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Sample records for long-term safety study

  1. 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

  2. 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.

  3. 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. PMID:25220180

  4. Long-term safety of retinoid therapy.

    PubMed

    Vahlquist, A

    1992-12-01

    The concern about long-term toxicity of oral synthetic retinoids has developed because many patients, especially those with genodermatoses, require lifelong therapy. Several organ systems are at risk, especially the hepatic, skeletal, and cardiovascular systems. Although acute hepatotoxicity is a rare side effect of etretinate and acitretin therapy, prospective studies have not demonstrated chronic liver toxicity. The frequency of bone changes induced by retinoids is difficult to estimate, because this adverse effect is usually asymptomatic and requires x-ray or scintigraphic examination for detection. Atherosclerosis develops in many patients who receive long-term retinoid therapy, but the extent to which the process is aggravated by drug-induced hyperlipidemia is not known. Many patients have now been treated with either etretinate or isotretinoin continuously for as many as 15 years and have not developed any signs of severe chronic toxicity. However, continued intense surveillance is recommended for patients expected to require lifelong therapy. PMID:1460122

  5. Long-term safety and efficacy of Gamma Knife surgery in classical trigeminal neuralgia: a 497-patient historical cohort study.

    PubMed

    Régis, Jean; Tuleasca, Constantin; Resseguier, Noémie; Carron, Romain; Donnet, Anne; Gaudart, Jean; Levivier, Marc

    2016-04-01

    OBJECT Gamma Knife surgery (GKS) is one of the surgical alternatives for the treatment of drug-resistant trigeminal neuralgia (TN). This study aims to evaluate the safety and efficacy of GKS in a large population of patients with TN with very long-term clinical follow-up. METHODS Between July 1992 and November 2010, 737 patients presenting with TN were treated using GKS. Data were collected prospectively and were further retrospectively evaluated at Timone University Hospital. The frequency and severity of pain, as well as trigeminal nerve function, were evaluated before GKS and regularly thereafter. Radiosurgery using the Gamma Knife (model B, C, 4C, or Perfexion) was performed with the help of both MR and CT targeting. A single 4-mm isocenter was positioned in the cisternal portion of the trigeminal nerve at a median distance of 7.6 mm (range 4-14 mm) anterior to the emergence of the nerve (retrogasserian target). A median maximum dose of 85 Gy (range 70-90 Gy) was prescribed. RESULTS The safety and efficacy are reported for 497 patients with medically refractory classical TN who were never previously treated by GKS and had a follow-up of at least 1 year. The median age in this series was 68.3 years (range 28.1-93.2 years). The median follow-up period was 43.8 months (range 12-174.4 months). Overall, 456 patients (91.75%) were initially pain free in a median time of 10 days (range 1-180 days). Their actuarial probabilities of remaining pain free without medication at 3, 5, 7, and 10 years were 71.8%, 64.9%, 59.7%, and 45.3%, respectively. One hundred fifty-seven patients (34.4%) who were initially pain free experienced at least 1 recurrence, with a median delay of onset of 24 months (range 0.6-150.1 months). However, the actuarial rate of maintaining pain relief without further surgery was 67.8% at 10 years. The hypesthesia actuarial rate at 5 years was 20.4% and at 7 years reached 21.1%, but remained stable until 14 years with a median delay of onset of 12

  6. A Study of the Safety and Efficacy of Calcipotriol and Betamethasone Dipropionate Scalp Formulation in the Long-Term Management of Scalp Psoriasis

    PubMed Central

    Luger, T.A.; Cambazard, F.; Larsen, F.G.; Bourcier, M.; Gupta, G.; Clonier, F.; Kidson, P.; Shear, N.H.

    2008-01-01

    Background Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g) for scalp psoriasis. Methods In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429) or calcipotriol (n = 440). Results Adverse drug reactions were less frequent in the two-compound group compared with the calcipotriol group (17.2 vs. 29.5%; p < 0.001). Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2.6%) and the calcipotriol (3.0%) groups. Disease was satisfactorily controlled in 92.3% of visits in the two-compound group versus 80.0% in the calcipotriol group (p < 0.001). Conclusion The two-compound scalp formulation demonstrated a high level of safety and efficacy in long-term management of scalp psoriasis. PMID:18787325

  7. Long-term efficacy and safety of human papillomavirus vaccination

    PubMed Central

    De Vincenzo, Rosa; Conte, Carmine; Ricci, Caterina; Scambia, Giovanni; Capelli, Giovanni

    2014-01-01

    In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines – bivalent (bHPV) and quadrivalent (qHPV) – are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman’s sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish

  8. The long-term safety and tolerability of ispaghula husk.

    PubMed

    Oliver, S D

    2000-06-01

    The safety and tolerability of ispaghula husk, which can now be used as an adjunct to diet for the treatment of mild-to-moderate hypercholesterolaemia, was assessed in 93 healthy subjects over a 52-week period. The study looked at the nutritional, biochemical, and haematological effects of ispaghula. Over the study period there were small but statistically significant changes in some measurements of minerals and vitamin levels, and in some haematological and biochemical parameters. However, none of these were of clinical significance, with the possible exception of changes in vitamin B12 levels. A daily dose of 10.5 g ispaghula was well tolerated and the majority of adverse events recorded were minor, of short duration and either unrelated or possibly related to the study treatment. The results suggest that ispaghula husk can be used with confidence for the long-term treatment of mild-to-moderate hypercholesterolaemia. PMID:10944885

  9. 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.

  10. 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.

  11. Long-term safety and efficacy of teriflunomide

    PubMed Central

    Comi, Giancarlo; Freedman, Mark S.; Miller, Aaron E.; Kappos, Ludwig; Bouchard, Jean-Pierre; Lebrun-Frenay, Christine; Mares, Jan; Benamor, Myriam; Thangavelu, Karthinathan; Liang, Jinjun; Truffinet, Philippe; Lawson, Victoria J.; Wolinsky, Jerry S.

    2016-01-01

    Objective: To report safety and efficacy outcomes from up to 9 years of treatment with teriflunomide in an extension (NCT00803049) of the pivotal phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563). Methods: A total of 742 patients entered the extension. Teriflunomide-treated patients continued the original dose; those previously receiving placebo were randomized 1:1 to teriflunomide 14 mg or 7 mg. Results: By June 2013, median (maximum) teriflunomide exposure exceeded 190 (325) weeks per patient; 468 patients (63%) remained on treatment. Teriflunomide was well-tolerated with continued exposure. The most common adverse events (AEs) matched those in the core study. In extension year 1, first AEs of transient liver enzyme increases or reversible hair thinning were generally attributable to patients switching from placebo to teriflunomide. Approximately 11% of patients discontinued treatment owing to AEs. Twenty percent of patients experienced serious AEs. There were 3 deaths unrelated to teriflunomide. Soon after the extension started, annualized relapse rates and gadolinium-enhancing T1 lesion counts fell in patients switching from placebo to teriflunomide, remaining low thereafter. Disability remained stable in all treatment groups (median Expanded Disability Status Scale score ≤2.5; probability of 12-week disability progression ≤0.48). Conclusions: In the TEMSO extension, safety observations were consistent with the core trial, with no new or unexpected AEs in patients receiving teriflunomide for up to 9 years. Disease activity decreased in patients switching from placebo and remained low in patients continuing on teriflunomide. Classification of evidence: This study provides Class III evidence that long-term treatment with teriflunomide is well-tolerated and efficacy of teriflunomide is maintained long-term. PMID:26865517

  12. Long-term food consumption and body weight changes in neotame safety studies are consistent with the allometric relationship observed for other sweeteners and during dietary restrictions.

    PubMed

    Flamm, W Gary; Blackburn, George L; Comer, C Phil; Mayhew, Dale A; Stargel, W Wayne

    2003-10-01

    In long-term safety studies with neotame, a new high-intensity sweetener 7000-13,000 times sweeter than sucrose, the percent changes (%Delta) in body weight gain (BWG) in Sprague-Dawley rats were several-fold greater than the %Delta in overall food consumption (FC). This study investigates the question of whether the changes in BWG were adverse or secondary to small, long-term decrements in FC. The hypothesis tested in Sprague-Dawley rats was that the relationship between long-term %Delta in FC and %Delta in BWG is linear and in a ratio of 1:1. The %Delta in FC were compared to %Delta in BWG after 52 weeks on study in one saccharin (825 rats), two sucralose (480 rats), two neotame (630 rats), and five dietary restriction (>1000 rats) studies. Non-transformed plotting of data points demonstrated an absence of linearity between %Delta in FC and %Delta in BWG; however, log-log evaluation demonstrated a robust (R2=0.97) linear relationship between %Delta in FC and %Delta in BWG. This relationship followed the well-known allometric equation, y=bxa where x is %DeltaFC, y is %DeltaBWG, b is %DeltaBWG when DeltaFC=1, and a is the log-log slope. Thus, in Sprague-Dawley rats at week 52, the long-term relationship between %Delta in FC and %Delta in BWG was determined to be: %DeltaBWG=3.45(%DeltaFC0.74) for males and %DeltaBWG=5.28(%DeltaFC0.68) for females. Sexes were statistically different but study types, i.e., the high-intensity sweeteners saccharin and sucralose versus dietary restriction, were not. The %Delta in BWG are allometrically consistent with the observed %Delta in FC for these high-intensity sweeteners, including neotame. BW parameters are not appropriate endpoints for setting no-observed-effect levels (NOELs) when materials with intense taste are admixed into food. An approach using objective criteria is proposed to delineate BW changes due to toxicity from those secondary to reduced FC. PMID:14550756

  13. 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

  14. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study.

    PubMed

    Neutel, Joel M; Giles, Thomas D; Punzi, Henry; Weiss, Robert J; Li, Huiling; Finck, Amy

    2014-12-01

    Long-term safety of a free-tablet combination of nebivolol and valsartan was assessed in a Phase III, open-label trial (NCT01415505). Adults with hypertension entered a 4-week placebo run-in phase, followed by a 52-week treatment phase. Initial dosage (Neb/Val 5/160 mg/d) was titrated up to 20/320 mg/d to achieve blood pressure (BP) goal (JNC7 criteria), with the addition of hydrochlorothiazide (up to 25 mg/d) if needed. Safety and tolerability parameters included adverse events. Efficacy assessments included baseline-to-endpoint change in diastolic BP and systolic BP and the percentage of patients who achieved BP goal. All analyses were performed using descriptive statistics. Study completion rate was 60.4% (489/810). The most frequent reason for discontinuation was insufficient therapeutic response (8.4%). Adverse events were experienced by 59.2% of patients, with the most common being headache (5.7%), nasopharyngitis (5.0%), and upper respiratory tract infection (4.6%). Three (0.4%) deaths occurred during the study; none was considered related to study medication. Mean ± standard deviation changes from baseline at week 52 (observed cases) were -25.5 ± 15.9 mm Hg (systolic BP) and -19.0 ± 8.7 mm Hg (diastolic BP). A total of 75.7% nebivolol/valsartan-treated and 57.8% nebivolol/valsartan/hydrochlorothiazide-treated completers achieved BP goal. Long-term treatment with nebivolol and valsartan in adults with hypertension was safe and well-tolerated. PMID:25492835

  15. Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study

    PubMed Central

    Nishimoto, N; Miyasaka, N; Yamamoto, K; Kawai, S; Takeuchi, T; Azuma, J

    2009-01-01

    Objectives: To evaluate the safety and efficacy of 5-year, long-term tocilizumab monotherapy for patients with rheumatoid arthritis. Methods: In an open-label, long-term extension trial following an initial 3-month randomised phase II trial, 143 of the 163 patients who participated in the initial blinded study received tocilizumab monotherapy (8 mg/kg) every 4 weeks. Concomitant therapy with non-steroidal anti-inflammatory drugs and/or oral prednisolone (10 mg daily maximum) was permitted. All patients were evaluated with American College of Rheumatology (ACR) improvement criteria, disease activity score (DAS) in 28 joints, and the European League Against Rheumatism response, as well as for safety issues. Results: 143 patients were enrolled in the open-label, long-term extension trial and 94 (66%) patients had completed 5 years as of March 2007. 32 patients (22%) withdrew from the study due to adverse events and one patient (0.7%) due to unsatisfactory response. 14 patients withdrew because of the patient’s request or other reasons. The serious adverse event rate was 27.5 events per 100 patient-years, with 5.7 serious infections per 100 patient-years, based on a total tocilizumab exposure of 612 patient-years. Of the 88 patients receiving corticosteroids at baseline, 78 (88.6%) were able to decrease their corticosteroid dose and 28 (31.8%) discontinued corticosteroids. At 5 years, 79/94 (84.0%), 65/94 (69.1%) and 41/94 (43.6%) of the patients achieved ACR20, ACR50, and ACR70 improvement criteria, respectively. Remission defined as DAS28 less than 2.6 was achieved in 52/94 (55.3%) of the patients. Conclusion: In this 5-year extension study, tocilizumab demonstrated sustained long-term efficacy and a generally good safety profile. PMID:19019888

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

    PubMed Central

    Nalamachu, Srinivas; Rauck, Richard L; Hale, Martin E; Florete, Orlando G; Robinson, Cynthia Y; Farr, Stephen J

    2014-01-01

    Objective To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. Methods This multicenter, open-label study started with a conversion/titration phase (≤6 weeks) where subjects (n=638) were converted to individualized doses (range 20–300 mg) of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424). The primary objective (safety and tolerability) and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain) were monitored throughout the study. Results Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator’s discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%), nausea (10.7% and 9.9%), vomiting (4.1% and 9.7%), and somnolence (7.7% and 4.2%). Four deaths occurred during the study; all were considered unrelated to treatment. One subject died 13 months after the study ended. From the start to end of the conversion/titration phase, 84% of subjects had a clinically meaningful improvement in average pain score (≥30% improvement), and the mean average pain scores remained stable through the maintenance phase. Conclusion This single-entity, extended-release formulation of hydrocodone was generally safe, well tolerated, and effective in

  17. 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. PMID:10805203

  18. LONG TERM IN SITU DISPOSAL ENGINEERING STUDY

    SciTech Connect

    ADAMS; CARLSON; BROCKMAN

    2003-07-23

    Patent application pulled per Ken Norris (FH General Counsel). The objective of this study is to devise methods, produce conceptual designs, examine and select alternatives, and estimate costs for the demonstration of long-term (300-year) in situ disposal of an existing waste disposal site. The demonstration site selected is the 216-A-24 Crib near the 200 East Area. The site contains a fission product inventory and has experienced plant, animal, and inadvertent than intrusion. Of the potential intrusive events and transport pathways at the site, potential human intrusion has been given primary consideration in barrier design. Intrusion by wind, plants, and animals has been given secondary consideration. Groundwater modeling for a number of barrier configurations has been carried out to help select a barrier that will minimize water infiltration and waste/water contact time. The estimated effective lifetime and cost of 20 barrier schemes, using a variety of materials, have been evaluated. The schemes studied include single component surface barriers, multicomponent barriers, and massively injected grout barriers. Five barriers with high estimated effective lifetimes and relatively low costs have been selected for detailed evaluation. They are basalt riprap barriers, massive soil barriers, salt basin barriers, multi-component fine/coarse barriers, and cemented basalt barriers. A variety of materials and configurations for marking the site have also been considered. A decision analysis was completed to select a barrier scheme for demonstration. The analysis indicated that the basalt riprap alternative would be the preferred choice for a full-scale demonstration. The recommended approach is to demonstrate the basalt riprap barrier at the 216-A-24 Crib as soon as possible. Methods and costs of assessing effectiveness of the demonstration are also described. Preliminary design modifications and costs for applying the five selected barrier schemes to other site types are

  19. Long-term safety issues associated with mixer pump operation

    SciTech Connect

    Kubic, W.L. Jr.

    1994-12-31

    In this report, we examine several long-term issues: the effect of pump operation on future gas release events (GREs), uncontrolled chemical reactions, chronic toxic gas releases, foaming, and erosion and corrosion. Heat load in excess of the design limit, uncontrolled chemical reactions, chronic toxic gas releases, foaming, and erosion and corrosion have been shown not to be safety concerns. The effect of pump operation on future GREs could not be quantified. The problem with evaluating the long-term effects of pump operation on GREs is a lack of knowledge and uncertainty. In particular, the phenomena governing gas retention, particle size distribution, and settling are not well understood, nor are the interactions among these factors understood. There is a possibility that changes in these factors could increase the size of future GREs. Bounding estimates of the potential increase in size of GREs are not possible because of a lack of engineering data. Proper management of the hazards can reduce, but not eliminate, the possibility of undesirable changes. Maintaining temperature within the historical limits can reduce the possibility of undesirable changes. A monitoring program to detect changes in the gas composition and crust thickness will help detect slowly occurring changes. Because pump operation has be shown to eliminate GREs, continued pump operation can eliminate the hazards associated with future GREs.

  20. Improved safety of biologic therapy for rheumatoid arthritis over the 8-year period since implementation in Japan: long-term results from a multicenter observational cohort study.

    PubMed

    Kojima, Toshihisa; Takahashi, Nobunori; Funahashi, Koji; Asai, Shuji; Terabe, Kenya; Kaneko, Atsushi; Hirano, Yuji; Hayashi, Masatoshi; Miyake, Hiroyuki; Oguchi, Takeshi; Takagi, Hideki; Kanayama, Yasuhide; Yabe, Yuichiro; Watanabe, Tsuyoshi; Fujibayashi, Takayoshi; Shioura, Tomone; Ito, Takayasu; Yoshioka, Yutaka; Ishikawa, Hisato; Asai, Nobuyuki; Takemoto, Toki; Kojima, Masayo; Ishiguro, Naoki

    2016-04-01

    This study aimed to compare the long-term safety of biologics by initiation year of treatment in patients with rheumatoid arthritis (RA) in Japan. RA patients who started their first biologics including infliximab, etanercept, adalimumab, and tocilizumab between 2003 and 2008 were identified in the Tsurumai Biologics Communication Registry (TBCR), multicenter observational cohort, and followed for 2 years or until discontinuation of the drugs. We identified baseline predictors for adverse events (AEs) resulting in discontinuation of the first TNFI using Cox proportional hazards regression analysis. A total of 874 cases (1,340 person-years) were observed. During the observation period, 96 AEs (4.7 events/100 person-years) occurred. From 2003 to 2008, there were significant changes in disease duration, Steinbrocker stage, and disease activity in those aged ≤64 years with no increase of incidence of AEs, whereas those aged >64 years had no significant changes in these variables. In the later initiation year of treatment with biologics, the fewer AEs were observed (log-rank, p = 0.017, 2008 vs. 2003-2005). Multivariate analysis showed that the initiation year significantly impacted the incidence of AEs 6 months into the observation period [initiation at 2008 (vs. 2003-2005): OR: 0.30, 95 % CI: (0.14-0.68)] after adjusting for variables at baseline. The decrease of AEs in the later initiation year was evident in those aged >64 years. The safety of biologic therapy improved over the course of the 8 years from its implementation in Japan. PMID:26846135

  1. 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)

  2. Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid® efficacy and long-term safety study

    PubMed Central

    Gugliotta, Luigi; Besses, Carlos; Griesshammer, Martin; Harrison, Claire; Kiladjian, Jean-Jacques; Coll, Ruth; Smith, Jonathan; Abhyankar, Brihad; Birgegård, Gunnar

    2014-01-01

    Available information is limited regarding the use of cytoreductive combination therapy in high-risk patients with essential thrombocythemia. This analysis aims to evaluate the clinical relevance and patterns of cytoreductive combination treatment in European high-risk patients with essential thrombocythemia in the Evaluation of Xagrid® Efficacy and Long-term Safety study. Of 3643 patients, 347 (9.5%) received combination therapy. Data were recorded at each 6-month update. Of 347 patients who received combination therapy, 304 (87.6%) received hydroxycarbamide + anagrelide. Monotherapies received before this combination were hydroxycarbamide (n=167, 54.9%) and anagrelide (n=123, 40.5%). Median weekly doses of hydroxycarbamide and anagrelide were: 7000 and 10.5 mg when used as prior monotherapy; 3500 and 7.0 mg when used as add-on treatment. Overall, median platelet counts were 581×109/L and 411×109/L before and after starting hydroxycarbamide + anagrelide, respectively. In patients with paired data (n=153), the number of patients with platelet counts less than 400×109/L increased from 33 (21.6%) to 74 (48.4%; P<0.0001), and with platelet counts less than 600×109/L, from 82 (53.6%) to 132 (86.3%; P<0.0001). Hydroxycarbamide + anagrelide was discontinued in 158 patients: 76 (48.1%) stopped hydroxycarbamide, 59 (37.3%) stopped anagrelide, 19 (12.0%) stopped both and 4 (2.5%) had another therapy added. The most frequent reasons for discontinuation were intolerance/side-effects, lack of efficacy, and therapeutic strategy. Combination therapy, usually hydroxycarbamide + anagrelide, is used in approximately 10% of all high-risk patients with essential thrombocythemia and may be a useful approach in treating patients for whom monotherapy is unsatisfactory. (Clinicaltrials.gov identifier:NCT00567502) PMID:24334294

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

    PubMed Central

    Elalouf, Ofir; Elkayam, Ori

    2015-01-01

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

  4. [Drug-eluting stents: long-term safety].

    PubMed

    Karpov, Iu A; Samko, A N; Buza, V V

    2009-01-01

    The review concerns the problem of late thromboses of drug-eluting stents and their influence on late prognosis of the patients; presents long-term results of the trial of sirolimus-eluting stents implanted to patients with coronary heart disease; analyses mechanisms of development of late stent thrombosis, data from different meta-analyses and registers comparing long-term outcomes in patients with implanted sirolimus-eluting stents and metallic stents; suggests risk factors of late thromboses of drug-eluting stents; presents original evidence on 3.5-year follow-up of patients with implanted sirolimus-eluting stents and metallic stents. PMID:19537584

  5. METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents – study protocol of a randomized controlled study

    PubMed Central

    2014-01-01

    Background The prevalence of childhood obesity and insulin resistance is rising, increasing the risk of diabetes mellitus type 2. To prevent these complications, lifestyle intervention is the corner stone in treatment. However, long-term efficacy of lifestyle intervention is questionable. In addition to lifestyle intervention, pharmacological treatments have been explored. Metformin has been shown to be moderately effective to reduce BMI in obese adolescents with hyperinsulinemia. However, data on pharmacokinetics and long-term efficacy and safety are lacking as well as an evidence-based dosing regimen for this age group. The primary objective of the METFORMIN study is to determine the effect of adding metformin treatment to lifestyle intervention in reducing BMI in obese adolescents with insulin resistance. In addition, the pharmacokinetics of metformin in obese adolescents will be studied. Methods/design The METFORMIN study is a multi-centre prospective study that consists of two 18-month phases: a double-blind randomized placebo-controlled trial (part 1) and an open-label follow-up study (part 2). During part 1, the participants will be given metformin 1,000 mg or placebo twice daily and will be offered a lifestyle intervention programme; 144 participants will be included, 72 in each arm. Primary endpoints are reduction in body mass index, insulin resistance, and percentage body fat. Discussion This study will provide data on short- and long-term efficacy and safety of metformin and on the pharmacokinetics of metformin in obese adolescents. Trial registration ClinicalTrials.gov number NCT01487993; EudraCT nr. 2010-023980-17. Registration date: 06-01-2011 PMID:24899137

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

    PubMed Central

    Mitra, Monjori; Shah, Nitin; Faridi, MMA; Ghosh, Apurba; Sankaranarayanan, VS; 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. PMID:26018443

  7. 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. PMID:26018443

  8. Overview of short- and long-term tolerability and safety of brexpiprazole in patients with schizophrenia.

    PubMed

    Kane, John M; Skuban, Aleksandar; Hobart, Mary; Ouyang, John; Weiller, Emmanuelle; Weiss, Catherine; U Correll, Christoph

    2016-07-01

    Second-generation antipsychotics have demonstrated efficacy for patients with schizophrenia but are associated with wide-ranging side effects. Brexpiprazole, a serotonin-dopamine activity modulator, has demonstrated efficacy in adult patients with schizophrenia. This paper provides an overview of the safety and tolerability of brexpiprazole in patients with schizophrenia through examination of pooled safety data from one Phase 2 and two Phase 3 6-week, short-term studies, and two open-label, 52-week, long-term studies. In the short-term studies, there were no reports of treatment-emergent adverse events (TEAEs) with an incidence≥5% and twice that of placebo in patients treated with brexpiprazole 2-4mg. In the long-term studies, TEAEs reported by ≥5% of patients were schizophrenia (10.7%), insomnia (8.0%), weight increase (7.7%), headache (6.0%), and agitation (5.2%). Akathisia rates were low in the short- (5.8%, pooled brexpiprazole group) and long-term studies (4.6%). Sedation rates were low in the short- (2.3%, pooled brexpiprazole group) and long-term studies (0.9%). Mean body weight increase was 1.1kg in both short- and long-term studies. For all studies, changes from baseline to last visit in laboratory parameters, electrocardiogram values, and vital signs were small and not clinically relevant. Changes in lipid profiles or other metabolic parameters were also small. Collectively, these studies suggest that brexpiprazole was well tolerated, with a favorable safety profile that does not exhibit significant rates of important adverse events that can be seen with existing antipsychotics (akathisia, sedation, weight gain, or QTc prolongation), and therefore may provide a useful treatment option for patients with schizophrenia. ClinicalTrials.gov: NCT00905307; NCT01396421; NCT01393613; NCT01649557; NCT01397786. PMID:27188270

  9. Sensitivity Study for Long Term Reliability

    NASA Technical Reports Server (NTRS)

    White, Allan L.

    2008-01-01

    This paper illustrates using Markov models to establish system and maintenance requirements for small electronic controllers where the goal is a high probability of continuous service for a long period of time. The system and maintenance items considered are quality of components, various degrees of simple redundancy, redundancy with reconfiguration, diagnostic levels, periodic maintenance, and preventive maintenance. Markov models permit a quantitative investigation with comparison and contrast. An element of special interest is the use of conditional probability to study the combination of imperfect diagnostics and periodic maintenance.

  10. 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. PMID:26123954

  11. 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

  12. 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…

  13. 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 Central

    Landry, John; Detke, Holland C.

    2014-01-01

    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). PMID:24850228

  14. Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs

    PubMed Central

    Matsubara, Tsukasa; Urata, Yukitomo; Suematsu, Eiichi; Ohta, Shuji; Honjo, Shigeru; Abe, Tohru; Yamamoto, Ami; Miyasaka, Nobuyuki

    2014-01-01

    Objectives To examine the long-term safety of intravenous (IV) abatacept treatment in Japanese patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX) or other conventional or biologic disease-modifying antirheumatic drugs. Methods This Phase III, open-label, long-term study (NCT00484289) comprised Japanese patients with RA who had completed abatacept Phase I or Phase II studies, and new patients intolerant to MTX. Patients from Phase I and Phase II studies received a weight-tiered dosing equivalent of 10 mg/kg abatacept, with MTX at doses up to 8 mg/week; newly enrolled patients received weight-tiered 10 mg/kg abatacept monotherapy. Safety and efficacy were assessed. Results A total of 217 patients (Phase I, n = 13; Phase II, n = 178; newly enrolled, n = 26) were treated with IV abatacept for a mean of 3 years. Serious adverse events occurred in 67/217 (30.9%) patients. Most adverse events were mild or moderate. For all cohorts combined, American College of Rheumatology 20% response rates ranged from 61.3 to 81.8% for as-observed and last observation carried forward analyses over 192 weeks. Following initial response, clinical and functional outcomes were maintained for up to 3 years. Conclusions In Japanese patients with RA, IV abatacept with and without background MTX showed tolerable safety and sustained efficacy over 3 years. PMID:24754273

  15. An Empirical Study of Long Term Effects of Education.

    ERIC Educational Resources Information Center

    Harnqvist, Kjell

    A large-scale study of Swedish men and women, each of whose intelligence level at age 13 was above the 25th percentile and whose father's education was only at the elementary level, was conducted in order to determine what educational level the participants had achieved and to study long-term effects of schooling. Subjects were sent questionnaires…

  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. Experimental protocols and preparations to study respiratory long term facilitation

    PubMed Central

    Mateika, Jason H.; Sandhu, Kulraj S.

    2011-01-01

    Respiratory long-term facilitation is a form of neuronal plasticity that is induced following exposure to intermittent hypoxia. Long-term facilitation is characterized by a progressive increase in respiratory motor output during normoxic periods that separate hypoxic episodes and by a sustained elevation in respiratory activity for up to 90 min after exposure to intermittent hypoxia. This phenomenon is associated with increases in phrenic, hypoglossal or carotid sinus nerve inspiratory-modulated discharge. The examination of long-term facilitation has been steadily ongoing for approximately 3 decades. During this period of time a variety of animal models (e.g. cats, rats and humans), experimental preparations and intermittent hypoxia protocols have been used to study long-term facilitation. This review is designed to summarize the strengths and weaknesses of the models, preparations and protocols that have been used to study LTF over the past 30 years. The review is divided into two primary sections. Initially, the models and protocols used to study LTF in animals other than humans will be discussed, followed by a section specifically focused on human studies. Each section will begin with a discussion of various factors that must be considered when selecting an experimental preparation and intermittent hypoxia protocol to examine LTF. Model and protocol design recommendations will follow, with the goal of presenting a prevailing model and protocol that will ultimately ensure standardized comparisons across studies. PMID:21292044

  18. Long-term field studies: positive impacts and unintended consequences.

    PubMed

    Strier, Karen B

    2010-09-01

    Long-term field studies of wild primates can have far-reaching impacts that transcend their contributions to science. These impacts can benefit not only the study animals, study areas, and local human communities, but they can also have unintended, potentially negative consequences. Examples of some of the positive impacts from the Northern Muriqui Project of Caratinga, in Minas Gerais, Brazil, include contributions to conservation efforts on behalf of this critically endangered species, capacity building through the training of Brazilian students, and employment opportunities for local people through our collaboration with a locally administered NGO that is facilitating ecotourism, education, and reforestation programs. Some concerns about unintended consequences of the research include the effects of our trails and trail traffic on surrounding vegetation and other aspects of the environmental "footprints" that both long-term researchers and short-term visitors may leave. In addition, although precautions against potential health risks from routine exposure to human observers are now standard protocol, little is known about the other ways in which our long-term research presence can affect the primates' experiences or alter their perceptions of their social and ecological environments. Risk analysis, which weighs both the positive and negative impacts can provide useful perspectives for addressing the ethical considerations that can arise during long-term field studies. PMID:20653002

  19. Long-Term Impact of Service Learning in Environmental Studies

    ERIC Educational Resources Information Center

    MacFall, Janet

    2012-01-01

    Long-term impacts from a senior course in Environmental Studies were evaluated by a survey of program graduates (36 respondents, 50% response rate) who had participated in the course over an 8-year permiod. Each year, the Senior Seminar used a service-learning pedagogy with a different environmentally focused project ranging from web resource…

  20. 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

  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. PMID:24937440

  2. Porous high-density polyethylene in functional rhinoplasty: Excellent long-term aesthetic results and safety

    PubMed Central

    Kim, Young Hyo; Jang, Tae Young

    2014-01-01

    BACKGROUND: Experience with the use of porous high-density polyethylene (PHDPE) for reconstruction of the nasal framework has been limited. OBJECTIVE: To confirm the safety and utility of PHDPE by analyzing aesthetic outcomes and assessing the frequency of complication related to PHDPE in a large, population-based, long-term follow-up study. METHODS: A total of 151 patients who had undergone septoplasty and/or functional rhinoplasty using PHDPE were enrolled. PHDPE sheets were used for diverse purposes such as septal extension graft, spreader graft, columellar strut or dorsal augmentation graft. After a long-term follow-up period (mean [± SD] 39.5±27.8 months; range six to 101 months), postoperative aesthetic outcome was evaluated objectively (by independent surgeons) and subjectively (patient self-report). Complications related to PHDPE were estimated through review of medical records. RESULTS: The most common use of the PHDPE graft was for septal extension (n=80 [42.6%]) and spreader graft (n=58 [30.9%]). Results of aesthetic evaluation by surgeons were excellent in 61 cases (40.4%), good in 54 (35.8%) and fair in 34 (22.5%). According to patient self-report, 100 were ‘satisfied’ (66.2%) and 36 rated their new profile as ‘better than the preoperative profile’ (23.8%). Complications were reported in six cases (4.0% [five cases of extrusion and one case of infection]). All complications were resolved after the surgical removal of PHDPE sheets under local anesthesia. CONCLUSION: The present study demonstrated that PHDPE could be used in functional primary rhinoplasty with excellent long-term aesthetic results and safety. PMID:25152641

  3. Archiving Primary Data: Solutions for Long-Term Studies.

    PubMed

    Mills, James A; Teplitsky, Céline; Arroyo, Beatriz; Charmantier, Anne; Becker, Peter H; Birkhead, Tim R; Bize, Pierre; Blumstein, Daniel T; Bonenfant, Christophe; Boutin, Stan; Bushuev, Andrey; Cam, Emmanuelle; Cockburn, Andrew; Côté, Steeve D; Coulson, John C; Daunt, Francis; Dingemanse, Niels J; Doligez, Blandine; Drummond, Hugh; Espie, Richard H M; Festa-Bianchet, Marco; Frentiu, Francesca; Fitzpatrick, John W; Furness, Robert W; Garant, Dany; Gauthier, Gilles; Grant, Peter R; Griesser, Michael; Gustafsson, Lars; Hansson, Bengt; Harris, Michael P; Jiguet, Frédéric; Kjellander, Petter; Korpimäki, Erkki; Krebs, Charles J; Lens, Luc; Linnell, John D C; Low, Matthew; McAdam, Andrew; Margalida, Antoni; Merilä, Juha; Møller, Anders P; Nakagawa, Shinichi; Nilsson, Jan-Åke; Nisbet, Ian C T; van Noordwijk, Arie J; Oro, Daniel; Pärt, Tomas; Pelletier, Fanie; Potti, Jaime; Pujol, Benoit; Réale, Denis; Rockwell, Robert F; Ropert-Coudert, Yan; Roulin, Alexandre; Sedinger, James S; Swenson, Jon E; Thébaud, Christophe; Visser, Marcel E; Wanless, Sarah; Westneat, David F; Wilson, Alastair J; Zedrosser, Andreas

    2015-10-01

    The recent trend for journals to require open access to primary data included in publications has been embraced by many biologists, but has caused apprehension amongst researchers engaged in long-term ecological and evolutionary studies. A worldwide survey of 73 principal investigators (Pls) with long-term studies revealed positive attitudes towards sharing data with the agreement or involvement of the PI, and 93% of PIs have historically shared data. Only 8% were in favor of uncontrolled, open access to primary data while 63% expressed serious concern. We present here their viewpoint on an issue that can have non-trivial scientific consequences. We discuss potential costs of public data archiving and provide possible solutions to meet the needs of journals and researchers. PMID:26411615

  4. 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

  5. Long-term safety of pegloticase in chronic gout refractory to conventional treatment

    PubMed Central

    Becker, Michael A; Baraf, Herbert S B; Yood, Robert A; Dillon, Aileen; Vázquez-Mellado, Janitzia; Ottery, Faith D; Khanna, Dinesh; Sundy, John S

    2013-01-01

    Objective To evaluate the long-term safety (up to 3 years) of treatment with pegloticase in patients with refractory chronic gout. Methods This open-label extension (OLE) study was conducted at 46 sites in the USA, Canada and Mexico. Patients completing either of two replicate randomised placebo-controlled 6-month trials received pegloticase 8 mg every 2 weeks (biweekly) or every 4 weeks (monthly). Safety was evaluated as the primary outcome, with special interest in gout flares and infusion-related reactions (IRs). Secondary outcomes included urate-lowering and clinical efficacy. Results Patients (n=149) received a mean±SD of 28±18 pegloticase infusions and were followed for a mean of 25±11 months. Gout flares and IRs were the most frequently reported adverse events; these were least common in patients with a sustained urate-lowering response to treatment and those receiving biweekly treatment. In 10 of the 11 patients with a serious IR, the event occurred when uric acid exceeded 6 mg/dl. Plasma and serum uric acid levels remained <6 mg/dl in most randomised controlled trial (RCT)-defined pegloticase responders throughout the OLE study and were accompanied by sustained and progressive improvements in tophus resolution and flare incidence. Conclusions The safety profile of long-term pegloticase treatment was consistent with that observed during 6 months of RCT treatment; no new safety signals were identified. Improvements in clinical status, in the form of flare and tophus reduction initiated during RCT pegloticase treatment in patients maintaining goal range urate-lowering responses were sustained or advanced during up to 2.5 years of additional treatment. PMID:23144450

  6. 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

  7. Long term decontamination at the Hanford Site: A case study

    SciTech Connect

    Geuther, W.J.; Hansen, G.E.

    1995-02-01

    This paper describes an engineering study that evaluates decontamination requirements at Hanford and the potential reutilization of the first plutonium processing production facility as a decontamination facility. The logic used to develop the study, the options available for a long-term decontamination mission, and the resultant strategy recommended in the study are presented. The paper provides a starting point for other similar study efforts. The process flowsheets, regulatory restrictions, and preconceptual designs developed in this study are common throughout the nuclear waste industry.

  8. Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults with ADHD: Final Report of a 4-Year Study

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas J.; Williams, David W.; Moore, Rodney J.; Michelson, David

    2008-01-01

    Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial…

  9. Long-term safety and efficacy of fasiglifam (TAK-875), a G-protein-coupled receptor 40 agonist, as monotherapy and combination therapy in Japanese patients with type 2 diabetes: a 52-week open-label phase III study.

    PubMed

    Kaku, K; Enya, K; Nakaya, R; Ohira, T; Matsuno, R

    2016-09-01

    This multicentre, open-label, phase III study investigated the safety and efficacy of the G-protein-coupled receptor 40 agonist fasiglifam. Japanese patients with type 2 diabetes and inadequate glycaemic control despite diet and/or exercise (n = 282), or despite diet and/or exercise plus one oral antidiabetic agent [sulphonylurea (n = 262), rapid-acting insulin secretagogue (n = 124), α-glucosidase inhibitor (n = 141), biguanide (n = 136), thiazolidinedione (n = 139) or dipeptidyl peptidase-4 inhibitor (n = 138)] were randomized to treatment with fasiglifam 25 or 50 mg once daily for 52 weeks. The primary endpoints were safety variables. The overall incidence of treatment-emergent adverse events (TEAEs) was 75.4-85.1% in the 25 mg group and 78.9-89.9% in the 50 mg group; most TEAEs were mild. Hypoglycaemia was negligible with fasiglifam monotherapy and most common with sulphonylurea combination therapy (12.4 and 9.1% for 25 and 50 mg groups, respectively). Abnormal liver-related laboratory values were uncommon. Glycated haemoglobin levels decreased from week 2 in all groups and were maintained to week 52. Although fasiglifam as monotherapy or in combination regimens was well tolerated during long-term treatment, global concerns about liver safety led to termination of its development after study completion. PMID:27178047

  10. 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%. PMID:26571090

  11. Quantitative study of long-term solar and climatic changes

    NASA Technical Reports Server (NTRS)

    Eddy, J. A.

    1982-01-01

    Long term variations in the diameter and the shape of the Sun were studied. Daily observations of the Sun's diameter made at the Greenwich Observatory between 1836 and 1953 were analysed and interpreted. The data was converted into digital form and then screened and processed. It was found that the horizontal diameter of the Sun measured at Greenwich appears to have decreased systematically between 1880 and 1953 at a rate of 1.2 plus or minus 0.6 minutes of arc per century.

  12. Long-Term Safety and Effectiveness of the 'OptEase' Vena Cava Filter

    SciTech Connect

    Kalva, Sanjeeva P.; Marentis, Theodore C.; Yeddula, Kalpana; Somarouthu, Bhanusupriya; Wicky, Stephan; Stecker, Michael S.

    2011-04-15

    Purpose: To assess the long-term safety and effectiveness of the OptEase inferior vena cava (IVC) filter. Materials and Methods: In this Institutional Review Board-approved, retrospective study, we reviewed data of 71 patients who received an OptEase filter at our institution from 2002 to 2007. Thirty-nine (55%) patients had symptoms of venous thromboembolism before filter placement. The indications for filter included contraindication to anticoagulation in 31 (44%) patients, prophylaxis against pulmonary embolism (PE) in 29 (41%) patients, and failure of anticoagulation in 11 (15%) patients. Procedure-related complications, such as symptomatic post-filter PE, deep venous thrombosis (DVT), IVC occlusion, and incidental imaging-evident filter-related complications, were recorded. Safety was assessed by the occurrence of filter-related complications during placement and follow-up. Effectiveness was assessed by the occurrence of post-filter PE. Results: Sixty-five (92%) filters were placed under fluoroscopy, and 6 (8%) were placed using intravascular ultrasound guidance. Seventy (99%) filters were placed successfully. Seven (10%) filters were placed in the suprarenal cava. Retrieval was attempted in 14 (20%) patients, and 12 filters were successfully retrieved. Clinical follow-up was available for 20 {+-} 21 months. Symptoms of postfilter PE and DVT occurred in 15% (n = 11) and 10% (n = 7) patients, respectively. None of these patients had computed tomography (CT)-proven PE, and only one had ultrasound-proven new DVT. One patient had symptomatic IVC occlusion. Follow-up abdominal CT in 20 patients showed thrombus in the filter in two of them. There were no instances of filter migration, filter tilt, or caval wall penetration. Conclusion: The OptEase filter appears to have an acceptable long-term safety profile. The filter was effective against PE.

  13. Long-term safety and efficacy of insulin degludec in the management of type 2 diabetes

    PubMed Central

    Thuillier, Philippe; Alavi, Zarrin; Kerlan, Véronique

    2015-01-01

    Insulin degludec (IDeg) is a novel antiglycemic agent belonging to the therapeutic class of ultra-long duration basal insulin analogs. Its half-life and duration of action are 25 hours and 42 hours, respectively. This pharmacodynamic profile leads to a strict dosing schedule, ie, IDeg is injected at the same time each day to ensure optimal biological action and consistent glycemic control. According to the literature, IDeg provides glycemic control and nocturnal hypoglycemia reduction comparable with other long-acting analogs in type 2 diabetes mellitus. The risk of severe hypoglycemic episodes seems also to be reduced when using IDeg therapy; however, long-term follow-up is warranted for monitoring of possible but relatively infrequent adverse events. IDeg is also available in combination with aspart insulin and with liraglutide. The above preparations have been approved by the European Medicines Agency and other national health authorities. In 2012, the US Food and Drug Administration asked for a complementary study on IDeg-associated cardiovascular risk. Future prospective evaluation of large cohorts of patients with type 2 diabetes mellitus treated with IDeg, with long-term follow-up, can provide further relevant information on the safety of IDeg therapy. PMID:26457056

  14. 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

  15. Long-term efficacy and safety of a generic atorvastatin in usual clinical care setting.

    PubMed

    Ong, L M; Punithavathi, N; Lena, Y L L; Mahanim, O; Leekha, S

    2011-08-01

    A multicentre study was conducted to assess the long term efficacy and safety of a generic atorvastatin in the treatment of primary hypercholesterolaemia. Eighty five patients who received 10mg or 20 mg of atorvastatin for 8 weeks depending on target cholesterol goal were followed up by their own physicians and had final evaluation at 52 weeks. Reduction in mean low density Lipoprotein (LDL-C) was 36.5%, 37.9% and 32.2% at weeks 4, 8 and 52 respectively. LDL-C target was maintained in 81% and 69% of patients at week 8 and 52 respectively without drug related serious adverse events. Generic atorvastatin is safe and effective in usual clinical care setting. PMID:22111443

  16. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan

    PubMed Central

    Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

    2016-01-01

    The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75–225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (−10.76; P=0.031), but not in the flexible-dose (−10.37; P=0.106) group compared with placebo (−9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan. PMID:26513202

  17. Tocilizumab in refractory rheumatoid arthritis: long-term efficacy, safety, and tolerability beyond 2 years

    PubMed Central

    Farah, Ziad; Ali, Sabreen; Price-Kuehne, Fiona; Mackworth-Young, Charles G

    2016-01-01

    Objectives To evaluate the long-term efficacy and safety of tocilizumab (TCZ) in clinical patients with rheumatoid arthritis (RA) refractory to synthetic disease-modifying antirheumatic drugs, anti-tumor necrosis factor agents, and B-cell depletion therapy with rituximab (RTX). Methods We conducted a single-center retrospective study of 22 patients with RA treated with TCZ. We collected data including demographics and medication histories. We recorded clinical parameters including tender joint counts and swollen joint counts, and laboratory parameters including inflammatory makers and lipid profiles over regular intervals of TCZ treatment. Results In all, 22 patients with RA were included, 20 of whom were female. The median age at the first dose of TCZ was 62 years (range: 35–75 years). The mean duration of the disease from diagnosis with RA to May 2015 was 15.7 years (range: 6–30 years). A total of 15 out of 22 patients remained on TCZ at the end of the study, and in all, there was an improvement in markers of disease activity following initiating TCZ. The effect was sustained for a mean of 35 months (SD±15.5 months, range: 9–72 months). Of the 17 patients who failed to respond to RTX previously, 12 patients remained on TCZ. In all, eight out of 22 patients developed adverse events, five of whom discontinued TCZ. In contrast to previously documented short-term data, TCZ did not result in a statistically significant (P<0.05) long-term deterioration in lipid profile for any of the lipid parameters measured in our cohort (mean ± SD at initiation of TCZ to most recent follow-up: total cholesterol 5.25±1.05 to 5.28±0.77 mmol/L, high-density lipoprotein 1.72±0.54 to 1.67±0.43 mmol/L, low-density lipoprotein 3.05±0.98 to 2.98±0.81 mmol/L, and cholesterol to high-density lipoprotein ratio 3.41±1.23 to 3.40±1.22). Conclusion The efficacy of TCZ in patients with RA refractory to disease-modifying drugs, including anti-tumor necrosis factor blockade and RTX

  18. Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes

    PubMed Central

    Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

    2016-01-01

    Objective. Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. Methods. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. Results. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. Conclusion. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. Trial registration: ClincialTrials.gov, clinicaltrials.gov, NCT00069329 PMID:27143789

  19. A phase 2, open-label, multicenter study of the long-term safety of siltuximab (an anti-interleukin-6 monoclonal antibody) in patients with multicentric Castleman disease

    PubMed Central

    van Rhee, Frits; Casper, Corey; Voorhees, Peter M.; Fayad, Luis E.; van de Velde, Helgi; Vermeulen, Jessica; Qin, Xiang; Qi, Ming; Tromp, Brenda; Kurzrock, Razelle

    2015-01-01

    Background Multicentric Castleman disease (MCD) is a rare, systemic lymphoproliferative disorder driven by interleukin (IL)-6 overproduction. Siltuximab, an anti-IL-6 monoclonal antibody, has demonstrated durable tumor and symptomatic responses in a multinational, randomized, placebo-controlled study of MCD. Methods This preplanned safety analysis was conducted to evaluate the long-term safety of siltuximab treatment among 19 patients with MCD who had stable disease or better and were enrolled in a phase-1 study and subsequent ongoing, open-label, phase-2 extension study. Dosing was 11 mg/kg administered intravenously every 3 weeks, per protocol, or every 6 weeks at the investigator's discretion. Safety monitoring focused on potential risks associated with the anti-IL-6 mechanism of action. Investigator-assessed disease control status was also documented. Results Median treatment duration for the 19 patients was 5.1 (range 3.4, 7.2) years, with 14 (74%) patients treated for >4 years. Grade-≥3 adverse events (AEs) reported in >1 patient included hypertension (n = 3) and nausea, cellulitis, and fatigue (n = 2 each). Grade-≥3 AEs at least possibly attributed to siltuximab were leukopenia, lymphopenia, and a serious AE of polycythemia (n = 1 each). Hypertriglyceridemia and hypercholesterolemia (total cholesterol) were reported in 8 and 9 patients, respectively. No disease relapses were observed, and 8 of 19 patients were able to switch to an every-6-week dosing schedule. Conclusions All MCD patients in this extension study have received siltuximab for a prolonged duration (up to 7 years) without evidence of cumulative toxicity or treatment discontinuations and with few serious infections. All patients are alive, demonstrate sustained disease control, and continue to receive siltuximab. PMID:26327301

  20. Patient Safety Policy in Long-Term Care: A Research Protocol to Assess Executive WalkRounds to Improve Management of Early Warning Signs for Patient Safety

    PubMed Central

    Hamers, Hub; van Achterberg, Theo; Schoonhoven, Lisette

    2014-01-01

    Background At many hospitals and long-term care organizations (such as nursing homes), executive board members have a responsibility to manage patient safety. Executive WalkRounds offer an opportunity for boards to build a trusting relationship with professionals and seem useful as a leadership tool to pick up on soft signals, which are indirect signals or early warnings that something is wrong. Because the majority of the research on WalkRounds has been performed in hospitals, it is unknown how board members of long-term care organizations develop their patient safety policy. Also, it is not clear if these board members use soft signals as a leadership tool and, if so, how this influences their patient safety policies. Objective The objective of this study is to explore the added value and the feasibility of WalkRounds for patient safety management in long-term care. This study also aims to identify how executive board members of long-term care organizations manage patient safety and to describe the characteristics of boards. Methods An explorative before-and-after study was conducted between April 2012 and February 2014 in 13 long-term care organizations in the Netherlands. After implementing the intervention in 6 organizations, data from 72 WalkRounds were gathered by observation and a reporting form. Before and after the intervention period, data collection included interviews, questionnaires, and studying reports of the executive boards. A mixed-method analysis is performed using descriptive statistics, t tests, and content analysis. Results Results are expected to be ready in mid 2014. Conclusions It is a challenge to keep track of ongoing development and implementation of patient safety management tools in long-term care. By performing this study in cooperation with the participating long-term care organizations, insight into the potential added value and the feasibility of this method will increase. PMID:25048598

  1. 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.

  2. Long-Term, Open-Label, Safety Study of Edivoxetine 12 to 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment.

    PubMed

    Ball, Susan G; Atkinson, Sarah; Sparks, JonDavid; Bangs, Mark; Goldberger, Celine; Dubé, Sanjay

    2015-06-01

    Long-term safety, tolerability, and efficacy of adjunctive edivoxetine hydrochloride (hereafter edivoxetine), a highly selective and potent norepinephrine reuptake inhibitor, was assessed in patients with major depressive disorder (MDD) experiencing partial response to selective serotonin reuptake inhibitor treatment. Data are from a multicenter, 54-week, open-label trial of adjunctive edivoxetine 12 to 18 mg once daily in patients with MDD who had experienced partial response by history to 6 or more weeks of current selective serotonin reuptake inhibitor therapy and who had a 17-item GRID Hamilton Rating Scale for Depression total score 16 or higher at study entry. Safety measures included discontinuation rate, treatment-emergent adverse events, serious adverse events, and vital signs. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale. Of 608 patients, 328 (54%) completed the open-label adjunctive treatment. Study discontinuation due to adverse events occurred in 17.0%, and there were 13 serious adverse events (1 death). Treatment-emergent adverse events 5% or higher were nausea, hyperhidrosis, constipation, headache, dry mouth, dizziness, vomiting, insomnia, and upper respiratory tract infection. Mean increases were observed in systolic blood pressure (range, 0.0-2.3 mm Hg), diastolic blood pressure (range, 1.9-3.3 mm Hg), and pulse (range, 5.9-8.4 beats per minute). Mean improvements on the Montgomery-Åsberg Depression Rating Scale (-17.0) were observed from baseline to week 54. The safety profile from this study provides an overview of outcomes associated with edivoxetine and norepinephrine reuptake inhibition as an adjunctive treatment in patients with MDD who were treated up to 1 year. PMID:25815754

  3. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination.

    PubMed

    Naud, Paulo S; Roteli-Martins, Cecilia M; De Carvalho, Newton S; Teixeira, Julio C; de Borba, Paola C; Sanchez, Nervo; Zahaf, Toufik; Catteau, Gregory; Geeraerts, Brecht; Descamps, Dominique

    2014-01-01

    HPV-023 (NCT00518336; ClinicalTrial.gov) is a long-term follow-up of an initial double-blind, randomized (1:1), placebo-controlled study (HPV-001, NCT00689741) evaluating the efficacy against human papillomavirus (HPV)-16/18 infection and associated cyto-histopathological abnormalities, persistence of immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine. Among the women, aged 15-25 years, enrolled in HPV-001 and who participated in the follow-up study HPV-007 (NCT00120848), a subset of 437 women from five Brazilian centers participated in this 36-month long-term follow-up (HPV-023) for a total of 113 months (9.4 years). During HPV-023, anti-HPV-16/18 antibodies were measured annually by enzyme-linked immunosorbent assay (ELISA) and pseudovirion-based neutralisation assay (PBNA). Cervical samples were tested for HPV DNA every 6 months, and cyto-pathological examinations were performed annually. During HPV-023, no new HPV-16/18-associated infections and cyto-histopathological abnormalities occurred in the vaccine group. Vaccine efficacy (VE) against HPV-16/18 incident infection was 100% (95%CI: 66.1, 100). Over the 113 months (9.4 years), VE was 95.6% (86.2, 99.1; 3/50 cases in vaccine and placebo groups, respectively) against incident infection, 100% (84·1, 100; 0/21) against 6-month persistent infection (PI); 100% (61·4, 100; 0/10) against 12-month PI; 97·1% (82.5, 99.9; 1/30) against ≥ ASC-US; 95·0% (68.0, 99.9; 1/18) against ≥ LSIL; 100% (45.2, 100; 0/8) against CIN1+; and 100% (-128.1, 100; 0/3) against CIN2+ associated with HPV-16/18. All vaccinees remained seropositive to HPV-16/18, with antibody titers remaining several folds above natural infection levels, as measured by ELISA and PBNA. There were no safety concerns. To date, these data represent the longest follow-up reported for a licensed HPV vaccine. PMID:25424918

  4. Zambia : long-term generation expansion study - executive summary.

    SciTech Connect

    Conzelmann, G.; Koritarov, V.; Buehring, W.; Veselka, T.; Decision and Information Sciences

    2008-02-28

    The objective of this study is to analyze possible long-term development options of the Zambian electric power system in the period up to 2015. The analysis involved the hydro operations studies of the Zambezi river basin and the systems planning studies for the least-cost generation expansion planning. Two well-known and widely accepted computer models were used in the analysis: PC-VALORAGUA model for the hydro operations and optimization studies and the WASP-III Plus model for the optimization of long-term system development. The WASP-III Plus model is a part of the Argonne National Laboratory's Energy and Power Evaluation Model (ENPEP). The analysis was conducted in close collaboration with the Zambia Electricity Supply Corporation (ZESCO). On the initiative from The World Bank, the sponsor of the study, ZESCO formed a team of experts that participated in the analysis and were trained in the use of computer models. Both models were transferred to ZESCO free of charge and installed on several computers in the ZESCO corporate offices in Lusaka. In September-October 1995, two members of the ZESCO National Team participated in a 4-week training course at Argonne National Laboratory near Chicago, U.S.A., focusing on the long-term system expansion planning using the WASP and VALORAGUA models. The hydropower operations studies were performed for the whole Zambezi river basin, including the full installation of the Kariba power station, and the Cahora Bassa hydro power station in Mozambique. The analysis also included possible future projects such as Itezhi-Tezhi, Kafue Gorge Lower, and Batoka Gorge power stations. As hydropower operations studies served to determine the operational characteristics of the existing and future hydro power plants, it was necessary to simulate the whole Zambezi river basin in order to take into account all interactions and mutual influences between the hydro power plants. In addition, it allowed for the optimization of reservoir management

  5. 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

  6. Long-term study of pig carrion entomofauna.

    PubMed

    Mądra, A; Frątczak, K; Grzywacz, A; Matuszewski, S

    2015-07-01

    Long-term changes of carrion entomofauna are poorly understood. No single carrion study lasted longer than one year. We studied entomofauna of large pig carcasses in the second and the third year postmortem. Ten carcasses were exposed in xerothermic grasslands of Western Poland in spring, early and late summer of 2012. Entomofauna was monitored until September of 2014. 72 species were found in the second year, and six in the third year. In the second or the third year carcasses from the late summer block revealed larger number of taxa compared to carcasses from the spring or the early summer block. Taxa differed in pattern of multiple larval colonizations. Only necrophagous taxa breeding in long-lasting carrion parts as well as predators feeding on arthropods present in these parts were found to recolonize. Recolonizations were always recorded in the second or the third year after death. Patterns of multiple colonization depended on the time of carcass exposure in the first year. Residencies of larvae were unexpectedly long in the second year. Several forensically important flies overwintered on carcasses in the larval stage. Current results support the view that insect fauna of cadavers with long post-mortem interval (PMI) may be used for PMI estimation. PMID:25933423

  7. Short- and Long-Term Safety of Weekly High-Dose Vitamin D3 Supplementation in School Children

    PubMed Central

    Maalouf, Joyce; Nabulsi, Mona; Vieth, Reinhold; Kimball, Samantha; El-Rassi, Rola; Mahfoud, Ziyad; El-Hajj Fuleihan, Ghada

    2008-01-01

    Background: Hypovitaminosis D is prevalent in youth worldwide, but the safety of vitamin D at doses exceeding 200 IU/d is unknown in this age group. We assessed the safety of high doses of vitamin D3 administered to apparently healthy schoolchildren. Methods: To assess short-term safety, 25 subjects randomly received placebo or vitamin D3 at doses of 14,000 IU/wk for 8 wk. To assess long-term safety, 340 subjects randomly received placebo, vitamin D3 as 1,400 IU/wk or 14,000 IU/wk for 1 yr. Biochemical variables were monitored at 0, 2, 4, 6, and 8 wk and 8 wk off therapy in the short-term study and at 0, 6, and 12 months in the long-term study. Results: In both the short- and long-term studies, mean serum calcium and 1,25-hydroxyvitamin levels did not change in any group. In the short-term study, mean 25-hydroxyvitamin concentrations increased from 44 (± 11) to 54 (± 19) ng/ml in the treated groups (P = 0.033). In the long-term study, mean 25-hydroxyvitamin D levels increased from 15 ± 8 to 19 ± 7 ng/ml (P < 0.0001) in subjects receiving 1,400 IU/wk and from 15 ± 7 to 36 ± 22 ng/ml (P < 0.0001) in the group receiving 14,000 IU/wk. No subject developed vitamin D intoxication. Conclusion: Vitamin D3 at doses equivalent to 2000 IU/d for 1 yr is safe in adolescents and results in desirable vitamin D levels. PMID:18445674

  8. Long-Term Safety and Longevity of a Mixture of Polymethyl Methacrylate and Cross-Linked Dextran (Lipen-10®) after Penile Augmentation: Extension Study from Six to 18 Months of Follow-Up

    PubMed Central

    Kim, Ma Tae; Ko, Kyungtae; Lee, Won Ki; Kim, Sae Chul

    2015-01-01

    Purpose The goal of this study was to investigate the long-term efficacy and safety of a mixture of polymethyl methacrylate (PMMA) and cross-linked dextran Lipen-10® used for penile augmentation under the physical impact generated during sexual intercourse. Materials and Methods From March 2010 to October 2011, a total of 20 patients with a mean age of 44 years (interquartile range, 20~70 years) who requested penile augmentation participated in this study. Lipen-10® filler is a mixture of 75% cross-linked dextran, 15% PMMA, and 10% hypromellose solution. With the patient in the supine position, Lipen-10® was injected into the subcutaneous tissue between the dartos fascia and Buck's fascia of the penis using a fanning technique. Penile length and circumference were measured before the procedure and six, 12, and 18 months after the procedure. Values were compared using the Student's t-test and the paired t-test. Results A total of 15 patients completed this study. The increases in circumference and length observed six months after the procedure were found to have been maintained without change at 12 and 18 months of follow-up. At 12 and 18 months of follow-up, no abnormal findings were observed. Pelvic magnetic resonance imaging conducted at 18 months of follow-up showed no trace of the injected filler having migrated to other sites, and the volume was well maintained. Conclusions Lipen-10®, a mixture of PMMA and cross-linked dextran, showed good durability and tolerability over 18 months of follow-up during which the participants were sexually active. PMID:26770941

  9. Mammary gland neoplasia in long-term rodent studies.

    PubMed Central

    Russo, I H; Russo, J

    1996-01-01

    Breast cancer, the most frequent spontaneous malignancy diagnosed in women in the western world, is continuously increasing in incidence in industrialized nations. Although breast cancer develops in women as the result of a combination of external and endogenous factors such as exposure to ionizing radiation, diet, socioeconomic status, and endocrinologic, familial, or genetic factors, no specific etiologic agent(s) or the mechanisms responsible of the disease has been identified as yet. Thus, experimental models that exhibit the same complex interactions are needed for testing various mechanisms and for assessing the carcinogenic potential of given chemicals. Rodent mammary carcinomas represent such a model to a great extent because, in these species, mammary cancer is a multistep complex process that can be induced by either chemicals, radiation, viruses, or genetic factors. Long-term studies in rodent models have been particularly useful for dissecting the initiation, promotion, and progression steps of carcinogenesis. The susceptibility of the rodent mammary gland to develop neoplasms has made this organ a unique target for testing the carcinogenic potential of specific genotoxic chemicals and environmental agents. Mammary tumors induced by indirect- or direct-acting carcinogens such as 7, 12-dimethlbenz(a)anthracene or N-methyl-N-nitrosourea are, in general, hormone dependent adenocarcinomas whose incidence, number of tumors per animal, tumor latency, and tumor type are influenced by the age, reproductive history, and endocarinologic milieu of the host at the time of carcinogen exposure. Rodent models are informative in the absence of human data. They have provided valuable information on the dose and route of administration to be used and optimal host conditions for eliciting maximal tumorigenic response. Studies of the influence of normal gland development on the pathogenesis of chemically induced mammary carcinomas have clarified the role of differentiation

  10. Long-term Efficacy and Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes Mellitus.

    PubMed

    Tada, Yuko; Kanazawa, Ippei; Notsu, Masakazu; Tanaka, Ken-Ichiro; Kiyohara, Nobuaki; Sasaki, Motofumi; Sugimoto, Toshitsugu

    2016-01-01

    Objective We herein conducted a retrospective study to evaluate the long-term efficacy and safety of sitagliptin treatment in elderly patients with type 2 diabetes mellitus. Methods We analyzed the changes in glycemic control in 112 Japanese type 2 diabetes patients over 65 years of age treated with 50 mg/day sitagliptin. Hemoglobin A1c (HbA1c) levels, liver and kidney functions, and usage of hypoglycemic agents were recorded for 24 months. Results HbA1c levels were significantly decreased, and the significance of HbA1c reduction was maintained during the observation period [from 7.7±1.1% to 7.2±0.7% (p<0.001) at the end of observational period]. The %change in HbA1c levels was significantly and negatively correlated with the baseline HbA1c levels (r=-0.51, p<0.001), but not with age, duration of diabetes, or the estimated glomerular filtration rate (eGFR). No patient experienced severe hypoglycemia episodes, and aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, and the eGFR remained unchanged. The dose of sulfonylurea was finally decreased in 72% of patients treated with sulfonylurea. Conclusion Sitagliptin treatment continually decreases the HbA1c level for 24 months and is useful to reduce the dose of sulfonylurea in elderly patients with type 2 diabetes. PMID:27181532

  11. A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia

    PubMed Central

    2013-01-01

    Background We compared the time to discontinuation due to lack of tolerability over 24 weeks in patients suffering from schizophrenia treated with pomaglumetad methionil (LY2140023 monohydrate, the prodrug of metabotropic glutamate 2/3 receptor agonist, LY404039) or standard of care (SOC: olanzapine, risperidone, or aripiprazole). Methods Study HBBR was a multicenter, randomized, open-label study comparing the long-term safety and tolerability of LY2140023 with SOC for schizophrenia. Patients had moderate symptomatology with prominent negative symptoms and evidence of functional impairment. Those who met entry criteria were randomized to open-label treatment with either LY2140023 (target dose: 40 mg twice daily [BID]; n = 130) or SOC (n = 131). Results There was no statistically significant difference between LY2140023 and SOC for time to discontinuation due to lack of tolerability (primary objective; P = .184). The Kaplan-Meier estimates revealed comparable time to event profiles. Only 27% of LY2140023 and 45% of SOC patients completed the 24-week open-label, active treatment phase. Twenty-seven patients (20.8%) in the LY2140023 group and 15 patients (11.5%) in the SOC group discontinued due to lack of efficacy (P = .044). Twenty-three patients (17.7%) in the LY2140023 group and 19 patients (14.5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P = .505). The incidence of serious adverse events was comparable between groups. LY2140023-treated patients reported significantly more treatment-emergent adverse events of vomiting, agitation, and dyspepsia, while SOC-treated patients reported significantly more akathisia and weight gain. The incidence of treatment-emergent parkinsonism (P = .011) and akathisia (P = .029) was significantly greater in SOC group. Improvement in PANSS total score over the initial 6 to 8 weeks of treatment was similar between groups, but improvement was

  12. A modelling study of long term green roof retention performance.

    PubMed

    Stovin, Virginia; Poë, Simon; Berretta, Christian

    2013-12-15

    This paper outlines the development of a conceptual hydrological flux model for the long term continuous simulation of runoff and drought risk for green roof systems. A green roof's retention capacity depends upon its physical configuration, but it is also strongly influenced by local climatic controls, including the rainfall characteristics and the restoration of retention capacity associated with evapotranspiration during dry weather periods. The model includes a function that links evapotranspiration rates to substrate moisture content, and is validated against observed runoff data. The model's application to typical extensive green roof configurations is demonstrated with reference to four UK locations characterised by contrasting climatic regimes, using 30-year rainfall time-series inputs at hourly simulation time steps. It is shown that retention performance is dependent upon local climatic conditions. Volumetric retention ranges from 0.19 (cool, wet climate) to 0.59 (warm, dry climate). Per event retention is also considered, and it is demonstrated that retention performance decreases significantly when high return period events are considered in isolation. For example, in Sheffield the median per-event retention is 1.00 (many small events), but the median retention for events exceeding a 1 in 1 yr return period threshold is only 0.10. The simulation tool also provides useful information about the likelihood of drought periods, for which irrigation may be required. A sensitivity study suggests that green roofs with reduced moisture-holding capacity and/or low evapotranspiration rates will tend to offer reduced levels of retention, whilst high moisture-holding capacity and low evapotranspiration rates offer the strongest drought resistance. PMID:24178313

  13. 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

  14. Related Studies in Long Term Lithium Battery Stability

    NASA Technical Reports Server (NTRS)

    Horning, R. J.; Chua, D. L.

    1984-01-01

    The continuing growth of the use of lithium electrochemical systems in a wide variety of both military and industrial applications is primarily a result of the significant benefits associated with the technology such as high energy density, wide temperature operation and long term stability. The stability or long term storage capability of a battery is a function of several factors, each important to the overall storage life and, therefore, each potentially a problem area if not addressed during the design, development and evaluation phases of the product cycle. Design (e.g., reserve vs active), inherent material thermal stability, material compatibility and self-discharge characteristics are examples of factors key to the storability of a power source.

  15. Long-term Studies of Marine Halogen Release

    NASA Astrophysics Data System (ADS)

    Tschritter, J.; Holla, R.; Frieß, U.; Platt, U.

    2009-04-01

    Institute of Enviromental Physics, Heidelberg, Germany. Long term measurements of atmospheric trace gases using multi-axis DOAS instruments are pursued at the new SOLAS observatory on the island of Sao Vicente, (Cape Verde). This research is part of the SOPRAN (Surface Ocean Processes in the ANthropocene) project (Fördernummer:03F0462F). Reactive halogen species (RHS) such as bromine- and iodine- containing species play major roles in the chemistry of ozone in both the troposphere and lower stratosphere and thus possibly influence the ozone budget on a global scale. In addition iodine-species emitted from the ocean surface have been shown to be responsible for the production of new atmospheric particles in the marine boundary layer. This may have an effect on cloud formation and radiation transfer on local and global scales. Long term measurements of RHS abundances will help to identify their key regions and processes for formation. A new long term Multi-MAX-DOAS instrument has been installed at the SOLAS observatory on the island of Sao Vicente, (Cape Verde). The main focus of these unique measurements is the investigation of reactive halogen chemistry in the subtropical marine boundary layer based on measurements of BrO, IO, and possibly OIO. Because of its wide spectral range also the use for O4-retrievals to gain aerosol profiles is possible. IO has been detected with mixing ratios up to 1.3 ppt. For BrO an upper limit of 2 ppt could be determined.

  16. 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)

  17. Long-term weather predictability: Ural case study

    NASA Astrophysics Data System (ADS)

    Kubyshen, Alexander; Shopin, Sergey

    2016-04-01

    The accuracy of the state-of-the-art long-term meteorological forecast (at the seasonal level) is still low. Here it is presented approach (RAMES method) realizing different forecasting methodology. It provides prediction horizon of up to 19-22 years under equal probabilities of determination of parameters in every analyzed period [1]. Basic statements of the method are the following. 1. Long-term forecast on the basis of numerical modeling of the global meteorological process is principally impossible. Extension of long-term prediction horizon could be obtained only by the revealing and using a periodicity of meteorological situations at one point of observation. 2. Conventional calendar is unsuitable for generalization of meteorological data and revealing of cyclicity of meteorological processes. RAMES method uses natural time intervals: one day, synodic month and one year. It was developed a set of special calendars using these natural periods and the Metonic cycle. 3. Long-term time series of meteorological data is not a uniform universal set, it is a sequence of 28 universal sets appropriately superseding each other in time. The specifics of the method are: 1. Usage of the original research toolkit consisting of - a set of calendars based on the Metonic cycle; - a set of charts (coordinate systems) for the construction of sequence diagrams (of daily variability of a meteorological parameter during the analyzed year; of daily variability of a meteorological parameter using long-term dynamical time series of periods-analogues; of monthly and yearly variability of accumulated value of meteorological parameter). 2. Identification and usage of new virtual meteorological objects having several degrees of generalization appropriately located in the used coordinate systems. 3. All calculations are integrated into the single technological scheme providing comparison and mutual verification of calculation results. During the prolonged testing in the Ural region, it was

  18. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

    PubMed Central

    Kavanaugh, Arthur; McInnes, Iain B; Mease, Philip; Krueger, Gerald G; Gladman, Dafna; van der Heijde, Désirée; Zhou, Yiying; Lu, Jiandong; Leu, Jocelyn H; Goldstein, Neil; Beutler, Anna

    2014-01-01

    Objectives Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA). Methods Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs). Results 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate). Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years. Trial registration number NCT00265096. PMID:24748630

  19. In Vivo Transplantation of Enteric Neural Crest Cells into Mouse Gut; Engraftment, Functional Integration and Long-Term Safety

    PubMed Central

    Cooper, Julie E.; McCann, Conor J.; Natarajan, Dipa; Choudhury, Shanas; Boesmans, Werend; Delalande, Jean-Marie; Vanden Berghe, Pieter; Burns, Alan J.; Thapar, Nikhil

    2016-01-01

    Objectives Enteric neuropathies are severe gastrointestinal disorders with unsatisfactory outcomes. We aimed to investigate the potential of enteric neural stem cell therapy approaches for such disorders by transplanting mouse enteric neural crest cells (ENCCs) into ganglionic and aganglionic mouse gut in vivo and analysing functional integration and long-term safety. Design Neurospheres generated from yellow fluorescent protein (YFP) expressing ENCCs selected from postnatal Wnt1-cre;R26R-YFP/YFP murine gut were transplanted into ganglionic hindgut of wild-type littermates or aganglionic hindgut of Ednrbtm1Ywa mice (lacking functional endothelin receptor type-B). Intestines were then assessed for ENCC integration and differentiation using immunohistochemistry, cell function using calcium imaging, and long-term safety using PCR to detect off-target YFP expression. Results YFP+ ENCCs engrafted, proliferated and differentiated into enteric neurons and glia within recipient ganglionic gut. Transplanted cells and their projections spread along the endogenous myenteric plexus to form branching networks. Electrical point stimulation of endogenous nerve fibres resulted in calcium transients (F/F0 = 1.16±0.01;43 cells, n = 6) in YFP+ transplanted ENCCs (abolished with TTX). Long-term follow-up (24 months) showed transplanted ENCCs did not give rise to tumours or spread to other organs (PCR negative in extraintestinal sites). In aganglionic gut ENCCs similarly spread and differentiated to form neuronal and glial networks with projections closely associated with endogenous neural networks of the transition zone. Conclusions Transplanted ENCCs successfully engrafted into recipient ganglionic and aganglionic gut showing appropriate spread, localisation and, importantly, functional integration without any long-term safety issues. This study provides key support for the development and use of enteric neural stem cell therapies. PMID:26824433

  20. A case study comparing a randomized withdrawal trial and a double-blind long-term trial for assessing the long-term efficacy of an antidepressant.

    PubMed

    Mallinckrodt, Craig; Chuang-Stein, Christy; McSorley, Paul; Schwartz, Jeffrey; Archibald, Donald G; Perahia, David G; Detke, Michael J; Alphs, Larry

    2007-01-01

    Assessing long-term efficacy in psychiatric drugs involves a number of complex questions, and the priaority of these questions is different for different disorders and for different stakeholders. Therefore, it is essential that we not adopt a one-method-fits-all approach, but rather adapt the specific details of the designs and analysis of data from long-term trials to individual disease states. Randomized withdrawal (RW) designs, even though addressing a specific question of particular interest, face some difficult methodological and ethical challenges. A less common alternative design, termed the double-blind long-term efficacy (DBLE) design, is logistically similar to traditional responder extension designs. However, use of an analytic approach that includes all randomized patients rather than only the selected subset that continued beyond acute treatment avoids the major criticism of the extender design. The present paper illustrates the attributes of the RW and DBLE designs by analyzing data from trials adopting these designs. The RW and DBLE designs address different questions, and are thus not directly comparable. Potential benefits of the DBLE design include: (1) the parsimonious use of patients and the resultant reduced exposure to placebo as each patient can contribute to multiple developmental objectives; (2) the results are generalizable to actual clinical practice as the design matches treatment guidelines; and, (3) results of safety assessments are meaningful as they involve all randomized patients. Our case study suggests that the DBLE design can provide definitive answers to important questions and may be a useful design for assessing long-term treatment effects. PMID:17238129

  1. Technology base studies of long-term MCFC performance

    SciTech Connect

    Selman, J.R.; Yazici, M.S.

    1996-12-31

    This project aims to identify the long-term endurance problems of the MCFC by investigating corrosion of stainless steel (310, 316L). This presentation focuses on results from SEM and cross-section analysis. Significant differences between immersed and film-wetted electrodes are summarized. Results suggest that pre-oxidation can be a solution to obtaining a compact oxide layer. Adding Al to alloy leads to a very stable oxide layer, but increases resistivity. Alloy behavior must be investigated under continuously polarized conditions. 4 figs.

  2. Evidence for Long-term Efficacy and Safety of Gene Therapy for Wiskott–Aldrich Syndrome in Preclinical Models

    PubMed Central

    Marangoni, Francesco; Bosticardo, Marita; Charrier, Sabine; Draghici, Elena; Locci, Michela; Scaramuzza, Samantha; Panaroni, Cristina; Ponzoni, Maurilio; Sanvito, Francesca; Doglioni, Claudio; Liabeuf, Marie; Gjata, Bernard; Montus, Marie; Siminovitch, Katherine; Aiuti, Alessandro; Naldini, Luigi; Dupré, Loïc; Roncarolo, Maria Grazia; Galy, Anne; Villa, Anna

    2009-01-01

    Wiskott–Aldrich Syndrome (WAS) is a life-threatening X-linked disease characterized by immunodeficiency, thrombocytopenia, autoimmunity, and malignancies. Gene therapy could represent a therapeutic option for patients lacking a suitable bone marrow (BM) donor. In this study, we analyzed the long-term outcome of WAS gene therapy mediated by a clinically compatible lentiviral vector (LV) in a large cohort of wasnull mice. We demonstrated stable and full donor engraftment and Wiskott–Aldrich Syndrome protein (WASP) expression in various hematopoietic lineages, up to 12 months after gene therapy. Importantly, we observed a selective advantage for T and B lymphocytes expressing transgenic WASP. T-cell receptor (TCR)-driven T-cell activation, as well as B-cell's ability to migrate in response to CXCL13, was fully restored. Safety was evaluated throughout the long-term follow-up of primary and secondary recipients of WAS gene therapy. WAS gene therapy did not affect the lifespan of treated animals. Both hematopoietic and nonhematopoietic tumors arose, but we excluded the association with gene therapy in all cases. Demonstration of long-term efficacy and safety of WAS gene therapy mediated by a clinically applicable LV is a key step toward the implementation of a gene therapy clinical trial for WAS. PMID:19259069

  3. Short-term and long-term safety and tolerability of interferon β-1b in multiple sclerosis.

    PubMed

    Reder, Anthony T; Oger, Joel F; Kappos, Ludwig; O'Connor, Paul; Rametta, Mark

    2014-05-01

    Clinical trials have generated a wealth of data on the safety profile of interferon β-1b for patients with multiple sclerosis (MS). In general, interferon β-1b has not been associated with serious or life-threatening side effects during long-term treatment. Flu-like symptoms, injection site reactions, depression, and elevated liver transaminases were the most common adverse events in clinical trials. This review will discuss the rates of these and other common adverse events observed in 3 clinical trials of interferon β-1b: BENEFIT, BEYOND, and the 16-year Long-Term Follow-up (LTF) of the pivotal interferon β-1b trial in MS, as well as how these adverse events may influence patient and physician decision making when selecting a disease-modifying therapy. In addition, we will discuss the effects of interferon β-1b on mortality in the 16-year and 21-year LTF studies. PMID:25876467

  4. 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

  5. [Long-term efficacy and safety of lurasidone in the treatment of schizophrenia].

    PubMed

    Samalin, L; Honciuc, M; Llorca, P-M

    2015-12-01

    Lurasidone is a new second-generation antipsychotic approved in March 2014 by the European Medicines Agency for the treatment of schizophrenia. Lurasidone has demonstrated its efficacy in long-term studies. It has been shown to reduce significantly the risk of relapse in comparison with placebo in patients with schizophrenia. In comparator study, lurasidone was noninferior to quetiapine XR in risk for relapse. In open-label studies, lurasidone was associated with sustained improvement in efficacy measures observed and well-tolerated inpatients with schizophrenia who had switched to lurasidone from another antipsychotic. Available evidence showed also that lurasidone might be involved in the long-term improvement of cognitive performance in schizophrenic patients. Lurasidone differs from the other second-generation antipsychotics by a good tolerability profile, in particular in terms of metabolic and cardiovascular profiles. Lurasidone seems to have a moderate link with the occurrence of akathisia and extrapyramidal symptoms. Although lurasidone long-acting formulation is lacking, the long-term profile of lurasidone appears compatible with a good acceptability and consequently a good compliance to treatment of patients with schizophrenia. PMID:26603973

  6. Importance of long-term studies for environmental and ecological studies

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The value of long-term ecological and agricultural experiments is often not recognized until their pioneering initiators are long dead. In times of decreasing resources for agricultural research, it has become increasingly difficult to sustain existing long-term studies, much less initiate new ones....

  7. The impact of systematic occupational health and safety management for occupational disorders and long-term work attendance.

    PubMed

    Dellve, Lotta; Skagert, Katrin; Eklöf, Mats

    2008-09-01

    Despite several years of conducting formalized systematic occupational health and safety management (SOHSM), as required by law in Sweden and most other industrialized countries, there is still little evidence on how SOHSM should be approached to have an impact on employees' health. The aim of this study was to investigate the importance of SOHSM, considering structured routines and participation processes, for the incidence of occupational disorders and the prevalence of long-term work attendance among home care workers (HCWs). Municipal human service organizations were compared concerning (a) their structured routines and participation processes for SOHSM and (b) employee health, i.e. the municipal five-year incidence of occupational disorders and prevalence of work attendance among HCWs. National register-based data from the whole population of HCWs (n=154 773) were linked to register-data of occupational disorders and prevalence of long-term work attendance. The top managers and safety representatives in selected high- and low-incidence organizations (n=60) answered a questionnaire about structure and participation process of SOHSM. The results showed that prevalence of long-term work attendance was higher where structure and routines for SOHSM (policy, goals and plans for action) were well organized. Highly structured SOHSM and human resource management were also related to high organizational incidence of reported occupational disorders. Allocated budget and routines related to HCWs' influence in decisions concerning performance of care were also related to long-term work attendance. The participation processes had a weak effect on occupational disorders and work attendance among HCWs. Reporting occupational disorders may be a functional tool to stimulate the development of effective SOHSM, to improve the work environment and sustainable work ability. PMID:18599173

  8. Criticality safety evaluation for long term storage of FFTF fuel in interim storage casks

    SciTech Connect

    Richard, R.F.

    1995-05-11

    It has been postulated that a degradation phenomenon, referred to as ``hot cell rot``, may affect irradiated FFTF mixed plutonium-uranium oxide (MOX) fuel during dry interim storage. ``Hot cell rot`` refers to a variety of phenomena that degrade fuel pin cladding during exposure to air and inert gas environments. It is thought to be a form of caustic stress corrosion cracking or environmentally assisted cracking. Here, a criticality safety analysis was performed to address the effect of the ``hot cell rot`` phenomenon on the long term storage of irradiated FFTF fuel in core component containers. The results show that seven FFTF fuel assemblies or six Ident-69 pin containers stored in core component containers within interim storage casks will remain safely subcritical.

  9. Parametric Analysis of PWR Spent Fuel Depletion Parameters for Long-Term-Disposal Criticality Safety

    SciTech Connect

    DeHart, M.D.

    1999-08-01

    Utilization of burnup credit in criticality safety analysis for long-term disposal of spent nuclear fuel allows improved design efficiency and reduced cost due to the large mass of fissile material that will be present in the repository. Burnup-credit calculations are based on depletion calculations that provide a conservative estimate of spent fuel contents (in terms of criticality potential), followed by criticality calculations to assess the value of the effective neutron multiplication factor (k(sub)eff) for the a spent fuel cask or a fuel configuration under a variety of probabilistically derived events. In order to ensure that the depletion calculation is conservative, it is necessary to both qualify and quantify assumptions that can be made in depletion models.

  10. [Drug supply and patient safety in long-term care facilities for the elderly].

    PubMed

    Uhrhan, T; Schaefer, M

    2010-05-01

    Nursing home residents are a continuously growing population with a need for intense pharmacotherapy due to numerous comorbid conditions. Polypharmacy and the frequent use of psychotropic medication increase the risk of adverse drug events, which may result in risk of increased morbidity and mortality in frail, elderly patients. The requirement to solve individual therapeutic problems has to be supported by not only an adequate and need-based pharmaceutical supply but also by suitable organizational and logistic solutions. In the nursing home environment, ineffective communication between the various professional groups involved in medical treatment may lead to inappropriate or unintentional medication use. In the present survey, data and research results that are relevant to assess the medical treatment situation in long-term care facilities particularly with regard to the safety of pharmacotherapy are presented. The two problem areas of patient-customized therapy and the handling of pharmaceuticals in the context of institutional care are addressed separately. PMID:20376418

  11. Bioresorbable scaffolds: focus on vascular response and long-term safety.

    PubMed

    Scalone, G; Brugaletta, S; Gomez, O; Otsuki, S; Sabate, M

    2015-03-01

    Bioresorbable vascular scaffolds (BVS) are considered the fourth revolution in Interventional Cardiology, thus promising to address some of the pending issues with current-generation drug eluting stents (DES). Notably, most of the potential advantages of BVS over other current devices are due to a peculiar vascular response, called "vascular restoration therapy". The emerging data from real-world expanded use registries suggest that BVS use is feasible in a wide variety of patients (from low- to high- risk), and lesions (from simplex to complex). However, few safety concerns with currently available BVS have arised from initial experiences all over the word. Data from ongoing large-scale randomized controlled trials will be able to demonstrate whether BVS improve patient early and long-term outcomes compared to best-in-class DES. PMID:25373397

  12. Efficacy and safety of hydrostatic balloon dilation of ileocolonic Crohn's strictures. A prospective long-term analysis.

    PubMed

    Gevers, A M; Couckuyt, H; Coremans, G; Hiele, M; Rutgeerts, P

    1994-01-01

    Gastro-intestinal stricture frequently is a complication in Crohn's disease and often recurs after surgical resection. Stenosis with acute inflammation can be treated by anti-inflammatory medication. A conservative approach of sclerotic strictures has been possible since the introduction of Gruentzig balloon catheters for dilating stenosis in different parts of the gastro-intestinal tract. We present a prospective follow-up study in 55 patients, on the long-term results and safety of hydrostatic balloon dilations of ileo-colonic Crohn's strictures. PMID:7709702

  13. 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

  14. Long-term studies with xamoterol in heart failure

    PubMed Central

    Waller, D. G.

    1989-01-01

    1 Xamoterol (Corwin, Carwin, Corwil, Xamtol, ICI 118,587) is a β1-adrenoceptor partial agonist which, unlike full β-adrenoceptor agonists, does not down-regulate β-adrenoceptors in the rat ventricle during chronic administration. 2 Improvements in myocardial performance have been demonstrated following acute administration of xamoterol to patients with mild or moderate heart failure, and these are sustained during at least 1 year of continued treatment. 3 Exercise duration is increased by xamoterol in patients with left ventricular dysfunction and benefit is still apparent after at least 1 year of therapy. 4 Despite sustained cardiac stimulation, xamoterol does not appear to affect adversely mortality in patients with mild or moderate heart failure. 5 Few adverse events directly attributable to xamoterol were reported during 3 month efficacy studies in more than 600 patients, and the laboratory safety profile over 1 year of treatment is good. 6 Xamoterol is a promising, well-tolerated addition to established therapies for chronic mild or moderate heart failure. PMID:2572255

  15. Study of long term options for electric vehicle air conditioning

    SciTech Connect

    Dieckmann, J.; Mallory, D. , Inc., Cambridge, MA )

    1991-07-01

    There are strong incentives in terms of national energy and environmental policy to encourage the commercialization of electrically powered vehicles in the U.S. Among these incentives are reduced petroleum consumption, improved electric generation capacity utilization, reduced IC engine emissions, and, depending on the primary fuel used for electric power generation, reduced emissions of carbon dioxide. A basic requirement for successfully commercializing any motor vehicle in the US is provision of adequate passenger comfort heating and air conditioning (cooling). Although air conditioning is generally sold as optional equipment, in excess of 80% of the automobiles and small trucks sold in the US have air conditioning systems. In current, pre-commercial electric vehicles, comfort heating is provided by a liquid fuel fired heater that heats water which is circulated through the standard heater core in the conventional interior air handling unit. Air conditioning is provided by electric motor driven compressors, installed in a system having, perhaps, an [open quotes]upsized[close quotes] condenser and a standard evaporator (front and rear evaporators in some instances) installed in the conventional interior air handler. Although this approach is adequate in the near term for initial commercialization efforts, a number of shortcomings of this arrangement, as well as longer range concerns need to be addressed. In this project, the long term alternatives for cooling and heating electric vehicles effectively, efficiently (with minimum range penalties), and without adverse environmental impacts have been examined. Identification of options that can provide both heating and cooling is important, in view of the disadvantages of carrying separate heating and cooling systems in the vehicle.

  16. Study of long term options for electric vehicle air conditioning

    SciTech Connect

    Dieckmann, J.; Mallory, D.

    1991-07-01

    There are strong incentives in terms of national energy and environmental policy to encourage the commercialization of electrically powered vehicles in the U.S. Among these incentives are reduced petroleum consumption, improved electric generation capacity utilization, reduced IC engine emissions, and, depending on the primary fuel used for electric power generation, reduced emissions of carbon dioxide. A basic requirement for successfully commercializing any motor vehicle in the US is provision of adequate passenger comfort heating and air conditioning (cooling). Although air conditioning is generally sold as optional equipment, in excess of 80% of the automobiles and small trucks sold in the US have air conditioning systems. In current, pre-commercial electric vehicles, comfort heating is provided by a liquid fuel fired heater that heats water which is circulated through the standard heater core in the conventional interior air handling unit. Air conditioning is provided by electric motor driven compressors, installed in a system having, perhaps, an {open_quotes}upsized{close_quotes} condenser and a standard evaporator (front and rear evaporators in some instances) installed in the conventional interior air handler. Although this approach is adequate in the near term for initial commercialization efforts, a number of shortcomings of this arrangement, as well as longer range concerns need to be addressed. In this project, the long term alternatives for cooling and heating electric vehicles effectively, efficiently (with minimum range penalties), and without adverse environmental impacts have been examined. Identification of options that can provide both heating and cooling is important, in view of the disadvantages of carrying separate heating and cooling systems in the vehicle.

  17. Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia.

    PubMed

    Tsunemi, Yuichiro; Irisawa, Ryokichi; Yoshiie, Hiromu; Brotherton, Betsy; Ito, Hisahiro; Tsuboi, Ryoji; Kawashima, Makoto; Manyak, Michael

    2016-09-01

    Androgenetic alopecia is an androgen-induced pattern of progressive hair loss, which occurs in genetically predisposed people. This study aimed to determine long-term safety, tolerability and efficacy of dutasteride 0.5 mg, an inhibitor of 5-α-reductase, in Japanese male patients with androgenetic alopecia. This was a multicenter, open-label, prospective outpatient study (clinicaltrials.gov NCT01831791, GSK identifier ARI114264) in which patients took dutasteride 0.5 mg p.o. once daily for 52 weeks. Primary end-points included adverse event assessment, incidence of drug-related adverse event and premature discontinuations. Secondary end-points included hair growth, hair restoration and global improvement in hair. A total of 120 patients were enrolled, of whom 110 completed 52 weeks of treatment. Nasopharyngitis, erectile dysfunction and decreased libido were the most frequently reported adverse events and most adverse events were mild. Drug-related adverse events were reported with an incidence of 17%, none of which led to study withdrawal. Hair growth (mean target area hair count at week 52), hair restoration (mean target area hair width at week 52) and global appearance of hair (mean of the median score at week 52) improved from baseline during the study. As a potential future treatment option for male androgenetic alopecia, dutasteride 0.5 mg exhibited long-term safety, tolerability and efficacy within this study population. PMID:26893187

  18. Long-term (5 years), high daily dosage of dietary agmatine--evidence of safety: a case report.

    PubMed

    Gilad, Gad M; Gilad, Varda H

    2014-11-01

    There is presently a great interest in the therapeutic potential of agmatine, decarboxylated arginine, for various diseases. Recent clinical studies have already shown that oral agmatine sulfate given for up to 3 weeks provides a safe and, as compared with current therapeutics, more effective treatment for neuropathic pain. These studies have ushered in the use of dietary agmatine as a nutraceutical. However, in view of information paucity, assessment of long-term safety of oral agmatine treatment is now clearly required. The authors of this report undertook to assess their own health status during ongoing consumption of a high daily dosage of oral agmatine over a period of 4-5 years. A daily dose of 2.67 g agmatine sulfate was encapsulated in gelatin capsules; the regimen consists of six capsules daily, each containing 445 mg, three in the morning and three in the evening after meals. Clinical follow-up consists of periodic physical examinations and laboratory blood and urine analyses. All measurements thus far remain within normal values and good general health status is sustained throughout the study period, up to 5 years. This case study shows for the first time that the recommended high dosage of agmatine may be consumed for at least 5 years without evidence of any adverse effects. These initial findings are highly important as they provide significant evidence for the extended long-term safety of a high daily dosage of dietary agmatine--a cardinal advantage for its utility as a nutraceutical. PMID:25247837

  19. 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

  20. [The interspinous U implant (now Coflex): long-term outcome, study overview and differential indication].

    PubMed

    Adelt, D

    2010-06-01

    The safety and effectiveness of the Coflex implant has been confirmed in a large retrospective data analysis. Further studies investigated the long-term clinical outcome up to 12 years and evaluated all associated complications showing a strong safety record. Prospective studies oversee only a small patient population at this point and exhibit scientific shortcomings. A large prospective, randomized, concurrently controlled multicenter trial is underway collecting data in seven spine centers in Germany. A similar study is being performed in the USA with a different control group regulated by the Food and Drug Administration (FDA). A differential indication is the stabilization of an adjacent segment next (above) to a fusion. Stabilization of a functional spinal unit after nucleotomy is not promoted by the author. PMID:20454889

  1. Right ventricular septal pacing: Safety and efficacy in a long term follow up

    PubMed Central

    Occhetta, Eraldo; Quirino, Gianluca; Baduena, Lara; Nappo, Rosaria; Cavallino, Chiara; Facchini, Emanuela; Pistelli, Paolo; Magnani, Andrea; Bortnik, Miriam; Francalacci, Gabriella; Dell’Era, Gabriele; Plebani, Laura; Marino, Paolo

    2015-01-01

    AIM: To evaluate the safety and efficacy of the permanent high interventricular septal pacing in a long term follow up, as alternative to right ventricular apical pacing. METHODS: We retrospectively evaluated: (1) 244 patients (74 ± 8 years; 169 men, 75 women) implanted with a single (132 pts) or dual chamber (112 pts) pacemaker (PM) with ventricular screw-in lead placed at the right ventricular high septal parahisian site (SEPTAL pacing); (2) 22 patients with permanent pacemaker and low percentage of pacing (< 20%) (NO pacing); (3) 33 patients with high percentage (> 80%) right ventricular apical pacing (RVA). All patients had a narrow spontaneous QRS (101 ± 14 ms). We evaluated New York Heart Association (NYHA) class, quality of life (QoL), 6 min walking test (6MWT) and left ventricular function (end-diastolic volume, LV-EDV; end-systolic volume, LV-ESV; ejection fraction, LV-EF) with 2D-echocardiography. RESULTS: Pacing parameters were stable during follow up (21 mo/patient). In SEPTAL pacing group we observed an improvement in NYHA class, QoL score and 6MWT. While LV-EDV didn’t significantly increase (104 ± 40 mL vs 100 ± 37 mL; P = 0.35), LV-ESV slightly increased (55 ± 31 mL vs 49 ± 27 mL; P = 0.05) and LV-EF slightly decreased (49% ± 11% vs 53% ± 11%; P = 0.001) but never falling < 45%. In the RVA pacing control group we observed a worsening of NYHA class and an important reduction of LV-EF (from 56% ± 6% to 43% ± 9%, P < 0.0001). CONCLUSION: Right ventricular permanent high septal pacing is safe and effective in a long term follow up evaluation; it could be a good alternative to the conventional RVA pacing in order to avoid its deleterious effects. PMID:26322189

  2. Long-term safety and efficacy of romiplostim for treatment of immune thrombocytopenia

    PubMed Central

    Vishnu, Prakash; Aboulafia, David M

    2016-01-01

    Inhibition of platelet production and mediated by antiplatelet antibodies is a well-known mechanism causing low platelet counts in immune thrombocytopenia (ITP). Use of thrombopoietin receptor agonists increases platelet counts and decreases the risk of bleeding in patients with ITP. Two such thrombopoietin receptor agonists, romiplostim and eltrombopag, are approved by the US Food and Drug Administration to treat thrombocytopenia in adults, and most recently, children with persistent or chronic ITP. This review focuses on the efficacy data and safety analysis of the pooled data from the clinical trials evaluating romiplostim for treatment of adults with ITP. The rates of hemorrhage, thrombosis, hematologic and nonhematologic cancers, and myelodysplastic syndrome were not overrepresented among the groups who received romiplostim versus placebo or other standard-of-care treatments. Yet, as after-market experience with thrombopoietin receptor agonists increases, there are emerging reports of increased incidence of thrombosis and bone marrow reticulin among patients who are treated with long-term use of these agents. Ongoing clinical research will continue to evaluate romiplostim’s efficacy and safety in other primary and secondary thrombocytopenic states. PMID:27307776

  3. Business Students' Choice of Short-Term or Long-Term Study Abroad Opportunities

    ERIC Educational Resources Information Center

    Fitzsimmons, Stacey R.; Flanagan, David J.; Wang, Xiaodan

    2013-01-01

    Recent years have seen a proliferation of short-term study abroad opportunities. Although they are both supplementing and replacing semester-long study abroad programs, research has focused primarily on semester (long-term) programs. We draw on the theory of planned behavior (TPB) to explore factors that predict why students choose long-term and…

  4. 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…

  5. Long-term safety and function of RPE from human embryonic stem cells in preclinical models of macular degeneration.

    PubMed

    Lu, Bin; Malcuit, Christopher; Wang, Shaomei; Girman, Sergej; Francis, Peter; Lemieux, Linda; Lanza, Robert; Lund, Raymond

    2009-09-01

    Assessments of safety and efficacy are crucial before human ESC (hESC) therapies can move into the clinic. Two important early potential hESC applications are the use of retinal pigment epithelium (RPE) for the treatment of age-related macular degeneration and Stargardt disease, an untreatable form of macular dystrophy that leads to early-onset blindness. Here we show long-term functional rescue using hESC-derived RPE in both the RCS rat and Elov14 mouse, which are animal models of retinal degeneration and Stargardt, respectively. Good Manufacturing Practice-compliant hESC-RPE survived subretinal transplantation in RCS rats for prolonged periods (>220 days). The cells sustained visual function and photoreceptor integrity in a dose-dependent fashion without teratoma formation or untoward pathological reactions. Near-normal functional measurements were recorded at >60 days survival in RCS rats. To further address safety concerns, a Good Laboratory Practice-compliant study was carried out in the NIH III immune-deficient mouse model. Long-term data (spanning the life of the animals) showed no gross or microscopic evidence of teratoma/tumor formation after subretinal hESC-RPE transplantation. These results suggest that hESCs could serve as a potentially safe and inexhaustible source of RPE for the efficacious treatment of a range of retinal degenerative diseases. PMID:19521979

  6. Bronchial Thermoplasty – Long Term Safety and Effectiveness in Severe Persistent Asthma

    PubMed Central

    Wechsler, Michael E.; Laviolette, Michel; Rubin, Adalberto S.; Fiterman, Jussara; Lapa e Silva, Jose R.; Shah, Pallav L.; Fiss, Elie; Olivenstein, Ronald; Thomson, Neil C.; Niven, Robert M.; Pavord, Ian D.; Simoff, Michael; Hales, Jeff B.; McEvoy, Charlene; Slebos, Dirk-Jan; Holmes, Mark; Phillips, Martin J.; Erzurum, Serpil C.; Hanania, Nicola A.; Sumino, Kaharu; Kraft, Monica; Cox, Gerard; Sterman, Daniel H.; Hogarth, Kyle; Kline, Joel N.; Mansur, Adel H.; Louie, Brian E.; Leeds, William M.; Barbers, Richard G.; Austin, John H.M.; Shargill, Narinder S.; Quiring, John; Armstrong, Brian; Castro, Mario

    2014-01-01

    Background Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. Objective To assess effectiveness and safety of BT in asthma patients 5 years post therapy. Methods BT-treated subjects from the Asthma Intervention Research 2 (AIR2) Trial (ClinicalTrials.gov NCT01350414) were evaluated annually for 5 years to assess long-term safety of BT and durability of treatment effect. Outcomes assessed post-BT included severe exacerbations, adverse events, healthcare utilization, spirometry data, and high resolution computed tomography (HRCT) scans. Results 162/190 BT-treated subjects (85.3%) from the AIR2 Trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and Emergency Room visits, and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months prior to BT treatment (average 5 year reduction in proportions: 44% for exacerbations and 78% for ER visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in Years 2 through 5 as compared to the first year after BT. Pre-BD FEV1 values remained stable between years 1 and 5 after BT, despite a 17% reduction in average daily inhaled corticosteroid dose. HRCT scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. Conclusions These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ER visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking ICS (inhaled corticosteroids) and LABA (long-acting-β2-agonists). PMID:23998657

  7. Long-Term Retention of Basic Science Knowledge: A Review Study

    ERIC Educational Resources Information Center

    Custers, Eugene J. F. M.

    2010-01-01

    In this paper, a review of long-term retention of basic science knowledge is presented. First, it is argued that retention of this knowledge has been a long-standing problem in medical education. Next, three types of studies are described that are employed in the literature to investigate long-term retention of knowledge in general. Subsequently,…

  8. Barriers and Facilitators in Pain Management in Long-Term Care Institutions: A Qualitative Study

    ERIC Educational Resources Information Center

    Fox, Patricia; Solomon, Patricia; Raina, Parminder; Jadad, Alejandro R.

    2004-01-01

    The purpose of this study was to identify barriers to the management of pain in long-term care institutions. Formal caregivers practising in four long-term care institutions in Hamilton, Ontario participated in eight focus groups. Participants included 6 physicians, 19 registered nurses, 8 registered practical nurses, 13 health care aides and 8…

  9. Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study

    PubMed Central

    Sargent, Randall; Brocklebank, Cynthia; Tam-Tham, Helen; Williamson, Tyler; Quail, Patrick; Turner, Diana; Drummond, Neil

    2016-01-01

    Background Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. Methods This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio (INR) tests in the range 2.0 to 3.0, time in range, number of tests, and frequency of bleeding at protocol and control sites. Our primary outcome, time in INR therapeutic range, is an indicator for assuring care quality. A cross-sectional survey at these sites compared health professionals’ perceptions of workload and effectiveness of warfarin management. Results Of the 197 residents’ charts reviewed in the study period, those on protocol had 45.0 INR tests while those on usual care had 52.7 tests (p = .034, 95% CI for the difference: 0.6 to 14.6 INR tests). No significant difference was found for time in therapeutic range, number of tests in range, or major bleeding events. Of 178 health professionals surveyed, those from protocol facilities were more satisfied with warfarin management (p = .013). Workload and safety were perceived similarly at all sites. Interpretation Our results suggest that a pharmacist-managed warfarin protocol is as effective as usual care and has advantages pertaining to work satisfaction, knowledge of drug interactions, consistent documentation, and fewer INR tests. Further research on teamwork and coagulation management in long-term care facilities is recommended. PMID:27403212

  10. Long-term safety and efficacy of sustained eculizumab treatment in patients with paroxysmal nocturnal haemoglobinuria

    PubMed Central

    Hillmen, Peter; Muus, Petra; Röth, Alexander; Elebute, Modupe O; Risitano, Antonio M; Schrezenmeier, Hubert; Szer, Jeffrey; Browne, Paul; Maciejewski, Jaroslaw P; Schubert, Jörg; Urbano-Ispizua, Alvaro; de Castro, Carlos; Socié, Gérard; Brodsky, Robert A

    2013-01-01

    Paroxysmal nocturnal haemoglobinuria (PNH) is characterized by chronic, uncontrolled complement activation resulting in elevated intravascular haemolysis and morbidities, including fatigue, dyspnoea, abdominal pain, pulmonary hypertension, thrombotic events (TEs) and chronic kidney disease (CKD). The long-term safety and efficacy of eculizumab, a humanized monoclonal antibody that inhibits terminal complement activation, was investigated in 195 patients over 66 months. Four patient deaths were reported, all unrelated to treatment, resulting in a 3-year survival estimate of 97·6%. All patients showed a reduction in lactate dehydrogenase levels, which was sustained over the course of treatment (median reduction of 86·9% at 36 months), reflecting inhibition of chronic haemolysis. TEs decreased by 81·8%, with 96·4% of patients remaining free of TEs. Patients also showed a time-dependent improvement in renal function: 93·1% of patients exhibited improvement or stabilization in CKD score at 36 months. Transfusion independence increased by 90·0% from baseline, with the number of red blood cell units transfused decreasing by 54·7%. Eculizumab was well tolerated, with no evidence of cumulative toxicity and a decreasing occurrence of adverse events over time. Eculizumab has a substantial impact on the symptoms and complications of PNH and results a significant improvement in patient survival. PMID:23617322

  11. Long-term efficacy and safety of raltegravir in the management of HIV infection.

    PubMed

    Liedtke, Michelle D; Tomlin, C Ryan; Lockhart, Staci M; Miller, Misty M; Rathbun, R Chris

    2014-01-01

    Raltegravir is an integrase strand-transfer inhibitor approved for the treatment of HIV infection. It was the first medication in a novel class of antiretroviral agents to be approved for use in the United States in 2007. Raltegravir exhibits potent activity against wild-type HIV-1, but resistance development has been noted through three different pathways. It is metabolized primarily through uridine diphosphate glucuronosyltransferase 1A1 and has a single inactive glucuronide metabolite. Raltegravir is not a substrate, inhibitor, or inducer of cytochrome P450 enzymes and exhibits low potential for drug-drug interactions; however, strong uridine diphosphate glucuronosyltransferase 1A1 inhibitors or inducers can alter the pharmacokinetics of raltegravir. It is well tolerated, and the most commonly reported adverse effects include headache, nausea, and diarrhea. Serious adverse effects with raltegravir are rare but include rhabdomyolysis and severe skin and hypersensitivity reactions. It has been approved for use in both treatment-naïve and treatment-experienced patients and is a preferred first-line agent in both United States and European HIV treatment guidelines. Although initial approval was granted on 48-week data, 5-year clinical data have recently been published. This article reviews the data supporting long-term efficacy and safety of raltegravir in the treatment of HIV infection. PMID:24672249

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

    PubMed Central

    Kivelevitch, Dario; Mansouri, Bobbak; Menter, Alan

    2014-01-01

    Psoriasis is a chronic, immune-mediated inflammatory disease affecting both the skin and joints. Approximately 20% of patients suffer a moderate to severe form of skin disease and up to 30% have joint involvement. Standard therapies for psoriasis include topical medications, phototherapy, and both oral systemic and biological therapies whereas therapies for psoriatic arthritis include nonsteroidal anti-inflammatory drugs followed by disease modifying antirheumatic drugs and/or tumor necrosis factor (TNF)-α inhibitors and interleukin-12/23p40 inhibitors. Treatment of both diseases is typically driven by disease severity. In the past decade, major advances in the understanding of the immunopathogenesis of psoriasis and psoriatic arthritis have led to the development of numerous biological therapies, which have revolutionized the treatment for moderate to severe plaque psoriasis and psoriatic arthritis. Anti-TNF-α agents are currently considered as first line biological therapies for the treatment of moderate to severe psoriasis and psoriatic arthritis. Currently approved anti-TNF-α agents include etanercept, adalimumab, and infliximab for psoriasis and psoriatic arthritis as well as golimumab and certolizumab for psoriatic arthritis. In this article, we aim to evaluate the long term safety and efficacy of etanercept in psoriasis and psoriatic arthritis. PMID:24790410

  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. Long-term efficacy and safety of raltegravir in the management of HIV infection

    PubMed Central

    Liedtke, Michelle D; Tomlin, C Ryan; Lockhart, Staci M; Miller, Misty M; Rathbun, R Chris

    2014-01-01

    Raltegravir is an integrase strand-transfer inhibitor approved for the treatment of HIV infection. It was the first medication in a novel class of antiretroviral agents to be approved for use in the United States in 2007. Raltegravir exhibits potent activity against wild-type HIV-1, but resistance development has been noted through three different pathways. It is metabolized primarily through uridine diphosphate glucuronosyltransferase 1A1 and has a single inactive glucuronide metabolite. Raltegravir is not a substrate, inhibitor, or inducer of cytochrome P450 enzymes and exhibits low potential for drug–drug interactions; however, strong uridine diphosphate glucuronosyltransferase 1A1 inhibitors or inducers can alter the pharmacokinetics of raltegravir. It is well tolerated, and the most commonly reported adverse effects include headache, nausea, and diarrhea. Serious adverse effects with raltegravir are rare but include rhabdomyolysis and severe skin and hypersensitivity reactions. It has been approved for use in both treatment-naïve and treatment-experienced patients and is a preferred first-line agent in both United States and European HIV treatment guidelines. Although initial approval was granted on 48-week data, 5-year clinical data have recently been published. This article reviews the data supporting long-term efficacy and safety of raltegravir in the treatment of HIV infection. PMID:24672249

  15. Studies on canine bone marrow long-term culture: effect of stem cell factor.

    PubMed

    Neuner, E; Schumm, M; Schneider, E M; Guenther, W; Kremmer, E; Vogl, C; Büttner, M; Thierfelder, S; Kolb, H J

    1998-02-16

    Long-term culture of canine marrow cells allows in vitro studies of the hematopoietic system of the dog and characterization of early progenitor cells. Colonies of fresh marrow cells grew equally good in both agar or methylcellulose supplemented with fetal calf serum, while colonies of long-term cultures required agar-based medium containing human serum. Optimum colony growth was obtained when stem cell factor (SCF) and granulocyte-macrophage-colony-stimulating factor (GM-CSF) were used as growth stimuli of colony forming units (CFU). Similar results were achieved with several cell culture media. Addition of hydrocortisone to long-term cultures improved clonogenic growth of cultured cells. Addition of 2-mercaptoethanol had no effect. Strong differences were observed in long-term culture with different horse serum lots and the addition of fetal calf serum to long-term culture suppressed CFU growth of cultured cells. Recharging of cultures with fresh marrow cells on day 7 of culture improved CFU growth only in the following week but had little effect on the outcome. Adding SCF to long-term cultures led to differentiation of more primitive cells and destruction of the stromal layer. Investigation of purified and cultured cell populations was possible when preestablished long-term cultures as stromal layers were used. Loss of long-term culture-initiating ability could be demonstrated in this system with lineage negative marrow cells expanded ex vivo with SCF and GM-CSF. PMID:9613468

  16. Long-term results of viscocanalostomy and phacoviscocanalostomy: a twelve-year follow-up study

    PubMed Central

    Gunenc, Uzeyir; Ozturk, Taylan; Arikan, Gul; Kocak, Nilufer

    2015-01-01

    AIM To evaluate the long-term efficacy and safety results of viscocanalostomy and phacoviscocanalostomy. METHODS The charts of 49 glaucoma patients who underwent viscocanalostomy or phacoviscocanalostomy surgery between February 1999 and August 2004 were reviewed retrospectively. Thirty-one eyes of 21 glaucoma patients who underwent filtering procedure with a postoperative follow-up of at least 5y were included in the study. Results of complete ophthalmologic examinations were recorded and statistically analyzed. Long-term surgical outcome was defined as an overall success when intraocular pressure (IOP) was found as ≤20 mm Hg with or without antiglaucomatous medication at the last follow-up visit, while it was defined as a complete success when IOP was measured ≤20 mm Hg without antiglaucomatous medication. RESULTS Mean age was 68.1±9.6y (range: 32-81y). Mean follow-up time was 101.5±27.3mo (range: 60-144mo). Viscocanalostomy was performed in 8 eyes (25.8%) and phacoviscocanalostomy was performed in 23 eyes (74.2%). The mean preoperative IOP was 23.1±7.6 mm Hg with 2.1±1.0 medications, while mean IOP was 16.8±3.8 mm Hg with 0.9±1.1 medication at the last follow-up visit. Both the IOP decrease and the reduction in the antiglaucomatous medication were statistically significant (P<0.001 and P<0.001). No case required further glaucoma surgery. Overall success and complete success were found as 87.1% and 51.6%, respectively. Complete success rate was statistically higher in phacoviscocanalostomy group compared with the viscocanalostomy group (P=0.031), however there was no significant difference in overall success rate between two groups (P=0.072). CONCLUSION Both viscocanalostomy and phacoviscocanalostomy provide good IOP reduction in the long-term period. PMID:26682166

  17. Long-term decontamination engineering study. Volume 1

    SciTech Connect

    Geuther, W.J.

    1995-04-03

    This report was prepared by Westinghouse Hanford Company (WHC) with technical and cost estimating support from Pacific Northwest Laboratories (PNL) and Parsons Environmental Services, Inc. (Parsons). This engineering study evaluates the requirements and alternatives for decontamination/treatment of contaminated equipment at the Hanford Site. The purpose of this study is to determine the decontamination/treatment strategy that best supports the Hanford Site environmental restoration mission. It describes the potential waste streams requiring treatment or decontamination, develops the alternatives under consideration establishes the criteria for comparison, evaluates the alternatives, and draws conclusions (i.e., the optimum strategy for decontamination). Although two primary alternatives are discussed, this study does identify other alternatives that may warrant additional study. hanford Site solid waste management program activities include storage, special processing, decontamination/treatment, and disposal facilities. This study focuses on the decontamination/treatment processes (e.g., waste decontamination, size reduction, immobilization, and packaging) that support the environmental restoration mission at the Hanford Site.

  18. Maintaining Long-Term Therapeutic Programmes: A Qualitative Case Study

    ERIC Educational Resources Information Center

    Brown, J. F.

    2006-01-01

    Maintaining therapeutic programmes for people with learning disabilities over long periods of time presents a major challenge to care systems as the limited and slow pace of client behavioural change is often insufficient to sustain staff behaviour. In this study, a 17-year-old young man with profound learning difficulties was successfully…

  19. Technology base studies of long-term MCFC performance

    SciTech Connect

    Selman, J.R.; Yazici, M.S.

    1995-12-01

    Cathode dissolution into the electrolyte matrix and endurance of current collector/separator plate materials are the main life-limiting factors of the state-of-the art MCFC. These components are also major contributors to the total system cost. Therefore, to reduce capital cost, it is necessary to minimize hardware corrosion and increase cell life. This study consists of experimental evaluation of corrosion processes with the objective to further practical; understanding of corrosion behavior of alloys and alloy components under cathodic gas conditions. Nickel, iron, cobalt and stainless steels 310 and 316L are analyzed. The experimental study consists of: (1) Observation of open circuit potential (OCP) changes. Surface reactions occurring without net passage of current are proposed based on this measurement. (2) Applying cyclic voltammetry, which provides information about the possible electrode reactions at different stages of polarization. (3) Applying AC impedance to support the result of tasks 1 and 2 at different stages of oxidation, and data analysis by means of equivalent circuits. Open circuit conditions as well as positive and negative polarization are used in the impedance measurements. (4) Surface analysis of the electrodes by SEM-EDX and X-ray diffraction. To obtain more information from electrochemical measurements a novel approach has been applied in cell design. In this two electrode approach, one electrode is fully immersed, and the other is wetted by carbonate melt via an alumina tube which has a thin film on it. While camera observation of these two different electrode conditions will identify the effect of carbonate wetting on the state of the surface, electrochemical measurements enable a quantitative comparison between complete submersion and wetting by a film of carbonate.

  20. Technology base studies of long-term MCFC performance

    SciTech Connect

    Selman, J.R.

    1995-08-01

    Cathode dissolution into the electrolyte matrix and endurance of current collector/separator plate materials are the main life-limiting factors of the state-of-the art MCFC. These components are also major contributors to the total system cost. Therefore, to reduce capital cost, it is necessary to minimize hardware corrosion and increase cell life. This study consists of experimental evaluation of corrosion processes with the objective to further practical; understanding of corrosion behavior of alloys and alloy components under cathodic gas conditions. Nickel, iron, cobalt and stainless steels 310 and 316L are analyzed. The experimental study consists of (1) Observation of open circuit potential (OCP) changes. Surface reactions occurring without net passage of current are proposed based on this measurement. (2) Applying cyclic voltammetry, which provides information about the possible electrode reactions at different stages of polarization. (3) Applying AC impedance to support the result of tasks 1 and 2 at different stages of oxidation, and data analysis by means of equivalent circuits. Open circuit conditions as well as positive and negative polarization are used in the impedance measurements. (4) Surface analysis of the electrodes by SEM-EDX and X-ray diffraction. To obtain more information from electrochemical measurements a novel approach has been applied in cell design. In this two-electrode approach, one electrode is fully immersed, and the other is wetted by carbonate melt via an alumina tube which has a thin film on it. While camera observation of these two different electrode conditions will identify the effect of carbonate wetting on the state of the surface, electrochemical measurements enable a quantitative comparison between complete submersion and wetting by a film of carbonate.

  1. Infantile eczema: A long-term follow-up study.

    PubMed

    Musgrove, K; Morgan, J K

    1976-10-01

    A 15-17 year follow-up study was conducted on ninety-nine patients who had suffered from infantile eczema. The persistance of the eczema and the occurrence of related conditions were noted. The persistence of eczema was shown to be greater in those patients with a positive family history of eczema and in those who had developed asthma or hay-fever. An attempt was made to see if the persistence of eczema was affected by the position of the child in the family, and some factors provoking relapses were noted. The patients were also questioned with regard to their achievements in academic examinations, and to their social, artistic and sporting activities. The results showed a success rate in examinations not significantly higher than average. It was not possible to show if there is a particular type of atopic personality. There was no constant characteristic in social or artistic patterns. The group as a whole were normal at the milestones of early development, i.e. walking, talking and reading, and also normal with regard to weight and height. PMID:974022

  2. Endoscopic vertical ramus osteotomy: a long-term prospective study.

    PubMed

    Papadaki, M E; Kaban, L B; Troulis, M J

    2014-03-01

    The purpose of this prospective study was to evaluate the outcomes of endoscopic vertical ramus osteotomy (EVRO) with rigid fixation for the treatment of mandibular prognathism or asymmetry. Inclusion criteria were age >15 years, adequate clinical and radiographic documentation, and minimum postoperative follow-up of 3 years. Exclusion criteria were refusal to consent, rheumatoid arthritis, steroid use, and smoking. Demographic data, pre-operative (T0), immediate postoperative (T1), and latest follow-up (T2) clinical examinations and cephalometric analysis, procedure data, complications, and length of hospital stay (LOS) were documented. Ten fulfilled the inclusion criteria. Diagnoses included mandibular hyperplasia (n = 5), stable condylar hyperplasia (n = 4), and mandibular asymmetry secondary to condylar resorption (n = 1). In total, 17 EVROs were performed. The mean operative time was 33 min per side. Mean mandibular setback was 4.7 mm. Mean LOS was 1.9 days. Latest follow-up ranged from 3 to 5 years. Skeletal stability was confirmed in nine patients. One patient exhibited recurrence of mandibular prognathism at 5 years due to late growth. No VII nerve deficits were encountered. Inferior alveolar nerve (IAN) paresthesia was noted in four patients, which resolved postoperatively. EVRO was fast and resulted in minimal blood loss, quick recovery, and skeletal stability. PMID:24246948

  3. 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.

  4. Long-term metapopulation study of the Glanville fritillary butterfly (Melitaea cinxia): survey methods, data management, and long-term population trends

    PubMed Central

    Ojanen, Sami P; Nieminen, Marko; Meyke, Evgeniy; Pöyry, Juha; Hanski, Ilkka

    2013-01-01

    Long-term observational studies conducted at large (regional) spatial scales contribute to better understanding of landscape effects on population and evolutionary dynamics, including the conditions that affect long-term viability of species, but large-scale studies are expensive and logistically challenging to keep running for a long time. Here, we describe the long-term metapopulation study of the Glanville fritillary butterfly (Melitaea cinxia) that has been conducted since 1991 in a large network of 4000 habitat patches (dry meadows) within a study area of 50 by 70 km in the Åland Islands in Finland. We explain how the landscape structure has been described, including definition, delimitation, and mapping of the habitat patches; methods of field survey, including the logistics, cost, and reliability of the survey; and data management using the EarthCape biodiversity platform. We describe the long-term metapopulation dynamics of the Glanville fritillary based on the survey. There has been no long-term change in the overall size of the metapopulation, but the level of spatial synchrony and hence the amplitude of fluctuations in year-to-year metapopulation dynamics have increased over the years, possibly due to increasing frequency of exceptional weather conditions. We discuss the added value of large-scale and long-term population studies, but also emphasize the need to integrate more targeted experimental studies in the context of long-term observational studies. For instance, in the case of the Glanville fritillary project, the long-term study has produced an opportunity to sample individuals for experiments from local populations with a known demographic history. These studies have demonstrated striking differences in dispersal rate and other life-history traits of individuals from newly established local populations (the offspring of colonizers) versus individuals from old, established local populations. The long-term observational study has stimulated the

  5. A Cohort Study on Long-Term Adverse Effects of Parental Drinking: Background and Study Design

    PubMed Central

    Lund, Ingunn Olea; Bukten, Anne; Storvoll, Elisabet E; Moan, Inger Synnøve; Skurtveit, Svetlana; Handal, Marte; Nordfjærn, Trond; Brunborg, Geir Scott; Rossow, Ingeborg

    2015-01-01

    Although many studies have addressed adverse outcomes in children of parents with alcohol abuse/dependence, less is known about the possible long-term effects of more normative patterns of parental alcohol consumption, including drinking at lower risk levels and heavy episodic or binge drinking. The extent of harm from parental drinking may therefore be underestimated. With this research proposal, we describe a project that aims to assess possible long-term adverse effects of parental drinking by combining survey and nationwide registry data. Advantages of a longitudinal general population cohort design include that it allows for detailed information on parental drinking through survey data and identification of possible negative long-term health and social outcomes from exposure to parental drinking 1–19 years after exposure through continuously updated nationwide registers. The rich information available from combining survey and registry data allows us to take into account important confounders, mediators, and moderators. PMID:26688663

  6. Influence of advancing age on clinical presentation, treatment efficacy and safety, and long-term outcome of pre-excitation syndromes: a retrospective cohort study of 961 patients included over a 25-year period

    PubMed Central

    Brembilla-Perrot, Béatrice; Olivier, Arnaud; Sellal, Jean-Marc; Manenti, Vladimir; Brembilla, Alice; Villemin, Thibaut; Admant, Philippe; Beurrier, Daniel; Bozec, Erwan; Girerd, Nicolas

    2016-01-01

    Objectives There are very little data on pre-excitation syndrome (PS) in the elderly. We investigated the influence of advancing age on clinical presentation, treatment and long-term outcome of PS. Setting Single-centre retrospective study of patient files. Participants In all, 961 patients (72 patients ≥60 years (mean 68.5±6), 889 patients <60 years (mean 30.5±14)) referred for overt pre-excitation and indication for electrophysiological study (EPS) were followed for 5.3±5 years. Usual care included 24 h Holter monitoring, echocardiography and EPS. Patients underwent accessory pathway (AP) ablation if necessary. Primary and secondary outcome measures Occurrence of atrial fibrillation (AF) or procedure-induced adverse event. Results Electrophysiological data and recourse to AP ablation (43% vs 48.5%, p=0.375) did not significantly differ between the groups. Older patients more often had symptomatic forms (81% vs 63%, p=0.003), history of spontaneous AF (8% vs 3%, p=0.01) or adverse presentation (poorly tolerated arrhythmias: 18% vs 7%, p=0.0009). In multivariable analysis, patients ≥60 years had a significantly higher risk of history of AF (OR=4.2, 2.1 to 8.3, p=0.001) and poorly tolerated arrhythmias (OR=3.8, 1.8 to 8.1, p=0.001). Age ≥60 years was associated with an increased major AP ablation complication risk (10% vs 1.9%, p=0.006). During follow-up, occurrence of AF (13.9% vs 3.6%, p<0.001) and incidence of poorly tolerated tachycardia (4.2% vs 0.6%, p=0.001) were more frequent in patients ≥60 years, although frequency of ablation failure or recurrence was similar (20% vs 15.5%, p=0.52). In multivariable analysis, patients ≥60 years had a significantly higher risk of AF (OR=2.9, 1.2 to 6.8, p≤0.01). Conclusions In this retrospective monocentre study, patients ≥60 years referred for PS work up appeared at higher risk of AF and adverse presentation, both prior and after the work up. These results suggest that, in elderly

  7. Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience.

    PubMed

    Martino, M; Console, G; Dattola, A; Callea, I; Messina, G; Moscato, T; Massara, E; Irrera, G; Fedele, R; Gervasi, A; Bresolin, G; Iacopino, P

    2009-08-01

    Healthy donors (HDs) who were mobilized using lenograstim (LENO) and who were undergoing peripheral haematopoietic progenitor cell collection with apheresis (HPC-A) were enrolled in a surveillance protocol. In all, 184 HDs have been assessed with a median follow-up of 62 months (range 2-155). HDs received LENO at a median dose of 10 microg/kg (range 5-15). Bone pain was reported as the most frequent short-term adverse event (71.2%). Other commonly observed short-term symptoms included fatigue (19.0%), fever (5.4%), headache (27.7%), nausea (12.0%) and insomnia (22.3%). Spleen size increased in 4.3% of the donors. No vascular disorders or cardiac disease occurred. Long-term follow-up included monitoring of adverse events, neoplastic disease or other pathologies. Transit ischaemic attack occurred in one donor (39 months post-donation). One autoimmune event was reported at 28 months post-recombinant human granulocyte (rhG)-CSF (ankylosing spondylitis); one donor with a history of chronic obstructive pulmonary disease developed secondary polyglobulia (50 months post-rhG-CSF). One donor was diagnosed with lung cancer at 19 months post-donation. No haematological disease was observed. In conclusion, the short-term safety appears to be verified, whereas, although the study identified no increased risks of malignancy among HDs who received rhG-CSF, long-term safety requires more complete data sets, especially a longer follow-up and a larger number of HDs. PMID:19182833

  8. Long-term academic stress increases the late component of error processing: an ERP study.

    PubMed

    Wu, Jianhui; Yuan, Yiran; Duan, Hongxia; Qin, Shaozheng; Buchanan, Tony W; Zhang, Kan; Zhang, Liang

    2014-05-01

    Exposure to long-term stress has a variety of consequences on the brain and cognition. Few studies have examined the influence of long-term stress on event related potential (ERP) indices of error processing. The current study investigated how long-term academic stress modulates the error related negativity (Ne or ERN) and the error positivity (Pe) components of error processing. Forty-one male participants undergoing preparation for a major academic examination and 20 non-exam participants completed a Go-NoGo task while ERP measures were collected. The exam group reported higher perceived stress levels and showed increased Pe amplitude compared with the non-exam group. Participants' rating of the importance of the exam was positively associated with the amplitude of Pe, but these effects were not found for the Ne/ERN. These results suggest that long-term academic stress leads to greater motivational assessment of and higher emotional response to errors. PMID:24657630

  9. A long-term, observational cohort study on the safety of low-dose glucocorticoids in ankylosing spondylitis: adverse events and effects on bone mineral density, blood lipid and glucose levels and body mass index

    PubMed Central

    Zhang, Yu-Ping; Gong, Yao; Zeng, Qing Yu; Hou, Zhi-Duo; Xiao, Zheng-Yu

    2015-01-01

    Objectives This study aimed to investigate the risk of adverse events and effects on bone mineral density (BMD), blood lipid and glucose levels and body mass index (BMI) of low-dose glucocorticoid (GC) treatment in ankylosing spondylitis. Design We performed a retrospective, observational cohort study. Adverse effects were compared between GC users and non-GC users, and we analysed differences in the duration of GC exposure (no GC exposure, <6 months, 6 months to 2 years and >2 years). Setting Outpatient clinic in a tertiary general hospital in China, rheumatology follow-up visits over the past 30 years. Participants We included 830 patients with ankylosing spondylitis who were followed up for at least 6 months without a previous history or current complications of active gastrointestinal problems, hypertension, psychiatric or mental problems, diabetes mellitus, tuberculosis and hepatitis. The median follow-up time was 1.6 years (range 0.5–15 years, a total of 1801 patient-years). Results A total of 555 (66.9%) patients were treated with low-dose GCs, and the median cumulative duration of GC therapy was 1.3 years (range 0.1–8.5 years). Dermatological incidents, including acne, bruisability and cutaneous infections, were the most common adverse events, with a cumulative incidence rate of 5.4% (22.2 events per 1000 patient-years), followed by a puffy and rounded face (1.6%), symptoms of weight gain (1.1%) and serious infections (1.0%). The rates of all other types of adverse events were less than 1%. The GC groups (GC users and non-GC users) and the duration of GC therapy were not associated with the frequency of low BMD, dyslipidaemia, hyperglycaemia or obesity (p<0.05). Conclusions Adverse events during long-term treatment of low-dose GCs are limited. Low-dose GCs do not have an adverse effect on BMD, blood lipid and glucose levels and BMI. PMID:26041488

  10. Long-term prescribing of antidepressants in the older population: a qualitative study

    PubMed Central

    Dickinson, Rebecca; Knapp, Peter; House, Allan O; Dimri, Vandana; Zermansky, Arnold; Petty, Duncan; Holmes, John; Raynor, David K

    2010-01-01

    Background High rates of long-term antidepressant prescribing have been identified in the older population. Aims To explore the attitudes of older patients and their GPs to taking long-term antidepressant therapy, and their accounts of the influences on long-term antidepressant use. Design of study Qualitative study using in-depth semi-structured interviews. Setting One primary care trust in North Bradford. Method Thirty-six patients aged ≥75 years and 10 GPs were interviewed. Patients were sampled to ensure diversity in age, sex, antidepressant type, and home circumstances. Results Participants perceived significant benefits and expressed little apprehension about taking long-term antidepressants, despite being aware of the psychological and social factors involved in onset and persistence of depression. Barriers to discontinuation were identified following four themes: pessimism about the course and curability of depression; negative expectations and experiences of ageing; medicine discontinuation perceived by patients as a threat to stability; and passive (therapeutic momentum) and active (therapeutic maintenance) decisions to accept the continuing need for medication. Conclusion There is concern at a public health level about high rates of long-term antidepressant prescribing, but no evidence was found of a drive for change either from the patients or the doctors interviewed. Any apprehension was more than balanced by attitudes and behaviours supporting continuation. These findings will need to be incorporated into the planning of interventions aimed at reducing long-term antidepressant prescribing in older people. PMID:20353660

  11. 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

  12. Long-term safety of budesonide/formoterol for the treatment of elderly patients with bronchial asthma

    PubMed Central

    KAGOHASHI, KATSUNORI; SATOH, HIROAKI; OHARA, GEN; MIYAZAKI, KUNIHIKO; KAWAGUCHI, MIO; KURISHIMA, KOICHI; HIZAWA, NOBUYUKI

    2014-01-01

    The long-term safety of budesonide/formoterol (BUD/FM) inhalation has not been fully evaluated, particularly in elderly patients with bronchial asthma. To evaluate the 12-month safety of BUD/FM inhalation for elderly asthmatic patients, the changes in serum potassium levels and pulse rate were examined. A retrospective chart review was conducted of consecutive patients who were treated with BUD/FM inhalation (two inhalations of 160/4.5 mg, twice daily; Symbicort Turbuhaler, AstraZeneca) at a hospital between February 2010 and January 2012. A total of 350 patients were treated with BUD/FM inhalation during the study period and were followed up over 12 months. The mean age of the patients was 60 years, and 19.4% and 21.4% of the patients were aged 65–74 years and ≥75 years, respectively. One hundred and fourteen (32.6%) of the 350 patients continued the inhalation therapy for >12 months. Compared with the pretreatment data, reductions in serum potassium levels at 1, 6 and 12 months were not observed, even in the patients aged 65–74 and ≥75 years. There was also no increase in the pulse rate at 1, 6 and 12 months, even in the patients aged 65–74 and ≥75 years. The usual dosage of BUD/FM showed no adverse effects on the serum potassium levels and pulse rate in the adults, including the elderly with persistent asthma. PMID:24669267

  13. Gauging the Purported Costs of Public Data Archiving for Long-Term Population Studies

    PubMed Central

    Evans, Simon Robin

    2016-01-01

    It was recently proposed that long-term population studies be exempted from the expectation that authors publicly archive the primary data underlying published articles. Such studies are valuable to many areas of ecological and evolutionary biological research, and multiple risks to their viability were anticipated as a result of public data archiving (PDA), ultimately all stemming from independent reuse of archived data. However, empirical assessment was missing, making it difficult to determine whether such fears are realistic. I addressed this by surveying data packages from long-term population studies archived in the Dryad Digital Repository. I found no evidence that PDA results in reuse of data by independent parties, suggesting the purported costs of PDA for long-term population studies have been overstated. PMID:27058254

  14. Study Abroad for Global Engagement: The Long-Term Impact of Mobility Experiences

    ERIC Educational Resources Information Center

    Paige, R. Michael; Fry, Gerald W.; Stallman, Elizabeth M.; Josic, Jasmina; Jon, Jae-Eun

    2009-01-01

    This paper reports on the preliminary results of a research project "'Beyond immediate impact: Study abroad for global engagement' (SAGE)" which examines the long-term impact of study abroad on various forms of global engagement. The study employs a retrospective tracer study and mixed methods research design. Survey results from 6391 study-abroad…

  15. Study on the Long-Term Results of Endovenous Laser Ablation for Treating Varicose Veins.

    PubMed

    Go, Seung Je; Cho, Byung Sun; Mun, Yun Su; Kang, Yoon Jung; Ahn, Hye Young

    2016-06-01

    Background Endovenous laser ablation (EVLA) is widely performed since the early 2000s, but there are few long-term results. Objectives The aim of this study was to evaluate the long-term results of EVLA employed for treating varicose veins of the lower limbs by duplex ultrasonographic study. Methods A total of 24 limbs of 17 patients who underwent EVLA between 2004 and 2007 were examined with duplex ultrasonographic scans. The mean follow-up period was 66.1 months. Results There were five recurrences of saphenofemoral junction reflux. The occlusion rate was 79.2% at a mean follow-up of 66.1 months. There were 14 recanalizations and 5 recurrences of the great saphenous vein. Five partial and nine total recanalizations were observed. Conclusions EVLA is an effective and minimally invasive treatment for varicose veins. Our long-term result was acceptable, but the result was not outstanding. PMID:27231428

  16. Long-term particulate matter exposure and mortality: a review of European epidemiological studies

    PubMed Central

    2009-01-01

    Background Several studies considered the relation between long-term exposure to particulate matter (PM) and total mortality, as well as mortality from cardiovascular and respiratory diseases. Our aim was to provide a comprehensive review of European epidemiological studies on the issue. Methods We searched the Medline database for epidemiological studies on air pollution and health outcomes published between January 2002 and December 2007. We also examined the reference lists of individual papers and reviews. Two independent reviewers classified the studies according to type of air pollutant, duration of exposure and health outcome considered. Among European investigations that examined long-term PM exposure we found 4 cohort studies (considering total and cardiopulmonary mortality), 1 case-control study (considering mortality from myocardial infarction), and 4 ecologic studies (2 studies considering total and cardiopulmonary mortality and 2 studies focused on cardiovascular mortality). Results Measurement indicators of PM exposure used in European studies, including PM10, PM2.5, total suspended particulate and black smoke, were heterogeneous. This notwithstanding, in all analytic studies total mortality was directly associated with long-term exposure to PM. The excesses in mortality were mainly due to cardiovascular and respiratory causes. Three out of 4 ecologic studies found significant direct associations between PM indexes and mortality. Conclusion European studies on long-term exposure to PM indicate a direct association with mortality, particularly from cardiovascular and respiratory diseases. PMID:19995424

  17. Long-Term Career Impact and Professional Applicability of the Study Abroad Experience

    ERIC Educational Resources Information Center

    Franklin, Kimberly

    2010-01-01

    Research shows that study abroad experience affects professional qualifications. It is evident that employers value the skills and knowledge potentially gained from study abroad and that these competencies are transferable on the job. Nearly all known research lacks a longitudinal component. Of the few studies that focus on long-term outcomes,…

  18. School-based prevention program associated with increased short- and long-term retention of safety knowledge.

    PubMed

    Klas, Karla S; Vlahos, Peter G; McCully, Michael J; Piche, David R; Wang, Stewart C

    2015-01-01

    Validation of program effectiveness is essential in justifying school-based injury prevention education. Although Risk Watch (RW) targets burn, fire, and life safety, its effectiveness has not been previously evaluated in the medical literature. Between 2007 and 2012, a trained fire service public educator (FSPE) taught RW to all second grade students in one public school district. The curriculum was delivered in 30-minute segments for 9 consecutive weeks via presentations, a safety smoke house trailer, a model-sized hazard house, a student workbook, and parent letters. A written pre-test (PT) was given before RW started, a post-test (PT#1) was given immediately after RW, and a second post-test (PT#2) was administered to the same students the following school year (ranging from 12 to 13 months after PT). Students who did not complete the PT or at least one post-test were excluded. Comparisons were made by paired t-test, analysis of variance, and regression analysis. After 183 (8.7%) were excluded for missing tests, 1,926 remaining students scored significantly higher (P = .0001) on PT#1 (mean 14.8) and PT#2 (mean 14.7) than the PT (mean 12.1). There was 1 FSPE and 36 school teachers with class size ranging from 10 to 27 (mean 21.4). Class size was not predictive of test score improvement (R = 0%), while analysis of variance showed that individual teachers trended toward some influence. This 6-year prospective study demonstrated that the RW program delivered by an FSPE effectively increased short-term knowledge and long-term retention of fire/life safety in early elementary students. Collaborative partnerships are critical to preserving community injury prevention education programs. PMID:25159554

  19. Animal Models to Study the Role of Long-Term Hypergastrinemia in Gastric Carcinogenesis

    PubMed Central

    Fossmark, Reidar; Qvigstad, Gunnar; Martinsen, Tom Chr.; Hauso, Øyvind; Waldum, Helge L.

    2011-01-01

    Patients with chronic hypergastrinemia due to chronic atrophic gastritis or gastrinomas have an increased risk of developing gastric malignancy, and it has been questioned whether also patients with hypergastrinemia caused by long-term use of acid inhibiting drugs are at risk. Gastric carcinogenesis in humans is affected by numerous factors and progresses slowly over years. When using animal models with the possibility of intervention, a complex process can be dissected by studying the role of hypergastrinemia in carcinogenesis within a relatively short period of time. We have reviewed findings from relevant models where gastric changes in animal models of long-term hypergastrinemia have been investigated. In all species where long-term hypergastrinemia has been induced, there is an increased risk of gastric malignancy. There is evidence that hypergastrinemia is a common causative factor in carcinogenesis in the oxyntic mucosa, while other cofactors may vary in the different models. PMID:21127707

  20. The long-term use of cyproterone acetate in pedophilia: a case study.

    PubMed

    Cooper, A J; Cernovsky, Z; Magnus, R V

    1992-01-01

    This investigation reports the long-term use of the antiandrogen cyproterone acetate (CPA) in a pedophile, who was studied continuously over 38 months. Measures of sexual arousal, serum testosterone, and gonadotropin levels were significantly reduced by the drug as compared with placebo and no treatment; prolactin levels were significantly elevated. Some workers have observed that long-term administration of CPA (more than one year, which was then discontinued) produced enduring (in some cases apparently permanent) anti-libidinal effects; however, in the case described, within three weeks of stopping the drug, all measures had returned to pretrial levels. The importance of continuous long-term monitoring in sex offenders receiving an antiandrogen is discussed. PMID:1291700

  1. Long-term benefits of full-day kindergarten: a longitudinal population-based study

    PubMed Central

    Brownell, M.D.; Nickel, N.C.; Chateau, D.; Martens, P.J.; Taylor, C.; Crockett, L.; Katz, A.; Sarkar, J.; Burland, E.; Goh, C.Y.

    2015-01-01

    In the first longitudinal, population-based study of full-day kindergarten (FDK) outcomes beyond primary school in Canada, we used linked administrative data to follow 15 kindergarten cohorts (n ranging from 112 to 736) up to grade 9. Provincial assessments conducted in grades 3, 7, and 8 and course marks and credits earned in grade 9 were compared between FDK and half-day kindergarten (HDK) students in both targeted and universal FDK programmes. Propensity score matched cohort and stepped-wedge designs allowed for stronger causal inferences than previous research on FDK. We found limited long-term benefits of FDK, specific to the type of programme, outcomes examined, and subpopulations. FDK programmes targeted at low-income areas showed long-term improvements in numeracy for lower income girls. Our results suggest that expectations for wide-ranging long-term academic benefits of FDK are unwarranted. PMID:25632172

  2. A prospective study of long-term care institutionalization among the aged.

    PubMed

    Branch, L G; Jette, A M

    1982-12-01

    A statewide probability sample of 1,625 elders living in Massachusetts are studied prospectively to identify key determinants of long-term care (LTC) institutionalization. One-hundred forty-seven elders, 9 per cent of the original cohort, entered a LTC institution during the six-year investigation. Using logistic multiple regression, we examine the predictive power of 19 independent variables grouped into six categories: demographic characteristics, attitude, social context, long-term care needs, physical disability, and mental/emotional disability. Five variables are significantly related to institutionalization: advancing age, using ambulatory aids, mental disorientation, living alone, and using assistance to perform "instrumental" ADL (activities of daily living). These results may be helpful to those trying to target non-institutional services to elders for use as substitutes for institutional long-term care. They may also help explain why recent experimental tests of substituting non-institutional care for institutional services have been less than successful. PMID:6814269

  3. Long-term safety of abatacept in patients with rheumatoid arthritis.

    PubMed

    Atzeni, Fabiola; Sarzi-Puttini, Piercarlo; Mutti, Alessandra; Bugatti, Serena; Cavagna, Lorenzo; Caporali, Roberto

    2013-10-01

    Abatacept is a selective T cell co-stimulation modulator that was first approved by the Italian Medicines Agency and reimbursed by the Italian National Health Service when used to treat active rheumatoid arthritis "not sufficiently responsive to other disease-modifying anti-rheumatic drugs (DMARDs) including at least one TNF inhibitor", and is now also approved as a first line biological agent. The aim of this review is to summarise the safety data collected in clinical trials and observational studies. PMID:23800448

  4. 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. PMID:23570986

  5. Long-Term Propranolol Use in Severely Burned Pediatric Patients: A Randomized Controlled Study

    PubMed Central

    Herndon, David N.; Rodriguez, Noe A.; Diaz, Eva C.; Hegde, Sachin; Jennings, Kristofer; Mlcak, Ronald P.; Suri, Jaipreet S.; Lee, Jong O.; Williams, Felicia N.; Meyer, Walter; Suman, Oscar E.; Barrow, Robert E.; Jeschke, Marc G.; Finnerty, Celeste C.

    2012-01-01

    Objective To determine the safety and efficacy of propranolol given for 1 year on cardiac function, resting energy expenditure, and body composition in a prospective randomized single-center controlled study in pediatric patients with large burns. Summary Background Data Severe burns trigger a hypermetabolic response that persists for up to 2 years after burn. Propranolol given for 1 month post burn blunts this response. Whether propranolol administration for 1 year after injury provides a continued benefit is currently unclear. Methods One-hundred seventy nine pediatric patients with >30% total body surface area burns were randomized to receive control (n = 89) or 4 mg/kg/d propranolol (n = 90) for 12 months after burn. Changes in resting energy expenditure, cardiac function, and body composition were measured acutely at 3, 6, 9, and 12 months postburn. Statistical analyses included techniques that adjust for non-normality, repeated measures, and regression analyses. P <0.05 was considered significant. Results Long-term propranolol treatment significantly reduced the percent of the predicted heart rate and percent of the predicted resting energy expenditure, decreased accumulation of central mass and central fat, prevented bone loss, and improved lean body mass accretion. There were very few adverse effects from the dose of propranolol used. Conclusions Propranolol treatment for 12 months, following thermal injury, ameliorates the hyperdynamic, hypermetabolic, hypercatabolic, and osteopenic responses in pediatric patients. This study is registered at clinicaltrials.gov, NCT00675714. PMID:22895351

  6. Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary disease.

    PubMed

    Yamagata, Eiji; Soutome, Toru; Hashimoto, Kenichi; Mihara, Kazuko; Tohda, Yuji

    2016-05-01

    Objective Umeclidinium bromide (UMEC) 62.5 μg is a long-acting muscarinic antagonist (LAMA) that is administered once daily via inhalation for chronic obstructive pulmonary disease (COPD) treatment. The objective of this study was to evaluate the safety and tolerability of long-term treatment with UMEC 125 μg in Japanese patients with COPD. Methods This was a 52 week, multicenter, open-label study to evaluate the safety and tolerability of UMEC 125 μg once daily delivered via a novel dry powder inhaler (nDPI) in Japanese patients with COPD. The primary endpoint was the incidence and severity of all adverse events (AEs) throughout the 52 week treatment period. Clinical trial registration number ClinicalTrials.gov identifier is NCT01702363. Results A total of 153 patients were enrolled in the study. Of these, 131 patients started treatment with UMEC 125 μg, and 111 patients (85%) completed the study. AEs did not differ greatly in incidence over the various time periods (Weeks 0 to 12, 13 to 24, 25 to 36, and 37 to 52 of treatment) and did not increase with continued treatment. The incidence of drug-related AEs associated with the pharmacological effects of LAMAs (including constipation, blurred vision, and thirst) was low. Serious adverse events (SAEs) during the treatment period were reported in 17 patients (13%). SAEs reported in more than one patient were COPD exacerbation and pneumonia (3 patients each, 2%). One SAE of angina pectoris was considered to be drug related. No fatalities were reported during this study. Conclusions No new AEs were identified beyond those attributable to the pharmacological effects of LAMAs. UMEC 125 μg was well tolerated over 52 weeks of treatment in Japanese patients with COPD. PMID:26782971

  7. A Long-Term Outcome Study of Selective Mutism in Childhood

    ERIC Educational Resources Information Center

    Steinhausen, Hans-Christoph; Wachter, Miriam; Laimbock, Karin; Metzke, Christa Winkler

    2006-01-01

    Objective: Controlled study of the long-term outcome of selective mutism (SM) in childhood. Method: A sample of 33 young adults with SM in childhood and two age- and gender-matched comparison groups were studied. The latter comprised 26 young adults with anxiety disorders in childhood (ANX) and 30 young adults with no psychiatric disorders during…

  8. The Long Term Effectiveness of Intensive Stuttering Therapy: A Mixed Methods Study

    ERIC Educational Resources Information Center

    Irani, Farzan; Gabel, Rodney; Daniels, Derek; Hughes, Stephanie

    2012-01-01

    Purpose: The purpose of this study was to gain a deeper understanding of client perceptions of an intensive stuttering therapy program that utilizes a multi-faceted approach to therapy. The study also proposed to gain a deeper understanding about the process involved in long-term maintenance of meaningful changes made in therapy. Methods: The…

  9. 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…

  10. Long term effect and safety of Wharton's jelly-derived mesenchymal stem cells on type 2 diabetes

    PubMed Central

    Hu, Jianxia; Wang, Yangang; Gong, Huimin; Yu, Chundong; Guo, Caihong; Wang, Fang; Yan, Shengli; Xu, Hongmei

    2016-01-01

    Cellular therapies offer novel opportunities for the treatment of type 2 diabetes mellitus (T2DM). The present study evaluated the long-term efficacy and safety of infusion of Wharton's jelly-derived mesenchymal stem cells (WJ-MSC) on T2DM. A total of 61 patients with T2DM were randomly divided into two groups on the basis of basal therapy; patients in group I were administered WJ-MSC intravenous infusion twice, with a four-week interval, and patients in group II were treated with normal saline as control. During the 36-month follow-up period, the occurrence of any adverse effects and the results of clinical and laboratory examinations were recorded and evaluated. The lack of acute or chronic adverse effects in group I was consistent with group II.. Blood glucose, glycosylated hemoglobin, C-peptide, homeostasis model assessment of pancreatic islet β-cell function and incidence of diabetic complications in group I were significantly improved, as compared with group II during the 36-month follow-up. The results of the present study demonstrated that infusion of WJ-MSC improved the function of islet β-cells and reduced the incidence of diabetic complications, although the precise mechanisms are yet to be elucidated. The infusion of WJ-MSC may be an effective option for the treatment of patients with type 2 diabetes. PMID:27588104

  11. Study on long-term irradiation aging of electrical cables (The VEILLE program)

    SciTech Connect

    Carlin, F.; Attal, M.; Gaussens, G.

    1995-04-01

    The VEILLE program (French acronym for study on long-term irradiation aging of electrical cables) was implemented in 1988 by the Institute of Protection and Nuclear Safety (IPSN) in collaboration with the US Nuclear Regulatory Commission (NRC) for a period of six years. It is intended to validate the assumptions put forward as regards aging of electrical cables and to develop criteria for early detection of degradation likely to lead to functional failures. The tests were carried out partly at the Sandia National Laboratories in the United States, partly in France in the CIS bio international Laboratories at the Saclay Nuclear Research Centre. The study focused on the radiation effects from cobalt 60 on electrical cables made up of various polymers for two temperatures and at various dose rates. Other tests were also performed using a device laid under water in the OSIRIS reactor pool at Saclay to test cables under irradiation and temperature conditions close to those found in nuclear power plant operation. Subsequently the aged cables were subjected to containment accident conditions (irradiation and thermodynamic profile) in order to show any degradation due to aging. The study showed the significant effect of radiation doses on EPR and EPDM cable insulations as well as synergy between radiation dose rates and temperature on the mechanical properties of the Hypalon sheath. Correlation between the mechanical properties and the function of cables is difficult to establish as electrical characteristics are preserved whatever the type of mechanical degradation observed. Finally, the performance of electrical cables after an accident remains a key criterion to define the materials likely to be used when manufacturing cables intended to ensure safety functions.

  12. Long-term safety evaluation of a novel oxygen-coordinated niacin-bound chromium (III) complex.

    PubMed

    Shara, Michael; Kincaid, Anthony E; Limpach, Aimee L; Sandstrom, Robert; Barrett, Laura; Norton, Neil; Bramble, J D; Yasmin, Taharat; Tran, Janet; Chatterjee, Archana; Bagchi, Manashi; Bagchi, Debasis

    2007-07-01

    Chromium (III) is an essential micronutrient required for normal protein, fat and carbohydrate metabolism, as well as helps insulin metabolize fat, turn protein into muscle and convert sugar into energy. A broad spectrum of research investigations including in vitro, in vivo and clinical studies demonstrated the beneficial effects of novel oxygen- coordinated niacin-bound chromium (III) complex (NBC) in promoting glucose-insulin sensitivity, lipid profile, cardioprotective ability and lean body mass. This study examined the long-term safety of NBC by orally administering either 0 or 25 ppm or the human equivalency dose of 1000 microg elemental chromium (III) as NBC per day for 52 consecutive weeks to male and female Sprague-Dawley rats. Animals of each group and each gender were sacrificed on 26, 39, or 52 weeks of treatment. Body weight, physical and ocular health, feed and water intake, selected organ weights as such and as a percentage of liver and brain weight, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological evaluations were conducted. At 26, 39, or 52 weeks of treatment, body weight gain was significantly reduced by 7.7%, 8.1% and 14.9% in male rats, and 5.5%, 11.4% and 9.6% in female rats, respectively, in the NBC treatment groups. No significant changes were observed in hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological evaluation between control and NBC groups at these time points. These findings, thus far, are in agreement with the subchronic studies in terms of the safety of NBC. PMID:17555823

  13. Safety and immunologic benefits of conversion to sirolimus in kidney transplant recipients with long-term exposure to calcineurin inhibitors

    PubMed Central

    Yu, Ji Hyun; Kim, Kyoung Woon; Kim, Bo-Mi; Chung, Byung Ha; Cho, Mi-La; Choi, Bum Soon; Park, Cheol Whee; Kim, Yong-Soo; Yang, Chul Woo

    2016-01-01

    Background/Aims: Sirolimus (SRL) is a promising immunosuppressant replacingcalcineurin inhibitors (CNIs). This study was performed to evaluate the safetyand immunologic benefits of conversion to SRL in stable kidney transplant (KT)recipients exposed to CNIs for long periods. Methods: Fourteen CNI-treated KT recipients with stable renal function for morethan 10 years were included. Either 2 or 3 mg per day of SRL was administeredwhile CNIs were reduced by half starting on day 1, and then stopped 2 weeks afterSRL introduction. The safety of SRL conversion was assessed considering thegraft function, acute rejection, and graft loss. Immunologic alterations were measuredvia serial changes of T cell and B cell subsets after SRL conversion. Adverseeffects of SRL conversion were also evaluated. Results: Conversion to SRL was successful in nine patients (64.2%). Conversionto SRL preserved graft function as compared to the baseline value (p = 0.115). Noacute rejection or allograft loss was observed during the follow-up period. Immunemonitoring of T and B cells revealed a regulatory T cells increase after SRL conversion (p = 0.028). Most adverse events developed within 6 weeks after SRLconversion, and oral mucositis was the main cause of SRL withdrawal. Conclusions: Conversion to SRL can be safe and has immunologic benefits in KTrecipients with long-term CNI exposure. Close monitoring of mucocutaneous adverseevents is, however, required in the early period after SRL conversion. PMID:26968190

  14. Long-term data collection at USDA experimental sites for studies of ecohydrology 1955

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The goal of this review is to show the value of long-term, continuous data from the network of USDA experimental watersheds, forests and ranges for studying the interaction between ecology and hydrology, termed ecohydrology. We identified 81 USDA experimental sites with data records of more than 20...

  15. Career Program Completers, 1993-94: A Long-Term Follow-up Study.

    ERIC Educational Resources Information Center

    Conklin, Karen A.

    This long-term follow-up study, conducted in the summer of 1998 by Johnson County Community College (JCCC, Kansas) focused on graduates, certificate recipients, and students identified by career program administrators as leaving with marketable skills in 1993-94. Since first administering this type of survey in 1989, JCCC has gained a broader…

  16. Reduced Requirements for Long-Term Institutional Care: Results of a Retrospective Study.

    ERIC Educational Resources Information Center

    Gurewitsch, Eleanor Chestnut

    1984-01-01

    Conducted a retrospective study of 102 Swiss seniors to determine nonmedical factors affecting substantial care days required prior to death. Protected senior housing and an independent and helpful personality seemed to contribute significantly to compression of morbidity and to reduced need for long-term institutional care. (JAC)

  17. Nurse-Physician Communication in the Long-Term Care Setting: Perceived Barriers and Impact on Patient Safety

    PubMed Central

    Tjia, Jennifer; Mazor, Kathleen M.; Field, Terry; Meterko, Vanessa; Spenard, Ann; Gurwitz, Jerry H.

    2009-01-01

    Purpose Clear and complete communication between health care providers is a prerequisite for safe patient management and is a major priority of the Joint Commission's 2008 National Patient Safety Goals. The goal of this study was to describe nurses' perceptions of nurse-physician communication in the long-term care (LTC) setting. Methods Mixed-method study including a self-administered questionnaire and qualitative semi-structured telephone interviews of licensed nurses from 26 LTC facilities in Connecticut. The questionnaire measured perceived openness to communication, mutual understanding, language comprehension, frustration, professional respect, nurse preparedness, time burden and logistical barriers. Qualitative interviews focused on identifying barriers to effective nurse-physician communication that may not have previously been considered and eliciting nurses' recommendations for overcoming those barriers. Results Three-hundred seventy-five (375) nurses completed the questionnaire and 21 nurses completed qualitative interviews. Nurses identified several barriers to effective nurse-physician communication: lack of physician openness to communication, logistic challenges, lack of professionalism, and language barriers. Feeling hurried by the physician was the most frequent barrier (28%), followed by finding a quiet place to call (25%) and difficulty reaching the physician (21%). In qualitative interviews, there was consensus that nurses needed to be brief and prepared with relevant clinical information when communicating with physicians and that physicians needed to be more open to listening. Conclusions A combination of nurse and physician behaviors contributes to ineffective communication in the LTC setting. These findings have important implications for patient safety and support the development of structured communication interventions to improve quality of nurse-physician communication. PMID:19927047

  18. Long-term efficacy and safety of incobotulinumtoxinA and conventional treatment of poststroke arm spasticity: a prospective, non-interventional, open-label, parallel-group study

    PubMed Central

    Dressler, Dirk; Rychlik, Reinhard; Kreimendahl, Fabian; Schnur, Nicole; Lambert-Baumann, Judith

    2015-01-01

    Objective To compare the efficacy and safety of incobotulinumtoxinA with conventional antispastic therapy for poststroke arm spasticity in routine clinical practice over a 1-year period. Design Prospective, non-interventional, open-label, parallel-group study. Setting 47 centres in Germany. Participants Patients with poststroke arm spasticity; 108 receiving incobotulinumtoxinA, 110 conventional therapy. Intervention Conventional antispastic treatment including oral antispastic medications, physiotherapy and occupational therapy or 3-monthly incobotulinumtoxinA injections plus conventional therapy if required. Main outcome measures The main outcome measure was changes in muscle tone (Ashworth Scale) over the 1-year treatment period. Changes in functional disability (Disability Assessment Scale) and quality of life (Short-Form-12 Health Survey) were additionally assessed. Ratings for therapy outcome (Goal Attainment Scale), and efficacy and tolerability of treatment (Global Clinical Impression Scale) were also obtained. Results Muscle tone improved for all spasticity patterns with the Ashworth Scale responder rates between 63% and 86% (incobotulinumtoxinA) and 16–27% (conventional therapy). Median improvement in functional disability was –1.0 (incobotulinumtoxinA) and 0.0 (conventional measures) for all domains. Treatment goals were attained by 93% of incobotulinumtoxinA patients and 30% of patients under conventional therapy. Most physicians (93%) and patients (90%) rated efficacy as good or very good under incobotulinumtoxinA; the proportions were much lower under conventional therapy (36% and 37%). Tolerability under incobotulinumtoxinA was considered good or very good by 99% of physicians and patients (76% and 66%, respectively, under conventional therapy). Quality of life under incobotulinumtoxinA improved by 8.0 (physical score) and 10.8 (mental score) and by 0.8 and 5.7, respectively, under conventional therapy. Conclusions IncobotulinumtoxinA combined

  19. Long-term outcome of Hurler syndrome patients after hematopoietic cell transplantation: an international multicenter study.

    PubMed

    Aldenhoven, Mieke; Wynn, Robert F; Orchard, Paul J; O'Meara, Anne; Veys, Paul; Fischer, Alain; Valayannopoulos, Vassili; Neven, Benedicte; Rovelli, Attilio; Prasad, Vinod K; Tolar, Jakub; Allewelt, Heather; Jones, Simon A; Parini, Rossella; Renard, Marleen; Bordon, Victoria; Wulffraat, Nico M; de Koning, Tom J; Shapiro, Elsa G; Kurtzberg, Joanne; Boelens, Jaap Jan

    2015-03-26

    Mucopolysaccharidosis type I-Hurler syndrome (MPS-IH) is a lysosomal storage disease characterized by multisystem morbidity and death in early childhood. Although hematopoietic cell transplantation (HCT) has been performed in these patients for more than 30 years, large studies on the long-term outcome of patients with MPS-IH after HCT are lacking. The goal of this international study was to identify predictors of the long-term outcome of patients with MPS-IH after successful HCT. Two hundred seventeen patients with MPS-IH successfully engrafted with a median follow-up age of 9.2 years were included in this retrospective analysis. Primary endpoints were neurodevelopmental outcomes and growth. Secondary endpoints included neurologic, orthopedic, cardiac, respiratory, ophthalmologic, audiologic, and endocrinologic outcomes. Considerable residual disease burden was observed in the majority of the transplanted patients with MPS-IH, with high variability between patients. Preservation of cognitive function at HCT and a younger age at transplantation were major predictors for superior cognitive development posttransplant. A normal α-l-iduronidase enzyme level obtained post-HCT was another highly significant predictor for superior long-term outcome in most organ systems. The long-term prognosis of patients with MPS-IH receiving HCT can be improved by reducing the age at HCT through earlier diagnosis, as well as using exclusively noncarrier donors and achieving complete donor chimerism. PMID:25624320

  20. The long-term performance of nuclear waste forms: Natural materials - three case studies

    SciTech Connect

    Ewing, R.C.

    1993-12-31

    Natural materials may be used to advantage in the evaluation of the long-term performance of nuclear waste forms. Three case studies are presented: (I) radiation effects in ceramic waste forms; (II) corrosion products of UO{sub 2} under oxic conditions; (III) corrosion rate of nuclear waste glasses. For each case, a natural phase which is structurally and chemically analogous to the waste form is identified and used to evaluate the long-term behavior of a nuclear waste form. Short-term experimental results are compared to the observations made of analogous natural phases. The three cases studies illustrate that results ma range between providing fundamental data needed for the long-term evaluation of a waste form to only providing qualitative data of limited use. Although in the most rigorous view the long-term behavior of a phase cannot be predicted, the correspondence between short-term experimental results and observations made of natural phases provides confidence in the {open_quotes}predicted{close_quotes} behavior of the waste form. The strength of this approach rests with the degree to which a mechanistic understanding of the phenomenon is attained.

  1. 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

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

    PubMed

    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

  3. Long-term outcome of epilepsy surgery: a retrospective study in a population of 379 cases.

    PubMed

    Yu, Shengkun; Lin, Zhiguo; Liu, Li; Pu, Song; Wang, Haiyang; Wang, Jiabin; Xie, Chuncheng; Yang, Changlin; Li, Meng; Shen, Hong

    2014-03-01

    We evaluated the long-term outcome of epilepsy surgery in drug-resistant epilepsy patients, and investigated preoperative factors associated with postoperative long-term surgical outcome. We performed a retrospective study of 379 patients who received epilepsy surgeries from 2000 to 2010. Patients had completed a minimum of 2-year and up to 12-year follow-up. Preoperative evaluations, surgical outcomes and clinical data of patients were collected and analyzed. We found that the epilepsy surgery was effective in drug-resistant patients and the long-term outcome of epilepsy surgery was satisfactory. The bipolar electro-coagulation could improve the surgical outcome when the epileptogenic focus was on the functional cortex. Results of the 2-year follow-up showed that preoperative seizure characteristics including the history of febrile seizure, seizure frequency, and location, quantity and range of seizure foci were significantly associated with the surgical outcome. The surgery procedure including the surgery type and the extent of resection also affected outcome. Abnormal head or hippocampus MRI, inconsistent results of preoperative investigations, seizure types, and pathology type might also be predictors of long-term surgical outcome. PMID:24461543

  4. Long-term attendance at a family practice teaching unit. Qualitative study of patients' views.

    PubMed Central

    Brown, J. B.; Dickie, I.; Brown, L.; Biehn, J.

    1997-01-01

    OBJECTIVE: To identify the factors that contribute to patients' long-term attendance at a family practice teaching unit. DESIGN: Qualitative method of focus groups. SETTING: A community-based family practice teaching unit in southwestern Ontario. PARTICIPANTS: Patients who had been coming to St Joseph's Family Medical Centre for more than 15 years were purposefully selected to participate. METHOD: Five focus groups composed of patients who had been affiliated with one of the three practices at the Centre for more than 15 years explored factors contributing to long-term attendance. MAIN FINDINGS: Four key themes were identified as the primary factors contributing to long-term attendance: the relationship context, the team concept, professional responsibility and attitudes, and comprehensive and convenient care. CONCLUSION: The resource-rich era of medical care, during which participants formulated their views and opinions about the factors contributing to their long-term attendance at a family practice teaching unit, has come to a close. The findings of this study provide important information that could help maintain one of the basic tenets of family medicine-continuity of care. PMID:9154362

  5. Long-term efficacy and safety of tocilizumab in giant cell arteritis and large vessel vasculitis

    PubMed Central

    Evans, Jobie; Steel, Lauren; Borg, Frances; Dasgupta, Bhaskar

    2016-01-01

    Giant cell arteritis (GCA) is a chronic systemic vasculitis affecting large-sized and medium-sized vessels. Glucocorticoids are currently the mainstay of treatment for GCA and associated large vessel vasculitis (LVV) but are associated with frequent adverse events. Methotrexate has only demonstrated a modest benefit while anti-TNF biological agents (infliximab and etanercept) have been inefficacious. Elevated levels of interleukin-6 (IL-6), a proinflammatory cytokine, has been associated with GCA. Tocilizumab (TCZ), a humanised antihuman IL-6 receptor antibody, has been used successfully in several reports as a treatment for GCA and LVV. We report the potentially long-term successful use of TCZ in 8 cases of refractory LVV. All of our patients achieved a good clinical response to TCZ and C reactive protein reduced from an average of 70.3 to 2.5. In all cases, the glucocorticoid dose was reduced, from an average of 24.6 mg prednisolone prior to TCZ treatment to 4.7 mg, indicating that TCZ may enable a reduction in glucocorticoid-associated adverse events. However, regular TCZ administration was needed for disease control in most cases. TCZ was discontinued in one case due to the development of an empyema indicating the need for careful monitoring of infection when using this treatment. PMID:26819753

  6. 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

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

    NASA Technical Reports Server (NTRS)

    Jeevarajan, Judith

    2012-01-01

    manufacturers. The results are varied and in some cases, unexpected. This paper presents a summary of the tests carried out on a few li-ion pouch cell designs from various cell manufacturers. The data will include performance under different conditions specifically cycling under vacuum conditions with and without restraints as well as safety test data. The presentation will also include detailed analysis of the pouch material for the cells studied.

  8. Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction

    PubMed Central

    McMurray, James G; Feldman, Robert A; Auerbach, Stephen M; DeRiesthal, Herb; Wilson, Neal

    2007-01-01

    Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction (ED), many men may choose to use it for an extended period. Men with ED who had previously completed 1 of 4 double-blind trials with short-term open-label extension (combined duration, 0.9–1.2 years) were eligible for this 4-year, open-label, extension study, which assessed the safety and effectiveness of flexible doses (25, 50, and 100 mg sildenafil) used as needed. Adverse events that were serious or led to dosing changes or discontinuation (temporary or permanent) were recorded. Many of the 979 participants (mean age, 58 [range, 27–82] years; mean ED duration, 4.5 years) had concomitant hypertension (28%), diabetes (22%), or hyperlipidemia (14%). Overall, 37 (3.8%) had treatment-related adverse events (none serious) requiring dosage change or discontinuation and 62 (6.3%) discontinued because of insufficient response. At each yearly assessment, more than 94% of participants responded affirmatively to the questions: “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?” These results argue against the loss of tolerability or the development of tachyphylaxis over a prolonged period of as needed, flexible-dose sildenafil treatment of men with ED. PMID:18516312

  9. Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

    PubMed Central

    Wirta, David; VanDenburgh, Amanda M; Weng, Emily; Whitcup, Scott M; Kurstjens, Sef; Beddingfield, Frederick C

    2011-01-01

    Background: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP) based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥12 months) were conducted; however, the aggregate safety profile of the six studies has not been reported. Methods: Adverse events (AEs) were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD) or twice daily (BID) as an eyedrop. AE terms were converted to MedDRA (V.11.0) Preferred Terms and analyzed. Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD) and 94.8% (BID) of subjects (≤12 months of treatment). AEs reported through month 12 (aggregate incidence of ≥5%) were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment. Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation. PMID:21691584

  10. The Value of Animations in Biology Teaching: A Study of Long-Term Memory Retention

    PubMed Central

    2007-01-01

    Previous work has established that a narrated animation is more effective at communicating a complex biological process (signal transduction) than the equivalent graphic with figure legend. To my knowledge, no study has been done in any subject area on the effectiveness of animations versus graphics in the long-term retention of information, a primary and critical issue in studies of teaching and learning. In this study, involving 393 student responses, three different animations and two graphics—one with and one lacking a legend—were used to determine the long-term retention of information. The results show that students retain more information 21 d after viewing an animation without narration compared with an equivalent graphic whether or not that graphic had a legend. Students' comments provide additional insight into the value of animations in the pedagogical process, and suggestions for future work are proposed. PMID:17785404

  11. 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.

  12. 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. PMID:23619797

  13. Long-term safety and efficacy of natalizumab in relapsing-remitting multiple sclerosis: impact on quality of life

    PubMed Central

    Planas, Raquel; Martin, Roland; Sospedra, Mireia

    2014-01-01

    Natalizumab was the first monoclonal antibody to be approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) based on its short-term efficacy and overall tolerability. However, the incidence of treatment-associated progressive multifocal leukoencephalopathy (PML), an infection of the brain caused by the John Cunningham virus, jeopardized this efficacious treatment from the beginning. Eight years after licensing of natalizumab, long-term studies confirm the considerable and sustained efficacy of natalizumab, although the PML complication still threatens one of the most successful treatments available for RRMS. During these years, considerable progress has been made in identification of risk factors that allow more effective management of PML risk. In addition, long-term studies to define better when to start or stop treatment and to optimize treatment strategies after cessation of natalizumab are ongoing, and hopefully will improve management and will allow natalizumab to remain as a valuable therapeutic option for patients with highly active RRMS. PMID:24741337

  14. A descriptive study of the handwashing environment in a long-term care facility.

    PubMed

    Hattula, J L; Stevens, P E

    1997-11-01

    The authors present a clinical research project accomplished by a nurse during her first year of practice after graduating from a B.S.N. program. In her caregiving at a long-term care facility subacute unit, she was unable to do proper handwashing. The poorly placed pump-style paper towel dispensers were inadequate for the task. She knew that handwashing before and after resident contact is the single most effective infection control measure to prevent nosocomial infections. In consultation with her university professor, she designed and implemented a descriptive study of the facility's handwashing environment. She mapped and measured handwashing areas, explained constrictions the environment placed on handwashing technique, collected random cultures from the sinks and dispenser levers, and illustrated for administrative and auxiliary personnel the basic principles of microbiology. Implications for infection prevention and control in long-term care facilities are discussed in light of increased "high-end skilled nursing" being offered in subacute units. PMID:9384056

  15. A role for high frequency hydrochemical sampling in long term ecosystem studies

    NASA Astrophysics Data System (ADS)

    Sebestyen, S. D.; Shanley, J. B.; Boyer, E. W.; Kendall, C.

    2007-12-01

    Monitoring of surface waters for major chemical constituents is needed to assess long-term trends and responses to ecological disturbance. However, the typical fixed-interval (weekly, monthly, or quarterly) sampling schemes of most long-term ecosystem studies may not capture the full range of stream chemical variation and do not always provide enough information to discern the landscape processes that control surface water chemistry and solute loadings. To expand upon traditional hydrochemical monitoring, we collected high frequency event-based surface water samples at an upland, forested basin of the Sleepers River Research Watershed (Vermont, USA), one of five intensively studied sites in the Water, Energy, and Biogeochemical Budgets (WEBB) program of the US Geological Survey. We present several examples that highlight the importance of linking long-term weekly data with intensive, high frequency sampling. We used end-member mixing analysis and isotopic approaches to trace sources of stream nutrients (e.g. nitrate, dissolved organic carbon) and quantified how atmospheric pollutants (e.g. nitrogen, sulfate, and mercury) affect stream chemistry. High frequency sampling generates large numbers of samples and is both labor and resource intensive but yields insights into ecosystem functions that are not readily discerned from less-frequent sampling. As the ecological community contemplates the scope and foci of environmental observatories as benchmarks for deciphering the effects of natural and anthropogenic change, incorporating high frequency hydrochemical sampling will further our understanding of ecosystem functions across a range of ecosystem types and disturbance effects.

  16. Glatiramer acetate: long-term safety and efficacy in relapsing-remitting multiple sclerosis.

    PubMed

    Boster, Aaron L; Ford, Corey C; Neudorfer, Orit; Gilgun-Sherki, Yossi

    2015-06-01

    Glatiramer acetate (GA) is approved for relapsing-remitting multiple sclerosis in 57 countries worldwide, with more than 2 million patient-years of exposure and over 20 years of continuous clinical use without new safety concerns. GA has an overall favorable risk-benefit profile: 30% reduced annual relapse rate and decreased brain lesion activity. In clinically definite MS or clinically isolated syndrome, GA slows brain atrophy, which may be related to its unique anti-inflammatory and neuroprotective mechanisms of action. Early treatment with GA delays the onset of clinically definite MS more effectively than late treatment in clinically isolated syndrome. GA is not associated with immunosuppression, autoimmune disease, infections or development of neutralizing antibodies. A new three-times-weekly formulation of GA is available to potentially reduce the incidence of injection-related side effects. Other safety advantages of GA include its pregnancy rating (Category B) and limited uncontrolled data suggesting that tolerability is similar in children with MS. PMID:25924547

  17. 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

  18. 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

  19. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review

    PubMed Central

    Marasinghe, Keshini Madara

    2015-01-01

    Objectives Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Methods Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Results Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. Conclusions CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians’ judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature

  20. Adaptive response studies may help choose astronauts for long-term space travel

    NASA Astrophysics Data System (ADS)

    Mortazavi, S.

    Long-term manned exploratory missions are planned for the next decades. Exposure to high-energy neutrons, protons and high charge and energy particles during a deep space mission, requires proper radiation protection planning against the detrimental effects of space radiation. It has been estimated that exposure to unpredictable extremely large solar particle events would kill the astronauts without massive shielding in interplanetary space. Recent findings concerning the induction of adaptive response by neutrons or high levels of external and internal exposures including radon in human cells have opened a new horizon for possible implications of adaptive response in radiation protection and especially in protection against detrimental effects of high levels of radiation during a long-term space journey. Significant adaptive response has been demonstrated in humans after exposure to high levels of natural radiation. It has been shown that in some individuals who fail to show an adaptive response, extraordinary synergism was observed. Interestingly, it was observed that even when the frequency of chromosome aberrations in cells exposed to adapting dose alone or challenge dose alone, were not different than those of other study participants, a severe synergism observed in the cells exposed to challenge dose after an adapting dose. Based on the results obtained in this experiment, due to possible interactions between a chronic low dose and an acute high dose, a common G2 radiosensitivity assay cannot predict radiation risk during a long-term space mission. It can be suggested that the magnitude of adaptive response in lymphocyte samples of potential crew for a deep space mission should be assessed in ground based laboratory studies. Selected space crew who show a high magnitude of adaptive response in ground experiments, will be exposed to adapting higher than normal background radiation doses during mission and they will be considerably more resistant to high doses

  1. Effects of approach and services under differential response on long term child safety and welfare.

    PubMed

    Loman, L Anthony; Siegel, Gary L

    2015-01-01

    An outcome analysis was conducted based on an extended follow-up of the implementation of differential response program reforms in Child Protective Services offices in 10 counties in a Midwestern U.S. State. Random assignment was conducted of families that were first determined to be appropriate for family assessments. Experimental families (n=2,382) were each assigned to a non-forensic family assessment, and control families (n=2,247) each received a forensic investigation. Families were assigned continuously over a 15-month period and then tracked from 45 to 60 months from the date of assignment. Detailed information on services provided and family responses was obtained via two subsamples of experimental and control families. Measures of family engagement and service reception and utilization were utilized to determine instrumental outcomes introduced through family assessments. Improved family engagement and increased and broadened services were found to have occurred, and it was theorized that these changes mediated extended outcomes. Extended outcomes included reductions of rates of subsequent screened-in reports of child maltreatment, proportions of families that experienced child removals, and instances of new safety threats and problems in parenting. Differences in outcomes were found among the participating counties with 4 counties accounting for most outcome differences. The relationships between instrumental and extended outcomes were discussed with suggestions for further research. PMID:24957562

  2. 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

  3. The long-term safety and efficacy of intrathecal therapy using sufentanil in chronic intractable non-malignant pain.

    PubMed

    Monsivais, Jose Jesus; Monsivais, Diane Burn

    2014-07-01

    This report describes the long term safety and efficacy of intrathecal therapy using Sufentanil for the management of chronic intractable neuropathic pain in 12 chronic pain patients. Standardized psychological screening was used to determine treatment suitability. Evaluation data included the Visual Analog Scale (VAS), Wong-Baker Faces Scale, Brief Pain Inventory (BPI), Disability of Arm, Shoulder, and Hand (DASH), McGill Quality of Life Questionnaire, and complications (granulomas, toxicity, withdrawal, or deaths). SPSS version 18 was used for data analysis. Pre- and post- treatment BPI measures and pain scale scores showed a statistically significant difference. There were no complications directly related to drug toxicity, nor drug withdrawals, granulomas, or deaths. Intrathecal therapy with Sufentanil therapy offers a good treatment alternative for those cases that have failed both surgery and standard pain treatment. Strict patient selection based on psychological screening, control of co-morbidities, a proper pain management may contribute to successful outcome. PMID:25031819

  4. Long-term conditioning of deep-seated rockslides in deglaciated valleys: the Spriana case study

    NASA Astrophysics Data System (ADS)

    Agliardi, Federico; Crosta, Giovanni B.

    2015-04-01

    Deep-seated rockslides in alpine valleys evolve over long time under the action of multiple triggers. Early Warning based on monitoring is often the only effective approach to cope with these landslides, but it requires an improved understanding of mechanisms interplaying over long time. Deep-seated rockslides are often characterized by long-term 'creep' and seasonal displacement components, contributing to measured displacement patterns which are often modelled as rockslide responses to hydrologic perturbations. Although this hydro-mechanical modelling approach fits the behaviour of disrupted rockslide masses with well-developed shear zones, it is often insufficient to explain the initial onset and the long-term components of creep movements of deep-seated rockslides. This outlines the need to link long-term evolution of rock slopes and their sensitivity to triggers. We discuss the Spriana rockslide, affecting the steep left-hand flank of Val Malenco (italian Central Alps). Documented instabilities date back to 1912, whereas the rockslide underwent major acceleration stages in 1960 and 1977-78 and later minor reactivations. We reviewed a large amount of data collected since 1978 by extensive geotechnical site investigation (borehole drilling, exploratory adits, and seismic refraction) and monitoring activities (ground surface and deep displacements, pore pressures) motivated by potential catastrophic collapse threatening the city of Sondrio area. We performed rock mass characterization based on laboratory studies on intact rock samples, field surveys and drillcore logging. These data allowed re-evaluating the geological model of the Spriana rockslide, which is a compound slide of up to 50 Mm3 of slope debris and fractured gneiss, with multiple shear failure zones up to 90 m deep. Two main scarps developed in different stages, suggesting progressive failure processes. The rockslide creeps at slow rates of 0.4-3 cm/a, and undergoes acceleration stages (weeks to

  5. Estimated long-term outdoor air pollution concentrations in a cohort study

    NASA Astrophysics Data System (ADS)

    Beelen, Rob; Hoek, Gerard; Fischer, Paul; Brandt, Piet A. van den; Brunekreef, Bert

    Several recent studies associated long-term exposure to air pollution with increased mortality. An ongoing cohort study, the Netherlands Cohort Study on Diet and Cancer (NLCS), was used to study the association between long-term exposure to traffic-related air pollution and mortality. Following on a previous exposure assessment study in the NLCS, we improved the exposure assessment methods. Long-term exposure to nitrogen dioxide (NO 2), nitrogen oxide (NO), black smoke (BS), and sulphur dioxide (SO 2) was estimated. Exposure at each home address ( N=21 868) was considered as a function of a regional, an urban and a local component. The regional component was estimated using inverse distance weighed interpolation of measurement data from regional background sites in a national monitoring network. Regression models with urban concentrations as dependent variables, and number of inhabitants in different buffers and land use variables, derived with a Geographic Information System (GIS), as predictor variables were used to estimate the urban component. The local component was assessed using a GIS and a digital road network with linked traffic intensities. Traffic intensity on the nearest road and on the nearest major road, and the sum of traffic intensity in a buffer of 100 m around each home address were assessed. Further, a quantitative estimate of the local component was estimated. The regression models to estimate the urban component explained 67%, 46%, 49% and 35% of the variances of NO 2, NO, BS, and SO 2 concentrations, respectively. Overall regression models which incorporated the regional, urban and local component explained 84%, 44%, 59% and 56% of the variability in concentrations for NO 2, NO, BS and SO 2, respectively. We were able to develop an exposure assessment model using GIS methods and traffic intensities that explained a large part of the variations in outdoor air pollution concentrations.

  6. The Long-Term Effects of Child Sexual Abuse by Female Perpetrators: A Qualitative Study of Male and Female Victims

    ERIC Educational Resources Information Center

    Denov, Myriam S.

    2004-01-01

    Although the long-term effects of sexual abuse by men have been studied extensively, minimal research has explored the effects of sexual abuse by women. This qualitative study explores the experience and long-term impact of sexual abuse by women. The data were derived from in-depth interviews with 14 adult victims (7 men, 7 women) of child sexual…

  7. Senescence in the wild: Insights from a long-term study on Seychelles warblers.

    PubMed

    Hammers, Martijn; Kingma, Sjouke A; Bebbington, Kat; van de Crommenacker, Janske; Spurgin, Lewis G; Richardson, David S; Burke, Terry; Dugdale, Hannah L; Komdeur, Jan

    2015-11-01

    Senescence--the progressive age-dependent decline in performance--occurs in most organisms. There is considerable variation in the onset and rate of senescence between and within species. Yet the causes of this variation are still poorly understood, despite being central to understanding the evolution of senescence. Long-term longitudinal studies on wild animals are extremely well-suited to studying the impact of environmental and individual characteristics (and the interaction between the two) on senescence, and can help us to understand the mechanisms that shape the evolution of senescence. In this review, we summarize and discuss the insights gained from our comprehensive long-term individual-based study of the Seychelles warbler (Acrocephalus sechellensis). This species provides an excellent model system in which to investigate the evolution of senescence in the wild. We found that Seychelles warblers show senescent declines in survival and reproduction, and discuss how individual characteristics (body condition, body size) and environmental effects (low- versus high-quality environments) may affect the onset and rate of senescence. Further, we highlight the evidence for trade-offs between early-life investment and senescence. We describe how key cellular and physiological processes (oxidative stress and telomere shortening) underpinning senescence are affected by individual and environmental characteristics in the Seychelles warbler (e.g. food availability, reproductive investment, disease) and we discuss how such physiological variation may mediate the relationship between environmental characteristics and senescence. Based on our work using Seychelles warblers as a model system, we show how insights from long-term studies of wild animals may help unravel the causes of the remarkable variation in senescence observed in natural systems, and highlight areas for promising future research. PMID:26344178

  8. Pitting, galvanic, and long-term corrosion studies on candidate container alloys for the Tuff Repository

    SciTech Connect

    Beavers, J.A.; Thompson, N.G.; Durr, C.L.

    1992-01-01

    Contest Columbus Technologies, Inc. (CC Technologies) investigated the long-term performance of container materials for high-level radioactive waste packages as part of the information needed by the Nuclear Regulatory Commission to assess the Department of Energy`s application to construct a geologic repository for the high-level radioactive waste. The scope of work focused on the Tuff Repository and employed short-term techniques, such as electrochemical and mechanical techniques to examine a wide range of possible failure modes. Two classes of alloys were evaluated for use as container materials for the Tuff Repository; Fe-Cr-Ni alloys and copper-base alloys. The candidate Fe-Cr-Ni alloys were Type 304L Stainless Steel (Alloy 304L) and Incoloy Alloy 825 (Alloy 825). The candidate copper-base alloys were CDA 102 Copper (Alloy CDA 102) and CDA 715 Copper-3D Nickel (Alloy CDA 715). The corrosion testing was performed in a simulated J-13 well water and in solutions selected from an experimental matrix from Task 2 of the program. This report summarizes the results of Task 4 (Pitting Studies), Task 6 (Other Failure Modes) and Task 7 (Long-Term Exposures) of the program. Pit-initiation studies, performed in Task 4, focused on anomalous Cyclic Potentiodynamic Polarization (CPP) behavior of the copper-base alloys reported in Task 2 of the program. Pit propagation studies were performed on Alloy CDA 102 in Task A of the program. Two types of galvanic corrosion studies were performed in Task 6 of the program; thermogalvanic couples and borehole linear-container interactions. In the thermogalvanic couples tests, the effect of temperature variation on the surface of the container on acceleration of corrosion was evaluated for two alloys; Alloy CDA 102 and Alloy 304L. Long-term immersion tests were conducted in Task 7 of the program.

  9. Pitting, galvanic, and long-term corrosion studies on candidate container alloys for the Tuff Repository

    SciTech Connect

    Beavers, J.A.; Thompson, N.G.; Durr, C.L. )

    1992-01-01

    Contest Columbus Technologies, Inc. (CC Technologies) investigated the long-term performance of container materials for high-level radioactive waste packages as part of the information needed by the Nuclear Regulatory Commission to assess the Department of Energy's application to construct a geologic repository for the high-level radioactive waste. The scope of work focused on the Tuff Repository and employed short-term techniques, such as electrochemical and mechanical techniques to examine a wide range of possible failure modes. Two classes of alloys were evaluated for use as container materials for the Tuff Repository; Fe-Cr-Ni alloys and copper-base alloys. The candidate Fe-Cr-Ni alloys were Type 304L Stainless Steel (Alloy 304L) and Incoloy Alloy 825 (Alloy 825). The candidate copper-base alloys were CDA 102 Copper (Alloy CDA 102) and CDA 715 Copper-3D Nickel (Alloy CDA 715). The corrosion testing was performed in a simulated J-13 well water and in solutions selected from an experimental matrix from Task 2 of the program. This report summarizes the results of Task 4 (Pitting Studies), Task 6 (Other Failure Modes) and Task 7 (Long-Term Exposures) of the program. Pit-initiation studies, performed in Task 4, focused on anomalous Cyclic Potentiodynamic Polarization (CPP) behavior of the copper-base alloys reported in Task 2 of the program. Pit propagation studies were performed on Alloy CDA 102 in Task A of the program. Two types of galvanic corrosion studies were performed in Task 6 of the program; thermogalvanic couples and borehole linear-container interactions. In the thermogalvanic couples tests, the effect of temperature variation on the surface of the container on acceleration of corrosion was evaluated for two alloys; Alloy CDA 102 and Alloy 304L. Long-term immersion tests were conducted in Task 7 of the program.

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

    ERIC Educational Resources Information Center

    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…

  11. Long term outcome of acute kidney injury due to leptospirosis? A longitudinal study in Sri Lanka

    PubMed Central

    2014-01-01

    Background Leptospirosis is an important zoonotic disease of variable severity and is a common cause of acute kidney injury (AKI) in tropics. However the knowledge on long term renal outcome in leptospirosis is scarce. This study aims to assess the long-term renal outcome of AKI caused by leptospirosis. Findings Hospital records of patients who had developed AKI following leptospirosis (Serologically confirmed) presented to two Teaching Hospitals in Kandy district over 3 years from 2007 were studied. A total of 44 patients were included and they had been followed up at least for one year in out patient clinics with regular assessment including renal status. Renal histology was studied in two patients. The primary outcome measure was normalization of renal function at one year. Of the 44 patients, 31 were in the risk and injury stage (Group 1), and the rest of them were in the failure stage (Group 2) under RIFLE criteria. Of group 2 patients, 11 had abnormal renal functions on discharge. Their mean serum creatinine and GFR values on discharge were 392 mmol/l and 20 ml/min/1.73 m2. Other two patients had full renal recovery whilst in the hospital. Nine in the group 2 required renal replacement therapy by means of peritoneal dialysis, intermittent haemodialysis or haemofiltration. Seventeen out of the total had persistently abnormal renal functions on discharge. Of them 13 recovered their renal functions to normal. Four patients (9%) who belonged to group 2, had persistently abnormal renal functions after first year compatible with stage 3 chronic kidney disease (CKD). Renal histology of two patients showed tubulointerstitial lymphocyte infiltrate, tubular atrophy and interstitial fibrosis. Conclusion The long term renal outcome of AKI following leptospirosis is satisfactory as only 9% of patients had abnormal renal functions compatible with early stage of CKD. Even among them, advanced CKD or dialysis dependency had not been observed. PMID:24964804

  12. The value of long-term environmental monitoring programs: an Ohio River case study.

    PubMed

    Lohner, Timothy W; Dixon, Douglas A

    2013-11-01

    As a subset of environmental monitoring, fish sampling programs have been an important part of assessing the potential impacts of water withdrawals and effluent discharges on fish populations for many years. New environmental regulations often require that adverse environmental impacts to fish populations be minimized. Without long-term field data, population evaluations may incorrectly indicate adverse impacts where none exist or no impact where one is likely to occur. Several electric utility companies have funded the Ohio River Ecological Research Program, which has been in existence for over 40 years and consists of fish, habitat, and water quality studies at multiple power plant sites on the mainstem Ohio River. Sampling includes seasonal night-time electrofishing and daytime beach seining at three upstream and three downstream locations near each plant. The long-term nature of the program allows for the establishment of aquatic community indices to support evaluations of technology performance, the collaborative development of compliance metrics, and the assessment of fish population trends. Studies have concluded that the Ohio River fish community has improved in response to better water quality and that power plant fish entrainment and impingement and thermal discharges have had little or no measureable impact. Through collaboration and the use of long-term data, $6.3 million in monitoring costs have been saved during recent fish impingement studies. The ability to access a multiyear fish abundance database, with its associated data on age, growth, and fecundity, improves the quality of such evaluations and reduces the need for extensive field sampling at individual locations. PMID:23715733

  13. Study of Disinfection By-Products and Long Term Storage of Drinking Water.

    NASA Astrophysics Data System (ADS)

    McGee, G.; White, D.; Garland, S.

    2002-12-01

    One of the challenges facing many of Alaska's communities is providing safe and reliable drinking water from sources containing high concentrations of natural organic material (NOM). These highly colored waters, locally referred to as "tundra tea," often result in the formation of disinfectant byproducts during treatment. Since surface water sources in the Arctic are often frozen for 6-9 months per year, communities are often forced to either store raw water for treatment during the winter or treat and store enough drinking water during the summer to last through the winter. Because long-term storage practices are somewhat unique to water treatment in the rural Northern communities, the practice has not been thoroughly studied and there is limited published information on how water quality is affected by extended storage. Anecdotal evidence and data collected by field engineers indicate that significant changes are occurring and that the quality of the treated water can be adversely impacted. The University of Alaska Small Drinking Water System Technical Assistance Center (ATTAC) is conducting fundamental and applied research to help Alaska's small communities provide safe and reliable drinking water. One research focus area is the formation of disinfection by-products (DBPs) in small drinking water systems. Studies to characterize the NOM present in Alaskan surface waters and demonstrations of NOM removal technologies have been have been conducted over the past several years. The study presented here examined the formation of disinfection by-products during long-term storage of water from five small Alaskan water systems. Results from this research suggest that long-term storage has a significant impact on DBP formation. The results suggest that the NOM escaping treatment is likely to react in the storage tank resulting in DBP concentrations that are well above the estimated DBP formation potential.

  14. Long-term drug administration in the adult zebrafish using oral gavage for cancer preclinical studies

    PubMed Central

    Dang, Michelle; Henderson, Rachel E.; Garraway, Levi A.

    2016-01-01

    ABSTRACT Zebrafish are a major model for chemical genetics, and most studies use embryos when investigating small molecules that cause interesting phenotypes or that can rescue disease models. Limited studies have dosed adults with small molecules by means of water-borne exposure or injection techniques. Challenges in the form of drug delivery-related trauma and anesthesia-related toxicity have excluded the adult zebrafish from long-term drug efficacy studies. Here, we introduce a novel anesthetic combination of MS-222 and isoflurane to an oral gavage technique for a non-toxic, non-invasive and long-term drug administration platform. As a proof of principle, we established drug efficacy of the FDA-approved BRAFV600E inhibitor, Vemurafenib, in adult zebrafish harboring BRAFV600E melanoma tumors. In the model, adult casper zebrafish intraperitoneally transplanted with a zebrafish melanoma cell line (ZMEL1) and exposed to daily sub-lethal dosing at 100 mg/kg of Vemurafenib for 2 weeks via oral gavage resulted in an average 65% decrease in tumor burden and a 15% mortality rate. In contrast, Vemurafenib-resistant ZMEL1 cell lines, generated in culture from low-dose drug exposure for 4 months, did not respond to the oral gavage treatment regimen. Similarly, this drug treatment regimen can be applied for treatment of primary melanoma tumors in the zebrafish. Taken together, we developed an effective long-term drug treatment system that will allow the adult zebrafish to be used to identify more effective anti-melanoma combination therapies and opens up possibilities for treating adult models of other diseases. PMID:27482819

  15. The Nordic long-term OCD treatment study (NordLOTS): rationale, design, and methods

    PubMed Central

    2013-01-01

    Background This paper describes and discusses the methodology of the Nordic long-term OCD-treatment study (NordLOTS). The purpose of this effectiveness study was to study treatment outcome of CBT, to identify CBT non- or partial responders and to investigate whether an increased number of CBT-sessions or sertraline treatment gives the best outcome; to identify treatment refractory patients and to investigate the outcome of aripiprazole augmentation; to study the outcome over a three year period for each responder including the risk of relapse, and finally to study predictors, moderators and mediators of treatment response. Methods Step 1 was an open and uncontrolled clinical trial with CBT, step 2 was a controlled, randomised non-blinded study of CBT non-responders from step 1. Patients were randomized to receive either sertraline plus CBT-support or continued and modified CBT. In step 3 patients who did not respond to either CBT or sertraline were treated with aripiprazole augmentation to sertraline. Conclusions This multicenter trial covering three Scandinavian countries is going to be the largest CBT-study for paediatric OCD to date. It is not funded by industry and tries in the short and long-term to answer the question whether further CBT or SSRI is better in CBT non-responders. PMID:24354717

  16. Long-term treatment with bisphosphonates and their safety in postmenopausal osteoporosis

    PubMed Central

    Pazianas, Michael; Cooper, Cyrus; Ebetino, F Hal; Russell, R Graham G

    2010-01-01

    Bisphosphonates are the leading drugs for the treatment of osteoporosis. In randomized controlled trials (RCTs), alendronate, risedronate, and zoledronate have shown to reduce the risk of vertebral, nonvertebral, and hip fractures, whereas RCTs with ibandronate show antifracture efficacy at vertebral sites. Bisphosphonates are generally well tolerated and safe. Nevertheless, adverse events have been noted, and it is important to consider the strength of the evidence for causal relationships. Effects on the gastrointestinal tract and kidney function are well recognized, as are transient acute-phase reactions. Atrial fibrillation was first identified as a potential adverse event in a zoledronate trial, but subsequent trials and analyses failed to substantiate an association with bisphosphonates. Case reports have suggested a relationship between oral bisphosphonates and esophageal cancer, but this has not been demonstrated in epidemiologic studies. A possible association between bisphosphonate use and osteonecrosis of the jaw (ONJ) has also been suggested. However, the risk of ONJ in patients with osteoporosis appears to be very low, with no evidence from prospective RCTs of a causal association. There are reports of occasional occurrence of subtrochanteric or diaphyseal fractures in osteoporotic patients, but an association with bisphosphonate therapy is not substantiated by epidemiologic studies or prospective RCTs. PMID:20668715

  17. Long-Term Multiwavelength Studies of High-Redshift Blazar 0836+710

    NASA Technical Reports Server (NTRS)

    Thompson, D. J.; Akyuz, A.; Donato, D.; Perkins, J. S.; Larsson, S.; Sokolovsky, K.; Fuhrmann, L.; Kurtanidze, O.

    2012-01-01

    Following gamma-ray flaring activity of high-redshift (z=2.218) blazar 0836+710 in 2011, we have assembled a long-term multiwavelength study of this object. Although this source is monitored regularly by radio telescopes and the Fermi Large Area Telescope, its coverage at other wavelengths is limited. The optical flux appears generally correlated with the gamma-ray flux, while little variability has been seen at X-ray energies. The gamma-ray/radio correlation is complex compared to some other blazars. As for many blazars, the largest variability is seen at gamma-ray wavelengths.

  18. A long-term comparative study of the mammalian larynx, based on whole organ serial sectioning.

    PubMed

    Harrison, D F

    1976-01-01

    The paper includes brief details of a long term three-dimensional study into the fine structure of the mammalian larynx using whole organ serial sections. Differential staining, including Glees silver technique, is essential if maximum information is to be gained. A specially designed punch card will enable any future investigator to rapidly retrieve relevant information and it is expected that specimens of all available mammalian larynges will be included. Illustrations are included in this paper of the cat, dog, horse and mongoose. PMID:57693

  19. Studies of long-term noopept and afobazol treatment in rats with learned helplessness neurosis.

    PubMed

    Uyanaev, A A; Fisenko, V P

    2006-08-01

    Long-lasting effects of new Russian psychotropic drugs Noopept and Afobazol on active avoidance conditioning and formation of learned helplessness neurosis were studied on an original experimental model in rats. Noopept eliminated the manifestations of learned helplessness after long-term (21-day) treatment by increasing the percent of trained animals. Afobazol was low effective in preventing manifestations of learned helplessness, but if used for a long time, it reduced the incidence of learned helplessness development by increasing the percent of untrained animals. PMID:17369939

  20. Long-Term Outcomes of Secondary Atrial Fibrillation in the Community: The Framingham Heart Study

    PubMed Central

    Lubitz, Steven A.; Yin, Xiaoyan; Rienstra, Michiel; Schnabel, Renate B.; Walkey, Allan J.; Magnani, Jared W.; Rahman, Faisal; McManus, David D.; Tadros, Thomas M.; Levy, Daniel; Vasan, Ramachandran S.; Larson, Martin G.; Ellinor, Patrick T.; Benjamin, Emelia J.

    2015-01-01

    Background Guidelines have proposed that atrial fibrillation (AF) can occur as an isolated event, particularly when precipitated by a secondary, or reversible, condition. However, knowledge of long-term AF outcomes after diagnosis during a secondary precipitant is limited. Methods and Results In 1409 Framingham Heart Study participants with new-onset AF, we examined associations between first-detected AF episodes occurring with and without a secondary precipitant, and both long-term AF recurrence and morbidity. We selected secondary precipitants based on guidelines (surgery, infection, acute myocardial infarction, thyrotoxicosis, acute alcohol consumption, acute pericardial disease, pulmonary embolism, or other acute pulmonary disease). Among 439 (31%) people with AF diagnosed during a secondary precipitant, cardiothoracic surgery (n=131, 30%), infection (n=102, 23%), non-cardiothoracic surgery (n=87, 20%), and acute myocardial infarction (n=78, 18%) were most common. AF recurred in 544 of 846 eligible individuals without permanent AF (5-, 10-, and 15-year recurrences of 42%, 56% and 62% with versus 59%, 69% and 71% without secondary precipitants; multivariable-adjusted hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.54–0.78). Stroke risk (n=209/1262 at risk, HR 1.13, 95%CI 0.82–1.57) and mortality (n=1098/1409 at risk, HR 1.00, 95%CI 0.87–1.15) were similar between those with and without secondary precipitants, though heart failure risk was reduced (n=294/1107 at risk, HR 0.74, 95%CI 0.56–0.97). Conclusions AF recurs in most individuals, including those diagnosed with secondary precipitants. Long-term AF-related stroke and mortality risks were similar between individuals with and without secondary AF precipitants. Future studies may determine whether increased arrhythmia surveillance or adherence to general AF management principles in patients with reversible AF precipitants will reduce morbidity. PMID:25769640

  1. Risperidone long-acting injection: a review of its long term safety and efficacy

    PubMed Central

    Rainer, Michael K

    2008-01-01

    A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data) that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low. PMID:19183782

  2. Long-term trends in ecological systems: an introduction to cross-site comparisons and relevance to global change studies

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This chapter explains the importance of long-term data to ecological studies and the needs of creating a way to provide accessible and comparable multi-site long-term data. The Earth’s environment is changing in many ways at local, regional, and global scales. Dramatic changes have occurred in clima...

  3. Drug usage review sample studies in long-term care facilities.

    PubMed

    Stewart, J E; Kabat, H F; Wertheimer, A I

    1976-02-01

    The usage of 10 drugs in five long-term care facilities was reviewed to evaluate the effectiveness of a five-step systematic method of drug usage review. Medical care evaluation sample studies are required under the Medicare and Medicaid programs, and drug usage review sample studies may satisfy this requirement. The five-step method involved selection of the health problem to be studied; development of criteria of care; measurement of specific performance data and comparison with the criteria; establishment of the audit committee evaluation process; and design and implementation of educational activities. In each facility, data were collected on abstract sheets designed to indicate when a patient's drug usage did not conform to criteria established by a committee of health professionals. Incidents of nonconformance were then examined. The largest number of exceptions to the criteria related to monitoring the effectiveness of drug therapy. Data by drug revealed higher nonconformance rates for digoxin, hydrochlorothiazide, methyldopa and thioridazine. A small number of exceptions was found in drug administration, indicating that the patients were receiving medications as ordered and that few errors were made in transcribing. This systematic approach to identifying drug usage patterns can be used by pharmacists to coordinate sample studies and to fulfill their consultant role in long-term facilities required by federal regulations. PMID:816197

  4. Barrier analogs: Long-term performance issues, preliminary studies, and recommendations

    SciTech Connect

    Waugh, W.J.; Chatters, J.C.; Last, G.V.; Bjornstad, B.N.; Link, S.O.; Hunter, C.R.

    1994-02-01

    The US Department of Energy`s Hanford Protective Barrier Development Program is funding studies of natural analogs of the long-term performance of waste site covers. Natural-analog studies examine past environments as evidence for projecting the future performance of engineered structures. The information generated by analog studies is needed to (1) evaluate the designs and results of short term experiments and demonstrations, (2) formulate performance-modeling problems that bound expected changes in waste site environments, and (3) understand emergent system attributes that cannot be evaluated with short-term experiments or computer models. Waste site covers will be part of dynamic environmental systems with attributes that transcend the traits of engineered components. This report discusses results of the previously unreported preliminary studies conducted in 1983 and 1984. These results indicate that analogs could play an important role in predicting the long-term behavior of engineered waste covers. Layered exposures of glacial-flood-deposited gravels mantled with silt or sand that resemble contemporary barrier designs were examined. Bergmounds, another anomaly left by cataclysmic glacial floods, were also examined as analogs of surface gravel.

  5. Long-Term Safety of Mometasone Furoate/Formoterol Combination for Treatment of Patients with Persistent Asthma

    PubMed Central

    Maspero, Jorge F; Nolte, Hendrik; Chérrez-Ojeda, Iván

    2010-01-01

    Objective: The combination of inhaled corticosteroid (ICS) and long-acting β2-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS. Methods: This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged >12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 μg) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 μg). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC0–24h) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored. Results: The incidence of >1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 μg, 77.3% [n = 109]; FP/S 250/50 μg, 82.4% [n = 56]; MF/F 400/10 μg, 79.2% [n = 103]; FP/S 500/50 μg, 76.9% [n = 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 μg, 28.4%; FP/S 250/50 μg, 23.5%; MF/F 400/10 μg, 23.1%; FP/S 500/50 μg, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC0–24 h observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2–6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10

  6. Long-term field study of sea kraits in New Caledonia: fundamental issues and conservation.

    PubMed

    Bonnet, Xavier

    2012-08-01

    This short review focuses on the findings associated with a long-term field study on two species of sea kraits in New Caledonia. Since 2002, more than 30 sites in the lagoon have been sampled, and in most places mark-recapture was implemented. We collected detailed data on more than 14,000 marked individuals (>6000 recaptures) and used different techniques (stable isotopes, bio-logging, analyses of diet). The objective was fundamental: to examine how amphibious snakes cope with both terrestrial and aquatic environments. As access to abundant food is likely the main evolutionary driver for the return transition toward the sea in marine tetrapods, foraging ecology was an important part of the research and novel information was obtained on this subject. Rapidly however, field observations revealed the potential interest of sea kraits for conservation issues. Our results show that these snakes are useful bio-indicators of marine biodiversity; they also provide a useful signal to monitor levels of contamination by heavy metals in the lagoon, and more generally as a means of studying the functioning of reef ecosystems. Importantly, anecdotal observations (e.g., a krait drinking during rain) provided unsuspected physiological insights of general importance to fundamental problems and conservation. One of the lessons of this long-term study is that key results emerged in an unexpected way, but all were dependent on intensive field work. PMID:22576814

  7. Creating Long Term Income Streams for the 100 Year Starship Study Initiative

    NASA Astrophysics Data System (ADS)

    Sylvester, A. J.

    Development and execution of long term research projects are very dependent on a consistent application of funding to maximize the potential for success. The business structure for the 100 Year Starship Study project should allow for multiple income streams to cover the expenses of the research objectives. The following examples illustrate the range of potential avenues: 1) affiliation with a charitable foundation for creating a donation program to fund a long term endowment for research, 2) application for grants to fund initial research projects and establish the core expertise of the research entity, 3) development of intellectual property which can then be licensed for additional revenue, 4) creation of spinout companies with equity positions retained by the lab for funding the endowment, and 5) funded research which is dual use for the technology goals of the interstellar flight research objectives. With the establishment of a diversified stream of funding options, then the endowment can be funded at a level to permit dedicated research on the interstellar flight topics. This paper will focus on the strategy of creating spinout companies to create income streams which would fund the endowment of the 100 Year Starship Study effort. This technique is widely used by universities seeking to commercially develop and market technologies developed by university researchers. An approach will be outlined for applying this technique to potentially marketable technologies generated as a part of the 100 Year Starship Study effort.

  8. Controlling for localised spatio-temporal autocorrelation in long-term air pollution and health studies

    PubMed Central

    Mitchell, Richard

    2014-01-01

    Estimating the long-term health impact of air pollution using an ecological spatio-temporal study design is a challenging task, due to the presence of residual spatio-temporal autocorrelation in the health counts after adjusting for the covariate effects. This autocorrelation is commonly modelled by a set of random effects represented by a Gaussian Markov random field (GMRF) prior distribution, as part of a hierarchical Bayesian model. However, GMRF models typically assume the random effects are globally smooth in space and time, and thus are likely to be collinear to any spatially and temporally smooth covariates such as air pollution. Such collinearity leads to poor estimation performance of the estimated fixed effects, and motivated by this epidemiological problem, this paper proposes new GMRF methodology to allow for localised spatio-temporal smoothing. This means random effects that are either geographically or temporally adjacent are allowed to be autocorrelated or conditionally independent, which allows more flexible autocorrelation structures to be represented. This increased flexibility results in improved fixed effects estimation compared with global smoothing models, which is evidenced by our simulation study. The methodology is then applied to the motivating study investigating the long-term effects of air pollution on respiratory ill health in Greater Glasgow, Scotland between 2007 and 2011. PMID:24648100

  9. Contemporary Reflections on the Safety of Long-Term Aspirin Treatment for the Secondary Prevention of Cardiovascular Disease.

    PubMed

    Fanaroff, Alexander C; Roe, Matthew T

    2016-08-01

    Aspirin has been the cornerstone of therapy for the secondary prevention treatment of patients with cardiovascular disease since landmark trials were completed in the late 1970s and early 1980s that demonstrated the efficacy of aspirin for reducing the risk of ischemic events. Notwithstanding the consistent benefits demonstrated with aspirin for both acute and chronic cardiovascular disease, there are a number of toxicities associated with aspirin that have been showcased by recent long-term clinical trials that have included an aspirin monotherapy arm. As an inhibitor of cyclooxygenase (COX), aspirin impairs gastric mucosal protective mechanisms. Previous trials have shown that up to 15-20 % of patients developed gastrointestinal symptoms with aspirin monotherapy, and approximately 1 % of patients per year had a clinically significant bleeding event, including 1 in 1000 patients who suffered an intracranial or fatal bleed. These risks have been shown to be compounded for patients with acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) who are also treated with other antithrombotic agents during the acute care/procedural period, as well as for an extended time period afterwards. Given observations of substantial increases in bleeding rates from many prior long-term clinical trials that have evaluated aspirin together with other oral platelet inhibitors or oral anticoagulants, the focus of contemporary research has pivoted towards tailored antithrombotic regimens that attempt to either shorten the duration of exposure to aspirin or replace aspirin with an alternative antithrombotic agent. While these shifts are occurring, the safety profile of aspirin when used for the secondary prevention treatment of patients with established cardiovascular disease deserves further consideration. PMID:27028617

  10. 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

  11. Long-Term Growth of Moss in Microfluidic Devices Enables Subcellular Studies in Development.

    PubMed

    Bascom, Carlisle S; Wu, Shu-Zon; Nelson, Katherine; Oakey, John; Bezanilla, Magdalena

    2016-09-01

    Key developmental processes that occur on the subcellular and cellular level or occur in occluded tissues are difficult to access, let alone image and analyze. Recently, culturing living samples within polydimethylsiloxane (PDMS) microfluidic devices has facilitated the study of hard-to-reach developmental events. Here, we show that an early diverging land plant, Physcomitrella patens, can be continuously cultured within PDMS microfluidic chambers. Because the PDMS chambers are bonded to a coverslip, it is possible to image P. patens development at high resolution over long time periods. Using PDMS chambers, we report that wild-type protonemal tissue grows at the same rate as previously reported for growth on solid medium. Using long-term imaging, we highlight key developmental events, demonstrate compatibility with high-resolution confocal microscopy, and obtain growth rates for a slow-growing mutant. By coupling the powerful genetic tools available to P. patens with long-term growth and imaging provided by PDMS microfluidic chambers, we demonstrate the capability to study cellular and subcellular developmental events in plants directly and in real time. PMID:27406170

  12. Torsion of the spermatic cord--a long term study of the contralateral testis.

    PubMed

    Chakraborty, J; Sinha Hikim, A P; Jhunjhunwala, J

    1986-01-01

    The object of the present investigation was to study the long-term effects of the unilateral torsion of the spermatic cord on the contralateral testis. Eighteen guinea pigs were divided into 3 groups. In group I of six animals, unilateral torsion of the spermatic cords was maintained until the time of sacrifice. In group II of six animals, torsion of the spermatic cords was maintained for 8-12 h, then the spermatic cords were untwisted and the animals were maintained until the day of sacrifice. Group III six animals, received an injection of pentobarbital, which served as control. All animals were sacrificed after 16 months. Extensive light and electron microscopic studies were carried out. In the contralateral testes of the experimental group of animals, several degenerative changes were noted, which included excessive intraepithelial vacuolization, a loss of germ cells and the presence of tubules containing only Sertoli cells and a few spermatogonia. 10.6% and 19.5% seminiferous tubules were damaged in the contralateral testes of torsion maintained and the torsion reversed groups of animals, respectively in comparison to 3.1% tubular damage (indicated only by occasional presence of intraepithelial vacuoles and necrotic germ cells), in the control testis. It was concluded that long-term effect of unilateral torsion of the spermatic cord is permanent and irreversible in nature. PMID:3798613

  13. Long-term clinical study and multiscale analysis of in vivo biodegradation mechanism of Mg alloy

    PubMed Central

    Lee, Jee-Wook; Han, Hyung-Seop; Han, Kyeong-Jin; Park, Jimin; Jeon, Hojeong; Ok, Myoung-Ryul; Seok, Hyun-Kwang; Ahn, Jae-Pyoung; Lee, Kyung Eun; Lee, Dong-Ho; Yang, Seok-Jo; Cho, Sung-Youn; Cha, Pil-Ryung; Kwon, Hoon; Nam, Tae-Hyun; Han, Jee Hye Lo; Rho, Hyoung-Jin; Lee, Kang-Sik; Kim, Yu-Chan; Mantovani, Diego

    2016-01-01

    There has been a tremendous amount of research in the past decade to optimize the mechanical properties and degradation behavior of the biodegradable Mg alloy for orthopedic implant. Despite the feasibility of degrading implant, the lack of fundamental understanding about biocompatibility and underlying bone formation mechanism is currently limiting the use in clinical applications. Herein, we report the result of long-term clinical study and systematic investigation of bone formation mechanism of the biodegradable Mg-5wt%Ca-1wt%Zn alloy implant through simultaneous observation of changes in element composition and crystallinity within degrading interface at hierarchical levels. Controlled degradation of Mg-5wt%Ca-1wt%Zn alloy results in the formation of biomimicking calcification matrix at the degrading interface to initiate the bone formation process. This process facilitates early bone healing and allows the complete replacement of biodegradable Mg implant by the new bone within 1 y of implantation, as demonstrated in 53 cases of successful long-term clinical study. PMID:26729859

  14. Long-term neurological outcomes in West Nile virus-infected patients: an observational study.

    PubMed

    Weatherhead, Jill E; Miller, Vicki E; Garcia, Melissa N; Hasbun, Rodrigo; Salazar, Lucrecia; Dimachkie, Mazen M; Murray, Kristy O

    2015-05-01

    The Houston West Nile Cohort (HWNC) was founded in 2002 when West Nile virus (WNV) reached Houston, TX. The long-term outcomes following WNV infection are still mostly unknown, though neurological abnormalities up to 1 year postinfection have been documented. We report an observational study of neurological abnormalities at 1-3 and 8-11 years following WNV infection in the HWNC. We conducted standard neurological examinations at two separate time points to assess changes in neurological status over time. The majority of patients (86%, 30/35) with encephalitis had abnormal neurological exam findings at the time of the first assessment compared with uncomplicated fever (27%, 3/11) and meningitis (36%, 5/14) cases. At the time of the second assessment, 57% (4/7) of West Nile fever (WNF), 33% (2/6) of West Nile meningitis (WNM), and 36% (5/14) of West Nile encephalitis (WNE) had developed new neurological complications. The most common abnormalities noted were tandem gait, hearing loss, abnormal reflexes, and muscle weakness. Long-term neurological abnormalities were most commonly found in patients who experienced primary WNV encephalitis. New abnormalities may develop over time regardless of initial clinical infection. Future studies should aim to differentiate neurological consequences due to WNV neuroinvasive infection versus neurological decline related to comorbid conditions. PMID:25802426

  15. Long-term clinical study and multiscale analysis of in vivo biodegradation mechanism of Mg alloy.

    PubMed

    Lee, Jee-Wook; Han, Hyung-Seop; Han, Kyeong-Jin; Park, Jimin; Jeon, Hojeong; Ok, Myoung-Ryul; Seok, Hyun-Kwang; Ahn, Jae-Pyoung; Lee, Kyung Eun; Lee, Dong-Ho; Yang, Seok-Jo; Cho, Sung-Youn; Cha, Pil-Ryung; Kwon, Hoon; Nam, Tae-Hyun; Han, Jee Hye Lo; Rho, Hyoung-Jin; Lee, Kang-Sik; Kim, Yu-Chan; Mantovani, Diego

    2016-01-19

    There has been a tremendous amount of research in the past decade to optimize the mechanical properties and degradation behavior of the biodegradable Mg alloy for orthopedic implant. Despite the feasibility of degrading implant, the lack of fundamental understanding about biocompatibility and underlying bone formation mechanism is currently limiting the use in clinical applications. Herein, we report the result of long-term clinical study and systematic investigation of bone formation mechanism of the biodegradable Mg-5wt%Ca-1wt%Zn alloy implant through simultaneous observation of changes in element composition and crystallinity within degrading interface at hierarchical levels. Controlled degradation of Mg-5wt%Ca-1wt%Zn alloy results in the formation of biomimicking calcification matrix at the degrading interface to initiate the bone formation process. This process facilitates early bone healing and allows the complete replacement of biodegradable Mg implant by the new bone within 1 y of implantation, as demonstrated in 53 cases of successful long-term clinical study. PMID:26729859

  16. Weekly injection of histaglobulin produces long-term remission in chronic urticaria: A prospective clinical study

    PubMed Central

    Rajesh, Gurumoorthy; Keerthi, Subramaniam; Karthikeyan, Kaliaperumal; Venkatesan, Murugan

    2016-01-01

    Objective: Treatment of chronic urticaria (CU) can be difficult in many patients. Achieving long-term remission and reducing the requirement of antihistamines are vital in CU. The objective of this study was to assess the effectiveness of injection histaglobulin, a complex of histamine and human immunoglobulin, in producing relief in patients with CU. Materials and Methods: Fifty-one patients with CU were enrolled into this prospective clinical study. Patients were administered 1 ml of injection histaglobulin subcutaneous for 8 consecutive weeks. They were also prescribed tablet levocetirizine 5 mg to be taken when required (but not more than the permitted dosage). Efficacy was assessed using urticaria activity score (UAS) which has a maximum score of 33/day, during each weekly visit. Final assessment was done after 24 weeks. Results: Twenty-nine patients had completed the entire 8-week drug regimen. Mean basal UAS was 18.9 ± 6.3 and it reduced to 80.4% by 8 weeks. The angioedema sub-score reduced by 89.8%. Anti-histamine pill burden also reduced significantly. By 24 weeks of starting the therapy, 23 patients (45%) had attained complete remission. No adverse effects to the drug were observed. Conclusions: Histaglobulin was found to be effective in producing long-term remission and it reduced the antihistamine requirement as well. Thus, it can serve as an effective alternative to existing treatment modalities. PMID:27298500

  17. Long-Term Health Correlates of Timing of Sexual Debut: Results From a National US Study

    PubMed Central

    Sandfort, Theo G.M.; Orr, Mark; Hirsch, Jennifer S.; Santelli, John

    2008-01-01

    Objectives. We explored long-term health consequences of age at sexual initiation and of abstinence until marriage to evaluate empirical support for the claim that postponing sexual initiation has beneficial health effects. Methods. We analyzed data from the 1996 National Sexual Health Survey, a cross-sectional study of the US adult population. We compared sexual health outcomes among individuals who had initiated sexual activity at an early or late age versus a normative age. We also compared individuals whose first sexual intercourse had occurred before versus after marriage. Results. Early initiation of sexual intercourse was associated with various sexual risk factors, including increased numbers of sexual partners and recent sexual intercourse under the influence of alcohol, whereas late initiation was associated with fewer risk factors. However, both early and late initiation were associated with sexual problems such as problems with arousal and orgasm, primarily among men. Relationship solidity and sexual relationship satisfaction were not associated with early or late initiation. Conclusions. Early sexual debut is associated with certain long-term negative sexual health outcomes, including increased sexual risk behaviors and problems in sexual functioning. Late initiation was also associated with sexual problems, especially among men. Further research is needed to understand how sexual initiation patterns affect later health outcomes. PMID:18048793

  18. The long-term studies of CO2 fluxes in southern taiga of European Russia

    NASA Astrophysics Data System (ADS)

    Kurbatova, Juliya; Varlagin, Andrei; Tatarinov, Fedor; Avilov, Vitalii; Astafieva, Elena; Ivanov, Dmitrii; Olchev, Alexander; Valentini, Riccardo

    2013-04-01

    Wetlands and bogged forests located in forest zone are main elements of natural landscapes of Russia, covering about 10% of country. The long-term studies (from 1998 - for present) of CO2 fluxes have conducted in southern taiga of European Russia (Central Forest reserve, Tver region) at ombrotrophic bog and bogged spruce forest. To estimate of seasonal and interannual variations of CO2 fluxes different methods such as eddy covariance, chamber methods and modeling calculations were used. Our researches have allowed to evaluate long-term variations of net ecosystems exchange, soil respiration, gross primary production and their depending on environmental factors. The results of researches have confirmed strong relations between CO2 fluxes and precipitations and/or temperatures and level of ground water. Wetlands and bogged forests can be as sink as source of CO2 for atmosphere. Variation in water level dynamics alone could significantly affect the C balance in wetland ecosystems mainly through altering the decomposition rate of the organic matter accumulated in the soil profile. The modeled results supported the hypothesis that the soil processes, especially the decomposition process, in wetlands could play an important role in altering the C dynamics in the ecosystems.

  19. Long term mortality study of chromate pigment workers who suffered lead poisoning.

    PubMed Central

    Davies, J M

    1984-01-01

    Long term mortality was studied in a group of 57 chromate pigment workers who suffered clinical lead poisoning, mostly between 1930 and 1945. One death was attributed to lead poisoning and there were significant excesses of deaths from nephritis (observed/expected 3/0.24) and cerebrovascular disease (9/2.20), as well as non-significant excesses for respiratory diseases (7/3.59) and accidents and violence (3/1.13). The deaths from nephritis followed long spells of service exceeding 10 years. Poisoning appeared to have more adverse long term effects on older workers: 15 men aged 40 or over at the time of acute poisoning experienced generally high mortality, and 30 years later or by the end of 1981 only two survived instead of the seven expected. The risk of cerebrovascular disease appeared to be unrelated to duration of exposure and affected even men employed for under one year. Excluding the 57 lead poisoned men, other contemporary workers at the factories showed no excess mortality from cerebrovascular disease. PMID:6722043

  20. Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

    PubMed Central

    Sönnerborg, Anders; Brockmeyer, Norbert; Thalme, Anders; Svedhem, Veronica; Dupke, Stephan; Eychenne, Jean-Luc; Nakonz, Tina; Jimenez-Exposito, Maria Jesus; Pugliese, Pascal

    2013-01-01

    Abstract Atazanavir-based regimens have established efficacy and safety in both antiretroviral (ARV)-naive and -experienced patients. However, data evaluating effectiveness beyond 2 years is sparse. Therefore, we assessed the long-term outcomes of ritonavir-boosted atazanavir (ATV/r)-containing regimens in ARV-experienced patients in a clinical setting in a noncomparative, retrospective, observational study collecting data from three European HIV databases on ARV-experienced adults with HIV-1 infection starting an ATV/r-based regimen. Data were extracted every 6 months (maximum follow-up 5 years). Primary outcome was the proportion of patients remaining on ATV/r by baseline HIV-1 RNA (<500 or ≥500 copies/ml). Secondary outcomes included time to virologic failure, reasons for discontinuation, and long-term safety profile. The duration of treatment and time to virologic failure were analyzed using the Kaplan–Meier method. Data were analyzed for 1,294 ARV-experienced patients (male 74%; mean ART exposure 5.7 years). After 3 years, 56% (95% CI: 52%, 60%) of patients with baseline HIV-1 RNA <500 copies/ml and 53% (95% CI: 49%, 58%) of those with HIV-1 RNA ≥500 copies/ml remained on ATV/r. After 3 years, 75% (95% CI: 69%, 80%) of patients with baseline HIV-1 RNA <50 copies/ml remained suppressed and 51% (95% CI: 47%, 55%) of those with baseline HIV-1 RNA ≥50 copies/ml achieved and maintained virologic suppression. Although adverse events (AEs) were the main known reason for discontinuation, no unexpected AEs were observed. In a real-life setting ATV/r-based regimens demonstrated sustained virologic suppression in ARV-experienced patients. After long-term therapy the majority of patients remained on treatment and no unexpected AEs were observed. PMID:23016535

  1. Trends in long-term opioid prescribing in primary care patients with musculoskeletal conditions: an observational database study

    PubMed Central

    Bedson, John; Chen, Ying; Hayward, Richard A.; Ashworth, Julie; Walters, Kate; Dunn, Kate M.; Jordan, Kelvin P.

    2016-01-01

    Abstract Long-term opioids may benefit patients with chronic pain but have also been linked to harmful outcomes. In the United Kingdom, the predominant source of opioids is primary care prescription. The objective was to examine changes in the incidence, length, and opioid potency of long-term prescribing episodes for musculoskeletal conditions in UK primary care (2002-2013). This was an observational database study (Clinical Practice Research Datalink, 190 practices). Participants (≥18 years) were prescribed an opioid for a musculoskeletal condition (no opioid prescribed in previous 6 months), and issued ≥2 opioid prescriptions within 90 days (long-term episode). Opioids were divided into short- and long-acting noncontrolled and controlled drugs. Annual incidence of long-term opioid episodes was determined, and for those still in a long-term episode, the percentage of patients prescribed each type 1 to 2 years, and >2 years after initiation. Annual denominator population varied from 1.25 to 1.38 m. A total of 76,416 patients started 1 long-term episode. Annual long-term episode incidence increased (2002-2009) by 38% (42.4-58.3 per 10,000 person-years), remaining stable to 2011, then decreasing slightly to 55.8/10,000 (2013). Patients prescribed long-acting controlled opioids within the first 90 days of long-term use increased from 2002 to 2013 (2.3%-9.9%). In those still in a long-term opioid episode (>2 years), long-acting controlled opioid prescribing increased from 3.5% to 22.6%. This study has uniquely shown an increase in prescribing long-term opioids to 2009, gradually decreasing from 2011 in the United Kingdom. The trend was towards increased prescribing of controlled long-acting opioids and earlier use. Further research into the risks and benefits of opioids is required. PMID:27003191

  2. Trends in long-term opioid prescribing in primary care patients with musculoskeletal conditions: an observational database study.

    PubMed

    Bedson, John; Chen, Ying; Hayward, Richard A; Ashworth, Julie; Walters, Kate; Dunn, Kate M; Jordan, Kelvin P

    2016-07-01

    Long-term opioids may benefit patients with chronic pain but have also been linked to harmful outcomes. In the United Kingdom, the predominant source of opioids is primary care prescription. The objective was to examine changes in the incidence, length, and opioid potency of long-term prescribing episodes for musculoskeletal conditions in UK primary care (2002-2013). This was an observational database study (Clinical Practice Research Datalink, 190 practices). Participants (≥18 years) were prescribed an opioid for a musculoskeletal condition (no opioid prescribed in previous 6 months), and issued ≥2 opioid prescriptions within 90 days (long-term episode). Opioids were divided into short- and long-acting noncontrolled and controlled drugs. Annual incidence of long-term opioid episodes was determined, and for those still in a long-term episode, the percentage of patients prescribed each type 1 to 2 years, and >2 years after initiation. Annual denominator population varied from 1.25 to 1.38 m. A total of 76,416 patients started 1 long-term episode. Annual long-term episode incidence increased (2002-2009) by 38% (42.4-58.3 per 10,000 person-years), remaining stable to 2011, then decreasing slightly to 55.8/10,000 (2013). Patients prescribed long-acting controlled opioids within the first 90 days of long-term use increased from 2002 to 2013 (2.3%-9.9%). In those still in a long-term opioid episode (>2 years), long-acting controlled opioid prescribing increased from 3.5% to 22.6%. This study has uniquely shown an increase in prescribing long-term opioids to 2009, gradually decreasing from 2011 in the United Kingdom. The trend was towards increased prescribing of controlled long-acting opioids and earlier use. Further research into the risks and benefits of opioids is required. PMID:27003191

  3. Cohort profile: golestan hepatitis B cohort study- a prospective long term study in northern iran ​.

    PubMed

    Poustchi, Hossein; Katoonizadeh, Aezam; Ostovaneh, Mohammad Reza; Moossavi, Shirin; Sharafkhah, Maryam; Esmaili, Saeed; Pourshams, Akram; Mohamadkhani, Ashraf; Besharat, Sima; Merat, Shahin; Mohamadnejad, Mehdi; George, Jacob; Malekzadeh, Reza

    2014-10-01

    Hepatitis B virus (HBV) infection is the most common cause of end stage liver disease in Iran and in Golestan province. Large-scale population-based prospective cohort studies with long term follow-up are the method of choice to accurately understand the natural course of HBV infection. To date, several studies of HBV epidemiology, natural history, progression to cirrhosis and association with HCC have been reported from other countries. However, few of these are prospective and fewer still are population-based. Moreover, the underlying molecular mechanisms and immunogenetic determinants of the outcome of HBV infection especially in low and middle income countries remains largely unknown. Therefore, the hepatitis B cohort study (HBCS), nested as part of the Golestan Cohort Study (GCS), Golestan, Iran was established in 2008 with the objective to prospectively investigate the natural course of chronic hepatitis B with reference to its epidemiology, viral/host genetic interactions, clinical features and outcome in the Middle East where genotype D HBV accounts for >90% of infections. In 2008, a baseline measurement of HBV surface antigen (HBsAg) was performed on stored serum samples of all GCS participants. A sub-cohort of 3,505 individuals were found to be HBsAg positive and were enrolled in the Golestan HBCS. In 2011, all first degree relatives of HBsAg positive subjects including their children and spouses were invited for HBV serology screening and those who were positive for HBsAg were also included in the Golestan HBCS. PMID:25349681

  4. Long-Term Air Pollution Exposure and Blood Pressure in the Sister Study

    PubMed Central

    Chan, Stephanie H.; Van Hee, Victor C.; Bergen, Silas; Szpiro, Adam A.; DeRoo, Lisa A.; London, Stephanie J.; Marshall, Julian D.; Sandler, Dale P.

    2015-01-01

    Background Exposure to air pollution has been consistently associated with cardiovascular morbidity and mortality, but mechanisms remain uncertain. Associations with blood pressure (BP) may help to explain the cardiovascular effects of air pollution. Objective We examined the cross-sectional relationship between long-term (annual average) residential air pollution exposure and BP in the National Institute of Environmental Health Sciences’ Sister Study, a large U.S. cohort study investigating risk factors for breast cancer and other outcomes. Methods This analysis included 43,629 women 35–76 years of age, enrolled 2003–2009, who had a sister with breast cancer. Geographic information systems contributed to satellite-based nitrogen dioxide (NO2) and fine particulate matter (≤ 2.5 μm; PM2.5) predictions at participant residences at study entry. Generalized additive models were used to examine the relationship between pollutants and measured BP at study entry, adjusting for cardiovascular disease risk factors and including thin plate splines for potential spatial confounding. Results A 10-μg/m3 increase in PM2.5 was associated with 1.4-mmHg higher systolic BP (95% CI: 0.6, 2.3; p < 0.001), 1.0-mmHg higher pulse pressure (95% CI: 0.4, 1.7; p = 0.001), 0.8-mmHg higher mean arterial pressure (95% CI: 0.2, 1.4; p = 0.01), and no significant association with diastolic BP. A 10-ppb increase in NO2 was associated with a 0.4-mmHg (95% CI: 0.2, 0.6; p < 0.001) higher pulse pressure. Conclusions Long-term PM2.5 and NO2 exposures were associated with higher blood pressure. On a population scale, such air pollution–related increases in blood pressure could, in part, account for the increases in cardiovascular disease morbidity and mortality seen in prior studies. Citation Chan SH, Van Hee VC, Bergen S, Szpiro AA, DeRoo LA, London SJ, Marshall JD, Kaufman JD, Sandler DP. 2015. Long-term air pollution exposure and blood pressure in the Sister Study. Environ Health

  5. Long-term outcome after haploidentical stem cell transplant and infusion of T cells expressing the inducible caspase 9 safety transgene

    PubMed Central

    Zhou, Xiaoou; Di Stasi, Antonio; Tey, Siok-Keen; Krance, Robert A.; Martinez, Caridad; Leung, Kathryn S.; Durett, April G.; Wu, Meng-Fen; Liu, Hao; Leen, Ann M.; Savoldo, Barbara; Lin, Yu-Feng; Grilley, Bambi J.; Gee, Adrian P.; Spencer, David M.; Rooney, Cliona M.; Heslop, Helen E.; Brenner, Malcolm K.

    2014-01-01

    Adoptive transfer of donor-derived T lymphocytes expressing a safety switch may promote immune reconstitution in patients undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT) without the risk for uncontrolled graft versus host disease (GvHD). Thus, patients who develop GvHD after infusion of allodepleted donor-derived T cells expressing an inducible human caspase 9 (iC9) had their disease effectively controlled by a single administration of a small-molecule drug (AP1903) that dimerizes and activates the iC9 transgene. We now report the long-term follow-up of 10 patients infused with such safety switch-modified T cells. We find long-term persistence of iC9-modified (iC9-T) T cells in vivo in the absence of emerging oligoclonality and a robust immunologic benefit, mediated initially by the infused cells themselves and subsequently by an apparently accelerated reconstitution of endogenous naive T lymphocytes. As a consequence, these patients have immediate and sustained protection from major pathogens, including cytomegalovirus, adenovirus, BK virus, and Epstein-Barr virus in the absence of acute or chronic GvHD, supporting the beneficial effects of this approach to immune reconstitution after haplo-HSCT. This study was registered at www.clinicaltrials.gov as #NCT00710892. PMID:24753538

  6. Study of archaeological artefacts to refine the model of iron long-term indoor atmospheric corrosion

    NASA Astrophysics Data System (ADS)

    Monnier, J.; Legrand, L.; Bellot-Gurlet, L.; Foy, E.; Reguer, S.; Rocca, E.; Dillmann, P.; Neff, D.; Mirambet, F.; Perrin, S.; Guillot, I.

    2008-09-01

    The study of long-term indoor atmospheric corrosion is involved in the field of the interim storage of nuclear wastes. Indeed study of archaeological artefacts is one of the only mean to gather information on very long periods. Concerning ancient items, due to the complexity of the system, it is necessary to couple many analytical techniques from the macro to the microscopic scale. This enables to propose a description of the Amiens cathedral chain rust layers, made of a matrix of goethite, with lepidocrocite and akaganeite locally present and marbling of a poor crystallized phase associated to ferrihydrite. Electrochemical measurements permit to study the reduction capacity of the rust layer and to draw reduction mechanisms of the so-called active phases, by in situ experiments coupled with X-ray diffraction and X-ray absorption spectroscopy.

  7. Life history and demographic variation in the lizard Sceloporus graciosus: A long-term study

    SciTech Connect

    Tinkle, D.W. ); Dunham, A.E. ); Congdon, J.D. )

    1993-12-01

    An 11-yr study of life history and demographic variation in the sagebrush lizard Sceloporus graciosus was carried out on two study areas (Rattlesnake Ridge and Ponderosa Flat) in the Kolob Mesa Section of Zion National Park, Utah. Two primary objectives of this mark-recapture study were to: (1) quantify variation in age structure, age, and size at maturity, age-specific survivorship and fecundity, and individual growth rates, and (2) conduct a series of density reduction experiments designed to elucidate the effects of density on growth rates and survival of posthatchling lizards. In addition, the authors examined the relationships of variation in population density and deviation from long-term average precipitation and temperature to variation in individual growth, reproduction, and demography. 43 refs., 5 figs., 11 tabs.

  8. Standardizing flow cytometric assays in long-term population-based studies

    NASA Astrophysics Data System (ADS)

    Melzer, Susanne; Bocsi, Jozsef; Tárnok, Attila

    2015-03-01

    Quantification of leukocyte subpopulations and characterization of antigen-expression pattern on the cellular surface can play an important role in diagnostics. The state of cellular immunology on the single-cell level was analyzed by polychromatic flow cytometry in a recent comparative study within the average Leipzig population (LIFE - Leipzig Research Centre for Civilization Diseases). Data of 1699 subjects were recorded over a long-time period of three years (in a total of 1126 days). To ensure compatibility of such huge data sets, quality-controls on many levels (stability of instrumentation, low intra-laboratory variance and reader independent data analysis) are essential. The LIFE study aims to analyze various cytometric pattern to reveal the relationship between the life-style, the environmental effects and the individual health. We therefore present here a multi-step quality control procedure for long-term comparative studies.

  9. Long-term data collection at USDA experimental sites for studies of ecohydrology

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Federally established watersheds, rangelands and forests have produced long-term records of biotic and abiotic measurements that span decades and centuries across the U.S. The goal of this review is to express the value of such long-term data for understanding and predicting ecosystem dynamics and ...

  10. Management and policy implications of cross-and within-site, long-term studies

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This chapter explains the implications long-term data bring to natural resource management and policy-making. It first explains the two perspectives of long-term data, then explains the values brought by the two perspectives to natural resource management. The two perspectives are retrospective an...

  11. Effect on endometrium of long term treatment with continuous combined oestrogen-progestogen replacement therapy: follow up study

    PubMed Central

    Wells, Michael; Sturdee, David W; Barlow, David H; Ulrich, Lian G; O'Brien, Karen; Campbell, Michael J; Vessey, Martin P; Bragg, Anthony J

    2002-01-01

    endometrial tissue after nine months of treatment with continuous combined hormone replacement therapy, and hyperplasia did not recur after up to five years of treatment. Conclusions Long term treatment (for up to five years) with continuous combined hormone replacement therapy containing oestradiol 2 mg and norethisterone 1 mg daily was associated with neither endometrial hyperplasia nor malignancy. In women who had complex hyperplasia during previous sequential or unopposed regimens, the endometrium returned to normal during treatment with continuous combined hormone replacement therapy. These findings provide reassurance about the long term safety of this continuous combined regimen in terms of the endometrium. What is already known on this topicLong term use of sequential oestrogen-progestogen hormone replacement therapy increases the risk of endometrial cancerContinuous combined hormone replacement therapy regimens are safe and effective in the short term treatment of postmenopausal womenPrevious trials have involved small numbers of patients (<100) or short durations of treatment (2-3 years), or bothWhat this study addsAll women who had complex hyperplasia while taking sequential or unopposed hormone replacement therapies reverted to normal endometrial patternsContinuous combined hormone replacement therapies that include continuous progestogen improve endometrial safety when used in the long term (up to five years) PMID:12153918

  12. Denitrification in a Sand and Gravel Aquifer: An Overview of a Long-Term Study

    NASA Astrophysics Data System (ADS)

    Smith, R. L.

    2002-12-01

    Denitrification can be a key process affecting the concentration and transport of nitrate in the subsurface. As a dissimilatory process, it has the potential to consume significant amounts of nitrate, once oxygen has been depleted, while serving as the predominant terminal electron-accepting reaction for the microbial food chain. Although denitrification has been extensively studied in soils and some surface water systems, relatively little is known about the process in the saturated subsurface. Consequently, a long-term study was established to examine the occurrence of denitrification in a sewage-contaminated, sand and gravel aquifer on Cape Cod, Massachusetts. This study included a characterization of the effect of the process on spatial and temporal distribution of inorganic nitrogen species along aquifer flow paths, the effect on nitrogen stable isotope distributions, and the overall effect on the process of dispersion and consumption of dissolved oxygen and dissolved organic carbon. A variety of laboratory and field studies have been conducted to quantify the overall rate of denitrification relative to subsurface flow, factors that control the process in the Cape Cod aquifer, and the steady-state dynamics of electron flow through the individual steps of the denitrification pathway. Under some conditions, the pathway was found to be unbalanced in the aquifer, causing accumulation of nitrogen oxide intermediates (nitrite, nitrous oxide, and nitric oxide) in the groundwater. Another aspect of this study was utilization of denitrification as a tool to remediate subsurface nitrate contamination. This included in situ enhancement tests using formate as an added electron donor and a laboratory project testing specific groups of denitrifiers isolated from the aquifer. Overall this long-term study has demonstrated that small-scale heterogeneity is a major factor that dictates and controls denitrification in an aquifer at any given locale, even systems viewed as

  13. Long-term airborne contamination studied by attic dust in an industrial area: Ajka, Hungary

    NASA Astrophysics Data System (ADS)

    Völgyesi, P.; Jordan, G.; Szabo, Cs.

    2012-04-01

    Heavy industrial activities such as mining, metal industry, coal fired power plants have produced large amount of by-products and wide-spread pollution, particularly in the period of centrally dictated economy after WWII, in Hungary. Several studies suggest that significant amount of these pollutants have been deposited in the urban environment. Nowadays, more than half of the world's population is living in urban areas and people spend almost 80% of their lives indoors in developed countries increasing human health risk due to contamination present in urban dwellings. Attic dust sampling was applied to determine the long-term airborne contamination load in the industrial town of Ajka (Hungary). There has been a high industrial activity in Ajka since the end of the 19th century. In addition to aluminum and alumina industry, coal mining, coal fired power plant and glass industry sites, generated numerous waste heaps which act as multi-contamination sources in the area. In October 2010 the Ajka red mud tailings pond failed and caused an accidental regional contamination of international significance. The major objective of this research was to study and map the spatial distribution of heavy metal contamination in airborne attic dust samples. At 27 sampling sites 30 attic dust samples were collected. Sampling strategy followed a grid-based stratified random sampling design. In each cell a house for attic dust sample collection was selected that was located the closest to a randomly generated point in the grid cell. The project area covers a 8x8 grid of 1x1 km cells with a total area of 64 km2. In order to represent long-term industrial pollution, houses with attics kept intact for at least 30-40 years were selected for sampling. Sampling included the collection of background samples remotely placed from the industrialized urban area. The concentration of the major and toxic elements (Al, Ca, Fe, K, Mg, Mn, Na, P, S, and As, Ba, Cd, Co, Cr, Cu, Li, Mo, Ni, Pb, Se, Sn

  14. Lumbar Zygapophysial Joint Radiofrequency Denervation: a Long-Term Clinical Outcome Study

    PubMed Central

    Manejias, Elizabeth Marie; Hu, Jason; Tatli, Yusuf

    2008-01-01

    Zygapophysial joint (z-joint) pain has long been suggested to be one of the sources of low back pain. Radiofrequency denervation of the medial branches of the dorsal rami to treat z-joint pain is an outpatient minimally invasive treatment option. There have been many short-term studies to determine the outcome of the procedure, but few long-term studies have been conducted. Our goal is to clarify whether radiofrequency denervation has any long-term clinical benefit. In this retrospective cohort study, a total of 42 patients (25 women and 17 men), with an average follow-up of 3.5 years, with clinical signs of zygapophysial joint involvement who had failed conservative treatment (pre-procedure symptom duration mean 6.03 years; range 5 months to 48 years) and had a favorable response to a diagnostic medial branch block or zygapophysial joint injection, were identified. The identified subjects underwent radiofrequency denervation at the Hospital for Special Surgery Physiatry Department from 1998 to 2006. Patient’s records were reviewed, and a questionnaire was provided, completed on phone call follow-up, or mailed by the patient. The success of this intervention in providing improvement in pain and function was analyzed using the Numerical Rating Scale (NRS)—11, North American Spine Society (NASS) four-point satisfaction index, and a modified Roland–Morris Disability Questionnaire (RMDQ). Fifty-two percent of patients reported a successful outcome with improved function at a minimum follow-up period of 2 years (mean 3.5 years, range 2–8.8 years). Patients in the failure group were more likely to be older and have moderate to severe neuroforaminal stenosis (77.8%) compared to patients in the success group (24.2%). Radiofrequency denervation in selected patients with chronic zygapophysial joint-mediated low back pain provides long-term reduction in pain and improved function with minimum morbidity. PMID:18815863

  15. Microsphere-based gradient implants for osteochondral regeneration: a long-term study in sheep

    PubMed Central

    Mohan, Neethu; Gupta, Vineet; Sridharan, Banu Priya; Mellott, Adam J; Easley, Jeremiah T; Palmer, Ross H; Galbraith, Richard A; Key, Vincent H; Berkland, Cory J; Detamore, Michael S

    2015-01-01

    Background: The microfracture technique for cartilage repair has limited ability to regenerate hyaline cartilage. Aim: The current study made a direct comparison between microfracture and an osteochondral approach with microsphere-based gradient plugs. Materials & methods: The PLGA-based scaffolds had opposing gradients of chondroitin sulfate and β-tricalcium phosphate. A 1-year repair study in sheep was conducted. Results: The repair tissues in the microfracture were mostly fibrous and had scattered fissures with degenerative changes. Cartilage regenerated with the gradient plugs had equal or superior mechanical properties; had lacunated cells and stable matrix as in hyaline cartilage. Conclusion: This first report of gradient scaffolds in a long-term, large animal, osteochondral defect demonstrated potential for equal or better cartilage repair than microfracture. PMID:26418471

  16. 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

  17. Long-Term Patterns of Online Evidence Retrieval Use in General Practice: A 12-Month Study

    PubMed Central

    Westbrook, Johanna I; Kidd, Michael R; Day, Richard O; Coiera, Enrico

    2008-01-01

    Background Provision of online evidence at the point of care is one strategy that could provide clinicians with easy access to up-to-date evidence in clinical settings in order to support evidence-based decision making. Objective The aim was to determine long-term use of an online evidence system in routine clinical practice. Methods This was a prospective cohort study. 59 clinicians who had a computer with Internet access in their consulting room participated in a 12-month trial of Quick Clinical, an online evidence system specifically designed around the needs of general practitioners (GPs). Patterns of use were determined by examination of computer logs and survey analysis. Results On average, 9.9 searches were conducted by each GP in the first 2 months of the study. After this, usage dropped to 4.4 searches per GP in the third month and then levelled off to between 0.4 and 2.6 searches per GP per month. The majority of searches (79.2%, 2013/2543) were conducted during practice hours (between 9 am and 5 pm) and on weekdays (90.7%, 2315/2543). The most frequent searches related to diagnosis (33.6%, 821/2291) and treatment (34.5%, 844/2291). Conclusion GPs will use an online evidence retrieval system in routine practice; however, usage rates drop significantly after initial introduction of the system. Long-term studies are required to determine the extent to which GPs will integrate the use of such technologies into their everyday clinical practice and how this will affect the satisfaction and health outcomes of their patients. PMID:18353750

  18. Pharmacokinetic study of eplerenone in rats after long-term coadministration with buckwheat tea.

    PubMed

    Zou, Liang; Jia, Kun; Li, Rui; Wang, Ping; Lin, Jun-Zhi; Chen, Hui-Juan; Zhao, Gang; Peng, Lian-Xin

    2016-04-01

    The aim of this study was to investigate the effect of long-term intake of Tartary buckwheat tea on the pharmacokinetics (PK) of eplerenone in rats. A validated high-performance liquid chromatography-mass spectrometry (HPLC-MS) method was established to determine the eplerenone in plasma, and the portal vein absorption model was applied to conduct the pharmacokinetic study. Two groups of animals-buckwheat tea group and control group-were involved in this study. Plasma samples were obtained at different time points after administration, and were separated on Shimadzu HPLC-MS 2020 instruments. The method showed good linearity (r=0.9988) over a wide dynamic range (0.20-50 μg/mL). Within- and between-batch precisions ranged from 2.13% to 7.90%. The extraction recovery rates ranged from 91.96% to 94.96%. The data showed that in the Tartarian buckwheat group the area under the curve and maximum concentration of eplerenone were reduced compared with those of the blank group (p<0.01), but the time to reach peak concentrations of eplerenone (p<0.01) was prolonged. The results suggested that long-term consumption of Tartary buckwheat tea might induce the activities of the hepatic drug metabolizing enzyme, which can accelerate the metabolism of eplerenone. According to the results, the dosage of eplerenone should be adjusted in hypertension treatment trials when administered with Tartary buckwheat or Tartary buckwheat-containing dietary supplements to avoid potential drug interactions. PMID:27185599

  19. Long-term study of Mkn 421 with the HAGAR Array of Telescopes

    NASA Astrophysics Data System (ADS)

    Sinha, A.; Shukla, A.; Saha, L.; Acharya, B. S.; Anupama, G. C.; Bhattacharjee, P.; Britto, R. J.; Chitnis, V. R.; Prabhu, T. P.; Singh, B. B.; Vishwanath, P. R.

    2016-06-01

    Context. The HAGAR Telescope Array at Hanle, Ladakh has been regularly monitoring the nearby blazar Mkn 421 for the past seven years. Aims: Blazars show flux variability in all timescales across the electromagnetic spectrum. While there is abundant literature characterizing the short-term flares from different blazars, comparatively little work has been carried out to study the long-term variability. We aim to study the long-term temporal and spectral variability in the radiation from Mkn 421 during 2009-2015. Methods: We quantify the variability and lognormality from the radio to very high-energy (VHE) bands, and compute the correlations between various wavebands using the z-transformed discrete correlation function. We construct the spectral energy distribution (SED) contemporaneous with HAGAR observation seasons and fit this SED with a one-zone synchrotron self-Compton model to study the spectral variability. Results: The flux is found to be highly variable across all timescales. The variability is energy dependant and is maximum in the X-ray and VHE bands. A strong correlation is found between the Fermi-LAT (gamma) and radio bands and between Fermi-LAT and optical, but no correlation is found between Fermi-LAT and X-ray. Lognormality in the flux distribution is clearly detected. This is the third blazar, following BL Lac and PKS 2155+304 to show this behaviour. The SED can be well fit by a one-zone SSC model, and variations in the flux states can be attributed mainly to changes in the particle distribution. A strong correlation is seen between the break energy γb of the particle spectrum and the total bolometric luminosity.

  20. Effects of long-term greywater disposal on soil: A case study.

    PubMed

    Siggins, Alma; Burton, Vanessa; Ross, Craig; Lowe, Hamish; Horswell, Jacqui

    2016-07-01

    This study investigated the environmental health risks to soil and potential risks to groundwater associated with long term (8-18years) greywater disposal practices. Land application of greywater is likely to have environmental impacts, which may be positive or negative. Greywater can contain plant macronutrients that may benefit plant growth. Conversely, high levels of surfactants, oils, grease, sodium and potentially pathogenic organisms may negatively impact environmental and human health. In this study, land disposal of untreated greywater was practiced at five coastal domestic properties. At each property, soil samples were collected at two depths from areas used for greywater disposal and from control areas that were not exposed to greywater. Soils were analysed for chemical and biological responses to greywater exposure. Generally, greywater irrigated soils had higher pH, Olsen P, base saturation, and increased soil microbial activity (as measured by biomass carbon, basal respiration and dehydrogenase activity). A pH of >9 was recorded for some greywater treated soil samples. Escherichia coli (E. coli) were detected at up to 10(3)MPN/g in the greywater exposed surface soils at some sites. Terminal Restriction Fragment Length Polymorphism (TRFLP) analysis revealed that greywater affected the soil microbial community structure, which may have implications for soil health and fertility. Overall, this study shows that the long-term application of greywater at the investigated sites had a moderate impact on the soil environment. This may have been due to the sandy soils and high rainfall that would flush the soil. Increases in microbial biomass and dehydrogenase indicate that greywater application may be beneficial for plant growth. However, high levels of E. coli in some soils may be a risk to human health and sub-surface irrigation should be the recommended application method. PMID:27037884

  1. Long-term musculoskeletal morbidity after adult burn injury: a population-based cohort study

    PubMed Central

    Randall, Sean M; Fear, Mark W; Wood, Fiona M; Rea, Suzanne; Boyd, James H; Duke, Janine M

    2015-01-01

    Objective To investigate if adults who are hospitalised for a burn injury have increased long-term hospital use for musculoskeletal diseases. Design A population-based retrospective cohort study using linked administrative health data from the Western Australian Data Linkage System. Subjects Records of 17 753 persons aged at least 20 years when hospitalised for a first burn injury in Western Australia during the period 1980–2012, and 70 758 persons who were age and gender-frequency matched with no injury admissions randomly selected from Western Australia's electoral roll. Main outcome measures Admission rates and cumulative length of stay for musculoskeletal diseases. Negative binomial and Cox proportional hazards regression modelling were used to generate incidence rate ratios (IRR) and HRs with 95% CIs, respectively. Results After adjustment for pre-existing health status and demographic characteristics, the burn cohort had almost twice the hospitalisation rate for a musculoskeletal condition (IRR, 95% CI 1.98, 1.86 to 2.10), and spent 3.70 times as long in hospital with a musculoskeletal diagnosis (95% CI 3.10 to 4.42) over the 33-year period, than the uninjured comparison cohort. Adjusted survival analyses of incident post-burn musculoskeletal disease admissions found significant increases for the 15-year post burn discharge period (0–6 months: HR, 95% CI 2.51, 2.04 to 3.11; 6 months–2 years: HR, 95% CI 1.77, 1.53 to 2.05; 2–15 years: HR, 95% CI 1.32, 1.23 to 1.42). Incident admission rates were significantly elevated for 20 years post-burn for minor and severe burn injury for a range of musculoskeletal diseases that included arthropathies, dorsopathies, osteopathies and soft tissue disorders. Conclusions Minor and severe burn injuries were associated with significantly increased post-burn incident admission rates, long-term hospital use and prolonged length of stay for a range of musculoskeletal diseases. Further research is required

  2. Confiding About Problems in Marriage and Long-Term Committed Relationships: A National Study.

    PubMed

    Lind Seal, Kirsten; Doherty, William J; Harris, Steven M

    2016-07-01

    This study examined confiding patterns in a national sample of 1000 U.S. adults aged 25-70 to inform the development of an educational program for confidants, called Marital First Responders. Results showed that 73% of U.S. adults have been a confidant to someone with a problem in a marriage or long-term committed relationship. The most common confiding relationship was between friends, followed by siblings. Confidants reported a wide range of problems brought to them, ranging from everyday complaints to serious issues such as infidelity and divorce. Confiders identified the most and least helpful responses. Findings suggest that naturally occurring confiding relationships have considerable potential to be the first level of help for troubled couple relationships. PMID:26201911

  3. [Karyological study of a long-term cell culture of calf kidney].

    PubMed

    Ignatova, M; Karadzhov, I

    1982-01-01

    Studied was the karyologic type of a long-term calf kidney cell culture. The optimal conditions were found for the preparation of good metaphase plaques of such cell culture, with clearly visible chromosomes. The changes in the chromosomes, setting in at the level of the 1st, 10th, 20th, and 27th passage were followed up. While the chromosomes in the first passage did not show any visible changes (with the exception of the 3rd chromosome where the presence of satelites was found), these underwent structural changes that started in the tenth passage, reached their peak in the twentieth passage, and receded later on. The most frequently encountered structural changes were the isochromosome gaps, dicentric configurations, acentric fragments, and polyploidy that appeared at the level of the 27th passage in four out of the twenty metaphase plaques. Discussed is the importance of the structural changes found. PMID:7168141

  4. Long term study of solar wind proton dynamics near 67P/Churyumov-Gerasimenko

    NASA Astrophysics Data System (ADS)

    Behar, Etienne; Nilsson, Hans; Steinberg Wieser, Gabriella

    2016-04-01

    The Rosetta mission has been escorting comet 67P/Churyumov-Gerasimenko since early August 2014, spanning heliocentric distances from 3.65AU to 1.24AU (the comet perihelion, reached on August 2015). Data presented here were collected during this phase: as the heliocentric distance decreases with time, the nucleus activity increases, and the interaction between the solar wind and the atmosphere of 67P evolves and becomes more complex. At low activity, the partially ionized coma is permeated by the solar wind. It adds mass to this plasma flow, which in turn is slowed down and deflected. As coma densities get gradually higher, this mass loading phenomenon intensifies, to the point where the solar wind is not observed anymore in the inner region of the coma. We present a long term study of the solar wind protons, focusing on their deflection and plasma parameters.

  5. The involvement of long-term serial-order memory in reading development: A longitudinal study.

    PubMed

    Bogaerts, Louisa; Szmalec, Arnaud; De Maeyer, Marjolijn; Page, Mike P A; Duyck, Wouter

    2016-05-01

    Recent findings suggest that Hebb repetition learning-a paradigmatic example of long-term serial-order learning-is impaired in adults with dyslexia. The current study further investigated the link between serial-order learning and reading using a longitudinal developmental design. With this aim, verbal and visual Hebb repetition learning performance and reading skills were assessed in 96 Dutch-speaking children who we followed from first through second grade of primary school. We observed a positive association between order learning capacities and reading ability as well as weaker Hebb learning performance in early readers with poor reading skills even at the onset of reading instruction. Hebb learning further predicted individual differences in later (nonword) reading skills. Finally, Hebb learning was shown to explain a significant part of the variance in reading performance above and beyond phonological awareness. These findings highlight the role of serial-order memory in reading ability. PMID:26835842

  6. Long-Term Outcome of Pyogenic Vertebral Osteomyelitis: A Cohort Study of 260 Patients

    PubMed Central

    Gupta, Arjun; Kowalski, Todd J.; Osmon, Douglas R.; Enzler, Mark; Steckelberg, James M.; Huddleston, Paul M.; Nassr, Ahmad; Mandrekar, Jayawant M.; Berbari, Elie F.

    2014-01-01

    Background  The long-term outcome of patients with pyogenic vertebral osteomyelitis (PVO) has not been fully assessed. Methods  We conducted a retrospective cohort study to describe the long-term outcome of PVO and to assess risk factors for treatment failure in patients evaluated at our institution between 1994 and 2002. Patients were observed until July 1, 2013. Results  Two hundred sixty patients with PVO were included in this study. Twenty-seven percent (70) of patients developed their infection after an invasive spinal procedure. Staphylococcus aureus accounted for 40% (103) of infections. Forty-nine percent (128) of patients underwent spinal surgery as part of their initial therapy. The median duration of parenteral antimicrobial therapy was 42 days (interquartile range, 38–53). The estimated 2-, 5-, and 10-year cumulative probability of treatment failure-free survival was 72%, 69%, and 69%, respectively. Seventy-five percent of patients who developed treatment failure did so within 4.7 months of diagnosis. Residual neurological defects and persistent back pain were seen in 16% and 32% of patients, respectively. In a multivariate analysis, longer duration of symptoms before diagnosis and having an infection with S. aureus were associated with increased risk of treatment failure. Conclusions  Increasing duration of symptoms and infection with S. aureus were associated with treatment failure in patients with PVO. Most treatment failures occurred early after initiation of treatment. Pyogenic vertebral osteomyelitis is associated with a high 2-year failure rate. Persistent neurological deficits and back pain are common after therapy. PMID:25734175

  7. Fitness predicts long-term survival after a cardiovascular event: a prospective cohort study

    PubMed Central

    Barons, Martine J; Turner, Sally; Parsons, Nicholas; Griffiths, Frances; Bethell, Hugh; Weich, Scott; Thorogood, Margaret

    2015-01-01

    Objectives To identify the role of fitness, fitness change, body mass index and other factors in predicting long-term (>5 years) survival in patients with coronary heart disease. Design Cohort study of patients with coronary heart disease recruited from 1 January 1993 to 31 December 2002, followed up to March 2011 (1 day to 18 years 3 months, mean 10.7 years). Setting A community-based National Health Service (NHS) cardiac rehabilitation programme serving the Basingstoke and Alton area in Hampshire, UK. Participants An unselected cohort of NHS patients, 2167 men and 547 women aged 28–88 years, who attended the rehabilitation programme following acute myocardial infarction, an episode of angina or revascularisation, and had a baseline fitness test. Main outcome measures Cardiovascular mortality and all-cause mortality. Results A high level of fitness (VO2≥22 mL/kg/min for men, VO2≥19 mL/kg/min for women) at completion of the programme was associated with decreased all-cause death, as was a prescription for statins or aspirin, and female gender. Increase in all-cause mortality was associated with higher age and ACE inhibitors prescription. Higher risk of cardiovascular mortality was associated with increasing age, prescriptions for ACE inhibitor, and diagnosis of myocardial infarction or angina as compared with the other diagnoses. Conclusions Prior fitness and fitness improvement are strong predictors of long-term survival in patients who have experienced a cardiac event or procedure. Some secondary prevention medications make a significant contribution to reducing all-cause mortality and cardiovascular mortality in these patients. This study supports public health messages promoting fitness for life. PMID:26493455

  8. Homeopathic medical practice: Long-term results of a cohort study with 3981 patients

    PubMed Central

    Witt, Claudia M; Lüdtke, Rainer; Baur, Roland; Willich, Stefan N

    2005-01-01

    Background On the range of diagnoses, course of treatment, and long-term outcome in patients who chose to receive homeopathic medical treatment very little is known. We investigated homeopathic practice in an industrialized country under everyday conditions. Methods In a prospective, multicentre cohort study with 103 primary care practices with additional specialisation in homeopathy in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: Patient and physician assessments (numeric rating scales from 0 to 10) and quality of life at baseline, and after 3, 12, and 24 months. Results A total of 3,981 patients were studied including 2,851 adults (29% men, mean age 42.5 ± 13.1 years; 71% women, 39.9 ± 12.4 years) and 1,130 children (52% boys, 6.5 ± 3.9 years; 48% girls, 7.0 ± 4.3 years). Ninety-seven percent of all diagnoses were chronic with an average duration of 8.8 ± 8 years. The most frequent diagnoses were allergic rhinitis in men, headache in women, and atopic dermatitis in children. Disease severity decreased significantly (p < 0.001) between baseline and 24 months (adults from 6.2 ± 1.7 to 3.0 ± 2.2; children from 6.1 ± 1.8 to 2.2 ± 1.9). Physicians' assessments yielded similar results. For adults and young children, major improvements were observed for quality of life, whereas no changes were seen in adolescents. Younger age and more severe disease at baseline were factors predictive of better therapeutic success. Conclusion Disease severity and quality of life demonstrated marked and sustained improvements following homeopathic treatment period. Our findings indicate that homeopathic medical therapy may play a beneficial role in the long-term care of patients with chronic diseases. PMID:16266440

  9. Long-Term Tracking of Physical Activity Behaviors in Women: The WIN Study

    PubMed Central

    Morrow, James R.; Bain, Tyson M.; Frierson, Georita M.; Trudelle-Jackson, Elaine; Haskell, William L.

    2010-01-01

    Purpose Interest lies in the prevalence of community-living women meeting 2008 Department of Health and Human Services physical activity guidelines across time. The purpose was to report prevalence and stability of long-term (up to 125 weeks) tracking of physical activity behaviors and compare self-reported physical activity behaviors using different measures. Methods The WIN study tracks nearly real-time physical activity behaviors in community-living women. At baseline, 918 women began weekly Internet reporting of physical activity behaviors, accessing a secure Internet site and answering 8 questions about physical activity behaviors for the previous week. Measures included days and minutes of moderate, vigorous, walking, and strengthening activities, and pedometer steps recorded weekly. Results Prevalence of meeting physical activity guidelines depended on the criterion used. Weekly averages across the surveillance period indicated 25% reported ≥150 mins of moderate physical activity, 47% reported ≥75 mins of vigorous physical activity, 57% reported ≥150 mins of moderate-to-vigorous physical activity, 63% conducted ≥500 MET-mins of physical activity, 15% reported ≥2 days of strengthening activities per week, and 39% reported ≥7500 steps per week. Alpha coefficients (≥.97) indicated stable physical activity behaviors across all measures. Conclusion Across reporting methods, it is estimated that approximately 50% or more of these community-living women engage in sufficient physical activity for health benefits weekly across long-term follow-up. Self-report physical activity behaviors are stable across long periods in these community-living women not participating in a specific physical activity intervention. PMID:20473221

  10. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study

    PubMed Central

    Noble, Simon; Lewis, Rhian; Whithers, Jodie; Lewis, Sarah; Bennett, Paul

    2014-01-01

    Objective To explore the psychological consequences of experiencing symptomatic pulmonary embolism (PE). Design Qualitative interview-based study using interpretative phenomenological analysis. Setting Outpatients who attended an anticoagulation clinic in a district general hospital. Participants Patients attending an anticoagulation clinic following hospital admission for symptomatic PE were approached to participate. A total of 9 (4 women, 5 men) of 11 patients approached agreed to be interviewed. Participants were aged between 26 and 72 years and had previously experienced a PE between 9 and 60 months (median=26 months, mean=24 months). Intervention Audiotaped semistructured qualitative interviews were undertaken to explore participants experiences of having a PE and how it had affected their lives since. Data were transcribed and analysed using interpretative phenomenological analysis to identify emergent themes. Results Three major themes with associated subthemes were identified. Participants described having a PE as a life-changing experience comprising initial shock, followed by feeling of loss of self, life-changing decisions and behaviour modification. Features of post-traumatic stress disorder (PTSD) were described with flashbacks, hypervigilance and intrusive thoughts being most prevalent. Participants identified several areas of support needed for such patients including easier access to support through information giving and emotional support. Conclusions Long-term consequences of venous thromboembolism go beyond the physical alone. Patients describe experiencing symptomatic PE to be a life-changing distressing event leading to behaviour modification and in some PTSD. It is likely that earlier psychological intervention may reduce such long-term sequelae. PMID:24694625

  11. Long-Term Health Effects of Atom Bomb on Japan Not as Bad as Feared: Study

    MedlinePlus

    ... News) -- The long-term health effects of the atomic bombs dropped on the Japanese cities of Hiroshima and ... should not cause complacency about the threat of nuclear weapons and nuclear accidents. The meltdowns that occurred in ...

  12. Study of advanced techniques for determining the long term performance of components

    NASA Technical Reports Server (NTRS)

    1973-01-01

    The application of existing and new technology to the problem of determining the long-term performance capability of liquid rocket propulsion feed systems is discussed. The long term performance of metal to metal valve seats in a liquid propellant fuel system is stressed. The approaches taken in conducting the analysis are: (1) advancing the technology of characterizing components through the development of new or more sensitive techniques and (2) improving the understanding of the physical of degradation.

  13. 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

  14. Emulsified halothane produces long-term epidural anesthetic effect: a study in rabbits

    PubMed Central

    Li, Fengshan; Liao, Daqing; Liu, Jin; Xiao, Lin; Guo, Jiao; Yi, Mingliang; Zhou, Cheng

    2015-01-01

    Previous studies have demonstrated that volatile anesthetics could produce local anesthesia. Emulsified isoflurane at 8% has been reported to produce epidural anesthetic effect in rabbits. This study was designed to investigate the long-term epidural anesthetic effect of emulsified halothane in rabbits. In this study, 40 healthy adult rabbits (weighting 2.0-2.5 kg) with an epidural catheter were randomly divided into 4 groups (n=10/group), receiving epidural administration of 1% lidocaine (lido group), 8% emulsified isoflurane 1ml (8% E-iso group), 8% emulsified halothane (8% E-Halo group) and 12% emulsified halothane (12% E-Halo group). After administration, sensory and motor functions as well as consciousness state were assessed until 60 minutes after sensory and motor function returned to its baseline or at least for 180 min. After epidural anesthesia, all the rabbits were continuously observed for 7 days and sacrificed for pathological evaluations. As a result, all the four study solutions produced typical epidural anesthesia. Onset times of sensory and motor function blockade were similar among the four groups (P>0.05). Duration of sensory blockade in 12% E-Halo group (83±13 min) was significantly longer than other groups: 51±12 min in 8% E-Halo group (P<0.01), 57±8 min in 8% E-iso group (P<0.01) and 47±9 min in lido group (P<0.01). Duration of sensory blockade in 8% E-iso group is longer than lido group (P<0.05). Duration of motor blockade in 12% E-Halo group (81±12 min) was also significantly longer than other groups: 40±8 min in 8% E-Halo group (P<0.01), 37±3 min in 8% E-iso group (P<0.01), 37±6 min in lido group (P<0.01). Normal consciousness was found in the rabbits from 8% E-Halo, 8% E-iso and lido groups while there were four rabbits in 12% E-Halo group (4/10) showed a light sedation. For all the rabbits, no pathological injury was found. The present study demonstrates that emulsified halothane produces reversible concentration

  15. Methane seepage and gas hydrates: The need for multidisciplinary and long-term methane flux studies

    NASA Astrophysics Data System (ADS)

    Greinert, J.

    2012-12-01

    Methane seepage and gas hydrates started to receive more interest in the marine science community in the early 80s; exploratory studies followed, which were often hampered by the limited technical capabilities when compared to modern technologies that are available today (e.g. ROVs, high resolution 3D seismic, pressurized coring). General research topics have changed from curiosity-driven 'what is out there' towards gaining a detailed understanding of microbial processes in the sediment and geophysical quantifications of gas hydrates in their different locations around the world. Environmental questions fueled by the 'clathrate gun hypothesis' and the possible future impact of decomposing gas hydrates on atmospheric methane concentrations became research topics for a number of scientists, whereas others are researching gas hydrates and its potential use as an energy resource coupled with CO2-sequestering. Today the general phenomenon of gas hydrate related seepage and the biogeochemical processes involved are well understood. Large uncertainties still exist with regard to large-scale methane flux extrapolations from the seafloor through the water column and into the atmosphere, mainly due to lack of multidisciplinary and long-term observations . Studying the temporal variability of fluid and bubble release from the seafloor in high spatial and temporal resolution still does not do away with the problem of how to extrapolate such local flux measurements, considering tidal, seasonal changes, let alone changes on a longer time scale (glacial/interglacial). Examples provided from studies in the Pacific, the Black Sea and North Sea as well as from offshore Svalbard will highlight the temporal variability of bubble release, the impact of environmental parameters on this release and biogeochemical processes related to methane oxidation and production in the water column. Although the assumption is true that bubble release from deeper than 100m water depth will not

  16. Lignin fate in soils studied at the long-term experimental field of "Les Closeaux" (France)

    NASA Astrophysics Data System (ADS)

    Dignac, M.-F.; Thevenot, M.; Bahri, H.; Rasse, D. P.; Rumpel, C.

    2009-04-01

    Lignins are one of the most abundant plant molecules in soils and are considered as having a great impact on the soil organic matter (SOM) content and fate. However, the dynamics and turnover of lignins in soils are not clear on the long-term basis. Some studies suggest that lignins turnover could be faster than that of the bulk SOM (Lobe et al., 2002; Dignac et al., 2005), whereas other studies suggest the opposite (Hoffman et al., 2009). The lignin fate in soils and their role in the SOM dynamics require further elucidation. To this end, a long-term study based on a wheat-maize transition chronosequence was set up in 1993, at the "Les Closeaux" experimental field in Versailles (France). In this field the C3 to C4 vegetation change makes it possible to use stable isotopes to study bulk and molecular SOM turnover. The influence of maize cropping on lignin and SOM dynamics was studied using the CuO oxidation and chromatographic methods coupled with isotopic measurements. Based on this experimental setup and methodology, we calculated a lignin turnover of 47% over a 9-year period, when 9% of the bulk soil organic matter had turned over. Moreover, we showed (Bahri et al., 2006) that the turnover of lignins is monomer specific. A simple two-pool model calibrated on the lignin-specific 13C isotopic analyses was developed to quantify the lignin turnover rates (Rasse et al., 2006). The first results obtained suggest that only 8% of the lignins applied to the soil is retained, the mechanisms of stabilization being to be elucidated. The "Les Closeaux" experimental field has already furnished much information on lignin fate in soils and will be used in the future to elucidate further the processes of lignin degradation in soil. Bahri H., Dignac M.-F., Rumpel C., Rasse D.P., Chenu C., Mariotti A., 2006. Soil Biology & Biochemistry 38, 1977-1988. Dignac M.-F, Bahri H., Rumpel C., Rasse D.P., Bardoux G., Balesdent J., Girardin C., Chenu C., Mariotti A., 2005. Geoderma 128, 3

  17. Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection.

    PubMed

    Oo, Khin May; Lwin, Aye Aye; Kyaw, Yi Yi; Tun, Win Maw; Fukada, Kazutake; Goshima, Akiko; Shimada, Takashi; Okada, Shigeru

    2016-01-01

    A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects. PMID:27508113

  18. Safety and long-term effect of the probiotic FK-23 in patients with hepatitis C virus infection

    PubMed Central

    OO, Khin May; LWIN, Aye Aye; KYAW, Yi Yi; TUN, Win Maw; FUKADA, Kazutake; GOSHIMA, Akiko; SHIMADA, Takashi; OKADA, Shigeru

    2016-01-01

    A clinical trial was conducted on 39 adult HCV-positive subjects to determine the safety and long-term effect of the probiotic FK-23 (heat-treated Enterococcus faecalis strain FK-23). Asymptomatic anti-HCV positive adults who fulfilled the selection criteria and gave voluntary consent were recruited from attendees of the Hepatitis Carrier Clinic, Department of Medical Research (Lower Myanmar). Each subject was given 2,700 mg of FK-23 per day by oral route. Blood samples were taken at enrollment and every 3 months and tested for alanine aminotransferase (ALT) and aspartate transaminase (AST). Viral load, urea, total protein, hemoglobin and platelet count were determined every 6 months. Among the subjects, 23 completed 36 months, 31 completed 24 months, 35 completed 12 months and 37 completed 6 months of probiotic therapy. Significant decreases in mean ALT levels were observed at 3 months (34. 9 ± 15.1 IU/l) as compared with the initial level (64.8 ± 17.5 IU/l) and persisted up to 36 months (43.7 ± 25.2 IU/l). Decrease of AST was detected after 9 months (46.2 ± 21.7 IU/l) of probiotic therapy as compared with the initial level (64.3 ± 28.7 IU/l). FK-23 was safe based on the stable levels of biochemical and hematological parameters and the absence of untoward side effects. The FK-23 preparation was well tolerated and accepted by the subjects.

  19. Long-term aerosol study on continental scale through EARLINET vertical profiles

    NASA Astrophysics Data System (ADS)

    Mona, Lucia; Pappalardo, Gelsomina; Linne, Holger; Wandinger, Ulla

    2015-04-01

    Lidar techniques offer the opportunity for investigating the aerosol vertical profiles, which is an important information for climatological, meteorological and air quality issues. EARLINET (European Aerosol Research Lidar Network) has been providing aerosol optical properties vertical profiles over Europe since May 2000. Long-term aerosol observations performed within EARLINET allows a climatological study of aerosol properties over Europe. All EARLINET stations perform almost simultaneously measurements three times per week following a scheduling established in 2000. Besides these climatological measurements, additional measurements are performed in order to monitor special events (as volcanic eruptions and desert dust intrusion), for satellite data evaluation and integrated studies and during intensive measurements campaigns. Aerosol optical properties vertical profiles are freely available at www.earlinet.org and through ACRIS data center http://www.actris.net/. This data are currently published on the CERA database with an associated doi number. Based mainly on Raman technique, EARLINET stations typically provide direct measurement of extinction profiles, and therefore of the aerosol optical depth (AOD), a key parameter for understanding the aerosol role on radiation budget. The free troposphere contribution to AOD and altitude of lofted layers are provided thanks to the vertical profiling capability of lidar technique. The representativeness of EARLINET regular scheduling for climatological studies is investigating through the comparison with AERONET and MODIS measurements. We find that the regular measurements schedule is typically sufficient for climatological studies. In addition lidar punctual measurements are representative for a larger area (1°x1°) in a climatological sense. Long term analysis of EARLINET profiles shows that the AOD in generally decreasing over Europe in agreement with both passive-sensors and in situ measurements. Mean vertical

  20. Long-term safety and tolerability of donepezil 23 mg in patients with moderate to severe Alzheimer’s disease

    PubMed Central

    2012-01-01

    Background Donepezil (23 mg/day) is approved by the US Food and Drug Administration for the treatment of patients with moderate to severe Alzheimer’s disease (AD). Approval was based on results from a 24-week, randomized, double-blind study of patients who were stable on donepezil 10 mg/day and randomized 2:1 to either increase their donepezil dose to 23 mg/day or continue taking 10 mg/day. The objective of this study was to assess the long-term safety and tolerability of donepezil 23 mg/day in patients with moderate to severe AD. Methods Patients who completed the double-blind study and were eligible could enroll into a 12-month extension study of open-label donepezil 23 mg/day. Clinic visits took place at open-label baseline and at months 3, 6, 9, and 12. Safety analyses comprised examination of the incidence, severity, and timing of treatment-emergent adverse events (AEs); changes in weight, electrocardiogram, vital signs, and laboratory parameters; and discontinuation due to AEs. Results 915 double-blind study completers were enrolled in the open-label extension study and 902 comprised the safety population. Mean treatment duration in this study was 10.3 ± 3.5 months. In total, 674 patients (74.7%) reported at least one AE; in 320 of these patients (47.5%) at least one AE was considered to be possibly or probably study drug related. The majority of patients reporting AEs (81.9%) had AEs of mild or moderate severity. There were 268 patients (29.7%) who discontinued early, of which 123 (13.6%) were due to AEs. Patients increasing donepezil dose from 10 mg/day in the double-blind study to 23 mg/day in the extension study had slightly higher rates of AEs and SAEs than patients who were already receiving 23 mg (78.0% and 16.9% vs 72.8% and 14.0%, respectively). The incidence of new AEs declined rapidly after the first 2 weeks and remained low throughout the duration of the study. Conclusion This study shows that long-term treatment with

  1. Long term variation study of the Sun from kodaikanal Digitised data

    NASA Astrophysics Data System (ADS)

    Banerjee, Dipankar; Ravindra, B.; Chatterjee, Subhamoy

    2016-07-01

    The century long (1907-2007) CaK spectroheliograms from Kodaikanal Solar Observatory (KSO) were calibrated, processed and analysed to study the the evolution plages, a possible representative of magnetic activity on the Sun. This has been the longest dataset studied in CaK till date covering about 9.5 cycles of 11 year periods. Plages were segmented with area > 1 arcmin2 using global thresholds for individual full disc images and subsequent application of morphological closing. Plage index was calculated and seen to have close positive correlation with fractional plage area. Obtained plage area cycle was compared with the same from Mount Wilson observatory (Correlation 94:7%) for the overlapping period 1915-2000. Study illustrated time-latitude distribution of plage centroids rendering Butterfly diagram (as observed for sunspots) and its 3D visualization combining the individual plage areas. This study further delineated positional correlation between magnetic patches and plage regions through comparison of synoptic maps derived from both Kodaikanal CaK images and space based full disc LOS (line of sight) magnetograms. Magnetograms from ground based observatories being available after 1950, this long term CaK data from KSO can be used as a proxy for estimating magnetic activity locations and their strengths at earlier times.

  2. Long-Term Disease Dynamics for a Specialized Parasite of Ant Societies: A Field Study

    PubMed Central

    Loreto, Raquel G.; Elliot, Simon L.; Freitas, Mayara L. R.; Pereira, Thairine M.; Hughes, David P.

    2014-01-01

    Many studies have investigated how social insects behave when a parasite is introduced into their colonies. These studies have been conducted in the laboratory, and we still have a limited understanding of the dynamics of ant-parasite interactions under natural conditions. Here we consider a specialized parasite of ant societies (Ophiocordyceps camponoti-rufipedis infecting Camponotus rufipes) within a rainforest. We first established that the parasite is unable to develop to transmission stage when introduced within the host nest. Secondly, we surveyed all colonies in the studied area and recorded 100% prevalence at the colony level (all colonies were infected). Finally, we conducted a long-term detailed census of parasite pressure, by mapping the position of infected dead ants and foraging trails (future hosts) in the immediate vicinity of the colonies over 20 months. We report new dead infected ants for all the months we conducted the census – at an average of 14.5 cadavers/month/colony. Based on the low infection rate, the absence of colony collapse or complete recovery of the colonies, we suggest that this parasite represents a chronic infection in the ant societies. We also proposed a “terminal host model of transmission” that links the age-related polyethism to the persistence of a parasitic infection. PMID:25133749

  3. Long-term corrosion study at nuclear power plant Bohunice (Slovakia)

    NASA Astrophysics Data System (ADS)

    Slugen, V.; Lipka, J.; Dekan, J.; Tóth, I.; Smieško, I.

    2010-03-01

    Steam generators of four VVER-440 units at nuclear power plants V-1 and V-2 in Jaslovske Bohunice (Slovakia) were gradually changed by new original "Bohunice" design in period 1994-1998. Corrosion processes before and after these design and material changes in Bohunice secondary circuit were studied using Mössbauer spectroscopy during last 25 years. Innovations in the feed water pipeline design as well as material composition improvements were evaluated positively. Mössbauer spectroscopy studies of phase composition of corrosion products were performed on real specimens scrapped from water pipelines or in form of filter deposits. The corrosion of new feed water pipelines system (from austenitic steel) in combination to innovated operation regimes goes dominantly to magnetite. The hematite presence is mostly on the internal surface of steam generator body and its concentration increases towards the top of the body. In the results interpretation it is necessary to consider also erosion as well as scope and type of maintenance activities. The long-term study of phase composition of corrosion products at VVER reactors is one of precondition for the safe operation over the projected NPP lifetime.

  4. The Study on Long-Term Toxicity of D-Psicose in Rats

    PubMed Central

    Yagi, Kanako; Matsuo, Tatsuhiro

    2009-01-01

    D-Psicose is a rare sugar present in small quantities in natural products. In a previous study, we showed that D-psicose suppresses plasma glucose increases and reduces body fat accumulation in rats. Based on acute toxicity testing in rats, D-psicose is classified as an ordinary substance (LD50 = 16 g/kg). Elucidating the effects of long term feeding of D-psicose in rats will be essential prior to its utilization as a physiologically functional food. In this study, male Wistar rats (3 weeks old) were fed diets containing 3% D-psicose or sucrose for 12–18 months. The rats actually ingested 1.28 g/kg body weight per day D-psicose or 1.22 g/kg body weight per day of sucrose. Body weight gain and intra-abdominal adipose tissue weight in rats fed the D-psicose diet for 18 months were significantly lower than those in rats fed the sucrose diet. Relative weights of liver and kidney were significantly higher in the D-psicose group than in the sucrose group. However, no gross pathological findings were evident at dietary doses of 3% D-psicose or correlated with hypertrophy of liver and kidney. No clinical chemical test value was suggestive of overt D-psicose treatment-related toxicity. Therefore, the present study found no adverse effects at 3% D-psicose in the diet. PMID:19902016

  5. Long term peatland subsidence: Experimental study and modeling scenarios in the Venice coastland

    NASA Astrophysics Data System (ADS)

    Zanello, Francesca; Teatini, Pietro; Putti, Mario; Gambolati, Giuseppe

    2011-12-01

    Land subsidence in drained cultivated peatlands is responsible for a number of serious environmental concerns and economical problems at both the local and the global scale. In low-lying coastal areas it enhances the risk of flooding, the saltwater contamination of shallow aquifers, and the maintenance costs of the systems that help keep the farmland drained. Since the subsidence is a major consequence of the bio-oxidation of the soil organic fraction in the upper aerated zone, cropped peatlands in temperate and tropic regions are important sources of CO2 into the atmosphere. A 4-year long experimental study has been performed in a drained peatland located south of the Venice Lagoon, Italy, to help calibrate a land subsidence model developed to predict the expected behavior of the ground surface elevation. Continuous monitoring of the hydrological regime and land displacements shows that the vertical movement of the peat surface consists of the superimposition of daily/seasonal time-scale reversible deformations related to soil moisture, depth to the water table, and temperature fluctuations, and long term irreversible subsidence due to peat oxidation. A novel two-step modeling approach to separate the two contributions from the available observations is presented. First, the elastic component is computed by integrating the peat vertical deformations evaluated by a constitutive relationship describing the porosity variation with the moisture content and pore pressure changes implemented into a variably saturated flow equation-based numerical code. The observed trend is then filtered from the computed reversible displacement and is used to calibrate an empirical relationship relating land subsidence rate to drainage depth and soil temperature. The results show that in recent years the subsidence rate ranged from 3 to 15 mm a-1. The large variability is due to the different climate conditions underlying the monitoring period, in particular a wet 2002 and a very dry

  6. Long-Term Structural and Functional Myocardial Adaptations in Healthy Living Kidney Donors: A Pilot Study

    PubMed Central

    Bellavia, Diego; Cataliotti, Alessandro; Clemenza, Francesco; Baravoglia, Cesar Hernandez; Luca, Angelo; Traina, Marcello; Gridelli, Bruno; Bertani, Tullio; Burnett, John C.; Scardulla, Cesare

    2015-01-01

    Background and Aims Compensatory renal hypertrophy following unilateral nephrectomy (UNX) occurs in the remaining kidney. However, the long-term cardiac adaptive process to UNX remains poorly defined in humans. Our goal was to characterize myocardial structure and function in living kidney donors (LKDs), approximately 12 years after UNX. Methods and Results Cardiac function and structure in 15 Italian LKDs, at least 5 years after UNX (median time from donation = 8.4 years) was investigated and compared to those of age and sex matched U.S. citizens healthy controls (n = 15). Standard and speckle tracking echocardiography (STE) was performed in both LKDs and controls. Plasma angiotensin II, aldosterone, atrial natriuretic peptide (ANP), N terminus pro B-type natriuretic peptide (NT-proBNP), cyclic guanylyl monophosphate (cGMP), and amino-terminal peptide of procollagen III (PIIINP) were also collected. Median follow-up was 11.9 years. In LKDs, LV geometry and function by STE were similar to controls, wall thickness and volumes were within normal limits also by CMR. In LKDs, CMR was negative for myocardial fibrosis, but apical rotation and LV torsion obtained by STE were impaired as compared to controls (21.4 ± 7.8 vs 32.7 ± 8.9 degrees, p = 0.04). Serum creatinine and PIIINP levels were increased [1.1 (0.9–1.3) mg/dL, and 5.8 (5.4–7.6)] μg/L, respectively), while urinary cGMP was reduced [270 (250–355) vs 581 (437–698) pmol/mL] in LKDs. No LKD developed cardiovascular or renal events during follow-up. Conclusions Long-term kidney donors have no apparent structural myocardial abnormalities as assessed by contrast enhanced CMR. However, myocardial deformation of the apical segments, as well as apical rotation, and LV torsion are reduced. The concomitant increase in circulating PIIINP level is suggestive of fibrosis. Further studies, focused on US and EU patients are warranted to evaluate whether these early functional modifications will progress to a more

  7. Long-Term Use of Everolimus in Patients with Tuberous Sclerosis Complex: Final Results from the EXIST-1 Study

    PubMed Central

    Franz, David N.; Belousova, Elena; Sparagana, Steven; Bebin, E. Martina; Frost, Michael D.; Kuperman, Rachel; Witt, Olaf; Kohrman, Michael H.; Flamini, J. Robert; Wu, Joyce Y.; Curatolo, Paolo; de Vries, Petrus J.; Berkowitz, Noah; Niolat, Julie; Jóźwiak, Sergiusz

    2016-01-01

    Background Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has demonstrated efficacy in treating subependymal giant cell astrocytomas (SEGAs) and other manifestations of tuberous sclerosis complex (TSC). However, long-term use of mTOR inhibitors might be necessary. This analysis explored long-term efficacy and safety of everolimus from the conclusion of the EXIST-1 study (NCT00789828). Methods and Findings EXIST-1 was an international, prospective, double-blind, placebo-controlled phase 3 trial examining everolimus in patients with new or growing TSC-related SEGA. After a double-blind core phase, all remaining patients could receive everolimus in a long-term, open-label extension. Everolimus was initiated at a dose (4.5 mg/m2/day) titrated to a target blood trough of 5–15 ng/mL. SEGA response rate (primary end point) was defined as the proportion of patients achieving confirmed ≥50% reduction in the sum volume of target SEGA lesions from baseline in the absence of worsening nontarget SEGA lesions, new target SEGA lesions, and new or worsening hydrocephalus. Of 111 patients (median age, 9.5 years) who received ≥1 dose of everolimus (median duration, 47.1 months), 57.7% (95% confidence interval [CI], 47.9–67.0) achieved SEGA response. Of 41 patients with target renal angiomyolipomas at baseline, 30 (73.2%) achieved renal angiomyolipoma response. In 105 patients with ≥1 skin lesion at baseline, skin lesion response rate was 58.1%. Incidence of adverse events (AEs) was comparable with that of previous reports, and occurrence of emergent AEs generally decreased over time. The most common AEs (≥30% incidence) suspected to be treatment-related were stomatitis (43.2%) and mouth ulceration (32.4%). Conclusions Everolimus use led to sustained reduction in tumor volume, and new responses were observed for SEGA and renal angiomyolipoma from the blinded core phase of the study. These findings support the hypothesis that everolimus can safely reverse

  8. Pectus excavatum; a clinical study with long term postoperavtive follow-up.

    PubMed

    Gyllenswärd, A; Irnell, L; Michaëlsson, M; Qvist, O; Sahlstedt, B

    1975-01-01

    There are divergent views about the harm that pectus excavatum and related chest deformities does to the respiratory and heart function. The indications for surgery and the optimal age for surgical intervention are debatable. In this study 37 operated and 38 nonoperated cases of about the same severity have been followed for more than ten years and examined after the age of 18 years. The examination included socio-economic, cosmetic and cardio-pulmonary function aspects. It could be shown that from the psychological aspect there were no significant differences between the operated and the non-operated cases. The tendency to contract bronchopneumonia is not influenced by operation. The physical working capacity was the same in the two groups. The operated cases have slightly lower pulmonary function values that the non-operated in spite of the fact that the non-operated group at the time of follow-up included the more seveee cases. Age at operation did not seem to be of any importance for the long-term results. The lower pulmonary function capacity in the operated cases is thought to be attributed to a restriction secondary to the operation. There are also indications that pectus excavatum tends to become less pronounced with increasing age. The study supports a restrictive attitude towards surgery. PMID:1058627

  9. The Seveso studies on early and long-term effects of dioxin exposure: a review.

    PubMed

    Bertazzi, P A; Bernucci, I; Brambilla, G; Consonni, D; Pesatori, A C

    1998-04-01

    The industrial accident that occurred in the town of Seveso, Italy, in 1976 exposed a large population to substantial amounts of relatively pure 2,3,7,8-tetrachlorodibenzo-p-dioxin. Extensive monitoring of soil levels and measurements of a limited number of human blood samples allowed classification of the exposed population into three categories, A (highest exposure), B (median exposure), and R (lowest exposure). Early health investigations including liver function, immune function, neurologic impairment, and reproductive effects yielded inconclusive results. Chloracne (nearly 200 cases with a definite exposure dependence) was the only effect established with certainty. Long-term studies were conducted using the large population living in the surrounding noncontaminated territory as reference. An excess mortality from cardiovascular and respiratory diseases was uncovered, possibly related to the psychosocial consequences of the accident in addition to the chemical contamination. An excess of diabetes cases was also found. Results of cancer incidence and mortality follow-up showed an increased occurrence of cancer of the gastrointestinal sites and of the lymphatic and hematopoietic tissue. Experimental and epidemiologic data as well as mechanistic knowledge support the hypothesis that the observed cancer excesses are associated with dioxin exposure. Results cannot be viewed as conclusive. The study is continuing in an attempt to overcome the existing limitations (few individual exposure data, short latency period, and small population size for certain cancer types) and to explore new research paths (e.g., differences in individual susceptibility). PMID:9599710

  10. Long-term live cell microscopy studies of lipid droplet fusion dynamics in adipocytes[S

    PubMed Central

    Jüngst, Christian; Klein, Matthias; Zumbusch, Andreas

    2013-01-01

    During the adipogenic differentiation process of mesenchymal stem cells, lipid droplets (LDs) grow slowly by transferring lipids between each other. Recent findings hint at the possibility that a fusion pore is involved. In this study, we analyze lipid transfer data obtained in long-term label-free microscopy studies in the framework of a Hagen-Poiseuille model. The data obtained show a LD fusion process in which the lipid transfer directionality depends on the size difference between LDs, whereas the respective rates depend on the size difference and additionally on the diameter of the smaller LDs. For the data analysis, the viscosity of the transferred material has to be known. We demonstrate that a viscosity-dependent molecular rotor dye can be used to measure LD viscosities in live cells. On this basis, we calculate the diameter of a putative lipid transfer channel which appears to have a direct dependence on the diameter of the smaller of the two participating LDs. PMID:24103784

  11. A comprehensive study of long-term skeletal changes after spinal cord injury in adult rats.

    PubMed

    Lin, Tiao; Tong, Wei; Chandra, Abhishek; Hsu, Shao-Yun; Jia, Haoruo; Zhu, Ji; Tseng, Wei-Ju; Levine, Michael A; Zhang, Yejia; Yan, Shi-Gui; Liu, X Sherry; Sun, Dongming; Young, Wise; Qin, Ling

    2015-01-01

    Spinal cord injury (SCI)-induced bone loss represents the most severe osteoporosis with no effective treatment. Past animal studies have focused primarily on long bones at the acute stage using adolescent rodents. To mimic chronic SCI in human patients, we performed a comprehensive analysis of long-term structural and mechanical changes in axial and appendicular bones in adult rats after SCI. In this experiment, 4-month-old Fischer 344 male rats received a clinically relevant T13 contusion injury. Sixteen weeks later, sublesional femurs, tibiae, and L4 vertebrae, supralesional humeri, and blood were collected from these rats and additional non-surgery rats for micro-computed tomography (µCT), micro-finite element, histology, and serum biochemical analyses. At trabecular sites, extreme losses of bone structure and mechanical competence were detected in the metaphysis of sublesional long bones after SCI, while the subchondral part of the same bones showed much milder damage. Marked reductions in bone mass and strength were also observed in sublesional L4 vertebrae but not in supralesional humeri. At cortical sites, SCI induced structural and strength damage in both sub- and supralesional long bones. These changes were accompanied by diminished osteoblast number and activity and increased osteoclast number and activity. Taken together, our study revealed site-specific effects of SCI on bone and demonstrated sustained inhibition of bone formation and elevation of bone resorption at the chronic stage of SCI. PMID:26528401

  12. Long-term study of coherent exchange over spruce forest using wavelet analysis

    NASA Astrophysics Data System (ADS)

    Thomas, C.; Foken, T.

    2003-04-01

    Turbulent time series obtained over tall vegetated surfaces consist of high frequent turbulent signal and additional low frequent ramp-like patterns. These ramp patterns are called coherent structures and show well-organized and regular presence during solar insolation. In the last decade coherent structures have been analyzed in turbulent signals mainly focussing on temperature and horizontal wind speed data of single events or short-term periods under varying stability regimes. These studies concluded that the exchange of energy and matter between tall vegetation and the surfacer layer through coherent structures significantly contribute to the overall budget of the stand. Wavelet analysis has recently been found a powerful and objective tool for detecting and characterizing the coherent exchange. The underlying new concept of this study aims to get information on the long-term behaviour of coherent structures through application of wavelet analysis and their contribution to the energy, carbon and water budget of a mid-european spruce forest. Particular attention is paid to possible origins of coherent motion due to wind shear and roughness changes, their typical length scales in space and time and the behaviour of stationarity and intermittency parameters during the presence of coherent exchange.

  13. The Seveso studies on early and long-term effects of dioxin exposure: a review.

    PubMed Central

    Bertazzi, P A; Bernucci, I; Brambilla, G; Consonni, D; Pesatori, A C

    1998-01-01

    The industrial accident that occurred in the town of Seveso, Italy, in 1976 exposed a large population to substantial amounts of relatively pure 2,3,7,8-tetrachlorodibenzo-p-dioxin. Extensive monitoring of soil levels and measurements of a limited number of human blood samples allowed classification of the exposed population into three categories, A (highest exposure), B (median exposure), and R (lowest exposure). Early health investigations including liver function, immune function, neurologic impairment, and reproductive effects yielded inconclusive results. Chloracne (nearly 200 cases with a definite exposure dependence) was the only effect established with certainty. Long-term studies were conducted using the large population living in the surrounding noncontaminated territory as reference. An excess mortality from cardiovascular and respiratory diseases was uncovered, possibly related to the psychosocial consequences of the accident in addition to the chemical contamination. An excess of diabetes cases was also found. Results of cancer incidence and mortality follow-up showed an increased occurrence of cancer of the gastrointestinal sites and of the lymphatic and hematopoietic tissue. Experimental and epidemiologic data as well as mechanistic knowledge support the hypothesis that the observed cancer excesses are associated with dioxin exposure. Results cannot be viewed as conclusive. The study is continuing in an attempt to overcome the existing limitations (few individual exposure data, short latency period, and small population size for certain cancer types) and to explore new research paths (e.g., differences in individual susceptibility). Images Figure 1 PMID:9599710

  14. A comprehensive study of long-term skeletal changes after spinal cord injury in adult rats

    PubMed Central

    Lin, Tiao; Tong, Wei; Chandra, Abhishek; Hsu, Shao-Yun; Jia, Haoruo; Zhu, Ji; Tseng, Wei-Ju; Levine, Michael A; Zhang, Yejia; Yan, Shi-Gui; Liu, X Sherry; Sun, Dongming; Young, Wise; Qin, Ling

    2015-01-01

    Spinal cord injury (SCI)-induced bone loss represents the most severe osteoporosis with no effective treatment. Past animal studies have focused primarily on long bones at the acute stage using adolescent rodents. To mimic chronic SCI in human patients, we performed a comprehensive analysis of long-term structural and mechanical changes in axial and appendicular bones in adult rats after SCI. In this experiment, 4-month-old Fischer 344 male rats received a clinically relevant T13 contusion injury. Sixteen weeks later, sublesional femurs, tibiae, and L4 vertebrae, supralesional humeri, and blood were collected from these rats and additional non-surgery rats for micro-computed tomography (µCT), micro-finite element, histology, and serum biochemical analyses. At trabecular sites, extreme losses of bone structure and mechanical competence were detected in the metaphysis of sublesional long bones after SCI, while the subchondral part of the same bones showed much milder damage. Marked reductions in bone mass and strength were also observed in sublesional L4 vertebrae but not in supralesional humeri. At cortical sites, SCI induced structural and strength damage in both sub- and supralesional long bones. These changes were accompanied by diminished osteoblast number and activity and increased osteoclast number and activity. Taken together, our study revealed site-specific effects of SCI on bone and demonstrated sustained inhibition of bone formation and elevation of bone resorption at the chronic stage of SCI. PMID:26528401

  15. Comparative study on short-term and long-term prognostic determinants in patients with acute cerebral infarction

    PubMed Central

    Wang, Jie; Yu, Xiao-Du; Li, Guang-Qin

    2015-01-01

    Background: At present, there are many studies on prognostic determinants in patients with acute cerebral infarction, while studies on short-term and long-term prognostic determinants are less. The purpose of this study was to explore the short-term and long-term association and same and different points of prognostic determinants in patients with acute cerebral infarction for guiding clinical treatment. Methods: 201 patients with acute cerebral infarction were included in the study, whose neurological functions were assessed via National Institute of Health Stroke Scale (NIHSS) within 24 h and computed tomography or magnetic resonance imaging were performed within 48 h of symptom onset. All of the patients were administered with same medication regimen (including medication and rehabilitation). The NIHSS and the modified Rankin Scale were used to assess the extent of disability at 15 d after admission and one year, respectively. Short-term and long-term prognostic determinants and its association were analyzed by single and multivariable logistic regression. Results: Infarct volume correlated with short-term prognosis (OR = 3.543, 95% CI: 1.632~10.212), while it showed no correlation with long-term prognosis; concurrent infection was independent risk factor for short-term prognosis of acute cerebral infarction (OR = 2.532, 95% CI: 1.803~6.886). Baseline NIHSS score independently correlated with short-term and long-term prognosis (odds ratio, respectively: OR = 1.880, 95% CI: 1.462~6.679; OR = 1.761, 95% CI: 1.372~6.758); gender (OR = 0.311, 95% CI: 0.140~0.681) and basal ganglia infarction (OR = 2.263, 95% CI: 1.349~11.662) were independently associated with long-term prognosis, while it showed no significant correlation with short-term prognosis. Short-term prognosis effect was an independent predictor for long-term prognosis (OR = 0.487, 95% CI: 0.141~0.895). Age, hospitalization time, short-term and long-term prognosis of patients showed no significant

  16. Long-term monitoring studies of pollutants on public lands: Bald Eagles in the Midwest

    SciTech Connect

    Bowerman, W.W.

    1995-12-31

    The role of public agencies to monitor the populations of wildlife species with protected status is paramount to the recovery of these species. Since the early 1960s, the bald eagle (Haliaeetus leucocephalus) populations within the Midwest have been monitored to determine number of breeding pairs, nest occupancy, and success rates. In addition to the reproductive outcome studies, abandoned eggs, blood samples, and feather samples have been collected to determine concentrations of organochlorine pesticides, PCBs, and heavy metals. These surveys give an actual measure of population dynamics of a top-predator species in aquatic systems that integrates the effects of many different environmental pollutants. As concentrations of the organochlorine compounds have declined, bald eagle populations have increased in numbers and their reproductive success has improved. The recovery of this species has not been uniform however. In regions where DDT and PCB concentrations are still above thresholds associated with reproductive impairment, eagles still have impaired reproduction. These areas include the shorelines of the Great Lakes and Voyageurs National Park. Some areas such as the Chippewa National Forest have begun to show declines in reproduction due to density dependent factors. Recent proposals for ecosystem management and reclassification of the bald eagle have led to reduced emphasis for maintaining these long-term data sets. The utility and importance of maintaining surveys of top-predators that can give a measure of population-level effects of pollutants rather than an index will be discussed using examples from the Midwest.

  17. A study of challenges and opportunities for long-term care dietitians in British Columbia.

    PubMed

    Black, Jennifer L; Dunham, Rebecca; Kafka, Tamar

    2013-01-01

    While demand for long-term care (LTC) in Canada is expected to grow in the coming years, little is known about the current LTC dietetic workforce or its members' practice-related concerns. A web-based survey was developed and distributed to and subsequently completed by 75 LTC dietitians in British Columbia. The survey was intended to characterize dietitians' demographic characteristics, educational and employment experiences, salaries and benefits, future employment plans, and concerns about current practice. Regression models were used to examine the associations between demographic, educational, and employment characteristics and self-reported hourly wages. The majority of respondents were employed at more than one facility (57%) and did not belong to a union (71%). The mean hourly wage for LTC dietetics positions was $37.50 ± $5.85, and was significantly higher for positions that did not provide additional employee benefits (p < 0.05). Hourly wages were not significantly higher for dietitians with more years of experience or graduate-level education. Concerns were raised about potential implications of revised residential care regulations for workload, and only 36% of respondents reported being committed to working in the area of LTC dietetics in the future. This study highlights practice-related challenges and future opportunities to build the LTC dietetic workforce, and can inform planning for training, recruitment, and retention. PMID:24018005

  18. A long-term Northern Hemisphere snow cover extent data record for climate studies and monitoring

    NASA Astrophysics Data System (ADS)

    Estilow, T. W.; Young, A. H.; Robinson, D. A.

    2015-06-01

    This paper describes the long-term, satellite-based visible snow cover extent National Oceanic and Atmospheric Administration (NOAA) climate data record (CDR) currently available for climate studies, monitoring, and model validation. This environmental data product is developed from weekly Northern Hemisphere snow cover extent data that have been digitized from snow cover maps onto a Cartesian grid draped over a polar stereographic projection. The data have a spatial resolution of 190.6 km at 60° latitude, are updated monthly, and span the period from 4 October 1966 to the present. The data comprise the longest satellite-based CDR of any environmental variable. Access to the data is provided in Network Common Data Form (netCDF) and archived by NOAA's National Climatic Data Center (NCDC) under the satellite Climate Data Record Program (doi:10.7289/V5N014G9). The basic characteristics, history, and evolution of the data set are presented herein. In general, the CDR provides similar spatial and temporal variability to its widely used predecessor product. Key refinements included in the CDR improve the product's grid accuracy and documentation and bring metadata into compliance with current standards for climate data records.

  19. Doing time: a qualitative study of long-term incarceration and the impact of mental illness.

    PubMed

    Yang, Suzanne; Kadouri, Alane; Révah-Lévy, Anne; Mulvey, Edward P; Falissard, Bruno

    2009-01-01

    Once convicted, the perpetrator of serious crime embarks upon a new journey: the challenge of adjusting to long-term imprisonment. Prisoners' views of incarceration and the meaning of this experience may affect their later adjustment to life in the community. On the basis of brief narrative responses collected during an epidemiological survey of the psychological health of prisoners in France, this study examined the impact of incarceration on psychological state in a group of 59 inmates serving long sentences. Qualitative content analysis and computer-assisted linguistic analysis (using ALCESTE software) were performed on the textual data of open responses to three standard questions. Using a combination of these two approaches, seven categories of the subjective experience of prisoners in the sample were identified: the Outside World, Others, Punishment, Time, Affects and Impulses, Self-Concept, and Speech. Further qualitative analyses were then performed to compare the responses of Severely Mentally Ill (SMI) subjects and subjects with no psychiatric disorder. These analyses revealed contrasting attitudes towards incarceration. SMI subjects spoke in more hostile and persecutory terms about their experience in prison, attributing suffering to external circumstances, while subjects with no psychiatric disorder evoked similar themes, but with an introspective attitude. The themes evoked by mentally ill individuals in our sample suggest that their reactions to the prison environment arise in part from aspects of their psychiatric symptoms, and this may have relevance to future mental health policy and practices in criminal corrections. PMID:19619895

  20. The long-term consequences of parental alcohol abuse: a cohort study of children in Denmark.

    PubMed

    Christoffersen, Mogens Nygaard; Soothill, Keith

    2003-09-01

    The aim of this study is to consider whether parents' abuse of alcohol has an impact on children during their formative years. The research is based on data from 84,765 children born in Denmark in 1966. These children and their parents were followed between 1979 and 1993. Information was analyzed from government registers covering health, education, family separation, suicidal behavior, criminality, and unemployment, using a discrete time Cox-regression model. Results showed that the parents' alcohol abuse may frame the childhood with parental violence, very high occurrence of family separations, and often foster care. The parental abuse of alcohol may influence several long-term consequences for their 15- to 27-year-old children such as increased mortality, self-destructive behaviors (e.g. attempted suicide or drug addiction). Hospitalization due to violence, an increased risk of teenage pregnancy and unemployment were also seen more frequently among cases where the parents were alcohol abusers. Mothers' alcohol abuse seemed to be associated with higher occurrences of all the mentioned disadvantages. PMID:14629993

  1. AMS studies of the long-term turnover of 14C-labelled fat in man

    NASA Astrophysics Data System (ADS)

    Gunnarsson, M.; Mattsson, S.; Stenström, K.; Leide-Svegborn, S.; Erlandsson, B.; Faarinen, M.; Hellborg, R.; Kiisk, M.; Nilsson, L.-E.; Nosslin, B.; Persson, P.; Skog, G.; Åberg, M.

    2000-10-01

    To estimate the biokinetics of 14C-labelled fatty acids and the associated radiation absorbed dose to man, long-term retention of 14C from oral intake of glycerol tri[1- 14C]oleate (triolein) has been studied using accelerator mass spectrometry (AMS). As a complement to earlier reported data for three individuals, we present here results for one person from measurements up to 4.6 yr after administration, now also including 14C-levels in fat, muscle and bone. In this subject, a total of 44% of the administered activity was recovered in the exhaled air. Fasting increased the exhalation of 14C. The "excess" 14CO2 due to fasting had a half-life of about 400 d. AMS measurements on fat, muscle and bone biopsies taken from the same subject 4.5 yr after ingestion indicated that a small fraction of the administered activity was still present in fat. Also, bone tissue had a higher 14C specific activity than the current environmental level. No significantly increased level was found in the muscle sample.

  2. Does menopausal transition really influence mental health? Findings from the prospective long-term Zurich study.

    PubMed

    Rössler, Wulf; Ajdacic-Gross, Vladeta; Riecher-Rössler, Anita; Angst, Jules; Hengartner, Michael P

    2016-06-01

    In the prospective long-term Zurich study, we re-examined the hypothesized association between mental health problems in women and the transition through menopausal stages. One hundred sixty-eight women from a population-based Swiss community cohort were prospectively followed up from age 21 to 50. At age 50, the occurrence of hot flushes/night sweats and sleep disturbances was significantly more frequent in peri- and post-menopausal women. Irritability/nervousness was increased only in peri-menopausal women, but that association was accounted for by neuroticism trait scores at age 30. Transitions to peri- or post-menopause were not related to changes in either the prevalence rates of DSM major depressive episode or anxiety disorders, or the course of psychopathological syndromes as assessed by the Symptom Checklist 90 - Revised. The null associations held when adjusting for duration of reproductive period or age at menopause. Preceding mental health problems between ages 21 and 41, increased neuroticism trait scores at age 30, and concurrent psychosocial distress were significantly related to mental health problems occurring between ages 41 and 50. Depending upon the cut-off point that was chosen, the arbitrary dichotomization of a continuous depression outcome produced spurious associations with the menopausal transition. We conclude that mental health problems between ages 41 and 50 are probably not directly related to the menopausal transition, and that previously reported associations could be false positives due to inadequate dichotomizations, reporting bias, undisclosed multiple adjustments or overfitting. PMID:27265705

  3. Two-Dimensional Assimilation Of Solar Occultation Satellite Data To Study Long-Term Ozone Trends

    NASA Astrophysics Data System (ADS)

    Geller, M. A.; Zhou, X.; Smyshlyaev, S.

    The methodology of two-dimensional chemistry-transport model driven data assimilation is used to evaluate atmospheric ozone changes for several decades. The SUNY-SPb two-dimensional transport-chemistry model, using the same mathematical framework, has been used to assimilate atmospheric composition data from two different solar occultation satellite instruments. The associated errors of the satellite observations are objectively calculated based on estimation theory. Two-dimensional data assimilation results for ozone are shown for SAGE II Version 6.2 and for HALOE Version 19 data. SAGE II was launched in October of 1984, and HALOE was launched on September of 1991. The SAGE II data spans two periods of high stratospheric aerosol loading (from El Chichon and Mt. Pinatubo), almost 10 QBO periods, 4 major ENSO events, and almost two complete solar cycles. The HALOE data spans one period of high stratospheric aerosol loading, almost 6 QBO periods, 3 major ENSO events, and about 1 1/2 solar cycles. HALOE and SAGE II results will be compared for the same periods. Assimilated satellite data are used to study the role of solar activity variations, atmospheric dynamics, and aerosol effects for long-term ozone variability in the lower and upper stratosphere and mesosphere.

  4. Early aging in Chernobyl clean-up workers: long-term study.

    PubMed

    Krasnov, V; Kryukov, V; Samedova, E; Emelianova, I; Ryzhova, I

    2015-01-01

    This paper represents data of long-term open prospective study. 312 male clean-up workers, who participated in elimination of the Chernobyl disaster consequences in 1986-87, were observed and examined in Moscow Research Institute of Psychiatry. The average age of patients was 57,0 ± 6,8 years. All patients were diagnosed with psychoorganic syndrome, caused by combination of different factors, which led to early cerebrovascular pathology, which was confirmed by clinical, neuropsychological, and instrumental examination. Anamnesis and the level of social adaptation were also assayed. Clinical estimation was done with the use of specially developed Clinical Psychopathological Chart. All the symptoms were divided into 4 groups (asthenic, psychovegetative, dysthymic, and cognitive symptom-complexes). No pronounced signs of dementia were observed. The control group included 44 clean-up workers without mental disorders. Predomination of various exogenous factors before and after accident was noted. Therapy included different vasotropic remedies, as well as family therapy, art therapy, and cognitive training. The possibilities of the reverse development of symptoms were statistically proved. The results allow making a conclusion that these disorders could not be explained either by radiation effects or by PTSD but connected with cerebrovascular pathology. PMID:25692150

  5. Early Aging in Chernobyl Clean-Up Workers: Long-Term Study

    PubMed Central

    Krasnov, V.; Kryukov, V.; Samedova, E.; Emelianova, I.; Ryzhova, I.

    2015-01-01

    This paper represents data of long-term open prospective study. 312 male clean-up workers, who participated in elimination of the Chernobyl disaster consequences in 1986-87, were observed and examined in Moscow Research Institute of Psychiatry. The average age of patients was 57,0 ± 6,8 years. All patients were diagnosed with psychoorganic syndrome, caused by combination of different factors, which led to early cerebrovascular pathology, which was confirmed by clinical, neuropsychological, and instrumental examination. Anamnesis and the level of social adaptation were also assayed. Clinical estimation was done with the use of specially developed Clinical Psychopathological Chart. All the symptoms were divided into 4 groups (asthenic, psychovegetative, dysthymic, and cognitive symptom-complexes). No pronounced signs of dementia were observed. The control group included 44 clean-up workers without mental disorders. Predomination of various exogenous factors before and after accident was noted. Therapy included different vasotropic remedies, as well as family therapy, art therapy, and cognitive training. The possibilities of the reverse development of symptoms were statistically proved. The results allow making a conclusion that these disorders could not be explained either by radiation effects or by PTSD but connected with cerebrovascular pathology. PMID:25692150

  6. ORTHODONTIC RETENTION. Studies of retention capacity, cost-effectiveness and long-term stability.

    PubMed

    Tynelius, Gudrun Edman

    2014-01-01

    Retention strategies, cost-effectiveness and long-term stability of treatment outcome are essential aspects of orthodontic treatment planning. The overall aim of this thesis was to compare and evaluate three different retention strategies, with special reference to short- and long-term clinical stability and cost-effectiveness. The approach was evidence-based, hence randomized controlled methodology was used in order to generate high levels of evidence. This thesis is based on four studies: Papers I and II are based on randomized controlled trials, evaluating the stability of treatment outcome after one and two years of retention, using three different retention strategies: a maxillary vacuum-formed retainer combined with a mandibular canine-to-canine retainer; a maxillary vacuum-formed retainer combined with stripping of the mandibular anterior teeth and a prefabricated positioner. Paper III presents a cost-minimization analysis of two years of retention treatment. Paper IV is based on a randomized controlled trial documenting the results five years post-retention. The following conclusions were drawn: Papers I and II. From a clinical perspective, asssessment after one year of retention disclosed that the three retention methods were successful in retaining the orthodontic treatment results. After two years of retention, all three retention methods were equally effective in controlling relapse at a clinically acceptable level. Most of the relapse occurred during the first year of retention; only minor or negligible changes were found during the second year. The subjects were grouped according to the level of compliance (excellent or good). After two years of retention there was a negative correlation between growth in body height and relapse of mandibular LII in the group of subjects with excellent compliance. The group with good compliance showed a positive correlation (Paper II, Figure 3). After two years of retention, growth in body height, initial crowding and

  7. 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

  8. Prospective evaluation of long-term safety of dual-release hydrocortisone replacement administered once daily in patients with adrenal insufficiency

    PubMed Central

    Nilsson, A G; Marelli, C; Fitts, D; Bergthorsdottir, R; Burman, P; Dahlqvist, P; Ekman, B; Edén Engström, B; Olsson, T; Ragnarsson, O; Ryberg, M; Wahlberg, J; Lennernäs, H; Skrtic, S; Johannsson, G

    2014-01-01

    Objective The objective was to assess the long-term safety profile of dual-release hydrocortisone (DR-HC) in patients with adrenal insufficiency (AI). Design Randomised, open-label, crossover trial of DR-HC or thrice-daily hydrocortisone for 3 months each (stage 1) followed by two consecutive, prospective, open-label studies of DR-HC for 6 months (stage 2) and 18 months (stage 3) at five university clinics in Sweden. Methods Sixty-four adults with primary AI started stage 1, and an additional 16 entered stage 3. Patients received DR-HC 20–40 mg once daily and hydrocortisone 20–40 mg divided into three daily doses (stage 1 only). Main outcome measures were adverse events (AEs) and intercurrent illness (self-reported hydrocortisone use during illness). Results In stage 1, patients had a median 1.5 (range, 1–9) intercurrent illness events with DR-HC and 1.0 (1–8) with thrice-daily hydrocortisone. AEs during stage 1 were not related to the cortisol exposure-time profile. The percentage of patients with one or more AEs during stage 1 (73.4% with DR-HC; 65.6% with thrice-daily hydrocortisone) decreased during stage 2, when all patients received DR-HC (51% in the first 3 months; 54% in the second 3 months). In stages 1–3 combined, 19 patients experienced 27 serious AEs, equating to 18.6 serious AEs/100 patient-years of DR-HC exposure. Conclusions This long-term prospective trial is the first to document the safety of DR-HC in patients with primary AI and demonstrates that such treatment is well tolerated during 24 consecutive months of therapy. PMID:24944332

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

    PubMed

    Downs, Matthew E; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Teichert, Tobias; 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 (500 kHz, 200-400 kPa, 4-5 μm 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

  10. Delorme's Procedure for Complete Rectal Prolapse: A Study of Recurrence Patterns in the Long Term

    PubMed Central

    Placer, Carlos; Enriquez-Navascués, Jose M.; Timoteo, Ander; Elorza, Garazi; Borda, Nerea; Gallego, Lander; Saralegui, Yolanda

    2015-01-01

    Introduction. The objective of this study was to determine the recurrence rate and associated risk factors of full-thickness rectal prolapse in the long term after Delorme's procedure. Patients and Methods. The study involved adult patients with rectal prolapse treated with Delorme's surgery between 2000 and 2012 and followed up prospectively in an outpatient unit. We assessed epidemiological data, Wexner constipation and incontinence score, recurrence patterns, and risk factors. Data were analyzed by univariate and multivariate studies and follow-up was performed according to Kaplan-Meier technique. The primary outcome was recurrence. Results. A total of 42 patients, where 71.4% (n = 30) were women, with a median age of 76 years (IQR 66 to 86), underwent Delorme's surgery. The median follow-up was 85 months (IQR 28 to 132). There was no mortality, and morbidity was 9.5%. Recurrence occurred in five patients (12%) within 14 months after surgery. Actuarial recurrence at five years was 9.9%. According to the univariate analysis, constipation and concomitant pelvic floor repair were the only factors found to be associated with recurrence. Multivariate analysis showed no statistically significant differences among variables studied. Kaplan-Meier estimate revealed that constipation was associated with a higher risk of recurrence (log-rank test, p = 0.006). Conclusions. Delorme's procedure is a safe technique with an actuarial recurrence at five years of 9.9%. The outcomes obtained in this study support the performance of concomitant postanal repair and levatorplasty to reduce recurrences. Also, severe constipation is associated with a higher recurrence rate. PMID:26783557

  11. Aripiprazole once-monthly 400 mg for long-term maintenance treatment of schizophrenia: a 52-week open-label study

    PubMed Central

    Peters-Strickland, Timothy; Baker, Ross A; McQuade, Robert D; Jin, Na; Eramo, Anna; Perry, Pamela; Johnson, Brian R; Duca, Anna; Sanchez, Raymond

    2015-01-01

    Background: Long-term maintenance treatment with an antipsychotic is often required to prevent relapse and mitigate functional deterioration in patients with schizophrenia. Aims: This study assessed the long-term safety, tolerability, and maintenance of the therapeutic effect of aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia. Methods: This 52-week, open-label study included patients previously enrolled in 1 of 2 AOM 400 randomized controlled trials (RCTs) and de novo patients. Safety endpoints included adverse events (AEs), suicidality, extrapyramidal symptoms, injection-site pain, and clinically relevant changes in clinical and laboratory values. The primary efficacy endpoint was the percentage of stable patients at baseline who remained stable at the last visit of the AOM 400 maintenance phase. All endpoints were assessed with descriptive statistics; there were no formal planned statistical analyses. Results: Of 1,247 patients screened, 1,178 enrolled in the study (194 de novo and 984 patients from the RCTs) and 1,081 received maintenance treatment with AOM 400. The maintenance phase completion rate was 79.4% at 52 weeks. Treatment-emergent AEs in ⩾5% of patients during open-label AOM 400 treatment were headache (7.6%), nasopharyngitis (7.0%), anxiety (6.8%), and insomnia (6.6%). There were no clinically relevant changes in safety parameters of interest. Ninety-five percent of stable patients at baseline remained stable at their last visit during the AOM 400 maintenance phase. Conclusions: The long-term safety and tolerability profile of AOM 400 was comparable to the RCTs, and the long-term therapeutic effect was maintained. PMID:27336044

  12. The Granite Mountain Atmospheric Sciences Testbed (GMAST): A Facility for Long Term Complex Terrain Airflow Studies

    NASA Astrophysics Data System (ADS)

    Zajic, D.; Pace, J. C.; Whiteman, C. D.; Hoch, S.

    2011-12-01

    This presentation describes a new facility at Dugway Proving Ground (DPG), Utah that can be used to study airflow over complex terrain, and to evaluate how airflow over a mountain barrier affects wind patterns over adjacent flatter terrain. DPG's primary mission is to conduct testing, training, and operational assessments of chemical and biological weapon systems. These operations require very precise weather forecasts. Most test operations at DPG are conducted on fairly flat test ranges having uniform surface cover, where airflow patterns are generally well-understood. However, the DPG test ranges are located alongside large, isolated mountains, most notably Granite Mountain, Camelback Mountain, and the Cedar Mountains. Airflows generated over, or influenced by, these mountains can affect wind patterns on the test ranges. The new facility, the Granite Mountain Atmospheric Sciences Testbed, or GMAST, is designed to facilitate studies of airflow interactions with topography. This facility will benefit DPG by improving understanding of how mountain airflows interact with the test range conditions. A core infrastructure of weather sensors around and on Granite Mountain has been developed including instrumented towers and remote sensors, along with automated data collection and archival systems. GMAST is expected to be in operation for a number of years and will provide a reference domain for mountain meteorology studies, with data useful for analysts, modelers and theoreticians. Visiting scientists are encouraged to collaborate with DPG personnel to utilize this valuable scientific resource and to add further equipment and scientific designs for both short-term and long-term atmospheric studies. Several of the upcoming MATERHORN (MountAin TERrain atmospHeric mOdeling and obseRvatioNs) project field tests will be conducted at DPG, giving an example of GMAST utilization and collaboration between DPG and visiting scientists.

  13. Developing Long-Term Physical Activity Participation: A Grounded Theory Study with African American Women

    ERIC Educational Resources Information Center

    Harley, Amy E.; Buckworth, Janet; Katz, Mira L.; Willis, Sharla K.; Odoms-Young, Angela; Heaney, Catherine A.

    2009-01-01

    Regular physical activity is linked to a reduced risk of obesity and chronic disease. African American women bear a disproportionate burden from these conditions and many do not get the recommended amount of physical activity. Long-term success of interventions to initiate and maintain a physically active lifestyle among African American women has…

  14. Reintegration Services for Long-Term Dangerous Offenders: A Case Study and Discussion

    ERIC Educational Resources Information Center

    Day, Andrew; Ward, Tony; Shirley, Lyn

    2011-01-01

    Successfully reintegrating long-term prisoners back into the community often presents significant challenges for service providers. Ex-prisoners typically experience high levels of social stigma; present with multiple needs; and can struggle to find meaningful employment, stable accommodation, and to maintain supportive relationships. There have,…

  15. A Long-Term Follow-Up Study of 1994-95 Career Program Completers.

    ERIC Educational Resources Information Center

    Conklin, Karen A.

    This report presents the 1999 major findings about long-term career program completers who left Kansas' Johnson County Community College in 1994-95. The report summarizes data on utilization of community college preparation, experiences with their full-time related job, hourly wage and satisfaction with their full-time related job, community…

  16. SHORT- AND LONG-TERM ENVIRONMENTAL PERCEPTIONS: A CASE STUDY OF LAKE LANIER

    EPA Science Inventory

    This paper investigates stakeholders' different perspectives on the environment over the short- (2-5 yrs) and long-term (25+ yrs). Stakeholders were surveyed to indicate their level of concern for a list of water quality indicators and water quality stressors over both time horiz...

  17. Impact of Pediatric Chronic Dialysis on Long-Term Patient Outcome: Single Center Study.

    PubMed

    Levy Erez, Daniella; Krause, Irit; Dagan, Amit; Cleper, Roxana; Falush, Yafa; Davidovits, Miriam

    2016-01-01

    Objective. Owing to a shortage of kidney donors in Israel, children with end-stage renal disease (ESRD) may stay on maintenance dialysis for a considerable time, placing them at a significant risk. The aim of this study was to understand the causes of mortality. Study Design. Clinical data were collected retrospectively from the files of children on chronic dialysis (>3 months) during the years 1995-2013 at a single pediatric medical center. Results. 110 patients were enrolled in the study. Mean age was 10.7 ± 5.27 yrs. (range: 1 month-24 yrs). Forty-five children (42%) had dysplastic kidneys and 19 (17.5%) had focal segmental glomerulosclerosis. Twenty-five (22.7%) received peritoneal dialysis, 59 (53.6%) hemodialysis, and 6 (23.6%) both modalities sequentially. Median dialysis duration was 1.46 years (range: 0.25-17.54 years). Mean follow-up was 13.5 ± 5.84 yrs. Seventy-nine patients (71.8%) underwent successful transplantation, 10 (11.2%) had graft failure, and 8 (7.3%) continued dialysis without transplantation. Twelve patients (10.9%) died: 8 of dialysis-associated complications and 4 of their primary illness. The 5-year survival rate was 84%: 90% for patients older than 5 years and 61% for younger patients. Conclusions. Chronic dialysis is a suitable temporary option for children awaiting renal transplantation. Although overall long-term survival rate is high, very young children are at high risk for life-threatening dialysis-associated complications. PMID:27597898

  18. Impact of Pediatric Chronic Dialysis on Long-Term Patient Outcome: Single Center Study

    PubMed Central

    Krause, Irit; Dagan, Amit; Cleper, Roxana; Falush, Yafa; Davidovits, Miriam

    2016-01-01

    Objective. Owing to a shortage of kidney donors in Israel, children with end-stage renal disease (ESRD) may stay on maintenance dialysis for a considerable time, placing them at a significant risk. The aim of this study was to understand the causes of mortality. Study Design. Clinical data were collected retrospectively from the files of children on chronic dialysis (>3 months) during the years 1995–2013 at a single pediatric medical center. Results. 110 patients were enrolled in the study. Mean age was 10.7 ± 5.27 yrs. (range: 1 month–24 yrs). Forty-five children (42%) had dysplastic kidneys and 19 (17.5%) had focal segmental glomerulosclerosis. Twenty-five (22.7%) received peritoneal dialysis, 59 (53.6%) hemodialysis, and 6 (23.6%) both modalities sequentially. Median dialysis duration was 1.46 years (range: 0.25–17.54 years). Mean follow-up was 13.5 ± 5.84 yrs. Seventy-nine patients (71.8%) underwent successful transplantation, 10 (11.2%) had graft failure, and 8 (7.3%) continued dialysis without transplantation. Twelve patients (10.9%) died: 8 of dialysis-associated complications and 4 of their primary illness. The 5-year survival rate was 84%: 90% for patients older than 5 years and 61% for younger patients. Conclusions. Chronic dialysis is a suitable temporary option for children awaiting renal transplantation. Although overall long-term survival rate is high, very young children are at high risk for life-threatening dialysis-associated complications. PMID:27597898

  19. Long-term Efficacy of Trabeculectomy on Chinese Patients with Pigmentary Glaucoma: A Prospective Case Series Observational Study

    PubMed Central

    Qing, Guo-Ping; Wang, Ning-Li; Wang, Tao; Chen, Hong; Mou, Da-Peng

    2016-01-01

    Background: Though trabeculectomy is often performed on patients with medically refractive pigmentary glaucoma (PG), the clinical outcomes of surgical treatment on PG remain unknown. The aim of this study was to summarize the long-term efficacy and safety of trabeculectomy on PG. Methods: This was a prospective case series observational study. Eighteen consecutive PG patients were followed up for 8 years after trabeculectomy from May 2006 to April 2007. Visual acuity (VA), best-corrected visual acuity (BCVA), slit lamp biomicroscopy, intraocular pressure (IOP) measurement, Humphrey visual field analysis (VFA), and stereoscopic funduscopy were performed on admission and every 6 months after the surgery. Postoperative IOP, VA, BCVA, VFA, adjunctive anti-glaucoma medication, treatment-related side-effects, changes in blebs, and main clinical findings in the anterior segment of PG were recorded and compared with the baseline. Results: Eighteen PG eyes from 18 patients, with average preoperative IOP of 34.5 ± 4.7 mmHg (range: 21–47 mmHg, 1 mmHg=0.133 kPa) were enrolled in this study. All enrolled patients completed the follow-up visits and required examinations. Eight years after trabeculectomy, all surgical eyes (18/18) had satisfactory IOP control with an average of 13.7 ± 2.5 mmHg (range: 9–19 mmHg), which was significantly lower than baseline (P = 0.001). Majority (15/18) of the PG eyes had stable VA, BCVA, VFA, and optic disc cupping parameters. Functional blebs still existed in 12/18 of the PG eyes at the last follow-up visit. Unanimously, pigmentation in the anterior segment attenuated with time after surgical treatment. No severe side-effects were recorded in any of the surgical eyes. Conclusions: All surgical PG eyes in this study had satisfactory IOP control 8 years after the surgery with well-preserved visual function. The long-term efficacy and safety of trabeculectomy are promising in PG patients. PMID:27231161

  20. Businesses assisting K--12 science instruction: Four case studies of long-term school partnerships

    NASA Astrophysics Data System (ADS)

    van Trieste, Lynne M.

    Businesses lack enough qualified applicants to fill the increasing need for scientists and engineers while educators lack many resources for science programs in K-12 schools. This series of case studies searched for successful collaborations between the two in four geographic locations: Boise, Idaho; Dallas, Texas; Los Angeles County, California, and Orange County, California. These science education partnerships were investigated to gain an understanding of long-term partnership structure, functioning and evaluation methods. Forty-nine individual interviews with representatives from the groups of stakeholders these programs impact were also conducted. Stakeholder groups included students, teachers, parents, school administrators, business liaisons, and non-profit representatives. Several recurring themes in these partnerships reinforced the existing literature research findings. Collaboration and communication between partners, teacher professional development, the need for more minority and female representation in physical science careers, and self-efficacy in relation to how people come to view their scientific abilities, are among these themes. Topics such as program replication, the importance of role models, programs using "hands-on" activities, reward systems for program participants, and program outcome measurement also emerged from the cases investigated. Third-party assistance by a non-profit entity is occurring within all of these partnerships. This assistance ranges from a service providing material resources such as equipment, lesson plans and meeting space, to managing the partnership fundraising, program development and evaluations. Discussions based upon the findings that support or threaten sustainment of these four partnerships, what a "perfect" partnership might look like, and areas in need of further investigation conclude this study.

  1. Long-term health-enhancing physical activity in rheumatoid arthritis - the PARA 2010 study

    PubMed Central

    2012-01-01

    Background People with rheumatoid arthritis (RA) suffer increased risk of disability andpremature mortality. Health-enhancing physical activity (HEPA) could be one importantfactor to reduce this risk. Rising health care costs call for the development and evaluation ofnew modes of rehabilitation, including physical activity in settings outside the health caresystem. Methods/Design This cohort study targets 450 patients with RA that do not currently meet HEPA recommendations, recruited from six hospitals reporting to the Swedish Rheumatology Quality Registers (SRQ). We have developed a two-year real-life intervention program including a minimum of twice-weekly circuit training, moderately intense physical activity the remaining days of the week and group meetings to support behavior change every other week. Our hypothesis is that increased physical activity and exercise will improve perceived health, reduce pain and fatigue, increase muscle function and aerobic capacity, impact psychosocial factors and prevent future cardiovascular events. Research questions regard outcomes, retention rates, dose–response matters and the exploration of responder characteristics. This protocol outlines recruitment procedure, design, assessment methods and the intervention program of the study. Discussion The PARA 2010 project is designed to expand the knowledge on HEPA in RA by a progressive approach regarding population, setting, intervention, time frames and outcome measures. To our knowledge this is the first long-term HEPA program based on Social Cognitive Theory, and performed in a real life environment to demonstrate if this new setting can promote increased and maintained physical activity in people with RA. Trial registration number ISRCTN25539102 PMID:22656861

  2. A long-term study to maximise migraine relief with zolmitriptan.

    PubMed

    Tepper, S J; Donnan, G A; Dowson, A J; Bomhof, M A; Elkind, A; Meloche, J; Fletcher, P E; Millson, D S

    1999-01-01

    Part 1 of this international study was a randomised, double-blind, placebo-controlled study of 2.5 mg and 5 mg zolmitriptan (Zomig) in the treatment of persistent migraine headache, two hours after an initial dose of 2.5 mg zolmitriptan. Part 2 was a non-comparative evaluation of long-term, unrestricted zolmitriptan use for treatment of initial, persistent and recurrent migraine headaches. In Part 1, following the treatment of moderate or severe persistent headache, two-hour headache response rates with 5 mg zolmitriptan (51.6%, n = 322), 2.5 mg zolmitriptan (49.7%, n = 324) and placebo (51.6%, n = 343) were not significantly different. However, the pain-free response rate following the treatment of persistent migraine headache of any intensity was significantly higher with 5 mg zolmitriptan than with placebo (36.0% vs. 25.5%; p < 0.001). This was predominantly due to effects in the subgroup of patients with mild headache. Thus, migraine relief in patients whose initial headache shows a partial response to 2.5 mg zolmitriptan may be maximised by a second 5 mg dose. In Part 2 (involving 2499 evaluable patients), 65.8% of attacks were treated with a single dose of zolmitriptan (2.5 mg or 5 mg). Of those migraine attacks initially treated with 2.5 mg zolmitriptan, 70.3% required no further dose, similarly 62.7% of migraine attacks treated initially with 5 mg zolmitriptan only required a single dose. Over the whole attack (i.e. initial and any persistent headache), headache response rates to one or two zolmitriptan doses were greater than 88.8%. 'Level of pain' was the primary factor influencing the choice of dose. Zolmitriptan provided consistent migraine headache relief in the majority of patients and was well tolerated. PMID:10640258

  3. Increased Long-Term Cardiovascular Risk After Total Hip Arthroplasty: A Nationwide Cohort Study.

    PubMed

    Gordon, Max; Rysinska, Agata; Garland, Anne; Rolfson, Ola; Aspberg, Sara; Eisler, Thomas; Garellick, Göran; Stark, André; Hailer, Nils P; Sköldenberg, Olof

    2016-02-01

    Total hip arthroplasty is a common and important treatment for osteoarthritis patients. Long-term cardiovascular effects elicited by osteoarthritis or the implant itself remain unknown. The purpose of the present study was to determine if there is an increased risk of late cardiovascular mortality and morbidity after total hip arthroplasty surgery.A nationwide matched cohort study with data on 91,527 osteoarthritis patients operated on, obtained from the Swedish Hip Arthroplasty Register. A control cohort (n = 270,688) from the general Swedish population was matched 1:3 to each case by sex, age, and residence. Mean follow-up time was 10 years (range, 7-21).The exposure was presence of a hip replacement for more than 5 years. The primary outcome was cardiovascular mortality after 5 years. Secondary outcomes were total mortality and re-admissions due to cardiovascular events.During the first 5 to 9 years, the arthroplasty cohort had a lower cardiovascular mortality risk compared with the control cohort. However, the risk in the arthroplasty cohort increased over time and was higher than in controls after 8.8 years (95% confidence interval [CI] 7.0-10.5). Between 9 and 13 years postoperatively, the hazard ratio was 1.11 (95% CI 1.05-1.17). Arthroplasty patients were also more frequently admitted to hospital for cardiovascular reasons compared with controls, with a rate ratio of 1.08 (95% CI 1.06-1.11).Patients with surgically treated osteoarthritis of the hip have an increased risk of cardiovascular morbidity and mortality many years after the operation when compared with controls. PMID:26871792

  4. A novel model for studies of blood-mediated long-term responses to cellular transplants

    PubMed Central

    Lindblom, Susanne; Hong, Jaan; Nilsson, Bo; Korsgren, Olle; Ronquist, Gunnar

    2015-01-01

    Aims Interaction between blood and bio-surfaces is important in many medical fields. With the aim of studying blood-mediated reactions to cellular transplants, we developed a whole-blood model for incubation of small volumes for up to 48 h. Methods Heparinized polyvinyl chloride tubing was cut in suitable lengths and sealed to create small bags. Multiple bags, with fresh venous blood, were incubated attached to a rotating wheel at 37°C. Physiological variables in blood were monitored: glucose, blood gases, mono- and divalent cations and chloride ions, osmolality, coagulation (platelet consumption, thrombin-antithrombin complexes (TAT)), and complement activation (C3a and SC5b-9), haemolysis, and leukocyte viability. Results Basic glucose consumption was high. Glucose depletion resulted in successive elevation of extracellular potassium, while sodium and calcium ions decreased due to inhibition of energy-requiring ion pumps. Addition of glucose improved ion balance but led to metabolic acidosis. To maintain a balanced physiological environment beyond 6 h, glucose and sodium hydrogen carbonate were added regularly based on analyses of glucose, pH, ions, and osmotic pressure. With these additives haemolysis was prevented for up to 72 h and leukocyte viability better preserved. Despite using non-heparinized blood, coagulation and complement activation were lower during long-term incubations compared with addition of thromboplastin and collagen. Conclusion A novel whole-blood model for studies of blood-mediated responses to a cellular transplant is presented allowing extended observations for up to 48 h and highlights the importance of stringent evaluations and adjustment of physiological conditions. PMID:25322825

  5. Infaunal macrobenthic community dynamics in a manipulated hyperhaline ecosystem: a long-term study

    PubMed Central

    2013-01-01

    Background Understanding the responses of ecological communities to human-induced perturbations is crucial for establishing conservation goals. Ecological communities are dynamic entities undergoing fluctuations due to their intrinsic characteristics as well as anthropogenic pressures varying over time. In this respect, long-term studies, based on large spatial and temporal datasets, may provide useful information in understanding patterns and processes influencing the communities’ structure. Theoretical evidence suggests that a role of biodiversity is acting as a compensatory buffer against environmental variability by decreasing the temporal variance in ecosystem functioning and by raising the level of community response to perturbations through the selection of better performing species. Therefore, the spatial and temporal changes in the specialization of the community components may be used as an effective tool to monitor the effects of natural and anthropogenic alterations of the environment in dynamic systems. We examined the temporal dynamics of macroinvertebrate community structure in the hyperhaline habitat of Tarquinia Saltworks (central Italy). We aimed at: (i) investigating the relationships between the level of community specialization and the alterations of the environment across fourteen years; (ii) comparing the ability of aggregate community parameters such as the average abundance vs. species specialization in describing patterns of community composition. Results We arranged the data in three sub-sets according to three periods, each characterized by different environmental conditions. The mean abundance of sampled macroinvertebrates showed a significant change (p < 0.01) only in the community inhabiting the saltwork basin closely connected to the sea, characterized by the highest environmental variation (i.e. the coefficient of variation, CV, of the aggregate environmental variability over the study period, CVrange = 0.010 - 0.2). Here

  6. Long-Term Evolution Studies of E. Coli under Combined Effects of Simulated Microgravity and Antibiotic.

    NASA Astrophysics Data System (ADS)

    Karouia, Fathi; Tirumalai, Madhan R.; Ott, Mark C.; Pierson, Duane L.; Fox, George E.; Tran, Quyen

    2016-07-01

    Multiple spaceflight and simulated microgravity experiments have shown changes in phenotypic microbial characteristics such as microbial growth, morphology, metabolism, genetic transfer, antibiotic and stress susceptibility, and an increase in virulence factors. However, while these studies have contributed to expand our understanding of the short-term effects of spaceflight or simulated microgravity on biological systems, it remains unclear the type of responses subsequent to long-term exposure to space environment and microgravity in particular. As such, organisms exposed to the space environment for extended periods of time may evolve in unanticipated ways thereby negatively impacting long duration space missions. We report here for the first time, an experimental study of microbial evolution in which the effect of long-term exposure to Low Shear Modeled MicroGravity (LSMMG) on microbial gene expression and physiology in Escherichia coli (E. coli) MG1655 was examined using functional genomics, and molecular techniques with and without simultaneous exposure to broad spectrum antibiotic chloramphenicol. E. coli cells were grown under simulated microgravity for 1000 generations in High Aspect Ratio Vessels (HARVs) that were either heat-sterilized (115 deg C, 15 min) or by using/rinsing the HARVs with a saturated solution of the broad-spectrum antibiotic chloramphenicol. In the case of the cells evolved using the antibiotic sterilized HARVs, the expression levels of 357 genes were significantly changed. In particular, fimbriae encoding genes were significantly up-regulated whereas genes encoding the flagellar motor complex were down-regulated. Re-sequencing of the genome revealed that a number of the flagellar genes were actually deleted. The antibiotic resistance levels of the evolved strains were analyzed using VITEK analyzer. The evolved strain was consistently resistant to the antibiotics used (viz., Ampicillin, Cefalotin, Cefurox-ime, Cefuroxime Axetil

  7. Inhibition of pyrite oxidation by surface coating: a long-term field study.

    PubMed

    Kang, Chan-Ung; Jeon, Byong-Hun; Park, Seong-Sook; Kang, Jin-Soo; Kim, Kang-Ho; Kim, Dong-Kwan; Choi, Ui-Kyu; Kim, Sun-Joon

    2016-10-01

    Pyrite and other iron sulfides are readily oxidized by dissolved oxygen in aqueous phase, producing acidity and Fe(2+), which causes significant environmental problems. Applications of surface coating agents (Na2SiO3 and KH2PO4) were conducted at Boeun (Chungbuk, South Korea) outcrop site, and their efficiencies to inhibit the oxidation of sulfide minerals were monitored for a long-term period (449 days). The rock sample showed positive Net Acid Production Potential (NAPP = 20.23) and low Net Acid Generation pH (NAGpH = 2.42) values, suggesting that the rock sample was categorized in the potential acid-forming group. For the monitored time period (449 days), field study results showed that the application of Na2SiO3 effectively inhibited the pyrite oxidation as compared to KH2PO4. Na2SiO3 as a surface coating agent maintained pH 5-6 and reduced oxidation of pyrite surface up to 99.95 and 97.70 % indicated by Fe(2+) and SO4 (2-) release, respectively. The scanning electron microscope and energy-dispersive X-ray spectrometer analysis indicated that the morphology of rock surface was completely changed attributable to formation of iron silicate coating. The experimental results suggested that the treatment with Na2SiO3 was highly effective and it might be applicable on field for inhibition of iron sulfide oxidation. PMID:26493832

  8. [Oxidation Stress Markers Dynamics in the Experiment of Long-Term Antiorthostatic Hypokinesia (Retrospective Study)].

    PubMed

    Zhuravlyova, O A; Markin, A A; Kuzichkin, D S; Loginov, V I; Zabolotskaya, I V; Vostrikova, L V

    2016-01-01

    In blood serum of 9 volunteers aged 27 to 42, participated in the experiment with 370-day antiorthostatic hypokinesia (-5 degrees), the lipid peroxidation derivates concentration--diene conjugates (DC), malonic dialdehyde (MDA), Schiff bases (SB) as well as antioxidant defense system indices--tocopherol (TP) concentration and total antioxidative activity level (AOA) were measured. The volunteers were divided into two groups subjected to physical training regimes and used prophylactic measures. In both groups the lipoperoxidation processes initial stages depression (by 54-73%) was observed starting from 50th day, thus the lipid peroxidation final product--SB level was decreased (by 50-61%) only to the 230 day and remains approximately at the same level till the end of the experiment. The restorative period was characterized by decreasing (in 1.6-2.3 times) of MDA and SB concentrations. The decrease in lotal AOA during the aftereffect period was detected in all volunteers, and its level was significantly lower physiological norm range. Probably, long-term adaptation to the simulated weightlessness conditions is accompanied by expressed decrease in biological oxidation processes intensity and significant stress effect, as indicates by essential depression of lipid free radical oxidation in the course of the experiment. At the same time the restorative period after 370-day antiorthostatic hypokinesia was characterized by significantly expressed and prolonged readaptation stress progress. It is evidenced by practically twofold decrease in lipoperoxidation processes intensity against significant increase in TP concentration and water-soluble antioxidants functional reserves exhaustion. Lipid peroxidation activation absence in all terms of examination reflects appropriate compensation of studying impact by volunteers. PMID:27188151

  9. Long-term effects of a sensitisation campaign on migraine: the Casilino study.

    PubMed

    Petolicchio, B; Di Clemente, L; Altieri, M; Vicenzini, E; Lenzi, G L; Di Piero, Vittorio

    2010-04-01

    In 2003, we conducted a sensitisation campaign on migraine in the Casilino district of Rome, by sending a letter with the ID Migraine test to all the households and placing posters in the GPs' waiting room. Out of 195 headache patients recruited, 92% had migraine while 73% had never consulted a physician for headache. The aim of this study was to evaluate the long-term impact of this campaign. The follow-up was performed by a telephone interview. The questionnaire considered the characteristics of headache, quality of life, preventive and acute treatments, drug efficacy, comorbidity and subjective usefulness of the campaign. Of the 179 migraineurs, 90.5% (mean age 40.7 +/- 16.5, 139 females) were included in the follow-up. An improvement was observed in mean pain intensity (-13.9%; p < 0.0001) and mean HIT-6 score (-6.1%; p = 0.0003). The campaign was considered to be useful by 63.6% of cases, while 66.1% reported an improvement in their clinical status. Improved patients showed a decreased mean number of days with headache per month (-51.7%; p < 0.0001), pain intensity (-21.8%; p < 0.0001), headache duration (-18.1%; p = 0.0008)and HIT-6 score (-11.7%; p < 0.0001). Our data suggest that the effects of a "single shot" campaign are beneficial not only in a short-term perspective, but even in the longterm. Moreover, the lack of benefit in more severe cases suggests that such patients should not be treated by GPs alone: patients in whom the HIT-6 score, frequency,severity or duration of headache worsen should be promptly referred to the headache clinic. PMID:20058047

  10. Oral health status among long-term hospitalized adults: a cross sectional study

    PubMed Central

    Yavnai, Nirit; Zini, Avi

    2014-01-01

    Background. Many Long-Term Care (LTC) institutionalized patients are the most frail and functionally dependent among the geriatric population and have significant oral health disparities.They often suffer from dental neglect due to limited access to appropriate professional dental care. These patients have chronic health situations and are treated with medications, which increase their risk of oral diseases. Despite the growth in elderly population in Israel, there is insufficient data regarding their oral health status and treatment needs. Objective. To describe the oral health status of the LTC hospitalized adults in a geriatric and psychiatric hospital in Israel. Methods. Data was recorded from LTC hospitalized adults with a physical and/or mental disabilities in a cross-sectional research design, which included general health anamnesis and clinical oral examination. Variables included gender, medicines, oral hygiene (OH), using dentures, number of caries lesions and residual teeth. Univariate analyses included Pearson χ2 and t-test analyses. Multivariate analyses included logistic and linear regressions while the outcome variables were categorical OH index and number of carious cavitations, number of residual teeth and carious teeth percentage. Results. 153 participants were included in the study with a mean age of 65.03 ± 18.67 years. 31.3% of the patients were edentulous, and only 14% had partial or full dentures. Females had a significantly higher number of caries cavitation than males (P = 0.044). The number of caries cavitation was higher among patients with poor OH (P < 0.001) and when taking Clonazepam (P = 0.018). Number of residual teeth was higher in the fair OH group (P < 0.001). Carious teeth percentage was higher among the poor OH group (P < 0.001). PMID:24949240

  11. 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 ...

  12. Long term trends in prevalence of neural tube defects in Europe: population based study

    PubMed Central

    Loane, Maria; de Walle, Hermien; Arriola, Larraitz; Addor, Marie-Claude; Barisic, Ingeborg; Beres, Judit; Bianchi, Fabrizio; Dias, Carlos; Draper, Elizabeth; Garne, Ester; Gatt, Miriam; Haeusler, Martin; Klungsoyr, Kari; Latos-Bielenska, Anna; Lynch, Catherine; McDonnell, Bob; Nelen, Vera; Neville, Amanda J; O’Mahony, Mary T; Queisser-Luft, Annette; Rankin, Judith; Rissmann, Anke; Ritvanen, Annukka; Rounding, Catherine; Sipek, Antonin; Tucker, David; Verellen-Dumoulin, Christine; Wellesley, Diana; Dolk, Helen

    2015-01-01

    Study question What are the long term trends in the total (live births, fetal deaths, and terminations of pregnancy for fetal anomaly) and live birth prevalence of neural tube defects (NTD) in Europe, where many countries have issued recommendations for folic acid supplementation but a policy for mandatory folic acid fortification of food does not exist? Methods This was a population based, observational study using data on 11 353 cases of NTD not associated with chromosomal anomalies, including 4162 cases of anencephaly and 5776 cases of spina bifida from 28 EUROCAT (European Surveillance of Congenital Anomalies) registries covering approximately 12.5 million births in 19 countries between 1991 and 2011. The main outcome measures were total and live birth prevalence of NTD, as well as anencephaly and spina bifida, with time trends analysed using random effects Poisson regression models to account for heterogeneities across registries and splines to model non-linear time trends. Summary answer and limitations Overall, the pooled total prevalence of NTD during the study period was 9.1 per 10 000 births. Prevalence of NTD fluctuated slightly but without an obvious downward trend, with the final estimate of the pooled total prevalence of NTD in 2011 similar to that in 1991. Estimates from Poisson models that took registry heterogeneities into account showed an annual increase of 4% (prevalence ratio 1.04, 95% confidence interval 1.01 to 1.07) in 1995-99 and a decrease of 3% per year in 1999-2003 (0.97, 0.95 to 0.99), with stable rates thereafter. The trend patterns for anencephaly and spina bifida were similar, but neither anomaly decreased substantially over time. The live birth prevalence of NTD generally decreased, especially for anencephaly. Registration problems or other data artefacts cannot be excluded as a partial explanation of the observed trends (or lack thereof) in the prevalence of NTD. What this study adds In the absence of mandatory fortification

  13. Methicillin-Resistant Staphylococcus aureus in Saarland, Germany: The Long-Term Care Facility Study

    PubMed Central

    Nillius, Dorothea; von Müller, Lutz; Wagenpfeil, Stefan; Klein, Renate; Herrmann, Mathias

    2016-01-01

    Background Multiresistant organisms pose a threat for patients and care recipients. Control interventions need to be tailored to region, the type of institution considered, and risk factors. The German state of Saarland is ideally suited to study colonisation epidemiology throughout its various health and care institutions. After conclusion of a large admission prevalence study in acute care hospitals, we now performed a methicillin-resistant Staphylococcus aureus (MRSA) point prevalence study in Saarland long term care facilities (LTCF), allowing for a direct comparison with respect of MRSA prevalence and associated risk factors between these two institutional types located within a confined region. Methodology and Principal Findings Of all LTCF of the region, 65/136 participated in the study performed between 09/2013 and 07/2014. Overall, complete microbiological specimen and questionnaires of 2,858 of 4,275 (66.8%) LTCF residents were obtained. 136/2,858 (4.8%) screened residents revealed MRSA carrier status. Multivariate risk factor analysis yielded ulcer/deep soft tissue infection, urinary tract catheter, and MRSA history with multiple MRSA decolonisation cycles to be independently associated with MRSA carrier status. Conclusion As already known from previous studies, colonisation with MRSA is common in LTCF residents even in an area with relatively low MRSA prevalence. This found prevalence can now be related to the acute care admission prevalence (2.2%) as well as to the admission prevalence in acute care geriatric departments (7.6%). The common clonal attribution (spa type) of MRSA isolates prevalent in the LTCF population as well as in the acute care admission population points towards a close relationship between both types of institutions. However, the ostensible absence of risk factors such as “previous hospitalisation” in conjunction with newly identified factors such as “multiple decolonisation cycles” refers to MRSA colonisation risks

  14. A Flying Qualities Study of Longitudinal Long-Term Dynamics of Hypersonic Planes

    NASA Technical Reports Server (NTRS)

    Cox, Timothy H.; Sachs, G.; Knoll, A.; Stich, R.

    1995-01-01

    The NASA Dryden Flight Research Center and the Technical University of Munich are cooperating in a research program to assess the impact of unstable long-term dynamics on the flying qualities of planes in hypersonic flight. These flying qualities issues are being investigated with a dedicated flight simulator for hypersonic vehicles located at NASA Dryden. Several NASA research pilots have flown the simulator through well defined steady-level turns with varying phugoid and height mode instabilities. The data collected include Pilot ratings and comments, performance measurements, and Pilot workload measurements. The results presented in this paper include design guidelines for height and Phugoid mode instabilities, an evaluation of the tapping method used to measure pilot workload, a discussion of techniques developed by the pilots to control large instabilities, and a discussion of how flying qualities of unstable long-term dynamics influence control Power design requirements.

  15. A flying qualities study of longitudinal long-term dynamics of hypersonic planes

    NASA Technical Reports Server (NTRS)

    Cox, T.; Sachs, G.; Knoll, A.; Stich, R.

    1995-01-01

    The NASA Dryden Flight Research Center and the Technical University of Munich are cooperating in a research program to assess the impact of unstable long-term dynamics on the flying qualities of planes in hypersonic flight. These flying qualities issues are being investigated with a dedicated flight simulator for hypersonic vehicles located at NASA Dryden. Several NASA research pilots have flown the simulator through well-defined steady-level turns with varying phugoid and height mode instabilities. Th data collected include pilot ratings and comments, performance measurements, and pilot workload measurements. The results presented in this paper include design guidelines for height and phugoid mode instabilities, an evaluation of the tapping method used to measure pilot workload, a discussion of techniques developed by the pilots to control large instabilities, and a discussion of how flying qualities of unstable long-term dynamics influence control power design requirements.

  16. Conditions for exercising residents' voting rights in long-term care residences: a prospective multicenter study.

    PubMed

    Bosquet, Antoine; El Massioui, Farid; Mahé, Isabelle

    2015-01-01

    To assess voting conditions in long-term care settings, we conducted a multicenter survey after the 2009 European elections in France. A questionnaire about voting procedures and European elections was proposed in 146 out of 884 randomized facilities. Sixty-four percent of facilities answered the questionnaire. Four percent of residents voted (national turnout: 40%), by proxy (58%) or at polling places (42%). Abstention related to procedural issues was reported in 32% of facilities. Sixty-seven percent of establishments had voting procedures, and 53% declared that they assessed residents' capacity to vote. Assistance was proposed to residents for voter registration, for proxy voting, and for voting at polling places, respectively, in 33%, 87%, and 80% of facilities. This survey suggests that residents may be disenfranchised and that more progress should be made to protect the voting rights of residents in long-term care facilities. PMID:25492566

  17. Surgical management of paranasal sinus mucoceles: a long-term study of 60 cases.

    PubMed

    Serrano, Elie; Klossek, Jean-Michel; Percodani, Josiane; Yardeni, Elie; Dufour, Xavier

    2004-07-01

    Paranasal sinus mucocele is a benign pseudocystic lesion, which may originate from any of the sinus cavities. Although the diagnosis may be suggested by the clinical presentation, CT is necessary to accurately analyze the regional anatomy and extent of the lesion. MRI is helpful in defining the limited unusual lesions occurring in critical areas. Standard treatment is surgical marsupialization, through endonasal sinus surgery, which offers a conservative, minimally invasive approach, and respects the sinus architecture and natural drainage. Our long-term experience with the endonasal endoscopic approach for the treatment of mucoceles led us to subsequently expand our indications to include most mucoceles, either as the sole approach or associated with an external approach. Comprising the surgical experience of two collaborating universities, this paper describes the indications for the endonasal surgical approach and the long-term postoperative followup. PMID:15243570

  18. Long-term photometric study of FK Com and HD 199178

    NASA Astrophysics Data System (ADS)

    Dimitrov, Dinko; Panov, Kiril

    The rapidly rotating active stars FK Com and HD 199178 are investigated using extensive long-term photometry. We look for periodicities in the long-term photometric behaviour of both stars, as well as for spots, using light curve modelling. The main result for FK Com is that the ``flip-flop'' phenomenon is a superposition of an oscillating process of activity and real and fast ``flip-flops''. For the oscillating component, we obtained a cycle of 5.8 yr. for FK Com and 4.2 yr. for HD 199178. Modelling of the light curves of both stars reveals a large high-latitude spot on each star and also smaller spots in the equatorial belt or at intermediate latitudes.

  19. Vigabatrin in the treatment of epilepsy: a long-term follow-up study.

    PubMed Central

    Tartara, A; Manni, R; Galimberti, C A; Mumford, J P; Iudice, A; Perucca, E

    1989-01-01

    Twenty-five adult epileptic patients who had shown a satisfactory clinical response to add-on vigabatrin under placebo-controlled conditions continued on long-term treatment for up to 47 months (median 22 months). The initially favourable therapeutic response was generally maintained throughout the observation period with an overall good clinical tolerance. No evidence of neurotoxicity was detected by multimodal evoked potentials monitoring. PMID:2661725

  20. Failure Analysis Study and Long-Term Reliability of Optical Assemblies with End-Face Damage

    NASA Technical Reports Server (NTRS)

    Kichak, Robert A.; Ott, Melanie N.; Leidecker, Henning W.; Chuska, Richard F.; Greenwell, Christopher J.

    2008-01-01

    In June 2005, the NESC received a multi-faceted request to determine the long term reliability of fiber optic termini on the ISS that exhibited flaws not manufactured to best workmanship practices. There was a lack of data related to fiber optic workmanship as it affects the long term reliability of optical fiber assemblies in a harsh environment. A fiber optic defect analysis was requested which would find and/or create various types of chips, spalls, scratches, etc., that were identified by the ISS personnel. Once the defects and causes were identified the next step would be to perform long term reliability testing of similar assemblies with similar defects. The goal of the defect analysis would be for the defects to be observed and documented for deterioration of fiber optic performance. Though this report mostly discusses what has been determined as evidence of poor manufacturing processes, it also concludes the majority of the damage could have been avoided with a rigorous process in place.

  1. Long-term results of BVS implantation: a focus on safety and efficacy of the bioresorbable technology.

    PubMed

    DEN Dekker, Wijnand K; VAN Geuns, Robert J; Diletti, Roberto

    2016-08-01

    The everolimus eluting bioresorbable vascular scaffold (BVS) represents a novel technology and a novel paradigm for treatment of coronary artery disease, with the potential of improving the long-term clinical outcomes after complete bioresorption. The increasing amount of clinical data is adding in a gradual understanding of the appropriate implantation technique, but long-term results after BVS implantation are sparse. In addition, concern related to a possible increased rate of scaffold thrombosis has recently risen. The present article reviews the current status of knowledge on bioresorbable vascular scaffold from the preclinical phase and the first-in-man experience to the recently reported large randomized trials. Challenging subsets are discussed as well as possible factors impacting on the occurrence of thrombotic events, particularly focusing on clinical outcomes reported in the longest follow-ups currently available. PMID:27175976

  2. Long-Term (Postnatal Day 70) Outcome and Safety of Intratracheal Transplantation of Human Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Neonatal Hyperoxic Lung Injury

    PubMed Central

    Ahn, So Yoon; Chang, Yun Sil; Kim, Soo Yoon; Sung, Dong Kyung; Kim, Eun Sun; Rime, So Yub; Yu, Wook Joon; Choi, Soo Jin; Oh, Won Il

    2013-01-01

    Purpose This study was performed to evaluate the long-term effects and safety of intratracheal (IT) transplantation of human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) in neonatal hyperoxic lung injury at postnatal day (P)70 in a rat model. Materials and Methods Newborn Sprague Dawley rat pups were subjected to 14 days of hyperoxia (90% oxygen) within 10 hours after birth and allowed to recover at room air until sacrificed at P70. In the transplantation groups, hUCB-MSCs (5×105) were administered intratracheally at P5. At P70, various organs including the heart, lung, liver, and spleen were histologically examined, and the harvested lungs were assessed for morphometric analyses of alveolarization. ED-1, von Willebrand factor, and human-specific nuclear mitotic apparatus protein (NuMA) staining in the lungs and the hematologic profile of blood were evaluated. Results Impaired alveolar and vascular growth, which evidenced by an increased mean linear intercept and decreased amount of von Willebrand factor, respectively, and the hyperoxia-induced inflammatory responses, as evidenced by inflammatory foci and ED-1 positive alveolar macrophages, were attenuated in the P70 rat lungs by IT transplantation of hUCB-MSCs. Although rare, donor cells with human specific NuMA staining were persistently present in the P70 rat lungs. There were no gross or microscopic abnormal findings in the heart, liver, or spleen, related to the MSCs transplantation. Conclusion The protective and beneficial effects of IT transplantation of hUCB-MSCs in neonatal hyperoxic lung injuries were sustained for a prolonged recovery period without any long-term adverse effects up to P70. PMID:23364976

  3. REVIEW OF RESULTS FOR THE OECD/NEA PHASE VII BENCHMARK: STUDY OF SPENT FUEL COMPOSITIONS FOR LONG TERM DISPOSAL

    SciTech Connect

    Radulescu, Georgeta; Wagner, John C

    2011-01-01

    This paper summarizes the problem specification and compares participants results for the OECD/NEA/WPNCS Expert Group on Burn-up Credit Criticality Safety Phase VII Benchmark Study of Spent Fuel Compositions for Long-Term Disposal. The Phase VII benchmark was developed to study the ability of relevant computer codes and associated nuclear data to predict spent fuel isotopic compositions and corresponding keff values in a cask configuration over the time duration relevant to spent nuclear fuel (SNF) disposal. The benchmark was divided into two sets of calculations: (1) decay calculations out to 1,000,000 years for provided pressurized-water-reactor (PWR) UO2 discharged fuel compositions and (2) burnup credit criticality calculations for a representative cask model at selected time steps. Contributions from 15 organizations and companies in 10 countries were submitted to the Phase VII benchmark exercise. This paper provides a description of the Phase VII benchmark and detailed comparisons of the participants isotopic compositions and keff values that were calculated with a diversity of computer codes and nuclear data sets. Differences observed in the calculated time-dependent nuclide densities are attributed to different decay data or code-specific numerical approximations. The variability of the keff results is consistent with the evaluated uncertainty associated with cross-section data.

  4. Sustained favorable long-term outcome in the treatment of schizophrenia: a 3-year prospective observational study

    PubMed Central

    2011-01-01

    Background This study of chronically ill patients with schizophrenia aimed to identify patients who achieve sustained favorable long-term outcome - when the outcome incorporates severity of symptoms, level of functioning, and use of acute care services - and to identify the best baseline predictors of achieving this sustained favorable long-term outcome. Methods Using data from the United States Schizophrenia Care and Assessment Program (US-SCAP) (N = 2327), a large 3-year prospective, multisite, observational study of individuals treated for schizophrenia in the US, a hierarchical cluster analysis was performed to group patients based upon baseline symptom severity. Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS) scores, level of functioning, and use of acute care services. Level of functioning reflected patient-reported productivity and clinician-rated occupational role functioning. Use of acute care services reflected self-reported psychiatric hospitalization and emergency service use. Change of health state was determined over the 3-year period. A patient was classified as having a sustained favorable long-term outcome if their health state values had the closest distance to the defined "best baseline cluster" at each point over the length of the study. Stepwise logistic regression was used to determine baseline predictors of sustained favorable long-term outcome. Results At baseline, 5 distinct health state clusters were identified, ranging from "best" to "worst." Of 1635 patients with sufficient data, only 157 (10%) experienced sustained favorable long-term outcome during the 2-years postbaseline. The baseline predictors associated with sustained favorable long-term outcome included better quality of life, more daily activities, patient-reported clearer thinking from medication, better global functioning, being employed, not being a victim of a crime, not having received individual therapy, and not having received help

  5. On the feasibility of tracking with differential-algebra maps in long-term stability studies for large hadron colliders

    SciTech Connect

    Kleiss, R.; Schmidt, F.; Yan, Y.

    1992-01-01

    A time-saving alternative to conventional element-by-element tracking in long-term stability studies is the use of truncated Taylor maps. This report discusses how the non-symplecticity of a moderately high-order truncated Taylor map affects its reliability when the map is used for tracking over several thousand turns. Various machines and two different map-constructing programs are compared. It is found that the discrepancies between the Taylor map results and those obtained by direct tracking grow with amplitude. Thus, such maps are not guaranteed to be sufficient for long-term tracking over millions of turns without suitable symplectification.

  6. Pilot Study on Long Term Effects of HZE Exposure on the Canine Brain

    NASA Astrophysics Data System (ADS)

    Budinger, T.; Brennan, K.; Pearlstein, R.

    A ground-based pilot experiment was initiated in December 1992 to evaluate the long term effects on health and aging after HZE cosmic radiation of the canine brain. Six adult male beagle dogs (1 yr) from the UC Davis breeding colony at the Laboratory for Energy Related Health Research were researched in this study. Iron nuclei at 600 MeV/amu (180 keV/mm) were used to irradiate the whole brain. The fluence of 3 x 106 iron nuclei/ cm2 mimics the HZE exposure (all > He) for a 2- year mission to Mars. The HZE irradiation was a fully stripped iron particle beam at the LBNL BEVALAC. Using a Raster Scanner we were able to spread the beam to deliver a uniform dose over the brain. The total dose to the brain was 200 cGy. Four dogs were whole brain irradiated with iron and two dogs served as litter-mate controls. The control dogs received a similar amount of background neutron irradiation as the irradiated dogs. One of the control dogs died suddenly 3/98 of intestinal cancer unrelated to the brain irradiation. That brain was not harvested before autolysis had prevented analysis. Periodic PET metabolism and yearly MRI studies have been done on these dog's brain since irradiation. All dogs had yearly physical, neurological and blood chemistry work-ups. PET imaging was performed with the Donner 600-crystal high-resolution PET (2.6 mm resolution) and with the commercial PET, CTI/Siemens ECAT 951 PET Scanner (5 mm resolution). NMR imaging is performed with the 1 5T GE Signa at UCSF using T spoiled gradient imaging.1 sequences for T1 contrast at 1 mm resolution as well as a T2 weighted spin echo imaging sequence at 1 mm resolution. A major goal of this work is to present an accurate method for measuring surface areas and volumes of the irradiated vs the non-irradiated canine brain using MRI data which are isotropic in resolution at the 1 mm level. This allows us to monitor the changes in brain size with aging and radiation exposure. Nine years post irradiation, these dog brains

  7. Simulation of long term renewable energy feed-in for European power system studies

    NASA Astrophysics Data System (ADS)

    Kies, Alexander; Nag, Kabitri; von Bremen, Lueder; Lorenz, Elke; Heinemann, Detlev; Späth, Stephan

    2014-05-01

    Renewable energies already play a remarkable role in Europe as of today. It is expected that wind and solar amongst other renewables will contribute strongly to the future European energy generation. However, wind and solar generation facilities have due to the weather dependent nature of their resources highly fluctuating feed-in profiles. To overcome the mismatch between energy demand and generation it is important to study and understand the generation patterns and balancing potentials. The goal of the current work is to investigate how the feed-in time series from different renewable sources like on- and offshore wind, photovoltaic, solar thermal, wave, hydro, geothermal and biomass power and combination of them look like in an European power supply system . The work is part of the RESTORE 2050 project (BMU) that investigates the requirements for cross-country grid extensions, usage of storage technologies and capacities, the development of new balancing technologies and the conceptual design of the future energy market which is suitable for high generation percentages of solar and wind. High temporally and spatially resolved long term weather data from COSMO-EU, MERRA and Meteosat (MFG/MSG) satellite data has been used to simulate feed-in from several types of renewable energy sources on a 7 x 7 km grid covering Europe. For wind speeds MERRA reanalysis data has been statistically downscaled to account for orography. Generation was aggregated on the country level and production patterns and their variations in time of different resources were investigated for the years ranging from 2002 to 2012. In a first step the quality of the simulated feed in time series has been investigated by comparison to real observations of wind power and PV generation. Furthermore, some sensitivity studies with respect to underlying assumptions like spatial distribution of wind and PV capacities, the chosen hub-height and wind power curve have been done and will be presented. While

  8. Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

    PubMed Central

    Bogan, Richard K.; Bornemann, Michel A. Cramer; Kushida, Clete A.; Trân, Pierre V.; Barrett, Ronald W.

    2010-01-01

    OBJECTIVE: To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome (RLS). PATIENTS AND METHODS: This study (conducted April 18, 2006, to November 14, 2007) comprised a 24-week, single-blind (SB) treatment phase (gabapentin enacarbil, 1200 mg) followed by a 12-week randomized, double-blind (DB) phase. Responders from the SB phase (patients with improvements on the International Restless Legs Scale [IRLS] and investigator-rated Clinical Global Impression–Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization) were randomized to gabapentin enacarbil, 1200 mg, or placebo once daily at 5 pm with food. The primary end point was the proportion of patients experiencing relapse (worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy) during the DB phase. RESULTS: A total of 221 of 327 patients completed the SB phase, 194 (96 in the gabapentin enacarbil group and 98 in the placebo group) were randomized to DB treatment, and 168 (84 in the gabapentin enacarbil group and 84 in the placebo group) completed the DB phase. A significantly smaller proportion of patients treated with gabapentin enacarbil (9/96 [9%]) experienced relapse compared with the placebo-treated patients (22/97 [23%]) (odds ratio, 0.353; 95% confidence interval, 0.2-0.8; P=.02). Somnolence and dizziness were the most common adverse events. One death occurred (unintentional choking during the SB phase) and was judged as being unrelated to the study drug. No clinically relevant changes were observed in laboratory values, in vital signs, or on electrocardiograms. CONCLUSION: Gabapentin enacarbil, 1200 mg, maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to

  9. Bleeding Risk with Long-Term Low-Dose Aspirin: A Systematic Review of Observational Studies

    PubMed Central

    García Rodríguez, Luis A.; Martín-Pérez, Mar; Hennekens, Charles H.; Rothwell, Peter M.; Lanas, Angel

    2016-01-01

    Background Low-dose aspirin has proven effectiveness in secondary and primary prevention of cardiovascular events, but is also associated with an increased risk of major bleeding events. For primary prevention, this absolute risk must be carefully weighed against the benefits of aspirin; such assessments are currently limited by a lack of data from general populations. Methods Systematic searches of Medline and Embase were conducted to identify observational studies published between 1946 and 4 March 2015 that reported the risks of gastrointestinal (GI) bleeding or intracranial hemorrhage (ICH) with long-term, low-dose aspirin (75–325 mg/day). Pooled estimates of the relative risk (RR) for bleeding events with aspirin versus non-use were calculated using random-effects models, based on reported estimates of RR (including odds ratios, hazard ratios, incidence rate ratios and standardized incidence ratios) in 39 articles. Findings The incidence of GI bleeding with low-dose aspirin was 0.48–3.64 cases per 1000 person-years, and the overall pooled estimate of the RR with low-dose aspirin was 1.4 (95% confidence interval [CI]: 1.2–1.7). For upper and lower GI bleeding, the RRs with low-dose aspirin were 2.3 (2.0–2.6) and 1.8 (1.1–3.0), respectively. Neither aspirin dose nor duration of use had consistent effects on RRs for upper GI bleeding. The estimated RR for ICH with low-dose aspirin was 1.4 (1.2–1.7) overall. Aspirin was associated with increased bleeding risks when combined with non-steroidal anti-inflammatory drugs, clopidogrel and selective serotonin reuptake inhibitors compared with monotherapy. By contrast, concomitant use of proton pump inhibitors decreased upper GI bleeding risks relative to aspirin monotherapy. Conclusions The risks of major bleeding with low-dose aspirin in real-world settings are of a similar magnitude to those reported in randomized trials. These data will help inform clinical judgements regarding the use of low-dose aspirin

  10. Results of the Recent Immigrant Pregnancy and Perinatal Long-term Evaluation Study (RIPPLES)

    PubMed Central

    Ray, Joel G.; Vermeulen, Marian J.; Schull, Michael J.; Singh, Gita; Shah, Rajiv; Redelmeier, Donald A.

    2007-01-01

    Background People who immigrate to Western nations may experience fewer chronic health problems than original residents of those countries, which raises concerns about long-term environmental or lifestyle factors in those countries. We tested whether the “healthy immigrant effect” extends to the risk of placental dysfunction during the short interval of pregnancy. Methods We conducted a population-based retrospective cohort study of data for 796 105 women who had a first documented obstetric delivery in Ontario between 1995 and 2005. Recency of immigration was determined for each woman as the time from her enrolment in universal health insurance to her date of delivery, classified as less than 3 months, 3–5 months, 6–11 months, 12–23 months, 24–35 months, 36–47 months, 48–59 months and 5 years or more (the referent). The primary composite outcome was maternal placental syndrome (defined as a diagnosis of pre-eclampsia or eclampsia, placental abruption or placental infarction). Results The mean age of the women was 28.8 years. Maternal placental syndrome occurred in 45 216 women (5.7%). The risk of this outcome was lowest among the women who had immigrated less than 3 months before delivery (3.8%) and highest among those living in Ontario at least 5 years (6.0%), for a crude odds ratio (OR) of 0.62 (95% confidence interval [CI] 0.54–0.71). After adjustment for maternal age, income status, pre-existing hypertension, diabetes mellitus, multiple gestation and receipt of prenatal ultrasonography, the risk of maternal placental syndrome was correlated with the number of months since immigration in a gradient manner (OR, 95% CI): less than 3 months (0.53, 0.47–0.61), 3–5 months (0.68, 0.61–0.76), 6–11 months (0.67, 0.63–0.71), 12–23 months (0.69, 0.66–0.73), 24–35 months (0.75, 0.70–0.79), 36–47 months (0.75, 0.70–0.80) and 48–59 months (0.82, 0.77–0.87). Interpretation There was a progressively lower risk of maternal placental

  11. Long-term safety and tolerability of long-acting injectable risperidone in patients with schizophrenia or schizoaffective disorder.

    PubMed

    Lindenmayer, Jean-Pierre; Khan, Akbar; Eerdekens, Mariëlle; Van Hove, Ilse; Kushner, Stuart

    2007-01-15

    Subjects were patients with schizophrenia or schizoaffective disorder enrolled in extension studies (Study A and Study B) after participating in 12-week studies of long-acting injectable risperidone [Kane, J.M., Eerdekens, M., Lindenmayer, J.-P., Keith, S.J., Lesem, M., Karcher, K., 2003. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am. J. Psychiatry 160, 1125-1132; Lindenmayer, J.-P., Eerdekens, L., Berry, S., Eerdekens, M., 2004. Safety and efficacy of long-acting risperidone in schizophrenia: a 12-week, multicenter, open-label study in stable patients switched from typical and atypical oral antipsychotics. J. Clin. Psychiatry 65, 1084-1089]. Twelve months of treatment were completed by 55% of Study A patients and 52% of Study B patients. The median modal dose of long-acting injectable risperidone was 50 mg/14 days in both studies. Most frequent adverse events were psychosis, headache, insomnia, agitation, and rhinitis. EPS-related adverse events were reported in 33% of patients in Study A and 22% in Study B. Patients with Clinical Global Impressions ratings of "not ill" and "mild" increased from 14% at baseline to 54% at endpoint in Study A and from 42% to 65% in Study B. It is concluded that treatment with long-acting injectable risperidone for 1 year or longer appeared to be safe and well tolerated in patients with schizophrenia or schizoaffective disorder. PMID:17049818

  12. Long-Term Immunogenicity Studies of Formalin-Inactivated Enterovirus 71 Whole-Virion Vaccine in Macaques

    PubMed Central

    Liu, Chia-Chyi; Hwang, Chyi-Sing; Yang, Wun-Syue; Tsai, Dan-Chin; Wu, Sze-Hsien; Chou, Ai-Hsiang; Chow, Yen-Hung; Wu, Suh-Chin; Wang, Jen-Ren; Chiang, Jen-Ron; Huang, Chin-Cheng; Pan, Chien-Hsiung; Chong, Pele

    2014-01-01

    Enterovirus 71 (EV71) has caused epidemics of hand, foot and mouth diseases in Asia during the past decades and no vaccine is available. A formalin-inactivated EV71 candidate vaccine (EV71vac) based on B4 subgenotype has previously been developed and found to elicit strong neutralizing antibody responses in mice and humans. In this study, we evaluated the long-term immunogenicity and safety of this EV71vac in a non-human primate model. Juvenile macaques were immunized at 0, 3 and 6 weeks either with 10 or 5 µg doses of EV71vac formulated with AlPO4 adjuvant, or PBS as control. During the 56 weeks of studies, no fever nor local redness and swelling at sites of injections was observed in the immunized macaques. After single immunization, 100% seroconversion based on 4-fold increased in neutralization titer (Nt) was detected in EV71vac immunized monkeys but not PBS controls. A dose-dependent IgG antibody response was observed in monkeys receiving EV71vac immunization. The Nt of EV71vac immunized macaques had reached the peak after 3 vaccinations, then decreased gradually; however, the GMT of neutralizing antibody in the EV71vac immunized macaques were still above 100 at the end of the study. Correspondingly, both dose- and time-dependent interferon-γ and CD4+ T cell responses were detected in monkeys receiving EV71vac. Interestingly, similar to human responses, the dominant T cell epitopes of macaques were identified mainly in VP2 and VP3 regions. In addition, strong cross-neutralizing antibodies against most EV71 subgenotypes except some C2 and C4b strains, and Coxsackievirus A16 were observed. In summary, our results indicate that EV71vac elicits dose-dependent T-cell and antibody responses in macaques that could be a good animal model for evaluating the long-term immune responses elicited by EV71 vaccines. PMID:25197967

  13. Does Student Philanthropy Work? A Study of Long-Term Effects of the "Learning by Giving" Approach

    ERIC Educational Resources Information Center

    Olberding, Julie Cencula

    2012-01-01

    Student philanthropy is a teaching strategy designed to engage students actively in the curriculum, increase awareness of social needs and nonprofit organizations, and teach grant-writing and grant-making skills. This is the first study to examine long-term effects of student philanthropy by surveying alumni years after their experience with this…

  14. Long-Term Impact of On-Demand Professional Development on Student Performance: A Longitudinal Multi-State Study

    ERIC Educational Resources Information Center

    Shaha, Steven H.; Glassett, Kelly F.; Ellsworth, Heather

    2015-01-01

    The long-term effects of Professional Development (PD) on educators' ability to affect student performance remain virtually unstudied. This quasi-experimental, longitudinal study compared student achievement scores from 25 states and 78 school districts over multiple years for schools whose teachers used an online, on-demand professional…

  15. ORAL TOXICITY OF 1,3-DICHLOROPROPANE: ACUTE, SHORT-TERM, AND LONG-TERM STUDIES IN RATS

    EPA Science Inventory

    The objective of this investigation was to characterize the acute and short- and long-term toxic potency of orally administered 1,2-dichloropropane (DCP). In the acute and short-term studies, male rats of 250-300 g were gavaged with 0, 100, 250, 500, or 1000 mg DCP/kg in corn oil...

  16. Long Term Follow-up of Vocational Education Graduates: A Study Based on Federal Income Tax Data.

    ERIC Educational Resources Information Center

    Ghazalah, I. A.

    A study used federal income tax data to examine the long-term earning, unemployment, and interregional mobility patterns among 15,055 persons who graduated from 14 Ohio vocational education programs in 1979. Income data on the graduates' income earned during the 1983 tax year were also compared with U.S. Census Bureau data on 1983 Money Income of…

  17. Four-year weight losses in the Look AHEAD study: Factors associated with long-term success

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This report provides a further analysis of the year 4 weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with long-term success. A total of 5,145 overweight/obese men and women with type 2 diabetes were randomly assigned to an intensive lifestyle ...

  18. The Long Term Effect of Employment Counselling on Disadvantaged Youth: A Four Year Follow-Up Study.

    ERIC Educational Resources Information Center

    Pitt, Don; And Others

    This study compared the long-term employment and educational status of disadvantaged youth who had received employment counseling at the Peterborough (Ontario) Employment Planning and Youth Career Centre (EPYC) in 1982-1983 with the status of youth who had not. EPYC subjects were 40 females and 64 males, 43 of whom had less than a grade 12…

  19. The Chronicity of Self-Injurious Behaviour: A Long-Term Follow-Up of a Total Population Study

    ERIC Educational Resources Information Center

    Taylor, Lorne; Oliver, Chris; Murphy, Glynis

    2011-01-01

    Background: Self-injurious behaviour (SIB) is a relatively common problem for people with intellectual disabilities and it is known to be associated with various risk markers, such as degree of disability, sensory impairments, and autism (McClintock "et al." 2003). Less is known about its long-term course however. Method: The present study was…

  20. The Long-Term Impact of Admission Policies: A Comparative Study of Two Emergent Research Institutions in Texas

    ERIC Educational Resources Information Center

    Crisp, Gloria; Horn, Catherine; Dizinno, Gerry; Barlow, Libby

    2013-01-01

    The present study explored the long-term impact of admission policies at two aspiring research institutions in Texas. Six years of longitudinal institutional data were analyzed for all full-time first time in college undergraduate students at both universities. Descriptive and inferential statistics were used to identify relationships and…

  1. A Grateful Recollecting: A Qualitative Study of the Long-Term Impact of Service-Learning on Graduates

    ERIC Educational Resources Information Center

    Fullerton, Ann; Reitenauer, Vicki L.; Kerrigan, Seanna M.

    2015-01-01

    Service-learning practitioners design community engagement activities to affect students in powerful and even transformative ways. This qualitative study explores the long-term impacts (3-16 years after graduation) of participation in a senior-level service-learning course. Through interviews with 20 randomly selected participants, the researchers…

  2. Disruption in proprioception from long-term thalamic deep brain stimulation: a pilot study

    PubMed Central

    Semrau, Jennifer A.; Herter, Troy M.; Kiss, Zelma H.; Dukelow, Sean P.

    2015-01-01

    Deep brain stimulation (DBS) is an excellent treatment for tremor and is generally thought to be reversible by turning off stimulation. For tremor, DBS is implanted in the ventrointermedius (Vim) nucleus of the thalamus, a region that relays proprioceptive information for movement sensation (kinaesthesia). Gait disturbances have been observed with bilateral Vim DBS, but the long-term effects on proprioceptive processing are unknown. We aimed to determine whether Vim DBS surgical implantation or stimulation leads to proprioceptive deficits in the upper limb. We assessed two groups of tremor subjects on measures of proprioception (kinaesthesia, position sense) and motor function using a robotic exoskeleton. In the first group (Surgery), we tested patients before and after implantation of Vim DBS, but before DBS was turned on to determine if proprioceptive deficits were inherent to tremor or caused by DBS implantation. In the second group (Stim), we tested subjects with chronically implanted Vim DBS ON and OFF stimulation. Compared to controls, there were no proprioceptive deficits before or after DBS implantation in the Surgery group. Surprisingly, those that received chronic long-term stimulation (LT-stim, 3–10 years) displayed significant proprioceptive deficits ON and OFF stimulation not present in subjects with chronic short-term stimulation (ST-stim, 0.5–2 years). LT-stim had significantly larger variability and reduced workspace area during the position sense assessment. During the kinesthetic assessment, LT-stim made significantly larger directional errors and consistently underestimated the speed of the robot, despite generating normal movement speeds during motor assessment. Chronic long-term Vim DBS may potentially disrupt proprioceptive processing, possibly inducing irreversible plasticity in the Vim nucleus and/or its network connections. Our findings in the upper limb may help explain some of the gait disturbances seen by others following Vim DBS

  3. Long-term low-level arsenic exposure is associated with poorer neuropsychological functioning: a Project FRONTIER study.

    PubMed

    O'Bryant, Sid E; Edwards, Melissa; Menon, Chloe V; Gong, Gordon; Barber, Robert

    2011-03-01

    Exposure to elements in groundwater (toxic or beneficial) is commonplace yet, outside of lead and mercury, little research has examined the impact of many commonly occurring environmental exposures on mental abilities during the aging process. Inorganic arsenic is a known neurotoxin that has both neurodevelopmental and neurocognitive consequences. The aim of this study was to examine the potential association between current and long-term arsenic exposure and detailed neuropsychological functioning in a sample of rural-dwelling adults and elders. Data were analyzed from 434 participants (133 men and 301 women) of Project FRONTIER, a community-based participatory research study of the epidemiology of health issues of rural-dwelling adults and elders. The results of the study showed that GIS-based groundwater arsenic exposure (current and long-term) was significantly related to poorer scores in language, visuospatial skills, and executive functioning. Additionally, long-term low-level exposure to arsenic was significantly correlated to poorer scores in global cognition, processing speed and immediate memory. The finding of a correlation between arsenic and the domains of executive functioning and memory is of critical importance as these are cognitive domains that reflect the earliest manifestations of Alzheimer's disease. Additional work is warranted given the population health implications associated with long-term low-level arsenic exposure. PMID:21556183

  4. GuLF Study: The Gulf Long-Term Follow-Up Study

    MedlinePlus

    ... of Environment, Lifestyle & Fibroids (SELF) Studies Study of Environment, Lifestyle & Fibroids (SELF) Study of Estrogen Activity and Development (SEAD) Soy Study Studies Study of Estrogen Activity ...

  5. A Long-Term Experimental Study Demonstrates the Costs of Begging That Were Not Found over the Short Term

    PubMed Central

    Soler, Manuel; Ruiz-Raya, Francisco; Carra, Laura G.; Medina-Molina, Eloy; Ibáñez-Álamo, Juan Diego; Martín-Gálvez, David

    2014-01-01

    Parent–offspring conflict theory predicts that begging behaviour could escalate continuously over evolutionary time if it is not prevented by costliness of begging displays. Three main potential physiological costs have been proposed: growth, immunological and metabolic costs. However, empirical evidence on this subject remains elusive because published results are often contradictory. In this study, we test for the existence of these three potential physiological costs of begging in house sparrow (Passer domesticus) nestlings by stimulating a group of nestlings to beg for longer and another group for shorter periods than in natural conditions. All nestlings were fed with the same quantity of food. Our study involves a long-term experimental treatment for begging studies (five consecutive days). Long-term studies frequently provide clearer results than short-term studies and, sometimes, relevant information not reported by the latter ones. Our long-term experiment shows (i) a clear effect on the immune response even since the first measurement (6 hours), but it was higher during the second (long-term) than during the first (short-term) test; (ii) evidence of a growth cost of begging in house sparrow nestlings not previously found by other studies; (iii) body condition was affected by our experimental manipulation only after 48 hour; (iv) a metabolic cost of begging never previously shown in any species, and (v) for the first time, it has shown a simultaneous effect of the three potential physiological costs of begging: immunocompetence, growth, and metabolism. This implies first, that a multilevel trade-off can occur between begging and all physiological costs and, second, that a lack of support in a short-term experiment for the existence of a tested cost of begging does not mean absence of that cost, because it can be found in a long-term experiment. PMID:25372280

  6. A long-term experimental study demonstrates the costs of begging that were not found over the short term.

    PubMed

    Soler, Manuel; Ruiz-Raya, Francisco; Carra, Laura G; Medina-Molina, Eloy; Ibáñez-Álamo, Juan Diego; Martín-Gálvez, David

    2014-01-01

    Parent-offspring conflict theory predicts that begging behaviour could escalate continuously over evolutionary time if it is not prevented by costliness of begging displays. Three main potential physiological costs have been proposed: growth, immunological and metabolic costs. However, empirical evidence on this subject remains elusive because published results are often contradictory. In this study, we test for the existence of these three potential physiological costs of begging in house sparrow (Passer domesticus) nestlings by stimulating a group of nestlings to beg for longer and another group for shorter periods than in natural conditions. All nestlings were fed with the same quantity of food. Our study involves a long-term experimental treatment for begging studies (five consecutive days). Long-term studies frequently provide clearer results than short-term studies and, sometimes, relevant information not reported by the latter ones. Our long-term experiment shows (i) a clear effect on the immune response even since the first measurement (6 hours), but it was higher during the second (long-term) than during the first (short-term) test; (ii) evidence of a growth cost of begging in house sparrow nestlings not previously found by other studies; (iii) body condition was affected by our experimental manipulation only after 48 hour; (iv) a metabolic cost of begging never previously shown in any species, and (v) for the first time, it has shown a simultaneous effect of the three potential physiological costs of begging: immunocompetence, growth, and metabolism. This implies first, that a multilevel trade-off can occur between begging and all physiological costs and, second, that a lack of support in a short-term experiment for the existence of a tested cost of begging does not mean absence of that cost, because it can be found in a long-term experiment. PMID:25372280

  7. Long-term efficacy and safety of otilonium bromide in the management of irritable bowel syndrome: a literature review

    PubMed Central

    Triantafillidis, John K; Malgarinos, George

    2014-01-01

    Irritable bowel syndrome (IBS) is a very common functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits. The disease affects a large part of the world population. The clinical course is mostly characterized by a cyclic recurrence of symptoms. Therefore, IBS patients should receive, as an initial therapeutic approach, a short course of treatment, and long-term treatment should be reserved for those patients with recurrent symptoms. The available clinical trials show that significant improvement of the symptoms over placebo could be achieved with various drugs, although this improvement is frequently time dependent and with high relapse rates after the cessation of the treatment. In a proportion of patients, clinically obvious relapse could appear long after stopping the treatment. Some of the available pharmacologic agents, including otilonium bromide (OB), are able to significantly prolong the time to the appearance of relapse, compared with placebo. As a consequence, some authors suggest that a cyclic treatment could be of benefit. Antispasmodic drugs have been used for many years in an effort to control the symptoms of IBS. OB is a poorly absorbed spasmolytic drug, exerting significantly greater control of the symptoms of IBS compared with placebo. Recent data suggest that the drug could effectively be used for the long-term management of patients with IBS. The aim of this review is to provide the reader with an evidence-based overview of the efficacy and tolerability of OB in the long-term management of IBS patients, based on the results of the clinical trials published so far. PMID:24741324

  8. Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry.

    PubMed

    Diemberger, Igor; Parisi, Quintino; De Filippo, Paolo; Narducci, Maria Lucia; Zanon, Francesco; Potenza, Domenico Rosario; Ciaramitaro, Gianfranco; Malacrida, Maurizio; Boriani, Giuseppe; Biffi, Mauro

    2015-10-01

    The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness. PMID:26282191

  9. Long-term photometric study of FK Comae Berenices and HD 199178

    NASA Astrophysics Data System (ADS)

    Panov, K.; Dimitrov, D.

    2007-05-01

    Aims:The rapidly rotating active stars FK Com and HD 199178 are investigated using extensive long-term photometry. The data set includes previously unpublished photometry, obtained at the Rozhen National Astronomical Observatory. We look for periodicities in the long-term photometric behaviour of both stars, as well as for spots, using light curve modelling. Special attention is paid to the behaviour of the "flip-flop" phenomenon. Methods: Light curves in UBV of FK Com and HD 199178 are used to construct an O-C diagram for each star, and they are modelled to obtain spot distribution. Results: The main result for FK Com is that the "flip-flop" phenomenon is a superposition of an oscillating process of activity and real and fast "flip-flops". For the oscillating component, we obtained a cycle of 5.8 years. The same cycle is also present in other photometric characteristics. The O-C diagram for HD 199178 shows a cycle of 4.2 years. Modelling of the light curves of both stars reveals a large high-latitude spot on each star and also smaller spots in the equatorial belt or at intermediate latitudes. Tables 2, 3, and 5 are only available in electronic form at the CDS via anonymous ftp to cdsarc.u-strasbg.fr (130.79.128.5) or via http://cdsweb.u-strasbg.fr/cgi-bin/qcat?J/A+A/467/229

  10. Long-term follow-up study of gastroduodenal lesions after radioembolization of hepatic tumors

    PubMed Central

    Rodríguez-Lago, Iago; Carretero, Cristina; Herráiz, Maite; Subtil, José C; Betés, Maite; Rodríguez-Fraile, Macarena; Sola, Jesús J; Bilbao, José I; Muñoz-Navas, Miguel; Sangro, Bruno

    2013-01-01

    AIM: To evaluate the long-term natural history of the gastroduodenal lesions secondary to extrahepatic embolization with Ytrium 90 (90Y) spheres. METHODS: From September 2003 to January 2012, 379 procedures of liver radioembolization (RE) using resin microspheres loaded with 90Y were performed in our center. We have retrospectively compiled the data from 379 RE procedures performed in our center. We report a comprehensive clinical, analytical, endoscopic and histologic long-term follow-up of a series of patients who developed gastroduodenal lesions after the treatment. RESULTS: Six patients (1.5%) developed gastrointestinal symptoms and had gastrointestinal lesions as shown by upper endoscopy in the next 12 wk after RE. The mean time between RE and the appearance of symptoms was 5 wk. Only one patient required endoscopic and surgical treatment. The incidence of gastrointestinal ulcerations was 3.75% (3/80) when only planar images were used for the pre-treatment evaluation. It was reduced to 1% (3/299) when single-photon emission computed tomography (SPECT) images were also performed. The symptoms that lasted for a longer time were nausea and vomiting, until 25 mo after the treatment. CONCLUSION: All patients were free from severe symptoms at the end of follow-up. The routine use of SPECT has decreased the incidence of gastrointestinal lesions due to unintended deployment of 90Y particles. PMID:23704826

  11. Long-term lamivudine for chronic hepatitis B and cirrhosis: A real-life cohort study

    PubMed Central

    Su, Ming-Hua; Lu, Ai-Lian; Li, Shi-Hua; Zhong, Shao-Hua; Wang, Bao-Jian; Wu, Xiao-Li; Mo, Yan-Yan; Liang, Peng; Liu, Zhi-Hong; Xie, Rong; He, Li-Xia; Fu, Wu-Dao; Jiang, Jian-Ning

    2015-01-01

    lower than that of the control group; the three-, and five-year cumulative rates were 0% vs 3.2% and 1.1% vs 3.2% (P = 0.05), respectively. The incidence of HCC in LC at baseline of LAM was lower than that of the control group: 9.8% (5/51) vs 25.0% (12/48), and the three-, and five-year cumulative rates were 4.5% vs 20.7% and 8.1% vs 37.5% (P < 0.01), respectively. The mortality rate in the LAM group was lower than the control group. CONCLUSION: Standardized long-term LAM treatment in combination with comprehensive management can reduce the incidence rates of LC and HCC as well as hepatitis B virus-related deaths. PMID:26673249

  12. 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

  13. 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

  14. Long-term development of the Czech landscape studied on the basis of old topographic maps

    NASA Astrophysics Data System (ADS)

    Skokanová, H.; Havlíček, M.

    2009-04-01

    The paper deals with long-term land use changes in the Czech Republic with the help of old topographic maps. Departments of Landscape Ecology and GIS Applications from the Silva Tarouca Research Institute for Landscape and Ornamental Gardening, v.v.i. study these changes mainly in the research project MSM 6293359101 Research into sources and indicators of biodiversity in cultural landscape in the context of its fragmentation dynamics, the subpart Quantitative analysis of the dynamics of the Czech landscape development. In this paper, the authors concentrate mainly on map sources, which were acquired for the purpose of the project and also introduce partial results. Maps, which are the sources for the analyses, are following: maps from 2nd Austrian military survey in the scale 1:28 800 (created for the territory of the Czech Republic in the period 1836-1852), maps from 3rd Austrian military survey in the scale 1:25 000 (created for the Czech Republic in the period 1876-1880), Czechoslovak military topographic maps in the scale 1:25 000 from 1950s and 1990s, and Czech topographic base maps in the scale 1:10 000 from 2002-2006. It is necessary to complete maps of the 2nd and 3rd Austrian military survey thanks to their incompleteness, mainly along state borders. Also maps from 1nd Austrian military survey in the scale 1:28 800 (created for the Czech Republic in the period 1764-1783) are available; however, their usage for the accurate analyses in the GIS environment is restricted by their poor cartographic accuracy. Apart of the above mentioned maps, there has been progress in collecting maps from the interwar and war period (revised maps of the 3rd Austrian military survey maps, maps of the provisional military survey from 1923-1933, maps of definitive military survey from 1934-1938 and maps from survey of Moravian part of the Protectorate of Bohemia and Moravia, so called Messtischblätter from 1939-1945). Maps from five periods are manually vectorised in the GIS

  15. 75 FR 62132 - Proposed Collection; Comment Request; GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-07

    ...: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers SUMMARY: In compliance.... Proposed Collection: Title: Gulf Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up... associated with oil spill clean-up activities and exposures surrounding the Deepwater Horizon disaster;...

  16. Oligometastases Treated With Stereotactic Body Radiotherapy: Long-Term Follow-Up of Prospective Study

    SciTech Connect

    Milano, Michael T.; Katz, Alan W.; Zhang Hong; Okunieff, Paul

    2012-07-01

    Purpose: To analyze the long-term survival and tumor control outcomes after stereotactic body radiotherapy (SBRT) for metastases limited in number and extent. Methods and Materials: We prospectively analyzed the long-term overall survival (OS) and cancer control outcomes of 121 patients with five or fewer clinically detectable metastases, from any primary site, metastatic to one to three organ sites, and treated with SBRT. Freedom from widespread distant metastasis (FFDM) was defined as metastatic disease not amenable to local therapy (i.e., resection or SBRT). Prognostic variables were assessed using log-rank and Cox regression analyses. Results: For breast cancer patients, the median follow-up was 4.5 years (7.1 years for 16 of 39 patients alive at the last follow-up visit). The 2-year OS, FFDM, and local control (LC) rate was 74%, 52%, and 87%, respectively. The 6-year OS, FFDM, and LC rate was 47%, 36%, and 87%, respectively. From the multivariate analyses, the variables of bone metastases (p = .057) and one vs. more than one metastasis (p = .055) were associated with a fourfold and threefold reduced hazard of death, respectively. None of the 17 bone lesions from breast cancer recurred after SBRT vs. 10 of 68 lesions from other organs that recurred (p = .095). For patients with nonbreast cancers, the median follow-up was 1.7 years (7.3 years for 7 of 82 patients alive at the last follow-up visit). The 2-year OS, FFDM, and LC rate was 39%, 28%, and 74%, respectively. The 6-year OS, FFDM, and LC rate was 9%, 13%, and 65%, respectively. For nonbreast cancers, a greater SBRT target volume was significantly adverse for OS (p = .012) and lesion LC (p < .0001). Patients whose metastatic lesions, before SBRT, demonstrated radiographic progression after systemic therapy experienced significantly worse OS compared with patients with stable or regressing disease. Conclusions: Select patients with limited metastases treated with SBRT are long-term survivors. Future

  17. Long-term effects of pegvisomant on comorbidities in patients with acromegaly: a retrospective single-center study

    PubMed Central

    Kuhn, Emmanuelle; Maione, Luigi; Bouchachi, Amir; Rozière, Myriam; Salenave, Sylvie; Brailly-Tabard, Sylvie; Young, Jacques; Kamenicky, Peter; Assayag, Patrick; Chanson, Philippe

    2015-01-01

    Context The effect of pegvisomant on IGF1 levels in patients with acromegaly is well documented, but little is known of its long-term impact on comorbidity. Aim The aim of this retrospective study was to evaluate the effects of long-term pegvisomant therapy on cardiorespiratory and metabolic comorbidity in patients with acromegaly. Patients and methods We analyzed the long-term (up to 10 years) effect of pegvisomant therapy given alone (n=19, 45%) or in addition to somatostatin analogues and/or cabergoline (n=23, 55%) on echocardiographic, polysomnographic and metabolic parameters in respectively 42, 12 and 26 patients with acromegaly followed in Bicêtre hospital. Results At the first cardiac evaluation, 20±16 months after pegvisomant introduction, IGF1 levels normalized in 29 (69%) of the 42 patients. The left ventricular ejection fraction (LVEF) improved significantly in patients whose basal LVEF was ≤60% and decreased in those whose LVEF was >70%. The left ventricular mass index (LVMi) decreased from 123±25 to 101±21 g/m2 (P<0.05) in the 17 patients with a basal LVMi higher than the median (91 g/m2), while it remained stable in the other patients. Pegvisomant reduced the apnoea–hypopnea index and cured obstructive sleep apnea (OSA) in four of the eight patients concerned. Long-term follow-up of 22 patients showed continuing improvements in cardiac parameters. The BMI and LDL cholesterol level increased minimally during pegvisomant therapy, and other lipid parameters were not modified. Conclusions Long-term pegvisomant therapy not only normalizes IGF1 in a large proportion of patients but also improves cardiac and respiratory comorbidity. PMID:26429918

  18. Management of problematic behaviours among individuals on long-term opioid therapy: protocol for a Delphi study

    PubMed Central

    Merlin, Jessica S; Young, Sarah R; Azari, Soraya; Becker, William C; Liebschutz, Jane M; Pomeranz, Jamie; Roy, Payel; Saini, Shalini; Starrels, Joanna L; Edelman, E Jennifer

    2016-01-01

    Introduction Given the sharp rise in opioid prescribing and heightened recognition of opioid addiction and overdose, opioid safety has become a priority. Clinical guidelines on long-term opioid therapy (LTOT) for chronic pain consistently recommend routine monitoring and screening for problematic behaviours. Yet, there is no consensus definition regarding what constitutes a problematic behaviour, and recommendations for appropriate management to inform front-line providers, researchers and policymakers are lacking. This creates a barrier to effective guideline implementation. Thus, our objective is to present the protocol for a Delphi study designed to: (1) elicit expert opinion to identify the most important problematic behaviours seen in clinical practice and (2) develop consensus on how these behaviours should be managed in the context of routine clinical care. Methods/analysis We will include clinical experts, defined as individuals who provide direct patient care to adults with chronic pain who are on LTOT in an ambulatory setting, and for whom opioid prescribing for chronic non-malignant pain is an area of expertise. The Delphi study will be conducted online in 4 consecutive rounds. Participants will be asked to list problematic behaviours and identify which behaviours are most common and challenging. They will then describe how they would manage the most frequently occurring common and challenging behaviours, rating the importance of each management strategy. Qualitative analysis will be used to categorise behaviours and management strategies, and consensus will be based on a definition established a priori. Ethics/dissemination This study has been approved by the Institutional Review Board (IRB) of the University of Alabama at Birmingham (UAB). This study will generate Delphi-based expert consensus on the management of problematic behaviours that arise in individuals on LTOT, which we will publish and disseminate to appropriate professional societies

  19. Schizophrenia in early adolescence. A study illustrated by long-term cases.

    PubMed

    Aarkrog, T; Mortensen, K V

    1985-11-01

    The purpose of this paper is to draw attention to schizophrenias starting in early adolescence, before age 15. Diagnosis may be difficult because such early manifestations may differ from the classical schizophrenias and from the traditional subgroups. The authors caution against a too liberal interpretation of normal problems in adolescence. In comment on the literature, particular weight is placed on descriptions of schizophrenias in adolescence. Some typical early manifestations of schizophrenia are described including, among other traits, depressive states and sociopathic behaviour. Key symptoms such as thought disturbances or flattening of affect may be lacking. Five long-term cases were chosen. None was classified in childhood as infantile borderline. A diagnosis of schizophrenia was made in adolescence. In the cases where Schneider's criteria are not fulfilled, other hard evidence of schizophrenia is given. Emphasis is placed on the importance of early diagnosis. PMID:4091026

  20. [Emotional response to long-term unemployment. A study in Lillesand].

    PubMed

    Ytterdahl, T

    1997-02-28

    Unemployment threatens the economic welfare of the family. It can affect self-respect and social status and remove the supportive network of the workplace. This cross-sectional survey from 1993-94 in a Norwegian community with 8,500 inhabitants describes emotional reactions to loss of job and the effects of unemployment on the lives of 148 long-term unemployed in Lillesand. A large majority were not mentally prepared for losing their job. Most reacted with defensive feelings, and a quarter experienced negative reactions from their social circle to their losing their job. Even if new extra leisure time was used for more social contact with friends and family, and more exercise and outdoor activity, satisfaction with life was reduced by being out of work. Women and the older unemployed seemed to adapt better to the new situation. The coping mechanisms of young men seemed much more limited. PMID:9102978

  1. A simple and accurate automated system for continuous long-term metabolic studies during artificial ventilation.

    PubMed

    Stam, H; van den Berg, B; Bogaard, J M; Versprille, A

    1987-08-01

    Energy expenditure and the amount of metabolised carbohydrate, protein and lipid can be calculated from the O2 consumption, CO2 production and nitrogen excretion using indirect calorimetry. A low-cost automatic system has been developed suitable for short- and long-term measurements during artificial ventilation, in which the gas analysers were calibrated automatically every 10 min and in which the desired variables were calculated and printed every 5 min. O2 and CO2 concentrations of mixed expired and inspiratory gas, the expired minute volume VE, and patient's rectal temperature, were sampled at regular time intervals and a simple programmable calculator with printer was used for the on-line data analysis. Tests on accuracy, stability, reproducibility and feasibility showed this system to be suitable for clinical application. PMID:3113814

  2. Search for correlated radio and optical events in long-term studies of extragalactic sources

    NASA Technical Reports Server (NTRS)

    Pomphrey, R. B.; Smith, A. G.; Leacock, R. J.; Olsson, C. N.; Scott, R. L.; Pollock, J. T.; Edwards, P.; Dent, W. A.

    1976-01-01

    For the first time, long-term records of radio and optical fluxes of a large sample of variable extragalactic sources have been assembled and compared, with linear cross-correlation analysis being used to reinforce the visual comparisons. Only in the case of the BL Lac object OJ 287 is the correlation between radio and optical records strong. In the majority of cases there is no evidence of significant correlation, although nine sources show limited or weak evidence of correlation. The results do not support naive extrapolation of the expanding source model. The general absence of strong correlation between the radio and optical regions has important implications for the energetics of events occurring in such sources.

  3. Long-Term Climate Sensitivity of Grazer Performance: A Cross-Site Study

    PubMed Central

    Craine, Joseph M.

    2013-01-01

    Climate change will affect grasslands in a number of ways, but the consequences of a warmer, drier world for grazers is uncertain. Predicting future grazer performance is complex since climate change affects both the quantity and quality of forage through a combination of processes that occur over a range of time scales. To better predict the consequences of climate change for grazer performance, a dataset was compiled of over a quarter million bison weights distributed across 22 US herds that span a large range of climates. Patterns of bison body mass among sites, age classes, and sexes were analyzed with respect to differences in geographic patterns of climate and interannual variation in climate. While short-term effects of climate variability are likely to depend on the magnitude and timing of precipitation during the year, grazers will be negatively affected by sustained hotter, drier conditions most likely associated with reductions in forage quality. Short-term, little effect of high temperatures on bison performance is observed, which suggests that the long-term effects of higher temperatures are likely to accrue over time as nitrogen availability in grasslands is reduced and forage quality declines. If relationships observed for bison are general for cattle, the economic consequences of higher temperatures due to decreased weight gain in US cattle could be on the order of US$1B per 1°C increase in temperature. Long-term monitoring of forage quality as well as native and domesticated grazer performance is recommended to better understand climate change effects on grazers. PMID:23840584

  4. Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension

    PubMed Central

    Ruperto, Nicolino; Lovell, Daniel J; Cuttica, Ruben; Woo, Patricia; Meiorin, Silvia; Wouters, Carine; Silverman, Earl D; Balogh, Zsolt; Henrickson, Michael; Davidson, Joyce; Foeldvari, Ivan; Imundo, Lisa; Simonini, Gabriele; Oppermann, Joachim; Xu, Stephen; Shen, Yaung-Kaung; Visvanathan, Sudha; Fasanmade, Adedigbo; Mendelsohn, Alan; Martini, Alberto; Giannini, Edward H

    2010-01-01

    Objective To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Methods Patients eligible for the open-label extension (OLE, weeks 52–204) received infliximab 3–6 mg/kg every 8 weeks plus methotrexate. Results Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. Conclusions In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate. Clinical trials registration number NCT00036374. PMID:20237125

  5. Long-term effects of course-embedded undergraduate research: The CASPiE longitudinal study

    NASA Astrophysics Data System (ADS)

    Szteinberg, Gabriela A.

    The Center for Authentic Science Practice in Education (CASPiE) is a National Science Foundation funded initiative that seeks to introduce first- and second-year undergraduate students to research in their mainstream laboratory courses. To investigate the effects of this research-based curriculum, a longitudinal study was initiated at Purdue University (PU) and University of Illinois-Chicago (UIC), where CASPiE was implemented in a portion of laboratory sections of a general chemistry course (CHEM 116 at PU/CHEM 114 at UIC). The study examined the long-term effects of the CASPiE program on students' chemistry course performance, research involvement, and retention in STEM majors and future careers. The results of the academic records analyses showed that PU CASPiE students from the opt-in semesters, i.e. those when students chose to enroll in the CASPiE sections, were higher-achieving students from the beginning of their college years and performed significantly higher than the students in the traditional sections. There were no significant differences in chemistry course performance among PU students from the randomly assigned semester. However, looking from the first semester chemistry course to the upper 300 level chemistry courses, randomly assigned PU students from the traditional sections had a significant performance decrease. The CASPiE students had a performance decrease that was not significant. At UIC, there were no significant differences between CASPiE and traditional students' chemistry performance. Analyses of the academic records also revealed that there were no differences in STEM major retention between CASPiE and traditional students, from both PU and UIC. However, CASPiE students from UIC and the ones from the opt-in sections at PU graduated faster in average than traditional students. Students' responses to an online survey showed that there were no differences in students' choice of future plans in STEM or non-STEM fields (such as graduate or

  6. 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

  7. 78 FR 66945 - Proposed Collection; 60-Day Comment request: Gulf Long-Term Follow-Up Study (GuLF STUDY)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... Collection: The purpose of the GuLF STUDY is to investigate potential short- and long-term health effects... HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment request: Gulf Long-Term... effect if received within 60 days of the date of this publication. Proposed Collection: Gulf...

  8. Long-Term Water Quality Studies in a Eutrophic Lake Catchment: Slapton Ley, SW England

    NASA Astrophysics Data System (ADS)

    Burt, T. P.; Worrall, F.; Howden, N. J. K.

    2014-12-01

    Monitoring is the process by which we keep the behaviour of the environment in view, an essential way of discovering whether there are significant undesirable changes taking place. Long-term datasets reveal important patterns for scientists to explain and are essential for testing hypotheses undreamt of at the time monitoring scheme was set up. Many environmental processes take place over relatively long periods of time; very often, subtle processes are embedded within highly variable systems so that their weak signal cannot be extracted without a long record. Slapton Ley is a freshwater coastal lagoon in SW England. The Ley is part of a National Nature Reserve, wetland 116 ha in area which is divided into two basins: the Higher Ley (39 ha) is mainly reed swamp; the Lower Ley (77 ha) is open water. In the 1960s it became apparent that the Ley was becoming increasingly eutrophic. In order to gauge water, sediment and nutrient inputs into the lake, measurements began on the main catchments in late 1969. Continuous monitoring of discharge and a weekly water-sampling programme have been maintained by the Slapton Ley Field Centre ever since. The monitoring programme has been supplemented by a number of research projects which have sought to identify the salient hydrological processes operating within the Slapton catchments and to relate these to the delivery of sediment and solute to the stream system. The nitrate issue has been of particular interest at Slapton; although many longer series exist for large rivers like the Thames, the long record of nitrate data for the Slapton catchments is unique in Britain for small rural basins. Other issues to be explored will be the phosphorus legacy in lake sediments and a long-term decline in lake pH. The Slapton water quality record has confirmed that undesirable changes are taking place, revealed evidence of important patterns to be explained, allowed testing of new hypotheses (e.g. links with land-use change) and helped

  9. Can we predict future change from long-term watershed studies? Fraser Experimental Forest case study

    SciTech Connect

    Stottlemyer, R.; Troendle, C.A.

    1995-06-01

    The Fraser Experimental Forest (FEF) has nine gauged watersheds, some monitored continuously since the early 1940`s. Hydrographs are dominated by snowmelt with >70% discharge variation accounted for by snow water equivalent. Mean annual flow is cyclic over a ten-year period. Climate models suggest that peak streamwater discharge and its timing respond to temperature change. FEF results suggest simulated climate changes are unlikely to shift the hydrograph magnitude outside of normal variability, but the time of peak discharge is sensitive to anticipated climate change. The fate of atmospheric contaminant input has been studied >10 y. Hydrologic variation accounts for most of the variation in surface water ion concentration and flux. The FEF record suggests that watershed-level nutrient study will not be very sensitive to projected future change in atmospheric contaminant input or climate.

  10. Hypopigmented mycosis fungoides in childhood and adolescence: a long-term retrospective study.

    PubMed

    Castano, Ekaterina; Glick, Sharon; Wolgast, Lucia; Naeem, Rizwan; Sunkara, Jaya; Elston, Dirk; Jacobson, Mark

    2013-11-01

    Patients with hypopigmented mycosis fungoides (HMF) present at a younger age than those with classic MF. Our goal was to describe the clinical presentation, histopathologic features and long-term outcome in patients who developed HMF before the age of 21. It was observed that among 69 pediatric patients diagnosed with MF between 1992 and 2010, 50 had HMF. Thirty-five patients had clinical follow-up. There were 37 males and 32 females with a mean age of 13.6 years. Most patients were African American or Hispanic and presented with multiple hypopigmented patches. All biopsies showed epidermotropism of T-lymphocytes, whereas fibroplasia and lichenoid infiltrate were variable. All specimens tested were CD8+. Treatment modalities included topical steroids, narrow band ultraviolet B and psoralen and ultraviolet A. HMF patients were followed for <1-12 years. Most children responded to treatment, but recurrence rates were high. One patient progressed to plaque/tumor stage. Others did not progress; however, many were lost to follow-up. We present a large cohort of children with HMF and report on the features of disease and progression. A major difference in histology of HMF was lack of fibroplasia and lichenoid infiltrate, probably because of presentation in the early patch stage. Most patients have a waxing-and-waning course and relapse after discontinuation of therapy, requiring repetitive treatment. PMID:24320808

  11. Efficacy of long-term coral tissue storage in ethanol for genotyping studies

    NASA Astrophysics Data System (ADS)

    Berkelmans, R.; Doyle, J.; van Oppen, M. J. H.; Asbridge, E. F.; Brown, A. R.

    2014-03-01

    With climate change threatening the future of coral reefs, there is an urgent need for effective coral tissue preservation and repositories from which DNA can be extracted. Most collections use 95 % ethanol as the storage medium, but its efficacy for long-term storage for short-fragment DNA use remains poorly documented. We conducted an accelerated DNA aging trial on three species of coral to ascertain whether ethanol-stored tissue and skeleton samples could yield fit-for-purpose DNA at time scales of 100+ yrs. We conclude that even using a crude DNA extraction technique, samples kept at 40 °C for 20 months yielded DNA of sufficient quality for Symbiodinium and coral host genotyping. If stored at -20 °C, these samples are likely to still yield useable DNA after 100 yrs. Ethanol-stored samples compared favorably in terms of DNA quality, quantity and sample integrity with those stored in an analogue of the commercial storage buffer RNA later ®.

  12. Long-term study of endonasal duraplasty and review of the literature.

    PubMed

    Schick, B; Ibing, R; Brors, D; Draf, W

    2001-02-01

    Many different techniques have been proposed to repair frontobasal dura mater lesions. Because of its low morbidity and high success rate, the endonasal approach has become a preferred route for treating cerebrospinal fluid fistulas of the anterior skull base. This article presents a retrospective evaluation of 136 endonasal duraplasties (126 patients) performed between July 1980 and May 1998 at a tertiary care facility. Follow-up consisted of clinical examinations including nasal endoscopy, objective measures, and telephone interviews. The following measures were used to evaluate the results of these duraplasties: postoperative nasal fluorescein endoscopy in 71 cases, computed tomographic cisternography in 2, nasal fluorescein endoscopy with computed tomographic cistemography in 19, magnetic resonance imaging in 6, and nasal fluorescein endoscopy with magnetic resonance imaging in 1. Tight closure was accomplished in 129 dural lesions (94.9%) on the first attempt. In 3 cases, recurrence of cerebrospinal fluid leakage was treated successfully by 1 endonasal revision, and in 1 case, a tight duraplasty was achieved after 2 endonasal revisions. Its high success rate, low rate of morbidity, and good long-term results recommend endonasal duraplasty as a primary treatment modality for frontobasal dural lesions. For extended frontobasal dural lesions, for which intracranial dural repair is the preferred approach, the endonasal approach should be used to close additional dural leaks of the sphenoid sinus. PMID:11219521

  13. Adaptive response studies may help choose astronauts for long-term space travel.

    PubMed

    Mortazavi, S M; Cameron, J R; Niroomand-rad, A

    2003-01-01

    Long-term manned exploratory missions are planned for the future. Exposure to high-energy neutrons, protons and high charge and energy particles during a deep space mission, needs protection against the detrimental effects of space radiation. It has been suggested that exposure to unpredictable extremely large solar particle events would kill the astronauts without massive shielding. To reduce this risk to astronauts and to minimize the need for shielding, astronauts with highest significant adaptive responses should be chosen. It has been demonstrated that some humans living in very high natural radiation areas have acquired high adaptive responses to external radiation. Therefore, we suggest that for a deep space mission the adaptive response of all potential crew members be measured and only those with high adaptive response be chosen. We also proclaim that chronic exposure to elevated levels of radiation can considerably decrease radiation susceptibility and better protect astronauts against the unpredictable exposure to sudden and dramatic increase in flux due to solar flares and coronal mass ejections. PMID:12971409

  14. Cherubism: An Unusual Study With Long-Term Follow-Up.

    PubMed

    Shokri, Abbas; Khavid, Atefeh

    2016-07-01

    Cherubism is an uncommon hereditary benign fibro-osseous disorder characterized by bilateral enlargement of the mandible and the maxilla that presents with varying degrees of involvement and a tendency toward spontaneous remission.The first visit was in 2002. A 16-year-old female was referred to an orthodontist for correction of her dental crowding. In the radiographic examination that was taken for her treatment the first time in 2002, a jaw bone lesion was discovered accidentally. X-ray panoramic imaging revealed well-defined multilocular radiolucencies involving the posterior body of the mandible and ascending rami with displaced teeth. This lesion had no effect on inferior alveolar canal and maxilla.There was no significant past medical history, and there was no family history suggestive of a similar complaint. On extraoral examination, there was no swelling in both rami of the mandible and face. Histopathological examination of the biopsy specimen showed proliferating fibrous connective tissue interspersed by multinucleated giant cells. It was diagnosed as a case nonfamilial cherubism. An extensive long-term follow-up till 12 years was maintained. In 2014, after 12-years follow-up for this lesion, panoramic imaging examination showed progress of this lesion in mandible and maxilla. PMID:27315317

  15. Postoperative radiotherapy in breast cancer--long-term results from the Oslo study

    SciTech Connect

    Host, H.; Brennhovd, I.O.; Loeb, M.

    1986-05-01

    The long-term results of a randomized clinical trial evaluating the effect of postoperative radiotherapy as an adjuvant to radical mastectomy are presented. There were 1115 patients including 27 protocol deviants. The follow-up time is 11-20 years. In the first part a conventional roentgen unit was used, and in the second part a /sup 60/Co unit, with considerably increased dosage and altered treatment plan. Both types of radiation techniques lowered the incidence of loco-regional recurrences significantly, but had no significant influence on the overall survival. The relapse-free survival was significantly improved by /sup 60/Co radiation in Stage II patients, but was unaffected by radiation in the other subgroups. Regarding survival, Stage II patients with medially located tumors seemed to benefit more from /sup 60/Co radiation than those with lateral tumors. A significant increase in the number of deaths caused by myocardial infarction was observed in Stage I patients having /sup 60/Co radiation, indicating that the radiation dose to the heart is of significance.

  16. Ziprasidone in Adolescents with Schizophrenia: Results from a Placebo-Controlled Efficacy and Long-Term Open-Extension Study

    PubMed Central

    Çavuş, Idil; Pappadopulos, Elizabeth; Vanderburg, Douglas G.; Schwartz, Jeffrey H.; Gundapaneni, Balarama K.; DelBello, Melissa P.

    2013-01-01

    Abstract Objective The purpose of this study was to evaluate the short- and long-term efficacy, safety, and tolerability of ziprasidone in adolescents with schizophrenia. Methods Subjects ages 13–17 years with schizophrenia (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. [DSM-IV]) were enrolled in a 6 week, randomized, double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week open-label extension study (OLE). Subjects were randomized in a 2:1 ratio to flexible-dose oral ziprasidone (40–160 mg/day, based on weight) or placebo. Primary end-point was change from baseline in Brief Psychiatric Rating Scale–Anchored (BPRS-A) total score. Safety assessments included adverse events, vital signs, laboratory measures, electrocardiograms, weight and body mass index, and movement disorder ratings. Results Planned interim analysis for the primary end-point in the RCT resulted in early termination of both studies because of futility. In the RCT, 283 subjects received ziprasidone (n=193) or placebo (n=90). In the intent-to-treat analysis population, the least squares mean (SE) BPRS–A score decrease from baseline at week 6 was not significantly different (p=0.15; −14.16 [0.78] for ziprasidone and −12.35 [1.05] for placebo). Per-protocol analysis was significant (p=0.02). In the OLE, 221 subjects entered the OLE and received ziprasidone for a median of 99 days. The mean (SD) change in BPRS-A score from end of RCT to end of OLE (last observation carried forward) was −6.9 (8.9). The most common treatment-emergent adverse events (≥10%) for all causalities during the RCT were somnolence and extrapyramidal disorders, and during OLE was somnolence only. No subjects had Fridericia's corrected QT (QTcF) ≥500 ms in the RCT or OLE phases. One completed suicide occurred during the OLE phase. For RCT and OLE, no clinically significant changes were reported in metabolic indices and laboratory measures

  17. Long-term ambient ozone concentration and the incidence of asthma in nonsmoking adults: The Ahsmog study

    SciTech Connect

    McDonnell, W.F.; Abbey, D.E.; Nishino, N.; Lebowitz, M.D.

    1999-02-01

    The authors conducted a prospective study of a cohort of 3091 nonsmokers, ages 27 to 87 years, to evaluate the association between long-term ambient ozone exposure and development of adult-onset asthma. Over a 15-year period, 3.2% of males and 4.3% of females reported new doctor diagnoses of asthma. For males, they observed a significant relationship between report of doctor diagnosis of asthma and 20-year mean 8-h average ambient ozone concentration. The authors observed no such relationship for females. Other variables significantly related to development of asthma were a history of ever-smoking for males, and for females, number of years worked with a smoker, age, and a history of childhood pneumonia or bronchitis. Addition of other pollutants to the models did not diminish the relationship between ozone and asthma for males. These data suggest that long-term exposure to ambient ozone is associated with development of asthma in adult males.

  18. Designing Program Roadmaps to Catalyze Community Formation: A Case Study of the Long-Term Stewardship Science and Technology Roadmapword

    SciTech Connect

    Dixon, Brent; Hanson, Duane; Matthern, Gretchen

    2003-02-27

    A number of broad perspective technology roadmaps have been developed in the last few years as tools for coordinating nation-wide research in targeted areas. These roadmaps share a common characteristic of coalescing the associated stakeholder groups into a special-interest community that is willing to work cooperatively in achieving the roadmap goals. These communities are key to roadmap implementation as they provide the collaborative energy necessary to obtain the political support and funding required for identified science and technology development efforts. This paper discusses the relationship between roadmaps and special-interest communities, using the recently drafted Department of Energy's Long-Term Stewardship Science and Technology Roadmap as a case study. Specific aspects this roadmap's design facilitated the development of a long-term stewardship community while specific realities during roadmap development impacted the realization of the design.

  19. Large-Scale Fluorescence Calcium-Imaging Methods for Studies of Long-Term Memory in Behaving Mammals.

    PubMed

    Jercog, Pablo; Rogerson, Thomas; Schnitzer, Mark J

    2016-01-01

    During long-term memory formation, cellular and molecular processes reshape how individual neurons respond to specific patterns of synaptic input. It remains poorly understood how such changes impact information processing across networks of mammalian neurons. To observe how networks encode, store, and retrieve information, neuroscientists must track the dynamics of large ensembles of individual cells in behaving animals, over timescales commensurate with long-term memory. Fluorescence Ca(2+)-imaging techniques can monitor hundreds of neurons in behaving mice, opening exciting avenues for studies of learning and memory at the network level. Genetically encoded Ca(2+) indicators allow neurons to be targeted by genetic type or connectivity. Chronic animal preparations permit repeated imaging of neural Ca(2+) dynamics over multiple weeks. Together, these capabilities should enable unprecedented analyses of how ensemble neural codes evolve throughout memory processing and provide new insights into how memories are organized in the brain. PMID:27048190

  20. Evaluating Aspects of Online Medication Safety in Long-Term Follow-Up of 136 Internet Pharmacies: Illegal Rogue Online Pharmacies Flourish and Are Long-Lived

    PubMed Central

    2013-01-01

    Background A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. Objective In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. Methods An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. Results The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription

  1. Rethinking how we understand individual healthcare needs for people living with long-term conditions: a qualitative study.

    PubMed

    Reeve, Joanne; Cooper, Lucy

    2016-01-01

    It has been suggested that we need to 'Think Differently' about how we organise care for people with long-term conditions. Current approaches prioritise reducing population disease burden, meaning health need is defined predominantly in terms of disease status, or even risk of disease. However, the result is care which overburdens some individuals. The World Health Organisation has described the need to view health as a 'resource for living' and not an end in itself. This study considers whether this view of health offers an alternative view of healthcare need in people living with long-term conditions. We know that chronic disease can be disruptive for some people; but not all. Our research question asked: Why do people experience long-term conditions differently, and what are the implications for understanding healthcare need? Our phenomenographic study involved qualitative interviews with 24 people living with at least one of the three conditions (diabetes, depression and chronic pain) and explored resources for and demands on daily living. Interviews all took place during 2012 and 2013. A narrative form analysis identified three patterns of illness experience (Gliding Swan, Stormy Seas and Stuck Adrift). Narrative content analysis revealed four factors explaining the variation: personalising care, existence of meaningful anchors, partnership and excess demands. We thus propose three new categories of healthcare need described by a consideration of health as a resource for living: Resilient, Vulnerable and Disconnected. We discuss how the emerging findings may offer scope to develop new needs assessment and patient-reported outcome measure tools. And so, offer a different way of thinking about the organisation for care for people with long-term conditions. PMID:25470421

  2. Long-term dietary patterns and carotid artery intima media thickness: the Cardiovascular Risk in Young Finns Study.

    PubMed

    Mikkilä, Vera; Räsänen, Leena; Laaksonen, Marika M L; Juonala, Markus; Viikari, Jorma; Pietinen, Pirjo; Raitakari, Olli T

    2009-11-01

    A whole-diet approach has proven useful for characterising dietary exposure in cardiovascular epidemiology research. In our previous analyses, we found dietary patterns to be significant determinants of CVD risk factor levels among the Cardiovascular Risk in Young Finns cohort. We investigated the associations of major dietary patterns with carotid intima media thickness (IMT), a subclinical predictor of CVD, in healthy adults. The Young Finns Study is an ongoing, prospective cohort study with a 21-year follow-up to date. The subjects were children and adolescents at baseline in 1980 (aged 3-18 years), and all had reached adulthood by the latest follow-up in 2001 (aged 24-39 years). Complete dietary data from the years 1980, 1986 and 2001 and outcome data from the year 2001 were obtained from 785 subjects. The long-term average pattern score for a traditional dietary pattern (characterised by high consumption of rye, potatoes, butter, sausages, milk and coffee) was associated with IMT especially among subjects with a low score for the health-conscious dietary pattern (characterised by high consumption of vegetables, legumes and nuts, rye, tea, cheese and other dairy products). In multivariable regression analyses using long-term pattern scores as predictors, the traditional dietary pattern was independently associated with IMT in men (P < 0.01), but not in women (P = 0.66). Long-term adherence to traditional food choices seems to increase the risk of developing subclinical atherosclerosis among Finnish men. PMID:19811695

  3. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain

    PubMed Central

    Sandner-Kiesling, A; Leyendecker, P; Hopp, M; Tarau, L; Lejcko, J; Meissner, W; Sevcik, P; Hakl, M; Hrib, R; Uhl, R; Dürr, H; Reimer, K

    2010-01-01

    Objective: The aim of this study was to assess safety and efficacy of fixed combination oxycodone prolonged release (PR)/naloxone PR in terms of both analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated symptoms, such as opioid-induced constipation (OIC), in adults with chronic non-cancer pain. Study design: These were open-label extension studies in which patients who had previously completed a 12-week, double-blind study received oxycodone PR/naloxone PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief Pain Inventory-Short Form (BPI-SF). The bowel function study assessed improvements in constipation using the Bowel Function Index (BFI). Results: At open-label baseline in the analgesia study (n = 379), mean score [± standard deviation (SD)] for the BPI-SF item ‘average pain over the last 24 h’ was 3.9 ± 1.52, and this remained low at 6 months (3.7 ± 1.59) and 12 months (3.8 ± 1.72). Mean scores for BPI-SF item ‘sleep interference’, and the BPI-SF ‘pain’ and ‘interference with activities’ subscales also remained low throughout the 52-week study. In the bowel function study (n = 258), mean BFI score (± SD) decreased from 35.6 ± 27.74 at the start of the extension study to 20.6 ± 24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores also remained low and stable during this study. Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed. Conclusion: Results from these two open-label extension studies demonstrate the long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR in the treatment of chronic pain. Patients experienced clinically relevant improvements in OIBD while receiving effective analgesic therapy. PMID:20370845

  4. The chemical durability of tektites - A laboratory study and correlation with long-term corrosion behavior

    NASA Astrophysics Data System (ADS)

    Barkatt, A.; Boulos, M. S.; Barkatt, A.; Sousanpour, W.; Boroomand, M. A.; Macedo, P. B.; O'Keefe, J. A.

    1984-02-01

    Leach tests carried out on tektite specimens (indochinites and australites) under high-dilution conditions show a common behavior characterized by low leach rates (0.00018 g/sq m per d, or 7.2 x 10 to the -12th m/d at 23 C) and an activation energy of (79,600 + or - 700 J/mol). The extent of selective leaching is very small, of the order of 10 to the -8th m. Extrapolation of test results over the lifetime of the tektites gives an excellent agreement with field observations on the extent of corrosion, and this is an important step in establishing the validity of laboratory tests as a basis for the development of models and predictions concerning long-term durabilities at least in the limiting case of high dilution or rapid flow. The results are also shown to be in agreement with various previous observations on the corrosion resistance of tektites. The chemical durability of tektites is observed to be consistent with their composition, highlighting requirements of high corrosion resistance in glasses; these requirements include a silica content in excess of 67 mol percent, an extremely low water content, and an alkali content which is low both absolutely and relative to the di- and poly-valent metal oxide levels. It is shown that artificial glasses which fulfil these criteria are no less corrosion-resistant than the corresponding natural glasses. These conclusions have bearing on the development, as well as on the evaluation, of glasses intended for very long service, such as radioactive waste vitrification media.

  5. Long-term effect of nitrate on Cr(VI) removal by Fe(0): column studies.

    PubMed

    Wei, Minghai; Yuan, Fang; Huang, Guoxin; Chen, Honghan; Liu, Fei

    2016-05-01

    Lab-scale parallel continuous-flow column experiments were performed to assess the long-term effect of nitrate (NO3 (-)) on hexavalent chromium (Cr(VI)) removal by scrap iron (Fe(0)). The first column (L1) was fed with the Cr(VI) solution and the second column (L2) was loaded with the Cr(VI) + NO3 (-) solution. Raman spectroscopy and scanning electron microscopy energy-dispersive X-ray analyses (SEM-EDS) were conducted to investigate the changes of the iron oxides on Fe(0). The results showed that the process of Cr(VI) removal by Fe(0) was divided into three different stages in the presence of NO3 (-): inhibition period (<198 pore volumes (PVs)); promotion period (198∼1025 PVs); and complete passivation period (1025∼1300 PVs). During the 462∼1025 PVs, Cr(VI) removal capacity in L2 was about 2.5 times higher than that in L1, and the longevity of L2 than L1 was 275PVs longer. NO3 (-) exhibited the most dominant effect on the Cr(VI) removal by Fe(0) in the last two stages. New magnetite (Fe3O4) produced by the redox reaction of NO3 (-) and Fe(0) was discovered on the surface of the Fe(0) obtained from L2. The new generated Fe3O4 could directly reduce the Cr(VI) and could also act as an inhibitor for the formation of passive film on the Fe(0) surface as well as an electron mediator that facilitated electron transport from Fe(0) to adsorbed Cr(VI). PMID:26797949

  6. National study of discontinuation of long-term opioid therapy among veterans.

    PubMed

    Vanderlip, Erik R; Sullivan, Mark D; Edlund, Mark J; Martin, Bradley C; Fortney, John; Austen, Mark; Williams, James S; Hudson, Teresa

    2014-12-01

    Veterans have high rates of chronic pain and long-term opioid therapy (LTOT). Understanding predictors of discontinuation from LTOT will clarify the risks for prolonged opioid use and dependence among this population. All veterans with at least 90 days of opioid use within a 180-day period were identified using national Veteran's Health Affairs (VHA) data between 2009 and 2011. Discontinuation was defined as 6 months with no opioid prescriptions. We used Cox proportional hazards analysis to determine clinical and demographic correlates for discontinuation. A total of 550,616 veterans met criteria for LTOT. The sample was primarily male (93%) and white (74%), with a mean age of 57.8 years. The median daily morphine equivalent dose was 26 mg, and 7% received high-dose (>100mg MED) therapy. At 1 year after initiation, 7.5% (n=41,197) of the LTOT sample had discontinued opioids. Among those who discontinued (20%, n=108,601), the median time to discontinuation was 317 days. Factors significantly associated with discontinuation included both younger and older age, lower average dosage, and having received less than 90 days of opioids in the previous year. Although tobacco use disorders decreased the likelihood of discontinuation, co-morbid mental illness and substance use disorders increased the likelihood of discontinuation. LTOT is common in the VHA system and is marked by extended duration of use at relatively low daily doses with few discontinuation events. Opioid discontinuation is more likely in veterans with mental health and substance use disorders. Further research is needed to delineate causes and consequences of opioid discontinuation. PMID:25277462

  7. Application of stable carbon isotopes in long term mesocosm studies for carbon cycle investigation

    NASA Astrophysics Data System (ADS)

    Esposito, Mario

    2016-04-01

    Carbon dioxide (CO2) is an effective greenhouse gas. The Oceans absorb ca. 30% of the anthropogenic CO2 emissions and thereby partly attenuate deleterious climate effects. A consequence of the oceanic CO2 uptake is a decreased seawater pH and planktonic community shifts. The quantification of the anthropogenic perturbation was investigated through stable carbon isotope analysis in three "long term" mesocosm experiments (Sweden 2013, Gran Canaria 2014, Norway 2015) which reproduced near natural ecosystem conditions under both controlled and modified future CO2 level (up to 2000 ppm) scenarios. Parallel measurements of the stable isotope composition of dissolved inorganic carbon (δ13CDIC) dissolved organic carbon (δ13CDOC) and particulate carbon (δ13CTPC) both from the mesocosms water column and sediment traps showed similar trends in all the three experiments. A CO2 response was noticeable in the isotopic dataset, but increased CO2 levels had only a subtle effect on the concentrations of the dissolved and particulate organic carbon pool. Distinctive δ13C signatures of the particulate carbon pool both in the water column and the sediments were detectable for the different CO2 treatments and they were strongly correlated with the δ13CDIC signatures but not with the δ13CDOC pool. The validity of the isotopic data was verified by cross-analyses of multiple substances of known isotopic signatures on a GasBench, Elemental Analyser (EA) and on an in-house TOC-IRMS setup for the analysis of δ13CDIC, δ13CTPC and δ13CDOC, respectively. Results from these mesocosm experiments proved the stable carbon isotope approach to be an effective tool for quantifying the uptake and carbon transfer among the various compartments of the marine carbon system.

  8. The chemical durability of tektites - A laboratory study and correlation with long-term corrosion behavior

    NASA Technical Reports Server (NTRS)

    Barkatt, A.; Boulos, M. S.; Barkatt, A.; Sousanpour, W.; Boroomand, M. A.; Macedo, P. B.; Okeefe, J. A.

    1984-01-01

    Leach tests carried out on tektite specimens (indochinites and australites) under high-dilution conditions show a common behavior characterized by low leach rates (0.00018 g/sq m per d, or 7.2 x 10 to the -12th m/d at 23 C) and an activation energy of (79,600 + or - 700 J/mol). The extent of selective leaching is very small, of the order of 10 to the -8th m. Extrapolation of test results over the lifetime of the tektites gives an excellent agreement with field observations on the extent of corrosion, and this is an important step in establishing the validity of laboratory tests as a basis for the development of models and predictions concerning long-term durabilities at least in the limiting case of high dilution or rapid flow. The results are also shown to be in agreement with various previous observations on the corrosion resistance of tektites. The chemical durability of tektites is observed to be consistent with their composition, highlighting requirements of high corrosion resistance in glasses; these requirements include a silica content in excess of 67 mol percent, an extremely low water content, and an alkali content which is low both absolutely and relative to the di- and poly-valent metal oxide levels. It is shown that artificial glasses which fulfil these criteria are no less corrosion-resistant than the corresponding natural glasses. These conclusions have bearing on the development, as well as on the evaluation, of glasses intended for very long service, such as radioactive waste vitrification media.

  9. Long-term outcome of patients after a single interruption of antiretroviral therapy: a cohort study

    PubMed Central

    2012-01-01

    Background To describe the long term outcome of patients who interrupted highly active antiretroviral therapy (HAART) once, identify the variables associated with earlier need to re-start HAART, and the response when therapy was resumed. A retrospective observational cohort of 66 adult patients with HIV-1 infection who interrupted HAART with a CD4+cell count ≥350 cells/μL and undetectable viral load (VL) was performed. The pre-established CD4+ cell count for restarting therapy was 300cells/μL. Cox regression was used to analyse the variables associated with earlier HAART reinitiation. Results The median follow-up was 209 weeks (range, 64–395). Rates of HIV-related or possible HIV-related events were 0.37 (one case of acute retroviral syndrome) and 1.49 per 100 patient-years, respectively. Two patients died after re-starting therapy and having reached undetectable VL. Three patients suffered a sexually transmitted disease while off therapy. Fifty patients (76%) resumed therapy after a median of 97 weeks (range, 17–267). Age, a nadir of CD4+ <250 cells/μL, and a mean VL during interruption of >10,000 copies/ml were independent predictors for earlier re-start. The intention-to-treat success rate of the first HAART resumed regimen was 85.4%. There were no differences by regimen used, nor between regimens that were the same as or different from the one that had been interrupted. Conclusions Our data suggest highly active antiretroviral therapy may be interrupted in selected patients because in these patients, when the HAART is restarted, the viral and clinical response may be achieved. PMID:23095460

  10. Long-term outcomes of a pediatric HIV treatment program in Maputo, Mozambique: a cohort study

    PubMed Central

    Walter, Jan; Molfino, Lucas; Moreno, Verena; Edwards, Celeste G.; Chissano, Mafalda; Prieto, Angels; Bocharnikova, Tatiana; Antierens, Annick; Lujan, Johnny

    2015-01-01

    Objective To describe long-term treatment outcomes of a pediatric HIV cohort in Mozambique. Design Retrospective analysis of routine monitoring data. Setting Secondary health care facilities in the Chamanculo Health District of Maputo. Subjects A total of 1,335 antiretroviral treatment (ART) naïve children <15 years of age enrolled in HIV care between 2002 and 2010. Intervention HIV care, ART (since 2003), task shifting to lower cadre nurses, counseling by lay counselors, active patient tracing, nutritional support, support by a psychologist, targeted viral load testing, and switch to second-line treatment. Main outcome measures Kaplan–Meier estimates for retention in care (RIC), CD4 cell percentage, body mass index for age z-score, and adjusted incidence rate ratios for attrition (death or loss to follow-up) as calculated by Poisson regression. Results The RIC at 6 years in the pre-ART cohort was 44% (95% confidence interval: 38–49), and the one at 8 years in the ART cohort was 70% (64–75). Risk factors for attrition included young age, low CD4 percentage, underweight, active tuberculosis, and enrollment/treatment initiation after 2006. The mean CD4 percentage increased strongly at 1 year on treatment and remained high thereafter. The body mass index for age z-score sharply increased at 1 year after treatment initiation before stabilizing at pre-ART levels thereafter. Conclusions Good clinical and immunological treatment outcomes up to 8 years of follow-up on ART can be achieved in a context of shortage of health workers and a high level of task-shifting approach. PMID:26287397

  11. Long-Term Variability in Bioassessments: A Twenty-Year Study from Two Northern California Streams

    NASA Astrophysics Data System (ADS)

    Mazor, Raphael D.; Purcell, Alison H.; Resh, Vincent H.

    2009-06-01

    Long-term variability of bioassessments has not been well evaluated. We analyzed a 20-year data set (1984-2003) from four sites in two northern California streams to examine the variability of bioassessment indices (two multivariate RIVPACS-type O/E scores and one multimetric index of biotic integrity, IBI), as well as eight metrics. All sites were sampled in spring; one site was also sampled in summer. Variability among years was high for most metrics (coefficients of variation, CVs ranging from 16% to 246% in spring) but lower for indices (CVs of 22-26% for the IBI and 21-32% for O/E scores in spring), which resulted in inconsistent assessments of biological condition. Variance components analysis showed that the time component explained variability in all metrics and indices, ranging from 5% to 35% of total variance explained. The site component was large (i.e., >40%) for some metrics (e.g., EPT richness), but nearly absent from others (e.g., Diptera richness). Seasonal analysis at one site showed that variability among seasons was small for some metrics or indices (e.g., Coleoptera richness), but large for others (e.g., EPT richness, O/E scores). Climatic variables did not show consistent trends across all metrics, although several were related to the El Niño Southern Oscillation Index at some sites. Bioassessments should incorporate temporal variability during index calibration or include climatic variability as predictive variables to improve accuracy and precision. In addition, these approaches may help managers anticipate alterations in reference streams caused by global climate change and high climatic variability.

  12. Assessing Multivariate Constraints to Evolution across Ten Long-Term Avian Studies

    PubMed Central

    Teplitsky, Celine; Tarka, Maja; Møller, Anders P.; Nakagawa, Shinichi; Balbontín, Javier; Burke, Terry A.; Doutrelant, Claire; Gregoire, Arnaud; Hansson, Bengt; Hasselquist, Dennis; Gustafsson, Lars; de Lope, Florentino; Marzal, Alfonso; Mills, James A.; Wheelwright, Nathaniel T.; Yarrall, John W.; Charmantier, Anne

    2014-01-01

    Background In a rapidly changing world, it is of fundamental importance to understand processes constraining or facilitating adaptation through microevolution. As different traits of an organism covary, genetic correlations are expected to affect evolutionary trajectories. However, only limited empirical data are available. Methodology/Principal Findings We investigate the extent to which multivariate constraints affect the rate of adaptation, focusing on four morphological traits often shown to harbour large amounts of genetic variance and considered to be subject to limited evolutionary constraints. Our data set includes unique long-term data for seven bird species and a total of 10 populations. We estimate population-specific matrices of genetic correlations and multivariate selection coefficients to predict evolutionary responses to selection. Using Bayesian methods that facilitate the propagation of errors in estimates, we compare (1) the rate of adaptation based on predicted response to selection when including genetic correlations with predictions from models where these genetic correlations were set to zero and (2) the multivariate evolvability in the direction of current selection to the average evolvability in random directions of the phenotypic space. We show that genetic correlations on average decrease the predicted rate of adaptation by 28%. Multivariate evolvability in the direction of current selection was systematically lower than average evolvability in random directions of space. These significant reductions in the rate of adaptation and reduced evolvability were due to a general nonalignment of selection and genetic variance, notably orthogonality of directional selection with the size axis along which most (60%) of the genetic variance is found. Conclusions These results suggest that genetic correlations can impose significant constraints on the evolution of avian morphology in wild populations. This could have important impacts on evolutionary

  13. Long Term Clinical Prognostic Factors in Relapsing-Remitting Multiple Sclerosis: Insights from a 10-Year Observational Study

    PubMed Central

    Ehling, Rainer; Lutterotti, Andreas; Hegen, Harald; Di Pauli, Franziska; Auer, Michael; Deisenhammer, Florian; Reindl, Markus; Berger, Thomas

    2016-01-01

    Background Multiple sclerosis (MS) has a highly heterogenic course making prediction of long term outcome very difficult. Objective The objective was to evaluate current and identify additional clinical factors that are linked to long term outcome of relapsing-remitting MS assessed by disability status 10 years after disease onset. Methods This observational study included 793 patients with relapsing-remitting MS. Clinical factors hypothesized to influence long term outcome measured by EDSS scores 10 years after disease onset were analysed by Kaplan-Meier-estimates. Multinomial logistic regression models regarding mild (EDSS ≤2.5), moderate (EDSS 3.0–5.5) or severe (EDSS ≥6.0) disability were calculated to correct for confounders. Results Secondary progression was the strongest predictor of severe disability (Hazard ratio [HR] 503.8, 95% confidence interval [CI] 160.0–1580.1); p<0.001). Complete remission of neurological symptoms at onset reduced the risk of moderate disability (HR 0.42; CI 0.23–0.77; p = 0.005), while depression (HR 3.59; CI 1.14–11.24; p = 0.028) and cognitive dysfunction (HR 4.64; CI 1.11–19.50; p = 0.036) 10 years after disease onset were associated with severe disability. Oligoclonal bands and pregnancy were not correlated with disability. Conclusion We were able to identify clinically apparent chronic depression and cognitive dysfunction to be associated with adverse long term outcome in MS and to confirm that pregnancy has no negative impact. Additionally, we emphasize the positive predictive value of complete remission of initial symptoms. PMID:27391947

  14. Value of Superficial Cultures for Prediction of Catheter-Related Bloodstream Infection in Long-Term Catheters: a Prospective Study

    PubMed Central

    Martín-Rabadán, P.; Echenagusia, A.; Camúñez, F.; Rodríguez-Rosales, G.; Simó, G.; Echenagusia, M.; Bouza, E.

    2013-01-01

    Cultures taken from the skin and from the hubs of short-term central venous catheters can help us to predict catheter-related bloodstream infections (C-RBSIs). The value of these cultures for such predictions has not been assessed in long-term catheters. Our objective was to assess the value of superficial cultures for the prediction of C-RBSI among patients with long-term catheters. Over a 2-year period, we prospectively obtained cultures from the skin overlying reservoir ports (group A) and from the skin insertion site and hubs of all tunneled catheters (group B). This routine was performed by vascular and interventional radiologists immediately before catheter removal (irrespective of the reason for withdrawal). Swabs were processed semiquantitatively. Catheter tips from both groups were cultured using Maki's semiquantitative technique and sonication. We also performed cultures of the reservoir ports at different sites. C-RBSI was defined as the isolation of the same species of microorganism(s) both in the colonized catheter and in at least 1 peripheral blood culture. We included 372 catheters (group A, 223; group B, 149) during the study period. The catheter colonization rate was 23.4% (87/372), and 28 patients had C-RBSI. Validity index values for the capacity of surface cultures to predict C-RBSI in groups A and B were, respectively, as follows: sensitivity, 23.5% and 45.5%; specificity, 59.7% and 63.0%; positive predictive value, 4.6% and 8.9%; and negative predictive value, 90.4% and 93.5%. Superficial cultures of patients with long-term catheters could help us to rule out the catheter as the portal of entry of bloodstream infections. Superficial cultures (from skin and hubs) proved to be a useful conservative diagnostic tool for ruling out C-RBSI among patients with long-term tunneled catheters and totally implantable venous access ports. PMID:23850957

  15. Bowel, Urinary, and Sexual Problems Among Long-Term Prostate Cancer Survivors: A Population-Based Study

    SciTech Connect

    Mols, Floortje Korfage, Ida J.; Vingerhoets, Ad J.J.M.; Kil, Paul J.M.; Coebergh, Jan Willem W.; Essink-Bot, Marie-Louise; Poll-Franse, Lonneke V. van de

    2009-01-01

    Purpose: To obtain insight into the long-term (5- to 10-year) effects of prostate cancer and treatment on bowel, urinary, and sexual function, we performed a population-based study. Prostate-specific function was compared with an age-matched normative population without prostate cancer. Methods and Materials: Through the population-based Eindhoven Cancer Registry, we selected all men diagnosed with prostate cancer between 1994 and 1998 in the southern Netherlands. In total, 964 patients, alive in November 2004, received questionnaire; 780 (81%) responded. Results: Urinary problems were most common after a prostatectomy; bowel problems were most common after radiotherapy. Compared with an age-matched normative population both urinary and bowel functioning and bother were significantly worse among survivors. Urinary incontinence was reported by 23-48% of survivors compared with 4% of the normative population. Bowel leakage occurred in 5-14% of patients compared with 2% of norms. Erection problems occurred in 40-74% of patients compared with 18% of norms. Conclusions: These results form an important contribution to the limited information available on prostate-specific problems in the growing group of long-term prostate cancer survivors. Bowel, urinary, and sexual problems occur more often among long-term survivors compared with a reference group and cannot be explained merely by age. Because these problems persist for many years, urologists should provide patients with adequate information before treatment. After treatment, there should be an appropriate focus on these problems.

  16. Secondary malignancies in chronic myeloid leukemia patients after imatinib-based treatment: long-term observation in CML Study IV

    PubMed Central

    Miranda, M B; Lauseker, M; Kraus, M-P; Proetel, U; Hanfstein, B; Fabarius, A; Baerlocher, G M; Heim, D; Hossfeld, D K; Kolb, H-J; Krause, S W; Nerl, C; Brümmendorf, T H; Verbeek, W; Fauser, A A; Prümmer, O; Neben, K; Hess, U; Mahlberg, R; Plöger, C; Flasshove, M; Rendenbach, B; Hofmann, W-K; Müller, M C; Pfirrmann, M; Hochhaus, A; Hasford, J; Hehlmann, R; Saußele, S

    2016-01-01

    Treatment of chronic myeloid leukemia (CML) has been profoundly improved by the introduction of tyrosine kinase inhibitors (TKIs). Long-term survival with imatinib is excellent with a 8-year survival rate of ∼88%. Long-term toxicity of TKI treatment, especially carcinogenicity, has become a concern. We analyzed data of the CML study IV for the development of secondary malignancies. In total, 67 secondary malignancies were found in 64 of 1525 CML patients in chronic phase treated with TKI (n=61) and interferon-α only (n=3). The most common malignancies (n⩾4) were prostate, colorectal and lung cancer, non-Hodgkin's lymphoma (NHL), malignant melanoma, non-melanoma skin tumors and breast cancer. The standardized incidence ratio (SIR) for all malignancies excluding non-melanoma skin tumors was 0.88 (95% confidence interval (0.63–1.20)) for men and 1.06 (95% CI 0.69–1.55) for women. SIRs were between 0.49 (95% CI 0.13–1.34) for colorectal cancer in men and 4.29 (95% CI 1.09–11.66) for NHL in women. The SIR for NHL was significantly increased for men and women. An increase in the incidence of secondary malignancies could not be ascertained. The increased SIR for NHL has to be considered and long-term follow-up of CML patients is warranted, as the rate of secondary malignancies may increase over time. PMID:26859076

  17. Secondary malignancies in chronic myeloid leukemia patients after imatinib-based treatment: long-term observation in CML Study IV.

    PubMed

    Miranda, M B; Lauseker, M; Kraus, M-P; Proetel, U; Hanfstein, B; Fabarius, A; Baerlocher, G M; Heim, D; Hossfeld, D K; Kolb, H-J; Krause, S W; Nerl, C; Brümmendorf, T H; Verbeek, W; Fauser, A A; Prümmer, O; Neben, K; Hess, U; Mahlberg, R; Plöger, C; Flasshove, M; Rendenbach, B; Hofmann, W-K; Müller, M C; Pfirrmann, M; Hochhaus, A; Hasford, J; Hehlmann, R; Saußele, S

    2016-06-01

    Treatment of chronic myeloid leukemia (CML) has been profoundly improved by the introduction of tyrosine kinase inhibitors (TKIs). Long-term survival with imatinib is excellent with a 8-year survival rate of ∼88%. Long-term toxicity of TKI treatment, especially carcinogenicity, has become a concern. We analyzed data of the CML study IV for the development of secondary malignancies. In total, 67 secondary malignancies were found in 64 of 1525 CML patients in chronic phase treated with TKI (n=61) and interferon-α only (n=3). The most common malignancies (n⩾4) were prostate, colorectal and lung cancer, non-Hodgkin's lymphoma (NHL), malignant melanoma, non-melanoma skin tumors and breast cancer. The standardized incidence ratio (SIR) for all malignancies excluding non-melanoma skin tumors was 0.88 (95% confidence interval (0.63-1.20)) for men and 1.06 (95% CI 0.69-1.55) for women. SIRs were between 0.49 (95% CI 0.13-1.34) for colorectal cancer in men and 4.29 (95% CI 1.09-11.66) for NHL in women. The SIR for NHL was significantly increased for men and women. An increase in the incidence of secondary malignancies could not be ascertained. The increased SIR for NHL has to be considered and long-term follow-up of CML patients is warranted, as the rate of secondary malignancies may increase over time. PMID:26859076

  18. 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

  19. A Long Term View of Forest Response to Environmental Change: 25 Years of Studying Harvard Forest

    NASA Astrophysics Data System (ADS)

    Munger, J. W.; Wofsy, S. C.; Lindaas, J.; David, F.; David, O.

    2014-12-01

    Forests influence the budgets of greenhouse gases, and understanding how they will respond to environmental change is critical to accurately predicting future GHG trends. The time scale for climate change is long and forest growth is slow, thus very long measurement periods are required to observe meaningful forest response. We established an eddy flux tower within a mixed forest stand dominated by red oak and red maple at the Harvard Forest LTER site in 1989 where CO2, H2O and energy fluxes together with meteorological observations have been measured continuously. An array of plots for biometric measurements was established in 1993. Flux measurement at an adjacent hemlock stand began in 2000. Records of land use and disturbance and vegetation plot data extend back to 1907. The combined suite of measurements merges observations of instantaneous ecosystem responses to environmental forcing with details of vegetation dynamics and forest growth that represent the emergent properties relevant to long-term ecosystem change. Both the deciduous stand and hemlock stand are accumulating biomass. Each has added over 20 Mg-C ha-1 as woody biomass in trees >10cm dbh since 1990, even though the hemlock stand is older. Net carbon exchange shows enhanced uptake in early spring and late fall months in response to warmer temperatures and likely an increase in evergreen foliage at the deciduous site. Net carbon uptake efficiency at the deciduous stand has increased over time as well as indicated by peak NEE under optimum light conditions. The trend is only partly explained by variation in mean leaf area index and cannot be directly attributed to climate response. The combination of longer growing season and increased uptake efficiency yields a general trend of increasing annual NEE (Fig. 1). However, significant excursions in the trend highlight the sensitivity of forest carbon stocks. The pulse of high annual carbon uptake (peak 6 Mg-C ha-1y-1 in 2008) from 2000-2008 is only

  20. Psychosexual Development in Men with Congenital Hypogonadotropic Hypogonadism on Long-Term Treatment: A Mixed Methods Study

    PubMed Central

    Dwyer, Andrew A; Quinton, Richard; Pitteloud, Nelly; Morin, Diane

    2015-01-01

    Introduction Congenital hypogonadotropic hypogonadism (CHH) is a rare, genetic, reproductive endocrine disorder characterized by absent puberty and infertility. Limited information is available on the psychosocial impact of CHH and psychosexual development in these patients. Aim The aim of this study was to determine the impact of CHH on psychosexual development in men on long-term treatment. Methods A sequential mixed methods explanatory design was used. First, an online survey (quantitative) was used to quantify the frequency of psychosexual problems among CHH men. Second, patient focus groups (qualitative) were conducted to explore survey findings in detail and develop a working model to guide potential nursing and interdisciplinary interventions. Main Outcome Measures Patient characteristics, frequency of body shame, difficulty with intimate relationships, and never having been sexually active were assessed. Additionally, we collected subjective patient-reported outcomes regarding the impact of CHH on psychological/emotional well-being, intimate relationships, and sexual activity. Results A total of 101 CHH men on long-term treatment (>1 year) were included for the analysis of the online survey (mean age 37 ± 11 years, range 19–66, median 36). Half (52/101, 51%) of the men had been seen at a specialized academic center and 37/101 (37%) reported having had fertility-inducing treatment. A high percentage of CHH men experience psychosexual problems including difficulty with intimate relationships (70%) and body image concerns/body shame (94/101, 93%), and the percentage of men never having been sexually active is five times the rate in a reference group (26% vs. 5.4%, P < 0.001). Focus groups revealed persisting body shame and low self-esteem despite long-term treatment that has lasting impact on psychosexual functioning. Conclusions CHH men frequently experience psychosexual problems that pose barriers to intimate relationships and initiating sexual

  1. Long-Term Exposure to Constituents of Fine Particulate Air Pollution and Mortality: Results from the California Teachers Study

    PubMed Central

    Ostro, Bart; Lipsett, Michael; Reynolds, Peggy; Goldberg, Debbie; Hertz, Andrew; Garcia, Cynthia; Henderson, Katherine D.; Bernstein, Leslie

    2010-01-01

    Background Several studies have reported associations between long-term exposure to ambient fine particulate matter (PM) and cardiovascular mortality. However, the health impacts of long-term exposure to specific constituents of PM2.5 (PM with aerodynamic diameter ≤ 2.5 μm) have not been explored. Methods We used data from the California Teachers Study, a prospective cohort of active and former female public school professionals. We developed estimates of long-term exposures to PM2.5 and several of its constituents, including elemental carbon, organic carbon (OC), sulfates, nitrates, iron, potassium, silicon, and zinc. Monthly averages of exposure were created using pollution data from June 2002 through July 2007. We included participants whose residential addresses were within 8 and 30 km of a monitor collecting PM2.5 constituent data. Hazard ratios (HRs) were estimated for long-term exposure for mortality from all nontraumatic causes, cardiopulmonary disease, ischemic heart disease (IHD), and pulmonary disease. Results Approximately 45,000 women with 2,600 deaths lived within 30 km of a monitor. We observed associations of all-cause, cardiopulmonary, and IHD mortality with PM2.5 mass and each of its measured constituents, and between pulmonary mortality and several constituents. For example, for cardiopulmonary mortality, HRs for interquartile ranges of PM2.5, OC, and sulfates were 1.55 [95% confidence interval (CI), 1.43–1.69], 1.80 (95% CI, 1.68–1.93), and 1.79 (95% CI, 1.58–2.03), respectively. Subsequent analyses indicated that, of the constituents analyzed, OC and sulfates had the strongest associations with all four outcomes. Conclusions Long-term exposures to PM2.5 and several of its constituents were associated with increased risks of all-cause and cardiopulmonary mortality in this cohort. Constituents derived from combustion of fossil fuel (including diesel), as well as those of crustal origin, were associated with some of the greatest risks

  2. Efficacy and long term safety of alipogene tiparvovec (AAV1-LPLS447X) gene therapy for lipoprotein lipase deficiency: an open label trial

    PubMed Central

    Gaudet, Daniel; Méthot, Julie; Déry, Stéphane; Brisson, Diane; Essiembre, Christiane; Tremblay, Gérald; Tremblay, Karine; de Wal, Janneke; Twisk, Jaap; van den Bulk, Nick; Sier-Ferreira, Valerie; van Deventer, Sander

    2016-01-01

    We describe the 2-year follow-up of an open-label trial (CT-AMT-011-01) of AAV1-LPLS447X gene therapy for lipoprotein lipase deficiency (LPLD), an orphan disease associated with chylomicronemia, severe hypertriglyceridemia, metabolic complications and potentially life-threatening pancreatitis. The LPL S447X gene variant, in an adeno-associated viral vector of serotype 1 (alipogene tiparvovec), was administered to 14 adult LPLD patients with a prior history of pancreatitis. Primary objectives were to assess the long-term safety of alipogene tiparvovec and achieve a ≥40% reduction in fasting median plasma triglyceride (TG) at 3–12 weeks compared with baseline. Cohorts 1 (n=2) and 2 (n=4) received 3 × 1011gc/kg, and cohort 3 (n=8) received 1 × 1012gc/kg. Cohorts 2 and 3 also received immunosuppressants from the time of alipogene tiparvovec administration and continued for 12 weeks. Alipogene tiparvovec was well tolerated, without emerging safety concerns for 2 years. Half of the patients demonstrated a ≥40% reduction in fasting TG between 3–12 weeks. TG subsequently returned to baseline, although sustained LPL S447X expression and long-term changes in TG-rich lipoprotein characteristics were noted independently of the effect on fasting plasma TG. PMID:22717743

  3. A PRA case study of extended long term decay heat removal for shutdown risk assessment

    SciTech Connect

    Roglans, J.; Ragland, W.A.; Hill, D.J.

    1992-12-01

    A Probabilistic Risk Assessment (PRA) of the Experimental Breeder Reactor II (EBR-II), a Department of Energy (DOE) Category A research reactor, has recently been completed at Argonne National Laboratory (ANL). The results of this PRA have shown that the decay heat removal system for EBR-II is extremely robust and reliable. In addition, the methodology used demonstrates how the actions of other systems not normally used for actions of other systems not normally used for decay heat removal can be used to expand the mission time of the decay heat removal system and further increase its reliability. The methodology may also be extended to account for the impact of non-safety systems in enhancing the reliability of other dedicated safety systems.

  4. A PRA case study of extended long term decay heat removal for shutdown risk assessment

    SciTech Connect

    Roglans, J.; Ragland, W.A.; Hill, D.J.

    1992-01-01

    A Probabilistic Risk Assessment (PRA) of the Experimental Breeder Reactor II (EBR-II), a Department of Energy (DOE) Category A research reactor, has recently been completed at Argonne National Laboratory (ANL). The results of this PRA have shown that the decay heat removal system for EBR-II is extremely robust and reliable. In addition, the methodology used demonstrates how the actions of other systems not normally used for actions of other systems not normally used for decay heat removal can be used to expand the mission time of the decay heat removal system and further increase its reliability. The methodology may also be extended to account for the impact of non-safety systems in enhancing the reliability of other dedicated safety systems.

  5. A study of a container for long term storage of high level waste using finite elements

    SciTech Connect

    Ladkany, S.G. ); Kniss, B.R. )

    1992-01-01

    Designs of selected components for a container are evaluated based on conservative loads and assumptions. The items selected for evaluation are a pintle and possible container topheads. An existing pintle for use in another application is evaluated under a more severe axial load. The results show that the pintle is adequate with the existing design to a safety factor of at least three. Improvements are suggested which raises this safety factor to approximately six. Several flat tophead designs are evaluated for stress under an annular load. The parameter selected for evaluation is the thickness of the circular plate. Results from a 1.5 inch thick plate are below a safety factor of three. Results with a 2 inch plate are improved, but marginal. Analysis results indicate that a thicker pintle or a stiffer plate will improve the design. Several curved tophead shapes are analyzed under an annular load. The ASME flanged and dished shape displays more desirable properties than others. A critical parameter is identified and changed to provide acceptable stress levels.

  6. Tackling Communication Barriers Between Long-Term Care Facility and Emergency Department Transfers to Improve Medication Safety in Older Adults.

    PubMed

    Callinan, Stephanie M; Brandt, Nicole J

    2015-07-01

    In 2013, the American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association, and Society for Academic Emergency Medicine created geriatric emergency department guidelines, making recommendations for staffing/administration, follow up and transitions of care, education, quality improvement, equipment/supplies, and other policies, procedures, and protocols to be implemented. Awareness of these guidelines, as well as communication barriers, can help improve the delivery of care for older adults during transitions in care, particularly regarding medication safety. PMID:26126025

  7. Long-term efficacy and safety of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors.

    PubMed

    Gambacorti-Passerini, Carlo; Kantarjian, Hagop M; Kim, Dong-Wook; Khoury, Hanna J; Turkina, Anna G; Brümmendorf, Tim H; Matczak, Ewa; Bardy-Bouxin, Nathalie; Shapiro, Mark; Turnbull, Kathleen; Leip, Eric; Cortes, Jorge E

    2015-09-01

    Long-term efficacy and safety of bosutinib (≥4 years follow-up from last enrolled patient) were evaluated in an ongoing phase 1/2 study in the advanced leukemia cohort with prior treatment failure (accelerated-phase [AP, n = 79] chronic myeloid leukemia [CML], blast-phase [BP, n = 64] CML, acute lymphoblastic leukemia [ALL, n = 24]). Fourteen AP, 2 BP, and 1 ALL patient remained on bosutinib at 4 years (vs. 38, 8, 1 at 1 year); median (range) treatment durations: 10.2 (0.1-88.6), 2.8 (0.03-55.9), 0.97 (0.3-89.2) months. Among AP and BP patients, 57% and 28% newly attained or maintained baseline overall hematologic response (OHR); 40% and 37% attained/maintained major cytogenetic response (MCyR) by 4 years (most by 12 months). In responders at 1 versus 4 years, Kaplan-Meier (KM) probabilities of maintaining OHR were 78% versus 49% (AP) and 28% versus 19% (BP); KM probabilities of maintaining MCyR were 65% versus 49% (AP) and 21% versus 21% (BP). Most common AEs (AP, BP) were gastrointestinal (96%; 83%), primarily diarrhea (85%; 64%), which was typically low grade (maximum grade 1/2: 81%; 59%) and transient; no patient discontinued due to diarrhea. Serious AEs occurred in 44 (56%) AP and 37 (58%) BP patients, most commonly pneumonia (n = 9) for AP and pyrexia (n = 6) for BP; 11 and 13 died within 30 days of last dose (2 considered bosutinib-related [AP] per investigator). Responses were durable in ∼50% AP responders at 4 years (∼25% BP patients responded at year 1, suggesting possible bridge-to-transplant role in BP patients); toxicity was manageable. PMID:26040495

  8. 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

  9. Long-term rotation studies and the effect on soil organic carbon in cotton soils.

    NASA Astrophysics Data System (ADS)

    Braunack, M.; Hulugalle, N.; Rochester, I.

    2012-04-01

    Three long-term experiments conducted at the Australian Cotton Research Institute (ACRI) on vertosols examined the effect of tillage and stubble management over 26 years (E1), crop rotations over 9 years (E2) and the use of legumes over 16 years (E3) in maintaining soil quality and nitrogen contribution for subsequent cotton crops. Two of the experiments (E 1, 2) were on soils with a subsoil constraint of sodicity (ESP>10 %), while the third (E3) was on soil with less subsoil sodicity (ESP=5%). E1 compared continuous cotton with conventional tillage (CC_MXT), continuous cotton with minimum tillage (CC_MNT) and a cotton-wheat rotation with minimum tillage where wheat stubble was incorporated until 1999 and retained as standing stubble thereafter (CW_MNT). Cotton stubble was incorporated in all treatments. E2 compared cotton-vetch-cotton (CVC), cotton-fallow-cotton (CFC), cotton-wheat-fallow-cotton (CWFC), fallow-cotton-wheat-fallow-cotton (FCWFC), cotton-wheat-fallow-vetch-cotton-wheat (CWFVCW) and fallow-cotton-wheat-fallow-vetch-cotton-wheat (FCWFVCW). Vetch was retained as surface mulch, wheat stubble incorporated in both CWFC and FCWFC but retained as standing stubble in CWFVCW and FCWFVCW. E3 compared cotton-vetch-cotton-vetch (CVCV), cotton-fallow-cotton-fallow (CFCFC), cotton-wheat-fallow-cotton (CWFC), cotton-wheat-vetch-cotton (CWVC) and cotton-faba bean-fallow-cotton (CFbFC). Soils were sampled to 1.2 m in E1 and E2 and to 0.9 m in E3 and analysed for total soil organic carbon. Stubble was conserved in all experiments, but was incorporated in E3 and retained as standing stubble in E1 and E2 except as noted. Results indicate that in E1, soil organic carbon decreased over time under continuous cotton for all tillage treatments, however including wheat in the rotation slowed the decline and tended to increase soil organic carbon in the immediate surface layer. In E2 soil organic carbon decreased with depth and remained relatively constant, while soil organic

  10. Handling glacially induced faults in the assessment of the long term safety of a repository for spent nuclear fuel at Forsmark, Sweden

    NASA Astrophysics Data System (ADS)

    Munier, R.

    2011-12-01

    Located deep into the Baltic shield, far from active plate boundaries and volcanism, Swedish bedrock is characterised by a low frequency of earthquakes of small magnitudes. Yet, faults, predominantly in the Lapland region, offsetting the quarternary regolith ten meters or more, reveal that Swedish bedrock suffered from substantial earthquake activity in connection to the retreat of the latest continental glacier, Weichsel. Storage of nuclear wastes, hazardous for hundreds of thousand years, requires, firstly, isolation of radionuclides and, secondly, retardation of the nuclides should the barriers fail. Swedish regulations require that safety is demonstrated for a period of a million years. Consequently, the repository must be designed to resist the impact of several continental glaciers. Large, glacially induced, earthquakes near the repository have the potential of triggering slip along fractures across the canisters containing the nuclear wastes, thereby simultaneously jeopardising isolation, retardation and, hence, long term safety. It has therefore been crucial to assess the impact of such intraplate earthquake upon the primary functions of the repository. We conclude that, by appropriate design of the repository, the negative impact of earthquakes on long term safety can be considerably lessened. We were, additionally, able to demonstrate compliance with Swedish regulations in our safety assessment, SR-Site, submitted to the authorities earlier this year. However, the assessment required a number of critical assumptions, e.g. concerning the strain rate and the fracture properties of the rock, many of which are subject of current research in the geoscientific community. By a conservative approach, though, we judge to have adequately propagated critical uncertainties through the assessment and bound the uncertainty space.

  11. Long-Term Pharmacotherapy of Adults With Attention Deficit Hyperactivity Disorder: A Literature Review and Clinical Study.

    PubMed

    Fredriksen, Mats; Peleikis, Dawn E

    2016-01-01

    This MiniReview reports and discusses the main findings of the author's thesis including a literature study of long-term pharmacological treatment of adults with attention deficit hyperactivity disorder (ADHD), and a clinical study of 1-year medication. Electronic databases were systematically reviewed for original studies on pharmacotherapy of the defined duration, 24 weeks or more. Although few trials were found with limitations such as excluding comorbidities, treatment with stimulants and atomoxetine was reported tolerated and effective compared to non-treatment. The clinical study of the thesis was conducted on 250 medication-naïve patients with ADHD referred to a specialized outpatient clinic. Comorbid psychiatric disorders were diagnosed among 75% of the patients. About 56% had not completed secondary school, and 51% had been unable to work the preceding year. Persisting inattentive symptoms and comorbid mental disorders in adulthood were related to long-term work disability. In the prospective observational study of the thesis, patients were treated with methylphenidate as first-line drug and atomoxetine or dexamphetamine as second-line drugs, according to current treatment guidelines. At 12-month follow-up, 232 patients completed evaluation and 70% persisted on medication. About 80% of these used methylphenidate. Sustained improvement of symptoms and functioning was related to continued medication. Comorbid mental disorders and side effects were related to lower effectiveness and adherence, and 12% stopped medication due to side effects. Summing up the MiniReview, treatment with stimulants and atomoxetine of adults with ADHD has long-term beneficial effects and is tolerated but more longitudinal studies should be performed. With stated limitations, the findings of the thesis should contribute to a relevant guidance for clinical practice. PMID:26404187

  12. The Earth Education Program Sunship™ Earth: A Mixed Methods Study of the Long-Term Influence on Environmental Attitudes and Actions

    ERIC Educational Resources Information Center

    Bires, Nancy K.

    2013-01-01

    There have been a limited number of studies on the short-term influence of environmental and earth education programs, however, not much information is available about the long-term influence of these programs on participants' environmental attitudes and actions. This mixed methods study explores the long-term influence of the earth education…

  13. Long-term scar quality in burns with three distinct healing potentials: A multicenter prospective cohort study.

    PubMed

    Goei, Harold; van der Vlies, Cornelis H; Hop, M Jenda; Tuinebreijer, Wim E; Nieuwenhuis, Marianne K; Middelkoop, Esther; van Baar, Margriet E

    2016-07-01

    The laser Doppler imager is used in cases of indeterminate burn depth to accurately predict wound healing time at an early stage. The laser Doppler imager classifies burns into three estimated healing potentials as follows: high, <14 days; intermediate, 14-21 days; and low, >21 days. At this time, the relationship between these healing potentials and long-term scar quality is unknown. The objective of this study was to determine the long-term scar quality of burns with three distinct healing potentials. The secondary objectives were to compare treatment strategies in intermediate wounds, to study the effect of the timing of surgery on low healing potential wounds and to identify predictors of reduced scar quality. Hence, in a prospective cohort study, scar quality was determined in patients whose burns were assessed with laser Doppler imaging. Scar Quality was assessed with objective and subjective measurement tools, including overall scar quality (Patient and Observer Scar Assessment Scale) as a primary outcome and color and elasticity parameters. A total of 141 patients (>19 months postburn) with 216 scars were included. Wounds with high and intermediate healing potential did not significantly differ regarding scar quality. Wounds with a low healing potential had a significantly lower scar quality. Analysis of 76 surgically treated low healing potential wounds showed no significant differences in the primary outcome regarding the timing of surgery (≤14 days vs. >14). Predictors of reduced long-term scar quality were darker skin type and multiple surgeries. In conclusion, scar quality was strongly related to the healing potential category. Scar quality was very similar in high and intermediate healing potential wounds. No positive effects were found on scar quality or on healing time in surgically treated wounds with intermediate healing potential, advocating a conservative approach. Further studies should focus on the optimal timing of surgery in low healing

  14. Dump Stability and Soil Fertility of a Coal Mine Spoil in Indian Dry Tropical Environment: A Long-Term Study

    NASA Astrophysics Data System (ADS)

    Tripathi, Nimisha; Singh, Raj Shekhar; Chaulya, Swadesh K.

    2012-10-01

    Plant available nitrogen, belowground (root) biomass, soil nitrogen (N) mineralization and microbial biomass N (MBN) were studied for 12 years at the interval of 2 years (0, 2, 4, 6, 8, 10 and 12 years) and mine dump stability at the intervals of 6 years (0, 6 and 12 years) after re-vegetation on coal mine spoil site. Plant available nitrogen in revegetated mine spoil ranged from 4.51 to 6.59 μg g-1, net N-mineralization from 1.87 to 13.85 μg g-1 month-1, MBN from 10 to 22.63 μg g-1, and root biomass from 28 to 566 g-2. Mining activity has caused a change in soil characteristics including plant available nutrients like nitrate-N, ammonium-N and phosphate-P by 70, 67, and 76 %, respectively, N-mineralization by 93 %, root biomass values by 97 % and MBN values by 91 % compared to forest ecosystems. Revegetation of mine spoil produced increase in root biomass values by 1.3, 7.6 and 17.2 times, mineral N values by 1.22, 1.43 and 1.79 times, N-mineralization values by 1.8, 5.2 and 12.6 times and MBN values by 1.6, 2.0, and 3.4 times in 2, 6 and 12 years, respectively. Below ground biomass was highly co-related with microbial biomass and plant available nutrients. N-mineralization, plant available nutrients and the clay content were positively correlated with age of revegetation ( P < 0.01). From the numerical modelling it was analyzed that revegetation increased the dump slope stability with a factor of safety of 1.7 and 2.1 after 6 and 12 years of plantation on dump slope, respectively, while it was 1.2 before revegetation. Thus, long term revegetation was found to have direct impact on dump stability and indirect impact on soil fertility status in mine spoil, where plant biomass and microbial biomass provide major contributions in ecological redevelopment of the mine spoil.

  15. Historic air pollution exposure and long-term mortality risks in England and Wales: prospective longitudinal cohort study

    PubMed Central

    Hansell, Anna; Ghosh, Rebecca E; Blangiardo, Marta; Perkins, Chloe; Vienneau, Danielle; Goffe, Kayoung; Briggs, David; Gulliver, John

    2016-01-01

    Introduction Long-term air pollution exposure contributes to mortality but there are few studies examining effects of very long-term (>25 years) exposures. Methods This study investigated modelled air pollution concentrations at residence for 1971, 1981, 1991 (black smoke (BS) and SO2) and 2001 (PM10) in relation to mortality up to 2009 in 367 658 members of the longitudinal survey, a 1% sample of the English Census. Outcomes were all-cause (excluding accidents), cardiovascular (CV) and respiratory mortality. Results BS and SO2 exposures remained associated with mortality decades after exposure—BS exposure in 1971 was significantly associated with all-cause (OR 1.02 (95% CI 1.01 to 1.04)) and respiratory (OR 1.05 (95% CI 1.01 to 1.09)) mortality in 2002–2009 (ORs expressed per 10 μg/m3). Largest effect sizes were seen for more recent exposures and for respiratory disease. PM10 exposure in 2001 was associated with all outcomes in 2002–2009 with stronger associations for respiratory (OR 1.22 (95% CI 1.04 to 1.44)) than CV mortality (OR 1.12 (95% CI 1.01 to 1.25)). Adjusting PM10 for past BS and SO2 exposures in 1971, 1981 and 1991 reduced the all-cause OR to 1.16 (95% CI 1.07 to 1.26) while CV and respiratory associations lost significance, suggesting confounding by past air pollution exposure, but there was no evidence for effect modification. Limitations include limited information on confounding by smoking and exposure misclassification of historic exposures. Conclusions This large national study suggests that air pollution exposure has long-term effects on mortality that persist decades after exposure, and that historic air pollution exposures influence current estimates of associations between air pollution and mortality. PMID:26856365

  16. Long-term behavior of (90)Sr and (137)Cs in the environment: Case studies in Switzerland.

    PubMed

    Corcho-Alvarado, J A; Balsiger, B; Sahli, H; Astner, M; Byrde, F; Röllin, S; Holzer, R; Mosimann, N; Wüthrich, S; Jakob, A; Burger, M

    2016-08-01

    We present long-term records of the (137)Cs and (90)Sr activity concentrations in soil, grass and milk from two lowland and two alpine pastures of Switzerland. The data is used for better understanding the long-term behavior of these radionuclides in the environment. Transfer factors between compartments are used as qualitative indicators of the magnitude of transfer and as a way to compare different elements (e.g. Cs and Sr) in similar conditions. The long-term behavior was quantified by means of the effective half-life which integrates all processes that cause a decrease of activity in a given medium such as leaching, fixation, erosion and radioactive decay. Our study shows that (90)Sr is more likely transferred from alpine soil to grass than (137)Cs. This is explained by a stronger fixation of Cs in the soils. We observed higher transfers of (90)Sr to grass in soils with lower Ca concentrations, and vice versa. In contrast, the transfer of (137)Cs to grass was not affected by the variations of the K content in the soil. We provide evidence that shows that (137)Cs, after intake by dairy cattle, is more likely transferred to milk than (90)Sr. However, as the (90)Sr and Ca transfers to milk are influenced by parameters/processes that were not taken into account in our study, our result cannot be entirely validated. The effective half-lives of (137)Cs and (90)Sr in soil, grass and milk corresponded with previous estimates in alpine soils. We have found that processes other than radioactive decay are responsible for a major decrease of the (90)Sr activity in soil. For (137)Cs, on the other hand, radioactive decay is among the most relevant process. Our data shows to be of interest in studying the trends of behavior of radionuclides in alpine regions. PMID:27132253

  17. A Study of the Wide Main Sequence: The Long-Term Photometric Variability of Low Mass Stars

    NASA Astrophysics Data System (ADS)

    Pewett, Tiffany; Henry, Todd J.; Hosey, Altonio D.; Dieterich, Sergio; Jao, Wei-Chun; Winters, Jennifer G.; Riedel, Adric R.; RECONS Team

    2016-01-01

    The RECONS (REsearch Consortium On Nearby Stars, www.recons.org) team has carried out a long-term photometric variability study using the SMARTS 0.9m telescope at the Cerro Tololo Inter-American Observatory (CTIO). The program has obtained up to 15 years of observations in the V band for hundreds of M dwarf stars. This unique study has provided insight into how the ubiquitous M dwarfs change over decadal timescales, revealing their long-term magnetic cycles and how the presence or lack of such activity may affect their sizes and consequent luminosities, and thus their positions on the H-R Diagram.Using carefully vetted parallaxes and photometric colors, many measured by the RECONS team, we have created a highly accurate H-R Diagram of the nearest (within 25pc) stars using their V-K colors to represent temperatures and absolute V magnitudes as proxies for luminosities. We find that for M dwarfs, the main sequence widens significantly, by up to four magnitudes in MV, corresponding to a factor of almost 40 in optical flux. This spread implies a wide range of stellar radii for M dwarfs of the same temperature. Our study of long-term photometric variability indicates that there is a trend in cyclic activity that is highest for the most luminous red dwarfs and lowest for the rare, cool red subdwarfs. This provides valuable insight into the complex interplay of age, metallicity, and magnetic fields that molds the character of the red dwarfs.This effort has been supported by the NSF through grants AST-0908402, AST-1109445, and AST-1412026, STScI grant HST-GO-13724.001-A, and via observations made possible by the SMARTS Consortium.

  18. Long-Term Aircraft Noise Exposure and Body Mass Index, Waist Circumference, and Type 2 Diabetes: A Prospective Study

    PubMed Central

    Hilding, Agneta; Pyko, Andrei; Bluhm, Gösta; Pershagen, Göran; Östenson, Claes-Göran

    2014-01-01

    Background: Long-term aircraft noise exposure may increase the risk of cardiovascular disease, but no study has investigated chronic effects on the metabolic system. Objectives: The aim of this study was to investigate effects of long-term aircraft noise exposure on body mass index (BMI), waist circumference, and type 2 diabetes. Furthermore, we explored the modifying effects of sleep disturbance. Methods: This prospective cohort study of residents of Stockholm County, Sweden, followed 5,156 participants with normal baseline oral glucose tolerance tests (OGTT) for up to 10 years. Exposure to aircraft noise was estimated based on residential history. Information on outcomes and confounders was obtained from baseline and follow-up surveys and examinations, and participants who developed prediabetes or type 2 diabetes were identified by self-reported physician diagnosis or OGTT at follow-up. Adjusted associations were assessed by linear, logistic, and random-effects models. Results: The mean (± SD) increases in BMI and waist circumference during follow-up were 1.09 ± 1.97 kg/m2 and 4.39 ± 6.39 cm, respectively. The cumulative incidence of prediabetes and type 2 diabetes was 8% and 3%, respectively. Based on an ordinal noise variable, a 5-dB(A) increase in aircraft noise was associated with a greater increase in waist circumference of 1.51 cm (95% CI: 1.13, 1.89), fully adjusted. This association appeared particularly strong among those who did not change their home address during the study period, which may be a result of lower exposure misclassification. However, no clear associations were found for BMI or type 2 diabetes. Furthermore, sleep disturbances did not appear to modify the associations with aircraft noise. Conclusions: Long-term aircraft noise exposure may be linked to metabolic outcomes, in particular increased waist circumference. Citation: Eriksson C, Hilding A, Pyko A, Bluhm G, Pershagen G, Östenson CG. 2014. Long-term aircraft noise exposure and

  19. The long-term risk of malignant astrocytic tumors after structural brain injury—a nationwide cohort study

    PubMed Central

    Munch, Tina Noergaard; Gørtz, Sanne; Wohlfahrt, Jan; Melbye, Mads

    2015-01-01

    Background Neoplastic transformation of damaged astrocytes has been proposed as a possible pathological mechanism behind malignant astrocytic tumors. This study investigated the association between structural brain injuries causing reactive astrogliosis and long-term risk for malignant astrocytic tumors. Methods The cohort consisted of all individuals living in Denmark between 1978 and 2011. The personal identification number assigned to all individuals allowed retrieval of diagnoses of traumatic brain injury, cerebral ischemic infarction, and intracerebral hemorrhage from the National Patient Discharge Register. Diagnoses of anaplastic astrocytoma and glioblastoma multiforme (World Health Organization grades III and IV) were retrieved from the Danish Cancer Registry. Rate ratios (RR's) were estimated using log-linear Poisson regression. Results In a cohort of 8.2 million individuals, 404 812 experienced a structural brain injury and 6152 developed a malignant astrocytic tumor. No significant association was observed 1–4 years after a structural brain injury (RR = 1.14; 95% CI: 0.87–1.46), whereas the long-term (5+ y) risk for malignant astrocytic tumors was significantly reduced (RR = 0.68; 95% CI: 0.49–0.90) compared with no injury. The specific long-term risks by type of injury were: traumatic brain injury RR = 0.32 (95% CI: 0.10–0.75); cerebral ischemic infarction RR = 0.69 (95% CI: 0.47–0.96); and intracerebral hemorrhage RR = 1.39 (95% CI: 0.64–2.60). Conclusion We found no evidence for an association between structural brain injury and malignant astrocytic tumors within the first 5 years of follow-up. However, our study indicated a protective effect of astrogliosis-causing injuries 5 or more years after structural brain injury. PMID:25416827

  20. Association between long-term exposure to traffic particles and blood pressure in the Veterans Administration Normative Aging Study

    PubMed Central

    Schwartz, Joel; Alexeeff, Stacey E; Mordukhovich, Irina; Gryparis, Alexandros; Vokonas, Pantel; Suh, Helen; Coull, Brent A

    2013-01-01

    Objectives Particulate air pollution is associated with cardiovascular events, but the mechanisms are not fully understood. The main objective was to assess the relationship between long-term exposure to traffic-related air pollution and blood pressure (BP). Methods The authors used longitudinal data from 853 elderly men participating in the Veterans Administration Normative Aging Study, followed during 1996–2008. Long-term average exposures to traffic particles were created from daily predictions of black carbon (BC) exposure at the geocoded address of each subject, using a validated spatiotemporal model based on ambient monitoring at 82 Boston-area locations. The authors examined the association of these exposures with BP using a mixed model. The authors included the following covariates: age, body mass index, smoking, alcohol, fasting glucose, creatinine clearance, use of cardiovascular medication, education, census-level poverty, day of week and season of clinical visit. Results The authors found significant positive associations between 1-year average BC exposure and both systolic and diastolic blood pressure. An IQR increase in 1-year average BC exposure (0.32 µg/m3) was associated with a 2.64 mm Hg increase in systolic blood pressure (95% CI 1.47 to 3.80) and a 2.41 mm Hg increase in diastolic blood pressure (95% CI 1.77 to 3.05). Conclusions Long-term exposure to traffic particles is associated with increased BP, which may explain part of the association with myocardial infarctions and cardiovascular deaths reported in cohort studies. PMID:22383587

  1. The FP7 ULTimateCO2 project: a study of the long term fate of CO2

    NASA Astrophysics Data System (ADS)

    Audigane, Pascal; Waldmann, Svenja; Pearce, Jonathan; Dimier, Alain; Le Gallo, Yann; Frykman, Peter; Maurand, Nicolas; Gherardi, Fabrizio; Yalamas, Thierry; Cremer, Holger; Spiers, Chris; Nussbaum, Christophe

    2014-05-01

    The objectives of the European FP7 ULTimateCO2 project are to study specific processes that could influence the long-term fate of geologically stored CO2, mainly: the trapping mechanisms occurring in the storage reservoir, the influence of fluid-rock interactions on mechanical integrity of caprock and well vicinity, and also the modifications induced at the regional scale (brine displacement, fault reactivation, hydrogeology changes...). A comprehensive approach combining laboratory experiments, numerical modeling and natural analogue studies is developed to assess all the processes mentioned above. A collection of data has been generated from natural and industrial (oil industry) analogues on the fluid flow and mechanical properties, structure, and mineralogy of faults and fractures that could affect the long-term storage capacity of underground CO2 storage sites. To address geochemical trapping at reservoir scale, an experimental approach is developed using sandstone core materials in batch reactive mode with CO2 and impurities at reservoir pressure and temperature conditions. Three inter-related lines of laboratory experiments investigate the long-term evolution of the mechanical properties and sealing integrity of fractured and faulted caprocks using Opalinus clay of Mont Terri Gallery (Switzerland), an analogue for caprock well investigated in the past for nuclear waste disposal purpose. To evaluate the interactions between CO2 (and formation fluid) and the well environment (formation, cement, casing) and to assess the consequences of these interactions on the transport properties of well materials, a 1 to 1 scale experiment has been set in the Mont Terri Gallery Opalinus clay to reproduce classical well objects (cemented annulus, casing and cement plug) perforating caprock formations. An extensive program of numerical modeling is also developed to calibrate, to reproduce and to extrapolate the experimental results at longer time scales including uncertainty

  2. Long-Term Effects of Segmental Lumbar Spinal Fusion on Adjacent Healthy Discs: A Finite Element Study

    PubMed Central

    Srinivas, Gunti Ranga; Deb, Anindya; Kurnool, Goutham

    2016-01-01

    Study Design Experimental study. Purpose The aim of the study was to develop a finite element (FE) model to study the long-term effects of various types of lumbar spinal interventions on the discs adjacent to the fused segment. Overview of Literature Earlier FE studies have been limited to one particular type of fusion and comparative quantification of the adjacent disc stresses for different types of surgical interventions has not been reported. Methods A computer aided engineering (CAE) based approach using implicit FE analysis assessed the stresses in the lumbar discs adjacent to the fused segment following anterior and posterior lumbar spine fusions at one, two and three levels (with and without instrumentation). Results It was found that instrumentation and length of fusion were the most significant factors in increasing adjacent level stresses in the lumbar discs. Conclusions In the present study, a calibrated FE model that examined spinal interventions under similar loading and boundary conditions was used to provide quantitative data which would be useful for clinicians to understand the probable long-term effect of their choice of surgical intervention. PMID:27114758

  3. An approach to quantitative assessment of crew well-being for providing safety of long-term space missions

    NASA Astrophysics Data System (ADS)

    Bartsev, S. I.; Mezhevikin, V. V.; Okhonin, V. A.

    The main destination of Life Support Systems - to support life and provide crew safety - put the problem of the most effective providing this function. In the scope of the whole mission the safety of crew depends on many interrelating features of space ship, LSS, and scenario of given mission itself. Effective risk mitigation needs optimal minimizing of all risk factors. Effective minimization presumes quantitative presentation of these factors. In the paper an approach to quantitative assessment of quality of life in the scope of previously introduced integrated coefficient of maximum reliability. One of the most significant risk factors is crew fatal mistake. There is always other-than-zero probability of a fatal human mistake in controlling the vehicle, landing module, nuclear reactor or other vital device. It is difficult to estimate the probability of such a mistake, but it is apparent that this probability increases with impaired human health. Under closed air cycling such a condition is highly probable as demonstrated by the Sick Building Syndrome (SBS) in highly sealed, so-called "energy efficient" buildings. Seemingly, the cause of SBS is a set of not completely identified factors, yet, it should be noted that in spite of complete pressurization the crew of Bios-3 did not have complaints typical for SBS. It cannot be ruled out that the higher plants may be the most realistic remedy to reduce the probability of the crew's fatal mistakes. All this gives the way to convert so difficultly formalizable parameter as quality of life into probability of accident. A simple monotonous dependence of deterioration of crew health and probability of a fatal mistake on mission time is discussed. Possible medical-biological experiments for more detailed estimations of this dependency are considered.

  4. Long-term outcomes of patients with lumbar disc herniation treated with percutaneous discectomy: comparative study with microendoscopic discectomy.

    PubMed

    Liu, Wen-Gui; Wu, Xiao-Tao; Guo, Jin-He; Zhuang, Su-Yang; Teng, Gao-Jun

    2010-08-01

    We assessed the long-term outcomes of patients with lumbar disc herniation treated with percutaneous lumbar discectomy (PLD) or microendoscopic discectomy (MED). A retrospective study was performed in consecutive patients with lumbar disc herniation treated with PLD (n = 129) or MED (n = 101) in a single hospital from January 2000 to March 2002. All patients were followed up with MacNab criteria and self-evaluation questionnaires comprising the Oswestry Disability Index and Medical Outcomes Study 36-Item Short-Form Health Survey. Several statistical methods were used for analyses of the data, and a p value of <0.05 was considered to be statistically significant. A total of 104 patients (80.62%) with PLD and 82 patients (81.19%) with MED were eligible for analyses, with a mean follow-up period of 6.64 +/- 0.67 years and 6.42 +/- 0.51 years, respectively. There were no significant differences between the two groups in age, number of lesions, major symptoms and physical signs, and radiological findings. According to the MacNab criteria, 75.96% in the PLD group and 84.15% in the MED group achieved excellent or good results, respectively, this was statistically significant (p = 0.0402). With the Oswestry Disability Index questionnaires, the average scores and minimal disability, respectively, were 6.97 and 71.15% in the PLD group and 4.89 and 79.27% in the MED group. Total average scores of Medical Outcomes Study 36-Item Short-Form Health Survey were 75.88 vs. 81.86 in PLD group vs. MED group (p = 0.0582). The cost and length of hospitalization were higher or longer in MED group, a statistically significant difference (both p < 0.0001). Long-term complications were observed in two patients (2.44%) in the MED group, no such complications were observed in the PLD group. Both PLD and MED show an acceptable long-term efficacy for treatment of lumbar disc herniation. Compared with MED patients, long-term satisfaction is slightly lower in the PLD patients; complications

  5. Late effects in long-term survivors of ALL in childhood: experiences from the SPOG late effects study.

    PubMed

    von der Weid, N

    2001-04-01

    With the use of more intensive regimens including prophylactic CNS treatment, the prognosis of children with ALL has dramatically improved over the last three decades. The aim of this cross-sectional, nationwide study was to comprehensively assess long-term toxicity in ALL survivors, with special attention given to neuropsychological morbidity, and to look for possible differences in cognitive outcome between children having received prophylactic cranial irradiation and those not having received it. Between 1994 and 1996, long-term survivors of ALL were assessed in a multi-center setting according to a standardized protocol which included, besides usual clinical and laboratory investigations, a comprehensive endocrine work-up. Additionally, children having received anthracyclines were checked for possible late cardio-toxicity with echocardiography and ECG. Intellectual performance was evaluated with standardized neuropsychological tests (age-adapted versions of the Wechsler test). One-hundred and fifty patients were eligible for the study. The median age at diagnosis was 5 years and at evaluation 16 years, for a median follow-up of 10 years. Thirty-five patients had cranial irradiation as part of the prophylactic CNS treatment. One-hundred and forty (93%) of the 150 eligible patients were completely evaluated in terms of global long-term toxicity: 117 (83%) long-term survivors had no (n = 61) or only minimal (n = 56) late toxicity; 19 (14%) suffered from moderate impairments; 4 (3%) showed severe somatic or neuropsychological sequelae. Intellectual performance could be assessed in 147 (98%) of the 150 eligible patients. The mean global, verbal and non-verbal IQs (103, 105 and 101 respectively) of the ALL survivors as a group were comparable with those found in the general population. The results of the comparison between children having and those not having received prophylactic cranial irradiation showed: 1) significantly higher scores in chemotherapy-only treated

  6. Long-Term Outcomes of Patients with Lumbar Disc Herniation Treated with Percutaneous Discectomy: Comparative Study with Microendoscopic Discectomy

    SciTech Connect

    Liu Wengui; Wu Xiaotao; Guo Jinhe; Zhuang Suyang; Teng Gaojun

    2010-08-15

    We assessed the long-term outcomes of patients with lumbar disc herniation treated with percutaneous lumbar discectomy (PLD) or microendoscopic discectomy (MED). A retrospective study was performed in consecutive patients with lumbar disc herniation treated with PLD (n = 129) or MED (n = 101) in a single hospital from January 2000 to March 2002. All patients were followed up with MacNab criteria and self-evaluation questionnaires comprising the Oswestry Disability Index and Medical Outcomes Study 36-Item Short-Form Health Survey. Several statistical methods were used for analyses of the data, and a p value of <0.05 was considered to be statistically significant. A total of 104 patients (80.62%) with PLD and 82 patients (81.19%) with MED were eligible for analyses, with a mean follow-up period of 6.64 {+-} 0.67 years and 6.42 {+-} 0.51 years, respectively. There were no significant differences between the two groups in age, number of lesions, major symptoms and physical signs, and radiological findings. According to the MacNab criteria, 75.96% in the PLD group and 84.15% in the MED group achieved excellent or good results, respectively, this was statistically significant (p = 0.0402). With the Oswestry Disability Index questionnaires, the average scores and minimal disability, respectively, were 6.97 and 71.15% in the PLD group and 4.89 and 79.27% in the MED group. Total average scores of Medical Outcomes Study 36-Item Short-Form Health Survey were 75.88 vs. 81.86 in PLD group vs. MED group (p = 0.0582). The cost and length of hospitalization were higher or longer in MED group, a statistically significant difference (both p < 0.0001). Long-term complications were observed in two patients (2.44%) in the MED group, no such complications were observed in the PLD group. Both PLD and MED show an acceptable long-term efficacy for treatment of lumbar disc herniation. Compared with MED patients, long-term satisfaction is slightly lower in the PLD patients; complications

  7. Long-Term Exposure to Particulate Matter and Self-Reported Hypertension: A Prospective Analysis in the Nurses’ Health Study

    PubMed Central

    Zhang, Zhenyu; Laden, Francine; Forman, John P.; Hart, Jaime E.

    2016-01-01

    Background: Studies have suggested associations between elevated blood pressure and short-term air pollution exposures, but the evidence is mixed regarding long-term exposures on incidence of hypertension. Objectives: We examined the association of hypertension incidence with long-term residential exposures to ambient particulate matter (PM) and residential distance to roadway. Methods: We estimated 24-month and cumulative average exposures to PM10, PM2.5, and PM2.5–10 and residential distance to road for women participating in the prospective nationwide Nurses’ Health Study. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated for incident hypertension from 1988 to 2008 using Cox proportional hazards models adjusted for potential confounders. We considered effect modification by age, diet, diabetes, obesity, region, and latitude. Results: Among 74,880 participants, 36,812 incident cases of hypertension were observed during 960,041 person-years. In multivariable models, 10-μg/m3 increases in 24-month average PM10, PM2.5, and PM2.5–10 were associated with small increases in the incidence of hypertension (HR: 1.02, 95% CI: 1.00, 1.04; HR: 1.04, 95% CI: 1.00, 1.07; and HR: 1.03, 95% CI: 1.00, 1.07, respectively). Associations were stronger among women < 65 years of age (HR: 1.04, 95% CI: 1.01, 1.06; HR: 1.07, 95% CI: 1.02, 1.12; and HR: 1.05, 95% CI: 1.01, 1.09, respectively) and the obese (HR: 1.07, 95% CI: 1.04, 1.12; HR: 1.15, 95% CI: 1.07, 1.23; and HR: 1.13, 95% CI: 1.07, 1.19, respectively), with p-values for interaction < 0.05 for all models except age and PM2.5–10. There was no association with roadway proximity. Conclusions: Long-term exposure to particulate matter was associated with small increases in risk of incident hypertension, particularly among younger women and the obese. Citation: Zhang Z, Laden F, Forman JP, Hart JE. 2016. Long-term exposure to particulate matter and self-reported hypertension: a prospective analysis in

  8. Uncemented Total Hip Replacement Stem Loosening after Long Term Compressive Stress Application: A Simulated FEA Study of Cortical Bone Remodeling

    NASA Astrophysics Data System (ADS)

    Jung, Duk-Young; Tsutsumi, Sadami; Nakai, Ryusuke; Ikeuchi, Ken; Sekel, Ron

    The purpose of this study is to predict with the use of FEA, the differing predisposition to cortical bone resorption and subsequent distal migration of an un-cemented femoral hip replacement stem subjected to long term biomechanical high compressive stresses, while varying the load angles, the material properties of the stem, and the stem length. A two-dimensional hip model was constructed to estimate the minimum principle stresses (P3) and migration magnitudes. Bone remodeling at the interface between the bone and the prosthesis was performed by comparison of the local compressive stress to physiological stress values governing bone resorption. With respect to load angles, migrations of the hip prosthesis did not occur with load angles between 63° and 74° load angle in relation to the longitudinal axis of the bony femur, as the compressive stress generated on the cortical bone was under the criteria threshold for bone resorption (-50MPa). In addition, the magnitude of migration (17%decrease) was relatively more sensitive to changes in stem length than those (92%decrease) of changes of material properties. In conclusion, using an FEA model for bone remodeling, based on the high compressive stresses exerted on distal cortical bone, it is possible to estimate migration magnitudes of cementless hip prostheses in the long term. The load angles have been shown to be an important parameter affecting the migration magnitudes and furthermore, it can be demonstrated that the stiffer materials and reduction of stem length can decrease the migration of cementless hip prosthesis in the long term.

  9. Predictors of long term survival after hepatic resection for hilar cholangiocarcinoma: A retrospective study of 5-year survivors

    PubMed Central

    Abd ElWahab, Mohamed; El Nakeeb, Ayman; El Hanafy, Ehab; Sultan, Ahmad M; Elghawalby, Ahmed; Askr, Waleed; Ali, Mahmoud; Abd El Gawad, Mohamed; Salah, Tarek

    2016-01-01

    AIM: To determine predictors of long term survival after resection of hilar cholangiocarcinoma (HC) by comparing patients surviving > 5 years with those who survived < 5 years. METHODS: This is a retrospective study of patients with pathologically proven HC who underwent surgical resection at the Gastroenterology Surgical Center, Mansoura University, Egypt between January 2002 and April 2013. All data of the patients were collected from the medical records. Patients were divided into two groups according to their survival: Patients surviving less than 5 years and those who survived > 5 years. RESULTS: There were 34 (14%) long term survivors (5 year survivors) among the 243 patients. Five-year survivors were younger at diagnosis than those surviving less than 5 years (mean age, 50.47 ± 4.45 vs 54.59 ± 4.98, P = 0.001). Gender, clinical presentation, preoperative drainage, preoperative serum bilirubin, albumin and serum glutamic-pyruvic transaminase were similar between the two groups. The level of CA 19-9 was significantly higher in patients surviving < 5 years (395.71 ± 31.43 vs 254.06 ± 42.19, P = 0.0001). Univariate analysis demonstrated nine variables to be significantly associated with survival > 5 year, including young age (P = 0.001), serum CA19-9 (P = 0.0001), non-cirrhotic liver (P = 0.02), major hepatic resection (P = 0.001), caudate lobe resection (P = 0.006), well differentiated tumour (P = 0.03), lymph node status (0.008), R0 resection margin (P = 0.0001) and early postoperative liver cell failure (P = 0.02). CONCLUSION: Liver status, resection of caudate lobe, lymph node status, R0 resection and CA19-9 were demonstrated to be independent risk factors for long term survival. PMID:27358676

  10. Long-term health outcomes in a British cohort of breast, colorectal and prostate cancer survivors: a database study

    PubMed Central

    Khan, N F; Mant, D; Carpenter, L; Forman, D; Rose, P W

    2011-01-01

    Background: The community-based incidence of cancer treatment-related long-term consequences is uncertain. We sought to establish the burden of health outcomes that have been associated with treatment among British long-term cancer survivors. Methods: We identified 26 213 adults from the General Practice Research Database who have survived 5 years or more following breast, colorectal or prostate cancer. Four age-, sex- and general practice-matched non-cancer controls were selected for each survivor. We considered the incidence of treatment-associated health outcomes using Cox proportional hazards models. Results: Breast cancer survivors had an elevated incidence of heart failure (hazards ratio (HR) 1.95, 95% confidence interval (CI) 1.27–3.01), coronary artery disease (HR 1.27, 95% CI 1.11–1.44), hypothyroidism (HR 1.26, 95% CI 1.02–1.56) and osteoporosis (HR 1.26, 95% CI 1.13–1.40). Among colorectal cancer survivors, there was increased incidence of dementia (HR 1.68, 95% CI 1.20–2.35), diabetes (HR 1.39, 95% CI 1.12–1.72) and osteoporosis (HR 1.41, 95% CI 1.15–1.73). Prostate cancer survivors had the highest risk of osteoporosis (HR 2.49, 95% CI 1.93–3.22). Conclusions: The study confirms the occurrence of increased incidence of chronic illnesses in long-term cancer survivors attributable to underlying lifestyle and/or cancer treatments. Although the absolute risk of the majority of late effects in the cancer survivors cohort is low, identifying prior risk of osteoporosis by bone mineral density scanning for prostate survivors should be considered. There is an urgent need to improve primary care recording of cancer treatment. PMID:22048030

  11. Mark I containment long-term program safety evaluation report, resolution of generic technical activity A-7. Report for February 1977-December 1979

    SciTech Connect

    Not Available

    1980-07-01

    During testing for an advanced Boiling Water Reactor (BWR) containment system design (Mark III), suppression pool hydrodynamic loads were identified which had not been considered in the original design of the Mark I containment system. To address this issue, a Mark I Owners Group was formed and the assessment was divided into a short-term and long-term program. The results of the NRC staff's review of the Mark I Containment Short Term Program are described in NUREG-0408. This report describes the results of the NRC staff's review of the generic Mark I Containment Long Term Program (LTP). The LTP was conducted to provide a generic basis to define suppression pool hydrodynamic loads and the related structural acceptance criteria, such that a comprehensive reassessment of each Mark I containment system would be performed. A series of experimental and analytical programs were conducted by the Mark I Owners Group to provide the necessary bases for the generic load definition and structural assessment techniques. The generic methods proposed by the Mark I Owners Group, as modified by the NRC staff's requirements, will be used to perform plant-unique analyses, which will identify the plant modifications, if any, that will be needed to restore the originally intended margin of safety in the Mark I containment designs.

  12. The Association between Obstructive Sleep Apnea and Neurocognitive Performance—The Apnea Positive Pressure Long-term Efficacy Study (APPLES)

    PubMed Central

    Quan, Stuart F.; Chan, Cynthia S.; Dement, William C.; Gevins, Alan; Goodwin, James L.; Gottlieb, Daniel J.; Green, Sylvan; Guilleminault, Christian; Hirshkowitz, Max; Hyde, Pamela R.; Kay, Gary G.; Leary, Eileen B.; Nichols, Deborah A.; Schweitzer, Paula K.; Simon, Richard D.; Walsh, James K.; Kushida, Clete A.

    2011-01-01

    Study Objectives: To determine associations between obstructive sleep apnea (OSA) and neurocognitive performance in a large cohort of adults. Study Design: Cross-sectional analyses of polysomnographic and neurocognitive data from 1204 adult participants with a clinical diagnosis of obstructive sleep apnea (OSA) in the Apnea Positive Pressure Long-term Efficacy Study (APPLES), assessed at baseline before randomization to either continuous positive airway pressure (CPAP) or sham CPAP. Measurements: Sleep and respiratory indices obtained by laboratory polysomnography and several measures of neurocognitive performance. Results: Weak correlations were found for both the apnea hypopnea index (AHI) and several indices of oxygen desaturation and neurocognitive performance in unadjusted analyses. After adjustment for level of education, ethnicity, and gender, there was no association between the AHI and neurocognitive performance. However, severity of oxygen desaturation was weakly associated with worse neurocognitive performance on some measures of intelligence, attention, and processing speed. Conclusions: The impact of OSA on neurocognitive performance is small for many individuals with this condition and is most related to the severity of hypoxemia. Citation: Quan SF; Chan CS; Dement WC; Gevins A; Goodwin JL; Gottlieb DJ; Green S; Guilleminault C; Hirshkowitz M; Hype PR; Kay GG; Leary EB; Nichols DA; Schweitzer PK; Simon RD; Walsh JK; Kushida CA. The association between obstructive sleep apnea and neurocognitive performance—the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2011;34(3):303-314. PMID:21358847

  13. Update on long-term efficacy and safety of dapagliflozin in patients with type 2 diabetes mellitus

    PubMed Central

    Liakos, Aris; Karagiannis, Thomas; Bekiari, Eleni; Boura, Panagiota

    2015-01-01

    Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a novel class of antihyperglycaemic agents with an insulin-independent mode of action. Dapagliflozin is a member of the SGLT2 inhibitors class that has received marketing authorization in Europe and the US for use in patients with type 2 diabetes. This review summarizes current evidence from clinical trials assessing the clinical efficacy and safety of dapagliflozin, and presents data regarding its cost-effectiveness. Treatment with dapagliflozin results in similar reduction in haemoglobin A1c with other oral antihyperglycaemic drugs, which is preserved over 4 years of treatment. However, compared with most antidiabetic agents, dapagliflozin provides additional clinical benefits including body weight loss and blood pressure reduction. Moreover, treatment with dapagliflozin does not increase risk for hypoglycaemia, but is associated with increased incidence of mild to moderate urinary and genital tract infections. A pivotal outcomes trial of dapagliflozin is expected to clarify its effect on cardiovascular endpoints, whilst a causative relationship between dapagliflozin and select malignancies is unlikely. Finally, based on recent economic evaluations dapagliflozin seems to be a cost-effective option for type 2 diabetes in some settings. PMID:25941564

  14. 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. PMID:3667473

  15. Understanding the Risk Factors and Long-Term Consequences of Cisplatin-Associated Acute Kidney Injury: An Observational Cohort Study.

    PubMed

    Bhat, Zeenat Yousuf; Cadnapaphornchai, Pravit; Ginsburg, Kevin; Sivagnanam, Milani; Chopra, Shamit; Treadway, Corey K; Lin, Ho-Sheng; Yoo, George; Sukari, Ammar; Doshi, Mona D

    2015-01-01

    Acute kidney injury (AKI) is a well-known complication of cisplatin-based chemotherapy; however, its impact on long-term patient survival is unclear. We sought to determine the incidence and risk factors for development of cisplatin-associated AKI and its impact on long-term renal function and patient survival. We identified 233 patients who received 629 cycles of high-dose cisplatin (99±9mg/m2) for treatment of head and neck cancer between 2005 and 2011. These subjects were reviewed for development of AKI. Cisplatin nephrotoxicity (CN) was defined as persistent rise in serum creatinine, with a concomitant decline in serum magnesium and potassium, in absence of use of nephrotoxic agents and not reversed with hydration. All patients were hydrated per protocol and none had baseline glomerular filtration rate (GFR) via CKD-EPI<60mL/min/1.73m2. The patients were grouped based on development of AKI and were staged for levels of injury, per KDIGO-AKI definition. Renal function was assessed via serum creatinine and estimated glomerular filtration rate (eGFR) via CKD-EPI at baseline, 6- and 12-months. Patients with AKI were screened for the absence of nephrotoxic medication use and a temporal decline in serum potassium and magnesium levels. Logistic regression models were constructed to determine risk factors for cisplatin-associated AKI. Twelve-month renal function was compared among groups using ANOVA. Kaplan-Maier curves and Cox proportional hazard models were constructed to study its impact on patient survival. Of 233 patients, 158(68%) developed AKI; 77 (49%) developed stage I, 55 (35%) developed stage II, and 26 (16%) developed stage III AKI. Their serum potassium and magnesium levels correlated negatively with level of injury (p<0.05). African American race was a significant risk factor for cisplatin-associated AKI, OR 2.8 (95% CI 1.3 to 6.3) and 2.8 (95% CI 1.2 to 6.7) patients with stage III AKI had the lowest eGFR value at 12 months (p = 0.05) and long-term

  16. Understanding the Risk Factors and Long-Term Consequences of Cisplatin-Associated Acute Kidney Injury: An Observational Cohort Study

    PubMed Central

    Bhat, Zeenat Yousuf; Cadnapaphornchai, Pravit; Ginsburg, Kevin; Sivagnanam, Milani; Chopra, Shamit; Treadway, Corey K.; Lin, Ho-Sheng; Yoo, George; Sukari, Ammar; Doshi, Mona D.

    2015-01-01

    Acute kidney injury (AKI) is a well-known complication of cisplatin-based chemotherapy; however, its impact on long-term patient survival is unclear. We sought to determine the incidence and risk factors for development of cisplatin-associated AKI and its impact on long-term renal function and patient survival. We identified 233 patients who received 629 cycles of high-dose cisplatin (99±9mg/m2) for treatment of head and neck cancer between 2005 and 2011. These subjects were reviewed for development of AKI. Cisplatin nephrotoxicity (CN) was defined as persistent rise in serum creatinine, with a concomitant decline in serum magnesium and potassium, in absence of use of nephrotoxic agents and not reversed with hydration. All patients were hydrated per protocol and none had baseline glomerular filtration rate (GFR) via CKD-EPI<60mL/min/1.73m2. The patients were grouped based on development of AKI and were staged for levels of injury, per KDIGO-AKI definition. Renal function was assessed via serum creatinine and estimated glomerular filtration rate (eGFR) via CKD-EPI at baseline, 6- and 12-months. Patients with AKI were screened for the absence of nephrotoxic medication use and a temporal decline in serum potassium and magnesium levels. Logistic regression models were constructed to determine risk factors for cisplatin-associated AKI. Twelve-month renal function was compared among groups using ANOVA. Kaplan-Maier curves and Cox proportional hazard models were constructed to study its impact on patient survival. Of 233 patients, 158(68%) developed AKI; 77 (49%) developed stage I, 55 (35%) developed stage II, and 26 (16%) developed stage III AKI. Their serum potassium and magnesium levels correlated negatively with level of injury (p<0.05). African American race was a significant risk factor for cisplatin-associated AKI, OR 2.8 (95% CI 1.3 to 6.3) and 2.8 (95% CI 1.2 to 6.7) patients with stage III AKI had the lowest eGFR value at 12 months (p = 0.05) and long-term

  17. Long-term morbidity and mortality after hospitalization with community-acquired pneumonia: a population-based cohort study.

    PubMed

    Johnstone, Jennie; Eurich, Dean T; Majumdar, Sumit R; Jin, Yan; Marrie, Thomas J

    2008-11-01

    Little is known about the long-term sequelae of community-acquired pneumonia (CAP). Therefore, we describe the long-term morbidity and mortality of patients after pneumonia requiring hospitalization. We specifically hypothesized that the Pneumonia Severity Index (PSI), designed to predict 30-day pneumonia-related mortality, would also be associated with longer-term all-cause mortality. Between 2000 and 2002, 3415 adults with CAP admitted to 6 hospitals in Edmonton, Alberta, Canada, were prospectively enrolled in a population-based cohort. At the time of hospital admission, demographic, clinical, and laboratory data were collected and the PSI was calculated for each patient. Postdischarge outcomes through to 2006 were ascertained using multiple linked administrative databases. Outcomes included all-cause mortality, hospital admissions, and re-hospitalization for pneumonia over a maximum of 5.4 years of follow-up. Follow-up data were available for 3284 (96%) patients; 66%were > or =65 years of age, 53% were male, and according to the PSI fully 63% were predicted to have greater than 18% 30-day pneumonia-related mortality (that is, PSI class IV-V). Median follow-up was 3.8 years. The 30-day, 1-year, and end of study mortality rates were 12%, 28%, and 53%, respectively. Overall, 82(19%) patients aged <45 years died compared with 1456 (67%) patients aged > or =65 years (hazard ratio [HR], 5.07; 95% confidence interval [CI], 4.06-6.34). Male patients were more likely to die than female patients during follow-up (971 [56%] vs. 767 [49%], respectively; HR, 1.20; 95% CI, 1.13-1.37). Initial PSI classification predicted not only 30-day mortality, but also long-term postdischarge mortality, with 92 (15%) of PSI class I-II patients dying compared with 616 (82%) PSI class V patients (HR, 11.80; 95% CI, 4.70-14.70). Of 2950 patients who survived the initial CAP hospitalization, 72% were hospitalized again (median, 2 admissions over follow-up) and 16% were re-hospitalized with

  18. Long term cerebral and vascular complications after irradiation of the neck in head and neck cancer patients: a prospective cohort study: study rationale and protocol

    PubMed Central

    2014-01-01

    Background Successful treatment options for cancer result in more young long-term survivors prone for long-term complications. Carotid artery vasculopathy is a potential long-term complication after radiotherapy of the neck, resulting in cerebrovascular events and probably deficits in cognitive and motor functioning. Better insight into the underlying pathofysiology of radiotherapy induced carotid artery vasculopathy is needed for prognostic purposes and to develop preventive strategies. Methods/Design The current study is a prospective cohort study on the long-term cerebral and vascular complications after radiotherapy of the neck, in 103 patients treated for head and neck cancer, included in our study database between 2002 and 2008. Baseline protocol (before radiotherapy) included screening for cerebrovascular risk factors and intima media thickness measurement of carotid arteries by ultrasonography. Follow-up assessment more than 5 years after radiotherapy included screening of cerebrovascular risk factors, cerebrovascular events, neurological examination with gait and balance tests, extensive neuropsychological examination, self-report questionnaires, ultrasonography of the carotid arteries with measurement of intima media thickness and elastography, magnetic resonance imaging of the brain and magnetic resonance angiography of the carotid arteries. Discussion The current study adds to the understanding of the causes and consequences of long-term cerebral and vascular changes after radiotherapy of the neck. These data will be helpful to develop a protocol for diagnostic and preventive strategies for long-term neurological complications in future head and neck cancer patients with anticipated radiotherapy treatment. PMID:24942263

  19. Plutonium isotopes in the terrestrial environment at the Savannah River Site, USA: a long-term study.

    PubMed

    Armstrong, Christopher R; Nuessle, Patterson R; Brant, Heather A; Hall, Gregory; Halverson, Justin E; Cadieux, James R

    2015-02-01

    This work presents the findings of a long-term plutonium (Pu) study at Savannah River Site (SRS) conducted between 2003 and 2013. Terrestrial environmental samples were obtained at the Savannah River National Laboratory (SRNL) in the A-Area. Plutonium content and isotopic abundances were measured over this time period by α particle and thermal ionization mass spectrometry (3STIMS). We detail the complete process of the sample collection, radiochemical separation, and measurement procedure specifically targeted to trace plutonium in bulk environmental samples. Total plutonium activities were determined to be not significantly above atmospheric global fallout. However, the (238)Pu/(239+240)Pu activity ratios attributed to SRS are substantially different than fallout due to past (238)Pu production on the site. The (240)Pu/(239)Pu atom ratios are reasonably consistent from year to year and are lower than fallout indicating an admixture of weapons-grade material, while the (242)Pu/(239)Pu atom ratios are higher than fallout values, again due to actinide production activities. Overall, the plutonium signatures obtained in this study reflect a distinctive mixture of weapons-grade, heat source, and higher burn-up plutonium with fallout material. This study provides a unique opportunity for developing and demonstrating a blue print for long-term low-level monitoring of trace plutonium in the environment. PMID:25535652

  20. Long-Term Ultrasonography Follow-Up of Thyroid Colloid Cysts at the Health Center: A Single-Center Study

    PubMed Central

    Rho, Myung Ho; Kim, Dong Wook

    2015-01-01

    Objective. No previous study has employed long-term follow-up ultrasonography (US) examinations for evaluating thyroid colloid cysts (TCCs) in the general population. This study aimed to assess the interval changes of TCCs at the health center by evaluating long-term US follow-up examinations. Methods. For evaluation of the thyroid gland at our health center from 2006 to 2010, 3692 individuals underwent 4 or more thyroid US examinations at an interval of 1 year or 2 years. We assessed the interval changes of TCCs ≥ 5 mm on US follow-up examinations. Results. Of the 3692 subjects, only 115 (3.1%) showed TCCs ≥ 5 mm on one or more thyroid US examinations. The interval changes in TCCs, as shown by the thyroid US examinations performed during the study period, were classified as follows: no interval change (n = 60), gradual increase (n = 37), gradual decrease (n = 6), positive fluctuation (n = 10), negative fluctuation (n = 0), and disappearance (n = 2). No subject reported any relevant symptom pertaining to TCCs. Conclusions. Overall, follow-up US examinations showed various interval changes in TCCs, but a majority of TCCs showed no interval change or a gradual increase in size. PMID:26579197

  1. Plutonium Isotopes in the Terrestrial Environment at the Savannah River Site, USA. A Long-Term Study

    DOE PAGESBeta

    Armstrong, Christopher R.; Nuessle, Patterson R.; Brant, Heather A.; Hall, Gregory; Halverson, Justin E.; Cadieux, James R.

    2015-01-16

    This work presents the findings of a long term plutonium study at Savannah River Site (SRS) conducted between 2003 and 2013. Terrestrial environmental samples were obtained at Savannah River National Laboratory (SRNL) in A-area. Plutonium content and isotopic abundances were measured over this time period by alpha spectrometry and three stage thermal ionization mass spectrometry (3STIMS). Here we detail the complete sample collection, radiochemical separation, and measurement procedure specifically targeted to trace plutonium in bulk environmental samples. Total plutonium activities were determined to be not significantly above atmospheric global fallout. However, the 238Pu/239+240Pu activity ratios attributed to SRS are abovemore » atmospheric global fallout ranges. The 240Pu/239Pu atom ratios are reasonably consistent from year to year and are lower than fallout, while the 242Pu/239Pu atom ratios are higher than fallout values. Overall, the plutonium signatures obtained in this study reflect a mixture of weapons-grade, higher burn-up, and fallout material. This study provides a blue print for long term low level monitoring of plutonium in the environment.« less

  2. Plutonium Isotopes in the Terrestrial Environment at the Savannah River Site, USA. A Long-Term Study

    SciTech Connect

    Armstrong, Christopher R.; Nuessle, Patterson R.; Brant, Heather A.; Hall, Gregory; Halverson, Justin E.; Cadieux, James R.

    2015-01-16

    This work presents the findings of a long term plutonium study at Savannah River Site (SRS) conducted between 2003 and 2013. Terrestrial environmental samples were obtained at Savannah River National Laboratory (SRNL) in A-area. Plutonium content and isotopic abundances were measured over this time period by alpha spectrometry and three stage thermal ionization mass spectrometry (3STIMS). Here we detail the complete sample collection, radiochemical separation, and measurement procedure specifically targeted to trace plutonium in bulk environmental samples. Total plutonium activities were determined to be not significantly above atmospheric global fallout. However, the 238Pu/239+240Pu activity ratios attributed to SRS are above atmospheric global fallout ranges. The 240Pu/239Pu atom ratios are reasonably consistent from year to year and are lower than fallout, while the 242Pu/239Pu atom ratios are higher than fallout values. Overall, the plutonium signatures obtained in this study reflect a mixture of weapons-grade, higher burn-up, and fallout material. This study provides a blue print for long term low level monitoring of plutonium in the environment.

  3. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia

    PubMed Central

    2013-01-01

    Introduction The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a prospective, multicenter, open-label, extension study in patients completing 1 of 2 phase 3 randomized, double-blind, controlled, 14-week trials that examined the efficacy and safety of SXB 4.5 g, SXB 6 g, and placebo for treatment of FM. Methods This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries. Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged ≥ 18 years met the American College of Rheumatology 1990 criteria for FM, had a body mass index (BMI) < 40 kg/m2, and had a score ≥ 50 on a 100-mm pain visual analog scale (VAS) at baseline. All patients began treatment in the extension study with SXB 4.5 g/night (administered in 2 equally divided doses) for at least 1 week, followed by possible serial 1.5 g/night dose increases to 9 g/night (maximum) or reductions to 4.5 g/night (minimum). Results Of the 560 FM patients enrolled in this extension study, 319 (57.0%) completed the study. The main reason for early discontinuation was adverse events (AEs; 23.0% of patients). Patients were primarily middle-aged (mean 46.9 ± 10.8 years), female (91.1%), white (91.4%), with a mean duration of FM symptoms of 9.9 ± 8.7 years. Serious AEs were experienced by 3.6% of patients. The most frequently reported AEs (incidence ≥ 5% at any dose or overall) were nausea, headache, dizziness, nasopharyngitis, vomiting, sinusitis, diarrhea, anxiety, insomnia, influenza, somnolence, upper respiratory tract infection, muscle spasms, urinary tract infection, and gastroenteritis viral. Maintenance of SXB therapeutic response was demonstrated with continued improvement from controlled-study baseline in pain VAS, Fibromyalgia Impact Questionnaire (FIQ) total scores, and other measures

  4. Long-Term Pot Use Tied to Gum Disease in Study

    MedlinePlus

    ... Term Pot Use Tied to Gum Disease in Study Besides gum health, researchers assessed lung function, risk ... gum disease and potential tooth loss, a new study indicates. In an analysis of about 1,000 ...

  5. Atherosclerotic effects of long-term old and new antiepileptic drugs monotherapy: a cross-sectional comparative study.

    PubMed

    El-Farahaty, Reham M; El-Mitwalli, Ashraf; Azzam, Hanan; Wasel, Yasser; Elrakhawy, Mohamed M; Hasaneen, Bothina Mohammed

    2015-03-01

    This work aimed to evaluate the metabolic and atherogenic effects of long-term antiepileptic drugs in a group of Egyptian epileptic patients. Sixty-nine epileptic patients on antiepileptic drug monotherapy for at least 2 years and 34 control subjects were recruited in this study. Patients were divided into 5 subgroups according to antiepileptic drugs used (valproate, carbamazepine, lamotrigine, topiramate, and levetiracetam). Fasting lipid profile (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol), lipoprotein(a), homocysteine, free thyroxine, thyroid-stimulating hormone, and common carotid artery intima-media thickness were measured for all subjects. Significant higher mean values of low-density lipoprotein cholesterol, low-density lipoprotein / high-density lipoprotein ratio, lipoprotein(a), homocysteine, significantly lower mean value of high-density lipoprotein cholesterol, and significantly larger diameter of common carotid artery intima-media thickness were observed in each drug-treated group versus control group. Our study supports that long-term monotherapy treatment with valproate, carbamazepine, lamotrigine, and topiramate had altered markers of vascular risk that might enhance atherosclerosis, whereas levetiracetam exerted minimal effect. PMID:25342306

  6. The long-term effects of prenatal nicotine exposure on response inhibition: an fMRI study of young adults.

    PubMed

    Longo, Carmelinda A; Fried, Peter A; Cameron, Ian; Smith, Andra M

    2013-01-01

    The long-term effects of prenatal nicotine exposure on response inhibition were investigated in young adults using functional magnetic resonance imaging (fMRI). Participants were members of the Ottawa Prenatal Prospective Study, a longitudinal study that collected a unique body of information on participants from infancy to young adulthood, which allowed for the measurement of an unprecedented number of potentially confounding drug exposure variables including: prenatal marijuana and alcohol exposure and current marijuana, nicotine and alcohol use. Twelve young adults with prenatal nicotine exposure and 13 non-exposed controls performed a Go/No-Go task while fMRI blood oxygen level-dependent responses were examined. Despite similar task performance, participants prenatally exposed to nicotine demonstrated significantly greater activity in several regions of the brain that typically subserve response inhibition including the inferior frontal gyrus, the inferior parietal lobe, the thalamus and the basal ganglia. In addition, prenatally exposed participants showed greater activity in relatively large posterior regions of the cerebellum. These results suggest that prenatal nicotine exposure leads to altered neural functioning during response inhibition that continues into adulthood. This alteration is compensated for by recruitment of greater neural resources within regions of the brain that subserve response inhibition and the recruitment of additional brain regions to successfully perform the task. Response inhibition is an important executive functioning skill and impairments can impede functioning in much of everyday life. Thus, awareness of the continued long-term neural physiological effects of prenatal nicotine exposure is critical. PMID:23743331

  7. A quality of life study in 20 adult long-term survivors of unrelated donor bone marrow transplantation.

    PubMed

    Marks, D I; Gale, D J; Vedhara, K; Bird, J M

    1999-07-01

    There are few specific data available concerning quality of life (QOL) of survivors of unrelated donor bone marrow transplantation (UD-BMT). The procedure is expensive, difficult and is being employed increasingly yet we have little information concerning the QOL of survivors to justify this intervention. In this study, 20 long-term (>1 year post-BMT) survivors were studied with four self report questionnaires designed to assess quality of life, satisfaction with life, social support and employment status. Overall, satisfaction with life measures was above average but there was dissatisfaction with physical strength and appearance. The post-transplant employment data indicates that 60% of long-term survivors returned to full-time work and 15% to part-time work. Failure to return to work was not correlated with graft-versus-host disease (GVHD), relapse, age at or time since transplant. In general, there was a good correlation between the clinician's and patient's view of their health but the clinician's assessment of the patients mental health and energy was higher than the patients reported. Further research is required in the area of QOL post-UD-BMT. This will enable transplant physicians to counsel patients better pre-BMT and to evaluate fully the results achieved by different centres performing the procedure. PMID:10455348

  8. Study of long term effect of Solar UV and X-ray radiation on the VLF signals

    NASA Astrophysics Data System (ADS)

    Ray, Suman; Chakrabarti, Sandip Kumar; Sanki, Dipak

    2016-07-01

    Very Low Frequency (VLF) is one of the bands of Radio waves having frequencies lying between 3-30 KHz, with wavelengths 100-10 Km. It propagates through the Earth-ionosphere wave-guide which is formed by lower part of the ionosphere and upper part of Earth's surface. Ionosphere is the ionized component of upper atmosphere. In the present work, we have studied the long term effect of the high energy solar UV and X-ray radiation on the VLF signals. We have analyzed the VLF signal transmitted at 24 KHz from NAA (Cutler, Maine) and received at Moore Observatory in Brownsboro, Kentucky. Also we have collected X-ray and UV data to study the long term effect of UV and X-ray radiation on the VLF signal. We have analyzed the VLF signal for 2007 to 2015. We calculate the average diurnal peak amplitude of the VLF signal for each day and compare it with the UV and X-ray solar radiation. We found that the correlation coefficient of diurnal peak VLF signal amplitude with both solar X-ray and UV radiation is 0.7 indicating a strong correlation between these two phenomena.

  9. The long-term outcomes of alternating chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma: a multiinstitutional phase II study

    PubMed Central

    Fuwa, Nobukazu; Kodaira, Takeshi; Daimon, Takashi; Yoshizaki, Tomokazu

    2015-01-01

    To examine the long-term outcomes of alternating chemoradiotherapy (ALCRT) for patients with locoregionally advanced nasopharyngeal carcinoma (NPC) and to assess the efficacy of ALCRT for NPC. Patients with stage IIB to IVB, ECOG PS 0–2, 18–70 years-old, and sufficient organ function were eligible for this study. First, chemotherapy, consisting of 5-fluorouracil (800 mg/m2 per 24 h on days 1–5) and cisplatin (100 mg/m2 per 24 h on day 6), was administered, then a wide field of radiotherapy (36 Gy/20 fraction), chemotherapy, a shrinking field of radiotherapy (34 Gy/17 fraction), and chemotherapy were performed alternately. Between December 2003 and March 2006, 90 patients in 25 facilities were enrolled in this study, 87 patients were finally evaluated. A total of 67 patients (76.1%) completed the course of treatment. The overall survival and the progression-free survival rates at 5 years were 78.04% (95% CI: 69.1∼87.0%), and 68.74% (95% CI: 58.8∼78.7%), respectively. The long-term outcomes of ALCRT for NPC were thought to be promising. ALCRT will be considered to be a controlled trial to compare therapeutic results with those of concurrent chemoradiotherapy for NPC. PMID:25991077

  10. 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

  11. Risk Factors for Long-Term Homelessness: Findings From a Longitudinal Study of First-Time Homeless Single Adults

    PubMed Central

    Caton, Carol L. M.; Dominguez, Boanerges; Schanzer, Bella; Hasin, Deborah S.; Shrout, Patrick E.; Felix, Alan; McQuistion, Hunter; Opler, Lewis A.; Hsu, Eustace

    2005-01-01

    Objectives. We examined risk factors for long-term homelessness among newly homeless men and women who were admitted to New York City shelters in 2001 and 2002. Methods. Interviews were conducted with 377 study participants upon entry into the shelter and at 6-month intervals for 18 months. Standardized assessments of psychiatric diagnosis, symptoms, and coping skills; social and family history; and service use were analyzed. Kaplan—Meier survival analysis and Cox regression were used to examine the association between baseline assessments and duration of homelessness. Results. Eighty-one percent of participants returned to community housing during the follow-up period; the median duration of homelessness was 190 days. Kaplan—Meier survival analysis showed that a shorter duration of homelessness was associated with younger age, current or recent employment, earned income, good coping skills, adequate family support, absence of a substance abuse treatment history, and absence of an arrest history. Cox regression showed that older age group P<.05) and arrest history (P<.01) were the strongest predictors of a longer duration of homelessness. Conclusions. Identification of risk factors for long-term homelessness can guide efforts to reduce lengths of stay in homeless shelters and to develop new preventive interventions. PMID:16131638

  12. Retrobulbar Hemodynamics and Visual Field Progression in Normal Tension Glaucoma: A Long-Term Follow-Up Study

    PubMed Central

    Kuerten, D.; Fuest, M.; Koch, E. C.; Koutsonas, A.; Plange, N.

    2015-01-01

    Purpose. Vascular risk factors are important factors in the pathogenesis of glaucoma. The purpose of this research was to investigate retrobulbar hemodynamics and visual field progression in patients with normal tension glaucoma (NTG). Patients and Methods. 31 eyes of 16 patients with NTG were included in a retrospective long-term follow-up study. Colour Doppler imaging was performed at baseline to determine various CDI parameters in the different retrobulbar vessels. The rate of visual field progression was determined using the Visual Field Index (VFI) progression rate per year (in %). To be included in the analysis, patients had at least 4 visual field examinations with a follow-up of at least 2 years. Results. Mean follow-up was 7.6 ± 4.1 years with an average of 10 ± 5 visual field tests. The mean MD (mean defect) at baseline was −7.61 ± 7.49 dB. The overall VFI progression was −1.14 ± 1.40% per year. A statistical significant correlation between VFI progression and the RI of the NPCA and PSV of the CRA was found. Conclusion. Long-term visual field progression may be linked to impaired retrobulbar hemodynamics in patients with NTG only to a limited degree. Interpretation of the data for an individual patient seems to be limited due to the variability of parameters. PMID:26557652

  13. The posterior bone block procedure in posterior shoulder instability: a long-term follow-up study.

    PubMed

    Meuffels, D E; Schuit, H; van Biezen, F C; Reijman, M; Verhaar, J A N

    2010-05-01

    We present the long-term outcome, at a median of 18 years (12.8 to 23.5) of open posterior bone block stabilisation for recurrent posterior instability of the shoulder in a heterogenous group of 11 patients previously reported on in 2001 at a median follow-up of six years. We found that five (45%) would not have chosen the operation again, and that four (36%) had further posterior dislocation. Clinical outcome was significantly worse after 18 years than after six years of follow-up (median Rowe score of 60 versus 90 (p = 0.027)). The median Western Ontario Shoulder Index was 60% (37% to 100%) at 18 years' follow-up, which is a moderate score. At the time of surgery four (36%) had glenohumeral radiological osteoarthritis, which was present in all after 18 years. This study showed poor long-term results of the posterior bone block procedure for posterior instability and a high rate of glenohumeral osteoarthritis although three patients with post-traumatic instability were pleased with the result of their operations. PMID:20436001

  14. Acute Anticholinesterase Pesticide Poisoning Caused a Long-Term Mortality Increase: A Nationwide Population-Based Cohort Study.

    PubMed

    Huang, Hung-Sheng; Hsu, Chien-Chin; Weng, Shih-Feng; Lin, Hung-Jung; Wang, Jhi-Joung; Su, Shih-Bin; Huang, Chien-Cheng; Guo, How-Ran

    2015-07-01

    Acute anticholinesterase pesticide (organophosphate and carbamate) poisoning (ACPP) often produces severe complications, and sometimes death. We investigated the long-term mortality of patients with ACPP because it is not sufficiently understood. In this retrospective nationwide population-based cohort study, 818 patients with ACPP and 16,360 healthy comparisons from 1999 to 2010 were selected from Taiwan's National Health Insurance Research Database. They were followed until 2011. Ninety-four (11.5%) ACPP patients and 793 (4.9%) comparisons died (P < 0.01) during follow-up. The incidence rate ratios (IRRs) of death were 2.5 times higher in ACPP patients than in comparisons (P < 0.01). The risk of death was particularly high in the first month after ACPP (IRR: 92.7; 95% confidence interval [CI]: 45.0-191.0) and still high for ~6 months (IRR: 3.8; 95% CI: 1.9-7.4). After adjusting for age, gender, selected comorbidities, geographic area, and monthly income, the hazard ratio of death for ACPP patients was still 2.4 times higher than for comparisons. Older age (≥35 years), male gender, diabetes mellitus, coronary artery disease, hypertension, stroke, mental disorder, and lower monthly income also predicted death. ACPP significantly increased long-term mortality. In addition to early follow-up after acute treatment, comorbidity control and socioeconomic assistance are needed for patients with ACPP. PMID:26222853