composite sorbent-based (68)Ge/(68)Ga generator reported. This generator used the new CeO2-PAN composite sorbent for preparation of the (68)Ge/(68)Ga generator. Since this sorbent has not been previously evaluated, a thorough long-term evaluation of the performance of the generator is necessary to ensure its applicability for clinical practice. The performance of the generator was evaluated in terms of (68)Ga yield, (68)Ge breakthrough, radioactive concentration of the (68)Ga solution, and suitability of the (68)Ga for the preparation of (68)Ga-labeled tracers. The (68)Ge/(68)Ga generator was able to provide a (68)Ga activity with consistent yields (>70%) and having acceptable radionuclidic (<10(-4)% of (68)Ge breakthrough), radiochemical, and chemical purities for an extended period of time. The eluted (68)GaCl3 is useful for the majority of the (68)Ga complexation chemistry.

  10. Long-term safety of a non-chlorofluorocarbon-containing triamcinolone acetonide inhalation aerosol in patients with asthma. Azmacort HFA Study Group.

    PubMed

    Nelson, H S; Kane, R E; Petillo, J; Banerji, D

    2000-04-01

    In response to environmental concerns regarding chlorofluorocarbon (CFC), two new triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol) formulations have been developed using a more environmentally favorable propellant, HFA-134a (1,1,1,2-tetrafluoroethane). This multicenter, open-label study evaluated the safety of switching asthma patients from TAA-CFC to one of two TAA-HFA formulations. After a 2- or 4-week baseline period during which patients received only CFC-containing TAA Inhaler, 552 patients were randomized to receive TAA-HFA 75 or 225 microg for 6 or 12 months. A total of 493 patients completed treatment. Seven patients discontinued because of adverse events and two because of ineffective asthma control. The incidence of adverse events was similar in the two treatment groups, and most events were mild to moderate in severity and were not considered related to study medication. No clinically relevant suppression of the hypophyseal-pituitary-adrenal (HPA) axis was observed. Pulmonary function tests were not adversely affected by use of either study medication, and improvements were noted in forced expiratory volume in 1 sec (FEV1) and forced expiratory flow between 25% and 75% of forced vital capacity (FEF25%-75%) throughout the course of treatment. This study confirms that TAA-HFA provides effective, long-term asthma control and can safely be substituted for the currently marketed CFC-containing TAA product.

  11. Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness

    PubMed Central

    De Franciscis, Pasquale; Grauso, Flavio; Luisi, Anna; Schettino, Maria Teresa; Torella, Marco; Colacurci, Nicola

    2017-01-01

    The effectiveness for vasomotor symptoms and sleep disorders plus the long-term safety of a nutraceutical combination of agnus-castus and magnolia extracts combined with soy isoflavones (SI) and lactobacilli were assessed in postmenopausal women. A controlled study was carried out in menopausal women comparing this nutraceutical combination (ESP group) with a formulation containing isoflavones alone (C group) at the dosage recommended. The Kuppermann index, The Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36) were determined at baseline, three, six and 12 months. Endometrial thickness, mammary density and liver function were evaluated at baseline and after 12 months. One hundred and eighty women were enrolled in the study (100 in the ESP group and 80 in the C group). At the end of the treatment, mammary density, endometrial thickness, and hepatic function did not show substantial differences between groups. The Kuppermann index and particularly the tendency for hot flashes progressively and significantly decreased in frequency and severity during ESP versus C treatment. At the same time, a significant increase in sleep quality and psychophysical wellness parameters was observed in the ESP versus C groups. No adverse events were observed. Agnus-castus and magnolia, combined with SI + lactobacilli, can effectively and safely be used in symptomatic postmenopausal women, mainly when quality of sleep is the most disturbing complaint. The endometrium, mammary glands and liver function were unaffected after 12 months of treatment. PMID:28208808

  12. Adding Agnus Castus and Magnolia to Soy Isoflavones Relieves Sleep Disturbances Besides Postmenopausal Vasomotor Symptoms-Long Term Safety and Effectiveness.

    PubMed

    De Franciscis, Pasquale; Grauso, Flavio; Luisi, Anna; Schettino, Maria Teresa; Torella, Marco; Colacurci, Nicola

    2017-02-13

    The effectiveness for vasomotor symptoms and sleep disorders plus the long-term safety of a nutraceutical combination of agnus-castus and magnolia extracts combined with soy isoflavones (SI) and lactobacilli were assessed in postmenopausal women. A controlled study was carried out in menopausal women comparing this nutraceutical combination (ESP group) with a formulation containing isoflavones alone (C group) at the dosage recommended. The Kuppermann index, The Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36) were determined at baseline, three, six and 12 months. Endometrial thickness, mammary density and liver function were evaluated at baseline and after 12 months. One hundred and eighty women were enrolled in the study (100 in the ESP group and 80 in the C group). At the end of the treatment, mammary density, endometrial thickness, and hepatic function did not show substantial differences between groups. The Kuppermann index and particularly the tendency for hot flashes progressively and significantly decreased in frequency and severity during ESP versus C treatment. At the same time, a significant increase in sleep quality and psychophysical wellness parameters was observed in the ESP versus C groups. No adverse events were observed. Agnus-castus and magnolia, combined with SI + lactobacilli, can effectively and safely be used in symptomatic postmenopausal women, mainly when quality of sleep is the most disturbing complaint. The endometrium, mammary glands and liver function were unaffected after 12 months of treatment.

  13. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease

    PubMed Central

    Burmester, Gerd R; Panaccione, Remo; Gordon, Kenneth B; McIlraith, Melissa J; Lacerda, Ana P M

    2013-01-01

    Background As long-term treatment with antitumour necrosis factor (TNF) drugs becomes accepted practice, the risk assessment requires an understanding of anti-TNF long-term safety. Registry safety data in rheumatoid arthritis (RA) are available, but these patients may not be monitored as closely as patients in a clinical trial. Cross-indication safety reviews of available anti-TNF agents are limited. Objective To analyse the long-term safety of adalimumab treatment. Methods This analysis included 23 458 patients exposed to adalimumab in 71 global clinical trials in RA, juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, psoriasis (Ps) and Crohn's disease (CD). Events per 100 patient-years were calculated using events reported after the first dose through 70 days after the last dose. Standardised incidence rates for malignancies were calculated using a National Cancer Institute database. Standardised death rates were calculated using WHO data. Results The most frequently reported serious adverse events across indications were infections with greatest incidence in RA and CD trials. Overall malignancy rates for adalimumab-treated patients were as expected for the general population; the incidence of lymphoma was increased in patients with RA, but within the range expected in RA without anti-TNF therapy; non-melanoma skin cancer incidence was raised in RA, Ps and CD. In all indications, death rates were lower than, or equivalent to, those expected in the general population. Conclusions Analysis of adverse events of interest through nearly 12 years of adalimumab exposure in clinical trials across indications demonstrated individual differences in rates by disease populations, no new safety signals and a safety profile consistent with known information about the anti-TNF class. PMID:22562972

  14. Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

    PubMed Central

    Abdalla, Abuelmagd; Byrne, Niamh; Conway, Richard; Walsh, Thomas; Mannion, Geraldine; Hanly, Michael; O’Sullivan, Miriam; Curran, Ann Maria; Carey, John J

    2017-01-01

    Purpose To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab. Conclusion Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. PMID:28331376

  15. A Retrospective Evaluation of 192 Implants Placed in Augmented Bone: Long-Term Follow-Up Study.

    PubMed

    Beretta, Mario; Cicciù, Marco; Poli, Pier Paolo; Rancitelli, Davide; Bassi, Gianluca; Grossi, Giovanni Battista; Maiorana, Carlo

    2015-12-01

    The purpose of the present study was to assess the cumulative survival rate (CSR) of 192 implants placed in association with guided bone regeneration (GBR) procedures to evaluate the long-term predictability of this technique. Moreover, the Kaplan Meier survival analysis was applied to the data in order to evaluate predictors of implant failures, including the source of the graft, the type of membrane, and the timing of implant placement. The CSR of the sample was 95.6% over a mean follow-up period of 78 months (range, 1-175 months). Considering the source of graft, a 95.0%, 93.3%, and 97.7% CSR was obtained for demineralized bovine bone mineral (DBBM), autologous, and 1:1 ratio mixture of autologous and DBBM grafts,, respectively. The CSR referred to bioabsorbable membranes was 96.5%, whereas 94.6% was the CSR reported for nonresorbable membranes. The CSR of simultaneous surgeries was 96.8%, whereas staged surgeries showed a CSR of 94.5%. According to the data, implants placed in conjunction with GBR procedures presented a satisfying survival rate even in the long term. All the procedures performed with different bone grafts and type of membranes guaranteed optimal results both in one- and two-stage approaches. No statistically significant differences could be detected among the groups; indeed, the use of DBBM associated with resorbable membranes may be suggested to reduce patients' morbidity and treatment time. Therefore, the dental implants placed in association with bone regenerative procedures presented safe and predictable long-term clinical results.

  16. Electrochemical Test Method for Evaluating Long-Term Propellant-Material Compatibility

    DTIC Science & Technology

    1978-12-01

    INSTRUCTIONS BEFORE COMPLETING FORM 2.GV CESSION NO.,. ftECIPIENT’S CATALOG NUMMEPI COVERED ý ,LECTROCHEMICALJEST METHOD FOR EVALUATING Fnl~pt LoNG -TERN...effects of each of these configurations were evaluated with respect to baseline tests where the metal was in the form of either a slug or a strip. The...system components beyond the limitations of real-time testing and evaluation. In the case of unmanned satellites, components which are in contact with

  17. Evaluation of the long-term energy analysis program used for the 1978 EIA Administrator's Report to Congress

    SciTech Connect

    Peelle, R. W.; Weisbin, C. R.; Alsmiller, Jr., R. G.

    1981-10-01

    An evaluation of the Long-Term Energy Analysis Program (LEAP), a computer model of the energy portion of the US economy that was used for the 1995-2020 projections in its 1978 Annual Report to Congress, is presented. An overview of the 1978 version, LEAP Model 22C, is followed by an analysis of the important results needed by its users. The model is then evaluated on the basis of: (1) the adequacy of its documentation; (2) the local experience in operating the model; (3) the adequacy of the numerical techniques used; (4) the soundness of the economic and technical foundations of the model equations; and (5) the degree to which the computer program has been verified. To show which parameters strongly influence the results and to approach the question of whether the model can project important results with sufficient accuracy to support qualitative conclusions, the numerical sensitivities of some important results to model input parameters are described. The input data are categorized and discussed, and uncertainties are given for some parameters as examples. From this background and from the relation of LEAP to other available approaches for long-term energy modeling, an overall evaluation is given of the model's suitability for use by the EIA.

  18. Dynamic Evaluation of Long-Term Air Quality Model Simulations Over the Northeastern U.S.

    EPA Science Inventory

    Dynamic model evaluation assesses a modeling system's ability to reproduce changes in air quality induced by changes in meteorology and/or emissions. In this paper, we illustrate various approaches to dynamic mode evaluation utilizing 18 years of air quality simulations perform...

  19. Evaluation and prediction of long-term environmental effects of nonmetallic materials, second phase

    NASA Technical Reports Server (NTRS)

    1983-01-01

    Changes in the functional properties of a number of nonmetallic materials were evaluated experimentally as a function of simulated space environments and to use such data to develop models for accelerated test methods useful for predicting such behavioral changes. The effects of changed particle irradiations on candidate space materials are evaluated.

  20. Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: 52-week results from an open-label extension of the J-RAPID study

    PubMed Central

    Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Shoji, Toshiharu; Miyasaka, Nobuyuki; Koike, Takao

    2014-01-01

    Abstract Objectives. To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) plus methotrexate treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients with an inadequate response to methotrexate. Methods. J-RAPID double-blind patients were entered into an open-label extension (OLE) study. Patients withdrawn due to lack of efficacy at 16 weeks and double-blind completers without a week-24 American College of Rheumatology (ACR) 20 response received CZP 200 mg every other week (Q2W) plus methotrexate. Double-blind completers with week-24 ACR20 responses were randomized to CZP 200 mg Q2W plus methotrexate or CZP 400 mg every 4 weeks plus methotrexate. Results. The ACR20/ACR50/ACR70 response rates of double-blind completers (n = 204) were 89.7%/67.2%/36.3% at OLE entry and 95.6%/84.8%/58.3% at 52 weeks, respectively. Other clinical, functional and radiographic outcomes were sustained with long-term CZP plus methotrexate. Long-term treatment with CZP was well-tolerated with no new unexpected adverse events observed. The efficacy and safety of CZP treatment were similar between the two dosing schedules. Conclusions. Continued CZP administration with methotrexate maintained efficacy over 52 weeks and was well-tolerated for Japanese RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules, giving flexibility in maintenance administration schedules. PMID:24593170

  1. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    PubMed Central

    Okada, Kenya; Sudo, Yohei; Itoh, Hiromichi; Yoshida, Hisao; Kuroda, Tatsuhiko

    2014-01-01

    Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy. PMID:26770729

  2. Life-long diseases need life-long treatment: long-term safety of ciclosporin in canine atopic dermatitis.

    PubMed

    Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

    2014-03-01

    Ciclosporin (Atopica; Novartis Animal Health) has been licensed for canine atopic dermatitis (AD) since 2002. Adverse events (AEs) have been reported in 55 per cent of 759 dogs in 15 clinical trials, but are rare in pharmacovigilance data (71.81 AEs/million capsules sold). Gastrointestinal reactions were most common, but were mild and rarely required intervention. Other AEs were rare (≤1 per cent in clinical trials; <10/million capsules sold). Hirsutism, gingival hyperplasia and hyperplastic dermatitis were rarely significant and resolved on dose reduction. Ciclosporin decreases staphylococcal and Malassezia infections in AD, and at the recommended dose is not a risk factor for other infections, neoplasia, renal failure or hypertension. The impact on glucose and calcium metabolism is not clinically significant for normal dogs. Concomitant treatment with most drugs is safe. Effects on cytochrome P450 and MDR1 P-glycoprotein activity may elevate plasma ciclosporin concentrations, but short-term changes are not clinically significant. Monitoring of complete blood counts, urinalysis or ciclosporin levels is not justified except with higher than recommended doses and/or long-term concurrent immunosuppressive drugs. Ciclosporin is not a contraindication for killed (including rabies) vaccines, but the licensed recommendation is that live vaccination is avoided during treatment. In conclusion, ciclosporin has a positive risk-benefit profile for the long-term management of canine AD.

  3. Life-long diseases need life-long treatment: long-term safety of ciclosporin in canine atopic dermatitis

    PubMed Central

    Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

    2014-01-01

    Ciclosporin (Atopica; Novartis Animal Health) has been licensed for canine atopic dermatitis (AD) since 2002. Adverse events (AEs) have been reported in 55 per cent of 759 dogs in 15 clinical trials, but are rare in pharmacovigilance data (71.81 AEs/million capsules sold). Gastrointestinal reactions were most common, but were mild and rarely required intervention. Other AEs were rare (≤1 per cent in clinical trials; <10/million capsules sold). Hirsutism, gingival hyperplasia and hyperplastic dermatitis were rarely significant and resolved on dose reduction. Ciclosporin decreases staphylococcal and Malassezia infections in AD, and at the recommended dose is not a risk factor for other infections, neoplasia, renal failure or hypertension. The impact on glucose and calcium metabolism is not clinically significant for normal dogs. Concomitant treatment with most drugs is safe. Effects on cytochrome P450 and MDR1 P-glycoprotein activity may elevate plasma ciclosporin concentrations, but short-term changes are not clinically significant. Monitoring of complete blood counts, urinalysis or ciclosporin levels is not justified except with higher than recommended doses and/or long-term concurrent immunosuppressive drugs. Ciclosporin is not a contraindication for killed (including rabies) vaccines, but the licensed recommendation is that live vaccination is avoided during treatment. In conclusion, ciclosporin has a positive risk-benefit profile for the long-term management of canine AD. PMID:24682696

  4. Long-term reproducibility optimization of an x-ray process for bone architectural evaluation during osteoporosis.

    PubMed

    Fidouh, F; Harba, R; Jacquet, G; Loussot, T; Lespessailles, E

    1999-01-01

    Non-invasive and in vivo assessment of bone architectural changes at high resolution is of considerable interest in osteoporosis. In this note, the use of an x-ray acquisition system in the evaluation of the architectural quality of trabecular bone by radiographic texture analysis is optimized to achieve good long-term reproducibility. First, radiographic and digitization processes are modelled and defined. Procedures to make radiographs and their digital images are fixed. Then, measurements of the modulation transfer function (MTF) of the entire acquisition chain were completed. These measurements provide an MTF in excess of 30% at a spatial frequency of 2.5 lp/mm. Also, results of a fractal texture analysis made on digital images of calcaneus radiographs show a mean coefficient of variation of 2.07%. These data show that good long-term reproducibility can make the x-ray acquisition system efficient for patient follow-up, or evaluation of treatment regimes for osteoporosis. Finally, it is shown that fractal texture parameters are statistically different in an osteoporotic population and in a control group. Therefore, this system should also be of medical interest.

  5. Root length and alveolar bone level of impacted canines and adjacent teeth after orthodontic traction: a long-term evaluation

    PubMed Central

    da SILVA, Aldir Cordeiro; CAPISTRANO, Anderson; de ALMEIDA-PEDRIN, Renata Rodrigues; CARDOSO, Maurício de Almeida; CONTI, Ana Cláudia de Castro Ferreira; CAPELOZZA, Leopoldino

    2017-01-01

    Abstract Objective The aim of this retrospective study was to evaluate the long-term effects of orthodontic traction on root length and alveolar bone level in impacted canines and adjacent teeth. Material and Methods Sample consisted of 16 patients (nine males and seven females), mean initial age 11 years and 8 months presenting with unilaterally maxillary impacted canines, palatally displaced, treated with the same surgical and orthodontic approach. Teeth from the impacted-canine side were assigned as Group I (GI), and contralateral teeth as control, Group II (GII). The mean age of patients at the end of orthodontic treatment was 14 years and 2 months and the mean post-treatment time was 5 years and 11 months. Both contralateral erupted maxillary canines and adjacent teeth served as control. Root length and alveolar bone level (buccal and palatal) were evaluated on cone-beam computed tomography (CBCT) images. The comparison of root length and alveolar bone level changes between groups were assessed by applying paired t-test, at a significance level of 5% (p<0.05). Results There were no statistically significant differences in root length and buccal and palatal bone levels of canines and adjacent teeth among groups. Conclusions Impacted canine treatment by closed-eruption technique associated with canine crown perforation, has a minimal effect on root length and buccal and palatal alveolar bone level in both canine and adjacent teeth, demonstrating that this treatment protocol has a good long-term prognosis. PMID:28198979

  6. A Longitudinal Evaluation of the Long-Term Effects of a Reading Recovery Program.

    ERIC Educational Resources Information Center

    Haenn, Joseph F.

    The Reading Recovery Program, designed to help low-achieving first graders learn to use effective reading strategies, was fully implemented in the Durham, North Carolina, public schools in the 1994-1995 school year. An evaluation was conducted to assess the effects of the program over time through the achievement of students in the 1994-1995…

  7. Evaluating Long-Term Complex Professional Development: Using a Variation of the Cohort Control Design

    ERIC Educational Resources Information Center

    Sample Mcmeeking, Laura B.; Cobb, R. Brian; Basile, Carole

    2010-01-01

    This paper introduces a variation on the post-test only cohort control design and addresses questions concerning both the methodological credibility and the practical utility of employing this design variation in evaluations of large-scale complex professional development programmes in mathematics education. The original design and design…

  8. Evaluating measures to assess soil health in long-term agroecosystem trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Monitoring and assessing soil health is an important component of any land management system with a vision of sustaining soil resources. Soil organic matter(SOM)characteristics are key to soil health and responsive to tillage regime and crop management. As metrics of soil health, we evaluated surfac...

  9. Evaluating the Appropriateness and Effectiveness of Long Term Inpatient Psychiatric Treatment for Adolescents.

    ERIC Educational Resources Information Center

    Dickert, Jeff; Sotinsky, Ted

    This paper describes the outcomes of a study that explored the significance of the Severity of Illness Rating Scale (SIRS) as a tool for utilization review and program evaluation. The SIRS was first introduced in March 1993 and soon became the centerpiece for the Arthur Brisbane Child Treatment Center's Utilization Review Plan. Since its…

  10. Evaluating Long-Term Effects of the Golden Lion Tamarin Environmental Education Program in Brazil

    ERIC Educational Resources Information Center

    Engels, Christine Archer; Jacobson, Susan K.

    2007-01-01

    The authors evaluated the environmental education program of the Golden Lion Tamarin Association in Brazil by comparing results of a 2001 survey with baseline data from 1986. Responses of 666 residents and results from 4 focus groups revealed an increase in public support for the tamarin and its habitat and an increase in general environmental…

  11. PERFORMANCE EVALUATION AT A LONG-TERM FOOD PROCESSING LAND TREATMENT SITE

    EPA Science Inventory

    The objective of this project was to determine the performance of a full scale, operating overland flow land (GEL) treatment system treating nonhazardous waste. Performance was evaluated in terms of treatment of the applied waste and the environmental impact of the system, partic...

  12. Prazosin versus quetiapine for nighttime posttraumatic stress disorder symptoms in veterans: an assessment of long-term comparative effectiveness and safety.

    PubMed

    Byers, Melanie G; Allison, Kristen M; Wendel, Christopher S; Lee, Jeannie K

    2010-06-01

    Posttraumatic stress disorder (PTSD) is an anxiety disorder experienced by combat veterans. Nighttime symptoms are often unrelieved by selective serotonin reuptake inhibitor therapy, and increased use of prazosin or quetiapine for treatment is seen. The purpose of this study was to determine the short- and long-term effectiveness and safety of prazosin versus quetiapine for treating nighttime symptoms in veteran PTSD patients. This is a historical prospective cohort study using retrospective chart review. Three hundred twenty-four patients with a diagnosis of PTSD, based on International Classification of Diseases, Ninth Revision coding, who were initially prescribed prazosin or quetiapine for nighttime symptoms were screened for inclusion. Short-term effectiveness was determined by documentation of symptomatic improvement within 6 months, and long-term effectiveness if patients continued therapy to study end date. Safety was assessed by comparing incidence of adverse drug effects causing discontinuation of either study drug. This study included 237 patients: 62 received prazosin, and 175 received quetiapine. Short-term effectiveness was similar for prazosin (61.3%) and quetiapine (61.7%; P = 0.54). However, patients prescribed prazosin were significantly more likely to continue their therapy to study end date compared with quetiapine (48.4% vs 24%; P < 0.001; odds ratio, 3.0; 95% confidence interval, 1.62-5.45), thus achieving long-term effectiveness. Alternatively, patients in the quetiapine group were more likely to discontinue therapy because of adverse effects compared with the prazosin group (34.9% vs 17.7%; P = 0.008). Because of similar rate of short-term effectiveness, superior long-term effectiveness, and lower incidence of events leading to discontinuation, compared with quetiapine, prazosin should be used first-line for treating nighttime PTSD symptoms in a veteran population.

  13. Long-term prospective evaluation of intestinal anastomosis using stainless steel staples in 14 dogs.

    PubMed

    Benlloch-Gonzalez, Manuel; Gomes, Eymeric; Bouvy, Bernard; Poncet, Cyrill

    2015-07-01

    This prospective clinical study evaluated the use, complications, and clinical and ultrasonographic follow-ups of end-to-end intestinal anastomoses with skin staples in naturally occurring diseases in canine small and large intestines. Intestinal anastomoses were performed in 14 dogs and pre-, peri-, and postoperative data were recorded. Postoperative clinical and ultrasound evaluations were performed at regular intervals for 1 year. The mean time taken to construct the anastomosis was 5 min. There were no intraoperative complications. Hemorrhage and colonic stricture were the main postoperative complications. Staple loss occurred in 2 cases. Absence of wall layering and focal wall thickening were observed in all cases at each ultrasonographic follow-up. Hyperechoic fat was observed in all but 1 of the cases at month 1. Nine dogs were alive with normal digestive function at the end of the study. The skin stapler technique enabled rapid construction of consistent anastomoses with inexpensive stapling material.

  14. Experiences in long-term evaluation of mercury emission monitoring systems

    SciTech Connect

    Chin-Min Cheng; Hung-Ta Lin; Qiang Wang; Chien-Wei Chen; Chia-Wei Wang; Ming-Chung Liu; Chi-Kuan Chen; Wei-Ping Pan

    2008-09-15

    Six mercury continuous emission monitoring (CEM) systems provided by two leading mercury (Hg) CEM system manufacturers were tested at five coal combustion utilities. The linearity, response time, day-to-day stability, efficiency of the Hg speciation modules, and ease of use were evaluated by following procedures specified in the Code of Federal Regulation Title 40 Part 75 (40 CFR Part 75). Mercury monitoring results from Hg CEM systems were compared to an EPA-recognized reference method. A sorbent trap sampling system was also evaluated in this study to compare the relative accuracy to the reference method as well as to Hg CEM systems. A conceptual protocol proposed by U.S. EPA (Method 30A) for using an Hg CEM system as the reference method for the Hg relative accuracy (RA) test was also followed to evaluate the workability of the protocol. This paper discusses the operational experience obtained from these field studies and the remaining challenges to overcome while using Hg CEM systems and the sorbent trap method for continuous Hg emission monitoring. 3 refs., 5 figs., 11 tabs.

  15. Evaluation of a therapeutic community treatment program: a long-term follow-up study in Spain.

    PubMed

    Fernández-Montalvo, Javier; López-Goñi, José J; Illescas, Cristina; Landa, Natalia; Lorea, Iñaki

    2008-01-01

    The aims of this study is to carry out a long-term follow-up evaluation of a well-established therapeutic community treatment for addictions in Navarre (Spain) and to make a comparison between the program completers and the dropouts, as well as between relapsing and nonrelapsing patients, on a broad set of variables. A long-term follow-up design (mean of 6 years after leaving treatment) was used to analyze the outcomes of the therapeutic program. The sample consisted of 155 subjects (113 completers and 42 dropouts). A personal interview was carried out with each one of the located subjects. The interviews took place between September 2000 and September 2004. Treatment "dropouts" manifested a higher and earlier rate both of relapses, and of new treatments for their drug addiction than the completion group. The program was also effective in reducing criminal behavior and improving the state of health. Significant differences were found across outcome variables when comparison was made between treatment completers and "dropouts." All subjects improved on outcome variables after receiving the treatment. When relapsing and nonrelapsing patients were compared, significant outcome differences were also found between groups. The study's limitations are noted and future needed research is suggested.

  16. Evaluation of p53 protein expression as a marker for long-term prognosis in colorectal carcinoma.

    PubMed Central

    Mulder, J. W.; Baas, I. O.; Polak, M. M.; Goodman, S. N.; Offerhaus, G. J.

    1995-01-01

    Mutation of the p53 gene is reported to be of prognostic importance in colorectal carcinomas. Immunohistochemical staining of the accumulated p53 gene product may be a simple alternative for p53 mutation analysis. Previous studies addressing the prognostic importance of p53 expression, however, yielded contradictory results. Therefore, we evaluated the importance of p53 expression as a marker for long-term prognosis in a well-characterised study population of 109 colorectal carcinomas. After antigen retrieval with target unmasking fluid (TUF), immunostaining of p53 was performed with both monoclonal antibody DO7 and polyclonal antibody CM1. Objective quantification of the p53 signal was assessed by a computerised image analyser. p53 expression was higher in non-mucinous tumours than in mucinous tumours (p53 labelling index = 30% and 17% respectively, P = 0.05), and in metastatic tumours compared with non-metastatic tumours (p53 labelling index = 37% and 22% respectively, P = 0.05). Other histopathological features were not related to p53 expression. In multivariate analysis, Dukes' stage (P = 0.02) and histological grade (P = 0.05) stood out as independent markers for prognosis. p53 expression was not an independent marker for prognosis. At present, p53 expression is not a useful marker for long-term prognosis. Further insight into the relationship between p53 mutations and p53 expression is needed to elucidate more precisely the clinical relevance of p53 alterations. PMID:7779721

  17. Evaluation of the biotic ligand model to predict long-term toxicity of nickel to Hyalella azteca.

    PubMed

    Schroeder, J E; Borgmann, U; Dixon, D G

    2010-11-01

    Three models were developed and evaluated for their ability to predict long-term bioaccumulation of nickel (Ni) and its toxicity to Hyalella azteca using data from 28-d toxicity tests. One of the models was based on competitive action of Ni with Ca and H (the biotic ligand model; BLM), and the other two models included expressions for the potential noncompetitive action of calcium on the ligand (i.e., acclimation), in addition to, or instead of, its competitive action (not accounted for in the BLM). Each model was able to predict lethal accumulation 50 (accumulation at 50% mortality; LA50s) within a factor of 2 of the corresponding observed LA50. The mean predicted LA50 from all three models was within 13% of the observed mean LA50 of 0.90 µmol/g (dry weight). The median lethal concentrations (LC50s) predicted by the three models were similar and were within a factor of 2 of the observed LC50s for 11 of 13 tests, providing encouragement for further development of a long-term Ni BLM. The similar performance of models based on competitive or noncompetitive action may reflect limitations in the data set or may suggest that effects of calcium on the ligand (L(T)) were insufficient to hamper the functionality of the competitive model or that the LA50/L(T) ratio, rather than the LA50 and L(T), is constant.

  18. Basalt glass: an analogue for the evaluation of the long-term stability of nuclear waste form borosilicate glasses

    SciTech Connect

    Byers, C.D.; Jercinovic, M.J.; Ewing, R.C.; Keil, K.

    1984-01-01

    The long-term stability of nuclear waste form borosilicate glasses can be evaluated by understanding the processes that effect the long-term alteration of glass and by comparing laboratory alteration of synthetic basalt and borosilicate glasses with the observed stability of naturally occurring basaltic glasses in diverse geologic environments. This paper presents detailed electron microprobe analyses of naturally altered basaltic glasses (with maximum ages of 10,000 to 20 million years) from low-temperature environments. These results are compared to laboratory data on the corrosion of a synthetic basaltic glass in MCC-1 tests (90/sup 0/C, a SA/V of 0.1 cm/sup -1/ and time periods up to 182 days), MCC-2 tests (190/sup 0/C, a SA/V of 0.1 cm/sup -1/ and time periods up to 210 days) and hydration tests in saturated water vapor (240/sup 0/C, an estimated SA/V of approx. 10/sup 6/ cm/sup -1/ and time periods up to 63 days). Additionally, laboratory-induced hydration alteration of synthetic basalt and borosilicate glasses is compared. These preliminary experiments provide evidence that the alteration processes observed for natural basalt glasses are relevant to understanding the alteration of nuclear waste glass, as both appear to react via similar processes. 12 references, 6 figures, 1 table.

  19. Long-term results of treatment for temporomandibular disorders: an evaluation by patients.

    PubMed

    Okeson, J P; Hayes, D K

    1986-04-01

    In this study, 110 patients with temporomandibular disorders who had been treated 2 to 81/2 years earlier were asked to evaluate the treatment they received. Of the patients, 85.5% reported that they were not experiencing pain or that they were experiencing much less pain; 79.1% reported that the treatment they had received had helped them completely or considerably. Analysis of the data did not disclose a subgroup or factor that could be correlated with the reduction of pain or the patient's perception of the success of treatment.

  20. Evaluation and long-term outcomes of the different modalities used in colonic endoscopic mucosal resection

    PubMed Central

    Gaglia, Asimina; Sarkar, Sanchoy

    2017-01-01

    Endoscopic mucosal resection (EMR) has been used in western countries to remove colonic polyps for at least the last two decades. Significant experience has been accumulated and the efficacy of the method has recently been evaluated in a large meta-analysis. A number of variations to modify the technique, including knife-assisted, cap-assisted, ligation devices, and underwater EMR, have been developed in an attempt to improve outcomes. However, to date there are only limited data comparing these techniques or demonstrating the superiority of any one of them. This article reviews the current evidence on the efficacy of each of these modified techniques. PMID:28243034

  1. New Rapid Evaluation for Long-Term Behavior in Deep Geological Repository by Geotechnical Centrifuge—Part 2: Numerical Simulation of Model Tests in Isothermal Condition

    NASA Astrophysics Data System (ADS)

    Sawada, Masataka; Nishimoto, Soshi; Okada, Tetsuji

    2017-01-01

    In high-level radioactive waste disposal repositories, there are long-term complex thermal, hydraulic, and mechanical (T-H-M) phenomena that involve the generation of heat from the waste, the infiltration of ground water, and swelling of the bentonite buffer. The ability to model such coupled phenomena is of particular importance to the repository design and assessments of its safety. We have developed a T-H-M-coupled analysis program that evaluates the long-term behavior around the repository (called "near-field"). We have also conducted centrifugal model tests that model the long-term T-H-M-coupled behavior in the near-field. In this study, we conduct H-M-coupled numerical simulations of the centrifugal near-field model tests. We compare numerical results with each other and with results obtained from the centrifugal model tests. From the comparison, we deduce that: (1) in the numerical simulation, water infiltration in the rock mass was in agreement with the experimental observation. (2) The constant-stress boundary condition in the centrifugal model tests may cause a larger expansion of the rock mass than in the in situ condition, but the mechanical boundary condition did not affect the buffer behavior in the deposition hole. (3) The numerical simulation broadly reproduced the measured bentonite pressure and the overpack displacement, but did not reproduce the decreasing trend of the bentonite pressure after 100 equivalent years. This indicates the effect of the time-dependent characteristics of the surrounding rock mass. Further investigations are needed to determine the effect of initial heterogeneity in the deposition hole and the time-dependent behavior of the surrounding rock mass.

  2. An evaluation of long-term preservation methods for brown bear (Ursus arctos) faecal DNA samples

    USGS Publications Warehouse

    Murphy, M.A.; Waits, L.P.; Kendall, K.C.; Wasser, S.K.; Higbee, J.A.; Bogden, R.

    2002-01-01

    Relatively few large-scale faecal DNA studies have been initiated due to difficulties in amplifying low quality and quantity DNA template. To improve brown bear faecal DNA PCR amplification success rates and to determine post collection sample longevity, five preservation methods were evaluated: 90% ethanol, DETs buffer, silica-dried, oven-dried stored at room temperature, and oven-dried stored at -20??C. Preservation effectiveness was evaluated for 50 faecal samples by PCR amplification of a mitochondrial DNA (mtDNA) locus (???146 bp) and a nuclear DNA (nDNA) locus (???200 bp) at time points of one week, one month, three months and six months. Preservation method and storage time significantly impacted mtDNA and nDNA amplification success rates. For mtDNA, all preservation methods had ??? 75% success at one week, but storage time had a significant impact on the effectiveness of the silica preservation method. Ethanol preserved samples had the highest success rates for both mtDNA (86.5%) and nDNA (84%). Nuclear DNA amplification success rates ranged from 26-88%, and storage time had a significant impact on all methods but ethanol. Preservation method and storage time should be important considerations for researchers planning projects utilizing faecal DNA. We recommend preservation of faecal samples in 90% ethanol when feasible, although when collecting in remote field conditions or for both DNA and hormone assays a dry collection method may be advantageous.

  3. Long-term evaluation of the performance of four point-of-use water filters.

    PubMed

    Pérez-Vidal, Andrea; Diaz-Gómez, Jaime; Castellanos-Rozo, Jose; Usaquen-Perilla, Olga Lucía

    2016-07-01

    Despite technological advances water supply quality and poor access to safe water remain a major problem in developing countries, especially in rural areas. Point-of-use (POU) water treatment has been shown to be a viable option to produce safe drinking water quality. The aim of this study was to evaluate, under laboratory conditions over 14 months, the performance of four household filtration systems: membrane filter (MF), one-candle ceramic filter (1CCF), two-candle ceramic filter (2CCF) and pot ceramic filter (PCF). The evaluation was made using spiked water having the required concentrations of turbidity, Escherichia coli and Total Dissolved Solids (TDS). The results show that all systems have high removal efficiencies for turbidity (98-99%), and E. coli 4-5 Log Reduction Value (LRV). The poorest efficiency was for TDS (9-18%). The MF and the CCF displayed no significant difference in efficiencies for these parameters. The PCF had less significant differences for turbidity removal than the other systems. The average filtration rate for all systems decreased during the operation time. The CPF showed the major potential to be used in rural communities mainly for its low operational level and maintenance requirements as well as its local craftsmanship. It was observed that the efficiency of the systems is highly sensitive to cleaning and maintenance activities and therefore, the system sustainability will depend considerably on the training and education of the potential users.

  4. Evaluation of Long-Term Calibrations of the AVHRR Visible Radiances

    NASA Technical Reports Server (NTRS)

    Rossow, William B.; Ferrier, Joseph

    2015-01-01

    Two systematic calibrations have been compiled for the visible radiances measured by the series of AVHRR instruments flown on the NOAA operational polar weather satellites: one by the International Satellite Cloud Climatology Project (ISCCP), anchored on NASA ER-2 underflights in the 1980s and early 1990s and covering the period 1981-2009, and one by the PATMOS-x project, anchored on comparisons to the MODIS instruments on the Aqua and Terra satellites in the 2000s and covering the period 1979-2010 (this result also includes calibration for the near-IR channels). Both methods have had to extend their anchor calibrations over a long series of instruments using different vicarious approaches, so a comparison provides an opportunity to evaluate how well this extension works by cross-checking the results at the anchor points. The basic result of this comparison is that for the ''afternoon'' series of AVHRRs, the calibrations agree to within their mutual uncertainties. However, this retrospective evaluation also shows that the representation of the time variations can be simplified. The ISCCP procedure had much more difficulty extending the calibration to the ''morning'' series of AVHRRs with the calibrations for NOAA-15 and NOAA-17 exceeding the estimated uncertainties. Given the general agreement, a new calibration for all AVHRR visible radiances (except TIROS-N, NOAA-6, NOAA-19, and MetOp-A) is proposed that is based on the average of the best linear fits to the two time records. The estimated uncertainty of these calibrations is 63% absolute (scaled radiance units).

  5. Evaluating the patients with thalassemia major for long-term endocrinological complications after bone marrow transplantation.

    PubMed

    Aldemir-Kocabaş, Bilge; Tezcan-Karasu, Gülsün; Bircan, Iffet; Bircan, Oğuz; Aktaş-Samur, Anıl; Yeşilipek, Mehmet Akif

    2014-10-01

    The aim of this study was to evaluate the endocrinological complications of the patients with thalassemia major (TM) who underwent bone marrow transplantation (BMT) and followed-up more than two years in our center, prospectively. "BMT group" consisted of 41 patients with TM. The mean age was 12.4 ± 5.4 years and transplantation age was mean 7.5 ± 4.9 years. Post-BMT follow-up lasted from 24 to 122 months (mean 65.07 months). Also, 32 TM patients with similar age group and same history of transfusion and chelation therapy were recruited for the study as "control (C) group". The weight SDS score after transplantation was found better than before transplantation (p = 0.010). There was a negative correlation between height SDS and BMT age (p = 0.008). The height SDS scores were better in patients whose BMT age was under seven years old compared to those older than seven years old (p = 0.02). Z-scores of femur neck and L2-4 vertebrae DEXA were decreased (p = 0.032, p = 0.0001) and incidence of insulin resistance increased (p = 0.01) in patients with increased BMT age. The risk of gonadal insufficiency was significantly lower in the patients who underwent BMT <7 years of age (p = 0.009). There was no statistically significant relationship between BMT age and complications such as hypothyroidism, hypoparathyroidism, and adrenal insufficiency. The patients with TM should be evaluated for transplantation in early stage of the disease, especially before the age of seven years. Because the BMT cannot correct the endocrinological complications of TM completely, the patients should be followed up regularly after the transplantation.

  6. Long term evaluation of mesenchymal stem cell therapy in a feline model of chronic allergic asthma

    PubMed Central

    Trzil, Julie E; Masseau, Isabelle; Webb, Tracy L; Chang, Chee-hoon; Dodam, John R; Cohn, Leah A; Liu, Hong; Quimby, Jessica M; Dow, Steven W; Reinero, Carol R

    2014-01-01

    Background Mesenchymal stem cells (MSCs) decrease airway eosinophilia, airway hyperresponsiveness (AHR), and remodeling in murine models of acutely induced asthma. We hypothesized that MSCs would diminish these hallmark features in a chronic feline asthma model. Objective To document effects of allogeneic, adipose-derived MSCs on airway inflammation, airway hyperresponsiveness (AHR), and remodeling over time and investigate mechanisms by which MSCs alter local and systemic immunologic responses in chronic experimental feline allergic asthma. Methods Cats with chronic, experimentally-induced asthma received six intravenous infusions of MSCs (0.36–2.5X10E7 MSCs/infusion) or placebo bimonthly at the time of study enrollment. Cats were evaluated at baseline and longitudinally for one year. Outcome measures included: bronchoalveolar lavage fluid cytology to assess airway eosinophilia; pulmonary mechanics and clinical scoring to assess AHR; and thoracic computed tomographic (CT) scans to assess structural changes (airway remodeling). CT scans were evaluated using a scoring system for lung attenuation (LA) and bronchial wall thickening (BWT). To assess mechanisms of MSC action, immunologic assays including allergen-specific IgE, cellular IL-10 production, and allergen-specific lymphocyte proliferation were performed. Results There were no differences between treatment groups or over time with respect to airway eosinophilia or AHR. However, significantly lower LA and BWT scores were noted in CT images of MSC-treated animals compared to placebo-treated cats at month 8 of the study (LA p=0.0311; BWT p=0.0489). No differences were noted between groups in the immunologic assays. Conclusions and Clinical Relevance When administered after development of chronic allergic feline asthma, MSCs failed to reduce airway inflammation and AHR. However, repeated administration of MSCs at the start of study did reduce computed tomographic measures of airway remodeling by month 8, though

  7. Evaluating satellite-derived long-term historical precipitation datasets for drought monitoring in Chile

    NASA Astrophysics Data System (ADS)

    Zambrano, Francisco; Wardlow, Brian; Tadesse, Tsegaye

    2016-10-01

    Precipitation is a key parameter for the study of climate change and variability and the detection and monitoring of natural disaster such as drought. Precipitation datasets that accurately capture the amount and spatial variability of rainfall is critical for drought monitoring and a wide range of other climate applications. This is challenging in many parts of the world, which often have a limited number of weather stations and/or historical data records. Satellite-derived precipitation products offer a viable alternative with several remotely sensed precipitation datasets now available with long historical data records (+30 years), which include the Climate Hazards Group InfraRed Precipitation with Station (CHIRPS) and Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks-Climate Data Record (PERSIANN-CDR) datasets. This study presents a comparative analysis of three historical satellite-based precipitation datasets that include Tropical Rainfall Measuring Mission (TRMM) Multi-satellite Precipitation Analysis (TMPA) 3B43 version 7 (1998-2015), PERSIANN-CDR (1983-2015) and CHIRPS 2.0 (1981-2015) over Chile to assess their performance across the country and evaluate their applicability for agricultural drought evaluation when used in the calculation of commonly used drought indicator as the Standardized Precipitation Index (SPI). In this analysis, 278 weather stations of in-situ rainfall measurements across Chile were initially compared to the satellite-based precipitation estimates. The study area (Chile) was divided into five latitudinal zones: North, North-Central, Central, South-Central and South to determine if there were a regional difference among these satellite-based estimates. Nine statistics were used to evaluate the performance of satellite products to estimate the amount and spatial distribution of historical rainfall across Chile. Hierarchical cluster analysis, k-means and singular value decomposition were used to

  8. Discriminative evaluative conditioning in the long-term after severe accidental injury.

    PubMed

    Oe, Misari; Schumacher, Sonja; Schnyder, Ulrich; Mueller-Pfeiffer, Christoph; Wilhelm, Frank H; Kuelen, Eveline; Martin-Soelch, Chantal

    2016-06-30

    Impairments in classical fear conditioning and deficits in discriminative learning are observed in posttraumatic stress disorder (PTSD). However, it is unknown whether similar impairments can be found with types of discriminative learning other than classical conditioning, such as evaluative conditioning (EC), in which the valence of a stimulus can be transferred to other stimuli. In this study, we investigated whether EC is also influenced by traumatic experiences independently of presence of PTSD. We tested 14 accident survivors with remitted PTSD, 14 survivors without PTSD, and 16 non-trauma controls. We used behavioral measures, psychophysiological indicators, and subjective ratings for tasks. General effects of learning were observed across groups and conditioning/extinction. Trauma controls had slower reaction times (RTs) to the aversive conditioned stimulus compared to appetitive conditioned and neutral stimuli, as well as slower RTs and increased accuracy during conditioning than during extinction. Remitted PTSD participants showed opposite results, demonstrating decreased accuracy and slower RTs during conditioning as compared to during extinction. No discriminative effect was found in the non-trauma controls and the remitted PTSD participants. These results suggest that a traumatic experience influences EC, and that this influence differs between individuals who have and have not developed PTSD after traumatic exposure.

  9. First Clinical Evaluation of a New Long-Term Subconjunctival Glucose Sensor

    PubMed Central

    Müller, Achim Josef; Knuth, Monika; Nikolaus, Katharina Sibylle; Herbrechtsmeier, Peter

    2012-01-01

    Background To evaluate the feasibility of an implantable subconjunctival glucose monitoring system (SGMS) for glucose monitoring in humans, we investigated the in vivo performance of the sensor in a clinical trial with five patients. Methods The new SGMS consists of an implantable ocular mini implant (OMI) and a hand-held fluorescence photometer. The implantable subconjunctival glucose sensor is composed of a fluorescence resonance energy transfer system based on Concanavalin A chemistry, embedded in a nelfilcon polymer hydrogel disk. Blood glucose changes in humans were induced by oral glucose intake and insulin injections. Results The in vivo response of the new SGMS was tested in a first human clinical study with five diabetes patients. The OMI was well tolerated in the eyes of the patients. The SGMS exhibited high correlation coefficients (>0.88) with blood glucose changes and a good stability of the sensor response to glucose for the study period of 2 weeks. Lag times were in the range of 5–10 min. A total of 98% of all data pairs was in the clinical acceptable ranges A and B of the consensus error grid. Conclusions For the first time, the possibility to measure glucose in vivo in the subconjunctival interstitial fluid for a period of 2 weeks was demonstrated in a human clinical trial. PMID:22920814

  10. Disabled patients and oral health in Rome, Italy: long-term evaluation of educational initiatives

    PubMed Central

    Avenali, Laura; Guerra, Fabrizio; Cipriano, Luigi; Corridore, Denise; Ottolenghi, Livia

    2012-01-01

    Summary This study is concerned with the educational intervention layout proposed as a possible answer for the disparities in healthcare services for disabled persons. Material and methods The data sampling was performed on individuals in Rome, affected by psychophysical disabilities, living in residential care facilities. Participants were randomly divided into two groups: Study and Control Group, consisting of patients who did or did not participate in the Educational Phase. All the caregivers participated in an educational course. Screening period: September 2008 – March 2009. Examinations were performed using Visible Plaque Index (VPI), Gingival Bleeding Index (GBI) and Microbiological Analysis. Results The total number of patients utilized for the study was 36 (18 in each group). The final sample amounted to 70% (14/20) in the Study Group and to 75% (15/20) in the Control Group. In both examined groups Oral Hygiene, Gingival Health State and Microbiological Analysis show an overall improvement of the indices, compared with the initial status, mostly at a follow-up after 4 weeks. However, Study Group show a significantly better improvement. Conversely, after 6 months the overall clinical indices worsened again. Conclusion The difference in the significant improvements of the groups, even if only over a short-time evaluation, endorses that the participation of the patients as well as tutors in the educational phase is an effective strategy for the short-term. PMID:22545186

  11. Evaluation of long-term sedation in cheetah (Acinonyx jubatus) with perphenazine enanthate and zuclopenthixol acetate.

    PubMed

    Huber, C; Walzer, C; Slotta-Bachmayr, L

    2001-09-01

    Two long-acting neuroleptics were used to tranquilize nine captive cheetahs (Acinonyx jubatus). Perphenazine enanthate (3.0 mg/kg) and zuclopenthixol acetate (0.6 mg/kg) were each administered to separate groups of three cheetahs in a double blind trial. Both products were administered together to a third group of three animals at the same dosages. Behavioral effect, duration of effect, and possible side effects were observed by a predefined protocol. Under standardized holding conditions, the cheetahs were observed 5 days before drug administration and 14 days after administration. Daily activity was defined and statistically evaluated by a U-test. A significant reduction of activity was observed after administration in all three trials. Zuclopenthixol acetate at 0.6 mg/kg alone and in combination with perphenazine enanthate caused inappetence, ataxia, extra pyramidal reactions, akathisia, and prolapse of the third eyelid. Zuclopenthixol acetate should not be used in cheetahs. Perphenazine enanthate did not cause inappetence, reduced appetite, or any of the previously mentioned side effects when used alone. It produced satisfactory tranquilization and is suitable and safe for cheetahs at 3.0 mg/kg. This dosage should be varied depending on health, age, and temperament of the individual cheetah.

  12. Validity of body impedance analysis for evaluating body composition in patients undergoing long-term hemodialysis.

    PubMed

    Noguchi, Masahiro; Yamaguchi, Shinichi; Koshino, Yoshitaka; Kimura, Akira; Miyagi, Shigeji

    2015-06-01

    [Purpose] This study assessed changes in body composition before and after dialysis in chronic hemodialysis patients and determined the relationships between various body composition parameters and blood lipid levels in these patients. [Subjects] The cross-sectional study included 19 dialysis outpatients (17 men and 2 women, aged 35-82 years). [Methods] Body mass index, body weight, percent body fat, and percent skeletal muscle were measured before and after dialysis by using body impedance analysis. Blood lipid levels were obtained from patients' clinical records. The body composition parameters before and after dialysis were compared using paired t-tests. Spearman's rank correlation coefficients were calculated to determine relationships between the body composition parameters, before and after dialysis, and the blood lipid levels. [Results] All body composition parameters differed significantly before and after dialysis. High-density lipoprotein cholesterol level significantly correlated with all the body composition parameters, whereas total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels significantly correlated with some of these parameters. The correlation coefficients revealed no major differences in the relationships between blood lipid parameters and body compositions before and after dialysis. [Conclusion] Our findings suggest that body composition parameters, whether measured before or after dialysis, can be used to evaluate obesity in longitudinal studies.

  13. Empirical evaluation of the conceptual model underpinning a regional aquatic long-term monitoring program using causal modelling

    USGS Publications Warehouse

    Irvine, Kathryn M.; Miller, Scott; Al-Chokhachy, Robert K.; Archer, Erik; Roper, Brett B.; Kershner, Jeffrey L.

    2015-01-01

    Conceptual models are an integral facet of long-term monitoring programs. Proposed linkages between drivers, stressors, and ecological indicators are identified within the conceptual model of most mandated programs. We empirically evaluate a conceptual model developed for a regional aquatic and riparian monitoring program using causal models (i.e., Bayesian path analysis). We assess whether data gathered for regional status and trend estimation can also provide insights on why a stream may deviate from reference conditions. We target the hypothesized causal pathways for how anthropogenic drivers of road density, percent grazing, and percent forest within a catchment affect instream biological condition. We found instream temperature and fine sediments in arid sites and only fine sediments in mesic sites accounted for a significant portion of the maximum possible variation explainable in biological condition among managed sites. However, the biological significance of the direct effects of anthropogenic drivers on instream temperature and fine sediments were minimal or not detected. Consequently, there was weak to no biological support for causal pathways related to anthropogenic drivers’ impact on biological condition. With weak biological and statistical effect sizes, ignoring environmental contextual variables and covariates that explain natural heterogeneity would have resulted in no evidence of human impacts on biological integrity in some instances. For programs targeting the effects of anthropogenic activities, it is imperative to identify both land use practices and mechanisms that have led to degraded conditions (i.e., moving beyond simple status and trend estimation). Our empirical evaluation of the conceptual model underpinning the long-term monitoring program provided an opportunity for learning and, consequently, we discuss survey design elements that require modification to achieve question driven monitoring, a necessary step in the practice of

  14. Long-Term Changes in Refractive Error and Clinical Evaluation in Partially Accommodative Esotropia after Surgery

    PubMed Central

    Oh, Shin Yeop; Lee, Ju-Yeun; Park, Kyung-Ah; Oh, Sei Yeul

    2016-01-01

    We investigate the changes in refractive error and clinical evaluation in partially accommodative esotropia(PAET) after surgery. A total of 68 patients PAET who received at least 2 years of follow-up after surgery were enrolled in this study. We performed a retrospective study in patients who underwent unilateral or bilateral medial rectus recession for a non-accommodative component of PAET between January 2005 and March 2013. Patients were divided into groups according to the presence of dominancy (dominant, non-dominant, alternative eye), and presence of amblyopia (amblyopic, fellow, normal eye). Changes and changing pattern in SE refractive error were analyzed in all patients and compared between groups. Patients were divided into two groups, those weaned off of hyperopic glasses and those who continued using them, then factors that significantly influenced the continued use of glasses were analyzed. The changes and changing pattern in SE refractive error according to time after operation and presence of amblyopia or dominancy. The mean length of follow-up was 4.89±1.74 years after surgery and the mean change in SE refractive error rate per year was -0.284±0.411 diopters (D). The pattern of changes in the mean SE refractive error for those with dominant, non-dominant, and alternative eyes was not significantly different (p = 0.292). The pattern of changes in the mean SE refractive error for those with amblyopic, fellow, and normal eyes was significantly different (p = 0.0002). Patients were successfully weaned off of hyperopic glasses at an average age of 9.41±2.74 years. The average SE refractive error in the group weaned off of hyperopic glasses was significantly lower than that in the group maintained on hyperopic glasses (p = 0.0002). The change of SE refractive error in amblyopic eyes decreased less than that in fellow or normal eyes, which may be correlated with the presence of amblyopia. Patients with a smaller esodeviated angle without hyperopic

  15. Evaluating for long-term impact of an environmental education program at the Kalinzu Forest Reserve, Uganda.

    PubMed

    Kuhar, C W; Bettinger, T L; Lehnhardt, K; Tracy, Osuo; Cox, D

    2010-05-01

    Although the importance of evaluating the effectiveness of conservation education programs cannot be underestimated, few evaluations of these programs and their resulting impact on the environment have been conducted. A partnership between scientists, educators, and local administrators on an evaluation program has been developed to evaluate a model of education program evaluation that includes short- and long-term evaluation of (1) knowledge and attitude change, (2) behavior change, and (3) positive biological impact. Previous work has shown short-term knowledge retention from this education program. In the current study follow-up evaluations were collected from students at 14 schools outside the Kalinzu Forest Reserve, Uganda. By comparing performance 30 days, 1 year and 2 years after the initial program we demonstrate that knowledge gain from this program is not transient. However, although knowledge is a prerequisite for appropriate conservation actions it does not guarantee appropriate behaviors will be performed. Anecdotal evidence of behavior change and positive biological impact is discussed within the context of the challenges with changing behavior and evaluating the true biological impacts of those behaviors. Ultimately, conservation professionals will need to partner with educators and social scientists to effectively measure the impact of conservation education and human-based conservation programs on primate populations and their habitat.

  16. Long-term safety of umbilical cord mesenchymal stem cells transplantation for systemic lupus erythematosus: a 6-year follow-up study.

    PubMed

    Wang, Dandan; Niu, Lingying; Feng, Xuebing; Yuan, Xinran; Zhao, Shengnan; Zhang, Huayong; Liang, Jun; Zhao, Cheng; Wang, Hong; Hua, Bingzhu; Sun, Lingyun

    2016-06-07

    The aim of this study is to assess the long-term safety of allogeneic umbilical cord mesenchymal stem cells (UC MSCs) transplantation for patients with refractory systemic lupus erythematosus (SLE). Nine SLE patients, who were refractory to steroid and immunosuppressive drugs treatment and underwent MSCs transplantation in 2009, were enrolled. One million allogeneic UC MSCs per kilogram of body weight were infused intravenously at days 0 and 7. The possible adverse events, including immediately after MSCs infusions, as well as the long-term safety profiles were observed. Blood and urine routine test, liver function, electrocardiogram, chest radiography and serum levels of tumor markers, including alpha fetal protein (AFP), cancer embryo antigen (CEA), carbohydrate antigen 155 (CA155) and CA199, were assayed before and 1, 2, 4 and 6 years after MSCs transplantation. All the patients completed two times of MSCs infusions. One patient had mild dizzy and warm sensation 5 min after MSCs infusion, and the symptoms disappeared quickly. No other adverse event, including fluster, headache, nausea or vomit, was observed. There was no change in peripheral white blood cell count, red blood cell count and platelet number in these patients after followed up for 6 years. Liver functional analysis showed that serum alanine aminotransferase, glutamic-oxalacetic transaminase, total bilirubin and direct bilirubin remained in normal range after MSCs infusions. No newly onset abnormality was detected on electrocardiogram and chest radiography. Moreover, we found no rise of serum tumor markers, including AFP, CEA, CA125 and CA199, before and 6 years after MSCs infusions. Our long-term observational study demonstrated a good safety profile of allogeneic UC MSCs in SLE patients.

  17. NDT evaluation of long-term bond durability of CFRP-structural systems applied to RC highway bridges

    NASA Astrophysics Data System (ADS)

    Crawford, Kenneth C.

    2016-06-01

    The long-term durability of CFRP structural systems applied to reinforced-concrete (RC) highway bridges is a function of the system bond behavior over time. The sustained structural load performance of strengthened bridges depends on the carbon fiber-reinforced polymer (CFRP) laminates remaining 100 % bonded to concrete bridge members. Periodic testing of the CFRP-concrete bond condition is necessary to sustain load performance. The objective of this paper is to present a non-destructive testing (NDT) method designed to evaluate the bond condition and long-term durability of CFRP laminate (plate) systems applied to RC highway bridges. Using the impact-echo principle, a mobile mechanical device using light impact hammers moving along the length of a bonded CFRP plate produces unique acoustic frequencies which are a function of existing CFRP plate-concrete bond conditions. The purpose of this method is to test and locate CFRP plates de-bonded from bridge structural members to identify associated deterioration in bridge load performance. Laboratory tests of this NDT device on a CFRP plate bonded to concrete with staged voids (de-laminations) produced different frequencies for bonded and de-bonded areas of the plate. The spectra (bands) of frequencies obtained in these tests show a correlation to the CFRP-concrete bond condition and identify bonded and de-bonded areas of the plate. The results of these tests indicate that this NDT impact machine, with design improvements, can potentially provide bridge engineers a means to rapidly evaluate long lengths of CFRP laminates applied to multiple highway bridges within a national transportation infrastructure.

  18. Key Performance Criteria Affecting the Most the Safety of a Nuclear Waste Long Term Storage : A Case Study Commissioned by CEA

    SciTech Connect

    Marvy, A.; Lioure, A; Heriard-Dubreuil, G.; Gadbois, S.; Schneider, T.; Schieber, C.

    2003-02-24

    As part of the work scope set in the French law on high level long lived waste R&D passed in 1991, CEA is conducting a research program to establish the scientific basis and assess the feasibility of long term storage as an option for the safe management of nuclear waste for periods as long as centuries. This goal is a significant departure from the current industrial practice where storage facilities are usually built to last only a few decades. From a technical viewpoint such an extension in time seems feasible provided care and maintenance is exercised. Considering such long periods of time, the risk for Society of loosing oversight and control of such a facility is real, which triggers the question of whether and how long term storage safety can be actually achieved. Therefore CEA commissioned a study (1) in which MUTADIS Consultants (2) and CEPN (3) were both involved. The case study looks into several past and actual human enterprises conducted over significant periods o f time, one of them dating back to the end of the 18th century, and all identified out of the nuclear field. Then-prevailing societal behavior and organizational structures are screened out to show how they were or are still able to cope with similar oversight and control goals. As a result, the study group formulated a set of performance criteria relating to issues like responsibility, securing funds, legal and legislative implications, economic sustainable development, all being areas which are not traditionally considered as far as technical studies are concerned. These criteria can be most useful from the design stage onward, first in an attempt to define the facility construction and operating guiding principles, and thereafter to substantiate the safety case for long term storage and get geared to the public dialogue on that undertaking should it become a reality.

  19. Long-Term Efficacy and Safety Profile of Lanthanum Carbonate: Results for up to 6 Years of Treatment

    PubMed Central

    Hutchison, Alastair J.; Barnett, M. Edwina; Krause, Rolfdieter; Kwan, Jonathan T.C.; Siami, Ghodrat A.

    2008-01-01

    Background/Aims Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods Patients from four previous trials entered this study. Results Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium × phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. Conclusions LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs. PMID:18667837

  20. [Autograft of the adrenal medulla to caudate nucleus as Parkinson disease treatment: long-term clinical evaluation].

    PubMed

    Madrazo, I; Franco-Bourland, R; Ostrosky-Solis, F; Aguilera Riestra, M C; Madrazo, M; Zarate, A

    1989-01-01

    This work presents the long-term evolution (12-27 months) of the patients with adrenomedullary autotransplants to the caudate nucleus for the treatment of Parkinson's disease. Sixteen men and 6 women, mean age of 49.9 years, received brain implants of their own adrenal medulla using the procedure of Madrazo et al. (1). Nineteen of the transplanted patients suffered idiopathic Parkinson's disease and 3 of them parkinsonism. Before surgery 20 patients were on L-dopa and suffered collateral signs due to the drug. The degree of severity of their disease was evaluated pre and postoperatively, with and without medication, in their "on" and "off" periods, using the international scales of Schwab and England, Hoehn and Yahr, Madrazo, and the UPRS, and was documented by videotape. Biochemical analyses were made of lumbar and ventricular cerebrospinal fluid, and neuropsychological and neurophysiological evaluations were performed before and after surgery. In some patients, the location and viability of the adrenal medullary implants were demonstrated by brain scintigraphy using 131-I-metaiodobenzylguanidine, a chromaffin specific radiopharmaceutical. The clinical evaluations of 18 autotransplanted patients (4 died) showed their significant functional recovery both in their "on" and "off" periods, that for the first patients operated has remained stable for 27 months. Also, their response to L-dopa improved allowing the reduction of their postoperative doses of medication to 30% of their preoperative requirements, with the disappearance of the collateral effects of the drug.

  1. Long-term safety of tiotropium delivered by Respimat® SoftMist™ Inhaler: patient selection and special considerations

    PubMed Central

    Tan, Ching Kuo; Say, Gui Quan; Geake, James B

    2016-01-01

    Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler® dry powder inhaler (DPI) device, and since 2007 as the Respimat® SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI. Although tiotropium bromide delivered via the HandiHaler DPI has been clearly shown to improve lung function, dyspnea, and quality of life and to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), there is accumulating evidence regarding the use of tiotropium HandiHaler in other respiratory diseases characterized by airflow limitation, such as asthma and cystic fibrosis. Developed more recently, tiotropium delivered via the Respimat SMI appears to have a similar efficacy and safety profile to the HandiHaler DPI, and early data raising the possibility of safety concerns with its use in COPD have been refuted by more recent evidence. The benefits over the HandiHaler DPI, however, remain unclear. This paper will review the evidence for tiotropium delivered via the Respimat SMI inhaler, in particular as an alternative to the HandiHaler DPI, and will focus on the safety profile for each of the chronic lung diseases in which it has been trialed, as well as an approach to appropriate patient selection. PMID:27703365

  2. Long-term safety of tiotropium delivered by Respimat(®) SoftMist™ Inhaler: patient selection and special considerations.

    PubMed

    Tan, Ching Kuo; Say, Gui Quan; Geake, James B

    2016-01-01

    Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler(®) dry powder inhaler (DPI) device, and since 2007 as the Respimat(®) SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI. Although tiotropium bromide delivered via the HandiHaler DPI has been clearly shown to improve lung function, dyspnea, and quality of life and to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), there is accumulating evidence regarding the use of tiotropium HandiHaler in other respiratory diseases characterized by airflow limitation, such as asthma and cystic fibrosis. Developed more recently, tiotropium delivered via the Respimat SMI appears to have a similar efficacy and safety profile to the HandiHaler DPI, and early data raising the possibility of safety concerns with its use in COPD have been refuted by more recent evidence. The benefits over the HandiHaler DPI, however, remain unclear. This paper will review the evidence for tiotropium delivered via the Respimat SMI inhaler, in particular as an alternative to the HandiHaler DPI, and will focus on the safety profile for each of the chronic lung diseases in which it has been trialed, as well as an approach to appropriate patient selection.

  3. Environmental management: Integrating ecological evaluation, remediation, restoration, natural resource damage assessment and long-term stewardship on contaminated lands

    PubMed Central

    Burger, Joanna

    2014-01-01

    Ecological evaluation is essential for remediation, restoration, and Natural Resource Damage Assessment (NRDA), and forms the basis for many management practices. These include determining status and trends of biological, physical, or chemical/radiological conditions, conducting environmental impact assessments, performing remedial actions should remediation fail, managing ecosystems and wildlife, and assessing the efficacy of remediation, restoration, and long-term stewardship. The objective of this paper is to explore the meanings of these assessments, examine the relationships among them, and suggest methods of integration that will move environmental management forward. While remediation, restoration, and NRDA, among others, are often conducted separately, it is important to integrate them for contaminated land where the risks to ecoreceptors (including humans) can be high, and the potential damage to functioning ecosystems great. Ecological evaluations can range from inventories of local plants and animals, determinations of reproductive success of particular species, levels of contaminants in organisms, kinds and levels of effects, and environmental impact assessments, to very formal ecological risk assessments for a chemical or other stressor. Such evaluations can range from the individual species to populations, communities, ecosystems or the landscape scale. Ecological evaluations serve as the basis for making decisions about the levels and kinds of remediation, the levels and kinds of restoration possible, and the degree and kinds of natural resource injuries that have occurred because of contamination. Many different disciplines are involved in ecological evaluation, including biologists, conservationists, foresters, restoration ecologists, ecological engineers, economists, hydrologist, and geologists. Since ecological evaluation forms the basis for so many different types of environmental management, it seems reasonable to integrate management options

  4. Environmental management: integrating ecological evaluation, remediation, restoration, natural resource damage assessment and long-term stewardship on contaminated lands.

    PubMed

    Burger, Joanna

    2008-08-01

    Ecological evaluation is essential for remediation, restoration, and Natural Resource Damage Assessment (NRDA), and forms the basis for many management practices. These include determining status and trends of biological, physical, or chemical/radiological conditions, conducting environmental impact assessments, performing remedial actions should remediation fail, managing ecosystems and wildlife, and assessing the efficacy of remediation, restoration, and long-term stewardship. The objective of this paper is to explore the meanings of these assessments, examine the relationships among them, and suggest methods of integration that will move environmental management forward. While remediation, restoration, and NRDA, among others, are often conducted separately, it is important to integrate them for contaminated land where the risks to ecoreceptors (including humans) can be high, and the potential damage to functioning ecosystems great. Ecological evaluations can range from inventories of local plants and animals, determinations of reproductive success of particular species, levels of contaminants in organisms, kinds and levels of effects, and environmental impact assessments, to very formal ecological risk assessments for a chemical or other stressor. Such evaluations can range from the individual species to populations, communities, ecosystems or the landscape scale. Ecological evaluations serve as the basis for making decisions about the levels and kinds of remediation, the levels and kinds of restoration possible, and the degree and kinds of natural resource injuries that have occurred because of contamination. Many different disciplines are involved in ecological evaluation, including biologists, conservationists, foresters, restoration ecologists, ecological engineers, economists, hydrologist, and geologists. Since ecological evaluation forms the basis for so many different types of environmental management, it seems reasonable to integrate management options

  5. Evaluating methods for estimating space-time paths of individuals in calculating long-term personal exposure to air pollution

    NASA Astrophysics Data System (ADS)

    Schmitz, Oliver; Soenario, Ivan; Vaartjes, Ilonca; Strak, Maciek; Hoek, Gerard; Brunekreef, Bert; Dijst, Martin; Karssenberg, Derek

    2016-04-01

    Air pollution is one of the major concerns for human health. Associations between air pollution and health are often calculated using long-term (i.e. years to decades) information on personal exposure for each individual in a cohort. Personal exposure is the air pollution aggregated along the space-time path visited by an individual. As air pollution may vary considerably in space and time, for instance due to motorised traffic, the estimation of the spatio-temporal location of a persons' space-time path is important to identify the personal exposure. However, long term exposure is mostly calculated using the air pollution concentration at the x, y location of someone's home which does not consider that individuals are mobile (commuting, recreation, relocation). This assumption is often made as it is a major challenge to estimate space-time paths for all individuals in large cohorts, mostly because limited information on mobility of individuals is available. We address this issue by evaluating multiple approaches for the calculation of space-time paths, thereby estimating the personal exposure along these space-time paths with hyper resolution air pollution maps at national scale. This allows us to evaluate the effect of the space-time path and resulting personal exposure. Air pollution (e.g. NO2, PM10) was mapped for the entire Netherlands at a resolution of 5×5 m2 using the land use regression models developed in the European Study of Cohorts for Air Pollution Effects (ESCAPE, http://escapeproject.eu/) and the open source software PCRaster (http://www.pcraster.eu). The models use predictor variables like population density, land use, and traffic related data sets, and are able to model spatial variation and within-city variability of annual average concentration values. We approximated space-time paths for all individuals in a cohort using various aggregations, including those representing space-time paths as the outline of a persons' home or associated parcel

  6. The long-term effects of a token economy on safety performance in open-pit mining.

    PubMed

    Fox, D K; Hopkins, B L; Anger, W K

    1987-01-01

    A token economy that used trading stamps as tokens was instituted at two dangerous open-pit mines. Employees earned stamps for working without lost-time injuries, for being in work groups in which all other workers had no lost-time injuries, for not being involved in equipment-damaging accidents, for making adopted safety suggestions, and for unusual behavior which prevented an injury or accident. They lost stamp awards if they or other workers in their group were injured, caused equipment damage, or failed to report accidents or injuries. The stamps could be exchanged for a selection of thousands of items at redemption stores. Implementation of the token economy was followed by large reductions in the number of days lost from work because of injuries, the number of lost-time injuries, and the costs of accidents and injuries. The reductions in costs far exceeded the costs of operating the token economy. All improvements were maintained over several years.

  7. Evaluation of performance of a BLSS model in long-term operation in dynamic and steady states

    NASA Astrophysics Data System (ADS)

    Gros, Jean-Bernard; Tikhomirov, Alex; Ushakova, Sofya; Velitchko, Vladimir; Tikhomirova, Natalia; Lasseur, Christophe

    Evaluation of performance of a BLSS model, including higher plants for food production and biodegradation of human waste, in long-term operation in dynamic and steady states was performed. The model system was conceived for supplying vegetarian food and oxygen to 0.07 human. The following data were obtained in steady-state operating conditions. Average rate of wheat, chufa, radish, lettuce and Salicornia edible biomass accumulation were 8.7, 5.5, 0.6, 0.6 and metricconverterProductID2.5 g2.5 g per day respectively. Thus, to mimic the vegetarian edible biomass consumption by a human it was necessary to withdraw 17.9 g/d from total mass ex-change. Simultaneously, human mineralized exometabolites (artificial mineralized urine, AMU) in the amount of approximately 7% of a daily norm were introduced into the nutrient solu-tion for irrigation of the plants cultivated on a neutral substrate (expanded clay aggregate). The estimated value of 5.8 g/d of wheat and Salicornia inedible biomass was introduced in the soil-like substrate (SLS) to fully meet the plants need in nitrogen. The rest of wheat and Salicornia inedible biomass, 5.7 g/d, was stored. Thus in all, 23.6g of vegetarian dry matter had been stored. Assuming edible biomass is eaten up by the human, the closure coefficient of the vegetarian biomass inclusion into matter recycling amounted to 88%. The analysis of the long-term model operation showed that the main factors limiting increase of recycling processes were the following: a) Partly unbalanced mineral composition of daily human waste with daily needs of plants culti-` vated in the system. Thus, when fully satisfied with respect to nitrogen, the plants experienced a lack of macro elements such as P, Mg and Ca by more than 50%; b) Partly unbalanced mineral composition of edible biomass of the plants cultivated in the SLS with that of inedible biomass of the plants cultivated by hydroponic method on neutral substrate introduced in the SLS; c) Accumulation of

  8. Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome

    PubMed Central

    Lee, Cheng-Ling; Kuo, Hann-Chorng

    2015-01-01

    Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A “top-up” dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O’Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention. PMID:26506388

  9. Assessment of long-term safety and efficacy of intranasal mesenchymal stem cell treatment for neonatal brain injury in the mouse

    PubMed Central

    Donega, Vanessa; Nijboer, Cora H.; van Velthoven, Cindy T. J.; Youssef, Sameh A.; de Bruin, Alain; van Bel, Frank; Kavelaars, Annemieke; Heijnen, Cobi J.

    2015-01-01

    Background: For clinical translation, we assessed whether intranasal mesenchymal stem cell (MSC) treatment after hypoxia–ischemia (HI) induces neoplasia in the brain or periphery at 14 mo. Furthermore, the long-term effects of MSCs on behavior and lesion size were determined. Method: HI was induced in 9-d-old mice. Pups received an intranasal administration of 0.5 × 106 MSCs or vehicle at 10 d post-HI. Full macroscopical and microscopical pathological analysis of 39 organs per mouse was performed. Sensorimotor behavior was assessed in the cylinder-rearing test at 10 d, 28 d, 6 mo, and 9 mo. Cognition was measured with the novel object recognition test at 3 and 14 mo post-HI. Lesion size was determined by analyzing mouse-anti-microtubule-associated protein 2 (MAP2) and mouse-anti-myelin basic protein (MBP) staining at 5 wk and 14 mo. Results: At 14 mo post-HI, we did not observe any neoplasia in the nasal turbinates, brain, or other organs of HI mice treated with MSCs. Furthermore, our results show that MSC-induced improvement of sensorimotor and cognitive function is long lasting. In contrast, HI-vehicle mice showed severe behavioral impairment. Recovery of MAP2- and MBP-positive area lasted up to 14 mo following MSC treatment. Conclusion: Our results provide strong evidence of the long-term safety and positive effects of MSC treatment following neonatal HI in mice. PMID:26270577

  10. Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome.

    PubMed

    Lee, Cheng-Ling; Kuo, Hann-Chorng

    2015-10-22

    Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A "top-up" dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O'Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention.

  11. Long-Term Results from Evaluation of Advanced New Construction Packages in Test Homes: Lake Elsinore, Californi

    SciTech Connect

    Stecher, D.; Brozyna, K.

    2013-08-01

    This report presents the long-term evaluation results from a hot-dry climate project that examines the room-to-room temperature conditions that exist in a high performance envelope, the performance of a simplified air distribution system, and a comparison of modeled energy performance with measured energy use. The project, a prototype house built by K. Hovnanian Homes’ Ontario Group, is located in Lake Elsinore, Riverside County, California, and achieves a 50% level of whole house source energy savings with respect to the Building America (BA) Benchmark Definition 2009 (Hendron and Engebrecht 2010). Temperature measurements in three rooms indicate that the temperature difference between the measured locations and the thermostat were within recommendations 90.3% of the time in heating mode and 99.3% of the time in cooling mode. The air distribution system is operating efficiently with average delivered temperatures adequate to facilitate proper heating and cooling and only minor average temperature differences observed between the system’s plenum and farthest register. Monitored energy use results for the house indicate that it is using less energy than predicted from modeling. A breakdown of energy use according to end use determined little agreement between comparable values.

  12. Long-Term Results from Evaluation of Advanced New Construction Packages in Test Homes: Lake Elsinore, California

    SciTech Connect

    Stecher, D.; Brozyna, K.

    2013-08-01

    This report presents the long-term evaluation results from a hot-dry climate project that examines the room-to-room temperature conditions that exist in a high performance envelope, the performance of a simplified air distribution system, and a comparison of modeled energy performance with measured energy use. The project, a prototype house built by K. Hovnanian Homes' Ontario Group, is located in Lake Elsinore, Riverside County, California, and achieves a 50% level of whole house source energy savings with respect to the Building America (BA) Benchmark Definition 2009 (Hendron and Engebrecht 2010). Temperature measurements in three rooms indicate that the temperature difference between the measured locations and the thermostat were within recommendations 90.3% of the time in heating mode and 99.3% of the time in cooling mode. The air distribution system is operating efficiently with average delivered temperatures adequate to facilitate proper heating and cooling and only minor average temperature differences observed between the system's plenum and farthest register. Monitored energy use results for the house indicate that it is using less energy than predicted from modeling. A breakdown of energy use according to end use determined little agreement between comparable values.

  13. Evaluation of the Universal Viral Transport system for long-term storage of virus specimens for microbial forensics.

    PubMed

    Hosokawa-Muto, Junji; Fujinami, Yoshihito; Mizuno, Natsuko

    2015-08-01

    Forensic microbial specimens, including bacteria and viruses, are collected at biocrime and bioterrorism scenes. Although it is preferable that the pathogens in these samples are alive and kept in a steady state, the samples may be stored for prolonged periods before analysis. Therefore, it is important to understand the effects of storage conditions on the pathogens contained within such samples. To evaluate the capacity to preserve viable virus and the viral genome, influenza virus was added to the transport medium of the Universal Viral Transport system and stored for over 3 months at various temperatures, after which virus titrations and quantitative analysis of the influenza hemagglutinin gene were performed. Although viable viruses became undetectable 29 days after the medium was stored at room temperature, viruses in the medium stored at 4°C were viable even after 99 days. A quantitative PCR analysis indicated that the hemagglutinin gene was maintained for 99 days at both 4°C and room temperature. Therefore, long-term storage at 4°C has little effect on viable virus and viral genes, so the Universal Viral Transport system can be useful for microbial forensics. This study provides important information for the handling of forensic virus specimens.

  14. A long-term evaluation of treated Class II division 2 malocclusions: a retrospective study model analysis.

    PubMed

    Canut, J A; Arias, S

    1999-08-01

    Pre-treatment, end of treatment, and post-retention study models of 30 subjects with a Class II division 2 malocclusion were assessed, after a period of at least 3 years, in order to evaluate the long-term changes in occlusion, alignment, and arch dimensions. Molar relationship correction was found to be stable after retention. There were no variables which could be used to establish a prognosis of vertical stability. Over-correction of overbite was seen to relapse. Ten per cent of the cases showed unacceptable anterior maxillary irregularities after retention. Mandibular arch width and length usually showed a decrease after retention. An increase in lower intercanine width and arch length achieved by orthodontic treatment always relapsed. This relapse was associated with post-retention mandibular irregularity and crowding. Nine cases (30 per cent) showed an unacceptable degree of mandibular irregularity after retention. Pre-treatment crowding in the mandible showed a relationship with post-retention lower irregularity and crowding. There was a correlation between the number of years which had elapsed after retention, overbite relapse and post-retention mandibular irregularity.

  15. Evaluation of biostimulation and Tween 80 addition for the bioremediation of long-term DDT-contaminated soil.

    PubMed

    Betancur-Corredor, Bibiana; Pino, Nancy J; Cardona, Santiago; Peñuela, Gustavo A

    2015-02-01

    The bioremediation of a long-term contaminated soil through biostimulation and surfactant addition was evaluated. The concentrations of 1,1,1-trichloro-2,2-bis(4-chlorophenyl) ethane (DDT) and its metabolites 1,1-dichloro-2,2-bis(4-chlorophenyl) ethane (DDD) and 1,1-dichloro-2,2-bis(4-chlorophenyl) ethylene (DDE) were monitored during an 8-week remediation process. Physicochemical characterization of the treated soil was performed before and after the bioremediation process. The isolation and identification of predominant microorganisms during the remediation process were also carried out. The efficiency of detoxification was evaluated after each bioremediation protocol. Humidity and pH and the heterotrophic microorganism count were monitored weekly. The DDT concentration was reduced by 79% after 8 weeks via biostimulation with surfactant addition (B+S) and 94.3% via biostimulation alone (B). Likewise, the concentrations of the metabolites DDE and DDD were reduced to levels below the quantification limits. The microorganisms isolated during bioremediation were identified as Bacillus thuringiensis, Flavobacterium sp., Cuprivadius sp., Variovorax soli, Phenylobacterium sp. and Lysobacter sp., among others. Analysis with scanning electron microscopy (SEM) allowed visualization of the colonization patterns of soil particles. The toxicity of the soil before and after bioremediation was evaluated using Vibrio fischeri as a bioluminescent sensor. A decrease in the toxic potential of the soil was verified by the increase of the concentration/effect relationship EC50 to 26.9% and 27.2% for B+S and B, respectively, compared to 0.4% obtained for the soil before treatment and 2.5% by natural attenuation after 8 weeks of treatment.

  16. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    PubMed

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  17. Long-Term Safety of Repeated Blood-Brain Barrier Opening via Focused Ultrasound with Microbubbles in Non-Human Primates Performing a Cognitive Task

    PubMed Central

    Downs, Matthew E.; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Chen, Shangshang; Konofagou, Elisa E.; Ferrera, Vincent P.

    2015-01-01

    Focused Ultrasound (FUS) coupled with intravenous administration of microbubbles (MB) is a non-invasive technique that has been shown to reliably open (increase the permeability of) the blood-brain barrier (BBB) in multiple in vivo models including non-human primates (NHP). This procedure has shown promise for clinical and basic science applications, yet the safety and potential neurological effects of long term application in NHP requires further investigation under parameters shown to be efficacious in that species (500kHz, 200–400 kPa, 4–5μm MB, 2 minute sonication). In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4–20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of’ visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4–5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used. PMID:25945493

  18. Grazing management contributions to net global warming potential: a long-term evaluation in the Northern Great Plains.

    PubMed

    Liebig, M A; Gross, J R; Kronberg, S L; Phillips, R L; Hanson, J D

    2010-01-01

    The role of grassland ecosystems as net sinks or sources of greenhouse gases (GHGs) is limited by a paucity of information regarding management impacts on the flux of nitrous oxide (N(2)O) and methane (CH(4)). Furthermore, no long-term evaluation of net global warming potential (GWP) for grassland ecosystems in the northern Great Plains (NGP) of North America has been reported. Given this need, we sought to determine net GWP for three grazing management systems located within the NGP. Grazing management systems included two native vegetation pastures (moderately grazed pasture [MGP], heavily grazed pasture [HGP]) and a heavily grazed crested wheatgrass [Agropyron desertorum (Fisch. ex. Link) Schult.] pasture (CWP) near Mandan, ND. Factors evaluated for their contribution to GWP included (i) CO(2) emissions associated with N fertilizer production and application, (ii) literature-derived estimates of CH(4) production for enteric fermentation, (iii) change in soil organic carbon (SOC) over 44 yr using archived soil samples, and (iv) soil-atmosphere N(2)O and CH(4) fluxes over 3 yr using static chamber methodology. Analysis of SOC indicated all pastures to be significant sinks for SOC, with sequestration rates ranging from 0.39 to 0.46 Mg C ha(-1) yr(-1). All pastures were minor sinks for CH(4) (<2.0 kg CH(4)-C ha(-1) yr(-1)). Greater N inputs within CWP contributed to annual N(2)O emission nearly threefold greater than HGP and MGP. Due to differences in stocking rate, CH(4) production from enteric fermentation was nearly threefold less in MGP than CWP and HGP. When factors contributing to net GWP were summed, HGP and MGP were found to serve as net CO(2equiv.) sinks, while CWP was a net CO(2equiv.) source. Values for GWP and GHG intensity, however, indicated net reductions in GHG emissions can be most effectively achieved through moderate stocking rates on native vegetation in the NGP.

  19. Health promotion and information provision during long-term follow-up for childhood cancer survivors: A service evaluation.

    PubMed

    Mayes, Jonathan; Brown, Morven C; Davies, Nicola; Skinner, Roderick

    2016-09-01

    Health promotion is an important component of long-term follow-up (LTFU) care for childhood cancer survivors (CCS). However, little information exists about how survivors perceive their own health promotion needs. As part of a service evaluation, 51 CCS who had previously attended the LTFU clinic took part in a single semistructured interview to seek their views on information they had received regarding late adverse effects (LAEs) of treatment, the purpose of LTFU, and the provision of health promotion information. Although most (93%) CCS were satisfied with the information received about LAEs, 37% desired further details. Over half (59%) believed that the purpose of LTFU was to screen for LAEs, whereas 31% felt that it was to check for relapse. No survivor reported health promotion to be an aim of LTFU; only 14% of CCS expected to receive healthy lifestyle advice, and fewer than 10% wanted dietary and physical activity advice. Most (88%) CCS felt that their hospital-based health care professional was best placed to give healthy lifestyle advice, but there was no consensus about the optimum timing for health promotion. CCS varied in their knowledge, needs, and wishes regarding LTFU care. The results of this evaluation strongly indicate that the profile of health promotion needs to be raised within our service and identifies issues that may be pertinent to similar services. Further research is needed to understand the views of CCS regarding health promotion and lifestyle behaviors, with the aim of tailoring and improving the delivery of effective health education to CCS.

  20. Long-term efficacy and safety results of taliglucerase alfa up to 36 months in adult treatment-naïve patients with Gaucher disease.

    PubMed

    Zimran, Ari; Durán, Gloria; Mehta, Atul; Giraldo, Pilar; Rosenbaum, Hanna; Giona, Fiorina; Amato, Dominick J; Petakov, Milan; Muñoz, Eduardo Terreros; Solorio-Meza, Sergio Eduardo; Cooper, Peter A; Varughese, Sheeba; Chertkoff, Raul; Brill-Almon, Einat

    2016-07-01

    Taliglucerase alfa is an intravenous enzyme replacement therapy approved for treatment of type 1 Gaucher disease (GD), and is the first available plant cell-expressed recombinant therapeutic protein. Herein, we report long-term safety and efficacy results of taliglucerase alfa in treatment-naïve adult patients with GD. Patients were randomized to receive taliglucerase alfa 30 or 60 U/kg every other week, and 23 patients completed 36 months of treatment. Taliglucerase alfa (30 U/kg; 60 U/kg, respectively) resulted in mean decreases in spleen volume (50.1%; 64.6%) and liver volume (25.6%; 24.4%) with mean increases in hemoglobin concentration (16.0%; 35.8%) and platelet count (45.7%; 114.0%), and mean decreases in chitotriosidase activity (71.5%; 82.2%). All treatment-related adverse events were mild to moderate in intensity and transient. The most common adverse events were nasopharyngitis, arthralgia, upper respiratory tract infection, headache, pain in extremity, and hypertension. These 36-month results of taliglucerase alfa in treatment-naïve adult patients with GD demonstrate continued improvement in disease parameters with no new safety concerns. These findings extend the taliglucerase alfa clinical safety and efficacy dataset. www.clinicaltrials.gov identifier NCT00705939. Am. J. Hematol. 91:656-660, 2016. © 2016 Wiley Periodicals, Inc.

  1. Long-term safety assessment of trench-type surface repository at Chernobyl, Ukraine - computer model and comparison with results from simplified models

    SciTech Connect

    Haverkamp, B.; Krone, J.; Shybetskyi, I.

    2013-07-01

    The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, the surface repository for solid low and intermediate level waste (LILW) is still being operated but its maximum capacity is nearly reached. Long-existing plans for increasing the capacity of the facility shall be implemented in the framework of the European Commission INSC Programme (Instrument for Nuclear Safety Co-operation). Within the first phase of this project, DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) for a future extended facility based on the planned enlargement. In addition to a detailed mathematical model, also simplified models have been developed to verify results of the former one and enhance confidence in the results. Comparison of the results show that - depending on the boundary conditions - simplifications like modeling the multi trench repository as one generic trench might have very limited influence on the overall results compared to the general uncertainties associated with respective long-term calculations. In addition to their value in regard to verification of more complex models which is important to increase confidence in the overall results, such simplified models can also offer the possibility to carry out time consuming calculations like probabilistic calculations or detailed sensitivity analysis in an economic manner. (authors)

  2. Long-term Satellite NDVI Data Sets: Evaluating Their Ability to Detect Ecosystem Functional Changes in South America

    PubMed Central

    Baldi, Germán; Nosetto, Marcelo D.; Aragón, Roxana; Aversa, Fernando; Paruelo, José M.; Jobbágy, Esteban G.

    2008-01-01

    In the last decades, South American ecosystems underwent important functional modifications due to climate alterations and direct human intervention on land use and land cover. Among remotely sensed data sets, NOAA-AVHRR “Normalized Difference Vegetation Index” (NDVI) represents one of the most powerful tools to evaluate these changes thanks to their extended temporal coverage. In this paper we explored the possibilities and limitations of three commonly used NOAA-AVHRR NDVI series (PAL, GIMMS and FASIR) to detect ecosystem functional changes in the South American continent. We performed pixel-based linear regressions for four NDVI variables (average annual, maximum annual, minimum annual and intra-annual coefficient of variation) for the 1982-1999 period and (1) analyzed the convergences and divergences of significant multi-annual trends identified across all series, (2) explored the degree of aggregation of the trends using the O-ring statistic, and (3) evaluated observed trends using independent information on ecosystem functional changes in five focal regions. Several differences arose in terms of the patterns of change (the sign, localization and total number of pixels with changes). FASIR presented the highest proportion of changing pixels (32.7%) and GIMMS the lowest (16.2%). PAL and FASIR data sets showed the highest agreement, with a convergence of detected trends on 71.2% of the pixels. Even though positive and negative changes showed substantial spatial aggregation, important differences in the scale of aggregation emerged among the series, with GIMMS showing the smaller scale (≤11 pixels). The independent evaluations suggest higher accuracy in the detection of ecosystem changes among PAL and FASIR series than with GIMMS, as they detected trends that match expected shifts. In fact, this last series eliminated most of the long term patterns over the continent. For example, in the “Eastern Paraguay” and “Uruguay River margins” focal regions

  3. Long-term Satellite NDVI Data Sets: Evaluating Their Ability to Detect Ecosystem Functional Changes in South America.

    PubMed

    Baldi, Germán; Nosetto, Marcelo D; Aragón, Roxana; Aversa, Fernando; Paruelo, José M; Jobbágy, Esteban G

    2008-09-03

    In the last decades, South American ecosystems underwent important functional modifications due to climate alterations and direct human intervention on land use and land cover. Among remotely sensed data sets, NOAA-AVHRR "Normalized Difference Vegetation Index" (NDVI) represents one of the most powerful tools to evaluate these changes thanks to their extended temporal coverage. In this paper we explored the possibilities and limitations of three commonly used NOAA-AVHRR NDVI series (PAL, GIMMS and FASIR) to detect ecosystem functional changes in the South American continent. We performed pixel-based linear regressions for four NDVI variables (average annual, maximum annual, minimum annual and intra-annual coefficient of variation) for the 1982-1999 period and (1) analyzed the convergences and divergences of significant multi-annual trends identified across all series, (2) explored the degree of aggregation of the trends using the O-ring statistic, and (3) evaluated observed trends using independent information on ecosystem functional changes in five focal regions. Several differences arose in terms of the patterns of change (the sign, localization and total number of pixels with changes). FASIR presented the highest proportion of changing pixels (32.7%) and GIMMS the lowest (16.2%). PAL and FASIR data sets showed the highest agreement, with a convergence of detected trends on 71.2% of the pixels. Even though positive and negative changes showed substantial spatial aggregation, important differences in the scale of aggregation emerged among the series, with GIMMS showing the smaller scale (≤11 pixels). The independent evaluations suggest higher accuracy in the detection of ecosystem changes among PAL and FASIR series than with GIMMS, as they detected trends that match expected shifts. In fact, this last series eliminated most of the long term patterns over the continent. For example, in the "Eastern Paraguay" and "Uruguay River margins" focal regions, the

  4. Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of a 1-year open-label study.

    PubMed

    Moore, Angela; Kempers, Steven; Murakawa, George; Weiss, Jonathan; Tauscher, Amanda; Swinyer, Leonard; Liu, Hong; Leoni, Matthew

    2014-01-01

    Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase. In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment. Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated. Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea. Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed. In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea.

  5. Enhanced Long-Term Brain Magnetic Resonance Imaging Evaluation of Children with Sickle Cell Disease after Hematopoietic Cell Transplantation.

    PubMed

    Green, Nancy S; Bhatia, Monica; Griffith, Erica Y; Qureshi, Mahvish; Briamonte, Courtney; Savone, Mirko; Sands, Stephen; Lee, Margaret T; Lignelli, Angela; Brickman, Adam M

    2017-04-01

    Progressive neurovasculopathy in children with sickle cell disease (SCD) results in decreased cognitive function and quality of life (QoL). Hematopoietic cell transplantation (HCT) is believed to halt progression of neurovasculopathy. Quantitative analysis of T2-weighted fluid attenuated inversion recovery (FLAIR) magnetic resonance imaging (MRI) for white matter hyperintensity (WMH) burden provides a meaningful estimate of small vessel cerebrovascular disease. We asked if quantitative analysis of WMH could complement standardized clinical assessment of MRI/magnetic resonance angiography (MRA) for assessing SCD central nervous system vasculopathy before and after HCT. Retrospective longitudinal clinical examination of scheduled annual MRI/MRA and quantitative analysis of WMH were performed before and 1 to 7 years after HCT at scheduled annual intervals, along with QoL measurements, in children who had engrafted after HCT. Of 18 patients alive and persistently engrafted (median age, 9.1 years), pretransplantation MRI demonstrated that 9 and 5 had sickle-related stroke and/or small infarcts, respectively. Patients were divided into WMH severity tertiles based on pretransplantation WMH volumes. MRI and WMH were assessed 1 to 7 years after HCT. MRI/MRA and WMH volume were stable or slightly better in 17 of 18 patients. By parent- and self-report, post-HCT QoL improved for children in the lowest WMH tertile significantly more than in the other groups. Based on this single-institution retrospective sample, we report that WMH appears to quantitatively support MRI-based findings that HCT stabilizes long-term small and large vessel cerebrovascular changes and is associated with the degree of improved QoL. While confirmation in larger prospective studies and evaluation by neurocognitive testing are needed, these findings suggest that WMH is a useful biomarker of neurovasculopathy after transplantation for SCD.

  6. Comparative evaluation of long-term monotherapies & combination therapies in patients with chronic hepatitis B: A pilot study

    PubMed Central

    Srivastava, Manjita; Singh, Neha; Dixit, Vinod Kumar; Nath, Gopal; Jain, Ashok Kumar

    2016-01-01

    Background & objectives: Reduction of viraemia in patients with chronic hepatitis B virus (HBV) infection using nucleoside/nucleotide analogues reduces fatal liver disease-related events, but development of resistance in virus presents serious clinical challenge. Therefore, comparative evaluation of prolonged antiviral monotherapy and combination therapies was prospectively studied to assess their influence on viral suppression, rapidity of response, development of drug resistance and surfacing mutants in chronic liver disease (CLD) patients. Methods: A total of 158 (62eAg-ve) chronic hepatitis B patients were prospectively studied for 24 months. Final analysis was performed on patients treated with lamivudine (LAM, n = 28), adefovirdipivoxil (ADV, n = 24), tenofovir disoproxil fumarate (TDF, n = 26), entecavir (ETV, n = 25), LAM + ADV (n = 28) and LAM + TDF (n = 27). Quantitative hepatitis B virus DNA was detected using real-time polymerase chain reaction. Multiple comparisons among drugs and genotypic mutations were analyzed. Results: Progressive biochemical and virological response were noted with all the regimens at 24 months except LAM and ADV which were associated with viral breakthrough (VBT) in 46.4 and 25 per cent, respectively. Mutations: rtM204V (39.3%), M204V+L180M (10.7%) while rtA181V (8.1%) and rtN236T (8.3%) were observed with LAM and ADV regimen, respectively. LAM + ADV combination therapy revealed VBT in seven per cent of the cases without mutations whereas TDF, ETV and LAM + TDF therapies neither showed VBT nor mutations. Interpretation & conclusions: LAM was the least potent drug among all therapeutic options followed by ADV. TDF and ETV were genetically stable antivirals with a strong efficacy. Among newer combination therapies, LAM + TDF revealed more efficacy in virological remission and acted as a profound genetic barrier on long term. Hence, newer generation molecules (TDF, ETV) and effective combination therapy should be a certain choice

  7. Estimating long-term regional groundwater recharge for the evaluation of potential solution alternatives to waterlogging and salinisation

    NASA Astrophysics Data System (ADS)

    Singh, Ajay

    2011-09-01

    SummaryAccurate estimation of the groundwater recharge is essential for efficient and sustainable groundwater management in arid and semi-arid regions, as water resources are critical to economic development in these areas. Various techniques are available to quantify recharge. The hydrological budget model proposed herein is unique, simple, and easy to apply. It uses data on groundwater level, groundwater extraction, and distributed specific yield information for estimating groundwater recharge. The Model is employed to estimate the seasonal long-term (35 years, e.g., from 1974 to 2009) groundwater recharge of an irrigated semi-arid area located in Haryana State of India, where groundwater levels are rising, continuously. The results are analysed to provide an overview of the process dynamics that led to imbalance of the system. Groundwater recharge analysis during the study period reveals that percolation from irrigated fields is the main recharge component with 49% contribution to the total recharge. An annual groundwater table rise of 0.14 m has been estimated for the study area. Various potential solution alternatives are evaluated to mitigate the problems of waterlogging and salinisation, considering the socio-economic issues which have wider policy significance on sustainability. Several suitable water management strategies such as reduction in rice area, increase in pumping volume and using the groundwater conjunctively with higher quality canal water, and lining of canal networks are suggested to bring the watertable down to a safe limit and to prevent further rising of the watertable. Among the potential solution alternatives studied, the one which considers 10% reduction in rice area along with 2% increase in pumping volume and 20% canal lining, yields best result for mitigating the waterlogging problems.

  8. Efficacy and Safety of Long-term Coadministration of Fenofibrate and Ezetimibe in Patients with Combined Hyperlipidemia: Results of the EFECTL Study

    PubMed Central

    Yamashita, Shizuya; Nakaya, Noriaki; Sasaki, Jun; Kono, Suminori

    2017-01-01

    Aim: We investigated the safety and efficacy of a long-term combination therapy with fenofibrate and ezetimibe in Japanese patients with combined hyperlipidemia, in comparison with fenofibrate or ezetimibe alone. Methods: The study was a three-arm parallel-group, open-label randomized trial. Eligible patients were assigned to a combination therapy with fenofibrate (200 mg/day in capsule form or 160 mg/day in tablet form) and ezetimibe (10 mg/day), the fenofibrate monotherapy, or the ezetimibe monotherapy, which lasted for 52 weeks. The changes in serum low-density lipoprotein (LDL) cholesterol and triglycerides were the primary outcomes. Results: A total of 236 patients were assigned to one of the three treatments, and the number of patients included in the final analysis was 107 in the combination therapy, 52 in the fenofibrate monotherapy, and 51 in the ezetimibe monotherapy. Mean ± SD changes in LDL cholesterol were −24.2% ± 14.7% with combination therapy, −16.0% ± 16.0% with fenofibrate alone, and −17.4% ± 10.1% with ezetimibe alone. The combination therapy resulted in a significantly greater reduction in LDL cholesterol as compared with each monotherapy (p < 0.01 for each). The corresponding values for triglycerides were −40.0% ± 29.5%, −40.1% ± 28.7%, and −3.4% ± 32.6%, respectively. Fenofibrate use was associated with some changes in laboratory measurements, but there was no differential adverse effect between the combination therapy and fenofibrate monotherapy. Conclusion: The combination therapy with fenofibrate and ezetimibe substantially reduces concentrations of LDL cholesterol and triglycerides and is safe in a long-term treatment in Japanese patients with combined hyperlipidemia. PMID:27397061

  9. Ductal Carcinoma In Situ With Microinvasion: Prognostic Implications, Long-Term Outcomes, and Role of Axillary Evaluation

    SciTech Connect

    Parikh, Rahul R.; Haffty, Bruce G.; Lannin, Donald; Moran, Meena S.

    2012-01-01

    Purpose: To compare the clinical-pathologic features and long-term outcomes for women with ductal carcinoma in situ (DCIS) vs. DCIS with microinvasion (DCISM) treated with breast conservation therapy (BCT), to assess the impact of microinvasion. Patients and Methods: A total of 393 patients with DCIS/DCISM from our database were analyzed to assess differences in clinical-pathologic features and outcomes for the two cohorts. Results: The median follow-up was 8.94 years, and the mean age was 55.8 years for the entire group. The DCISM cohort was comprised of 72 of 393 patients (18.3%). Surgical evaluation of the axilla was performed in 58.3% (n = 42) of DCISM vs. 18.1% (n = 58) of DCIS, with only 1 of 42 DCISM (2.3%) vs. 0 of 58 DCIS with axillary metastasis. Surgical axillary evaluation was not an independent predictor of local-regional relapse (LRR), distant relapse-free survival (DRFS), or overall survival (OS) in Cox proportional hazards analysis (p > 0.05). For the DCIS vs. DCISM groups, respectively, the 10-year breast relapse-free survival was 89.0% vs. 90.7% (p = 0.36), DRFS was 98.5% vs. 97.9% (p = 0.78), and OS was 93.2% vs. 95.7% (p = 0.95). The presence of microinvasion did not correlate with LRR, age, presentation, race, family history, margin status, and use of adjuvant hormonal therapy (all p > 0.05). In univariate analysis, pathology (DCIS vs. DCISM) was not an independent predictor of LRR (hazard ratio [HR], 1.58; 95% confidence interval [CI], 0.58-4.30; p = 0.36), DRFS (HR, 0.72; 95% CI, 0.07-6.95; p = 0.77), or OS (HR, 1.03; 95% CI, 0.28-3.82; p = 0.95). Conclusions: Our data imply that the natural history of DCISM closely resembles that of DCIS, with a low incidence of local-regional and distant failures. On the basis of our large dataset, the incidence of axillary metastasis in DCISM appears to be small and not appear to correlate to outcomes, and thus, microinvasion alone should not be the sole criterion for more aggressive treatment.

  10. Locking-In Effects Due to Early Interventions? An Evaluation of a Multidisciplinary Screening Programs for Avoiding Long-Term Sickness

    ERIC Educational Resources Information Center

    Johansson, Per; Lindahl, Erica

    2012-01-01

    Objective: In this article, we estimate the effect of a multidisciplinary collaboration program on the length of sickness absence. The intention with the program was to avoid long-term sickness absence by providing an early and holistic evaluation of the sick-listed individuals' conditions. The target group was individuals who were at risk of…

  11. ENVIRONMENTAL RESEARCH BRIEF: LONG-TERM PERFORMANCE OF PERMEABLE REACTIVE BARRIERS USING ZERO-VALENT IRON: AN EVALUATION AT TWO SITES

    EPA Science Inventory

    Geochemical and microbiological factors that control long-term performance of subsurface permeable reactive barriers were evaluated at the Elizabeth City, NC and the Denver Federal Center, CO sites. These groundwater treatment systems use zero-valent iron filings to intercept an...

  12. Evaluating the Effectiveness of Intervention in Long-Term Aphasia Post-Stroke: The Experience from CHANT (Communication Hub for Aphasia in North Tyneside)

    ERIC Educational Resources Information Center

    Mumby, Katharyn; Whitworth, Anne

    2012-01-01

    Background: Despite recognition of the need for increased long-term support for people with aphasia following stroke, there remains limited evidence for effective service-level interventions. Aims: To evaluate the outcomes and experiences of people participating in the Communication Hub for Aphasia in North Tyneside (CHANT), a 2-year partnership…

  13. Long-Term Outcomes of an Australian Universal Prevention Trial of Anxiety and Depression Symptoms in Children and Youth: An Evaluation of the Friends Program

    ERIC Educational Resources Information Center

    Barrett, Paula M.; Farrell, Lara J.; Ollendick, Thomas H.; Dadds, Mark

    2006-01-01

    This study evaluated the long-term effectiveness of the FRIENDS Program in reducing anxiety and depression in a sample of children from Grade 6 and Grade 9 in comparison to a control condition. Longitudinal data for Lock and Barrett's (2003) universal prevention trial is presented, along with data from 12-month follow-up to 24- and 36-month…

  14. Field Evaluations of Sampling Methods for Long-Term Monitoring of Upland Ecosystems on the Colorado Plateau

    USGS Publications Warehouse

    Miller, Mark E.; Witwicki, Dana L.; Mann, Rebecca K.; Tancreto, Nicole J.

    2007-01-01

    To inform planning for long-term ecological monitoring, we sampled vegetation and soil-surface attributes across a range of terrestrial ecosystems (physiognomic types) in seven National Park Service units on the Colorado Plateau. Primary objectives were (1) to evaluate a suite of sampling methods according to measures of repeatability, efficiency, and impacts on plot conditions; and (2) to characterize within- and among-plot variability in monitoring measures. This work was designed to support NPS staff in selecting the combination of methods that best meets their monitoring objectives and resource constraints. We found no differences among cover-estimation techniques in terms of repeatability between observers (measurement precision). Estimates for total live understory canopy cover, cover of individual species, and cover of soil-surface features were highly repeatable between observers for 10-m2 quadrats, 1-m2 quadrats, and line-point intercept sampling methods. Estimates of shrub and tree density in 10-m2 quadrats also were repeatable between observers, although sample sizes for were small for many species. At 10 of 11 ecological sites, we found that sampling with 10-m2 quadrats was the most efficient cover-estimation technique with respect to within-plot variability in cover estimates and numbers of subsamples required to estimate plot-level cover with 20 percent precision. According to these same measures, sampling with 1-m2 quadrats was the least efficient cover-estimation technique at eight of 11 ecological sites. The line-point technique was most efficient at eight of 11 ecological sites in terms of the amount of time required to estimate total plot-level cover with 20 percent precision - largely because 10-m2 quadrats were more time consuming and 1-m2 quadrats had greater within-plot variability relative to line-point sampling. However, there was no statistical difference among methods with respect to median subsampling times for 20 percent precision

  15. An Evaluation of Long-Term Performance of Liner Systems for Low-Level Waste Disposal Facilities

    SciTech Connect

    Arthur S. Rood; Annette L. Schafer; A. Jeffrey Sondrup

    2011-03-01

    Traditional liner systems consisting of a geosynthetic membrane underlying a waste disposal facility coupled with a leachate collection system have been proposed as a means of containing releases of low-level radioactive waste within the confines of the disposal facility and thereby eliminating migration of radionuclides into the vadose zone and groundwater. However, this type of hydraulic containment liner system is only effective as long as the leachate collection system remains functional or an overlying cover limits the total infiltration to the volumetric pore space of the disposal system. If either the leachate collection system fails, or the overlying cover becomes less effective during the 1,000’s of years of facility lifetime, the liner may fill with water and release contaminated water in a preferential or focused manner. If the height of the liner extends above the waste, the waste will become submerged which could increase the release rate and concentration of the leachate. If the liner extends near land surface, there is the potential for contamination reaching land surface creating a direct exposure pathway. Alternative protective liner systems can be engineered that eliminate radionuclide releases to the vadose zone during operations and minimizing long term migration of radionuclides from the disposal facility into the vadose zone and aquifer. Non-traditional systems include waste containerization in steel or composite materials. This type of system would promote drainage of clean infiltrating water through the facility without contacting the waste. Other alternatives include geochemical barriers designed to transmit water while adsorbing radionuclides beneath the facility. Facility performance for a hypothetical disposal facility has been compared for the hydraulic and steel containerization liner alternatives. Results were compared in terms of meeting the DOE Order 435.1 low-level waste performance objective of 25 mrem/yr all-pathways dose

  16. Long-Term Evaluation of the AMSR-E Soil Moisture Product Over the Walnut Gulch Watershed, AZ

    NASA Astrophysics Data System (ADS)

    Bolten, J. D.; Jackson, T. J.; Lakshmi, V.; Cosh, M. H.; Drusch, M.

    2005-12-01

    The Advanced Microwave Scanning Radiometer -Earth Observing System (AMSR-E) was launched aboard NASA's Aqua satellite on May 4th, 2002. Quantitative estimates of soil moisture using the AMSR-E provided data have required routine radiometric data calibration and validation using comparisons of satellite observations, extended targets and field campaigns. The currently applied NASA EOS Aqua ASMR-E soil moisture algorithm is based on a change detection approach using polarization ratios (PR) of the calibrated AMSR-E channel brightness temperatures. To date, the accuracy of the soil moisture algorithm has been investigated on short time scales during field campaigns such as the Soil Moisture Experiments in 2004 (SMEX04). Results have indicated self-consistency and calibration stability of the observed brightness temperatures; however the performance of the moisture retrieval algorithm has been poor. The primary objective of this study is to evaluate the quality of the current version of the AMSR-E soil moisture product for a three year period over the Walnut Gulch Experimental Watershed (150 km2) near Tombstone, AZ; the northern study area of SMEX04. This watershed is equipped with hourly and daily recording of precipitation, soil moisture and temperature via a network of raingages and a USDA-NRCS Soil Climate Analysis Network (SCAN) site. Surface wetting and drying are easily distinguished in this area due to the moderately-vegetated terrain and seasonally intense precipitation events. Validation of AMSR-E derived soil moisture is performed from June 2002 to June 2005 using watershed averages of precipitation, and soil moisture and temperature data from the SCAN site supported by a surface soil moisture network. Long-term assessment of soil moisture algorithm performance is investigated by comparing temporal variations of moisture estimates with seasonal changes and precipitation events. Further comparisons are made with a standard soil dataset from the European

  17. Evaluation of a long-term operation of a submerged nanofiltration membrane bioreactor (NF MBR) for advanced wastewater treatment.

    PubMed

    Choi, J H; Fukushi, K; Ng, H Y; Yamamoto, K

    2006-01-01

    Nanofiltration (NF) is considered as one of the most promising separation technologies to obtain a very good-quality permeate in water and wastewater treatment. A submerged NF membrane bioreactor (NF MBR) using polyamide membranes was tested for a long-term operation and the performance of the NF MBR was compared with that of a microfiltration MBR (MF MBR). Total organic carbon (TOC) concentration in the permeate of the NF MBR ranged from 0.5 to 2.0 mg/L, whereas that of the MF MBR showed an average of 5 mg/L. This could be explained by the tightness of the NF membrane. Although the concentration of organic matter in the supernatant of the NF MBR was higher than that in the permeate due to high rejection by the NF membrane, the NF MBR showed excellent treatment efficiency and satisfactory operational stability for a long-term operation.

  18. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis.

    PubMed

    Chen, R-C; Cai, Y-J; Wu, J-M; Wang, X-D; Song, M; Wang, Y-Q; Zheng, M-H; Chen, Y-P; Lin, Z; Shi, K Q

    2017-03-01

    Long-term prognosis varies widely among patients with hepatitis B virus (HBV)-related liver cirrhosis. Our study aimed to investigate the applicability of albumin-bilirubin (ALBI), Child-Pugh and model for end-stage liver disease (MELD) scores to the long-term prognosis prediction of HBV-related cirrhosis. Patients diagnosed with HBV-associated cirrhosis from the First Affiliated Hospital of Wenzhou Medical University between January 2010 and December 2015 were enrolled in this study. The patients were followed up every 3 months. The prognostic performance of ALBI in long-term outcome prediction for HBV-related cirrhosis was compared with Child-Pugh and MELD scores using time-dependent receiver operating characteristic curve (tdROC) and decision curve analysis. A total of 806 patients were included in our study with 275 (34.1%) deceased during the follow-up. Multivariate Cox regression analysis showed that ALBI grade was an independent predictor associated with mortality. The tdROC analysis showed that ALBI score (0.787, 0.830 and 0.833) was superior to MELD (0.693, P=.003; 0.717, P<.001; 0.744, P<.001) and Child-Pugh score (0.641, P<.001; 0.649, P<.001; 0.657, P<.001) for predicting 1-year, 2-year and 3-year mortality. Additionally, decision curves also got the similar results. In addition, patients with lower ALBI score had a longer life expectancy, even among patients within the same Child-Pugh class. Thus, ALBI score was effective in predicting the long-term prognosis for patients with HBV-related cirrhosis and more accurate than Child-Pugh and MELD scores.

  19. Long-term evaluation of paroxetine, clomipramine and placebo in panic disorder. Collaborative Paroxetine Panic Study Investigators.

    PubMed

    Lecrubier, Y; Judge, R

    1997-02-01

    Paroxetine has been shown to be effective in panic disorder in three 10- to 12-week studies. This trial studied the longer term effects of paroxetine in patients with DSM-III-R defined panic disorder. Patients who satisfactorily completed a 12-week, double-blind, placebo-controlled study of paroxetine and clomipramine could choose to continue receiving their randomized treatment for a further 36 weeks. Efficacy assessments included the daily panic attack diary, the Clinical Global Impression Scale, the Hamilton Anxiety Rating Scale, the Marks Sheehan Phobia Scale and the Sheehan Disability Scale. In total, 176 patients were included in the intention-to-treat population. The number of full panic attacks decreased in all three groups during the 12-week study, and improvements continued with long-term therapy. Paroxetine was statistically significantly more effective than placebo throughout the long-term study with respect to reduction from baseline of full panic attacks, and at the end of treatment with respect to the proportion of patients who eventually experienced no panic attacks. There were no significant differences between paroxetine and clomipramine. The proportion of patients who withdrew from the study due to adverse effects was greater in the clomipramine group (19%) than in either the paroxetine group (7%) or the placebo group (9%). Paroxetine was significantly more effective than placebo and as effective as (but better tolerated than) clomipramine in the long-term treatment of panic disorder. Not only was efficacy maintained, but continued improvement was also seen, indicating the importance of long-term treatment in patients with panic disorder.

  20. Development and evaluation of a workshop to support evidence-based practice change in long-term care.

    PubMed

    Higuchi, Kathryn Smith; Edwards, Nancy; Carr, Tracy; Marck, Patricia; Abdullah, Ghadah

    2015-01-01

    To support evidence-based practice changes in long-term care, we used a practice development approach with interactive workshops to engage teams from 10 organizations in participatory change. Data from postworkshop surveys and subsequent semistructured interviews indicated that participants felt empowered to identify a priority challenge and initiate change. Notably, the workshop intervention enhanced collaboration between professional and unregulated staff, fostered the development of shared vision, and provided the impetus to tackle workplace barriers to change.

  1. Short-, middle- and long-term safety of superparamagnetic iron oxide-labeled allogeneic bone marrow stromal cell transplantation in rat model of lacunar infarction.

    PubMed

    Tan, Chengbo; Shichinohe, Hideo; Abumiya, Takeo; Nakayama, Naoki; Kazumata, Ken; Hokari, Masaaki; Hamauchi, Shuji; Houkin, Kiyohiro

    2015-06-01

    Recently, both basic and clinical studies demonstrated that bone marrow stromal cell (BMSC) transplantation therapy can promote functional recovery of patients with CNS disorders. A non-invasive method for cell tracking using MRI and superparamagnetic iron oxide (SPIO)-based labeling agents has been applied to elucidate the behavior of transplanted cells. However, the long-term safety of SPIO-labeled BMSCs still remains unclear. The aim of this study was to investigate the short-, middle- and long-term safety of the SPIO-labeled allogeneic BMSC transplantation. For this purpose, BMSCs were isolated from transgenic rats expressing green fluorescent protein (GFP) and were labeled with SPIO. The Na/K ATPase pump inhibitor ouabain or vehicle was stereotactically injected into the right striatum of wild-type rats to induce a lacunar lesion (n = 22). Seven days after the insult, either BMSCs or SPIO solution were stereotactically injected into the left striatum. A 7.0-Tesla MRI was performed to serially monitor the behavior of BMSCs in the host brain. The animals were sacrificed after 7 days (n = 7), 6 weeks (n = 6) or 10 months (n = 9) after the transplantation. MRI demonstrated that BMSCs migrated to the damage area through the corpus callosum. Histological analysis showed that activated microglia were present around the bolus of donor cells 7 days after the allogeneic cell transplantation, although an immunosuppressive drug was administered. The SPIO-labeled BMSCs resided and started to proliferate around the route of the cell transplantation. Within 6 weeks, large numbers of SPIO-labeled BMSCs reached the lacunar infarction area from the transplantation region through the corpus callosum. Some SPIO nanoparticles were phagocytized by microglia. After 10 months, the number of SPIO-positive cells was lower compared with the 7-day and 6-week groups. There was no tumorigenesis or severe injury observed in any of the animals. These findings suggest that

  2. Long-term safety and efficacy of taliglucerase alfa in pediatric Gaucher disease patients who were treatment-naïve or previously treated with imiglucerase.

    PubMed

    Zimran, Ari; Gonzalez-Rodriguez, Derlis Emilio; Abrahamov, Aya; Cooper, Peter A; Varughese, Sheeba; Giraldo, Pilar; Petakov, Milan; Tan, Ee Shien; Chertkoff, Raul

    2016-10-20

    Taliglucerase alfa is an enzyme replacement therapy approved for treatment of Gaucher disease (GD) in children and adults in several countries. This multicenter extension study assessed the efficacy and safety of taliglucerase alfa in pediatric patients with GD who were treatment-naïve (n=10) or switched from imiglucerase (n=5). Patients received taliglucerase alfa 30 or 60U/kg (treatment-naïve) or the same dose as previously treated with imiglucerase every other week. In treatment-naïve patients, taliglucerase alfa 30 and 60U/kg, respectively, reduced mean spleen volume (-18.6 multiples of normal [MN] and -26.0MN), liver volume (-0.8MN and -0.9MN), and chitotriosidase activity (-72.7% and -84.4%), and increased mean Hb concentration (+2.0g/dL and +2.3g/dL) and mean platelet count (+38,200/mm(3) and +138,250/mm(3)) from baseline through 36 total months of treatment. In patients previously treated with imiglucerase, these disease parameters remained stable through 33 total months of treatment with taliglucerase alfa. Most adverse events were mild/moderate; treatment was well tolerated. These findings extend the taliglucerase alfa safety and efficacy profile and demonstrate long-term clinical improvement in treatment-naïve children receiving taliglucerase alfa and maintenance of disease stability in children switched to taliglucerase alfa. Treatment was well-tolerated, with no new safety signals. This study is registered at www.clinicaltrials.gov as NCT01411228.

  3. HOW DO WORK HIERARCHIES AND STRICT DIVISIONS OF LABOUR IMPACT CARE WORKERS’ EXPERIENCES OF HEALTH AND SAFETY? CASE STUDIESOF LONG TERM CARE IN TORONTO

    PubMed Central

    SYED, I.; DALY, T.; ARMSTRONG, P.; LOWNDES, R.; CHADOIN, M.; NAIDOO, V.

    2016-01-01

    Background According to the Canadian Health Care Association (1), there are 2,577 long-term care (“LTC”) facilities across Canada, with the largest proportion (33.4%) located in Ontario. Most studies focus on residents’ health, with less attention paid to the health and safety experiences of staff. Given that the work performed in Ontario LTC facilities is very gendered, increasingly racialized, task-oriented, and with strict divisions of labour, this paper explores in what ways some of these factors impact workers’ experiences of health and safety. Objectives The study objectives included the following research question: How are work hierarchies and task orientation experienced by staff? Design and Setting This paper draws on data from rapid team-based ethnographies of the shifting division of labour in LTC due to use of informal carers in six non-profit LTC facilities located in Toronto, Ontario. Methods Our method involved conducting observations and key informant interviews (N=167) with registered nurses, registered practical nurses, personal support workers, dietary aides, recreation therapists, families, privately paid companions, students, and volunteers. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed. For observations, researchers were paired and covered shifts between 7 a.m. and 11 p.m., as well as into the late night over six days, at each of the six sites. Detailed ethnographic field notes were written during and immediately following observational fieldwork. Results Our results indicate that employee stress is linked to the experiences of care work hierarchies, task orientation, and strict divisions of labour between and among various staff designations. Conclusion Findings from this project confirm and extend current research that demonstrates there are challenging working conditions in LTC, which can result in occupational health and safety problems, as well as stress for individual workers. PMID:28066839

  4. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects.

    PubMed

    Hayashi, Noriko; Iida, Tetsuo; Yamada, Takako; Okuma, Kazuhiro; Takehara, Isao; Yamamoto, Takashi; Yamada, Koji; Tokuda, Masaaki

    2010-01-01

    This clinical study was conducted to investigate the safety and effect of D-psicose on postprandial blood glucose levels in adult men and women, including borderline diabetes patients. A randomized double-blind placebo-controlled crossover experiment of single ingestion was conducted on 26 subjects who consumed zero or 5 g of D-psicose in tea with a standard meal. The blood glucose levels at fasting and 30, 60, 90, and 120 min after the meal were compared. The blood glucose level was significantly lower 30 and 60 min after the meal with D-psicose (p<0.01, p<0.05), and a significant decrease was also shown in the area under the curve (p<0.01). The results suggest that D-psicose had an effect to suppress the postprandial blood glucose elevation mainly in borderline diabetes cases. A randomized double-blind placebo-controlled parallel-group experiment of long-term ingestion was conducted on 17 normal subjects who took 5 g of D-psicose or D-glucose with meals three times a day for 12 continuous weeks. Neither any abnormal effects nor clinical problems caused by the continuous ingestion of D-psicose were found.

  5. Long-Term Efficacy and Patterns of Failure After Accelerated Partial Breast Irradiation: A Molecular Assay-Based Clonality Evaluation

    SciTech Connect

    Vicini, Frank A. . E-mail: fvicini@beaumont.edu; Antonucci, J. Vito; Wallace, Michelle R.N.; Gilbert, Samuel; Goldstein, Neal S.; Kestin, Larry; Chen, Peter; Kunzman, Jonathan; Boike, Thomas; Benitez, Pamela; Martinez, Alvaro

    2007-06-01

    Purpose: To determine the long-term efficacy and cosmetic results of accelerated partial breast irradiation (APBI) by reviewing our institution's experience. Methods and Materials: A total of 199 patients with early-stage breast cancer were treated prospectively with adjuvant APBI after lumpectomy using interstitial brachytherapy. All patients had negative margins, 82% had Stage I disease, median tumor size was 1.1 cm, and 12% had positive lymph nodes. The median follow-up for surviving patients was 8.6 years. Fifty-three patients (27%) have been followed for {>=}10 years. Results: Six ipsilateral breast tumor recurrences (IBTRs) were observed, for a 5-year and 10-year actuarial rate of 1.6% and 3.8%, respectively. A total of three regional nodal failures were observed, for a 10-year actuarial rate of 1.6%. Five contralateral breast cancers developed, for a 5- and 10-year actuarial rate of 2.2% and 5.2%, respectively. The type of IBTR (clonally related vs. clonally distinct) was analyzed using a polymerase chain reaction-based loss of heterozygosity assay. Eighty-three percent of IBTRs (n = 5) were classified as clonally related. Multiple clinical, pathologic, and treatment-related factors were analyzed for an association with the development of an IBTR, regional nodal failure, or contralateral breast cancer. On multivariate analysis, no variable was associated with any of these events. Cosmetic results were rated as excellent/good in 99% of patients. Conclusions: Long-term results with APBI using interstitial brachytherapy continue to demonstrate excellent long-term local and regional control rates and cosmetic results. According to a polymerase chain reaction-based loss of heterozygosity assay, 83% of recurrences were classified as clonally related.

  6. Long-term (three-year) safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents (from the SPIRIT III Trial).

    PubMed

    Applegate, Robert J; Yaqub, Manejeh; Hermiller, James B; Sood, Poornima; Yu, Shui; Doostzadeh, Julie; Williams, Jerome E; Farhat, Naim; Caputo, Ronald; Lansky, Alexandra J; Cutlip, Donald E; Sudhir, Krishnankutty; Stone, Gregg W

    2011-03-15

    The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

  7. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

    PubMed Central

    González-Rodríguez, Alexandre; Catalán, Rosa; Penadés, Rafael; Garcia-Rizo, Clemente; Bioque, Miquel; Parellada, Eduard; Bernardo, Miquel

    2015-01-01

    Background and objectives Short-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations. Method Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available. Results Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted. Conclusion Several studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release. PMID:26082620

  8. Long-term pharmacokinetic efficacy and safety of low-dose ritonavir as a booster and atazanavir pharmaceutical formulation based on solid dispersion system in rats.

    PubMed

    Fukushima, Keizo; Haraya, Kenta; Terasaka, Shuichi; Ito, Yukako; Sugioka, Nobuyuki; Takada, Kanji

    2008-06-01

    Atazanavir (ATV) is clinically coadministered with low-dose ritonavir (RTV), which boosts the oral bioavailability (BA) of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway; however, it is well known that in the chronic phase, the inhibition effect of RTV on Pgp and CYP3A becomes an induction effect. In this study, we investigated the long-term efficacy and safety of RTV-boosted ATV in rats with a clinical relevant dosage of ATV and RTV, 7 mg/kg and 2 mg/kg, respectively, and drew a direct comparison with RTV-boosted ATV and the previously reported ATV pharmaceutical formulation based on a solid dispersion system (ATV-SLS SD+G). Rats received RTV-boosted ATV or ATV-SLS SD+G for 14 d in the pharmacokinetic study. In addition, after 14-d repeated administration of each formulation, cyclosporine A (CyA) was administered to rats and Western blot analysis of Pgp and CYP3A was performed to investigate the impact on pharmacokinetic interaction of each ATV formulation. After repeated administration of both formulations, there was no significant difference between ATV pharmacokinetic parameters on day 1 and 14; therefore, it was considered that the long-term efficacy of both ATV formulations was maintained. However, after treatment with RTV-boosted ATV, the Cmax and AUC0-infinity of the following CyA significantly decreased to 49% and 47% in comparison to the control, respectively, and the Pgp expression in the small intestine by Western blot analysis was approximately 2-fold higher than the control, whereas after treatment with ATV pharmaceutical formulation, neither significant alteration of CyA nor notable change in the expression of intestinal Pgp and hepatic CYP3A was observed. Therefore, it was considered that the BA of CyA after treatment with RTV-boosted ATV would decrease by the induction effect of RTV in chronic phase as described above. The results of this study revealed that the chronic use of low-dose RTV as a

  9. Evaluation of results obtained with corifollitropin alfa after poor ovarian response in previous cycle using recombinant follicular stimulating hormone in the long-term protocol

    PubMed Central

    Salgueiro, Lister L.; Rolim, Juliana R.; Moura, Bernardo R. L.; Machado, Suelen P. P.; Haddad, Carolina

    2016-01-01

    Objective This study evaluated the use of Corifollitropin alfa in patients with previous poor response to recombinant follicle stimulating hormone in long-term protocols using gonadotropin-releasing hormone. Methods Twenty-seven poor responders to previous treatment with the long term protocol using the recombinant follicle stimulating hormone (Group 1) were selected and then submitted to a second attempt using the same long term protocol with Corifollitropin alfa instead of the recombinant follicle stimulating hormone (Group 2). Ovarian down-regulation was achieved using subcutaneous administration of Leuprolide Acetate. Ovarian stimulation was performed with recombinant follicle stimulating hormone until the administration of human chorionic gonadotropin, followed by follicular aspiration (Group 1). Group 2 was submitted to this same protocol using Corifollitropin alfa instead of recombinant follicle stimulating hormone. Results There were significant differences in the number of aspirated oocytes, percentage of mature oocytes, amount of injected oocytes and transferred embryos - with all of these parameters being increased in the Corifollitropin alfa group. In addition, the rates of pregnancy and ongoing pregnancy were also significantly higher in the Corifollitropin alfa group. Conclusion The present study demonstrated that the use of Corifollitropin alfa in the long-term protocol could be a highly effective alternative for patients with poor ovarian response, who were unsuccessful in a previous treatment with In Vitro Fertilization - Intracytoplasmic Sperm Injection. PMID:27584604

  10. Long-term Local and Systemic Safety of Poly(L-lactide-co-epsilon-caprolactone) after Subcutaneous and Intra-articular Implantation in Rats.

    PubMed

    Ramot, Yuval; Nyska, Abraham; Markovitz, Elana; Dekel, Assaf; Klaiman, Guy; Zada, Moran Haim; Domb, Abraham J; Maronpot, Robert R

    2015-12-01

    The use of biodegradable materials is gaining popularity in medicine, especially in orthopedic applications. However, preclinical evaluation of biodegradable materials can be challenging, since they are located in close contact with host tissues and might be implanted for a long period of time. Evaluation of these compounds requires biodegradability and biocompatibility studies and meticulous pathology examination. We describe 2 preclinical studies performed on Sprague-Dawley rats for 52 weeks, to evaluate clinical pathology, biocompatibility, biodegradability, and systemic toxicity after implantation of 2-layered films or saline-inflated balloon-shaped implants of downsized InSpace™ devices (termed "test device"). The test devices are made from a copolymer of poly-L-lactide-co-∊-caprolactone in a 70:30 ratio, identical to the device used in humans, intended for the treatment of rotator cuff tears. Intra-articular film implantation and subcutaneous implantation of the downsized device showed favorable local and systemic tolerability. Although the implanted materials have no inherent toxic or tumorigenic properties, one animal developed a fibrosarcoma at the implantation site, an event that is associated with a rodent-predilection response where solid materials cause mesenchymal neoplasms. This effect is discussed in the context of biodegradable materials along with a detailed description of expected pathology for biodegradable materials in long-term rodent studies.

  11. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naïve Patients with HIV-1 Infection: the REMAIN Study

    PubMed Central

    Teófilo, Eugénio; Rocha-Pereira, Nuno; Kuhlmann, Birger; Antela, Antonio; Knechten, Heribert; Santos, Jesús; Jiménez-Expósito, Maria Jesús

    2016-01-01

    Background: Boosted protease inhibitors (PIs), including ritonavir-boosted atazanavir (ATV/r), are a recommended option for the initial treatment of HIV-1 infection based upon clinical trial data; however, long-term real-life clinical data are limited. Objective: We evaluated the long-term use of ATV/r as a component of antiretroviral combination therapy in the real-life setting in the REMAIN study. Methods: This was an observational cohort study conducted at sites across Germany, Portugal, and Spain. Retrospective historical and prospective longitudinal follow-up data were extracted every six months from medical records of HIV-infected treatment-naïve patients aged ≥ 18 years initiating a first-line ATV/r-containing regimen. Results: Eligible patients (n = 517) were followed up for a median of 3.4 years. The proportion remaining on ATV/r at 5 years was 51.5% with an estimated Kaplan-Meier median time to treatment discontinuation of 4.9 years. Principal reasons for discontinuation were adverse events (15.9%; 8.9% due to hyperbilirubinemia) and virologic failure (6.8%). The Kaplan-Meier probability of not having virologic failure (HIV-1 RNA < 50 copies/mL) was 0.79 (95% CI: 0.75, 0.83) at five years. No treatment-emergent major PI resistance occurred. ATV/r was generally well tolerated during long-term treatment with no significant changes in estimated glomerular filtration rate over five years. Conclusions: In a real-life clinical setting over five years, treatment-naïve patients with HIV-1 infection initiating an ATV/r-based regimen showed sustained virologic suppression, an overall treatment persistence rate of 51.5%, an absence of treatment-emergent major PI resistance mutations at virologic failure, a long-term safety profile consistent with that observed in clinical trials, and no significant decline in renal function. PMID:26899539

  12. Evaluation of the long-term variability of seawater salinity and temperature in response to natural and anthropogenic stressors in the Arabian Gulf.

    PubMed

    Elhakeem, Abubaker; Elshorbagy, Walid

    2013-11-15

    Evaluating the long-term variability of the seawater salinity and temperature due to climate change is a limiting economical and operational factor in planning the design of new and expansion of existing desalination plants. This need is amplified in the Arabian Gulf due to the natural arid climate and anthropological stresses related to energy exploration and ongoing major developments. The lack of data in this region further adds additional dimension to the problem. The present work represents a systematic innovative approach to evaluate the anticipated long-term changes in the seawater salinity and temperature under the stresses of projected climate change and massive industrial effluents using statistical correlation and hydrodynamic simulation. The proposed approach employs the direct relation between the net freshwater losses (evaporation) entrenched with the investigated stressors and the mean sea salinity and sea temperature variation of an inverse estuary to formulate the statistical correlation and the hydrodynamic simulation conditions.

  13. Evaluation of Long-term Outcomes of Correction of Severe Blepharoptosis with Advancement of External Levator Muscle Complex: Descriptive Statistical Analysis of the Results

    PubMed Central

    INNOCENTI, ALESSANDRO; MORI, FRANCESCO; MELITA, DARIO; DREASSI, EMANUELA; CIANCIO, FRANCESCO; INNOCENTI, MARCO

    2017-01-01

    Aim: Evaluation of long-term results after aponeurotic blepharoptosis correction with external levator muscle complex advancement. Patients and Methods: We carried out a retrospective study with medical record review of 20 patients (40 eyes) affected by bilateral aponeurotic moderate and severe ptosis who underwent primary surgery between January 2010 and December 2013. Criteria for outcome evaluations included 3-year postoperative follow-up of upper margin reflex index (uMRD) and symmetry. Results: 3-Year postoperative follow-up showed 17 (85%) cases of successful correction of ptosis and three cases (15%) showed partial success. Two eyes showed hypocorrection, while one eye was overcorrected. The symmetry was maintained in all patients except for the oldest. Conclusion: External superior levator advancement is an effective procedure for moderate and severe aponeurotic blepharoptosis correction, and establishes good long-term eyelid position and symmetry. PMID:28064228

  14. Long-term potentiation in hippocampal oriens interneurons: postsynaptic induction, presynaptic expression and evaluation of candidate retrograde factors.

    PubMed

    Nicholson, Elizabeth; Kullmann, Dimitri M

    2014-01-05

    Several types of hippocampal interneurons exhibit a form of long-term potentiation (LTP) that depends on Ca(2+)-permeable AMPA receptors and group I metabotropic glutamate receptors. Several sources of evidence point to a presynaptic locus of LTP maintenance. The retrograde factor that triggers the expression of LTP remains unidentified. Here, we show that trains of action potentials in putative oriens-lacunosum-moleculare interneurons of the mouse CA1 region can induce long-lasting potentiation of stimulus-evoked excitatory postsynaptic currents that mimics LTP elicited by high-frequency afferent stimulation. We further report that blockers of nitric oxide production or TRPV1 receptors failed to prevent LTP induction. The present results add to the evidence that retrograde signalling underlies N-methyl-d-aspartate (NMDA) receptor-independent LTP in oriens interneurons, mediated by an unidentified factor.

  15. Long-term impact of sewage sludge application on soil microbial biomass: An evaluation using meta-analysis.

    PubMed

    Charlton, Alex; Sakrabani, Ruben; Tyrrel, Sean; Rivas Casado, Monica; McGrath, Steve P; Crooks, Bill; Cooper, Pat; Campbell, Colin D

    2016-12-01

    The Long-Term Sludge Experiments (LTSE) began in 1994 as part of continuing research into the effects of sludge-borne heavy metals on soil fertility. The long-term effects of Zn, Cu, and Cd on soil microbial biomass carbon (Cmic) were monitored for 8 years (1997-2005) in sludge amended soils at nine UK field sites. To assess the statutory limits set by the UK Sludge (Use in Agriculture) Regulations the experimental data has been reviewed using the statistical methods of meta-analysis. Previous LTSE studies have focused predominantly on statistical significance rather than effect size, whereas meta-analysis focuses on the magnitude and direction of an effect, i.e. the practical significance, rather than its statistical significance. The results presented here show that significant decreases in Cmic have occurred in soils where the total concentrations of Zn and Cu fall below the current UK statutory limits. For soils receiving sewage sludge predominantly contaminated with Zn, decreases of approximately 7-11% were observed at concentrations below the UK statutory limit. The effect of Zn appeared to increase over time, with increasingly greater decreases in Cmic observed over a period of 8 years. This may be due to an interactive effect between Zn and confounding Cu contamination which has augmented the bioavailability of these metals over time. Similar decreases (7-12%) in Cmic were observed in soils receiving sewage sludge predominantly contaminated with Cu; however, Cmic appeared to show signs of recovery after a period of 6 years. Application of sewage sludge predominantly contaminated with Cd appeared to have no effect on Cmic at concentrations below the current UK statutory limit.

  16. Carbon sequestration strategies for crop- and grasslands evaluated in long-term field experiments in Northern Europe

    NASA Astrophysics Data System (ADS)

    Kätterer, Thomas; Bolinder, Martin; Börjesson, Gunnar; Kirchmann, Holger

    2013-04-01

    Improved management of grass- and croplands is a win-win strategy resulting in both increased soil fertility and carbon sequestration. We quantified the effect of N fertilization, organic amendments and ley-arable rotations versus continuous annual cropping systems on soil carbon stocks by analyzing data from long-term field experiments in Nordic countries. Increasing net primary production was found to be the main driver for higher soil carbon storage. Mineral N fertilization increased soil carbon stocks by about 1-2 kg C ha-1 for each kg of N applied to cropland. Ley-arable rotations, being a combination of annual and perennial crops, are expected to have C stocks intermediate between continuous grass- and croplands. A summary of data from 15 long-term sites showed that on average 0.5 Mg ha-1 yr-1 (range 0.3 to 1.1; median 0.4 Mg ha-1 yr-1) more carbon was retained in soils in ley-arable compared to exclusively annual systems, depending on species composition, management, soil depth and the duration of the studies. We also quantified the effect of organic amendments on soil carbon stocks. Retention factors calculated for straw, manure, sawdust, peat, sewage sludge and composted household waste varied widely from about 15% for above-ground crop residues to about 90% for composted household waste. We also emphasize that increased soil carbon stocks not always lead to carbon sequestration of atmospheric CO2 and discuss misunderstandings related to mitigation options earlier proposed for carbon sequestration such as organic farming, manure application, residue handling or application of biochar. Finally, the consequences of different land use and management are discussed, taking into account two critical boundaries - the limited area of agricultural land on Earth and requirements to produce sufficient food, fibres and energy for a growing population.

  17. Evaluating long-term effects of heroin-assisted treatment: the results of a 6-year follow-up.

    PubMed

    Güttinger, Franziska; Gschwend, Patrick; Schulte, Bernd; Rehm, Jürgen; Uchtenhagen, Ambros

    2003-04-01

    Since January 1994, heroin-assisted treatment for opiate addicts has been available in Switzerland. This is the first report of the long-term effects of this form of treatment. The report examines subjects who entered a study involving medical prescription of opiates (Projekt zur ärztlichen Verschreibung von Betäubungsmitteln; PROVE) in Switzerland between January 1994 and March 1995 (n = 366). Opiates were dispensed in eight treatment centres. A follow-up was conducted 6 years after treatment entry. Two groups were assessed: clients who have continuously been on heroin-assisted treatment since entry into the PROVE study or who re-entered this treatment, and ex-clients who had discontinued heroin-assisted treatment at the time of follow-up. Two kinds of comparisons were conducted. Firstly, conditions at treatment entry were compared to 6-year follow-up outcomes, and secondly, outcomes were compared between clients still on heroin-assisted treatment and those who had been discharged. It was found that 46% of the clients still alive were on heroin-assisted treatment at the time of follow-up. A comparison of the present living conditions showed very little difference between those in treatment and those who had terminated treatment. Compared to the situation at entry, the results of the follow-up showed a significant decrease in the use of illegal substances, illegal income and most other variables concerning social conditions, but they also showed an increase in unemployment and reliance on social benefits. Heroin-assisted treatment is thus efficacious in the long-term course of treatment and is still effective after termination of treatment with respect to living conditions and use of illicit substances.

  18. Long-Term Safety and Efficacy of Atazanavir-Based Therapy in HIV-Infected Infants, Children and Adolescents: The Pediatric AIDS Clinical Trials Group Protocol 1020A

    PubMed Central

    Rutstein, Richard M.; Samson, Pearl; Fenton, Terry; Fletcher, Courtney V.; Kiser, Jennifer J.; Mofenson, Lynne M.; Smith, Elizabeth; Graham, Bobbie; Mathew, Marina; Aldrovani, Grace

    2014-01-01

    Background Atazanavir is an attractive option for the treatment of Pediatric HIV infection, based on once daily dosing and the availability of a formulation appropriate for younger children. PACTG 1020A was a phase I/II open label study of atazanavir (ATV) (with/without ritonavir [RTV] boosting)-based treatment of HIV-infected children; here we report the long-term safety and virologic and immunologic responses. Methods Antiretroviral-naïve and experienced children, ages 91 days to 21 years, with baseline plasma HIV RNA >5000 copies/ml (cpm) were enrolled at sites in the United States and South Africa. Results Of 195 children enrolled 142 (73%) subjects received ATV-based regimens at the final protocol recommended dose. 58% were treatment naive. Overall, at week 24, 84/139 subjects (60.4%) and at week 48, 83/142 (58.5%), had HIV RNA ≤400 cpm. At week 48, 69.5% of naïve and 43.3% of experienced subjects had HIV RNA ≤400 cpm; median CD4 increase was 196.5 cells/mm3. The primary adverse event was increased serum bilirubin; 9% of subjects had levels > 5.1 times upper limit of normal and 1.4% noted jaundice. 3% of subjects experienced Grade 2 or 3 prolongation in PR or QTc intervals. At week 48, there was a 15% increase in total cholesterol (TC), with TC >199 mg/dL increasing from 1% at baseline to 5.7%. Conclusions Use of once-daily ATV, with/without RTV, was safe and well tolerated in children, with acceptable levels of viral suppression and CD4 count increase. The primary adverse event, as expected, was an increase in bilirubin levels. PMID:25232777

  19. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain

    PubMed Central

    Onouchi, Kenji; Koga, Hiroaki; Yokoyama, Kazumasa; Yoshiyama, Tamotsu

    2014-01-01

    Purpose Studies of pregabalin for the treatment of central neuropathic pain have been limited to double-blind trials of 4–17 weeks in duration. The purpose of this study was to assess the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. The efficacy of pregabalin was also assessed as a secondary measure. Patients and methods This was a 53-week, multicenter, open-label trial of pregabalin (150–600 mg/day) in Japanese patients with central neuropathic pain due to spinal cord injury, multiple sclerosis, or cerebral stroke. Results A total of 103 patients received pregabalin (post-stroke =60; spinal cord injury =38; and multiple sclerosis =5). A majority of patients (87.4%) experienced one or more treatment-related adverse events, most commonly somnolence, weight gain, dizziness, or peripheral edema. The adverse event profile was similar to that seen in other indications of pregabalin. Most treatment-related adverse events were mild (89.1%) or moderate (9.2%) in intensity. Pregabalin treatment improved total score, sensory pain, affective pain, visual analog scale (VAS), and present pain intensity scores on the Short-Form McGill Pain Questionnaire (SF-MPQ) and ten-item modified Brief Pain Inventory (mBPI-10) total score at endpoint compared with baseline. Improvements in SF-MPQ VAS and mBPI-10 total scores were evident in all patient subpopulations. Mean changes from baseline in SF-MPQ VAS and mBPI-10 scores at endpoint were −20.1 and −1.4, respectively. Conclusion These findings demonstrate that pregabalin is generally well tolerated and provides sustained efficacy over a 53-week treatment period in patients with chronic central neuropathic pain. PMID:25114584

  20. Evaluation of Long-term Agroecosystem Management on Changes in Subsurface vs. Surface Soil Carbon Fractions and Dynamics

    NASA Astrophysics Data System (ADS)

    Wolfe, D.; Beem-Miller, J.; Kong, A.; Comstock, J.; Sherpa, S.; Wine, E.; Mallorino, A.

    2013-12-01

    Most studies of terrestrial soil organic carbon (SOC) have focused on the upper soil profile (e.g., 0-30 cm), so our knowledge of C dynamics in deeper layers is incomplete. Here, we examine the depth-dependent mechanisms and constraints by which management of the upper soil profile for optimum crop yield in agroecosystems can influence SOC fractions and change in both the surface and subsurface. Our study includes continuous corn systems under long-term conventional tillage (CT) vs no-tillage (NT) at Willsboro, New York (NY) (Kingsbury silty loam soil; 19 y) and Chazy, NY (Raynham silt loam; 38 y), and long-term crop rotation experiments under CT at Algona, Iowa (IA) (Clarion loam; 11 y) and Kanawha, IA (Canisteo clay loam; 57 y). Rotations in IA compared continuous corn to corn rotations with soybean, alfalfa, and/or oats. Cores were collected in 2011 and 2012 at 0-10, 10-20, 20-30, 30-50 and 50-75 cm, and analyzed for bulk density, soil texture, percent organic matter, total C and nitrogen (N), soil inorganic C, and active C (permanganate oxidizable C, POXC). Recent studies have documented that POXC is closely correlated with heavy, small-sized particulate organic C, reflecting a relatively processed and stable pool of labile C that is well-suited to assess land management effects on C dynamics. Overall, cumulative SOC stocks (0-75 cm) in the IA and NY soils ranged from 109.9-168.8 MgC ha-1, and 37.8-104.1 MgC ha-1, respectively. The proportion of total SOC stocks that occurred in the subsurface (30-75 cm) ranged from 39-44% in the IA soils, compared to 16-26% in NY. Across all sites and management we found no examples of statistically significant SOC change below 30 cm, although this may be in part an artifact of greater variability and smaller absolute values of C concentration at depth. SOC data were correlated with POXC measurements, although depth- and site-specific discrepancies in these two measures were observed. For example, POXC was relatively

  1. Determination of epileptic focus side in mesial temporal lobe epilepsy using long-term noninvasive fNIRS/EEG monitoring for presurgical evaluation

    PubMed Central

    Rizki, Edmi Edison; Uga, Minako; Dan, Ippeita; Dan, Haruka; Tsuzuki, Daisuke; Yokota, Hidenori; Oguro, Keiji; Watanabe, Eiju

    2015-01-01

    Abstract. Noninvasive localization of an epileptogenic zone is a fundamental step for presurgical evaluation of epileptic patients. Here, we applied long-term simultaneous functional near-infrared spectroscopy (fNIRS)/electroencephalogram (EEG) monitoring for focus diagnosis in patients with mesial temporal lobe epilepsy (MTLE). Six MTLE patients underwent long-term (8–16 h per day for 4 days) fNIRS/EEG monitoring for the occurrence of spontaneous seizures. Four spontaneous seizures were successfully recorded out of the six patients. To determine oxy-Hb amplitude, the period-average values of oxy-Hb across 20 s from the EEG- or clinically defined epileptic onset were calculated for both hemispheres from the simultaneously recorded fNIRS data. The average oxy-Hb values for the temporal lobe at the earlier EEG- or clinically defined epileptic onsets were greater for the epileptic side than for the contralateral side after EEG activity suppression, spike train, and clinical seizure in all four cases. The true laterality was determined based on the relief of seizures by selective amygdalo-hippocampectomy. Thus, oxy-Hb amplitude could be a reliable measure for determining the epileptic focus side. Long-term simultaneous fNIRS/EEG measurement serves as an effective tool for recording spontaneous seizures. Cerebral hemodynamic measurement by fNIRS would serve as a valuable supplementary noninvasive measurement method for presurgical evaluation of MTLE. PMID:26158007

  2. Evaluation of pre-breeding reproductive tract scoring as a predictor of long term reproductive performance in beef heifers.

    PubMed

    Holm, D E; Nielen, M; Jorritsma, R; Irons, P C; Thompson, P N

    2015-01-01

    In a 7-year longitudinal study 292 Bovelder beef cows in a restricted breeding system in South Africa were observed from 1 to 2 days before their first breeding season, when reproductive tract scoring (RTS, scored from 1 to 5) was performed, until weaning their 5th calves. The objective was to determine whether pre-breeding RTS in heifers is a valid tool to predict long-term reproductive performance. Outcomes measured were failure to show oestrus during the first 24 days of the first 50-day AI season (24-day anoestrus), failure to become pregnant during each yearly artificial insemination (AI) season (reproductive failure), number of days from the start of each AI season to calving, and number of years to reproductive failure. The effect of RTS on each outcome was adjusted for year of birth, pre-breeding age, BW and body condition score (BCS), and for 24-day anoestrus, bull, gestation length, previous days to calving and previous cow efficiency index, the latter two in the case of the 2nd to the 5th calving season. During their first breeding season, heifers with RTS 1 and 2 combined were more likely to be in anoestrus for the first 24 days (OR=3.0, 95% CI 1.5, 6.4, P=0.003), and were also more likely to fail to become pregnant even after adjusting for 24-day anoestrus (OR=2.1, 95% CI 1.1, 3.9, P=0.025), compared to those with RTS 4 and 5 combined. Animals with RTS 1 and 2 combined were at increased risk of early reproductive failure compared to those with RTS 4 and 5 combined (HR=1.4, 95% CI 1.0, 1.9, P=0.045) although RTS was not associated with calving rate or days to calving after the second calving season. Low RTS at a threshold of 1 had consistent specificity of ≥94% for both 24-day anoestrus and pregnancy failure, however its predictive value was lower in the age cohort with a higher prevalence of anoestrus. We conclude that RTS is a valid management tool for culling decisions intended to improve long-term reproductive success in a seasonal breeding system

  3. Evaluation of different nitrous oxide production models with four continuous long-term wastewater treatment process data series.

    PubMed

    Spérandio, Mathieu; Pocquet, Mathieu; Guo, Lisha; Ni, Bing-Jie; Vanrolleghem, Peter A; Yuan, Zhiguo

    2016-03-01

    Five activated sludge models describing N2O production by ammonium oxidising bacteria (AOB) were compared to four different long-term process data sets. Each model considers one of the two known N2O production pathways by AOB, namely the AOB denitrification pathway and the hydroxylamine oxidation pathway, with specific kinetic expressions. Satisfactory calibration could be obtained in most cases, but none of the models was able to describe all the N2O data obtained in the different systems with a similar parameter set. Variability of the parameters can be related to difficulties related to undescribed local concentration heterogeneities, physiological adaptation of micro-organisms, a microbial population switch, or regulation between multiple AOB pathways. This variability could be due to a dependence of the N2O production pathways on the nitrite (or free nitrous acid-FNA) concentrations and other operational conditions in different systems. This work gives an overview of the potentialities and limits of single AOB pathway models. Indicating in which condition each single pathway model is likely to explain the experimental observations, this work will also facilitate future work on models in which the two main N2O pathways active in AOB are represented together.

  4. Evaluating the long-term hydrology of an evapotranspiration-capillary barrier with a 1000 year design life

    NASA Astrophysics Data System (ADS)

    Zhang, Z. Fred

    2016-06-01

    A surface barrier is a commonly used technology for isolation of subsurface contaminants. Surface barriers for isolating radioactive waste are expected to perform for centuries to millennia, yet there are very few data for field-scale surface barriers for periods approaching a decade or longer. The Prototype Hanford Barrier (PHB) with a design life of 1000 years was constructed over an existing radioactive waste site in 1994 to demonstrate its long-term performance. The primary element of the PHB is an evapotranspiration-capillary (ETC) barrier in which precipitation water is stored in a fine-textured soil layer and later released to the atmosphere via evapotranspiration. To address the barrier performance under extreme conditions, this study included an enhanced precipitation stress test from 1995 to 1997 to determine barrier response to extreme precipitation events. During this period a 1000 year 24 h return rainstorm was simulated in March every year. The loss of vegetation on barrier hydrology was tested with a controlled fire test in 2008. The 19 year monitoring record shows that the store-and-release mechanism worked as well as or better than the design criterion. Average drainage from the ETC barrier amounted to an average of 0.005 mm yr-1, which is well below the design criterion of 0.5 mm yr-1. After a simulated wildfire, the naturally reestablished vegetation and increased evaporation combined to release the stored water and summer precipitation to the atmosphere such that drainage did not occur in the 5 years subsequent to the fire.

  5. Financing institutional long-term care for the elderly in China: a policy evaluation of new models.

    PubMed

    Yang, Wei; Jingwei He, Alex; Fang, Lijie; Mossialos, Elias

    2016-12-01

    A rapid ageing population coupled with changes in family structure has brought about profound implications to social policy in China. Although the past decade has seen a steady increase in public funding to long-term care (LTC), the narrow financing base and vast population have created significant unmet demand, calling for reforms in financing. This paper focuses on the financing of institutional LTC care by examining new models that have emerged from local policy experiments against two policy goals: equity and efficiency. Three emerging models are explored: Social Health Insurance (SHI) in Shanghai, LTC Nursing Insurance (LTCNI) in Qingdao and a means-tested model in Nanjing. A focused systematic narrative review of academic and grey literature is conducted to identify and assess these models, supplemented with qualitative interviews with government officials from relevant departments, care home staff and service users. This paper argues that, although SHI appears to be a convenient solution to fund LTC, this model has led to systematic bias in affordable access among participants of different insurance schemes, and has created a powerful incentive for the over-provision of unnecessary services. The means-tested method has been remarkably constrained by narrow eligibility and insufficiency of funding resources. The LTCNI model is by far the most desirable policy option among the three studied here, but the narrow definition of eligibility has substantively excluded a large proportion of elders in need from access to care, which needs to be addressed in future reforms. This paper proposes three lines of LTC financing reforms for policy-makers: (1) the establishment of a prepaid financing mechanism pooled specifically for LTC costs; (2) the incorporation of more stringent eligibility rules and needs assessment; and (3) reforming the dominant fee-for-service methods in paying LTC service providers.

  6. Re-evaluating the use of beached bird oiling rates to assess long-term trends in chronic oil pollution.

    PubMed

    Wilhelm, Sabina I; Robertson, Gregory J; Ryan, Pierre C; Tobin, Stan F; Elliot, Richard D

    2009-02-01

    The oiling rate (oiled birds/total birds) has become the international standard to analyze beached bird survey data. However, this index may not reliably track long-term changes in marine oil pollution in regions where other activities that kill seabirds vulnerable to oil, such as hunting and gill-netting, are also changing. We compare the oiling rate from beached bird surveys conducted in southeastern Newfoundland between 1984 and 2006 to an alternative approach, namely trends derived from a model examining the linear density of oiled birds (birds/km). In winter, there was no change in the oiling rate since 1984, while in summer oiling rates significantly increased. In contrast, the number of oiled birds/km showed a significant decline in both winter and summer. The discrepancy in these trends was attributed to steep declines in the number of unoiled birds found in both seasons. In winter, the decline in unoiled birds/km was related to a reduction in the legal murre hunt and less onshore winds, while in summer a reduced cod fishery resulting in fewer murres drowning in nets and warming summers may have lead to the decline. The significant declines in oiled birds/km over the past three decades are hopefully an indication of less oil being present in the marine environment. Although oiled bird densities since 2000 have remained relatively low for the region (winter: 0.58 birds/km, summer: 0.27 birds/km), they still exceed densities reported elsewhere in the world.

  7. Efficacy and safety of short- and long-term, regular and on-demand regimens of phosphodiesterase type 5 inhibitors in treating erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis

    PubMed Central

    Tian, Daxue; Wang, Xiao-yan; Zong, Huan-tao; Zhang, Yong

    2017-01-01

    Background We performed a meta-analysis to evaluate the efficacy and safety of short-term (≤6 months) and long-term (>6 months), regular (OaD) and on-demand (PRN) regimens of phosphodiesterase type 5 inhibitors (PDE5-Is) in treating erectile dysfunction (ED) after nerve-sparing radical prostatectomy (NSRP). Methods We conducted a literature search in August 2016. Sources included PubMed, EMBASE, and MEDLINE databases. The main outcome was International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, and the secondary outcome was treatment-emergent adverse events (TEAEs). Results Eight articles involving 13 randomized controlled trials (RCTs) were used in this analysis: they suggested that PDE5-Is can improve the IIEF-EF distinctly in comparison with placebo in short and long term (mean difference [MD]: 2.26, 95% confidence interval [CI]: 1.45–3.08, P<0.00001, and MD: 4.5, 95% CI: 3.6–5.4, P<0.00001), and long-term use of PDE5-Is (>6 months) can improve the IIEF-EF distinctly in comparison with short-term use of PDE5-Is (≤6 months) (MD: 3.9, 95% CI: 3.01–4.8, P<0.00001). OaD of PDE5-Is significantly improved the IIEF-EF compared to placebo in short and long term (MD: 4.08, 95% CI: 3.2–4.97, P<0.00001, and MD: 4.74, 95% CI: 3.79–5.69, P<0.00001). No significant differences were found in IIEF-EF changes between PRN and placebo (≤6 months) (MD: 2.64, 95% CI: −0.87 to 6.14, P=0.14), and between PRN and OaD group (>6 months) (MD: −0.58, 95% CI: −9.86 to 8.74, P=0.91). There were more TEAEs in PDE5-Is group in comparison with placebo (odds ratio [OR]: 1.55, 95% CI: 1.26–1.91, P<0.0001), and TEAEs in OaD group were not significantly different from those seen in PRN group (OR: 1.05, 95% CI: 0.78–1.4, P=0.77). Conclusion Our meta-analysis suggests that PDE5-Is are efficient and safe for treatment of ED after NSRP, and we should choose the regular regimen for short term and regular or on-demand regimen for long term. Further high

  8. Long-Term Efficacy, Safety, and Pharmacokinetics of Drisapersen in Duchenne Muscular Dystrophy: Results from an Open-Label Extension Study

    PubMed Central

    Goemans, Nathalie M.; Tulinius, Már; van den Hauwe, Marleen; Kroksmark, Anna-Karin; Buyse, Gunnar; Wilson, Rosamund J.; van Deutekom, Judith C.; de Kimpe, Sjef J.; Lourbakos, Afrodite; Campion, Giles

    2016-01-01

    Background Drisapersen induces exon 51 skipping during dystrophin pre-mRNA splicing and allows synthesis of partially functional dystrophin in Duchenne muscular dystrophy (DMD) patients with amenable mutations. Methods This 188-week open-label extension of the dose-escalation study assessed the long-term efficacy, safety, and pharmacokinetics of drisapersen (PRO051/GSK2402968), 6 mg/kg subcutaneously, in 12 DMD subjects. Dosing was once weekly for 72 weeks. All subjects had a planned treatment interruption (weeks 73–80), followed by intermittent dosing (weeks 81–188). Results Subjects received a median (range) total dose of 5.93 (5.10 to 6.02) mg/kg drisapersen. After 177 weeks (last efficacy assessment), median (mean [SD]) six-minute walk distance (6MWD) improved by 8 (-24.5 [161]) meters for the 10 subjects able to complete the 6MWD at baseline (mean age [SD]: 9.5 [1.9] years). These statistics include 2 subjects unable to complete the test at later visits and who scored “zero”. When only the 8 ambulant subjects at week 177 were taken into account, a median (mean [SD]) increase of 64 (33 [121]) meters in 6MWD was observed. Of 7 subjects walking ≥330 m at extension baseline, 5 walked farther at week 177. Of 3 subjects walking <330 m, 2 lost ambulation, while 1 declined overall but walked farther at some visits. Over the 188 weeks, the most common adverse events were injection-site reactions, raised urinary α1-microglobulin and proteinuria. Dystrophin expression was detected in all muscle biopsies obtained at week 68 or 72. Conclusion Drisapersen was generally well tolerated over 188 weeks. Possible renal effects, thrombocytopenia and injection-site reactions warrant continued monitoring. Improvements in the 6MWD at 12 weeks were sustained after 3.4 years of dosing for most patients. For a small, uncontrolled study, the outcomes are encouraging, as natural history studies would anticipate a decline of over 100 meters over a 3-year period in a comparable

  9. PleurX drain use in the management of malignant ascites: safety, complications, long-term patency and factors predictive of success

    PubMed Central

    Tapping, C R; Ling, L; Razack, A

    2012-01-01

    Objectives The aim of this article was to assess the success, safety, complication profile and factors associated with long-term patency of tunnelled peritoneal drains (PleurX) in the treatment of refractory malignant ascites. Methods Over a 4-year period, 28 consecutive patients (32 drain insertions) with refractory malignant ascites were treated with a PleurX drain. The study group comprised 7 males and 21 females (mean age, 61 years). A combination of fluoroscopic and ultrasound guidance was used to insert 4 drains; the remaining 28 drains were inserted under ultrasound guidance alone. Patient history, biochemical profiles, pathological and procedural records and clinical follow-up until death were reviewed. Statistical analysis included multivariate logistic regression analysis and Kaplan–Meier curves (p<0.05 was considered significant). Results There was a 100% technical success rate for the insertion of the drain; there were no procedure-related deaths and no major complications. Only minor complications were reported: three (10%) immediate; three (10%) early; and two (7%) late. Factors significantly associated with these complications included current chemotherapy, low haemoglobin levels, low albumin levels, high white cell count and high c-reactive protein levels. The length of time the drains remained in situ, and therefore patent, ranged from 5 to 365 days (mean, 113 days). Out of the original 28 tunnelled drains, 24 (86%) remained in situ and functioning until the patients’ death. Four (14%) drains dislodged and a subsequent PleurX drain was inserted on the opposite side of the abdominal wall. These new drains remained patent until the patient’s death. The annual event rate was 0.45 events per year. A comorbid diagnosis of renal disease or chemotherapy was significantly related to a decreased length of patency. Conclusion The use of tunnelled peritoneal drains is safe and effective and we would advocate their use as a first-line approach in

  10. Evaluation of long-term side effects after shock-wave lithotripsy for renal calculi using a third generation electromagnetic lithotripter.

    PubMed

    Pirola, Giacomo Maria; Micali, Salvatore; Sighinolfi, Maria Chiara; Martorana, Eugenio; Territo, Angelo; Puliatti, Stefano; Bianchi, Giampaolo

    2016-10-01

    To assess the incidence of long-term side effects after shock-wave lithotripsy treatment performed with an electromagnetic Dornier Lithotripter S device. A specific follow-up was undertaken on a cohort of 100 selected patients that underwent SWL for a single renal stone in our center from 2002 to 2004. Previous and current data were compared using the Student t test. Factors associated with the incidence of hypertension and diabetes mellitus were determined. Ten years after treatment, mean serum creatinine level and glomerular filtration rate remained similar to previous values (serum creatinine level: 0.96 ± 0.22 vs. 0.92 ± 0.19 mg/dL; glomerular filtration rate: 92.8 ± 17.8 vs. 88.1 ± 21.7 mL/min). There were marked increases in blood cholesterol, blood pressure, and blood glucose levels, while smoking decreased. Age, glomerular filtration rate, body mass index, blood glucose and blood pressure at the time of treatment were significantly associated with the presence of hypertension and diabetes mellitus at follow-up; blood cholesterol was associated with diabetes mellitus development. After 10 years, overall renal function appeared to have been unaffected by shock-wave lithotripsy treatment. The increased rate of hypertension and diabetes mellitus were consistent with the incidence in the global population. This is the first report on the long-term safety of a third generation electromagnetic lithotripter, and indicates that there are no long-term sequelae.

  11. ISR II study: a long-term evaluation of sirolimus-eluting stent in the treatment of patients with in-stent restenotic native coronary artery lesions.

    PubMed

    Commeau, Philippe; Barragan, Paul T; Roquebert, Pierre O; Siméoni, Jean B

    2005-10-01

    The aim of this pilot study was to determine the safety and long-term efficacy of treating intrastent restenosis (ISR) with the slow-release sirolimus-eluting stent Bx Velocity (Cypher stent) without intravascular ultrasound (IVUS) guidance. Of patients who received a bare metal stent implantation and presented an ISR, 30-80% of the patients will develop a second restenosis within the stent, at the stent edges or both. To date, intravascular brachytherapy using beta- and gamma-radiation has been the only effective treatment for ISR. Twenty-three patients with ISR and evidence of ischemia were treated with Cypher stent. Clinical information was collected 1, 8, 12, and 24 months after stent implantation. During the first 8 months of the study, in-stent lumen diameter remained essentially unchanged from postprocedure in 80% of the case. The target lesion repeat revascularization (TLR) was 17%, of which 50% were oculostenotic reflexes. Only one patient presented a restenosis greater than 70%. During the 2-year study period, the TLR rate was 17%; the major adverse coronary event rate was 26%, and the non-Q-wave myocardial infarction (MI) rate was 9%. There were no reports of death, coronary artery bypass grafting, or Q-wave MI during the study. This study demonstrates the feasibility of using sirolimus-eluting stents without IVUS guidance for the treatment of ISR, providing long-term stability of immediate results.

  12. The efficacy and safety of reinstitution of tocilizumab in patients with relapsed active rheumatoid arthritis after long-term withdrawal of tocilizumab: retreatment of patients with rheumatoid arthritis with novel anti-IL-6 receptor antibody after a long-term interval following SAMURAI: the RONIN study.

    PubMed

    Sagawa, Akira

    2011-08-01

    We have evaluated the efficacy and safety of tocilizumab (TCZ) re-administration in patients with active rheumatoid arthritis (RA) who had previously received TCZ treatment for about 31 months. Four patients whose RA had been well-controlled with 8 mg/kg TCZ treatment every 4 weeks and had withdrawn from the treatment were enrolled. They resumed TCZ treatment after TCZ was authorized for RA treatment in Japan. Disease activity was assessed by the Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR), and synovitis in the wrists and elbows was measured by ultrasonography at baseline and during follow-up. The mean DAS28-ESR was 6.32 before the first TCZ infusion. After fewer than 20 months of initial TCZ treatment, the mean DAS28-ESR decreased to 1.87. However, after withdrawal of TCZ treatment, the disease activity could not be sufficiently controlled with conventional disease-modifying antirheumatic drugs or biologic agents. The maximum interval between TCZ treatments was approximately 34 months. Following reinstatement of the TCZ treatment, within 12 months the mean DAS28-ESR improved from 5.21 to 2.87, with the synovitis in the wrists and elbow joints also showing great improvement. These findings demonstrate that TCZ retreatment in active RA patients who had relapsed after long-term discontinuation of TCZ treatment led to an improvement in the signs and symptoms of RA and in synovitis without any severe adverse events.

  13. Is fire a long term sink or source of atmospheric carbon? A comprehensive evaluation of a boreal forest fire

    NASA Astrophysics Data System (ADS)

    Santin, C.; Doerr, S. H.; Preston, C.; Bryant, R.

    2012-12-01

    -fire fuel assessment, ii) fire behaviour monitoring and iii) immediate post-fire fuel and PyC inventory. Before the fire, fuel characteristics were established and the site was instrumented with auto-logging thermocouples to provide temperature-duration profiles during burning. Also, different types of PyC were placed on the ground to determine PyC loss during the fire. Immediately after fire, the various post-burn PyC products and stores were sampled. Total PyC was quantified and the chemical recalcitrance of the different PyC forms found was determined. The results obtained will be discussed in the context of PyC production, and its different forms and quantities, with respect to (i) fire characteristics and fuel consumed, and (ii) the long term carbon balance in this boreal forest environment for recurring fire-regrowth cycles under current and predicted future climatic conditions.

  14. Evaluation of nurses’ changing perceptions when trained to implement a self-management programme for dual sensory impaired older adults in long-term care: a qualitative study

    PubMed Central

    Roets-Merken, Lieve M; Vernooij-Dassen, Myrra J F J; Zuidema, Sytse U; Dees, Marianne K; Hermsen, Pieter G J M; Kempen, Gertrudis I J M; Graff, Maud J L

    2016-01-01

    Objectives To gain insights into the process of nurses’ changing perceptions when trained to implement a self-management programme for dual sensory impaired older adults in long-term care, and into the factors that contributed to these changes in their perceptions. Design Qualitative study alongside a cluster randomised controlled trial. Setting 17 long-term care homes spread across the Netherlands. Participants 34 licensed practical nurses supporting 54 dual sensory impaired older adults. Intervention A 5-month training programme designed to enable nurses to support the self-management of dual sensory impaired older adults in long-term care. Primary outcomes Nurses’ perceptions on relevance and feasibility of the self-management programme collected from nurses’ semistructured coaching diaries over the 5-month training and intervention period, as well as from trainers’ reports. Results Nurses’ initial negative perceptions on relevance and feasibility of the intervention changed to positive as nurses better understood the concept of autonomy. Through interactions with older adults and by self-evaluations of the effect of their behaviour, nurses discovered that their usual care conflicted with client autonomy. From that moment, nurses felt encouraged to adapt their behaviour to the older adults’ autonomy needs. However, nurses’ initial unfamiliarity with conversation techniques required a longer exploration period than planned. Once client autonomy was understood, nurses recommended expanding the intervention as a generic approach to all their clients, whether dual sensory impaired or not. Conclusions Longitudinal data collection enabled exploration of nurses’ changes in perceptions when moving towards self-management support. The training programme stimulated nurses to go beyond ‘protocol thinking’, discovering client autonomy and exploring the need for their own behavioural adaptations. Educational programmes for practical nurses should offer

  15. An approach to design long-term monitoring and evaluation frameworks in multi-actor systems--a case in water management.

    PubMed

    Hermans, Leon M; Naber, Arienne C; Enserink, Bert

    2012-11-01

    Learning-by-doing and adaptive management require careful monitoring and evaluation of the outcomes of environmental policies and programs under implementation. Selecting relevant indicators is difficult, especially when monitoring over a longer period of time. Further challenges arise when policies are developed as a collaborative effort among multiple actors. This paper discusses an approach to design frameworks for long-term monitoring and evaluation in multi-actor systems. It uses Dynamic Actor Network Analysis (DANA) as an actor-sensitive method to reconstruct program theories. This is combined with elements of assumption-based planning to identify critical assumptions and associated indicators to incorporate the dynamic aspects related to long-term monitoring. An application of this approach is described for a case of water management in the Netherlands. Here, mapping multiple perspectives and identifying critical assumptions helped to broaden the scope of monitoring in important ways. Identifying associated indicators and expectations on their development in response to policy implementation proved more difficult. From this case, it can be concluded that the approach is feasible, useful, but also demanding. However, with continuing trends of networked governance and adaptive management, additional efforts to reflect these trends in monitoring and evaluation, through this and similar approaches, are needed.

  16. The Long-Term Safety, Public Health Impact, and Cost-Effectiveness of Routine Vaccination with a Recombinant, Live-Attenuated Dengue Vaccine (Dengvaxia): A Model Comparison Study

    PubMed Central

    Longini, Ira; Lourenco, Jose; Pearson, Carl A. B.; Reiner, Robert C.; Mier-y-Terán-Romero, Luis; Vannice, Kirsten

    2016-01-01

    Background Large Phase III trials across Asia and Latin America have recently demonstrated the efficacy of a recombinant, live-attenuated dengue vaccine (Dengvaxia) over the first 25 mo following vaccination. Subsequent data collected in the longer-term follow-up phase, however, have raised concerns about a potential increase in hospitalization risk of subsequent dengue infections, in particular among young, dengue-naïve vaccinees. We here report predictions from eight independent modelling groups on the long-term safety, public health impact, and cost-effectiveness of routine vaccination with Dengvaxia in a range of transmission settings, as characterised by seroprevalence levels among 9-y-olds (SP9). These predictions were conducted for the World Health Organization to inform their recommendations on optimal use of this vaccine. Methods and Findings The models adopted, with small variations, a parsimonious vaccine mode of action that was able to reproduce quantitative features of the observed trial data. The adopted mode of action assumed that vaccination, similarly to natural infection, induces transient, heterologous protection and, further, establishes a long-lasting immunogenic memory, which determines disease severity of subsequent infections. The default vaccination policy considered was routine vaccination of 9-y-old children in a three-dose schedule at 80% coverage. The outcomes examined were the impact of vaccination on infections, symptomatic dengue, hospitalised dengue, deaths, and cost-effectiveness over a 30-y postvaccination period. Case definitions were chosen in accordance with the Phase III trials. All models predicted that in settings with moderate to high dengue endemicity (SP9 ≥ 50%), the default vaccination policy would reduce the burden of dengue disease for the population by 6%–25% (all simulations: –3%–34%) and in high-transmission settings (SP9 ≥ 70%) by 13%–25% (all simulations: 10%– 34%). These endemicity levels are

  17. Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized, parallel-group, multicenter, extension clinical trial

    PubMed Central

    Fujishiro, Mitsuhiro; Higuchi, Kazuhide; Kato, Mototsugu; Kinoshita, Yoshikazu; Iwakiri, Ryuichi; Watanabe, Toshio; Takeuchi, Toshihisa; Sugisaki, Nobuyuki; Okada, Yasushi; Ogawa, Hisao; Arakawa, Tetsuo; Fujimoto, Kazuma

    2015-01-01

    A 24-week, double-blind, clinical trial of rabeprazole for the prevention of recurrent peptic ulcers caused by low-dose aspirin (LDA) has been reported, but trials for longer than 24 weeks have not been reported. The aim of this study is to assess the long-term efficacy and safety of rabeprazole for preventing peptic ulcer recurrence on LDA therapy. Eligible patients had a history of peptic ulcers on long-term LDA (81 or 100 mg/day) therapy. Patients with no recurrence of peptic ulcers at the end of the 24-week double-blind phase with rabeprazole (10- or 5-mg once daily) or teprenone (50 mg three times daily) entered the extension phase. Rabeprazole doses were maintained for a maximum of 76 weeks, including the double-blind 24-week period and the extension phase period (long-term rabeprazole 10- and 5-mg groups). Teprenone was randomly switched to rabeprazole 10 or 5 mg for a maximum of 52 weeks in the extension phase (newly-initiated rabeprazole 10- and 5-mg groups). The full analysis set consisted of 151 and 150 subjects in the long-term rabeprazole 10- and 5-mg groups, respectively, and the cumulative recurrence rates of peptic ulcers were 2.2 and 3.7%, respectively. Recurrent peptic ulcers were not observed in the newly-initiated rabeprazole 10- and 5-mg groups. No bleeding ulcers were reported. No clinically significant safety findings, including cardiovascular events, emerged. The use of long-term rabeprazole 10- and 5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-dose aspirin therapy, and both were well-tolerated. PMID:26060354

  18. Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized, parallel-group, multicenter, extension clinical trial.

    PubMed

    Fujishiro, Mitsuhiro; Higuchi, Kazuhide; Kato, Mototsugu; Kinoshita, Yoshikazu; Iwakiri, Ryuichi; Watanabe, Toshio; Takeuchi, Toshihisa; Sugisaki, Nobuyuki; Okada, Yasushi; Ogawa, Hisao; Arakawa, Tetsuo; Fujimoto, Kazuma

    2015-05-01

    A 24-week, double-blind, clinical trial of rabeprazole for the prevention of recurrent peptic ulcers caused by low-dose aspirin (LDA) has been reported, but trials for longer than 24 weeks have not been reported. The aim of this study is to assess the long-term efficacy and safety of rabeprazole for preventing peptic ulcer recurrence on LDA therapy. Eligible patients had a history of peptic ulcers on long-term LDA (81 or 100 mg/day) therapy. Patients with no recurrence of peptic ulcers at the end of the 24-week double-blind phase with rabeprazole (10- or 5-mg once daily) or teprenone (50 mg three times daily) entered the extension phase. Rabeprazole doses were maintained for a maximum of 76 weeks, including the double-blind 24-week period and the extension phase period (long-term rabeprazole 10- and 5-mg groups). Teprenone was randomly switched to rabeprazole 10 or 5 mg for a maximum of 52 weeks in the extension phase (newly-initiated rabeprazole 10- and 5-mg groups). The full analysis set consisted of 151 and 150 subjects in the long-term rabeprazole 10- and 5-mg groups, respectively, and the cumulative recurrence rates of peptic ulcers were 2.2 and 3.7%, respectively. Recurrent peptic ulcers were not observed in the newly-initiated rabeprazole 10- and 5-mg groups. No bleeding ulcers were reported. No clinically significant safety findings, including cardiovascular events, emerged. The use of long-term rabeprazole 10- and 5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-dose aspirin therapy, and both were well-tolerated.

  19. Long-term evaluation and cross-checking of two geometric calibrations of kV and MV imaging systems for Linacs.

    PubMed

    Chiu, Tsuicheng D; Yan, Yulong; Foster, Ryan; Mao, Weihua

    2015-07-08

    Geometric or mechanical accuracy of kV and MV imaging systems of two Varian TrueBeam linacs have been monitored by two geomertirc calibration systems, Varian IsoCal geometric calibration system and home-developed gQA system. Results of both systems are cross-checked and the long-term geometric stabilities of linacs are evaluated. Two geometric calibration methodologies have been used to assess kV and MV imaging systems and their coincidence periodically on two TrueBeam linacs for about one year. Both systems analyze kV or MV projection images of special designed phantoms to retrieve geometric parameters of the imaging systems. The isocenters — laser isocenter and centers of rotations of kV imager and EPID — are then calculated, based on results of multiple projections from different angles. Long-term calibration results from both systems are compared for cross-checking. There are 24 sessions of side-by-side calibrations performed by both systems on two TrueBeam linacs. All the disagreements of isocenters between two calibrations systems are less than 1 mm with ± 0.1 mm SD. Most of the large disagreements occurred in vertical direction (AP direction), with an averaged disagreement of 0.45 mm. The average disagreements of isocenters are 0.09 mm in other directions. Additional to long-term calibration monitoring, for the accuracy test, special tests were performed by misaligning QA phantoms on purpose (5 mm away from setup isocenter in AP, SI, and lateral directions) to test the liability performance of both systems with the known deviations. The errors are within 0.5 mm. Both geometric calibration systems, IsoCal and gQA, are capable of detecting geometric deviations of kV and MV imaging systems of linacs. The long-term evaluation also shows that the deviations of geometric parameters and the geometric accuracies of both linacs are small and very consistent during the one-year study period.

  20. Long-term evaluation and cross-checking of two geometric calibrations of kV and MV imaging systems for Linacs.

    PubMed

    Chiu, Tsuicheng D; Yan, Yulong; Foster, Ryan; Mao, Weihua

    2015-07-01

    Geometric or mechanical accuracy of kV and MV imaging systems of two Varian TrueBeam linacs have been monitored by two geomertirc calibration systems, Varian IsoCal geometric calibration system and home-developed gQA system. Results of both systems are cross-checked and the long-term geometric stabilities of linacs are evaluated. Two geometric calibration methodologies have been used to assess kV and MV imaging systems and their coincidence periodically on two TrueBeam linacs for about one year. Both systems analyze kV or MV projection images of special designed phantoms to retrieve geometric parameters of the imaging systems. The isocenters - laser isocenter and centers of rotations of kV imager and EPID - are then calculated, based on results of multiple projections from different angles. Long-term calibration results from both systems are compared for cross-checking. There are 24 sessions of side-by-side calibrations performed by both systems on two TrueBeam linacs. All the disagreements of isocenters between two calibrations systems are less than 1 mm with ± 0.1 mm SD. Most of the large disagreements occurred in vertical direction (AP direction), with an averaged disagreement of 0.45 mm. The average disagreements of isocenters are 0.09 mm in other directions. Additional to long-term calibration monitoring, for the accuracy test, special tests were performed by misaligning QA phantoms on purpose (5 mm away from setup isocenter in AP, SI, and lateral directions) to test the liability performance of both systems with the known deviations. The errors are within 0.5 mm. Both geometric calibration systems, IsoCal and gQA, are capable of detecting geometric deviations of kV and MV imaging systems of linacs. The long-term evaluation also shows that the deviations of geometric parameters and the geometric accuracies of both linacs are small and very consistent during the one-year study period. PACS number: 87.56.Fc.

  1. Long-Term Monitoring Network Optimization Evaluation for Operable Unit 2, Bunker Hill Mining and Metallurgical Complex Superfund Site, Idaho

    EPA Pesticide Factsheets

    This report presents a description and evaluation of the ground water and surface water monitoring program associated with the Bunker Hill Mining and Metallurgical Complex Superfund Site (Bunker Hill) Operable Unit (OU) 2.

  2. Nurse-led educative consultation setting personalized tertiary prevention goals after cardiovascular rehabilitation: evaluation of patient satisfaction and long-term effects.

    PubMed

    Dedoncker, Anne; Lejeune, Corinne; Dupont, Catherine; Antoine, Daniel; Laurent, Yves; Casillas, Jean-Marie; Gremeaux, Vincent

    2012-01-01

    This study aimed to evaluate the perception and long-term effects of an educative consultation performed before cardiac rehabilitation discharge. The patient and the referring nurse summed up the educative interventions, and filled a personalized form summarizing tertiary prevention goals. Fifty patients were contacted by mail at 11 ± 1 months, and called at 4.2 ± 0.2 years after discharge, to evaluate their satisfaction and assess cardiovascular risk factors (CVRF) control. Mail response rate was 82%, and 90% of patients believed that it had encouraged them to adopt a healthier lifestyle. Almost half the number of patients declared that they considered the nurse intervention as positive. Telephone response rate was 54%. Most long-term effects were better than usually reported in the field of multidisciplinary secondary prevention of CVRF. Patients felt that this educational action was positive, even though highlighting this role of nurses seems necessary. Additional controlled trials are needed to provide rigorous validation of this strategy.

  3. Ionizer assisted air filtration for collection of submicron and ultrafine particles-evaluation of long-term performance and influencing factors.

    PubMed

    Shi, Bingbing; Ekberg, Lars

    2015-06-02

    Previous research has demonstrated that unipolar ionization can enhance the filter performance to collect airborne particles, aeroallergens, and airborne microorganisms, without affecting the filter pressure drop. However, there is a lack of research on the long-term system performance as well as the influence of environmental and operational parameters. In this paper, both field and laboratory tests were carried out to evaluate the long-term particle collection efficiency of a synthetic filter of class M6 with and without ionization. The effect of air velocity, temperature, relative humidity, and particle concentration were further investigated in laboratory tests. Results showed that ionization enhanced the filtration efficiency by 40%-units during most of the operation time. When the ionization system was managed by periodically switching the ionizer polarity, the filtration efficiency against PM0.3-0.5 was maintained above 50% during half a year. Furthermore, the pressure drop of the ionizer-assisted M6 filter was 25-30% lower than that of a filter of class F7. The evaluation of various influencing factors demonstrated that (1) air moisture reduced the increase of filtration efficiency; (2) higher upstream particle concentration and air velocity decreased the filtration efficiency; and (3) the air temperature had very limited effect on the filtration efficiency.

  4. Bipolar Electrochemistry for Concurrently Evaluating the Stability of Anode and Cathode Electrocatalysts and the Overall Cell Performance during Long-Term Water Electrolysis.

    PubMed

    Eßmann, Vera; Barwe, Stefan; Masa, Justus; Schuhmann, Wolfgang

    2016-09-06

    Electrochemical efficiency and stability are among the most important characteristics of electrocatalysts. These parameters are usually evaluated separately for the anodic and cathodic half-cell reactions in a three-electrode system or by measuring the overall cell voltage between the anode and cathode as a function of current or time. Here, we demonstrate how bipolar electrochemistry can be exploited to evaluate the efficiency of electrocatalysts for full electrochemical water splitting while simultaneously and independently monitoring the individual performance and stability of the half-cell electrocatalysts. Using a closed bipolar electrochemistry setup, all important parameters such as overvoltage, half-cell potential, and catalyst stability can be derived from a single galvanostatic experiment. In the proposed experiment, none of the half-reactions is limiting on the other, making it possible to precisely monitor the contribution of the individual half-cell reactions on the durability of the cell performance. The proposed approach was successfully employed to investigate the long-term performance of a bifunctional water splitting catalyst, specifically amorphous cobalt boride (Co2B), and the durability of the electrocatalyst at the anode and cathode during water electrolysis. Additionally, by periodically alternating the polarization applied to the bipolar electrode (BE) modified with a bifunctional oxygen electrocatalyst, it was possible to explicitly follow the contributions of the oxygen reduction (ORR) and the oxygen evolution (OER) half-reactions on the overall long-term durability of the bifunctional OER/ORR electrocatalyst.

  5. Evaluation of Long-Term Cloud-Resolving Model Simulations Using Satellite Radiance Observations and Multi-Frequency Satellite Simulators

    NASA Technical Reports Server (NTRS)

    Matsui, Toshihisa; Zeng, Xiping; Tao, Wei-Kuo; Masunaga, Hirohiko; Olson, William S.; Lang, Stephen

    2008-01-01

    This paper proposes a methodology known as the Tropical Rainfall Measuring Mission (TRMM) Triple-Sensor Three-step Evaluation Framework (T3EF) for the systematic evaluation of precipitating cloud types and microphysics in a cloud-resolving model (CRM). T3EF utilizes multi-frequency satellite simulators and novel statistics of multi-frequency radiance and backscattering signals observed from the TRMM satellite. Specifically, T3EF compares CRM and satellite observations in the form of combined probability distributions of precipitation radar (PR) reflectivity, polarization-corrected microwave brightness temperature (Tb), and infrared Tb to evaluate the candidate CRM. T3EF is used to evaluate the Goddard Cumulus Ensemble (GCE) model for cases involving the South China Sea Monsoon Experiment (SCSMEX) and Kwajalein Experiment (KWAJEX). This evaluation reveals that the GCE properly captures the satellite-measured frequencies of different precipitating cloud types in the SCSMEX case but underestimates the frequencies of deep convective and deep stratiform types in the KWAJEX case. Moreover, the GCE tends to simulate excessively large and abundant frozen condensates in deep convective clouds as inferred from the overestimated GCE-simulated radar reflectivities and microwave Tb depressions. Unveiling the detailed errors in the GCE s performance provides the best direction for model improvements.

  6. Structuring Long-Term Faculty Training According to Needs Exhibited by Students' Written Comments in Course Evaluations

    ERIC Educational Resources Information Center

    Fulkerth, Robert

    2014-01-01

    A comprehensive adjunct faculty training program is described, whose aim is to improve student perceptions of courses and programs in a private, not-for-profit MBA and Law degree granting university in San Francisco, The program is somewhat novel in that it uses (a) student input from open-ended responses on course evaluations to determine faculty…

  7. Clozapine Treatment of Childhood-Onset Schizophrenia: Evaluation of Effectiveness, Adverse Effects, and Long-Term Outcome

    ERIC Educational Resources Information Center

    Sporn, Alexandra L.; Vermani, Anoop; Greenstein, Deanna K.; Bobb, Aaron J.; Spencer, Edgar P.; Clasen, Liv S.; Tossell, Julia W.; Stayer, Catherine C.; Gochman, Peter A.; Lenane, Marge C.; Rapoport, Judith L.; Gogtay, Nitin

    2007-01-01

    Objective: Clozapine is a unique atypical antipsychotic with superior efficacy in treatment-resistant schizophrenia. Plasma concentration of clozapine and its major metabolite N-desmethylclozapine (NDMC) as well as the ratio of NDMC to clozapine have been reported to be predictors of clozapine response. Here we evaluate these as well as other…

  8. Development of a multidisciplinary plan for evaluation of the long-term health effects of the Mount St. Helens eruptions

    SciTech Connect

    Buist, A.S.; Martin, T.R.; Shore, J.H.; Butler, J.; Lybarger, J.A.

    1986-03-01

    The emphasis of this article is on the approach that was taken to evaluating the chronic or delayed effects of the volcanic eruptions of Mount St. Helens in 1980. This strategy has been very successful and may be useful as a model for addressing the possible health effects of other environmental hazards. The steps in this process were: 1) identification of the physical and physicochemical characteristics of the hazard; 2) formation of hypotheses about biologically plausible effects of the hazard on human health; and 3) development of a plan for evaluating the health effects and, were possible, for controlling or minimizing adverse health effects. The third step involved a multidisciplinary group that included public health officials, medical specialists, and research scientists, including a geologist.

  9. Development and application of a procedure for evaluating the long-term integrity of membranes for the anaerobic fluidized membrane bioreactor (AFMBR).

    PubMed

    Shin, Chungheon; Kim, Kihyun; McCarty, Perry L; Kim, Jeonghwan; Bae, Jaeho

    A bench-scale short-term test, developed to predict the long-term integrity of membranes with potential for use in anaerobic fluidized-bed membrane bioreactors, was used to evaluate several commercial hollow-fiber membranes. It was found that membrane performance varied widely, some membranes failing much more rapidly than others. Also found was that larger sizes of the fluidized media, in this case granular activated carbon (GAC), severely affected membrane structural integrity more than did smaller sizes, as did the method used for membrane attachment. Within the limits studied, the GAC packing ratio had only a minor impact. A decrease in membrane permeability that sometimes resulted during the testing and was caused by the deposition of fine GAC particles could be eliminated without membrane damage through simultaneous chemical cleaning and sonication. This new testing procedure should be useful for selecting membranes and reactor operating conditions to better ensure long-term operating performance of anaerobic fluidized-bed membrane bioreactors.

  10. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand.

    PubMed

    Poovorawan, Yong; Chongsrisawat, Voranush; Theamboonlers, Apiradee; Crasta, Priya Diana; Messier, Marc; Hardt, Karin

    2013-08-01

    Hepatitis B vaccine has been available worldwide since the mid-1980s. This vaccine was evaluated in a clinical trial in Thailand, conducted on subjects born to hepatitis B surface antigen positive and hepatitis B e-antigen positive mothers and vaccinated according to a 4-dose schedule at 0, 1, 2 and 12 mo of age and a single dose of hepatitis B immunoglobulin concomitantly at birth. All enrolled subjects seroconverted and were followed for 20 y to assess the persistence of antibody to the hepatitis B surface antigen (anti-HBs) (NCT00240539). At year 20, 64% of subjects had anti-HBs antibody concentrations≥10 milli-international units per milli liter (mIU/ml) and 92% of subjects had detectable levels (≥3.3 mIU/ml) of anti-HBs antibodies. At year 20, subjects with anti-HBs antibody titer<100 mIU/ml were offered an additional dose of hepatitis B virus (HBV) vaccine to assess immune memory (NCT00657657). Anamnestic response to the challenge dose was observed in 96.6% of subjects with an 82-fold (13.2 to 1082.4 mIU/ml) increase in anti-HBs antibody geometric mean concentrations. This study confirms the long-term immunogenicity of the 4-dose regimen of the HBV vaccine eliciting long-term persistence of antibodies and immune memory against hepatitis B for up to at least 20 y after vaccination.

  11. Evaluation of the packaging and encapsulation reliability in fully integrated, fully wireless 100 channel Utah Slant Electrode Array (USEA): Implications for long term functionality

    PubMed Central

    Sharma, A.; Rieth, L.; Tathireddy, P.; Harrison, R.; Oppermann, H.; Klein, M.; Töpper, M.; Jung, E.; Normann, R.; Clark, G.; Solzbacher, F.

    2011-01-01

    The encapsulation and packaging reliability in fully integrated, fully wireless 100 channel Utah Slant Electrode Array (USEA)/integrated neural interface-recording version 5 (INI-R5) has been evaluated by monitoring the extended long term in-vitro functional stability and recording longevity. The INI encapsulated with 6-μm Parylene-C was immersed in phosphate buffer saline (PBS) at room temperature for a period of over 12 months. The USEA/INI-R5, while being soaked was powered and configured wirelessly through 2.765 MHz inductive link and the transmitted frequency shift keying (FSK) modulated radio-frequency (RF) (900 MHz Industrial, scientific, medical-ISM band) signal was also recorded wirelessly as a function of soak time. In order to test the long term recording ability, in-vitro wireless recording was performed in agarose for few channels. The full functionality and the ability of the electrodes to record artificial neural signals even after 12 months of PBS soak provides a measure of encapsulation reliability, the functional and recording stability in fully integrated wireless neural interface and potential usefulness for future chronic implants. PMID:23288983

  12. Evaluation of the packaging and encapsulation reliability in fully integrated, fully wireless 100 channel Utah Slant Electrode Array (USEA): Implications for long term functionality.

    PubMed

    Sharma, A; Rieth, L; Tathireddy, P; Harrison, R; Oppermann, H; Klein, M; Töpper, M; Jung, E; Normann, R; Clark, G; Solzbacher, F

    2012-12-01

    The encapsulation and packaging reliability in fully integrated, fully wireless 100 channel Utah Slant Electrode Array (USEA)/integrated neural interface-recording version 5 (INI-R5) has been evaluated by monitoring the extended long term in-vitro functional stability and recording longevity. The INI encapsulated with 6-μm Parylene-C was immersed in phosphate buffer saline (PBS) at room temperature for a period of over 12 months. The USEA/INI-R5, while being soaked was powered and configured wirelessly through 2.765 MHz inductive link and the transmitted frequency shift keying (FSK) modulated radio-frequency (RF) (900 MHz Industrial, scientific, medical-ISM band) signal was also recorded wirelessly as a function of soak time. In order to test the long term recording ability, in-vitro wireless recording was performed in agarose for few channels. The full functionality and the ability of the electrodes to record artificial neural signals even after 12 months of PBS soak provides a measure of encapsulation reliability, the functional and recording stability in fully integrated wireless neural interface and potential usefulness for future chronic implants.

  13. [Adenotonsillectomy: the evaluation of the long-term results after more than 7 years from the intervention].

    PubMed

    Esposito, E; Pucci, V; Mesolella, M; Motta, S

    1992-01-01

    A study was carried out on 110 patients with various diseases related to chronic inflammation of the tonsils and to hypertrophic adenoids. Sixty-two of these patients underwent adenotonsillectomy, while the others were followed clinically and, where necessary, given medical treatment. At the first observation the patients were between the ages of 2 and 12 (mean age 6.1 years). At the start of the present study the patients ages ranged from 10 to 22 (mean age 17 years). Clinical follow-up was carried out on the patients 2 and 7 years after the first observation and/or adenotonsillectomy. The patients were divided into homogeneous groups according to the severity of symptoms. The A.A. evaluated changes of the following clinical parameters: annual frequency of inflammatory pharyngotonsillar episodes, nasal respiratory obstruction, sore throat, otologic pathology. Evaluations were carried out statistically in each group. After more than 7 years from surgery, the significant reduction of various diseases related to chronic inflammation of the tonsils and to hypertrophic adenoids, in accordance with the findings after 2 years from surgery, underline the effectiveness of adenotonsillectomy in correctly selected candidates.

  14. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme

    PubMed Central

    Angelo, Maria-Genalin; David, Marie-Pierre; Zima, Julia; Baril, Laurence; Dubin, Gary; Arellano, Felix; Struyf, Frank

    2014-01-01

    Purpose The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies. Methods Unsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies. Results Thirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0–113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups. Conclusions Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and

  15. Long-term evaluation of different strategies of cationic polyelectrolyte dosage to control fouling in a membrane bioreactor treating refinery effluent.

    PubMed

    Alkmim, Aline R; da Costa, Paula R; Moser, Priscila B; França Neta, Luzia S; Santiago, Vânia M J; Cerqueira, Ana C; Amaral, Míriam C S

    2016-01-01

    In this article, the long-term use of cationic polyelectrolyte to improve the sludge filterability and to control membrane fouling in bioreactor membrane while treating refinery effluents have been evaluated in pilot scale. Corrective and preventive cationic polyelectrolyte dosages have been added to the membrane bioreactor (MBR) to evaluate the membrane fouling mitigation in both strategies. The results have confirmed that the use of the Membrane performance enhancer (MPE) increased the sludge filterability and reduced the membrane fouling. During the monitoring period, stress events occurred due to the increase in oil and grease and phenol concentrations in the MBR feeds. The preventive use of cationic polyelectrolyte allowed for a more effective and stable sludge filterability, with lower cationic polyelectrolyte consumption and without decreasing MBR's overall pollutant removal performance.

  16. Long-term evaluation of the needle surface wax condition of Pinus sylvestris around different industries in Lithuania.

    PubMed

    Kupcinskiene, Eugenija; Huttunen, Satu

    2005-10-01

    The aim of our study was to evaluate the annual dynamics of needle surface wax erosion and wettability in Scots pines exposed to a gradient of industrial pollutants emitted from the main factories of Lithuania: a nitrogen fertilizer factory, an oil refinery and a cement factory. Decreased emissions (in the case of the oil refinery and the cement factory) were reflected in the increased structural surface area (SSA, i.e. area covered by tubular waxes) on the needles. The nearly constant amount of emissions from the nitrogen fertilizer factory within the 1994-2000 period corresponded to negligible annual differences in SSA. Annual changes in the hydrophobicity of needles on the investigated transects were small. Despite the decreased pollution within the 7-year period, industrial emissions are still causing significantly accelerated wax erosion and increased wettability in needles sampled from the stands most heavily affected by pollutants.

  17. Evaluation of the need for emergency heat exchangers for long term emergency cooling of the Advanced Neutron Source Reactor

    SciTech Connect

    Khayat, M.I.; Anderson, J.L.; Battle, R.E.; March-Leuba, J.

    1994-05-01

    This report summarizes the work performed to evaluate the heat transferred to the light water pools from the primary piping system for the Advanced Neutron Source reactor (ANSR) conceptual design. It has been determined that the ANSR primary piping system will remove sufficient heat from the primary coolant system to the pools for certain design basis event accidents without the emergency heat exchangers if the design parameters, such as pool volumes and pipe sizes (length and surface area), are selected appropriately. Based on this analysis, the emergency heat exchangers might be removed, and their function can be performed by the primary piping passing through the light water pools described in the conceptual design report. This study also shows that connecting the pipe chase pool and the heat exchanger pools improve performance for ANSR emergency heat removal.

  18. Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

    PubMed Central

    El-Agroudy, A. E.; Alarrayed, S. M.; Al-Ghareeb, S. M.; Farid, E.; Alhelow, H.; Abdulla, S.

    2017-01-01

    We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival. PMID:28182044

  19. Long-Term Follow-Up Radiologic and Clinical Evaluation of Cylindrical Cage for Anterior Interbody Fusion in Degenerative Cervical Disc Disease

    PubMed Central

    Kim, Suhyeong; Yi, Hyeon-Joong; Bak, Koang Hum; Kim, Dong Won; Lee, Yoon Kyoung

    2012-01-01

    Objective Various procedures have been introduced for anterior interbody fusion in degenerative cervical disc disease including plate systems with autologous iliac bone, carbon cages, and cylindrical cages. However, except for plate systems, the long-term results of other methods have not been established. In the present study, we evaluated radiologic findings for cylindrical cervical cages over long-term follow up periods. Methods During 4 year period, radiologic findings of 138 patients who underwent anterior cervical fusion with cylindrical cage were evaluated at 6, 12, 24, and 36 postoperative months using plain radiographs. We investigated subsidence, osteophyte formation (anterior and posterior margin), cage direction change, kyphotic angle, and bone fusion on each radiograph. Results Among the 138 patients, a minimum of 36 month follow-up was achieved in 99 patients (mean follow-up : 38.61 months) with 115 levels. Mean disc height was 7.32 mm for preoperative evaluations, 9.00 for immediate postoperative evaluations, and 4.87 more than 36 months after surgery. Osteophytes were observed in 107 levels (93%) of the anterior portion and 48 levels (41%) of the posterior margin. The mean kyphotic angle was 9.87° in 35 levels showing cage directional change. There were several significant findings : 1) related subsidence [T-score (p=0.039) and anterior osteophyte (p=0.009)], 2) accompanying posterior osteophyte and outcome (p=0.05). Conclusion Cage subsidence and osteophyte formation were radiologically observed in most cases. Low T-scores may have led to subsidence and kyphosis during bone fusion although severe neurologic aggravation was not found, and therefore cylindrical cages should be used in selected cases. PMID:23091668

  20. Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

    PubMed

    Cezar, Cristina; Tchartchian, Garri; Korell, Matthias; Ziegler, Nicole; Senshu, Kazuhisa; De Wilde, Maya Sophie; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment

  1. Economic analysis including long-term risks and costs of alternative diagnostic strategies to evaluate patients with chest pain

    PubMed Central

    Bedetti, Gigliola; Pasanisi, Emilio Maria; Pizzi, Carmine; Turchetti, Giuseppe; Loré, Cosimo

    2008-01-01

    Background Diagnosis costs for cardiovascular disease waste a large amount of healthcare resources. The aim of the study is to evaluate the clinical and economic outcomes of alternative diagnostic strategies in low risk chest pain patients. Methods We evaluated direct and indirect downstream costs of 6 strategies: coronary angiography (CA) after positive troponin I or T (cTn-I or cTnT) (strategy 1); after positive exercise electrocardiography (ex-ECG) (strategy 2); after positive exercise echocardiography (ex-Echo) (strategy 3); after positive pharmacologic stress echocardiography (PhSE) (strategy 4); after positive myocardial exercise stress single-photon emission computed tomography with technetium Tc 99m sestamibi (ex-SPECT-Tc) (strategy 5) and direct CA (strategy 6). Results The predictive accuracy in correctly identifying the patients was 83,1% for cTn-I, 87% for cTn-T, 85,1% for ex-ECG, 93,4% for ex-Echo, 98,5% for PhSE, 89,4% for ex-SPECT-Tc and 18,7% for CA. The cost per patient correctly identified results $2.051 for cTn-I, $2.086 for cTn-T, $1.890 for ex-ECG, $803 for ex-Echo, $533 for PhSE, $1.521 for ex-SPECT-Tc ($1.634 including cost of extra risk of cancer) and $29.673 for CA ($29.999 including cost of extra risk of cancer). The average relative cost-effectiveness of cardiac imaging compared with the PhSE equal to 1 (as a cost comparator), the relative cost of ex-Echo is 1.5×, of a ex-SPECT-Tc is 3.1×, of a ex-ECG is 3.5×, of cTnI is ×3.8, of cTnT is ×3.9 and of a CA is 56.3×. Conclusion Stress echocardiography based strategies are cost-effective versus alternative imaging strategies and the risk and cost of radiation exposure is void. PMID:18510723

  2. Bayesian evaluation of a physiologically-based pharmacokinetic (PBPK) model of long-term kinetics of metal nanoparticles in rats

    PubMed Central

    Sweeney, Lisa M.; MacCalman, Laura; Haber, Lynne T.; Kuempel, Eileen D.; Tran, C. Lang

    2015-01-01

    Biomathematical modeling quantitatively describes the disposition of metal nanoparticles in lungs and other organs of rats. In a preliminary model, adjustable parameters were calibrated to each of three data sets using a deterministic approach, with optimal values varying among the different data sets. In the current effort, Bayesian population analysis using Markov chain Monte Carlo (MCMC) simulation was used to recalibrate the model while improving assessments of parameter variability and uncertainty. The previously-developed model structure and some physiological parameter values were modified to improve physiological realism. The data from one of the three previously-identified studies and from two other studies were used for model calibration. The data from the one study that adequately characterized mass balance were used to generate parameter distributions. When data from a second study of the same nanomaterial (iridium) were added, the level of agreement was still acceptable. Addition of another data set (for silver nanoparticles) led to substantially lower precision in parameter estimates and large discrepancies between the model predictions and experimental data for silver nanoparticles. Additional toxicokinetic data are needed to further evaluate the model structure and performance and to reduce uncertainty in the kinetic processes governing in vivo disposition of metal nanoparticles. PMID:26145831

  3. gamma. -irradiated sewage solids in diets for sheep: nutritive evaluations and long-term assessments of possible toxicants

    SciTech Connect

    Sanson, D.W.

    1983-01-01

    Air-dried solids from primary (undigested) sewage sludge were collected at Las Cruces, New Mexico (a non-industrial town with population about 50,000). Bagged sewage solids were ..gamma..-irradiated (1 megarad dosage) to kill parasites and pathogenic organisms and evaluated as prospective feedstuffs for sheep. Pelleted, complete diets for gestating-lactating fine-wool ewes and for their growing-finishing lambs were formulated to be isonitrogenous with either 3.5% cottonseed meal (conventional diet) or 7% sewage solids (experimental diet). Digestibility of organic matter and crude protein, and biological value of nitrogen, did not differ (P > .05) between diets, as determined with wethers. Wether lambs fed to slaughter with conventional or experimental diets did not differ (P > .05) in rate of gain, carcass characteristics, element concentrations in blood and serum chemistry profiles, although liver Cu and kidney Pb levels were increased (P < .05) about 1.6-fold by sewage solids. Element contents of spleen and muscles did not differ (P > .05) due to diets. These studies confirm previous research at New Mexico State University which indicates that dried solids from municipal (primary) sludge provide nutritive benefits to sheep with risks of toxicity and heavy metal accumulation that appear tolerable where managed properly.

  4. Long-Term Histopathologic and IVUS Evaluations of a Novel Coiled Sheet Stent in Porcine Carotid Arteries

    SciTech Connect

    Kaneda, Hideaki; Ikeno, Fumiaki Lyons, Jennifer; Rezaee, Mehrdad; Yeung, Alan C.; Fitzgerald, Peter J.

    2006-06-15

    Carotid angioplasty with stent placement has been proposed as an alternative method for revascularization of carotid artery stenosis. A novel stent with a laser-cut, rolled sheet of Nitinol (EndoTex Interventional Systems, Inc., Cupertino, CA) has been developed to customize treatment of stenotic lesions in carotid arteries utilizing a single stent, designed to adapt to multiple diameters and to tapered or nontapered configurations. The purpose of this study is to evaluate the conformability and vascular response to a novel stent in a chronic porcine carotid model using serial three-dimensional intravascular ultrasound (IVUS) analysis as well as histological examination. Ten Yucatan pigs underwent stent implantation in both normal carotid arteries with adjunctive balloon angioplasty. Three-dimensional IVUS analysis was performed before stent implantation, after adjunctive balloon angioplasty, and at follow-up [1 month (n = 6), 3 months (n = 6), or 6 months (n = 8)]. Histological examination (injury score, percent plaque obstruction, and qualitative analysis) was also performed. All stents were successfully deployed and well apposed in different sized vessels (lumen area range: 19-30 mm{sup 2}). Volumetric IVUS analysis showed no significant difference between the lumen areas before stent implantation and after adjunctive balloon angioplasty and no stent area change at each follow-up point compared to immediately postprocedure. Histological examination revealed minimal injury and neointimal hyperplasia at each follow-up point. In the chronic porcine carotid model, the novel stent system demonstrated good conformability, resulting in minimal vessel injury and neointimal formation.

  5. Bayesian evaluation of a physiologically-based pharmacokinetic (PBPK) model of long-term kinetics of metal nanoparticles in rats.

    PubMed

    Sweeney, Lisa M; MacCalman, Laura; Haber, Lynne T; Kuempel, Eileen D; Tran, C Lang

    2015-10-01

    Biomathematical modeling quantitatively describes the disposition of metal nanoparticles in lungs and other organs of rats. In a preliminary model, adjustable parameters were calibrated to each of three data sets using a deterministic approach, with optimal values varying among the different data sets. In the current effort, Bayesian population analysis using Markov chain Monte Carlo (MCMC) simulation was used to recalibrate the model while improving assessments of parameter variability and uncertainty. The previously-developed model structure and some physiological parameter values were modified to improve physiological realism. The data from one of the three previously-identified studies and from two other studies were used for model calibration. The data from the one study that adequately characterized mass balance were used to generate parameter distributions. When data from a second study of the same nanomaterial (iridium) were added, the level of agreement was still acceptable. Addition of another data set (for silver nanoparticles) led to substantially lower precision in parameter estimates and large discrepancies between the model predictions and experimental data for silver nanoparticles. Additional toxicokinetic data are needed to further evaluate the model structure and performance and to reduce uncertainty in the kinetic processes governing in vivo disposition of metal nanoparticles.

  6. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study.

    PubMed

    McDonnell, David P; Landry, John; Detke, Holland C

    2014-11-01

    The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18-76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2-4 weeks. The mean duration of exposure was ∼3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome).

  7. Pharmacokinetic Evaluation of a Single Intramuscular High Dose versus an Oral Long-Term Supplementation of Cholecalciferol

    PubMed Central

    Krannich, Alexander; Heine, Guido; Dölle, Sabine; Worm, Margitta

    2017-01-01

    Background and Objectives Vitamin D deficiency is frequent during the winter and occurs throughout the year in the elderly or patients suffering from autoimmune diseases. The objective of this study was to evaluate the pharmacokinetic properties of oral supplementation versus a single intramuscular injection of cholecalciferol in healthy individuals. Research design and methods Up to 8,000 I.U. oral cholecalciferol was administered daily for 84 days in a 4 week dose-escalation setting to vitamin D deficient individuals. In another cohort, a single intramuscular injection of 100,000 I.U. cholecalciferol was given. In both cohorts, individuals without vitamin D intake served as the comparison group. 25-hydroxyvitamin D (25(OH)D) concentrations were measured in all individuals at defined time points throughout the studies. Results The mean 25(OH)D serum concentration increased significantly after oral cholecalciferol intake compared to the control group (day 28: 83.4 nmol/l and 42.5 nmol/l; day 56: 127.4 nmol/l and 37.3 nmol/l; day 84: 159.7 nmol/l and 30.0 nmol/l). In individuals receiving 100,000 I.U. cholecalciferol intramuscular, the mean 25(OH)D serum concentration peaked after 4 weeks measuring 70.9 nmol/l compared to 32.7 nmol/l in the placebo group (p = 0.002). The increase of 25(OH)D serum concentrations after 28 days was comparable between both routes of administration (p = 0.264). Conclusions Oral and intramuscular cholecalciferol supplementation effectively increased serum 25(OH)D concentrations. PMID:28114352

  8. Towards an assistive peripheral visual prosthesis for long-term treatment of retinitis pigmentosa: evaluating mobility performance in immersive simulations

    NASA Astrophysics Data System (ADS)

    Zapf, Marc Patrick H.; Boon, Mei-Ying; Matteucci, Paul B.; Lovell, Nigel H.; Suaning, Gregg J.

    2015-06-01

    Objective. The prospective efficacy of a future peripheral retinal prosthesis complementing residual vision to raise mobility performance in non-end stage retinitis pigmentosa (RP) was evaluated using simulated prosthetic vision (SPV). Approach. Normally sighted volunteers were fitted with a wide-angle head-mounted display and carried out mobility tasks in photorealistic virtual pedestrian scenarios. Circumvention of low-lying obstacles, path following, and navigating around static and moving pedestrians were performed either with central simulated residual vision of 10° alone or enhanced by assistive SPV in the lower and lateral peripheral visual field (VF). Three layouts of assistive vision corresponding to hypothetical electrode array layouts were compared, emphasizing higher visual acuity, a wider visual angle, or eccentricity-dependent acuity across an intermediate angle. Movement speed, task time, distance walked and collisions with the environment were analysed as performance measures. Main results. Circumvention of low-lying obstacles was improved with all tested configurations of assistive SPV. Higher-acuity assistive vision allowed for greatest improvement in walking speeds—14% above that of plain residual vision, while only wide-angle and eccentricity-dependent vision significantly reduced the number of collisions—both by 21%. Navigating around pedestrians, there were significant reductions in collisions with static pedestrians by 33% and task time by 7.7% with the higher-acuity layout. Following a path, higher-acuity assistive vision increased walking speed by 9%, and decreased collisions with stationary cars by 18%. Significance. The ability of assistive peripheral prosthetic vision to improve mobility performance in persons with constricted VFs has been demonstrated. In a prospective peripheral visual prosthesis, electrode array designs need to be carefully tailored to the scope of tasks in which a device aims to assist. We posit that maximum

  9. Evaluation of collagen/heparin coated TCP/HA granules for long-term delivery of BMP-2.

    PubMed

    Hannink, Gerjon; Geutjes, Paul J; Daamen, Willeke F; Buma, Pieter

    2013-02-01

    Bone morphogenetic proteins (BMPs) are the most potent osteoinductive growth factors. However, a delivery system is essential to take advantage of the osteoinductive effect of BMPs. The purpose of this study was to develop a sustained delivery system for recombinant human bone morphogenetic protein-2 (BMP-2). We covalently attached heparin to a cross-linked collagen type I coated tricalciumphosphate/hydroxyapatite (TCP/HA) bone substitute and subsequently loaded it with BMP-2. To systematically evaluate the contribution of each component with respect to the binding and release of BMP-2, six constructs were prepared and characterized: TCP/HA, TCP/HA with collagen (TCP/HACol), and TCP/HA with collagen and heparin (TCP/HAColHep) with and without BMP-2 (B). More BMP-2 bound to the TCP/HAColHep + B (92.9 ± 4.8 ng BMP-2/mg granule) granules as compared to the TCP/HACol + B (69.0 ± 9.6 ng BMP-2/mg granule) and TCP/HA + B granules (62.9 ± 5.4 ng BMP-2/mg granule). No difference in release pattern was found between the TCP/HA + B and TCP/HACol + B granules. Up to day 14, BMP-2 was still bound to the TCP/HAColHep + B granules, whereas most BMP had been released from TCP/HACol + B and TCP/HA + B granules at that time. After 21 days most BMP-2 also had been released from the TCP/HAColHep + B granules. The local and sustained delivery system for BMP-2 developed in this study may be useful as a carrier for BMP-2 and could possibly enhance bone regeneration efficacy for the treatment of large bone defects.

  10. Evaluation of long-term surface-retrieved cloud droplet number concentration with in situ aircraft observations

    NASA Astrophysics Data System (ADS)

    Lim, Kyo-Sun Sunny; Riihimaki, Laura; Comstock, Jennifer M.; Schmid, Beat; Sivaraman, Chitra; Shi, Yan; McFarquhar, Greg M.

    2016-03-01

    A new operational retrieval of cloud droplet number concentration (ND) at cloud base has been produced from surface remote sensors at the Atmospheric Radiation Measurement (ARM) Southern Great Plains site for 13 years from January 1998 to January 2011. The retrieval is based on surface radiometer measurements of cloud optical depth from the multifilter rotating shadow band radiometer and liquid water path from the microwave radiometer (MWR). It is only applicable for single-layered overcast warm (stratus or stratocumulus) clouds. Evaluation with in situ aircraft measurements during the extended-term aircraft field campaign, Routine ARM Aerial Facility (AAF) Clouds with Low Optical Water Depths (CLOWD) Optical Radiative Observations (RACORO), shows that the retrieved ND robustly reproduces the primary mode of the in situ measured probability density function (PDF) but produces too wide a distribution, primarily caused by frequent high cloud droplet number concentration. Our analysis shows that the error in the MWR retrievals at low liquid water paths is one possible reason for this deficiency. Modification through the diagnosed liquid water path from the coordinate solution improves not only the PDF of the retrieved ND but also the relationship between the cloud droplet number concentration and cloud droplet effective radius. Consideration of entrainment effects rather than assuming an adiabatic cloud improves the values of the ND retrieval by reducing the magnitude of cloud droplet number concentration. Aircraft measurements and retrieval comparisons suggest that retrieving the vertical distribution of cloud droplet number concentration and effective radius is feasible with an improvement of the parameter representing the mixing effects between environment and clouds and with a better understanding of the effect of mixing degree on cloud properties.

  11. Long-term evaluation of the antimicrobial susceptibility and microbial profile of subgingival biofilms in individuals with aggressive periodontitis

    PubMed Central

    Lourenço, Talita Gomes Baêta; Heller, Débora; do Souto, Renata Martins; Silva-Senem, Mayra Xavier e; Varela, Victor Macedo; Torres, Maria Cynesia Barros; Feres-Filho, Eduardo Jorge; Colombo, Ana Paula Vieira

    2015-01-01

    This study evaluates the antimicrobial susceptibility and composition of subgingival biofilms in generalized aggressive periodontitis (GAP) patients treated using mechanical/antimicrobial therapies, including chlorhexidine (CHX), amoxicillin (AMX) and metronidazole (MET). GAP patients allocated to the placebo (C, n = 15) or test group (T, n = 16) received full-mouth disinfection with CHX, scaling and root planning, and systemic AMX (500 mg)/MET (250 mg) or placebos. Subgingival plaque samples were obtained at baseline, 3, 6, 9 and 12 months post-therapy from 3–4 periodontal pockets, and the samples were pooled and cultivated under anaerobic conditions. The minimum inhibitory concentrations (MICs) of AMX, MET and CHX were assessed using the microdilution method. Bacterial species present in the cultivated biofilm were identified by checkerboard DNA-DNA hybridization. At baseline, no differences in the MICs between groups were observed for the 3 antimicrobials. In the T group, significant increases in the MICs of CHX (p < 0.05) and AMX (p < 0.01) were detected during the first 3 months; however, the MIC of MET decreased at 12 months (p < 0.05). For several species, the MICs significantly changed over time in both groups, i.e., Streptococci MICs tended to increase, while for several periodontal pathogens, the MICs diminished. A transitory increase in the MIC of the subgingival biofilm to AMX and CHX was observed in GAP patients treated using enhanced mechanical therapy with topical CHX and systemic AMX/MET. Both protocols presented limited effects on the cultivable subgingival microbiota. PMID:26273264

  12. Pharmacoeconomic evaluation of tiotropium bromide in the long-term treatment of chronic obstructive pulmonary disease (COPD) in Italy.

    PubMed

    Zaniolo, O; Iannazzo, S; Pradelli, L; Miravitlles, M

    2012-02-01

    The randomized, double-blind trial UPLIFT(®) demonstrated in 5,993 patients with moderate to very severe COPD that 4 years of tiotropium bromide therapy were associated with improvements in lung function, exacerbations, quality of life, and mortality compared with placebo. The pharmacoeconomic evaluation was performed through a probabilistic, patient-level simulation Markov model. Routine COPD care (RC) was compared with the inclusion of tiotropium bromide on it. The analysis was conducted over a lifetime horizon, with 1 year cycles and a 3.5% annual discount rate. Patients were characterized by gender, age, height, smoking status, and forced expiratory volume in 1 s (FEV1). FEV1 time trend was modeled according to the annual decline recorded in UPLIFT®. Mortality derived from that of the general Italian population was adjusted by smoking status and FEV1. Health utilities derived from published Italian observational studies and were varied in time according to UPLIFT® data. Exacerbation rates were derived from a published Italian observational prospective study. The cost perspective was that of the Italian National Health Service. Healthcare resource consumption for RC and exacerbations derived from Italian observational studies were valued according to current price and tariffs. Simulated patients in the tiotropium arm gained an average (95% CI) 0.50 (-1.63 to 6.27) Life Years (LYs) and 0.42 (-0.25 to 3.05) Quality-Adjusted Life Years (QALYs). The incremental lifetime cost resulted €3,357 (-€10,669 to €29,820). The incremental cost-effectiveness ratio (ICER) was €6,698/LY and €7,916/QALY. In the cost-effectiveness acceptability curve (CEAC), tiotropium had a 90% probability of being cost-effective for a willingness to pay (WTP) threshold of € 10,000/QALY.

  13. [Epidemiological studies on viral hepatitis among long-term sojourners in the developing countries and evaluation of preventive measures].

    PubMed

    Ohara, H; Naruto, H

    1992-04-01

    It is known that acute viral hepatitis is very common among sojourners in developing countries. In order to conduct effective health control, epidemiological studies were made on viral hepatitis which occurred among Japanese staying in developing countries, and evaluations were carried out on preventive measures. The subjects of present study were a group of Japanese people staying in developing countries for two years. Mid year population of the group was 1732 in 1988. Period of the present study is ten years from 1979 to 1988. The study was conducted based on the reports from offices in each country, survey trips and serological studies on the subjects. In 1979, frequency of hepatitis A (HA) was very high showing 79% of total hepatitides. However after starting of inoculation of human immune serum globulin (ISG), the frequency of HA declined remarkably. Statistical significance was recognized in the efficacy of ISG. Among 35 cases of hepatitis B (HB) (34 males and 1 female), 2 derived from HBe antigen carrier while the remaining 34 were regarded as infected during their stay in developing countries. No cases of HB were recognized among those who received injections of HB vaccine. The rate of people whose HB marker turned positive during their stay is showing a tendency of increase (4.2% in 1987). The frequency of infection with HB virus is especially high in Asian and African countries where the carrier rates of native people were also high. Ten cases of non-A non-B hepatitis were recognized. Among them 7 were infected in Asia, 1 in Africa and 1 in Central America.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. Collected Evaluations on the WCPSS Alternative School Program for Students with Long-Term Suspensions. Executive Summary. Eye on Evaluation. E&R Report.

    ERIC Educational Resources Information Center

    Carruthers, William L.

    The Wake County Public School System (WCPSS) has provided an alternative school program for students with long-term suspensions since the 1995-96 school year. Since 1996-97, the WCPSS has contracted with a private firm to operate the Richard M. Milburn High School (RMHS), as an alternative learning center. This Executive Summary highlights the…

  15. Human acellular dermal matrix allograft: A randomized, controlled human trial for the long-term evaluation of patients with extensive burns.

    PubMed

    Li, Xueyong; Meng, Xianghai; Wang, Xiaolin; Li, Yuejun; Li, Wangzhou; Lv, Xiaoxing; Xu, Xiaoli; Lei, Zhanjun; Li, Jinqing

    2015-06-01

    The potential of acellular dermal matrix (ADM) to improve cosmetic and functional outcomes has been demonstrated; however, there have been few clinical comparative studies assessing the long-term morphological, histological and functional changes after ADM placement. This study was designed to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix with autologous thin split-thickness skin for the coverage of wounds in extensively burned patients. Thirty burn patients treated with a composite graft of ADM with autologous split-thickness skin from January 2007 to December 2009 were enrolled in this study. Another group of thirty patients who received only an autogenous split-thickness skin implant served as the control. Our study revealed that the collagen in the dermis treated with ADM were ordered, and the proportion of collagen III/I was much higher in the control group than in the ADM group. The basement membrane was prominent and continuous. Meanwhile, the VBSS (Vancouver Burn Skin Score) was used to evaluate skin quality, which shows a significant differences between the two group (P<0.001). Then the functional level was evaluated by the BI (Barthel Index), and the ADM group was much better than the control group (P=0.005). Based on these results, we concluded that the composite graft of ADM with autologous thin split-thickness skin was suitable for repairing the defects in functional areas after a burn. This technique might facilitate wound management with acceptable esthetic outcomes, good functional recovery and less scar hyperplasia at the donor site.

  16. Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study

    PubMed Central

    Liew, Steven; Scamp, Terrence; de Maio, Mauricio; Halstead, Michael; Johnston, Nicole; Silberberg, Michael; Rogers, John D.

    2016-01-01

    Background There is increasing interest among patients and plastic surgeons for alternatives to rhinoplasty, a common surgical procedure performed in Asia. Objectives To evaluate the safety, efficacy, and longevity of a hyaluronic acid filler in the correction of aesthetically detracting or deficient features of the Asian nose. Methods Twenty-nine carefully screened Asian patients had their noses corrected with the study filler (Juvéderm VOLUMA [Allergan plc, Dublin, Ireland] with lidocaine injectable gel), reflecting individualized treatment goals and utilizing a standardized injection procedure, and were followed for over 12 months. Results A clinically meaningful correction (≥1 grade improvement on the Assessment of Aesthetic Improvement Scale) was achieved in 27 (93.1%) patients at the first follow-up visit. This was maintained in 28 (96.6%) patients at the final visit, based on the independent assessments of a central non-injecting physician and the patients. At this final visit, 23 (79.3%) patients were satisfied or very satisfied with the study filler and 25 (86.2%) would recommend it to others. In this small series of patients, there were no serious adverse events (AEs), with all treatment-related AEs being mild to moderate, transient injection site reactions, unrelated to the study filler. Conclusions Using specific eligibility criteria, individualized treatment goals, and a standardized injection procedure, the study filler corrected aesthetically detracting or deficient features of the Asian nose, with the therapeutic effects lasting for over 12 months, consistent with a high degree of patient satisfaction. This study supports the safety and efficacy of this HA filler for specific nose augmentation procedures in selected Asian patients. Level of Evidence: 3 Therapeutic PMID:27301371

  17. Effectiveness and Safety of Spot Scanning Proton Radiation Therapy for Chordomas and Chondrosarcomas of the Skull Base: First Long-Term Report

    SciTech Connect

    Ares, Carmen; Hug, Eugen B.; Lomax, Antony J.; Bolsi, Alessandra; Timmermann, Beate; Rutz, Hans Peter; Schuller, Jan C.; Pedroni, Eros; Goitein, Gudrun

    2009-11-15

    Purpose: To evaluate effectiveness and safety of spot-scanning-based proton radiotherapy (PT) in skull-base chordomas and chondrosarcomas. Methods and Materials: Between October 1998 and November 2005, 64 patients with skull-base chordomas (n = 42) and chondrosarcomas (n = 22) were treated at Paul Scherrer Institute with PT using spot-scanning technique. Median total dose for chordomas was 73.5 Gy(RBE) and 68.4 Gy(RBE) for chondrosarcomas at 1.8-2.0 Gy(RBE) dose per fraction. Local control (LC), disease specific survival (DSS), and overall survival (OS) rates were calculated. Toxicity was assessed according to CTCAE, v. 3.0. Results: Mean follow-up period was 38 months (range, 14-92 months). Five patients with chordoma and one patient with chondrosarcoma experienced local recurrence. Actuarial 5-year LC rates were 81% for chordomas and 94% for chondrosarcomas. Brainstem compression at the time of PT (p = 0.007) and gross tumor volume >25 mL (p = 0.03) were associated with lower LC rates. Five years rates of DSS and OS were 81% and 62% for chordomas and 100% and 91% for chondrosarcomas, respectively. High-grade late toxicity consisted of one patient with Grade 3 and one patient with Grade 4 unilateral optic neuropathy, and two patients with Grade 3 central nervous system necrosis. No patient experienced brainstem toxicity. Actuarial 5-year freedom from high-grade toxicity was 94%. Conclusions: Our data indicate safety and efficacy of spot-scanning based PT for skull-base chordomas and chondrosarcomas. With target definition, dose prescription and normal organ tolerance levels similar to passive-scattering based PT series, complication-free, tumor control and survival rates are at present comparable.

  18. TREATMENT EFFECTS OF WST11 VASCULAR TARGETED PHOTODYNAMIC THERAPY IN UROTHELIAL CELL CARCINOMA AND FEASIBILITY, SAFETY, AND LONG TERM OUTCOMES IN THE UPPER URINARY TRACT OF SWINE

    PubMed Central

    Murray, Katie S; Winter, Ashley G; Corradi, Renato Beluco; LaRosa, Stephen; Jebiwott, Sylvia; Somma, Alexander; Takaki, Haruyuki; Srimathveeravalli, Govindarajan; Lepherd, Michelle; Monette, Sebastien; Kim, Kwanghee; Scherz, Avigdor; Coleman, Jonathan A

    2016-01-01

    Purpose Surgical management of upper tract urothelial carcinoma requires removal of kidney and ureter, compromising renal function. Non-surgical alternatives have potentially prohibitive safety concerns. We examine the feasibility and safety of ablation of the ureter and renal pelvis using endoluminal vascular-targeted photodynamic therapy in a porcine model and report efficacy of WST11 vascular-targeted photodynamic therapy in a murine model. Materials and Methods Following approval, we performed 28 endoluminal ablations in the ureters and renal pelvis of 18 swine. Intravenous infusion of WST11 (4mg/kg) followed by laser illumination (10 minutes) was performed via percutaneous access or retrograde ureteroscopic approach. Animals were followed clinically with laboratory testing, imaging and histology was evaluated at several post-ablation time points. A murine xenograft was created with the 5637 human urothelial cell carcinoma line to determine sensitivity to this therapy. Results At 24 hours, 50 mW/cm laser fluence produced superficial necrosis of the ureter and deeper necrosis (penetrating the muscularis propria or adventitia) was produced by treatment with 200 mW/cm in the ureter and renal pelvis. At 4 weeks, superficial urothelium had regenerated over the treatment site. No symptomatic obstruction, clinically relevant hydronephrosis, or abnormality of lab testing was noted up to 4 weeks. In mice, 80% had no evidence of tumor at 19 days after WST11 vascular-targeted photodynamic therapy. Conclusions Urothelial cell carcinoma appears to be sensitive to WST11 vascular-targeted photodynamic therapy. Depth of WST11 vascular-targeted photodynamic therapy treatment effects can be modulated in a dose-dependent manner by titration of light intensity. Moreover, this treatment modality, applied to the porcine upper urinary tract, is feasible via antegrade and retrograde access. PMID:26860792

  19. KINET: a social marketing programme of treated nets and net treatment for malaria control in Tanzania, with evaluation of child health and long-term survival.

    PubMed

    Schellenberg, J R; Abdulla, S; Minja, H; Nathan, R; Mukasa, O; Marchant, T; Mponda, H; Kikumbih, N; Lyimo, E; Manchester, T; Tanner, M; Lengeler, C

    1999-01-01

    We present a large-scale social marketing programme of insecticide-treated nets in 2 rural districts in southwestern Tanzania (population 350,000) and describe how the long-term child health and survival impact will be assessed. Formative and market research were conducted in order to understand community perceptions, knowledge, attitudes and practice with respect to the products to be socially marketed. We identified Zuia Mbu (Kiswahili for 'prevent mosquitoes') as a suitable brand name for both treated nets and single-dose insecticide treatment sachets. A mix of public and private sales outlets is used for distribution. In the first stage of a stepped introduction 31 net agents were appointed and trained in 18 villages: 15 were shop owners, 14 were village leaders, 1 was a parish priest and 1 a health worker. For net treatment 37 young people were appointed in the same villages and trained as agents. Further institutions in both districts such as hospitals, development projects and employers were also involved in distribution. Promotion for both products was intense and used a variety of channels. A total of 22,410 nets and 8072 treatments were sold during the first year: 18 months after launching, 46% of 312 families with children aged under 5 years reported that their children were sleeping under treated nets. A strong evaluation component in over 50,000 people allows assessment of the long-term effects of insecticide-treated nets on child health and survival, anaemia in pregnancy, and the costs of the intervention. This evaluation is based on cross-sectional surveys, and case-control and cohort studies.

  20. Evaluation of hoop creep behaviors in long-term dry storage condition of pre-hydrided and high burn-up nuclear fuel cladding

    SciTech Connect

    Kim, Sun-Ki; Bang, J.G.; Kim, D.H.; Yang, Y.S.

    2007-07-01

    Related to the degradation of the mechanical properties of Zr-based nuclear fuel cladding tubes under long term dry storage condition, the mechanical tests which can simulate the degradation of the mechanical properties properly are needed. Especially, the degradation of the mechanical properties by creep mechanism seems to be dominant under long term dry storage condition. Accordingly, in this paper, ring creep tests were performed in order to evaluate the creep behaviors of high burn-up fuel cladding under a hoop loading condition in a hot cell. The tests are performed with Zircaloy-4 fuel cladding whose burn-up is approximately {approx}60,000 MWd/tU in the temperature range from 350 deg. to 550 deg.. The tests are also performed with pre-hydrided Zircaloy-4 and ZIRLO up to 1,000 ppm. First of all, the hoop loading grip for the ring creep test was designed in order that a constant curvature of the specimen was maintained during the creep deformation, and the graphite lubricant was used to minimize the friction between the outer surface of the die insert and the inner surface of the ring specimen. The specimen for the ring creep test was designed to limit the deformation within the gauge section and to maximize the uniformity of the strain distribution. It was confirmed that the mechanical properties under a hoop loading condition can be correctly evaluated by using this test technique. In this paper, secondary creep rate with increasing hydrogen content are drawn, and then kinetic data such as pre-exponential factor and activation energy for creep process are also drawn. In addition, creep life are predicted by obtaining LMP (Larson-Miller parameter) correlation in the function of hydrogen content and applied stress to yield stress ratio. (authors)

  1. A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures.

    PubMed

    Steinhoff, Bernhard J; Eckhardt, Klaus; Doty, Pamela; De Backer, Marc; Brunnert, Marcus; Schulze-Bonhage, Andreas

    2016-05-01

    This noninterventional, observational, postauthorization safety study (SP0942, NCT00771927) evaluated the incidence of predefined cardiovascular- (CV) and psychiatric-related treatment-emergent adverse events (TEAEs), in patients with epilepsy and uncontrolled partial-onset seizures, when initiating adjunctive therapy with lacosamide or another approved antiepileptic drug (AED) according to standard medical practice. Active recording of predefined TEAEs of interest took place at three-monthly recommended visits for up to 12months. Of 1004 patients who received at least one dose of adjunctive AEDs, 511 initially added lacosamide therapy, 493 added another AED, 69 were ≥65years of age, and 72 took concomitant antiarrhythmic drugs. Patients in the lacosamide cohort had a higher median frequency of partial-onset seizures (6.0 versus 3.5 per 28days) despite taking more concomitant AEDs (84.9% versus 66.9% took ≥2) at baseline. Patients who added lacosamide took a modal dose of 200mg/day over the treatment period (n=501), and 50.1% (256/511) completed 12months of treatment. Fifty-one point nine percent (256/493) of patients who added another AED completed the study, with the most commonly added AED being levetiracetam (28.4%). Four patients (0.8%) in each cohort, all <65years of age, reported predefined CV-related TEAEs. None were considered serious or led to discontinuation. One event each of sinus bradycardia (lacosamide), atrioventricular block first degree (lacosamide), and syncope (other AED) were judged to be treatment-related. Another patient in the other AED cohort reported bradycardia while taking concomitant antiarrhythmic drugs. Predefined psychiatric-related TEAEs were reported by 21 patients (4.1%) in the lacosamide cohort and 27 patients (5.5%) in the other AED cohort. Depression was the most common to be treatment-related (7/11 and 12/18 of patients reporting treatment-related psychiatric TEAEs, respectively). Serious psychiatric-related TEAEs were

  2. Long-term effectiveness of the integrated schistosomiasis control strategy with emphasis on infectious source control in China: a 10-year evaluation from 2005 to 2014.

    PubMed

    Wang, Xiaoli; Wang, Wei; Wang, Peng

    2017-02-01

    Schistosomiasis is a neglected tropical parasitic disease of great public health significance worldwide. Currently, mass drug administration with praziquantel remains the major strategy for global schistosomiasis control programs. Since 2005, an integrated strategy with emphasis on infectious source control was implemented for the control of schistosomiasis japonica, a major public health concern in China, and pilot studies have demonstrated that such a strategy is effective to reduce the prevalence of Schistosoma japonicum infection in both humans and bovines. However, there is little knowledge on the long-term effectiveness of this integrated strategy for controlling schistosomiasis japonica. The aim of this study was to evaluate the long-term effectiveness of the integrated strategy for schistosomiasis control following the 10-year implementation, based on the data from the national schistosomiasis control program released by the Ministry of Health, People's Republic of China. In 2014, there were 5 counties in which the transmission of schistosomiasis japonica had not been interrupted, which reduced by 95.2% as compared to that in 2005 (105 counties). The number of schistosomiasis patients and acute cases reduced by 85.5 and 99.7% in 2014 (115,614 cases and 2 cases) as compared to that in 2005 (798,762 cases and 564 cases), and the number of bovines and S. japonicum-infected bovines reduced by 47.9 and 98% in 2014 (919,579 bovines and 666 infected bovines) as compared to that in 2005 (1,764,472 bovines and 33,736 infected bovines), respectively. During the 10-year implementation of the integrated strategy, however, there was a minor fluctuation in the area of Oncomelania hupensis snail habitats, and there was only a 5.6% reduction in the area of snail habitats in 2014 relative to in 2005. The results of the current study demonstrate that the 10-year implementation of the integrated strategy with emphasis on infectious source has greatly reduced schistosomiasis

  3. Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.

    PubMed

    Paolicelli, Damiano; Direnzo, Vita; Manni, Alessia; D'Onghia, Mariangela; Tortorella, Carla; Zoccolella, Stefano; Di Lecce, Valentina; Iaffaldano, Antonio; Trojano, Maria

    2016-07-01

    Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was approved as add-on therapy for spasticity in patients with multiple sclerosis (MS). We show our 40-week postmarketing experience regarding efficacy and safety of THC/CBD spray in an Italian cohort of 102 MS patients. Patients were evaluated using the Expanded Disability Status Scale (EDSS) score, the Numerical Rating Scale (NRS) for spasticity, the Ambulation Index (AI), and Timed 25-Foot Walk (T25-FW) at the beginning of treatment and then every 3 months. After 4 weeks, if a clinically significant improvement in spasticity (at least 20% of baseline NRS score) was not seen, administration of the drug was stopped. In our cohort, patients received an average of 6.5 ± 1.6 sprays each day. The mean reduction to the NRS spasticity score was 2.5 ± 1.2 points (P < .0001). Thirty-seven patients (36.2%) discontinued the treatment. The incidence of adverse events (AEs) was 40.2%. Fifty-eight patients (56.9%) were also assessed using the NRS for pain, and 46 patients (45.1%) with bladder dysfunction were assessed for the IPSS (International Prostatic Symptoms Score) score, showing a significant improvement in these scales (P = .011 and P = .001, respectively). In conclusion, treatment with THC/CBD spray appears to be a valid answer to some of the unmet needs in MS patients, such as spasticity and other refractory-to-treatment symptoms.

  4. Modeling the impact of climate change in Germany with biosphere models for long-term safety assessment of nuclear waste repositories.

    PubMed

    Staudt, C; Semiochkina, N; Kaiser, J C; Pröhl, G

    2013-01-01

    Biosphere models are used to evaluate the exposure of populations to radionuclides from a deep geological repository. Since the time frame for assessments of long-time disposal safety is 1 million years, potential future climate changes need to be accounted for. Potential future climate conditions were defined for northern Germany according to model results from the BIOCLIM project. Nine present day reference climate regions were defined to cover those future climate conditions. A biosphere model was developed according to the BIOMASS methodology of the IAEA and model parameters were adjusted to the conditions at the reference climate regions. The model includes exposure pathways common to those reference climate regions in a stylized biosphere and relevant to the exposure of a hypothetical self-sustaining population at the site of potential radionuclide contamination from a deep geological repository. The end points of the model are Biosphere Dose Conversion factors (BDCF) for a range of radionuclides and scenarios normalized for a constant radionuclide concentration in near-surface groundwater. Model results suggest an increased exposure of in dry climate regions with a high impact of drinking water consumption rates and the amount of irrigation water used for agriculture.

  5. Long-term environmental stewardship.

    SciTech Connect

    Nagy, Michael David

    2010-08-01

    The purpose of this Supplemental Information Source Document is to effectively describe Long-Term Environmental Stewardship (LTES) at Sandia National Laboratories/New Mexico (SNL/NM). More specifically, this document describes the LTES and Long-Term Stewardship (LTS) Programs, distinguishes between the LTES and LTS Programs, and summarizes the current status of the Environmental Restoration (ER) Project.

  6. Long-term urethral catheterisation.

    PubMed

    Turner, Bruce; Dickens, Nicola

    This article discusses long-term urethral catheterisation, focusing on the relevant anatomy and physiology, indications for the procedure, catheter selection and catheter care. It is important that nurses have a good working knowledge of long-term catheterisation as the need for this intervention will increase with the rise in chronic health conditions and the ageing population.

  7. Evaluation of pesticide monitoring strategies in agricultural streams based on the toxic-unit concept--experiences from long-term measurements.

    PubMed

    Bundschuh, Mirco; Goedkoop, Willem; Kreuger, Jenny

    2014-06-15

    The European Water Framework Directive requires surface water bodies to have a good chemical and ecological status. Although relatively few pesticides are included in the list of priority pollutants, they pose, due to their intrinsic biological activity, a significant risk for the integrity of aquatic ecosystems. In this context, the pesticide (up to 128 pesticides including some transformation products) exposure pattern in four agricultural streams and two rivers was determined from 2002 to 2011 under the umbrella of the Swedish national monitoring program employing time-proportional and grab sampling strategies, respectively. After transforming the measured pesticide concentrations into toxic units, the European Uniform Principles for algae (chronic), invertebrates and fish (both acute), which are partly employed as benchmark for pesticide regulation, were only occasionally (<2%) exceeded. Moreover, this evaluation showed no long-term trends over the years. However, recent publications suggested that those thresholds are not protective for ecosystem structure and function, indicating a risk of up to 20% and 35% of the samples from the agricultural streams and the rivers, respectively. Moreover, the monitoring data show a continuous but rather low toxic potential of pesticides for all three trophic levels throughout the year, which suggests pesticides as an evolutionary force in agriculturally impacted aquatic ecosystems. However, the flow-triggered sampling, which was implemented as an additional sampling strategy in one of the agricultural streams starting in 2006, displayed an up to 7-fold underestimation of the maximum concentration in terms of toxic units for daphnids and fish during run-off events. The present study thus underpins that the optimal sampling design for pesticide monitoring strongly depends on its overall purpose. If the long-term exposure pattern is of concern a time-proportional composite sampling strategy is recommended, while for an

  8. Evaluation of a deposit in the vicinity of the PBU L-106 Site, North Slope, Alaska, for a potential long-term test of gas production from hydrates

    SciTech Connect

    Moridis, G.J.; Reagan, M.T.; Boyle, K.L.; Zhang, K.

    2010-05-01

    As part of the effort to investigate the technical feasibility of gas production from hydrate deposits, a long-term field test (lasting 18-24 months) is under consideration in a project led by the U.S. Department of Energy. We evaluate a candidate deposit involving the C-Unit in the vicinity of the PBU-L106 site in North Slope, Alaska. This deposit is stratigraphically bounded by impermeable shale top and bottom boundaries (Class 3), and is characterized by high intrinsic permeabilities, high porosity, high hydrate saturation, and a hydrostatic pressure distribution. The C-unit deposit is composed of two hydrate-bearing strata separated by a 30-ft-thick shale interlayer, and its temperatrure across its boundaries ranges between 5 and 6.5 C. We investigate by means of numerical simulation involving very fine grids the production potential of these two deposits using both vertical and horizontal wells. We also explore the sensitivity of production to key parameters such as the hydrate saturation, the formation permeability, and the permeability of the bounding shale layers. Finally, we compare the production performance of the C-Unit at the PBU-L106 site to that of the D-Unit accumulation at the Mount Elbert site, a thinner, single-layer Class 3 deposit on the North Slope of Alaska that is shallower, less-pressurized and colder (2.3-2.6 C). The results indicate that production from horizontal wells may be orders of magnitude larger than that from vertical ones. Additionally, production increases with the formation permeability, and with a decreasing permeability of the boundaries. The effect of the hydrate saturation on production is complex and depends on the time frame of production. Because of higher production, the PBU-L106 deposit appears to have an advantage as a candidate for the long-term test.

  9. Evaluating litter decomposition in earth system models with long-term litterbag experiments: an example using the Community Land Model version 4 (CLM4).

    PubMed

    Bonan, Gordon B; Hartman, Melannie D; Parton, William J; Wieder, William R

    2013-03-01

    Decomposition is a large term in the global carbon budget, but models of the earth system that simulate carbon cycle-climate feedbacks are largely untested with respect to litter decomposition. We tested the litter decomposition parameterization of the community land model version 4 (CLM4), the terrestrial component of the community earth system model, with data from the long-term intersite decomposition experiment team (LIDET). The LIDET dataset is a 10-year study of litter decomposition at multiple sites across North America and Central America. We performed 10-year litter decomposition simulations comparable with LIDET for 9 litter types and 20 sites in tundra, grassland, and boreal, conifer, deciduous, and tropical forest biomes using the LIDET-provided climatic decomposition index to constrain temperature and moisture effects on decomposition. We performed additional simulations with DAYCENT, a version of the CENTURY model, to ask how well an established ecosystem model matches the observations. The results show large discrepancy between the laboratory microcosm studies used to parameterize the CLM4 litter decomposition and the LIDET field study. Simulated carbon loss is more rapid than the observations across all sites, and nitrogen immobilization is biased high. Closer agreement with the observations requires much lower decomposition rates, obtained with the assumption that soil mineral nitrogen severely limits decomposition. DAYCENT better replicates the observations, for both carbon mass remaining and nitrogen, independent of nitrogen limitation. CLM4 has low soil carbon in global earth system simulations. These results suggest that this bias arises, in part, from too rapid litter decomposition. More broadly, the terrestrial biogeochemistry of earth system models must be critically tested with observations, and the consequences of particular model choices must be documented. Long-term litter decomposition experiments such as LIDET provide a real

  10. Presynaptic long-term plasticity

    PubMed Central

    Yang, Ying; Calakos, Nicole

    2013-01-01

    Long-term synaptic plasticity is a major cellular substrate for learning, memory, and behavioral adaptation. Although early examples of long-term synaptic plasticity described a mechanism by which postsynaptic signal transduction was potentiated, it is now apparent that there is a vast array of mechanisms for long-term synaptic plasticity that involve modifications to either or both the presynaptic terminal and postsynaptic site. In this article, we discuss current and evolving approaches to identify presynaptic mechanisms as well as discuss their limitations. We next provide examples of the diverse circuits in which presynaptic forms of long-term synaptic plasticity have been described and discuss the potential contribution this form of plasticity might add to circuit function. Finally, we examine the present evidence for the molecular pathways and cellular events underlying presynaptic long-term synaptic plasticity. PMID:24146648

  11. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs

    PubMed Central

    2013-01-01

    Background Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan. Methods This was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20 mg once daily) in Japanese patients (aged ≥20 years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive. Results A total of 130 patients (73.1% women, mean age 62.1 years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased γ-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1 year. Conclusion Long-term treatment with esomeprazole (20 mg once daily) is well tolerated and

  12. Usability testing, initial implementation, and formative evaluation of an evidence-based intervention: lessons from a demonstration project to reduce long-term foster care.

    PubMed

    Akin, Becci A; Bryson, Stephanie A; Testa, Mark F; Blase, Karen A; McDonald, Tom; Melz, Heidi

    2013-12-01

    The field of child welfare faces an undersupply of evidence-based interventions to address long-term foster care. The Permanency Innovations Initiative is a five-year federal demonstration project intended to generate evidence to reduce long stays in foster care for those youth who encounter the most substantial barriers to permanency. This article describes a systematic and staged approach to implementation and evaluation of a PII project that included usability testing as one of its key activities. Usability testing is an industry-derived practice which analyzes early implementation processes and evaluation procedures before they are finalized. This article describes the iterative selection, testing, and analysis of nine usability metrics that were designed to assess three important constructs of the project's initial implementation and evaluation: intervening early, obtaining consent, and engaging parents. Results showed that seven of nine metrics met a predetermined target. This study demonstrates how findings from usability testing influenced the initial implementation and formative evaluation of an evidence-supported intervention. Implications are discussed for usability testing as a quality improvement cycle that may contribute to better operationalized interventions and more reliable, valid, and replicable evidence.

  13. Long term effects of bosentan treatment in adult patients with pulmonary arterial hypertension related to congenital heart disease (Eisenmenger physiology): safety, tolerability, clinical, and haemodynamic effect

    PubMed Central

    D'Alto, M; Vizza, C D; Romeo, E; Badagliacca, R; Santoro, G; Poscia, R; Sarubbi, B; Mancone, M; Argiento, P; Ferrante, F; Russo, M G; Fedele, F; Calabrò, R

    2007-01-01

    Background Oral bosentan is an established treatment for pulmonary arterial hypertension (PAH). Objective To evaluate safety, tolerability, and clinical and haemodynamic effects of bosentan in patients with PAH related to congenital heart disease (CHD). Patients 22 patients with CHD related PAH (8 men, 14 women, mean (SD) age 38 (10) years) were treated with oral bosentan (62.5 mg×2/day for the first 4 weeks and then 125 mg×2/day). Main outcome measures Clinical status, liver enzymes, World Health Organisation (WHO) functional class, resting oxygen saturations and 6‐min walk test (6MWT) were assessed at baseline and at 1, 3, 6, and 12 months. Haemodynamic evaluation with cardiac catheterisation was performed at baseline and at 12 month follow‐up. Results 12 patients had ventricular septal defect, 5 atrioventricular canal, 4 single ventricle, and 1 atrial septal defect. All patients tolerated bosentan well. No major side effects were seen. After a year of treatment, an improvement was seen in WHO functional class (2.5 (0.7) v 3.1 (0.7); p<0.05), oxygen saturation at rest (87 (6%) v 81 (9); p<0.001), heart rate at rest (81 (10) v 87 (14) bpm; p<0.05), distance travelled in the 6MWT (394 (73) v 320 (108) m; p<0.001), oxygen saturation at the end of the 6MWT (71 (14) v 63 (17%); p<0.05), Borg index (5.3 (1.8) v 6.5 (1.3); p<0.001), pulmonary vascular resistances index (14 (9) v 22 (12) WU m2; p<0.001), systemic vascular resistances index (23 (11) v 27 (10) WU.m2; p<0.01), pulmonary vascular resistances index/systemic vascular resistances index (0.6 (0.5) v 0.9 (0.6); p<0.05); pulmonary (4.0 (1.3) v 2.8 (0.9) l/min/m2; p<0.001) and systemic cardiac output (4.2 (1.4) v 3.4 (1.1) l/min/m2; p<0.05). Conclusions Bosentan was safe and well tolerated in adults with CHD related PAH during 12 months of treatment. Clinical status, exercise tolerance, and pulmonary haemodynamics improved considerably. PMID:17135220

  14. Long-term efficacy and safety of oxycodone–naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study

    PubMed Central

    Guerriero, Fabio; Roberto, Anna; Greco, Maria Teresa; Sgarlata, Carmelo; Rollone, Marco; Corli, Oscar

    2016-01-01

    Background Two-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone–naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years. Methods In this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52). Results Fifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0–10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated. Conclusion This study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs. PMID:27143857

  15. Conditions, components and outcomes of Integrative Validation Therapy in a long-term care facility for people with dementia. A qualitative evaluation study.

    PubMed

    Erdmann, Anke; Schnepp, Wilfried

    2016-09-01

    In this study, the practical application of Integrative Validation Therapy (IVA) in a nursing home for people with dementia was investigated and evaluated from the perspectives of professionals and relatives by using Fourth Generation Evaluation. IVA, a complex intervention frequently applied in Germany's long-term care settings, is a modification of Feil's Validation Therapy and contains a specific attitude and several components of action. The findings demonstrate that professionals as well as relatives of nursing home residents gave the intervention a positive rating. From the perspective of the participating professionals, the application of IVA results in less agitated residents which also has an influence on the consumption of benzodiazepine and neuroleptics. The authors conclude that IVA is a beneficial nursing intervention helping to facilitate the illness-related transition process of people with dementia. IVA is able to support them to cope with emotional distress during transition (e.g. irritability, anxiety, depression, changes in self-esteem). Another conclusion is that IVA supports person-centred care because, with IVA, professionals react to typical needs people with dementia have: comfort, inclusion, attachment and identity (Kitwood, 2012).

  16. Long-term effects of dredging operations program. long-term evaluation of plants and animals colonizing contaminated estuarine dredged material placed in both upland and wetland environments. Final report

    SciTech Connect

    Brandon, D.L.; Lee, C.R.; Simmers, J.W.; Skogerboe, J.G.; Wilhelm, G.S.

    1991-09-01

    Contaminated sediment was dredged from Black Rock Harbor, Connecticut, in October 1983 and placed in aquatic, upland, and wetland environments as part of the Field Verification Program (FVP), conducted during the period 1981-1986. Laboratory tests were conducted on the sediment prior to dredging to evaluate potential contaminant mobility under each of the disposal alternatives. Prior to dredging for upland disposal and wetland creation at the FVP field site, upland tests (i.e., plant and earthworm bioassays) and wetland tests (i.e., plant, sandworm, snail, and mussel bioassays) were conducted. Laboratory test results were sub-subsequently field verified at the field test site at Tongue Point, Bridgeport, CT. The results of the upland disposal and wetland creation portions of the FVP, and the changes occurring since completion of the FVP for each disposal environment, are summarized herein. The emphasis of this report is on the contaminant mobility of heavy metals. This interim report includes data collected through 1989. Contaminant mobility and the progressive development of the upland and wetland ecosystems at this site will be evaluated until September 1985.

  17. Long term complications of diabetes

    MedlinePlus

    ... medlineplus.gov/ency/patientinstructions/000327.htm Long-term complications of diabetes To use the sharing features on this page, ... other tests. All these may help you keep complications of diabetes away. You will need to check your blood ...

  18. Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

    PubMed Central

    Pelegrín, L; de la Maza, M S; Molins, B; Ríos, J; Adán, A

    2015-01-01

    Purpose To compare dexamethasone (DEX) intravitreal implant effect in non-vitrectomized (non-PPV) vs vitrectomized (PPV) eyes with macular edema (ME) secondary to non-infectious uveitis. Methods Medical records of patients with uveitic ME treated with DEX-intravitreal implant were reviewed. Main outcome measures were changes in central retinal thickness (CRT), best corrected visual acuity (BCVA), intraocular pressure (IOP), vitreous haze and adverse events. Statistical analysis was performed by Longitudinal Linear model using the General Estimating Equation methodology. Results Forty-two eyes of 32 patients were included. Median follow-up time was 18 months (interquartile range (IQR): 12–24). Median CRT showed its maximum decrease at the first month in non-PPV and PPV eyes without statistically significant differences between both groups (P=NS). Median Snellen BCVA, converted to logarithm (LogMAR), showed its maximum improvement at third month in both groups without statistically significant differences between them (P=NS). Median IOP was higher in non-PPV eyes than in PPV eyes from third (P=0.025) to 12th month (P=0.013). Vitreous haze score improved in both groups since first month and showed no differences (P=0.706). Reinjection was performed in 45.2% of eyes at a median time of 5 months IQR: (5–6). Ocular hypertension (47.6%) was the most common adverse event. Conclusions DEX-intravitreal implant for uveitic ME has similar long-term safety profile and good response measured in terms of CRT decrease, BCVA, and vitreous haze improvement in both groups. Non-PPV eyes following DEX-intravitreal implant showed higher IOP increase than PPV eyes, showing the need for close IOP monitoring. PMID:25998942

  19. Long-term infusions of p-boronophenylalanine for boron neutron capture therapy: evaluation using rat brain tumor and spinal cord models.

    PubMed

    Morris, G M; Micca, P L; Nawrocky, M M; Weissfloch, L E; Coderre, J A

    2002-12-01

    .2 Gy ( approximately 30 photon-equivalent Gy) to all tumors. In the present study, the long-term survival was approximately 50% and was not significantly different between the 2-h and the 6-h infusion groups. The mode of BPA administration and the time between administration and irradiation influence the 10B partition ratio between the CNS and the blood, which in turn influences the measured CBE factor. These findings underline the need for clinical biodistribution studies to be carried out to establish 10B partition ratios as a key component in the evaluation of modified administration protocols involving BPA.

  20. Evaluation of long-term corrosion durability and self-healing ability of scratched coating systems on carbon steel in a marine environment

    NASA Astrophysics Data System (ADS)

    Zhao, Xia; Chen, Changwei; Xu, Weichen; Zhu, Qingjun; Ge, Chengyue; Hou, Baorong

    2016-09-01

    Defects in protective-coating systems on steel surfaces are inevitable in practical engineering applications. A composite coating system, including a primer, middle coat and topcoat, were used to protect carbon steel from corrosion in a marine environment. Two environmental additives, glass fibers and thiourea, were applied in the middle coat to modify the coating system. The long-term corrosion durability and self-healing ability of the scratched coating system were evaluated by multiple methods. Results of the electrochemical technologies indicated that the coating system that contained 0.5 wt.% fibers and 0.5 wt.% thiourea presented good corrosion protection and self-healing for carbon steel when immersed in 3.5% NaCl for 120 d. Evolution of localized corrosion factors with time, as obtained from the current distribution showed that fibers combined with thiourea could inhibit the occurrence of local corrosion in scratched coating systems and retarded the corrosion development significantly. Surface characterization suggested that adequate thiourea could be absorbed uniformly on fibers for a long time to play an important role in protecting the carbon steel. Finally, schematic models were established to demonstrate the action of fibers and thiourea on the exposed surface of the carbon steel and the scratched coating system in the entire deterioration process.

  1. A modelling approach to evaluate the long-term effect of soil texture on spring wheat productivity under a rain-fed condition.

    PubMed

    He, Yong; Hou, Lingling; Wang, Hong; Hu, Kelin; McConkey, Brian

    2014-07-30

    Soil surface texture is an important environmental factor that influences crop productivity because of its direct effect on soil water and complex interactions with other environmental factors. Using 30-year data, an agricultural system model (DSSAT-CERES-Wheat) was calibrated and validated. After validation, the modelled yield and water use (WU) of spring wheat (Triticum aestivum L.) from two soil textures (silt loam and clay) under rain-fed condition were analyzed. Regression analysis showed that wheat grown in silt loam soil is more sensitive to WU than wheat grown in clay soil, indicating that the wheat grown in clay soil has higher drought tolerance than that grown in silt loam. Yield variation can be explained by WU other than by precipitation use (PU). These results demonstrated that the DSSAT-CERES-Wheat model can be used to evaluate the WU of different soil textures and assess the feasibility of wheat production under various conditions. These outcomes can improve our understanding of the long-term effect of soil texture on spring wheat productivity in rain-fed condition.

  2. Long-term continuous acoustical suspended-sediment measurements in rivers – Theory, evaluation, and results from 14 stations on five rivers

    USGS Publications Warehouse

    Topping, David; Wright, Scott A.; Griffiths, Ronald; Dean, David

    2016-01-01

    We have developed a physically based method for using two acoustic frequencies to measure suspended-silt-and-clay concentration, suspended-sand concentration, and suspended-sand median grain size in river cross sections at 15-minute intervals over decadal timescales. The method is strongly grounded in the extensive scientific literature on the scattering of sound by suspensions of small particles. In particular, the method takes advantage of the specific theoretical relations among acoustic frequency, acoustic attenuation, acoustic backscatter, suspended-sediment concentration, and suspended-sediment grain-size distribution. We briefly describe the theory and methods, demonstrate the application of the method, and compute biases and errors in the method at 14 stations in the Colorado River and Rio Grande basins, where large numbers of suspended-sediment samples have been collected concurrently with acoustical measurements over many years. Quantification of errors in sediment-transport measurements made using this method is essential if the measurements are to be used effectively, e.g., to evaluate uncertainty in long-term sediment loads and budgets

  3. Upscaling SOC changes from long term field experiments to regional level - evaluation of agri-environmental measures on their contribution to mitigate climate change

    NASA Astrophysics Data System (ADS)

    Freudenschuss, Alexandra; Sedy, Katrin; Spiegel, Heide; Zethner, Gerhard

    2010-05-01

    Several agri-environment measures in Austria are presumed to also mitigate climate change. These are mainly measures that lead to an increase or stabilization of soil organic carbon (SOC) in arable soils, like e.g. organic farming, legumes and cover crops in the crop rotation as well as the application of organic fertilizers. A reduction of mineral fertiliser application may also reduce greenhouse gas emissions. The results of the study aim to evaluate different agricultural practices on their impact on SOC changes. Data from long term field experiments in Austria with different tillage systems and incorporation rates of crop residues and manure are used to determine effects of agricultural practices on SOC changes. Management factors that compare results from different activities on cropland are calculated and compared with international data. Furthermore these data are used to verify results gained from the application of humus balance model (VDLUFA). For the upscaling of potential SOC changes at regional level (federal states of Austria) data of the IACS - Integrated Administrative Control System are applied in the humus balance model. In order to cover the range of possible SOC changes three different approaches of the humus balance model are introduced and the results will be presented.

  4. Evaluation of the resilience of a full-scale down-flow hanging sponge reactor to long-term outages at a sewage treatment plant in India.

    PubMed

    Onodera, Takashi; Takayama, Daisuke; Ohashi, Akiyoshi; Yamaguchi, Takashi; Uemura, Shigeki; Harada, Hideki

    2016-10-01

    Resilience to process outages is an essential requirement for sustainable wastewater treatment systems in developing countries. In this study, we evaluated the ability of a full-scale down-flow hanging sponge (DHS) reactor to recover after a 10-day outage. The DHS tested in this study uses polyurethane sponge as packing material. This full-scale DHS reactor has been tested over a period of about 4 years in India with a flow rate of 500 m(3)/day. Water was not supplied to the DHS reactor that was subjected to the 10-day outage; however, the biomass did not dry out because the sponge was able to retain enough water. Soon after the reactor was restarted, a small quantity of biomass, amounting to only 0.1% of the total retained biomass, was eluted. The DHS effluent achieved satisfactory removal of suspended solids, chemical oxygen demand, and ammonium nitrogen within 90, 45, and 90 min, respectively. Conversely, fecal coliforms in the DHS effluent did not reach satisfactory levels within 540 min; instead, the normal levels of fecal coliforms were achieved within 3 days. Overall, the tests demonstrated that the DHS reactor was sufficiently robust to withstand long-term outages and achieved steady state soon after restart. This reinforces the suitability of this technology for developing countries.

  5. Long-term effects of palatal plate therapy on oral motor function in children with Down syndrome evaluated by video registration.

    PubMed

    Carlstedt, K; Henningsson, G; McAllister, A; Dahllöf, G

    2001-04-01

    Oral motor function was evaluated after 4 years of palatal plate therapy in nine children with Down syndrome (DS); 11 children with DS constituted the control group. During the treatment period all children had orofacial physiotherapy with their speech pathologist. An extraoral examination was performed, as was a video registration of the face. Nine different variables showing positions of the lips, tongue, and facial expression were examined. Children in the palatal plate group (n = 9) had significantly more rounding lips during speech (P< 0.05) than children in the control group (n = 11). The active variables describing normal muscle tension were diagnosed to constitute 81.0% +/- 11.0% of the registered video time in the palatal plate group, compared with 68.2% +/- 22.5% in the control group. Statistically significant differences were found between the groups in the summary variables describing an inactive open mouth and inactive tongue protrusion (P< 0.01). The results indicate that palatal plate therapy has a long-term effect on oral motor function.

  6. A modelling approach to evaluate the long-term effect of soil texture on spring wheat productivity under a rain-fed condition

    PubMed Central

    He, Yong; Hou, Lingling; Wang, Hong; Hu, Kelin; McConkey, Brian

    2014-01-01

    Soil surface texture is an important environmental factor that influences crop productivity because of its direct effect on soil water and complex interactions with other environmental factors. Using 30-year data, an agricultural system model (DSSAT-CERES-Wheat) was calibrated and validated. After validation, the modelled yield and water use (WU) of spring wheat (Triticum aestivum L.) from two soil textures (silt loam and clay) under rain-fed condition were analyzed. Regression analysis showed that wheat grown in silt loam soil is more sensitive to WU than wheat grown in clay soil, indicating that the wheat grown in clay soil has higher drought tolerance than that grown in silt loam. Yield variation can be explained by WU other than by precipitation use (PU). These results demonstrated that the DSSAT-CERES-Wheat model can be used to evaluate the WU of different soil textures and assess the feasibility of wheat production under various conditions. These outcomes can improve our understanding of the long-term effect of soil texture on spring wheat productivity in rain-fed condition. PMID:25074796

  7. [Effects of long-term fertilization on reddish paddy soil quality and its evaluation in a typical double-rice cropping region of China].

    PubMed

    Nie, Jun; Yang, Zeng-Ping; Zheng, Sheng-Xian; Liao, Yu-Lin; Xie, Jian; Xiang, Yan-Wen

    2010-06-01

    In order to quantify the effects of 27 years application of chemical fertilizers, pig manure, and rice straw on the reddish paddy soil quality in double rice cropping region, the indices of soil bulk density, porosity, maximum water holding capacity, normalized mean weight diameter, pH, cation exchange capacity, available nutrients, organic matter, microbial biomass C, enzyme activities, and rice yield were selected as the evaluation indicators, and classified into four functional groups, i. e., resistance to physical degradation, plant nutrients supply and storage, resistance to biochemical degradation, and sustaining of crop productivity. The soil quality index (SQI) was calculated based on the four functional groups. The results showed that the SQI ranged from 0.544 in treatment CK to 0.729 in treatment NPK plus rice straw. Treatments PK, NP, and NK induced soil degradation, compared to treatment NPK. The deficiencies of soil P and K were the main limiting factors for the double rice productivity in reddish paddy soil area. Even though 30 t x hm(-2) x a(-1) of pig manure and 4.2 t x hm(-2) x a(-1) of rice straw were applied, the soil P and K were still not adequate for the requirement of rice growth. There was no obvious effect of long-term application of lime on the reddish paddy soil quality. The combined application of NPK with organic manure was an important and effective measure in improving soil quality in double rice cropping regions of Southern China.

  8. Evaluation of Passive Samplers for Long-Term Monitoring of Organic Compounds in the Untreated Drinking Water Supply for the City of Eugene, Oregon, September-October 2007

    USGS Publications Warehouse

    McCarthy, Kathleen A.; Alvarez, David A.; Anderson, Chauncey W.; Cranor, Walter L.; Perkins, Stephanie D.; Schroeder, Vickie

    2009-01-01

    Two types of passive samplers, polar organic chemical integrative samplers (POCIS) and semipermeable membrane devices (SPMDs), were deployed at three sites in the McKenzie River basin during September-October 2007. The McKenzie River is the source of drinking water for the city of Eugene, Oregon, and the work presented here was designed to evaluate the use of POCIS and SMPDs as part of a long-term monitoring plan for the river. Various compounds were detected in extracts from the POCIS and SPMDs, indicating that some compounds of concern are present in the McKenzie River basin, including the intake for the drinking water plant. However, most concentrations were near the quantitation limits of the analytical methods used - generally at subnanogram per liter concentrations - and would not have been detectable with conventional water sampling and analysis methods. These results indicate that both POCIS and SPMDs are well suited to monitor organic compounds in the McKenzie River basin.

  9. Long-term consequences of non-intentional flows of substances: Modelling non-intentional flows of lead in the Dutch economic system and evaluating their environmental consequences

    SciTech Connect

    Elshkaki, Ayman Voet, Ester van der; Holderbeke, Mirja van; Timmermans, Veerle

    2009-06-15

    Substances may enter the economy and the environment through both intentional and non-intentional flows. These non-intentional flows, including the occurrence of substances as pollutants in mixed primary resources (metal ores, phosphate ores and fossil fuels) and their presence in re-used waste streams from intentional use may have environmental and economic consequences in terms of pollution and resource availability. On the one hand, these non-intentional flows may cause pollution problems. On the other hand, these flows have the potential to be a secondary source of substances. This article aims to quantify and model the non-intentional flows of lead, to evaluate their long-term environmental consequences, and compare these consequences to those of the intentional flows of lead. To meet this goal, the model combines all the sources of non-intentional flows of lead within one model, which also includes the intentional flows. Application of the model shows that the non-intentional flows of lead related to waste streams associated with intentional use are decreasing over time, due to the increased attention given to waste management. However, as contaminants in mixed primary resources application, lead flows are increasing as demand for these applications is increasing.

  10. Evaluation of long-term stability of mesiodistal axial inclinations of maxillary molars through panoramic radiographs in subjects treated with Pendulum appliance

    PubMed Central

    Rocha, Caroline Andrade; de Almeida, Renato Rodrigues; Henriques, José Fernando Castanha; Flores-Mir, Carlos; de Almeida, Marcio Rodrigues

    2016-01-01

    Objective: To evaluate the stability of mesiodistal inclination of maxillary molars produced by a pendulum appliance, five years after completion of orthodontic treatment. Angulation changes were compared to an untreated sample. Methods: The sample consisted of 20 patients (14 females and 6 males) with Class II, Division 1 malocclusion that was treated through molar distalization with a pendulum appliance followed by cervical headgear and full fixed appliances. Maxillary molar inclination was evaluated through panoramic radiograph. The mean age at pretreatment was 14.3 ± 1.6 years, whereas at immediate post-treatment it was 18.6 ± 1.8 years, and at long-term post-treatment it was 23.8 ± 2.0 years. A control group of 16 untreated individuals with untreated normocclusion ranging in age from 12 to 17 years old were used as comparison group. Data were statistically analyzed with independent t-tests and ANOVA test followed by Tukey post-hoc tests. Results: Statistically significant differences were found between T1(94.50) and T2 (98.80) as well as between T2 and T3 (94.70) for maxillary first molars. Maxillary second molars did not show any statistically significant positional changes during the evaluated time periods T1 (107.50), T2 (109.30) and T3 (106.90). Conclusion: Although maxillary first molars underwent distal crown inclination immediately after treatment, approximately five years thereafter their roots tended to upright close to the pretreatment positions. PMID:27007764

  11. Long-term recovery from hippocampal-related behavioral and biochemical abnormalities induced by noise exposure during brain development. Evaluation of auditory pathway integrity.

    PubMed

    Uran, S L; Gómez-Casati, M E; Guelman, L R

    2014-10-01

    Sound is an important part of man's contact with the environment and has served as critical means for survival throughout his evolution. As a result of exposure to noise, physiological functions such as those involving structures of the auditory and non-auditory systems might be damaged. We have previously reported that noise-exposed developing rats elicited hippocampal-related histological, biochemical and behavioral changes. However, no data about the time lapse of these changes were reported. Moreover, measurements of auditory pathway function were not performed in exposed animals. Therefore, with the present work, we aim to test the onset and the persistence of the different extra-auditory abnormalities observed in noise-exposed rats and to evaluate auditory pathway integrity. Male Wistar rats of 15 days were exposed to moderate noise levels (95-97 dB SPL, 2 h a day) during one day (acute noise exposure, ANE) or during 15 days (sub-acute noise exposure, SANE). Hippocampal biochemical determinations as well as short (ST) and long term (LT) behavioral assessments were performed. In addition, histological and functional evaluations of the auditory pathway were carried out in exposed animals. Our results show that hippocampal-related behavioral and biochemical changes (impairments in habituation, recognition and associative memories as well as distortion of anxiety-related behavior, decreases in reactive oxygen species (ROS) levels and increases in antioxidant enzymes activities) induced by noise exposure were almost completely restored by PND 90. In addition, auditory evaluation shows that increased cochlear thresholds observed in exposed rats were re-established at PND 90, although with a remarkable supra-threshold amplitude reduction. These data suggest that noise-induced hippocampal and auditory-related alterations are mostly transient and that the effects of noise on the hippocampus might be, at least in part, mediated by the damage on the auditory pathway

  12. [Fetal pain: immediate and long term consequences].

    PubMed

    Houfflin Debarge, Véronique; Dutriez, Isabelle; Pusniak, Benoit; Delarue, Eléonore; Storme, Laurent

    2010-06-01

    Several situations are potentially painful for fetuses, such as malformations and invasive procedures. Nociceptive pathways are known to be functional at 26 weeks. Even if it is not possible to evaluate the fetal experience of pain, it is essential to examine its immediate and long-term consequences. As early as the beginning of the second trimester, hemodynamic and hormonal responses are observed following fetal nociceptive stimulation, In experimental studies, long-term changes have been noted in the corticotrop axis, subsequent responses to pain, and behavior after perinatal nociceptive stimulation.

  13. Long-Term Stability of Tutor Performance.

    ERIC Educational Resources Information Center

    Dolmans, Diana H. J. M.; And Others

    1996-01-01

    Examined the extent to which tutor ratings remained stable in the long term by evaluating 291 ratings of 140 tutors at Maastricht University in the Netherlands between 1992 and 1995. The results indicated that, if the aggregated score and overall judgement are used to interpret the precision of individual scores, four and two occasions,…

  14. Long-term liquid storage and reproductive evaluation of an innovative boar semen extender (Formula12(®)) containing a non-reducing disaccharide and an enzymatic agent.

    PubMed

    Bresciani, Carla; Bianchera, Annalisa; Bettini, Ruggero; Buschini, Annamaria; Marchi, Laura; Cabassi, Clotilde Silvia; Sabbioni, Alberto; Righi, Federico; Mazzoni, Claudio; Parmigiani, Enrico

    2017-02-24

    There are no reports of saccharolytic enzymes being used in the preparation of formulations for animal semen extenders. In the present study, the use of an innovative semen extender (Formula12(®)) in the long-term liquid storage of boar semen at 17°C was evaluated. The formulation included use of a disaccharide (sucrose) as the energy source precursor coupled to an enzymatic agent (invertase). The innovative extender was evaluated and compared in vitro to a commercial extender (Vitasem LD(®)) for the following variables: Total Motility (TM), Forward Progressive Motility (FPM), sperm morphology, membrane integrity, acrosome integrity, and chromatin instability. Boar sperm diluted in Formula12(®) and stored for 12 days at 17°C maintained a commercially acceptable FPM (>70%). Using the results from the in vitro study, an AI field trial was performed. A total of 170 females were inseminated (135 with Formula12(®) and 35 with Vitasem LD(®)). The pregnancy rates were 97.8% compared with 91.4%, and the farrowing rates were 96.3% compared with 88.6% when Formula12(®) and Vitasem LD(®) were used, respectively. The mean number of piglets born/sow were 14.92±0.46 compared with 13.83±0.70, and the number of piglets born alive/sow were 14.07±0.46 compared with 12.12±0.70 (P<0.05). The results obtained in this study demonstrated that use of the innovative concept to provide a precursor of glucose and fructose as energy sources for an enzymatic agent in an extender allowed for meeting the metabolic requirements of boar sperm during storage at 17°C. It is suggested that there was a beneficial effect on fertilizing capacity of boar sperm in the female reproductive tract with use of these technologies.

  15. Evaluation of impact factors on PM2.5 based on long-term chemical components analyses in the megacity Beijing, China.

    PubMed

    Chen, Yuan; Schleicher, Nina; Cen, Kuang; Liu, Xiuli; Yu, Yang; Zibat, Volker; Dietze, Volker; Fricker, Mathieu; Kaminski, Uwe; Chen, Yizhen; Chai, Fahe; Norra, Stefan

    2016-07-01

    Nine years of sampling and analyses of fine particles (PM2.5) were performed in Beijing from 2005 to 2013. Twenty-seven chemical elements and black carbon (BC) in PM2.5 were analyzed in order to study chemical characteristics and temporal distribution of Beijing aerosols. Principle component analysis defined different types of elemental sources, based on which, the influences of a variety of anthropogenic activities including governmental intervention measures and natural sources on air quality were evaluated. For the first time, Ga is used as a tracer element for heating activities mainly using coal in Beijing, due to its correlation with BC and coal combustion, as well as its concentration variation between the heating- and non-heating periods. The traffic restrictions effectively reduced emissions of relevant heavy metals such as As, Cd, Sn and Sb. The expected long-term effectiveness of the steel smelters relocation was not observed due to the nearby relocation with increased capacity. Firework display during every Chinese spring festival season and special events such as the Olympic Games resulted in several times higher concentrations of K, Sr and Ba than other days and thus they were proposed as tracers for firework display. The impacts of all these factors were quantified and evaluated. Sand dust or dust storms induced higher concentrations of geogenic elements in PM2.5 compared to non-dust days. Sustainable mitigation measures, such as traffic restrictions, are necessary to be continued and improved to obtain more "blue sky" days in the future.

  16. IN VIVO EVALUATION OF SKIN IRRITATION POTENTIAL, MELASMA AND SEBUM CONTENT FOLLOWING LONG TERM APPLICATION OF SKIN CARE CREAM IN HEALTHY ADULTS, USING NON-INVASIVE BIOMETROLOGICAL TECHNIQUES.

    PubMed

    Arshad, Atif I; Khan, Shoaib H M; Akhtar, Naveed; Mahmood, Asif; Sarfraz, Rai Muhammad

    2016-01-01

    The present investigation was conducted to evaluate non-invasively, various functional skin parameters i.e., irritation potential, melasma and sebum contents following long term application of topical cream (w/o) loaded with 2% methanolic extract of Ananas comosus L. versus placebo control (base) in healthy adults. Healthy human volunteers (n = 11, aged 20-30 years) were recruited for investigation and written informed consent was taken from each volunteer. In this single blinded study every volunteer applied formulation on one side of face and placebo on the other side of face twice daily for a period of 12 weeks (three months). Different skin parameters i.e., skin irritancy, melasma, and sebum contents were measured on both sides of face at baseline and after two weeks interval, using photometric device Mexameter and Sebumeter in a draught free room with modulated conditions of temperature (22-25°C) and humidity (55-60%). It was evident from the results that no primary skin irritancy was observed with patch test. Besides, statistical interpretation indicates that treatment with formulation is superior to placebo because it significantly (p ≤ 0.05) reduced the skin irritancy, melasma and sebum secretions throughout the study and reaching maximum -20.76 ± 0.89, -54.2 ± 0.37 and -40.71 ± 0.75%, respectively, at the end of study period. Antioxidant activity of extract was 92% compared to standard antioxidant. Conclusively, active cream loaded with fruit extract was well tolerated by all the volunteers and suitable to treat contact dermatitis, greasy skin, acne and seborrheic dermatitis and augmenting beauty and attraction by depigmentation of human skin. So, in the future, there is need to clinically evaluate these formulations in patients with compromised skin functions i.e., contact dermatitis, melasma, and acne vulgaris in order to explore the actual potential of this fruit.

  17. Long-term efficacy and safety results of taliglucerase alfa through 5years in adult treatment-naïve patients with Gaucher disease.

    PubMed

    Zimran, Ari; Durán, Gloria; Giraldo, Pilar; Rosenbaum, Hanna; Giona, Fiorina; Petakov, Milan; Terreros Muñoz, Eduardo; Solorio-Meza, Sergio Eduardo; Cooper, Peter A; Varughese, Sheeba; Alon, Sari; Chertkoff, Raul

    2016-07-18

    Taliglucerase alfa, the first available plant cell-expressed recombinant therapeutic protein, is an enzyme replacement therapy approved for Gaucher disease (GD). PB-06-001, a pivotal phase 3, multicenter, randomized, double-blind, parallel-dose study investigated taliglucerase alfa 30 or 60U/kg every other week through 9months in treatment-naïve adults with GD; 30-month extension study PB-06-003 followed. Patients completing PB-06-001 and PB-06-003 could continue treatment in PB-06-007. Nineteen patients enrolled in PB-06-007 (30U/kg, n=8; 60U/kg, n=9; dose adjusted, n=2); 17 completed 5 total years of treatment. In these 3 groups, respectively, taliglucerase alfa resulted in mean decreases in spleen volume (-8.7, -6.9, -12.4 multiples of normal), liver volume (-0.6, -0.4, -0.5 multiples of normal), chitotriosidase activity (-83.1%, -93.4%, -87.9%), and chemokine (CC motif) ligand 18 concentration (-66.7%, -83.3%, -78.9%), as well as mean increases in hemoglobin concentration (+2.1, +2.1, +1.8mg/dL) and platelet count (+31,871, +106,800, +34,000/mm(3)). The most common adverse events were nasopharyngitis and arthralgia. Most adverse events were mild/moderate; no serious adverse events were considered treatment-related. These results demonstrate continued improvement of disease parameters during 5years of taliglucerase alfa therapy in 17 treatment-naive patients with no new safety concerns, extending the taliglucerase alfa clinical efficacy and safety dataset. This study was registered at www.clinicaltrials.gov as NCT01422187.

  18. Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.

    PubMed

    Stein Gold, Linda; Kircik, Leon; Fowler, Joseph; Jackson, J Mark; Tan, Jerry; Draelos, Zoe; Fleischer, Alan; Appell, Melanie; Steinhoff, Martin; Lynde, Charles; Sugarman, Jeffrey; Liu, Hong; Jacovella, Jean

    2014-11-01

    Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR. Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated. Two 40-week extension studies of those trials were conducted to assess the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects originally treated with IVM 1% continued on IVM 1% and those originally treated with vehicle switched to AzA 15% gel. IVM 1% cream was safe throughout the study with a lower incidence of related adverse events (AEs) compared to AzA 15% gel. No subjects in the IVM 1% cream group discontinued either study due to a related AE. IVM 1% also continued to be efficacious during the 40-week extension studies as the percentage of subjects with IGA scores of clear or almost clear was higher at the end of the study compared to baseline. The results of these 40-week extension studies support the use of IVM 1% cream as a long-term therapy for PPR as IVM 1% cream was shown to be safe and effective for up to 52 weeks of total treatment.

  19. Evaluation of the drug release patterns and long term stability of aqueous and organic coated pellets by using blends of enteric and gastrointestinal insoluble polymers.

    PubMed

    Kranz, H; Gutsche, S

    2009-10-01

    The major aim of this study was to identify an efficient tool to adjust drug release patterns from aqueous and organic ethylcellulose (a gastrointestinal insoluble polymer) coated pellets and to evaluate the long term stability of the film coatings. Drug release was monitored during open and closed storage at 25 degrees C/60% RH (ambient conditions) and 40 degrees C/75% RH (stress conditions) for up to 24 months. Release of vatalanib succinate, a poorly soluble drug that demonstrates pH-dependent solubility, from pure ethylcellulose coated pellets was slow irrespectively of the type of coating and release medium. By addition of the enteric polymer methacrylic acid/ethyl acrylate copolymer (applied as aqueous Kollicoat MAE 30 DP dispersion or organic solution of Kollicoat MAE 100 P) to ethylcellulose broad ranges of drug release patterns could be achieved. For aqueous film coatings the addition of Kollicoat MAE 30 DP to ethylcellulose dispersions resulted in unaltered drug release kinetics during closed storage at ambient and stress conditions. The storage stabilizing effect of the added enteric polymer might be explained by the more hydrophilic nature of Kollicoat MAE 30 DP compared to ethylcellulose trapping water during film formation and improving polymer particle coalescence. However, during open storage of aqueous coated ethylcellulose:Kollicoat MAE 30 DP pellets at stress conditions drug release decreased due to further gradual polymer particle coalescence. In contrast, drug release rates from organic coated ethylcellulose:Kollicoat MAE 100 P pellets stored at ambient and stress conditions did not change which could be explained by differences in the film formation process. This clearly indicates that the presented concept of the addition of methacrylic acid/ethyl acrylate copolymer to ethylcellulose film coatings in combination with an organic coating process is able to achieve broad ranges of drug release patterns and to overcome storage instability.

  20. Analyses of fecal and hair glucocorticoids to evaluate short- and long-term stress and recovery of Asiatic black bears (Ursus thibetanus) removed from bile farms in China.

    PubMed

    Malcolm, K D; McShea, W J; Van Deelen, T R; Bacon, H J; Liu, F; Putman, S; Zhu, X; Brown, J L

    2013-05-01

    Demand for traditional Chinese medicines has given rise to the practice of maintaining Asiatic black bears (Ursus thibetanus) in captivity to harvest bile. We evaluated hypothalamic-pituitary-adrenal (HPA) activity in Asiatic black bears on a bile farm in China by measuring cortisol in hair. We also monitored hair and fecal glucocorticoid metabolites as bears acclimated to improved husbandry at the Animals Asia Foundation China Bear Rescue Center (CBRC) after removal from other bile farms. Fecal samples were collected twice weekly for ~1 year, and hair was obtained from bears upon arrival at the CBRC and again ≥163 days later. Paired hair samples showed declines in cortisol concentrations of 12-88% in 38 of 45 (84%, p<0.001) bears after arrival and acclimation at the rehabilitation facility. Concentrations of cortisol in hair from bears on the bile farm were similar to initial concentrations upon arrival at the CBRC but were higher than those collected after bears had been at the CBRC for ≥163 days. Fecal glucocorticoid concentrations varied across months and were highest in April and declined through December, possibly reflecting seasonal patterns, responses to the arrival and socialization of new bears at the CBRC, and/or annual metabolic change. Data from segmental analysis of hair supports the first of these explanations. Our findings indicate that bears produced elevated concentrations of glucocorticoids on bile farms, and that activity of the HPA axis declined following relocation. Thus, hair cortisol analyses are particularly well suited to long-term, retrospective assessments of glucocorticoids in ursids. By contrast, fecal measures were not clearly associated with rehabilitation, but rather reflected more subtle endocrine changes, possibly related to seasonality.

  1. Meteorological detrending of primary and secondary pollutant concentrations: Method application and evaluation using long-term (2000-2012) data in Atlanta

    NASA Astrophysics Data System (ADS)

    Henneman, Lucas R. F.; Holmes, Heather A.; Mulholland, James A.; Russell, Armistead G.

    2015-10-01

    The effectiveness of air pollution regulations and controls are evaluated based on measured air pollutant concentrations. Air pollution levels, however, are highly sensitive to both emissions and meteorological fluctuations. Therefore, an assessment of the change in air pollutant levels due to emissions controls must account for these meteorological fluctuations. Two empirical methods to quantify the impact of meteorology on pollutant levels are discussed and applied to the 13-year time period between 2000 and 2012 in Atlanta, GA. The methods employ Kolmogorov-Zurbenko filters and linear regressions to detrended pollutant signals into long-term, seasonal, weekly, short-term, and white-noise components. The methods differ in how changes in weekly and holiday emissions are accounted for. Both can provide meteorological adjustments on a daily basis for future use in acute health analyses. The meteorological impact on daily signals of ozone, NOx, CO, SO2, PM2.5, and PM species are quantified. Analyses show that the substantial decreases in seasonal averages of NOx and SO2 correspond with controls implemented in the metropolitan Atlanta area. Detrending allows for the impacts of some controls to be observed with averaging times of as little as 3 months. Annual average concentrations of NOx, SO2, and CO have all fallen by at least 50% since 2000. Reductions in NOx levels, however, do not lead to uniform reductions in ozone. While average detrended summer average maximum daily average 8 h ozone (MDA8h O3) levels fell by 4% (2.2 ± 2 ppb) between 2000 and 2012, winter averages have increased by 12% (3.8 ± 1.4 ppb), providing further evidence that high ozone levels are NOx-limited and lower ozone concentrations are NOx-inhibited. High ozone days (with MDA8h O3 greater than 60 ppb) decreased both in number and in magnitude over the study period.

  2. Evaluation of an integrated system for classification, assessment and comparison of services for long-term care in Europe: the eDESDE-LTC study

    PubMed Central

    2013-01-01

    Background The harmonization of European health systems brings with it a need for tools to allow the standardized collection of information about medical care. A common coding system and standards for the description of services are needed to allow local data to be incorporated into evidence-informed policy, and to permit equity and mobility to be assessed. The aim of this project has been to design such a classification and a related tool for the coding of services for Long Term Care (DESDE-LTC), based on the European Service Mapping Schedule (ESMS). Methods The development of DESDE-LTC followed an iterative process using nominal groups in 6 European countries. 54 researchers and stakeholders in health and social services contributed to this process. In order to classify services, we use the minimal organization unit or “Basic Stable Input of Care” (BSIC), coded by its principal function or “Main Type of Care” (MTC). The evaluation of the tool included an analysis of feasibility, consistency, ontology, inter-rater reliability, Boolean Factor Analysis, and a preliminary impact analysis (screening, scoping and appraisal). Results DESDE-LTC includes an alpha-numerical coding system, a glossary and an assessment instrument for mapping and counting LTC. It shows high feasibility, consistency, inter-rater reliability and face, content and construct validity. DESDE-LTC is ontologically consistent. It is regarded by experts as useful and relevant for evidence-informed decision making. Conclusion DESDE-LTC contributes to establishing a common terminology, taxonomy and coding of LTC services in a European context, and a standard procedure for data collection and international comparison. PMID:23768163

  3. Evaluation of Short-Term and Long-Term Migration Testing from Can Coatings into Food Simulants: Epoxy and Acrylic-Phenolic Coatings.

    PubMed

    Paseiro-Cerrato, Rafael; DeVries, Jonathan; Begley, Timothy H

    2017-03-29

    Traditionally, migration testing during 10 days at 40 °C has been considered sufficient and appropriate for simulating the potential migration of substances from food-contact materials into foods. However, some packages, such as food cans, may be stored holding food for extended time periods (years). This study attempts to verify whether common testing conditions accurately estimate long-term migration. Two types of can coatings, epoxy and acrylic-phenolic, were subjected to short-term and long-term migration testing (1 day-1.5 years) using food simulants (water, 3% acetic acid, 50% ethanol, and isooctane) at 40 °C. Using HPLC-DAD/CAD, HPLC-MS, UHPLC-HRMS (where HRMS is accurate mass, mass spectrometry), and DART-HRMS, we identified potential migrants before starting the experiment: BPA, BADGE, BADGE derivatives, benzoguanamine, and other relevant marker compounds. During the experiment using a water-based food simulant, migrants remained stable. Most of the cans in contact with 3% acetic acid did not survive the experimental conditions. Tracked migrants were not detected in isooctane. In the presence of 50% ethanol, the traditional migration test during 10 days at 40 °C did not predict migration during long-term storage. These results suggest that migration protocols should be modified to account for long-term storage.

  4. IN SITU SOURCE TREATMENT OF CR(VI) USING A FE(II)-BASED REDUCTANT BLEND: LONG-TERM MONITORING AND EVALUATION

    EPA Science Inventory

    The long-term effectiveness of a FeSO4 + Na2S2O4 reductant solution blend for in situ saturated zone treatment of dissolved and solid phase Cr(VI) in a high pH chromite ore processing solid waste (COPSW) fill material was investigated. Two field pilot injection studies were cond...

  5. Evaluating long-term relationship of protein sequence by use of D-interval conditional probability and its impact on protein structural class prediction.

    PubMed

    Gu, Fei; Chen, Hang

    2009-01-01

    To fix the large and expanding gap between sequence known proteins and structure known proteins, it is important to study on protein structural class prediction (PSCP) for its foundation and usefulness in protein structure analysis. In this paper, the d-interval conditional probability index was proposed to reflect the long-term correlation between amino acids. Based on this index, the impact of residues' long-term relationship on PSCP was analyzed. Two new information theory based algorithms were proposed and were used combining with the long-term information between residues to predict protein structural class (PSC). The dataset 5714 was tested for its low sequence similarity and high reliability. The result showed that the new index was 3-6% higher than traditional index by use of the same algorithms, and the PSCP accuracy was 4-10% improved using the new algorithms. The presented index, algorithms and the long-term relationship of residues on PSCP can be extensively applied in other sequence based protein structure analysis.

  6. Design and Formative Evaluation of the Policy Liaison Initiative: A Long-Term Knowledge Translation Strategy to Encourage and Support the Use of Cochrane Systematic Reviews for Informing

    ERIC Educational Resources Information Center

    Brennan, Sue E.; Cumpston, Miranda; Misso, Marie L.; McDonald, Steve; Murphy, Matthew J.; Green, Sally E.

    2016-01-01

    The Policy Liaison Initiative (PLI) is a long-term knowledge translation initiative designed to support the use of Cochrane systematic reviews in health policy. A joint initiative between the Australasian Cochrane Centre and Australian Government Department of Health and Ageing, the PLI includes: 1) a community of practice for evidence-informed…

  7. Effects of Long-Term Low-Level Radiofrequency Radiation Exposure on Rats. Volume 8. Evaluation of Longevity, Cause of Death, and Histopathological Findings.

    DTIC Science & Technology

    1985-04-01

    relatively short and few animal~s have been exposed; thus little insight has been gained into questions about potential * long-term cutmulative biological...lymph nodes, muscles, head of the S femur, and exposed joint cavity. C. Examine the mammary glands (may be found in some male rats). D. Open prepuce

  8. Long-term parenteral nutrition

    PubMed Central

    Ladefoged, Karin; Jarnum, Stig

    1978-01-01

    Nineteen patients (11 women and eight men) aged 20-68 received long-term parenteral nutrition, mostly at home, for six to 63 months (mean 19 months). Indications for LTPN were extensive, active Crohn's disease in three patients, intestinocutaneous fistulas in three, and short-bowel syndrome in the remaining 13 patients. Subclavian or intra-atrial (Broviac) catheters were most commonly used, for which the average life was four and seven months respectively. Complications of long-term parenteral nutrition included pneumothorax in four out of 48 subclavian vein punctures. Catheter-induced thrombosis of central veins was shown by phlebography 17 times in nine patients, and eight episodes of total occlusion occurred. Two of these patients had pulmonary infarction. Nineteen episodes of catheter sepsis occurred in 11 patients, but only one was fatal. Complications related to intestinal disease included intra-abdominal abscesses and intestinal fistulas, and disturbances of liver function. Five patients died, though in only two was death related to long-term parenteral nutrition. One of these patients died from catheter sepsis, the other had subdural haematoma possibly caused by anticoagulant treatment. Eight of the 14 surviving patients still needed parenteral nutrition. All received a disability pension, but six had an acceptable quality of life with almost normal social activities. Despite problems such as difficulties in maintaining standardised infusion programmes, it was concluded that long-term parenteral nutrition at home is practicable and consistent with an acceptable quality of life. ImagesFIG 2 PMID:98199

  9. Long-term complications of splenectomy in adult immune thrombocytopenia

    PubMed Central

    Thai, Lan-Huong; Mahévas, Matthieu; Roudot-Thoraval, Françoise; Limal, Nicolas; Languille, Laetitia; Dumas, Guillaume; Khellaf, Mehdi; Bierling, Philippe; Michel, Marc; Godeau, Bertrand

    2016-01-01

    Abstract The recent large decrease in splenectomy use for chronic immune thrombocytopenia (ITP) is partly due to still-unsolved questions about long-term safety. We performed the first single-center exposed/unexposed cohort study evaluating the long-term incidence of splenectomy complications in patients with primary ITP. Overall, 83 patients who underwent splenectomy more than 10 years ago (exposed) were matched with 83 nonsplenectomized patients (unexposed) on the date of ITP diagnosis ±5 years, age and gender. After a median follow-up of 192 months (range 0.5–528), 43 patients (52%) achieved overall response after splenectomy. Splenectomized patients experienced more venous thromboembolism (VTE) than controls (n = 13 vs n = 2, P = 0.005). On multivariate analysis, splenectomy was an independent risk factor of VTE (hazard ratio = 4.006, P = 0.032 [95% confidence interval: 1.13–14.21]). Splenectomized patients presented more severe infections on long-term follow-up: all required hospitalization, and 5/26 (19%) infections led to severe sepsis or septic shock and to death for 3 cases (none in controls). However, the incidence of malignancy was similar in both groups, as was cardiovascular risk, which appeared to be related more to ITP than splenectomy. Finally, splenectomy did not significantly decrease overall survival. Despite the risk of thrombosis and severe sepsis, splenectomy remains an effective and curative treatment for ITP. PMID:27902585

  10. A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain.

    PubMed

    Hoggart, B; Ratcliffe, S; Ehler, E; Simpson, K H; Hovorka, J; Lejčko, J; Taylor, L; Lauder, H; Serpell, M

    2015-01-01

    Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.

  11. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy.

    PubMed

    Taniwaki, Masanori; Radu, Maria D; Garcia-Garcia, Hector M; Heg, Dik; Kelbæk, Henning; Holmvang, Lene; Moschovitis, Aris; Noble, Stephane; Pedrazzini, Giovanni; Saunamäki, Kari; Dijkstra, Jouke; Landmesser, Ulf; Wenaweser, Peter; Meier, Bernhard; Stefanini, Giulio G; Roffi, Marco; Lüscher, Thomas F; Windecker, Stephan; Räber, Lorenz

    2015-06-01

    We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared with the results from a cohort of 485 STEMI patients undergoing primary PCI without additional imaging. Imaging of the infarct-related artery at baseline (and follow-up) was successful in 92.2% (96.6%) of patients using OCT and in 93.2% (95.5%) using IVUS. Imaging of the non-infarct-related vessels was successful in 88.7% (95.6%) using OCT and in 90.5% (93.3%) using IVUS. Periprocedural complications occurred <2.0% of OCT and none during IVUS. There were no differences throughout 2 years between the imaging and control group in terms of MACE (16.7 vs. 13.3%, adjusted HR1.40, 95% CI 0.77-2.52, p = 0.27). Multi-modality three-vessel i.c. imaging in STEMI patients undergoing primary PCI is consistent a high degree of success and can be performed safely without impact on cardiovascular events at long-term follow-up.

  12. Long-term evaluation of three satellite ocean color algorithms for identifying harmful algal blooms (Karenia brevis) along the west coast of Florida: A matchup assessment

    PubMed Central

    Carvalho, Gustavo A.; Minnett, Peter J.; Banzon, Viva F.; Baringer, Warner; Heil, Cynthia A.

    2011-01-01

    We present a simple algorithm to identify Karenia brevis blooms in the Gulf of Mexico along the west coast of Florida in satellite imagery. It is based on an empirical analysis of collocated matchups of satellite and in situ measurements. The results of this Empirical Approach is compared to those of a Bio-optical Technique – taken from the published literature – and the Operational Method currently implemented by the NOAA Harmful Algal Bloom Forecasting System for K. brevis blooms. These three algorithms are evaluated using a multi-year MODIS data set (from July, 2002 to October, 2006) and a long-term in situ database. Matchup pairs, consisting of remotely-sensed ocean color parameters and near-coincident field measurements of K. brevis concentration, are used to assess the accuracy of the algorithms. Fair evaluation of the algorithms was only possible in the central west Florida shelf (i.e. between 25.75°N and 28.25°N) during the boreal Summer and Fall months (i.e. July to December) due to the availability of valid cloud-free matchups. Even though the predictive values of the three algorithms are similar, the statistical measure of success in red tide identification (defined as cell counts in excess of 1.5 × 104 cells L−1) varied considerably (sensitivity—Empirical: 86%; Bio-optical: 77%; Operational: 26%), as did their effectiveness in identifying non-bloom cases (specificity—Empirical: 53%; Bio-optical: 65%; Operational: 84%). As the Operational Method had an elevated frequency of false-negative cases (i.e. presented low accuracy in detecting known red tides), and because of the considerable overlap between the optical characteristics of the red tide and non-bloom population, only the other two algorithms underwent a procedure for further inspecting possible detection improvements. Both optimized versions of the Empirical and Bio-optical algorithms performed similarly, being equally specific and sensitive (~70% for both) and showing low levels of

  13. Brazilian network for the surveillance of maternal potentially life threatening morbidity and maternal near-miss and a multidimensional evaluation of their long term consequences

    PubMed Central

    Cecatti, Jose G; Souza, João P; Parpinelli, Mary A; Haddad, Samira M; Camargo, Rodrigo S; Pacagnella, Rodolfo C; Silveira, Carla; Zanardi, Dulce T; Costa, Maria L; Pinto e Silva, João L; Passini, Renato; Surita, Fernanda G; Sousa, Maria H; Calderon, Iracema MP; Say, Lale; Pattinson, Robert C

    2009-01-01

    Background It has been suggested that the study of women who survive life-threatening complications related to pregnancy (maternal near-miss cases) may represent a practical alternative to surveillance of maternal morbidity/mortality since the number of cases is higher and the woman herself is able to provide information on the difficulties she faced and the long-term repercussions of the event. These repercussions, which may include sexual dysfunction, postpartum depression and posttraumatic stress disorder, may persist for prolonged periods of time, affecting women's quality of life and resulting in adverse effects to them and their babies. Objective The aims of the present study are to create a nationwide network of scientific cooperation to carry out surveillance and estimate the frequency of maternal near-miss cases, to perform a multicenter investigation into the quality of care for women with severe complications of pregnancy, and to carry out a multidimensional evaluation of these women up to six months. Methods/Design This project has two components: a multicenter, cross-sectional study to be implemented in 27 referral obstetric units in different geographical regions of Brazil, and a concurrent cohort study of multidimensional analysis. Over 12 months, investigators will perform prospective surveillance to identify all maternal complications. The population of the cross-sectional component will consist of all women surviving potentially life-threatening conditions (severe maternal complications) or life-threatening conditions (the maternal near miss criteria) and maternal deaths according to the new WHO definition and criteria. Data analysis will be performed in case subgroups according to the moment of occurrence and determining cause. Frequencies of near-miss and other severe maternal morbidity and the association between organ dysfunction and maternal death will be estimated. A proportion of cases identified in the cross-sectional study will comprise

  14. Long-term evaluation of three satellite ocean color algorithms for identifying harmful algal blooms (Karenia brevis) along the west coast of Florida: A matchup assessment.

    PubMed

    Carvalho, Gustavo A; Minnett, Peter J; Banzon, Viva F; Baringer, Warner; Heil, Cynthia A

    2011-01-17

    We present a simple algorithm to identify Karenia brevis blooms in the Gulf of Mexico along the west coast of Florida in satellite imagery. It is based on an empirical analysis of collocated matchups of satellite and in situ measurements. The results of this Empirical Approach is compared to those of a Bio-optical Technique - taken from the published literature - and the Operational Method currently implemented by the NOAA Harmful Algal Bloom Forecasting System for K. brevis blooms. These three algorithms are evaluated using a multi-year MODIS data set (from July, 2002 to October, 2006) and a long-term in situ database. Matchup pairs, consisting of remotely-sensed ocean color parameters and near-coincident field measurements of K. brevis concentration, are used to assess the accuracy of the algorithms. Fair evaluation of the algorithms was only possible in the central west Florida shelf (i.e. between 25.75°N and 28.25°N) during the boreal Summer and Fall months (i.e. July to December) due to the availability of valid cloud-free matchups. Even though the predictive values of the three algorithms are similar, the statistical measure of success in red tide identification (defined as cell counts in excess of 1.5 × 10(4) cells L(-1)) varied considerably (sensitivity-Empirical: 86%; Bio-optical: 77%; Operational: 26%), as did their effectiveness in identifying non-bloom cases (specificity-Empirical: 53%; Bio-optical: 65%; Operational: 84%). As the Operational Method had an elevated frequency of false-negative cases (i.e. presented low accuracy in detecting known red tides), and because of the considerable overlap between the optical characteristics of the red tide and non-bloom population, only the other two algorithms underwent a procedure for further inspecting possible detection improvements. Both optimized versions of the Empirical and Bio-optical algorithms performed similarly, being equally specific and sensitive (~70% for both) and showing low levels of

  15. Pesticide residues in leafy vegetables, stalk and stem vegetables from South Korea: a long-term study on safety and health risk assessment.

    PubMed

    Park, Duck Woong; Kim, Kwang Gon; Choi, Eun Ah; Kang, Gyeong Ri; Kim, Tae Sun; Yang, Yong Shik; Moon, Su Jin; Ha, Dong Ryong; Kim, Eun Sun; Cho, Bae Sik

    2016-01-01

    South Korea has a unique food culture. South Koreans enjoy wrapping meat and eating or making kimchi (traditionally fermented Korean food) and eating using raw leafy vegetables, stalk and stem vegetables. Therefore, there is a high chance of being exposed to pesticide residues of vegetables. The objective of this study was to investigate pesticide residues in leafy vegetables, stalk and stem vegetables from South Korea. A total of 8496 samples were mainly collected from Gwangju and Jeonnam area (the largest production region of leafy vegetables, stalk and stem vegetables) in South Korea from 2010 to 2014. A total of 230 pesticides were used for multi-residue analysis of pesticides. Among 8496 samples, 61 different pesticides (1029 times) were detected in 890 samples, of which 118 samples (1.4%) exceeded the Korea maximum residue limits (MRLs). Samples exceeding the MRLs were mostly found in leafy vegetables (brassica lee ssp. namai, leafy lettuce, spinach, perilla leaves, crown daisy, marsh mallow, aster scaber, pimpinella brachycarpa) and Chinese chive. Procymidone, dimethomorph and azoxystrobin were the most frequently found pesticides. A risk assessment of pesticides exceeding the MRLs was evaluated by calculating the estimated daily intake (EDI) and the acceptable daily intake (ADI). The ratio of EDI to ADI was 0.003-30.4%.

  16. Long-term data archiving

    SciTech Connect

    Moore, David Steven

    2009-01-01

    Long term data archiving has much value for chemists, not only to retain access to research and product development records, but also to enable new developments and new discoveries. There are some recent regulatory requirements (e.g., FDA 21 CFR Part 11), but good science and good business both benefit regardless. A particular example of the benefits of and need for long term data archiving is the management of data from spectroscopic laboratory instruments. The sheer amount of spectroscopic data is increasing at a scary rate, and the pressures to archive come from the expense to create the data (or recreate it if it is lost) as well as its high information content. The goal of long-term data archiving is to save and organize instrument data files as well as any needed meta data (such as sample ID, LIMS information, operator, date, time, instrument conditions, sample type, excitation details, environmental parameters, etc.). This editorial explores the issues involved in long-term data archiving using the example of Raman spectral databases. There are at present several such databases, including common data format libraries and proprietary libraries. However, such databases and libraries should ultimately satisfy stringent criteria for long term data archiving, including readability for long times into the future, robustness to changes in computer hardware and operating systems, and use of public domain data formats. The latter criterion implies the data format should be platform independent and the tools to create the data format should be easily and publicly obtainable or developable. Several examples of attempts at spectral libraries exist, such as the ASTM ANDI format, and the JCAMP-DX format. On the other hand, proprietary library spectra can be exchanged and manipulated using proprietary tools. As the above examples have deficiencies according to the three long term data archiving criteria, Extensible Markup Language (XML; a product of the World Wide Web

  17. An evaluation study of the determinants of future perspective and global Quality of Life in Spanish long-term premenopausal early-stage breast cancer survivors

    PubMed Central

    Illarramendi, Jose Juan; Salgado, Esteban; de la Cruz, Susana; Asin, Gemma; Manterola, Ana; Ibañez, Berta; Zarandona, Uxue; Dominguez, Miguel Angel; Vera, Ruth

    2016-01-01

    Aim of the study Quality of life (QL) is important in premenopausal long-term breast cancer survivors. In this study we assessed QL and factors associated with future perspective and global QL in premenopausal early-stage long-term breast cancer survivors from Spain. Material and methods 243 premenopausal stage I-IIIA relapse-free breast cancer patients who had received surgery 5–20 years previously completed EORTC QLQ-C30 and QLQ-BR23 questionnaires once during follow-up. Univariate and multivariate logistic regression analyses were performed. Results QL mean scores were high in most areas (> 80 in functioning; < 20 in symptoms). The main factors for future perspective were emotional and social functioning, fatigue, breast symptom, and body image. The main factors for global QL were fatigue, pain and physical functioning, and emotional and social functioning. The best logistic model to explain future perspective associated high emotional and social functioning and low breast symptoms with a lower risk of low future perspective (R2 = 0.56). Higher scores in physical and emotional functioning and lower scores in fatigue were associated with a lower risk of low global QL (R2 = 0.50). Conclusions Psychological, social, and physical factors were found to be possible determinants of global QL and future perspective. QL in premenopausal early-stage long-term breast cancer survivors may benefit from multidisciplinary treatment. PMID:27358597

  18. Evaluation of the CENTURY model using long-term fertilization trials under corn-wheat cropping systems in the typical croplands of China.

    PubMed

    Cong, Rihuan; Wang, Xiujun; Xu, Minggang; Ogle, Stephen M; Parton, William J

    2014-01-01

    Soil organic matter models are widely used to study soil organic carbon (SOC) dynamics. Here, we used the CENTURY model to simulate SOC in wheat-corn cropping systems at three long-term fertilization trials. Our study indicates that CENTURY can simulate fertilization effects on SOC dynamics under different climate and soil conditions. The normalized root mean square error is less than 15% for all the treatments. Soil carbon presents various changes under different fertilization management. Treatment with straw return would enhance SOC to a relatively stable level whereas chemical fertilization affects SOC differently across the three sites. After running CENTURY over the period of 1990-2050, the SOC levels are predicted to increase from 31.8 to 52.1 Mg ha-1 across the three sites. We estimate that the carbon sequestration potential between 1990 and 2050 would be 9.4-35.7 Mg ha-1 under the current high manure application at the three sites. Analysis of SOC in each carbon pool indicates that long-term fertilization enhances the slow pool proportion but decreases the passive pool proportion. Model results suggest that change in the slow carbon pool is the major driver of the overall trends in SOC stocks under long-term fertilization.

  19. Long-term management of prolactinomas.

    PubMed

    Schlechte, Janet A

    2007-08-01

    Prolactinomas are a frequent cause of gonadal dysfunction and infertility, especially in young women. The regulation of prolactin secretion and the efficacy of dopamine agonists in the therapy of prolactinomas are well established. The current challenges in management of prolactinomas are related to follow-up after successful therapy. Issues and questions to be addressed in this approach to long-term management of prolactinomas include the frequency of radiographic monitoring, effect of pregnancy and menopause, safety of estrogen in women taking oral contraceptives, and the potential for discontinuation of dopamine agonist therapy.

  20. Performance considerations in long-term spaceflight

    NASA Technical Reports Server (NTRS)

    Akins, F. R.

    1979-01-01

    Maintenance of skilled performance during extended space flight is of critical importance to both the health and safety of crew members and to the overall success of mission goals. An examination of long term effects and performance requirements is therefore a factor of immense importance to the planning of future missions. Factors that were investigated include: definition of performance categories to be investigated; methods for assessing and predicting performance levels; in-flight factors which can affect performance; and factors pertinent to the maintenance of skilled performance.

  1. Atorvastatin has cardiac safety at intensive cholesterol-reducing protocols for long term, yet its cancer-treatment doses with chemotherapy may cause cardiomyopathy even under coenzyme-Q10 protection.

    PubMed

    Caner, Metin; Sonmez, Bingur; Kurnaz, Ozlem; Aldemir, Caner; Salar, Seda; Altug, Tuncay; Bilir, Ayhan; Altinoz, Meric A

    2007-01-01

    Statins provide strong clinical benefits via reducing stroke deaths, and they are also considered for tumor reduction and chemo-sensitization. High dose atorvastatin in adults (80 mg daily, approx. 1 mg/kg) is proven to afford greater protection against cardiac deaths than does a standard lipid-lowering dose in coronary syndrome. For cancer trials, mega doses up to 30 mg/kg have been used for short term treatments but neither a high nor a mega-dose of atorvastatin has been tested for long term cardiac safety. This may be of special concern, since some animal studies showed deleterious effects of statins on cardiac tissue, which may be related with coenzymeQ (CoQ) depletion. We performed an electron microscopic analysis of rat hearts after low, high-or mega-dose atorvastatin therapy and with or without MNU (methyl-nitrosourea)-stress. MNU + daily high dose atorvastatin treatment for 13 months did not produce severe cardiac toxicity with CoQ. However, at mega doses (30 mg/kg) and with MNU, mitochondrial damage and myofibrillary disintegration was obvious. Strong proliferation of mitochondria under high dose atorvastatin therapy with CoQ may explain the lack of cardiotoxicity; and this finding seems to parallel recent data that statins induce HNF-4 and PPAR-alpha, both responsible for mitochondria-proliferation. Employment of statins for tumor chemo-sensitization at high-dosage and for long term treatments may require strategies to direct the mevalonate-entry differentially into cardiac and tumor cells and to develop a protocol analogous to folic acid salvage of methotrexate toxicity.

  2. Low-frequency rTMS in patients with subacute ischemic stroke: clinical evaluation of short and long-term outcomes and neurophysiological assessment of cortical excitability

    PubMed Central

    Blesneag, AV; Slăvoacă, DF; Popa, L; Stan, AD; Jemna, N; Isai Moldovan, F; Mureșanu, DF

    2015-01-01

    Rationale: Repetitive transcranial magnetic stimulation (rTMS) is used alone or in combination with physiotherapy for rehabilitation of stroke patients. TMS mapping can also quantify the excitability of the motor area in both the ipsilesional (IL) and contralateral (CL) hemisphere. Objective: This study is the first to measure the dynamics of cortical excitability by TMS mapping before and after treatment with low-frequency (LF) rTMS in the contralesional hemisphere at three different timepoints. Furthermore, the patients were clinically evaluated during the same visit as the mapping to establish both short and long-term outcomes after rTMS treatment. Methods and Results: A total of 16 participants with acute ischemic stroke were assessed 10 days post-stroke by TMS mapping. The patients were randomized into two equal groups: a real rTMS group and a sham group. The rTMS group received LF-rTMS to the contralesional hemisphere for 10 days, starting on the first day after the first mapping. Each subject was also evaluated by mapping on days 45 and 90 after stroke onset. The primary clinical outcome measured was the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) on days 10, 45 and 90 post-stroke. At 10 days after stroke onset, both groups presented low excitability in the lesion side and high excitability in the non-affected side. In the real rTMS group, at 45 days after stroke, a downward trend in the excitability of the contralesional hemisphere and an upward trend in the excitability of the lesioned side were observed. At 90 days after stroke, a tendency toward balanced excitability between both hemispheres was observed. In the sham group, at both 45 and 90 days, we observed increased excitability in the non-affected side compared to the side with the lesioned motor area. At 45 days, the real rTMS group demonstrated a better recovery of the upper limb motor function than the sham group, but at 90 days, there was no significant difference between the two groups

  3. What Is Essential in Developmental Evaluation? On Integrity, Fidelity, Adultery, Abstinence, Impotence, Long-Term Commitment, Integrity, and Sensitivity in Implementing Evaluation Models

    ERIC Educational Resources Information Center

    Patton, Michael Quinn

    2016-01-01

    Fidelity concerns the extent to which a specific evaluation sufficiently incorporates the core characteristics of the overall approach to justify labeling that evaluation by its designated name. Fidelity has traditionally meant implementing a model in exactly the same way each time following the prescribed steps and procedures. The essential…

  4. Subjective and objective peer approval evaluations and self-esteem development: A test of reciprocal, prospective, and long-term effects.

    PubMed

    Gruenenfelder-Steiger, Andrea E; Harris, Michelle A; Fend, Helmut A

    2016-10-01

    A large body of literature suggests a clear, concurrent association between peer approval and self-esteem in adolescence. However, little empirical work exists on either the prospective or reciprocal relation between peer approval and self-esteem during this age period. Moreover, it is unclear from past research whether both subjectively perceived peer approval and objectively measured peer approval are related to subsequent self-esteem over time (and vice versa) and whether these paths have long-term associations into adulthood. Using data from a large longitudinal study that covers a time span of 2 decades, we examined reciprocal, prospective relations between self-esteem and peer approval during ages 12-16 in addition to long-term relations between these variables and later social constructs at age 35. Cross-lagged regression analyses revealed small but persistent effect sizes from both types of peer approval to subsequent self-esteem in adolescence, controlling for prior self-esteem. However, effects in the reverse direction were not confirmed. These findings support the notion that peer relationships serve an important function for later self-esteem, consistent with many theoretical tenets of the importance of peers for building a strong identity. Finally, we found long-term relations between adult social constructs and adolescent objective and subjective peer approval as well as self-esteem. Therefore, not only do peer relationships play a role in self-esteem development across adolescence, but they remain impactful throughout adulthood. In sum, the current findings highlight the lasting, yet small link between peer relationships and self-esteem development and call for investigations of further influential factors for self-esteem over time. (PsycINFO Database Record

  5. Simulation of Long-Term Carbon and Nitrogen Dynamics in Grassland-Based Dairy Farming Systems to Evaluate Mitigation Strategies for Nutrient Losses.

    PubMed

    Shah, Ghulam Abbas; Groot, Jeroen C J; Shah, Ghulam Mustafa; Lantinga, Egbert A

    2013-01-01

    Many measures have been proposed to mitigate gaseous emissions and other nutrient losses from agroecosystems, which can have large detrimental effects for the quality of soils, water and air, and contribute to eutrophication and global warming. Due to complexities in farm management, biological interactions and emission measurements, most experiments focus on analysis of short-term effects of isolated mitigation practices. Here we present a model that allows simulating long-term effects at the whole-farm level of combined measures related to grassland management, animal housing and manure handling after excretion, during storage and after field application. The model describes the dynamics of pools of organic carbon and nitrogen (N), and of inorganic N, as affected by farm management in grassland-based dairy systems. We assessed the long-term effects of delayed grass mowing, housing type (cubicle and sloping floor barns, resulting in production of slurry and solid cattle manure, respectively), manure additives, contrasting manure storage methods and irrigation after application of covered manure. Simulations demonstrated that individually applied practices often result in compensatory loss pathways. For instance, methods to reduce ammonia emissions during storage like roofing or covering of manure led to larger losses through ammonia volatilization, nitrate leaching or denitrification after application, unless extra measures like irrigation were used. A strategy of combined management practices of delayed mowing and fertilization with solid cattle manure that is treated with zeolite, stored under an impermeable sheet and irrigated after application was effective to increase soil carbon stocks, increase feed self-sufficiency and reduce losses by ammonia volatilization and soil N losses. Although long-term datasets (>25 years) of farm nutrient dynamics and loss flows are not available to validate the model, the model is firmly based on knowledge of processes and

  6. Simulation of Long-Term Carbon and Nitrogen Dynamics in Grassland-Based Dairy Farming Systems to Evaluate Mitigation Strategies for Nutrient Losses

    PubMed Central

    Shah, Ghulam Abbas; Groot, Jeroen C.J.; Shah, Ghulam Mustafa; Lantinga, Egbert A.

    2013-01-01

    Many measures have been proposed to mitigate gaseous emissions and other nutrient losses from agroecosystems, which can have large detrimental effects for the quality of soils, water and air, and contribute to eutrophication and global warming. Due to complexities in farm management, biological interactions and emission measurements, most experiments focus on analysis of short-term effects of isolated mitigation practices. Here we present a model that allows simulating long-term effects at the whole-farm level of combined measures related to grassland management, animal housing and manure handling after excretion, during storage and after field application. The model describes the dynamics of pools of o