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Sample records for long-term safety study

  1. Assessment of GE food safety using '-omics' techniques and long-term animal feeding studies.

    PubMed

    Ricroch, Agnès E

    2013-05-25

    Despite the fact that a thorough, lengthy and costly evaluation of genetically engineered (GE) crop plants (including compositional analysis and toxicological tests) is imposed before marketing some European citizens remain sceptical of the safety of GE food and feed. In this context, are additional tests necessary? If so, what can we learn from them? To address these questions, we examined data from 60 recent high-throughput '-omics' comparisons between GE and non-GE crop lines and 17 recent long-term animal feeding studies (longer than the classical 90-day subchronic toxicological tests), as well as 16 multigenerational studies on animals. The '-omics' comparisons revealed that the genetic modification has less impact on plant gene expression and composition than that of conventional plant breeding. Moreover, environmental factors (such as field location, sampling time, or agricultural practices) have a greater impact than transgenesis. None of these '-omics' profiling studies has raised new safety concerns about GE varieties; neither did the long-term and multigenerational studies on animals. Therefore, there is no need to perform such long-term studies in a case-by-case approach, unless reasonable doubt still exists after conducting a 90-day feeding test. In addition, plant compositional analysis and '-omics' profiling do not indicate that toxicological tests should be mandatory. We discuss what complementary fundamental studies should be performed and how to choose the most efficient experimental design to assess risks associated with new GE traits. The possible need to update the current regulatory framework is discussed.

  2. 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

  3. 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.

  4. 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.

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

    PubMed Central

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

    2011-01-01

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

  6. Safety of long-term PPI therapy.

    PubMed

    Reimer, Christina

    2013-06-01

    Proton pump inhibitors have become the mainstay of medical treatment of acid-related disorders. Long-term use is becoming increasingly common, in some cases without a proper indication. A large number of mainly observational studies on a very wide range of possible associations have been published in the past decade and are critically reviewed in this article and the existing evidence is evaluated and translated into possible clinical consequences. Based on the existing evidence the benefits of PPI treatment seem to outweigh potential risks in the large majority of patients especially if PPI use is based on a relevant indication. The concern for complications should primarily be directed at elderly, malnourished with significant co-morbidity. In this population an increased risk for enteric infections, fractures and nutritional deficiencies might have clinical consequences and should lead to a careful evaluation of the indication for PPI treatment. PMID:23998981

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

    PubMed

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

    2009-10-01

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

  8. 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.

  9. 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.

  10. 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

  11. Safety of long-term large doses of aspartame.

    PubMed

    Leon, A S; Hunninghake, D B; Bell, C; Rassin, D K; Tephly, T R

    1989-10-01

    Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a randomized, double-blind, placebo-controlled, parallel-group design in 108 male and female volunteers aged 18 to 62 years. Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks. No persistent changes over time were noted in either group in vital signs; body weight; results of standard laboratory tests; fasting blood levels of aspartame's constituent amino acids (aspartic acid and phenylalanine), other amino acids, and methanol; or blood formate levels and 24-hour urinary excretion of formate. There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject. These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day.

  12. 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

  13. Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: A 1-year, randomised controlled study.

    PubMed

    van den Brink, Wim; Sørensen, Per; Torup, Lars; Mann, Karl; Gual, Antoni

    2014-08-01

    This study evaluated the long-term efficacy and safety of nalmefene treatment in reducing alcohol consumption. We randomised (1:3) 675 alcohol-dependent patients ≥ 18 years of age to 52 weeks of as-needed treatment with placebo or nalmefene 18 mg/day: A total of 112 patients (68%) in the placebo group and 310 (62%) in the nalmefene group completed the study. At month 6, the co-primary outcome variables showed no statistically-significant differences between the treatment groups; but at month 13, nalmefene was more effective than placebo, both in the reduction of the number of heavy drinking days (HDDs) (- 1.6 days/month (95% CI - 2.9; - 0.3); p = 0.017) and the reduction of total alcohol consumption (TAC) (- 6.5 g/day last month (95% CI - 12.5; - 0.4); p = 0.036). In a subgroup analysis of patients with high/very high drinking risk levels at screening and at randomisation (the target population), there was a significant effect in favour of nalmefene on TAC at month 6, and on both HDD and TAC at month 13. Improvements in Clinical Global Impression and liver enzymes were greater with nalmefene, compared to placebo. Most adverse events were mild or moderate, and transient; adverse events, including those leading to dropout, were more common with nalmefene. This study provides evidence for the long-term safety and efficacy of nalmefene as-needed in alcohol-dependent patients whom continue to drink heavily, following a brief intervention.

  14. The long-term safety of antiepileptic drugs.

    PubMed

    Gaitatzis, Athanasios; Sander, Josemir W

    2013-06-01

    Antiepileptic drugs (AEDs) are used by millions of people worldwide for the treatment of epilepsy, as well as in many other neurological and psychiatric conditions. They are frequently associated with adverse effects (AEs), which have an impact on the tolerability and success of treatment. Half the people who develop intolerable AEs discontinue treatment early on after initiation, while the majority of people will continue to be exposed to their effects for long periods of time. The long-term safety of AEDs reflects their potential for chronic, cumulative dose effects; rare, but potentially serious late idiosyncratic effects; late, dose-related effects; and delayed, teratogenic or neurodevelopmental effects. These AEs can affect every body system and are usually insidious. With the exception of delayed effects, most other late or chronic AEs are reversible. To date, there is no clear evidence of a carcinogenic effect of AEDs in humans. While physicians are aware of the long-term AEs of old AEDs (the traditional liver enzyme-inducing AEDs and valproate), information about AEs of new AEDs (such as lamotrigine, levetiracetam, oxcarbazepine, topiramate or zonisamide), particularly of their teratogenic effects, has emerged over the years. Sporadic publications have raised issues about AEs of the newer AEDs eslicarbazepine, retigabine, rufinamide, lacosamide and perampanel but their long-term safety profiles may take years to be fully appreciated. Physicians should not only be aware of the late and chronic AEs of AEDs but should systematically enquire and screen for these according to the individual AED AE profile. Care should be taken for individuals with comorbid conditions that may render them more susceptible to specific AEs. Prevention and appropriate management of long-term AED AEs is expected to improve adherence to treatment, quality of life and control of epilepsy. PMID:23673774

  15. Safety and efficacy of long-term combination therapy with bezafibrate and ezetimibe in patients with dyslipidemia in the prospective, observational J-COMPATIBLE study

    PubMed Central

    2013-01-01

    Background There are numerous reports describing the efficacy of fenofibrate in combination with ezetimibe for treating dyslipidemia. In contrast, a study combining bezafibrate and ezetimibe has not yet been conducted. In this study, we examined the safety, including the risk of gallstone formation, and the efficacy of long-term combination therapy with bezafibrate and ezetimibe for treating dyslipidemia. Methods Dyslipidemic patients treated with 400 mg/day bezafibrate in combination with 10 mg/day ezetimibe for the first time were eligible. We selected 157 institutions in Japan and conducted a 12-month prospective observational study, with patients enrolled on the day they started combination therapy. Safety of the combination was examined in terms of the type, onset, and severity of adverse drug reactions (ADRs). Efficacy was evaluated in terms of the changes in low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), triglyceride (TG), and non-HDL cholesterol (non-HDL-C) levels from the start of combination therapy (baseline) to the last observation carried forward (LOCF). Lipid levels were assessed at 1, 3, 6, and 12 months after starting combination therapy. Results We enrolled 665 patients in this observational study. Safety was evaluated in 659, and ADRs occurred in 42 patients (6.4%). The most frequent ADRs were blood creatine phosphokinase increase (1.5%) and myalgia (0.8%). Asymptomatic gallstones were observed in four patients (0.6%). Effectiveness was evaluated in 622 patients. LDL-C, HDL-C, TG, and non-HDL-C levels improved significantly from baseline to LOCF by −17.4%, 8.8%, –40.5%, and −21.6%, respectively (all, p < 0.001). Lipid levels also improved from baseline to each evaluation time-point. Conclusions Bezafibrate in combination with ezetimibe is safe and effective, and is potentially useful for comprehensive management of dyslipidemia. PMID:24195788

  16. Study on the postprandial blood glucose suppression effect of D-psicose in borderline diabetes and the safety of long-term ingestion by normal human subjects.

    PubMed

    Hayashi, Noriko; Iida, Tetsuo; Yamada, Takako; Okuma, Kazuhiro; Takehara, Isao; Yamamoto, Takashi; Yamada, Koji; Tokuda, Masaaki

    2010-01-01

    This clinical study was conducted to investigate the safety and effect of D-psicose on postprandial blood glucose levels in adult men and women, including borderline diabetes patients. A randomized double-blind placebo-controlled crossover experiment of single ingestion was conducted on 26 subjects who consumed zero or 5 g of D-psicose in tea with a standard meal. The blood glucose levels at fasting and 30, 60, 90, and 120 min after the meal were compared. The blood glucose level was significantly lower 30 and 60 min after the meal with D-psicose (p<0.01, p<0.05), and a significant decrease was also shown in the area under the curve (p<0.01). The results suggest that D-psicose had an effect to suppress the postprandial blood glucose elevation mainly in borderline diabetes cases. A randomized double-blind placebo-controlled parallel-group experiment of long-term ingestion was conducted on 17 normal subjects who took 5 g of D-psicose or D-glucose with meals three times a day for 12 continuous weeks. Neither any abnormal effects nor clinical problems caused by the continuous ingestion of D-psicose were found.

  17. 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

  18. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain

    PubMed Central

    Onouchi, Kenji; Koga, Hiroaki; Yokoyama, Kazumasa; Yoshiyama, Tamotsu

    2014-01-01

    Purpose Studies of pregabalin for the treatment of central neuropathic pain have been limited to double-blind trials of 4–17 weeks in duration. The purpose of this study was to assess the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. The efficacy of pregabalin was also assessed as a secondary measure. Patients and methods This was a 53-week, multicenter, open-label trial of pregabalin (150–600 mg/day) in Japanese patients with central neuropathic pain due to spinal cord injury, multiple sclerosis, or cerebral stroke. Results A total of 103 patients received pregabalin (post-stroke =60; spinal cord injury =38; and multiple sclerosis =5). A majority of patients (87.4%) experienced one or more treatment-related adverse events, most commonly somnolence, weight gain, dizziness, or peripheral edema. The adverse event profile was similar to that seen in other indications of pregabalin. Most treatment-related adverse events were mild (89.1%) or moderate (9.2%) in intensity. Pregabalin treatment improved total score, sensory pain, affective pain, visual analog scale (VAS), and present pain intensity scores on the Short-Form McGill Pain Questionnaire (SF-MPQ) and ten-item modified Brief Pain Inventory (mBPI-10) total score at endpoint compared with baseline. Improvements in SF-MPQ VAS and mBPI-10 total scores were evident in all patient subpopulations. Mean changes from baseline in SF-MPQ VAS and mBPI-10 scores at endpoint were −20.1 and −1.4, respectively. Conclusion These findings demonstrate that pregabalin is generally well tolerated and provides sustained efficacy over a 53-week treatment period in patients with chronic central neuropathic pain. PMID:25114584

  19. 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)

  20. Long-term botulinum toxin efficacy, safety, and immunogenicity.

    PubMed

    Mejia, Nicte I; Vuong, Kevin Dat; Jankovic, Joseph

    2005-05-01

    To determine the long-term efficacy of botulinum toxin (BTX) treatments, we analyzed longitudinal follow-up data on 45 patients (32 women; mean age, 68.8 years) currently followed in the Baylor College of Medicine Movement Disorders Clinic, who have received BTX treatments continuously for at least 12 years (mean 15.8 +/- 1.5 years). Their mean response rating after the last injection, based one a previously described scale 0-to-4 scale (0 = no effect; 4 = marked improvement) was 3.7 +/- 0.6 and the mean total duration of response was 15.4 +/- 3.4 weeks. Although the latency and total duration of the response to treatment have not changed over time, the peak duration of response (P < 0.005) and dose per visit (P < 0.0001) have increased since the initial visit. Furthermore, global rating (P < 0.02) and peak effect (P < 0.05) have improved. In total, 20 adverse events occurred in 16 of 45 (35.6%) patients after their initial visit and 11 adverse events in 10 of 45 (22.2%) patients at their most recent injection visit. Antibody (Ab) testing was carried out in 22 patients due to nonresponsiveness; blocking Abs were confirmed by the mouse protection assay in 4 of 22 (18%) patients. Of the Ab-negative patients, 16 resumed responsiveness after dose adjustments and 2 persisted as nonrespondents. Except for 1 patient, the 4 Ab-positive and the 2 clinical nonresponders are being treated with BTX-B. This longest reported follow-up of BTX injections confirms the long-term efficacy and safety of this treatment.

  1. Long-term safety and efficacy of continuous intrathecal baclofen.

    PubMed

    Campbell, William M; Ferrel, Anne; McLaughlin, John F; Grant, Gerald A; Loeser, John D; Graubert, Catherine; Bjornson, Kristie

    2002-10-01

    Long-term continuous intrathecal baclofen (CITB) infusion is a treatment option used to manage otherwise intractable spasticity and is delivered via an implantable pump. The purpose of this single-center multidisciplinary review was to report on the long-term safety and efficacy of CITB in the treatment of 21 children with intractable severe spasticity of cerebral origin. Nineteen recipients had spastic quadriplegia and two had spastic diplegia. Seven recipients had level IV severity on the Gross Motor Functional Classification System and 14 had level V. Median age at implantation was 12 years (range 4 to 20). Fifteen recipients were male, 6 were female. Seventeen recipients were alive at the end of the follow-up period (31 to 78 months; mean 53, SD 4). The Ashworth scale showed a substantial decrease in spasticity in the upper and lower extremities at 6 months and at the most recent follow-up. The Gross Motor Function Measure and Pediatric Evaluation of Disability Inventory showed no functional change. Most treatment goals were at least partly achieved. Caregivers reported a reduction in use of oral medication for spasticity, and improvements in comfort, function, and ease of care. Caregiver satisfaction was high. During 80 recipient-years of pump operation, 153 treatment-associated adverse events occurred: 27 of these were device-related. There were four deaths unrelated to CITE, including one from acute pancreatitis. Our findings might assist in establishing patient selection criteria and treatment goals, improving patient follow-up, and monitoring adverse events. PMID:12418790

  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 Efficacy, Safety, and Pharmacokinetics of Drisapersen in Duchenne Muscular Dystrophy: Results from an Open-Label Extension Study

    PubMed Central

    Goemans, Nathalie M.; Tulinius, Már; van den Hauwe, Marleen; Kroksmark, Anna-Karin; Buyse, Gunnar; Wilson, Rosamund J.; van Deutekom, Judith C.; de Kimpe, Sjef J.; Lourbakos, Afrodite; Campion, Giles

    2016-01-01

    Background Drisapersen induces exon 51 skipping during dystrophin pre-mRNA splicing and allows synthesis of partially functional dystrophin in Duchenne muscular dystrophy (DMD) patients with amenable mutations. Methods This 188-week open-label extension of the dose-escalation study assessed the long-term efficacy, safety, and pharmacokinetics of drisapersen (PRO051/GSK2402968), 6 mg/kg subcutaneously, in 12 DMD subjects. Dosing was once weekly for 72 weeks. All subjects had a planned treatment interruption (weeks 73–80), followed by intermittent dosing (weeks 81–188). Results Subjects received a median (range) total dose of 5.93 (5.10 to 6.02) mg/kg drisapersen. After 177 weeks (last efficacy assessment), median (mean [SD]) six-minute walk distance (6MWD) improved by 8 (-24.5 [161]) meters for the 10 subjects able to complete the 6MWD at baseline (mean age [SD]: 9.5 [1.9] years). These statistics include 2 subjects unable to complete the test at later visits and who scored “zero”. When only the 8 ambulant subjects at week 177 were taken into account, a median (mean [SD]) increase of 64 (33 [121]) meters in 6MWD was observed. Of 7 subjects walking ≥330 m at extension baseline, 5 walked farther at week 177. Of 3 subjects walking <330 m, 2 lost ambulation, while 1 declined overall but walked farther at some visits. Over the 188 weeks, the most common adverse events were injection-site reactions, raised urinary α1-microglobulin and proteinuria. Dystrophin expression was detected in all muscle biopsies obtained at week 68 or 72. Conclusion Drisapersen was generally well tolerated over 188 weeks. Possible renal effects, thrombocytopenia and injection-site reactions warrant continued monitoring. Improvements in the 6MWD at 12 weeks were sustained after 3.4 years of dosing for most patients. For a small, uncontrolled study, the outcomes are encouraging, as natural history studies would anticipate a decline of over 100 meters over a 3-year period in a comparable

  4. 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.

  5. Day Care as a Long-Term Care Service Study.

    ERIC Educational Resources Information Center

    Zaki, Gamel; Zaki, Sylvia

    Day care is a growing service in the field of long-term care, increasing the options available to the impaired elderly. To study the development of adult day care centers in southeastern New England, and to identify the relationship of day care centers to the long term care network of services, the 11 day care centers in the catchment area of the…

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

    PubMed

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

    2015-09-01

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

  7. 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.

  8. 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.

  9. 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…

  10. Acute And Long-Term Bioeffects And Lamp Safety

    NASA Astrophysics Data System (ADS)

    Andersen, F. Alan

    1980-10-01

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

  11. Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope® in children requiring growth hormone treatment

    PubMed Central

    Pfäffle, Roland; Schwab, Karl Otfried; Marginean, Otilia; Walczak, Mieczyslaw; Szalecki, Mieczyslaw; Schuck, Ellen; Zucchini, Stefano

    2013-01-01

    Objective: To describe the rationale, design and first data from PATRO Children, a postmarketing surveillance of the long-term efficacy and safety of somatropin (Omnitrope®) for the treatment of children requiring growth hormone treatment. Methods: PATRO Children is a multicentre, open, longitudinal, noninterventional study being conducted in children’s hospitals and specialised endocrinology clinics. The primary objective is to assess the long-term safety of Omnitrope® in routine clinical practice. Eligible patients are infants, children and adolescents (male or female) who are receiving treatment with Omnitrope® and who have provided informed consent. Patients who have been treated with another recombinant human growth hormone (rhGH) product before starting Omnitrope® are eligible for inclusion. All adverse events (AEs) are monitored and recorded, with particular emphasis on: long-term safety; the recording of malignancies; the occurrence and clinical impact of anti-hGH antibodies; the development of diabetes during Omnitrope® treatment in children short for gestational age (SGA); safety issues in patients with Prader–Willi syndrome (PWS). Efficacy assessments include auxological parameters, plus insulin-like growth factor-1 and insulin-like growth factor binding protein-3. Results: As of September 2012, 1837 patients were enrolled in the study from 184 sites in 10 European countries. To date, efficacy data are reassuring and consistent with previous studies. In addition, there have been no confirmed cases of diabetes occurring under Omnitrope® treatment, no reports of malignancy and no safety issues in PWS patients. Conclusions: The efficacy and safety profile of Omnitrope® in the PATRO Children study so far are as expected. The ongoing study will extend the safety database for Omnitrope®, and rhGH products more generally, in paediatric indications. Of particular interest, PATRO Children will add important information on the diabetogenic potential of

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

    PubMed

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

    2014-01-01

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

  13. Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

    PubMed

    Cezar, Cristina; Tchartchian, Garri; Korell, Matthias; Ziegler, Nicole; Senshu, Kazuhisa; De Wilde, Maya Sophie; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment

  14. 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

  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. 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

  17. 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

  18. 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…

  19. 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.

  20. 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.

  1. 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

  2. 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

  3. A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain.

    PubMed

    Hoggart, B; Ratcliffe, S; Ehler, E; Simpson, K H; Hovorka, J; Lejčko, J; Taylor, L; Lauder, H; Serpell, M

    2015-01-01

    Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.

  4. 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

  5. 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.

  6. 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%.

  7. 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

  8. 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

  9. 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.

  10. An inventory of European data sources for the long-term safety evaluation of methylphenidate.

    PubMed

    Murray, Macey L; Insuk, Suppachai; Banaschewski, Tobias; Neubert, Antje C; McCarthy, Suzanne; Buitelaar, Jan K; Coghill, David; Dittmann, Ralf W; Konrad, Kerstin; Panei, Pietro; Rosenthal, Eric; Sonuga-Barke, Edmund J; Wong, Ian C K

    2013-10-01

    To compile an inventory of European healthcare databases with potential to study long-term effects of methylphenidate (MPH) in patients with attention deficit hyperactivity disorder (ADHD). Potential databases were identified through expert opinion, the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, and literature search. An online survey was conducted among database providers/coordinators to ascertain the databases' appropriateness for inclusion into the inventory. It included questions about database characteristics, sample size, availability of information on drug exposure, clinical data and accessibility. Forty-two databases from 11 countries were identified and their coordinators invited to participate; responses were obtained for 22 (52.4 %) databases of which 15 record ADHD diagnoses. Eleven had sufficient data on ADHD diagnosis, drug exposure, and at least one type of outcome information (symptoms/clinical events, weight, height, blood pressure, heart rate) to assess MPH safety. These were Aarhus University Prescription Database, Danish National Birth Cohort (Denmark); German Health Interview and Examination Survey for Children and Adolescents; Health Search Database Thales, Italian ADHD Register, Lombardy Region ADHD Database (Italy); Avon Longitudinal Study of Parents and Children, General Practice Research Database, The Health Improvement Network, QResearch (UK) and IMS Disease Analyzer (UK, Germany, France). Of the 20 databases with no responses, information on seven from publications and/or websites was obtained; Pedianet and the Integrated Primary Care Information database were considered suitable. Many European healthcare databases can be used for multinational long-term safety studies of MPH. Methodological research is underway to investigate the feasibility of their pooling and analysis. PMID:23508655

  11. Long-term efficacy, safety, and patient acceptability of ibandronate in the treatment of postmenopausal osteoporosis.

    PubMed

    Inderjeeth, Charles A; Glendenning, Paul; Ratnagobal, Shoba; Inderjeeth, Diren Che; Ondhia, Chandni

    2015-01-01

    Several second-generation bisphosphonates (BPs) are approved in osteoporosis treatment. Efficacy and safety depends on potency of farnesyl pyrophosphate synthase (FPPS) inhibition, hydroxyapatite affinity, compliance and adherence. The latter may be influenced by frequency and route of administration. A literature search using "ibandronate", "postmenopausal osteoporosis", "fracture", and "bone mineral density" (BMD) revealed 168 publications. The Phase III BONE study, using low dose 2.5 mg daily oral ibandronate demonstrated 49% relative risk reduction (RRR) in clinical vertebral fracture after 3 years. Non-vertebral fracture (NVF) reduction was demonstrated in a subgroup (pretreatment T-score ≤ -3.0; RRR 69%) and a meta-analysis of high annual doses (150 mg oral monthly or intravenous equivalent of ibandronate; RRR 38%). Hip fracture reduction was not demonstrated. Long-term treatment efficacy has been confirmed over 5 years. Long term safety is comparable to placebo over 3 years apart from flu-like symptoms which are more common with oral monthly and intravenous treatments. No cases of atypical femoral fracture or osteonecrosis of the jaw have been reported in randomized controlled trial studies. Ibandronate inhibits FPPS more than alendronate but less than other BPs which could explain rate of action onset. Ibandronate has a higher affinity for hydroxyapatite compared with risedronate but less than other BPs which could affect skeletal distribution and rate of action offset. High doses (150 mg oral monthly or intravenous equivalent) were superior to low doses (oral 2.5 mg daily) according to 1 year BMD change. Data are limited by patient selection, statistical power, under-dosing, and absence of placebo groups in high dose studies. Ibandronate treatment offers different doses and modalities of administration which could translate into higher adherence rates, an important factor when the two main limitations of BP treatment are initiation and adherence rates

  12. An inventory of European data sources for the long-term safety evaluation of methylphenidate.

    PubMed

    Murray, Macey L; Insuk, Suppachai; Banaschewski, Tobias; Neubert, Antje C; McCarthy, Suzanne; Buitelaar, Jan K; Coghill, David; Dittmann, Ralf W; Konrad, Kerstin; Panei, Pietro; Rosenthal, Eric; Sonuga-Barke, Edmund J; Wong, Ian C K

    2013-10-01

    To compile an inventory of European healthcare databases with potential to study long-term effects of methylphenidate (MPH) in patients with attention deficit hyperactivity disorder (ADHD). Potential databases were identified through expert opinion, the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, and literature search. An online survey was conducted among database providers/coordinators to ascertain the databases' appropriateness for inclusion into the inventory. It included questions about database characteristics, sample size, availability of information on drug exposure, clinical data and accessibility. Forty-two databases from 11 countries were identified and their coordinators invited to participate; responses were obtained for 22 (52.4 %) databases of which 15 record ADHD diagnoses. Eleven had sufficient data on ADHD diagnosis, drug exposure, and at least one type of outcome information (symptoms/clinical events, weight, height, blood pressure, heart rate) to assess MPH safety. These were Aarhus University Prescription Database, Danish National Birth Cohort (Denmark); German Health Interview and Examination Survey for Children and Adolescents; Health Search Database Thales, Italian ADHD Register, Lombardy Region ADHD Database (Italy); Avon Longitudinal Study of Parents and Children, General Practice Research Database, The Health Improvement Network, QResearch (UK) and IMS Disease Analyzer (UK, Germany, France). Of the 20 databases with no responses, information on seven from publications and/or websites was obtained; Pedianet and the Integrated Primary Care Information database were considered suitable. Many European healthcare databases can be used for multinational long-term safety studies of MPH. Methodological research is underway to investigate the feasibility of their pooling and analysis.

  13. 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

  14. Safety of long-term dietary supplementation with L-arginine in pigs.

    PubMed

    Hu, Shengdi; Li, Xilong; Rezaei, Reza; Meininger, Cynthia J; McNeal, Catherine J; Wu, Guoyao

    2015-05-01

    This study was conducted with a swine model to determine the safety of long-term dietary supplementation with L-arginine-HCl or L-arginine free base. Beginning at 30 days of age, pigs were fed a corn- and soybean meal-based diet (31.5 g/kg body weight/day) supplemented with 0, 1.21, 1.81 or 2.42 % L-arginine-HCl (Experiment 1) or with 0, 1, 1.5 or 2 % L-arginine (Experiment 2). The supplemental doses of 0, 1, 1.5, and 2 % L-arginine provided pigs with 0, 315, 473, and 630 mg L-arginine/kg body weight/day, respectively, which were equivalent to 0, 286, 430, and 573 mg L-arginine/kg body weight/day, respectively, in humans. At 121 days of age (91 days after initiation of supplementation), blood samples were obtained from the jugular vein of pigs at 1 and 4 h after feeding for hematological and clinical chemistry tests. Dietary supplementation with L-arginine increased plasma concentrations of arginine, ornithine, proline, albumin and reticulocytes, while reducing plasma concentrations of ammonia, free fatty acids, triglyceride, cholesterol, and neutrophils. L-Arginine supplementation enhanced protein gain and reduced white-fat deposition in the body. Other variables in standard hematology and clinical chemistry tests, serum concentrations of insulin, growth hormone and insulin-like growth factor-I did not differ among all the groups of pigs. These results indicate that dietary supplementation with L-arginine (up to 630 mg/kg body weight/day) is safe in pigs for at least 91 days. Our findings help guide clinical studies to determine the safety of long-term oral administration of L-arginine to humans.

  15. 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

  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. 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

    Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Itamura, Rio; 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.

  18. 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.

  19. 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

  20. 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

  1. The safety and long-term efficacy of zonisamide as adjunctive therapy for focal epilepsy.

    PubMed

    Schulze-Bonhage, Andreas

    2015-01-01

    Epilepsy is a chronic disease which affects 1% of the population worldwide. As treatment is required for many years or decades, the long-term efficacy and tolerability of antiepileptic drugs are particularly important. Zonisamide (ZNS) is a second-generation antiepileptic drug with a unique structure and multiple mechanisms of action. Here, recently published long-term outcomes of patient cohorts with focal epilepsy undergoing ZNS treatment are discussed. Whereas ZNS monotherapy maintains similar seizure control efficacy to carbamazepine after 2 years of treatment, seizure-free rates are low in pharmacoresistant patients undergoing late adjunctive therapy. In preselected patient populations derived from double-blind studies, long-term seizure reduction and responder rates support sustained ZNS efficacy, good adherence and long-term retention. Adverse effects include somnolence and weight decrease, but data suggest that long-term treatment with ZNS is safe with only rare newly occurring adverse effects, and good long-term tolerability also regarding mood, behavior, cognition and bone maturation.

  2. Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study

    PubMed Central

    Kavanaugh, Arthur; McInnes, Iain B; Mease, Philip J; Krueger, Gerald G; Gladman, Dafna D; van der Heijde, Désirée; Mudivarthy, Surekha; Xu, Weichun; Mack, Michael; Xu, Zhenhua; Beutler, Anna

    2013-01-01

    Objectives To assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis (PsA). Methods Adult PsA patients (≥3 swollen, ≥3 tender joints, active psoriasis) were randomly assigned to subcutaneous injections of placebo, golimumab 50 mg or 100 mg every 4 weeks (q4wks) through week 20. All patients received golimumab 50 or 100 mg beginning week 24. Findings through 2 years are reported. Efficacy evaluations included ≥20% improvement in American College of Rheumatology (ACR20) response, good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein (DAS28-CRP), ≥75% improvement in Psoriasis Area and Severity Index (PASI75) and changes in PsA-modified Sharp/van der Heijde scores (SHS). Results Golimumab treatment through 2 years was effective in maintaining clinical response (response rates: ACR20 63%–70%, DAS28-CRP 77%–86%, PASI75 56%–72%) and inhibiting radiographic progression (mean change in PsA-modified SHS in golimumab-treated patients: −0.36), with no clear difference between doses. No new safety signals were identified through 2 years. With the study's tuberculosis screening and prophylactic measures, no patient developed active tuberculosis through 2 years. Conclusions Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit. Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis. PMID:23161902

  3. 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

  4. 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

  5. Torticollis: a long-term follow-up study.

    PubMed

    Chang, P Y; Tan, C K; Huang, Y F; Sheu, J C; Wang, N L; Yeh, M L; Chen, C C

    1996-01-01

    To achieve better guidelines for the future management of torticollis, this study analyzed surgical and nonsurgical management of 253 torticollis patients who were treated in this hospital from 1971 to 1993. Of those, 37 cases received operation only, 78 cases were operated after failed physical therapy, and 138 cases were treated only at the Rehabilitation Department. If free neck movement was considered to be the primary goal of treatment, most parents were satisfied with the results. However, if facial and skull deformities were the serious sequelae of torticollis, then only less than half of the surgical and nonsurgical groups of patients were graded as normal. Further, 10.9% of physical therapy group and 7% of the surgical patients need further operation to release the fibrotic bundle which limited their neck movement. Therefore, it is suggested that torticollis treatment should include early interventions such as adjusting sleep position, careful planning of physical therapy and/or operation and a long term follow-up period as essential for better management of torticollis.

  6. 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

  7. 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

  8. 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

  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 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

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. Sodium tetraphenylborate solution stability: A long term study

    SciTech Connect

    Barnes, M.J.

    1992-06-11

    Sodium tetraphenylborata (NaTPB) is a specialty chemical required for the In Tank Precipitation Process (ITP). It precipitates cesium, aiding in the decontamination of high level radioactive waste solutions. Long term stability of aqueous alkaline solutions of NATPB has been investigated. The focus of the investigation is on the relative stabilities of NATPB solutions exposed to varying temperatures and copper concentrations over an extended period of time. Additionally, vendor-supplied samples, incubated at 40{degree}C, were stored for more than a year without decomposing. Collected data demonstrates that in the absence of elevated copper concentrations, NATPB solutions will remain stable for periods of 1 to 2 years (at a minimum) at maximum expected operating conditions (<40{degree}C). Additionally, biuret, (H{sub 2}NCO){sub 2}NH, was tested as an additive to prevent copper-induced decomposition without success.

  18. Sodium tetraphenylborate solution stability: A long term study

    SciTech Connect

    Barnes, M.J.

    1992-06-11

    Sodium tetraphenylborata (NaTPB) is a specialty chemical required for the In Tank Precipitation Process (ITP). It precipitates cesium, aiding in the decontamination of high level radioactive waste solutions. Long term stability of aqueous alkaline solutions of NATPB has been investigated. The focus of the investigation is on the relative stabilities of NATPB solutions exposed to varying temperatures and copper concentrations over an extended period of time. Additionally, vendor-supplied samples, incubated at 40[degree]C, were stored for more than a year without decomposing. Collected data demonstrates that in the absence of elevated copper concentrations, NATPB solutions will remain stable for periods of 1 to 2 years (at a minimum) at maximum expected operating conditions (<40[degree]C). Additionally, biuret, (H[sub 2]NCO)[sub 2]NH, was tested as an additive to prevent copper-induced decomposition without success.

  19. 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.

  20. [Further enhance the long-term myopia control efficacy and safety of orthokeratology].

    PubMed

    Xie, Peiying

    2014-01-01

    Strategies and methods of myopia prevention and control has been more and more. In recent years optical correction method is focusing on promoting the retinal mid-peripheral myopic defocus, improving the visual quality and promoting the accommodative function. Among the all, orthokeratology is the most notable optometry technology. This article will combine research progress both local and international achievements, the present situation of the domestic popularized the technique, and the existing problems. From the realistic approach, keep improving, the pursuit of stability, the pursuit of harmony and eliminate the false five aspects, to discuss how to promote orthokeratology for the myopia control with long-term stably efficacy and safety. How to promote the harmony and cooperation between doctors, patients and manufactures. And how to correctly guide the orthokeratology Having both specification and continued development. PMID:24709125

  1. 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

  2. Long-term study on workers occupationally exposed to ethylbenzene.

    PubMed

    Bardodĕj, Z; Círek, A

    1988-01-01

    Ethylbenzene is synthesized from benzene; subject to catalytic dehydrogenation it yields styrene, a raw material for the production of synthetic rubber and plastics. Long-term biomonitoring of occupational ethylbenzene exposures, carried out in the past 20 years in some 200 ethylbenzene-production workers, revealed this substance to pose little hazard to human health. As it turned out, mandelic acid concentrations in these workers' urine never exceeded 3.25 mmol.l-1 and none of the exposed showed damage to hematopoiesis and/or liver tissue. Over the last 10 years no case of malignancy has been recorded in this industrial facility belonging to a larger chemical complex where the overall incidence of cancer is about 3 times the national average. Today's low-level ethylbenzene exposures would make it fully justifiable if the present-day MAC limits, both whole-shift (200 mg.m-3) and peak (1,000 mg.m-3), were to be halved, i.e. to be lowered to 100 mg.m3 and 500 mg.m3 respectively. These newly recommended limit values are no more exceeded nowadays.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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…

  9. 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…

  10. 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.

  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.

  12. 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

  13. 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

  14. 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…

  15. A Study of the Long-Term Stability of GRE General Test Scores.

    ERIC Educational Resources Information Center

    Wilson, Kenneth M.

    1988-01-01

    A study of the long-term stability of Graduate Record Examination scores for graduate program admission purposes investigated the changes in scores among test repeaters. Results suggest that long-term test repeaters have greater gains on verbal than quantitative tests. Explanations and implications are considered. (MSE)

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

    PubMed Central

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

    2013-01-01

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

  17. 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

  18. Long-term intrathecal ziconotide for chronic pain: an open-label study.

    PubMed

    Webster, Lynn R; Fisher, Robert; Charapata, Steven; Wallace, Mark S

    2009-03-01

    This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated. PMID:18715748

  19. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2).

    PubMed

    Rubin, Lewis J; Galiè, Nazzareno; Grimminger, Friedrich; Grünig, Ekkehard; Humbert, Marc; Jing, Zhi-Cheng; Keogh, Anne; Langleben, David; Fritsch, Arno; Menezes, Flavia; Davie, Neil; Ghofrani, Hossein-Ardeschir

    2015-05-01

    Riociguat is a soluble, guanylate cyclase stimulator, approved for pulmonary arterial hypertension. In the 12-week PATENT-1 study, riociguat was well tolerated and improved several clinically relevant end-points in patients with pulmonary arterial hypertension who were treatment naïve or had been pretreated with endothelin-receptor antagonists or prostanoids. The PATENT-2 open-label extension evaluated the long-term safety and efficacy of riociguat. Eligible patients from the PATENT-1 study received riociguat individually adjusted up to a maximum dose of 2.5 mg three times daily. The primary objective was to assess the safety and tolerability of riociguat; exploratory efficacy assessments included 6-min walking distance and World Health Organization (WHO) functional class. Overall, 396 patients entered the PATENT-2 study and 324 (82%) were ongoing at this interim analysis (March 2013). The safety profile of riociguat in PATENT-2 was similar to that observed in PATENT-1, with cases of haemoptysis and pulmonary haemorrhage also being observed in PATENT-2. Improvements in the patients', 6-min walking distance and WHO functional class observed in PATENT-1 persisted for up to 1 year in PATENT-2. In the observed population at the 1-year time point, mean±sd 6-min walking distance had changed by 51±74 m and WHO functional class had improved in 33%, stabilised in 61% and worsened in 6% of the patients versus the PATENT-1 baseline. Long-term riociguat was well tolerated in patients with pulmonary arterial hypertension, and led to sustained improvements in exercise capacity and functional capacity for up to 1 year.

  20. 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.

  1. 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.

  2. Long Term Study of Prematures: Summary of Published Findings.

    ERIC Educational Resources Information Center

    Wiener, Gerald

    Are children intellectually impaired as a result of low birth weight and does relative impairment change as children grow older? Premature infants from a range of socioeconomic groups were studied in five rounds over 13 years to provide neurological, psychological, achievement, and sociological data on 582 children in three birth weight groups. A…

  3. Long term photometric and period study of AU Serpentis

    NASA Astrophysics Data System (ADS)

    Gürol, Birol

    2005-08-01

    In the present study, the activity of the eclipsing binary AU Ser is examined by analyzing the photometric data covering the period from 1969 till 2003. The orbital-period changes and light-curve variations of the binary system are studied. 4 new times of minima are obtained from our data. A period study covering almost 60,000 cycles based on the visual, photoelectric and CCD times of minima confirms the light-time effect of the system with a period of 94.15 year. With the assumption of a coplanar orbit of the third-body we find a mass of m3 = 0.53 M⊙. Including our data a total of six light curves are formed from the observations published in the literature that are completely covered in B and V. The differences between the two maxima in each light curve appear to be cyclic over a time-scale over 30 years. Based on a spot model, the light curves are analyzed with the Wilson-Devinney code. Using the spectroscopic mass ratio obtained by Hrivnak [Hrivnak, B.J., 1993. in: Leung, K.-C., Nha, I.S., Eds., New Frontiers in Binary Star Research, ASP Conference Series 38, p. 269] the masses and radii for the components are deduced as 0.895 M⊙, 0.635 M⊙, 1.10 R⊙, 0.94 R⊙ for the primary and secondary, respectively.

  4. 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.

  5. 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.

  6. A prospective, multicenter, observational study of long-term decitabine treatment in patients with myelodysplastic syndrome.

    PubMed

    Jeong, Seong Hyun; Kim, Yoo-Jin; Lee, Je-Hwan; Kim, Yeo-Kyeoung; Kim, Soo Jeong; Park, Sung Kyu; Do, Young Rok; Kim, Inho; Mun, Yeung-Chul; Kim, Hoon Gu; Lee, Won Sik; Yi, Hyeon Gyu; Joo, Young-Don; Choi, Chul Won; Kim, Suk Ran; Na, Sang Min; Jang, Jun Ho

    2015-12-29

    This prospective observational study evaluated the efficacy and safety of long-term decitabine treatment in patients with myelodysplastic syndrome (MDS). Decitabine 20 mg/m(2)/day was administered intravenously for 5 consecutive days every 4 weeks to MDS patients in intermediate-1 or higher International Prognostic Scoring System (IPSS) risk categories. Active antimicrobial prophylaxis was given to prevent infectious complications. Overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and time to response were evaluated, as were adverse events. The final analysis included 132 patients. IPSS risk was intermediate-2/high in 34.9% patients. The patients received a median of 5 cycles, with responders receiving a median of 8 cycles (range, 2-30). ORR was 62.9% (complete response [CR], 36; partial response [PR], 3; marrow complete response [mCR], 19; and hematologic improvement, 25). Among responders, 39% showed first response at cycle 3 or later. OS at 2 years was 60.9%, with 17% progressing to acute myeloid leukemia. PFS at 2 years was 51.0%. Patients achieving mCR showed comparable survival outcomes to those with CR/PR. With active antibiotic prophylaxis, febrile neutropenia events occurred in 61 of 1,033 (6%) cycles. Long-term decitabine treatment with antibiotic prophylaxis showed favorable outcomes in MDS patients, and mCR predicted favorable survival outcomes.

  7. 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

  8. Long-term efficacy and safety of polyalkylimide gel for the treatment of HIV-associated lipoatrophy.

    PubMed

    Antoniou, Tony; Raboud, Janet M; Kovacs, Colin; Diong, Christina; Brunetta, Jason; Smith, Graham; Halpenny, Roberta; Beninger, Francis; Loutfy, Mona R

    2009-10-01

    The long-term safety and efficacy of products used in the correction of HIV-associated facial lipoatrophy (FLA) are largely unknown. The purpose of this study was to describe the long-term efficacy and safety of polyalkylimide gel (PAIG) in the treatment of HIV-associated FLA. In this open-label, randomized, single-center study, 31 HIV-positive individuals (median age 48 years (interquartile ranges (IQR) 45, 55, 97% male) with FLA were randomized to immediate (week 0 and six) or delayed (week 12 and 18) PAIG injections. Week 96 endpoints included change in FLA severity scores (FLSS) (five-point scale), proportion of patients with adverse events, and changes in quality of life, depression and anxiety using validated surveys. Results at week 96 were available for 28 patients. Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of three days following the injection. At week 96, median changes in physician and patient FLSS scores were -2 (IQR -3, -1; p<0.001 vs. baseline) and -2 (IQR -2, -1; p<0.001 vs. baseline), respectively. Physician and patient FLSS scores were not significantly different between the groups at week 96. Significant improvements in patient's anxiety (p<0.001), depression (p<0.001) and mental health (p=0.01) were observed from baseline to week 96. In conclusion, treatment with PAIG was associated with sustained improvements in both the physical and psychological components of FLA through 96 weeks of follow-up.

  9. Long-Term Care Providers and services users in the United States: data from the National Study of Long-Term Care Providers, 2013-2014.

    PubMed

    Harris-Kojetin, Lauren; Sengupta, Manisha; Park-Lee, Eunice; Valverde, Roberto; Caffrey, Christine; Rome, Vincent; Lendon, Jessica

    2016-02-01

    Long-term care services provided by paid, regulated providers are an important component of personal health care spending in the United States. This report presents the most current national descriptive results from the National Study of Long-Term Care Providers (NSLTCP), which is conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics (NCHS). Data presented are drawn from multiple sources, primarily NCHS surveys of adult day services centers and residential care communities (covers 2014 data year); and administrative records obtained from the Centers for Medicare and Medicare Services (CMS) on home health agencies, hospices, and nursing homes (covers 2013 and 2014 data years). This report provides information on the supply, organizational characteristics, staffing, and services offered by paid, regulated providers of long-term care services; and the demographic, health, and functional composition of users of these services. Services users include residents of nursing homes and residential care communities, patients of home health agencies and hospices, and participants of adult day services centers. This report updates "Long-Term Care Services in the United States: 2013 Overview" (available from: http://www.cdc.gov/nchs/data/nsltcp/long_term_care_services_2013.pdf), which covered data years 2011 and 2012. In contrast, the title of this report and future reports will reflect the years of the data used rather than the publication year, in this case 2013 through 2014. A forthcoming companion product to this report, "Long-Term Care Providers and Services Users in the United States—State Estimates Supplement: National Study of Long-Term Care Providers, 2013–2014," contains tables and maps showing comparable state estimates for the national findings in this report, and will be available from: http://www.cdc.gov/nchs/ nsltcp/nsltcp_products.htm. PMID:27023287

  10. Long-Term Care Providers and services users in the United States: data from the National Study of Long-Term Care Providers, 2013-2014.

    PubMed

    Harris-Kojetin, Lauren; Sengupta, Manisha; Park-Lee, Eunice; Valverde, Roberto; Caffrey, Christine; Rome, Vincent; Lendon, Jessica

    2016-02-01

    Long-term care services provided by paid, regulated providers are an important component of personal health care spending in the United States. This report presents the most current national descriptive results from the National Study of Long-Term Care Providers (NSLTCP), which is conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics (NCHS). Data presented are drawn from multiple sources, primarily NCHS surveys of adult day services centers and residential care communities (covers 2014 data year); and administrative records obtained from the Centers for Medicare and Medicare Services (CMS) on home health agencies, hospices, and nursing homes (covers 2013 and 2014 data years). This report provides information on the supply, organizational characteristics, staffing, and services offered by paid, regulated providers of long-term care services; and the demographic, health, and functional composition of users of these services. Services users include residents of nursing homes and residential care communities, patients of home health agencies and hospices, and participants of adult day services centers. This report updates "Long-Term Care Services in the United States: 2013 Overview" (available from: http://www.cdc.gov/nchs/data/nsltcp/long_term_care_services_2013.pdf), which covered data years 2011 and 2012. In contrast, the title of this report and future reports will reflect the years of the data used rather than the publication year, in this case 2013 through 2014. A forthcoming companion product to this report, "Long-Term Care Providers and Services Users in the United States—State Estimates Supplement: National Study of Long-Term Care Providers, 2013–2014," contains tables and maps showing comparable state estimates for the national findings in this report, and will be available from: http://www.cdc.gov/nchs/ nsltcp/nsltcp_products.htm.

  11. 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

  12. 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.

  13. 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

  14. Depot-medroxyprogesterone acetate injection (Depo-Provera): a highly effective contraceptive option with proven long-term safety.

    PubMed

    Westhoff, Carolyn

    2003-08-01

    Depot-medroxyprogesterone acetate (Depo-Provera(R)) is a highly effective, nondaily hormonal contraceptive option that has been available in the United States for a decade, and worldwide for 40 years. Benefits and risks of hormonal therapy are often under scrutiny; however, long-term clinical experience has established the safety of this long-acting contraceptive. This article reviews the contraceptive efficacy, potential noncontraceptive health benefits and long-term safety of with regard to risk of cardiovascular events, breast and gynecologic malignancy and osteopenia. Comparisons with other hormonal contraceptives are made as clinically appropriate. Common patient management issues, including effects on menstrual cycle, body weight and mood, are also addressed. Finally, this review provides recommendations for appropriate patient selection.

  15. 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.

  16. Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies.

    PubMed

    Hill, Karl G; Woodward, Danielle; Woelfel, Tiffany; Hawkins, J David; Green, Sara

    2016-10-01

    Preventive interventions are often designed and tested with the immediate program period in mind, and little thought that the intervention sample might be followed up for years or even decades beyond the initial trial. However, depending on the type of intervention and the nature of the outcomes, long-term follow-up may well be appropriate. The advantages of long-term follow-up of preventive interventions are discussed and include the capacity to examine program effects across multiple later life outcomes, the ability to examine the etiological processes involved in the development of the outcomes of interest, and the ability to provide more concrete estimates of the relative benefits and costs of an intervention. In addition, researchers have identified potential methodological risks of long-term follow-up such as inflation of type 1 error through post hoc selection of outcomes, selection bias, and problems stemming from attrition over time. The present paper presents a set of seven recommendations for the design or evaluation of studies for potential long-term follow-up organized under four areas: Intervention Logic Model, Developmental Theory and Measurement Issues; Design for Retention; Dealing with Missing Data; and Unique Considerations for Intervention Studies. These recommendations include conceptual considerations in the design of a study, pragmatic concerns in the design and implementation of the data collection for long-term follow-up, as well as criteria to be considered for the evaluation of an existing intervention for potential for long-term follow-up. Concrete examples from existing intervention studies that have been followed up over the long term are provided.

  17. 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

  18. 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…

  19. 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

  20. 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…

  1. 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

  2. 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,…

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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…

  8. 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…

  9. 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.

  10. 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

  11. 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

  12. 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

  13. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results

    PubMed Central

    Blum, Kristie A.; Martin, Peter; Goy, Andre; Auer, Rebecca; Kahl, Brad S.; Jurczak, Wojciech; Advani, Ranjana H.; Romaguera, Jorge E.; Williams, Michael E.; Barrientos, Jacqueline C.; Chmielowska, Ewa; Radford, John; Stilgenbauer, Stephan; Dreyling, Martin; Jedrzejczak, Wieslaw Wiktor; Johnson, Peter; Spurgeon, Stephen E.; Zhang, Liang; Baher, Linda; Cheng, Mei; Lee, Dana; Beaupre, Darrin M.; Rule, Simon

    2015-01-01

    Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. We report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of ibrutinib (median 26.7-month follow-up). Patients (N = 111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84), with a median of 3 prior therapies (range, 1-5). The median treatment duration was 8.3 months; 46% of patients were treated for >12 months, and 22% were treated for ≥2 years. The ORR was 67% (23% complete response), with a median duration of response of 17.5 months. The 24-month progression-free survival and overall survival rates were 31% (95% confidence interval [CI], 22.3-40.4) and 47% (95% CI, 37.1-56.9), respectively. The most common adverse events (AEs) in >30% of patients included diarrhea (54%), fatigue (50%), nausea (33%), and dyspnea (32%). The most frequent grade ≥3 infections included pneumonia (8%), urinary tract infection (4%), and cellulitis (3%). Grade ≥3 bleeding events in ≥2% of patients were hematuria (2%) and subdural hematoma (2%). Common all-grade hematologic AEs were thrombocytopenia (22%), neutropenia (19%), and anemia (18%). The prevalence of infection, diarrhea, and bleeding was highest for the first 6 months of therapy and less thereafter. With longer follow-up, ibrutinib continues to demonstrate durable responses and favorable safety in relapsed/refractory MCL. The trial is registered to www.ClinicalTrials.gov as #NCT01236391. PMID:26059948

  14. Long-term safety and efficacy of telmisartan/amlodipine single pill combination in the treatment of hypertension

    PubMed Central

    Billecke, Scott S; Marcovitz, Pamela A

    2013-01-01

    The use of multiple drug regimens is increasingly recognized as a tacit requirement for the management of hypertension, a necessity fueled in part by rising rates of metabolic syndrome and diabetes. By targeting complementary pathways, combinations of antihypertensive drugs can be applied to provide effective blood pressure control while minimizing side effects and reducing exposure to high doses of individual medications. In addition, combination therapies, including angiotensin converting enzyme (ACE) inhibitors and calcium channel blockers (CCBs), have the added benefit of reducing cardiovascular mortality and morbidity over other dual therapies while providing equivalent blood pressure control. It is possible that angiotensin receptor blockers (ARBs), which unlike ACE inhibitors are minimally affected by upregulation of alternative pathways for angiotensin II accumulation following long-term treatment, would also provide such outcome benefits. At issue, however, is maintaining patient compliance, as adding medications is known to reduce adherence to treatment regimens. The purpose of this review is to summarize existing trial data for the long-term safety and efficacy of a recent addition to the armamentarium of dual-antihypertensive therapeutic options, the telmisartan/amlodipine single pill combination. The areas where long-term data are lacking, notably clinical information regarding minorities and women, will also be discussed. PMID:23662062

  15. Long-Term Effects of Risperidone in Children with Autism Spectrum Disorders: A Placebo Discontinuation Study

    ERIC Educational Resources Information Center

    Troost, Pieter W.; Lahuis, Bertine E.; Steenhuis, Mark-Peter; Ketelaars, Cees E. J.; Buitelaar, Jan K.; van Engeland, Herman; Scahill, Lawrence; Minderaa, Ruud B.; Hoekstra, Pieter J.

    2005-01-01

    Objective: The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established; however, only one placebo-controlled, long-term study of efficacy is available. Method: Thirty-six children with an autism spectrum disorder (5-17 years old) accompanied by severe…

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

    ERIC Educational Resources Information Center

    O'Day, Danton H.

    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…

  18. The Effect of Long-Term Outcome Studies on the Therapy of Schizophrenia: A Critique.

    ERIC Educational Resources Information Center

    Stein, Leonard I.

    1989-01-01

    Comments on Haley's paper "The Effect of Long-Term Outcome Studies on the Therapy of Schizophrenia." Criticizes Haley for making gratuitous, demeaning remarks about psychiatry; concluding that schizophrenia is a psychological and social problem; recommending ineffective treatments for the psychotic phase; and recommending psychotherapy without…

  19. Long-term diagnostic stability and outcome in recent first-episode cohort studies of schizophrenia.

    PubMed

    Bromet, Evelyn J; Naz, Bushra; Fochtmann, Laura J; Carlson, Gabrielle A; Tanenberg-Karant, Marsha

    2005-07-01

    Knowing the long-term outcomes of schizophrenia and stability of a schizophrenia diagnosis are important from a clinical standpoint as well as essential to future research on diagnostic classifications and outcome. As in prior research on schizophrenia, prospectively designed long-term studies over the past 30 years find that the predominant course of illness includes chronically poor functioning, with little evidence of long-term improvement. Mortality due to suicide is significant at about 10% over 10-year periods of follow-up. Within studies, outcome domains are interrelated, and the relatively consistent predictors of poorer outcome include family history of schizophrenia, insidious onset, poor premorbid functioning, severity of negative symptoms, and severity and duration of untreated psychosis. Residing in a developed rather than a developing country is also associated with a poorer long-term course. The diagnostic stability of schizophrenia is less well studied. The positive predictive value exceeds 90%, and preliminary findings from the 10-year follow-up of the Suffolk County Mental Health Project cohort have found that the agreement across time increased from k = .52 (baseline to 10 years) to k = .76 (6 or 24 months to 10 years). After discussing several limitations of the existing body of research, we suggest that future studies incorporate more "modifiable" risk factors into the assessment battery that could potentially be used as building blocks in experimental intervention designs.

  20. 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…

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

    PubMed

    Frazzoli, Chiara; Petrini, Carlo; Mantovani, Alberto

    2009-01-01

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

  2. 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

  3. Australian men's long term experiences following prostatectomy: a qualitative descriptive study.

    PubMed

    O'Shaughnessy, Peter 'kevin'; Laws, Tom A

    The experiences of men in the immediate postoperative period following surgery for primary prostate cancer are well reported in the literature. Recognition of the unresolved morbidity encountered by men in the medium term suggests that a more complete understanding of how men cope in the long term is needed. Health professionals are deserving of a more complete literature for the purpose of providing holistic care for this group of men, providing informed advocacy and better support for men living with the diagnosis of prostate cancer. Emerging literature reveals that men's knowledge of the long term problems associated with prostatectomy was inadequate at the time they consented to treatment; the likely outcomes at all phases of recovery should be taken into account when deciding on choice of treatment or no treatment. This qualitative study aims to describe men's long term recovery following prostatectomy for the purpose identifying the effects of unresolved post surgical morbidity. The content analysis of focus group interviews revealed that incontinence and impotence were a major source of emotional tension affecting the men's social interactions and sense of self-worth. The men expressed great regret over the lack of information accessible to them for evaluating the risk and nature of long term problems. The thick description provided in this study identifies the need for empathetic assessment of men with ongoing post surgical issues and alerts the reader to the inadequacies of information provided prior to consent to prostatectomy. PMID:20230176

  4. 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.

  5. 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

  6. Long-term efficacy, safety and durability of Juvéderm® XC.

    PubMed

    Ballin, Annelyse C; Cazzaniga, Alex; Brandt, Fredric S

    2013-01-01

    Over the last decade, there has been increasing interest in minimally invasive cosmetic treatments, especially for facial rejuvenation. Next to botulinum toxin injection, the injection of soft tissue fillers is the second most frequent minimally invasive procedure performed in the USA. Hyaluronic acid (HA) is the most commonly used dermal filler. One of patients' main concerns about filler injections pertains to pain and discomfort. Topical anesthetics, nerve blocks, and/or the incorporation of lidocaine to the filler have been applied in order to reduce distress and pain. Despite nerve blocks being an effective form of anesthesia, they may distort the area to be treated, as well as lengthen and complicate the procedure. Studies have shown that the incorporation of lidocaine to HA fillers significantly reduces pain and discomfort. Yet, one of the dilemmas about the addition of lidocaine solution to HA fillers is the possible alteration of the physical characteristics of the product by negatively impacting the efficacy and/or duration of the filler. The concern is that the addition of lidocaine could dilute the product, creating less correction per mL, changing the product's viscosity and consequently the "lifting" ability. Also, this dilution could reduce the product's duration. There may be a difference between a physician adding an aqueous solution into a lidocaine-free version of HA and the pre-incorporated lidocaine version of HA. An aqueous solution might dilute the product, while the pre-incorporated powder lidocaine appears to avoid this problem. Juvéderm® XC is manufactured with powder lidocaine 0.3%; it is associated with significantly less injection pain than Juvéderm® and other lidocaine-free versions of HA. Studies have shown that lidocaine enhances treatment comfort and optimizes the injection experience while maintaining a similar safety and effectiveness profile. Regarding the longevity, further study is necessary to determine if there is any

  7. 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

  8. 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.

  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. 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.

  11. Spontaneous nonneoplastic lesions in control Syrian hamsters in three 24-month long-term carcinogenicity studies.

    PubMed

    McInnes, Elizabeth F; Ernst, Heinrich; Germann, Paul-Georg

    2015-02-01

    Information about the incidence of spontaneously occurring, nonneoplastic background findings in Syrian hamsters is essential if Syrian hamsters are to be used for toxicity studies. Male and female Syrian hamsters of the strain Han:AURA from the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) breeding colony were maintained as control animals for carcinogenicity studies and were examined for the presence of nonneoplastic background findings either when they died or when the study was terminated. The nonneoplastic background lesions observed at an incidence of >50% (high), >25% (moderate), and >10% (low) in either male or female animals or in both sexes in one or more long-term studies are detailed. The results are compared to previous published reports of nonneoplastic, spontaneous background lesions in Syrian hamsters. Background information about the incidence of background lesions in Syrian hamsters on short- and long-term studies is useful to both toxicologists and toxicological pathologists.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. Long-term endurance and safety of elosulfase alfa enzyme replacement therapy in patients with Morquio A syndrome.

    PubMed

    Hendriksz, Christian J; Parini, Rossella; AlSayed, Moeenaldeen D; Raiman, Julian; Giugliani, Roberto; Solano Villarreal, Martha L; Mitchell, John J; Burton, Barbara K; Guelbert, Norberto; Stewart, Fiona; Hughes, Derralynn A; Berger, Kenneth I; Slasor, Peter; Matousek, Robert; Jurecki, Elaina; Shaywitz, Adam J; Harmatz, Paul R

    2016-09-01

    Long-term efficacy and safety of elosulfase alfa enzyme replacement therapy were evaluated in Morquio A patients over 96weeks (reaching 120weeks in total from pre-treatment baseline) in an open-label, multi-center, phase III extension study. During this extension of a 24-week placebo-controlled phase III study, all patients initially received 2.0mg/kg elosulfase alfa either weekly or every other week, prior to establishment of 2.0mg/kg/week as the recommended dose, at which point all patients received weekly treatment. Efficacy measures were compared to baseline of the initial 24-week study, enabling analyses of changes over 120weeks. In addition to performing analyses for the entire intent-to-treat (ITT) population (N=173), analyses were also performed for a modified per-protocol (MPP) population (N=124), which excluded patients who had orthopedic surgery during the extension study or were non-compliant with the study protocol (as determined by ≥20% missed infusions). Six-minute walk test (6MWT) was the primary efficacy measure; three-minute stair climb test (3MSCT) and normalized urine keratan sulfate (uKS) were secondary efficacy measures. Mean (SE) change from baseline to Week 120 in 6MWT distance was 32.0 (11.3)m and 39.9 (10.1)m for patients receiving elosulfase alfa at 2.0mg/kg/week throughout the study (N=56) and 15.1 (7.1)m and 31.7 (6.8)m in all patients combined, regardless of dosing regimen, for the ITT and MPP populations, respectively. Further analyses revealed that durability of 6MWT improvements was not impacted by baseline 6MWT distance, use of a walking aid, or age. Mean (SE) change at Week 120 in the 3MSCT was 5.5 (1.9) and 6.7 (2.0)stairs/min for patients receiving elosulfase alfa at 2.0mg/kg/week throughout the study and 4.3 (1.2) and 6.8 (1.3)stairs/min in all patients combined, regardless of dosing regimen, for the ITT and MPP populations, respectively Across all patients, mean (SE) change at Week 120 in normalized uKS was -59.4 (1.8)% and

  18. 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

  19. Cytogenetic studies of blood lymphocytes from cosmonauts after long-term space flights on MIR station

    NASA Astrophysics Data System (ADS)

    Fedorenko, B.; Druzhinin, S.; Yudaeva, L.; Petrov, V.; Akatov, Yu.; Snigiryova, G.; Novitskaya, N.; Shevchenko, V.; Rubanovich, A.

    Long-term space missions may increase risks of unfavorable consequences for cosmonauts as a result of radiation effects. This paper presents results of a study of cytogenetic damage in cosmonauts' peripheral blood lymphocytes induced by space radiation. Cultivation of lymphocytes and analysis of chromosomal aberrations were made according to generally accepted methods. It is shown that the yields of dicentrics and centric rings scored after long-term space flights are considerably higher than those scored prior to the flights. An attempt was made to assess individual doses received by cosmonauts. Individual biodosimetry doses received by cosmonauts who showed a reliable increase in the yields of chromosomal-type aberrations after their first flights were estimated to be from 0.02 to 0.28 Gy.

  20. Cytogenetic studies of blood lymphocytes from cosmonauts after long-term space flights on Mir station.

    PubMed

    Fedorenko, B; Druzhinin, S; Yudaeva, L; Petrov, V; Akatov, Y; Snigiryova, G; Novitskaya, N; Shevchenko, V; Rubanovich, A

    2001-01-01

    Long-term space missions may increase risks of unfavorable consequences for cosmonauts as a result of radiation effects. This paper presents results of a study of cytogenetic damage in cosmonauts' peripheral blood lymphocytes induced by space radiation. Cultivation of lymphocytes and analysis of chromosomal aberrations were made according to generally accepted methods. It is shown that the yields of dicentrics and centric rings scored after long-term space flights are considerably higher than those scored prior to the flights. An attempt was made to assess individual doses received by cosmonauts. Individual biodosimetry doses received by cosmonauts who showed a reliable increase in the yields of chromosomal-type aberrations after their first flights were estimated to be from 0.02 to 0.28 Gy. PMID:11642297

  1. Cabergoline and cardiac valve disease in prolactinoma patients: additional studies during long-term treatment are required.

    PubMed

    Kars, M; Pereira, A M; Bax, J J; Romijn, J A

    2008-10-01

    The increased risk of cardiac valve disease in patients treated for Parkinson's disease with cabergoline has raised concerns about the safety of treatment with ergot-derived dopamine agonists in patients with endocrine diseases, especially prolactinoma. Six cross-sectional studies have been published recently, of which five studies do not show an association between the treatment of prolactinoma with cabergoline during 45-79 months and clinically relevant valvular regurgitation in a total of 413 patients. Nonetheless, concern is raised because the use of cabergoline was associated in one study with an increased prevalence of moderate tricuspid regurgitation, and in two other studies with mild tricuspid regurgitation. Furthermore, the use of cabergoline was associated with increased frequencies of valvular thickening, calcifications and increased mitral tenting area. At present, the clinical relevance of these findings is still uncertain, but concern is raised with respect to the safety of the use of cabergoline in the long-term treatment of prolactinomas. Echocardiographic evaluation should be considered in patients, who require long-term treatment with cabergoline, especially in high doses. There is a need for larger, preferably prospective, studies with careful echocardiographic assessment and with longer durations of follow-up than the currently available studies.

  2. Complementary and alternative medicine use among long-term lymphoma survivors: a pilot study.

    PubMed

    Habermann, Thomas M; Thompson, Carrie A; LaPlant, Betsy R; Bauer, Brent A; Janney, Carol A; Clark, Matthew M; Rummans, Teresa A; Maurer, Matthew J; Sloan, Jeff A; Geyer, Susan M; Cerhan, James R

    2009-12-01

    No published survey has specifically addressed the beliefs, knowledge, and usage of complementary and alternative medicine (CAM) in long-term (5-20 years) lymphoma survivors alone. In this pilot project, 95 subjects were randomly selected from a population of 2,475 long-term lymphoma survivors and mailed a questionnaire. The median time from lymphoma diagnosis to completion of the questionnaire was 11 years (range 6-20). Overall, 68% (95% CI: 54-80%) of the long-term lymphoma survivors reported that they have used CAM, a rate higher than the estimated usage rate reported for the general population The most commonly used modalities were chiropractic (39%, 95% CI: 27-53%) and massage therapy (21%, 95% CI: 12-34%). Less than 10% used meditation (5%, 95% CI: 1-15%) and relaxation (7%, 95% CI: 2-17%). In terms of common herbal usage, 5% (95% CI: 1-15%) had used St. John's Wort and 7% (95% CI: 2-17%) had used shark cartilage. Although none of the patients reported that CAM usage was directed specifically towards treating their lymphoma, 4% (95% CI: 0-12%) of patients reported that CAM could cure cancer, and 14% (95% CI: 6-26%) reported that CAM could increase their feeling of control over their health. This pilot study suggests that long-term lymphoma survivors appear to use CAM at a rate higher than the general population. The use of potential agents of risk by the survivors and the lack of access to potentially beneficial modalities highlights the need for further study of CAM in this population.

  3. 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.

  4. Long-term Follow-up Study of Endovascularly Treated Intracranial Aneurysms

    PubMed Central

    Pyysalo, L.M.; Keski-Nisula, L.H.; Niskakangas, T.T.; Kähärä, V.J.; Öhman, J.E.

    2010-01-01

    Summary Long-term follow-up studies after endovascular treatment for intracranial aneurysm are still rare and inconclusive. The aim of this study was to assess long-term clinical and angiographic outcome of patients with endovascularly treated aneurysms. The Clinical outcome of all 185 patients with endovascularly treated aneurysms were analyzed and 77 out of 122 surviving patients were examined with MRI and MRA nine to 16 years (mean 11 years) after the initial endovascular treatment. Sixty-three patients were deceased at the time of follow-up. The cause of death was aneurysm- related in 34 (54%) patients. The annual re- bleeding rate from the treated aneurysms was 1.3% in the ruptured group and 0.1% in the unruptured group. In long-term follow-up MRA 18 aneurysms (53%) were graded as complete, 11 aneurysms (32%) had neck remnants and five aneurysms (15%) were incompletely occluded in the ruptured group. Occlusion grade was lower in the unruptured group with 20 an- eurysms (41%) graded as complete, 11 (22%) had neck remnants and 18 (37%) were incomplete. However, only three aneurysms were unstable during the follow-up period and needed retreatment. Endovascular treatment of unruptured aneu- rysms showed incomplete angiographic outcome in 37% of cases. However, annual bleeding rate was as low as 0.1%. Endovascular treatment of ruptured aneurysms showed incomplete angiographic outcome in 15% of cases and the annual rebleeding rate was 1.3%. PMID:21162766

  5. Long-Term Follow-Up Study of Endovascularly Treated Intracranial Aneurysms

    PubMed Central

    Pyysalo, L.M.; Keski-Nisula, L.H.; Niskakangas, T.T.; Kähärä, V.J.; Öhman, J.E.

    2010-01-01

    Summary Long-term follow-up studies after endovascular treatment for intracranial aneurysm are still rare and inconclusive. The aim of this study was to assess the long-term clinical and angiographic outcome of patients with endovascularly treated aneurysms. The clinical outcome of all 185 patients with endovascularly treated aneurysms were analyzed and 77 out of 122 surviving patients were examined with MRI and MRA nine to 16 years (mean 11 years) after the initial endovascular treatment. Sixty-three patients were deceased at the time of follow-up. The cause of death was aneurysm-related in 34 (54ċ) patients. The annual rebleeding rate from the treated aneurysms was 1.3% in the ruptured group and 0.1% in the unruptured group. In long-term follow-up MRA 18 aneurysms (53%) were graded as complete, 11 aneurysms (32%) had neck remnants and five aneurysms (15%) were incompletely occluded in the ruptured group. The occlusion grade was lower in the unruptured group with 20 aneurysms (41%) graded as complete, 11 (22%) had neck remnants and 18 (37%) were incomplete. However, only three aneurysms were unstable during the follow-up period and needed retreatment. Endovascular treatment of unruptured aneurysms showed incomplete angiographic outcome in 37% of cases. However, the annual bleeding rate was as low as 0.1%. Endovascular treatment of ruptured aneurysms showed incomplete angiographic outcome in 15% of cases and the annual rebleeding rate was 1,3%. PMID:20977853

  6. Mycophenolate mofetil as maintenance therapy for proliferative lupus nephritis: a long-term observational prospective study

    PubMed Central

    2010-01-01

    Introduction While the role of mycophenolate mofetil (MMF) in the management of lupus nephritis has been increasingly recognized, limited information is available regarding its efficacy and safety as a long-term maintenance treatment. The aim of the present study was to evaluate the efficacy and safety profile of MMF as maintenance therapy for proliferative lupus nephritis. Methods Thirty-three consecutive patients with proliferative lupus nephritis received induction therapy with five to seven monthly intravenous (iv) pulses of cyclophosphamide (CYC) plus iv steroids followed by oral MMF 2 g/day as maintenance therapy for a median time of 29 months (range 9 to 71 months). Primary end points were the achievement of renal remission, complete renal remission, disease remission - renal and extrarenal -, the occurrence of renal relapse, chronic renal failure and death. Secondary end points were the extrarenal disease activity and drug adverse events. The clinical and laboratory parameters were compared during follow-up by means of nonparametric statistical tests. Time to event analysis was performed according to the Kaplan-Meier method. Results A significant improvement of all renal parameters was observed at the end of the induction treatment and at the latest follow-up compared to baseline. The rate of patients achieving renal remission until the end of follow-up was 73%, whereas that of complete renal remission was 58%. The median survival times in the Kaplan-Meier analyses were 7 and 16 months, respectively. Remission was maintained in all but four (12%) patients who relapsed within 19 to 39 months after initial response. At the end of follow-up, 51% of the patients had reached disease remission. The median survival time of disease remission was 18 months. Extrarenal manifestations were well controlled in most of the patients. In one patient receiving MMF, extrarenal activity led to treatment discontinuation. Non life-threatening drug adverse events developed in 18

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

    PubMed Central

    Van Meter, W S

    1997-01-01

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

  8. 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

  9. 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

  10. Acute and long-term safety and tolerability of risperidone in children with autism.

    PubMed

    Aman, Michael G; Arnold, L Eugene; McDougle, Christopher J; Vitiello, Benedetto; Scahill, Lawrence; Davies, Mark; McCracken, James T; Tierney, Elaine; Nash, Patricia L; Posey, David J; Chuang, Shirley; Martin, Andres; Shah, Bhavik; Gonzalez, Nilda M; Swiezy, Naomi B; Ritz, Louise; Koenig, Kathleen; McGough, James; Ghuman, Jaswinder K; Lindsay, Ronald L

    2005-12-01

    Treatment-emergent adverse events (AEs) were monitored during an 8-week, double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 children and adolescents with a lifetime diagnosis of autistic disorder. In addition, 37 placebo nonresponders received open-label risperidone for another 8 weeks. Of all the risperidone responders (n=65), 63 entered an open extension of another 16 weeks (6 months total risperidone exposure), and 32 of them were rerandomized to either continued risperidone therapy (n=16) or gradual replacement with placebo (n=16) over 8 weeks. We collected the following measures of safety and tolerability: (1) laboratory blood assessments (CBC with differential, electrolytes, and liver function tests) and urinalyses, (2) vital signs, (3) Side Effects Review of AEs thought to be associated with risperidone, (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No clinically significant changes were found on the lab tests. During the 8-week acute trial, the most common AEs on the Side Effects Review, scored as moderate or higher, were as follows (placebo and risperidone, respectively): Somnolence (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). "Difficulty falling asleep" and anxiety actually favored the risperidone condition at statistically significant levels. The same AEs tended to recur through 6 months of treatment, although often at reduced levels. Using Centers for Disease Control (CDC) standardized scores, both weight and body mass index (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and into open-label extension (0.19 and 0.16 SDs, respectively), although the amount of gain decelerated with time. Extrapyramidal symptoms, as

  11. 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

  12. 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…

  13. 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

  14. 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

  15. Assessment of Safety and Long-Term Outcomes of Initial Treatment With Placebo in TADS

    PubMed Central

    Kennard, Betsy D.; Silva, Susan G.; Mayes, Taryn L.; Rohde, Paul; Hughes, Jennifer L.; Vitiello, Benedetto; Kratochvil, Christopher J.; Curry, John F.; Emslie, Graham J.; Reinecke, Mark A.; March, John S.

    2010-01-01

    Objective The authors examined whether initial assignment to receive placebo for 12 weeks followed by open active treatment as clinically indicated was associated with different levels of benefit and risk of harm across 36 weeks as compared with initial assignment to receive active treatments. Method Adolescents with major depressive disorder (N=439) were randomly assigned to receive an initial 12 weeks of treatment with fluoxetine, cognitive-behavioral therapy (CBT), combination treatment with fluoxetine and CBT, or clinical management with placebo; those assigned to placebo received open active treatment as clinically indicated after 12 weeks of placebo. Assessments were conducted every 6 weeks for 36 weeks. The primary outcome measures were response and remission based on scores on the Children’s Depression Rating Scale–Revised and the Clinical Global Impression improvement subscale. Results At week 36, the response rate was 82% in the placebo/open group and 83% in the active treatment groups. The remission rate was 48% in the placebo/open group and 59% in the active treatment groups, a difference that approached statistical significance. Patients who responded to placebo generally retained their response. Those who did not respond to placebo subsequently responded to active treatment at the same rate as those initially assigned to active treatments. There were no differences between groups in rates of suicidal events, study retention, or symptom worsening. Conclusions Remission rates at 9 months were lower in patients treated initially with placebo, but 3 months of placebo treatment was not associated with any harm or diminished response to subsequent treatment. PMID:19147693

  16. Who Is at Greatest Risk of Adverse Long-Term Outcomes? The Finnish from a Boy to a Man Study

    ERIC Educational Resources Information Center

    Sourander, Andre; Jensen, Peter; Davies, Mark; Niemela, Solja; Elonheimo, Henrik; Ristkari, Terja; Helenius, Hans; Sillanmaki, Lauri; Piha, Jorma; Kumpulainen, Kirsti; Tamminen, Tuula; Moilanen, Irma; Almqvist, Fredrik

    2007-01-01

    Objective: To study associations between comorbid psychopathology and long-term outcomes in a large birth cohort sample from age 8 to early adulthood. Method: The sample included long-term outcome data on 2,556 Finnish boys born in 1981. The aim was to study the impact of early childhood psychopathology types (externalizing versus internalizing…

  17. 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…

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. 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

  3. 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.

  4. Developing a long-term ventilation service in a children's hospice: an illustrative case study.

    PubMed

    Cockett, Andrea

    2012-06-01

    Children who use long-term ventilation at home and their parents find it difficult to access suitable respite services for short breaks. This article describes, through the use of a case study, a project to develop a respite service for such children at a children's hospice in England. The service development was a response to local need, which included a requirement to develop bespoke assessment documentation and processes as well as a comprehensive staff development package. The article follows the journey of one family through the development and use of the new service.

  5. 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

  6. 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

  7. 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

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

    PubMed Central

    2012-01-01

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

  9. [Study on mechanism of SOM stabilization of paddy soils under long-term fertilizations].

    PubMed

    Luo, Lu; Zhou, Ping; Tong, Cheng-Li; Shi, Hui; Wu, Jin-Shui; Huang, Tie-Ping

    2013-02-01

    Fourier transform infrared spectroscopy (FTIR) was applied to study the structure of soil organic matter (SOM) of paddy soils under long-term different fertilization treatments. The aim was to clarify the different distribution of SOM between different fertilization methods and between topsoil and subsoil, and to explore the stability mechanism of SOM under different fertilization treatments. The results showed that the content of topsoil organic carbon (SOC) was the highest under organic-inorganic fertilizations, with the increment of SOC by 18.5%, 12.9% and 18.4% under high organic manure (HOM), low organic manure (LOM) and straw returning (STW) respectively compared with no fertilization treatment (CK). The long-term fertilizations also changed the chemical structure of SOM. As compared with CK, different fertilization treatments increased the functional group absorbing intensity of chemical resistance compounds (aliphatic, aromaticity), carbohydrate and organo-silicon compounds, which was the most distinctive under treatments of HOM, LOM and STW. For example, the absorbing intensity of alkyl was 0.30, 0.25 and 0.29 under HOM, LOM and STW, respectively. These values were increased by 87% , 56% and 81% as compared with that under CK treatment. The functional group absorbing intensity of SOM in the topsoil was stronger than that in the subsoil, with the most distinctive difference under HOM, LOM and STW treatments. The present research indicated that the enhanced chemical resistance of functional group of SOM may contribute to the high contents of SOC in the paddy soils under long-term organic-inorganic fertilizations, which also suggested a chemical stabilization mechanism of SOM in the paddy soils.

  10. 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.

  11. 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.

  12. Long-term follow-up study of radial forearm free flap reconstruction after hemiglossectomy.

    PubMed

    Akashi, Masaya; Hashikawa, Kazunobu; Sakakibara, Akiko; Komori, Takahide; Terashi, Hiroto

    2015-01-01

    Previous studies on postoperative long-term results in patients who underwent reconstructive free flap transfer following hemiglossectomy had some issues, including the heterogeneity of the patient population and the observation period. The present study aimed to evaluate changes of reconstructed tongues in patients who underwent radial forearm free flap (RFFF) after hemiglossectomy with long-term follow-up. We enrolled 23 patients who underwent RFFF after hemiglossectomy with a postoperative follow-up of 5 years or more. Postoperative status (eating, speech, sensation function) was assessed by concise medical inquiries. Morphological changes of flaps were evaluated by reviewing clinical photographs. Hemiglossectomy involving the base of the tongue was performed in 4 cases (17.4%) and was limited to the mobile tongue in 19 cases (82.6%). The mean follow-up was 85.4 months (range, 60-122 months). All patients experienced gradually improved postoperative status. The most significant improvement was found between 1 and 5 years after surgery (P = 0.007), but not between 1 and 3 years (P = 0.075) or between 3 and 5 years (P = 0.530). In almost all of the flaps, there were few morphological changes throughout the follow-up period. Postoperative status in patients who underwent reconstructive RFFF following hemiglossectomy improved sequentially.

  13. Long-term importance of fundamental motor skills: a 20-year follow-up study.

    PubMed

    Lloyd, Meghann; Saunders, Travis J; Bremer, Emily; Tremblay, Mark S

    2014-01-01

    The purpose of this study was to investigate the potential long-term association of motor skill proficiency at 6 years of age and self-reported physical activity (PA) at age 26. Direct motor performance data were collected in 1991 with a follow-up study occurring in 1996, and then indirect questionnaires (self-report) administered in 2001 and 2011. In 2011, 17 participants who were identified as either having high motor proficiency (HMP) or low motor proficiency (LMP) in 1991 completed a series of 4 questionnaires. Analyses were conducted to determine whether there were differences between groups for motor skill proficiency, PA, or sedentary behavior, and whether these outcomes were related across ages. Motor skill proficiency at age 6 was related to self-reported proficiency at age 16 (r = .77, p = .006), and self-reported proficiency between 16 and 26 years (r = .85, p = .001). Motor skill proficiency at age 6 was positively associated with leisure time PA at age 26 in females and participants in the HMP group. The results may provide preliminary evidence about the importance of how early motor skill proficiency relates to long-term PA. More research with larger sample sizes is needed to investigate the importance of motor skills over time.

  14. 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

  15. 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.

  16. 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.

  17. Long-Term Growth of Moss in Microfluidic Devices Enables Subcellular Studies in Development1[OPEN

    PubMed Central

    2016-01-01

    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

  18. A time-course study of long term over-expression of ARR19 in mice

    PubMed Central

    Qamar, Imteyaz; Ahmad, Mohammad Faiz; Narayanasamy, Arul

    2015-01-01

    A leucine-rich protein, ARR19 (androgen receptor corepressor-19 kDa), is highly expressed in male reproductive organs and moderately in others. Previously, we have reported that ARR19 is differentially expressed in adult Leydig cells during the testis development and inhibits steroidogenesis by reducing the expression of steroidogenic enzymes. Whereas in prostate, ARR19 represses the transcriptional activity of AR (androgen receptor), it is important for male sexual differentiation and maturation in prostate and epididymis, through the recruitment of HDAC4. In this study we show that long term adenovirus mediated overexpression of ARR19 in mice testis has the potential of inhibiting the differentiation of testicular and prostatic cells by reducing the size of testis and prostate but has no effect on the growth of seminal vesicles. Further, it reduces the level of progesterone and testosterone by reducing the steroidogenic enzymes such as 3HSD, P450c17 and StAR. This is the first study reporting a time-course analysis of the implications of long term overexpression of ARR19 in mice testis and its effect on other organs such as prostate and seminal vesicles. Taken together, these results suggest that ARR19 may play an important role in the differentiation of male reproductive organs such as testis and prostate. PMID:26260329

  19. 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

  20. Long-term efficacy and safety of all-trans retinoic acid/arsenic trioxide-based therapy in newly diagnosed acute promyelocytic leukemia.

    PubMed

    Hu, Jiong; Liu, Yuan-Fang; Wu, Chuan-Feng; Xu, Fang; Shen, Zhi-Xiang; Zhu, Yong-Mei; Li, Jun-Min; Tang, Wei; Zhao, Wei-Li; Wu, Wen; Sun, Hui-Ping; Chen, Qiu-Sheng; Chen, Bing; Zhou, Guang-Biao; Zelent, Arthur; Waxman, Samuel; Wang, Zhen-Yi; Chen, Sai-Juan; Chen, Zhu

    2009-03-01

    All-trans retinoic acid (ATRA)/arsenic trioxide (ATO) combination-based therapy has benefitted newly diagnosed acute promyelocytic leukemia (APL) in short-term studies, but the long-term efficacy and safety remained unclear. From April 2001, we have followed 85 patients administrated ATRA/ATO with a median follow-up of 70 months. Eighty patients (94.1%) entered complete remission (CR). Kaplan-Meier estimates of the 5-year event-free survival (EFS) and overall survival (OS) for all patients were 89.2% +/- 3.4% and 91.7% +/- 3.0%, respectively, and the 5-year relapse-free survival (RFS) and OS for patients who achieved CR (n = 80) were 94.8% +/- 2.5% and 97.4% +/- 1.8%, respectively. Upon ATRA/ATO, prognosis was not influenced by initial white blood cell count, distinct PML-RARalpha types, or FLT3 mutations. The toxicity profile was mild and reversible. No secondary carcinoma was observed, and 24 months after the last dose of ATRA/ATO, patients had urine arsenic concentrations well below the safety limit. These results demonstrate the high efficacy and minimal toxicity of ATRA/ATO treatment for newly diagnosed APL in long-term follow-up, suggesting a potential frontline therapy for de novo APL.

  1. Pre-college Students Contributing to Long-Term Climate Studies

    NASA Astrophysics Data System (ADS)

    Sparrow, E. B.

    2001-12-01

    Students in primary and secondary schools are engaged in long-term monitoring of the environment at or near their schools, in collaboration with scientists and educators, through the Global Learning and Observations to Benefit the Environment (GLOBE) Program. GLOBE students in more than 10,000 schools in 97 countries have reported data from almost 4 million science measurements in the areas of Atmosphere/Climate, Hydrology, Soils, Land Cover and Plant Phenology. These global data sets are available via the Internet to the world community for scientific research. After professional development workshops, GLOBE teachers guide their students in taking measurements according to scientific protocols and then in reporting their data through the Internet to the GLOBE Data Archive. Students are also guided in using these data for their own inquiry studies, analyzing scientific data, and in developing student-scientist and student-student partnerships at GLOBE schools around the world. Inclusion of GLOBE students in the research team would augment the problem of the huge expense and time involved for ground truthing remotely sensed data. NOAA's National Climate Data Center is using GLOBE student data to validate extreme events such as flash floods, hurricanes and tropical storms. The advantage of using GLOBE data is that much of the data arrives in real time compared to other volunteer data that comes by mail. The comprehensive suite of GLOBE measurements being collected by K-12 students is highly useful and complementary to long-term climate observations and Earth science research.

  2. The Cottonwood Lake study area, a long-term wetland ecosystem monitoring site

    USGS Publications Warehouse

    Mushet, David M.; Euliss, Ned H.

    2012-01-01

    The Cottonwood Lake study area is one of only three long-term wetland ecosystem monitoring sites in the prairie pothole region of North America; the other two are Orchid Meadows in South Dakota and St. Denis in Saskatchewan. Of the three, Cottonwood Lake has, by far, the longest continuous data-collection record. Research was initiated at the study area in 1966, and intensive investigations of the hydrology, chemistry, and biology of prairie pothole wetlands continue at the site today. This fact sheet describes the study area, provides an overview of wetland ecology research that has been conducted at the site in the past, and provides an introduction to current work being conducted at the study area by USGS scientists.

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

    PubMed

    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.

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

    PubMed Central

    Böhm, Stephan Karl; Kruis, Wolfgang

    2014-01-01

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

  5. 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

  6. Comparative long-term preclinical safety evaluation of two glatiramoid compounds (glatiramer Acetate, Copaxone(R), and TV-5010, protiramer) in rats and monkeys.

    PubMed

    Ramot, Yuval; Rosenstock, Moti; Klinger, Ety; Bursztyn, Dizza; Nyska, Abraham; Shinar, Doron M

    2012-01-01

    Glatiramer acetate (GA), the active ingredient in Copaxone®, is a complex mixture of polypeptides used for the treatment of relapsing remitting multiple sclerosis. Glatiramoids are related mixtures that may differ in some characteristics of the prototype molecule. Our aim is to describe the long-term toxicity studies with protiramer (TV-5010), a new glatiramoid, in comparison with similar studies conducted with GA. The toxicity of twice-weekly subcutaneous injections of protiramer to Sprague-Dawley rats (twenty-six weeks) and cynomolgus monkeys (fifty-two weeks) was compared with similar studies done with daily subcutaneous injections of GA. Daily treatment with GA was safe and well tolerated, without systemic effects or death. Protiramer administration was not as well tolerated as GA and led to dose- and time-related mortalities, probably mediated through severe injection-site lesions both in rats and in monkeys. Bridging fibrosis in the liver and severe progressive nephropathy were seen in rats. A dose-related increase in eosinophils was observed in monkeys. The protiramer toxicity studies show that minor variations in the manufacturing of glatiramoids may lead to significant toxic effects. It is therefore essential that the safety of any new glatiramoid be studied in long-term preclinical studies before exposing humans. PMID:22083585

  7. Long-term engraftment of single genetically modified human epidermal holoclones enables safety pre-assessment of cutaneous gene therapy.

    PubMed

    Larcher, Fernando; Dellambra, Elena; Rico, Laura; Bondanza, Sergio; Murillas, Rodolfo; Cattoglio, Claudia; Mavilio, Fulvio; Jorcano, José L; Zambruno, Giovanna; Del Rio, Marcela

    2007-09-01

    Predicting the risks of permanent gene therapy approaches involving the use of integrative gene-targeting vectors has become a critical issue after the unfortunate episode of a clinical trial in children with X-linked severe combined immunodeficiency (X-SCID). Safety pre-assessment of single isolated gene-targeted stem cells or their derivative clones able to regenerate their tissue of origin would be a major asset in addressing untoward gene therapy effects in advance. Human epidermal stem cells, which have extensive proliferative potential in vitro, theoretically offer such a possibility as a method of assessment. By means of optimized organotypic culture and grafting methods, we demonstrate the long-term in vivo regenerative capacity of single gene-targeted human epidermal stem cell clones (holoclones). Both histopathological analysis of holoclone-derived grafts in immunodeficient mice and retroviral insertion site mapping performed in the holoclone in vitro and after grafting provide proof of the feasibility of pre-assessing genotoxicity risks in isolated stem cells before transplantation into patients. Our results provide an experimental basis for previously untested assumptions about the in vivo behavior of epidermal stem cells prospectively isolated in vitro and pave the way for a safer approach to cutaneous gene therapy.

  8. 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.

  9. 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.

  10. 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.

  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. 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...

  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. Early behavioral adherence predicts short and long-term weight loss in the POUNDS LOST study.

    PubMed

    Williamson, Donald A; Anton, Stephen D; Han, Hongmei; Champagne, Catherine M; Allen, Ray; Leblanc, Eric; Ryan, Donna H; Rood, Jennifer; McManus, Katherine; Laranjo, Nancy; Carey, Vincent J; Loria, Catherine M; Bray, George A; Sacks, Frank M

    2010-08-01

    The primary aim of this study was to test the association of early (first 6 months) adherence related to diet, self-monitoring, and attendance with changes in adiposity and cardiovascular risk factors. This study used data from the 24-month POUNDS LOST trial that tested the efficacy of four dietary macronutrient compositions for short-and long-term weight loss. A computer tracking system was used to record data on eight indicator variables related to adherence. Using canonical correlations at the 6 and 24 month measurement periods, early behavioral adherence was associated with changes in percent weight loss and waist circumference at 6 months (R = 0.52) and 24 months (R = 0.37), but was not associated with cardiovascular disease risk factor levels. Early dietary adherence was associated with changes in insulin at 6 months (R = 0.19), but not at 24 months (R = 0.08, ns). Early dietary adherence was not associated with changes in adiposity.

  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 Cross-validation of Everolimus Therapeutic Drug Monitoring Assays: The Zortracker Study

    PubMed Central

    Schniedewind, B; Niederlechner, S; Galinkin, JL; Johnson-Davis, KL; Christians, U; Meyer, EJ

    2015-01-01

    Background This ongoing academic collaboration was initiated for providing support to set up, validate, and maintain everolimus therapeutic drug monitoring (TDM) assays and to study long-term inter- laboratory performance. Methods This study was based on EDTA whole blood samples collected from transplant patients treated with everolimus in a prospective clinical trial. Samples were handled under controlled conditions during collection, storage, and were shipped on dry ice to minimize freeze-thaw cycles. For more than 1.5 years participating laboratories received a set of 3 blinded samples on a monthly basis. Among others, these samples included individual patient samples, patient sample pools to assess long-term performance and patient samples pools enriched with isolated everolimus metabolites. Results The results between LC-MS/MS and the everolimus Quantitative Microsphere System (QMS, Thermo Fisher) assay were comparable. The monthly inter-laboratory variability (CV%) for cross validation samples ranged from 6.5 – 23.2% (average of 14.8%) for LC-MS/MS and 4.2 – 26.4% (average of 11.1%) for laboratories using the QMS assay. A blinded long-term pool sample was sent to the laboratories for 13 months. The result was 5.31 ± 0.86 ng/mL (range 2.9–7.8 ng/mL) for the LC-MS/MS and 5.20 ± 0.54 ng/mL (range 4.0–6.8 ng/mL) for QMS laboratories. Conclusions Enrichment of patient sample pools with 5–25 ng/mL of purified everolimus metabolites (46-hydroxy everolimus and 39-O-desmethyl everolimus) did not affect the results of either LC-MS/MS or QMS assays. Both LC-MS/MS and QMS assays gave similar results and showed similar performance, albeit with a trend towards higher inter-laboratory variability among laboratories using LC-MS/MS than the QMS assay. PMID:25970506

  17. 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

  18. Family burden in long-term diseases: a comparative study in schizophrenia vs. physical disorders.

    PubMed

    Magliano, Lorenza; Fiorillo, Andrea; De Rosa, Corrado; Malangone, Claudio; Maj, Mario

    2005-07-01

    This study explored burden and social networks in families of patients with schizophrenia or a long-term physical disease. It was carried out in 169 specialised units (mental health department, and units for the treatment of chronic heart, brain, diabetes, kidney, lung diseases) recruited in 30 randomly selected geographic areas of Italy. The study sample consisted of 709 key relatives of patients with a DSM-IV diagnosis of schizophrenia and 646 key relatives of patients with physical diseases. Each relative was asked to fill in the Family Problems Questionnaire (FPQ) and the Social Network Questionnaire (SNQ). In all selected pathologies, the consequences of caregiving most frequently reported as always present in the past 2 months were constraints in social activities, negative effects on family life, and a feeling of loss. Objective burden was higher in brain diseases, and subjective burden was higher in schizophrenia and brain diseases than in the other groups. Social support and help in emergencies concerning the patient were dramatically lower among relatives of patients with schizophrenia than among those of patients with physical diseases. In the schizophrenia group, both objective and subjective burden were significantly higher among relatives who reported lower support from their social network and professionals. The results of this study highlight the need to provide the families of those with long-term diseases with supportive interventions, including: (a) the management of relatives' psychological reactions to patient's illness; (b) the provision of information on the nature, course and outcome of patient's disease; (c) training for the relatives in the management of the patient's symptoms; and (d) the reinforcement of relatives' social networks, especially in the case of schizophrenia.

  19. 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

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Long-term optical stimulation of channelrhodopsin-expressing neurons to study network plasticity

    PubMed Central

    Lignani, Gabriele; Ferrea, Enrico; Difato, Francesco; Amarù, Jessica; Ferroni, Eleonora; Lugarà, Eleonora; Espinoza, Stefano; Gainetdinov, Raul R.; Baldelli, Pietro; Benfenati, Fabio

    2013-01-01

    Neuronal plasticity produces changes in excitability, synaptic transmission, and network architecture in response to external stimuli. Network adaptation to environmental conditions takes place in time scales ranging from few seconds to days, and modulates the entire network dynamics. To study the network response to defined long-term experimental protocols, we setup a system that combines optical and electrophysiological tools embedded in a cell incubator. Primary hippocampal neurons transduced with lentiviruses expressing channelrhodopsin-2/H134R were subjected to various photostimulation protocols in a time window in the order of days. To monitor the effects of light-induced gating of network activity, stimulated transduced neurons were simultaneously recorded using multi-electrode arrays (MEAs). The developed experimental model allows discerning short-term, long-lasting, and adaptive plasticity responses of the same neuronal network to distinct stimulation frequencies applied over different temporal windows. PMID:23970852

  6. 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.

  7. 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

  8. Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa.

    PubMed

    Schmidt, Claudia; Jaoko, Walter; Omosa-Manyonyi, Gloria; Kaleebu, Pontiano; Mpendo, Juliet; Nanvubya, Annet; Karita, Etienne; Bayingana, Roger; Bekker, Linda-Gail; Chomba, Elwyn; Kilembe, William; Nchabeleng, Maphoshane; Nyombayire, Julien; Stevens, Gwynn; Chetty, Paramesh; Lehrman, Jennifer; Cox, Josephine; Allen, Susan; Dally, Len; Smith, Carol; Fast, Patricia E

    2014-01-01

    Long-term safety is critical for the development and later use of a vaccine to prevent HIV/AIDS. Likewise, the persistence of vaccine-induced antibodies and their impact on HIV testing must be established. IAVI has sponsored several Phase I and IIA HIV vaccine trials enrolling healthy, HIV-seronegative African volunteers. Plasmid DNA and viral vector based vaccines were tested. No vaccine-related serious adverse events were reported. After completion of vaccine trials conducted between 2001-2007, both vaccine and placebo recipients were offered enrolment into an observational long-term follow-up study (LTFU) to monitor potential late health effects and persistence of immune responses. At scheduled 6-monthly clinic visits, a health questionnaire was administered; clinical events were recorded and graded for severity. Blood was drawn for HIV testing and cellular immune assays. 287 volunteers were enrolled; total follow-up after last vaccination was 1463 person years (median: 5.2 years). Ninety-three (93)% of volunteers reported good health at their last LTFU visit. Infectious diseases and injuries accounted for almost 50% of the 175 reported clinical events, of which over 95% were mild or moderate in severity. There were 30 six pregnancies, six incident HIV infections and 14 volunteers reported cases of social harm. Persistence of immune responses was rare. No safety signal was identified. No potentially vaccine-related medical condition, no immune mediated disease, or malignancy was reported. HIV vaccines studied in these trials had a low potential of induction of persisting HIV antibodies.

  9. Long-term fracture risk among infertile women: a population-based cohort study.

    PubMed

    Melton, L J; Hesdorffer, D C; Malkasian, G D; Atkinson, E J; Brinton, L A; O'Fallon, W M

    2001-04-01

    Nulliparity has been linked to bone loss and fractures, but the contribution of infertility is unclear. The purpose of this study was to assess the long-term risk of fractures among infertile women. In a population-based retrospective cohort study, all 658 Olmsted County, Minnesota, women with infertility (failure to conceive after 1 year despite intercourse without contraception) first diagnosed at Mayo Clinic in 1935-1964 were followed for fractures. Risk was assessed by comparing new fractures of each type to the number expected from sex-specific and age-specific fracture rates in the general population (standardized incidence ratios [SIR]). During 18,130 person-years of follow-up, 184 women experienced at least one fracture when 291 would have been expected on the basis of fracture incidence rates in the general population (SIR 0.6, 95% CI 0.5-0.7). There was no increase in proximal femur fractures (SIR 1.0, 95% CI 0.6-1.6) and a statistically significant decrease in the risk of distal forearm fractures (SIR 0.7, 95% CI 0.5-0.97), two of the three sites traditionally associated with osteoporosis. By contrast, there was a significant increase in subsequent vertebral fractures (SIR 1.9, 95% CI 1.4-2.4) that was consistent across divergent causes of infertility and reported menstrual patterns. Although an apparent increase in the risk of vertebral fractures requires further investigation, we saw no indication of an increase in limb fractures, suggesting that infertility does not have long-term adverse skeletal effects like those reported for athletes and dieters with irregular menses.

  10. 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

  11. Long-term outcomes in primary spinal osteochondroma: a multicenter study of 27 patients

    PubMed Central

    Sciubba, Daniel M.; Macki, Mohamed; Bydon, Mohamad; Germscheid, Niccole M.; Wolinsky, Jean-Paul; Boriani, Stefano; Bettegowda, Chetan; Chou, Dean; Luzzati, Alessandro; Reynolds, Jeremy J.; Szövérfi, Zsolt; Zadnik, Patti; Rhines, Laurence D.; Gokaslan, Ziya L.; Fisher, Charles G.; Varga, Peter Paul

    2016-01-01

    OBJECT Clinical outcomes in patients with primary spinal osteochondromas are limited to small series and sporadic case reports. The authors present data on the first long-term investigation of spinal osteochondroma cases. METHODS An international, multicenter ambispective study on primary spinal osteochondroma was performed. Patients were included if they were diagnosed with an osteochondroma of the spine and received surgical treatment between October 1996 and June 2012 with at least 1 follow-up. Perioperative prognostic variables, including patient age, tumor size, spinal level, and resection, were analyzed in reference to long-term local recurrence and survival. Tumor resections were compared using Enneking appropriate (EA) or Enneking inappropriate surgical margins. RESULTS Osteochondromas were diagnosed in 27 patients at an average age of 37 years. Twenty-two lesions were found in the mobile spine (cervical, thoracic, or lumbar) and 5 in the fixed spine (sacrum). Twenty-three cases (88%) were benign tumors (Enneking tumor Stages 1–3), whereas 3 (12%) exhibited malignant changes (Enneking tumor Stages IA–IIB). Sixteen patients (62%) underwent en bloc treatment—that is, wide or marginal resection—and 10 (38%) underwent intralesional resection. Twenty-four operations (92%) followed EA margins. No one received adjuvant therapy. Two patients (8%) experienced recurrences: one in the fixed spine and one in the mobile spine. Both recurrences occurred in latent Stage 1 tumors following en bloc resection. No osteochondroma-related deaths were observed. CONCLUSIONS In the present study, most patients underwent en bloc resection and were treated as EA cases. Both recurrences occurred in the Stage 1 tumor cohort. Therefore, although benign in character, osteochondromas still require careful management and thorough follow-up. PMID:25793467

  12. The San Dimas Experimental Forest - Long Term Study of Fire, Water and Vegetation

    NASA Astrophysics Data System (ADS)

    Meixner, T.; Wohlgemuth, P.

    2001-12-01

    The San Dimas Experimental Forest was established in 1934. A large data base of fire history and stream flow has been generated for the forest. This database is now available electronically. San Dimas was selected as a perfect example of the hydrology, geology, and ecology of the mountains of southern California. As such the long term data set provides the best examples available of rainfall runoff relationships in a mountainous Mediterannean climate. The effect of fire on streamflow is a pertinent topic considering the current national discussion about changes in fire policy in the western United States. The data sets at San Dimas provide an opportunity to investigate what the short and long term impacts of fire are on water resources in chaparral ecosystems. In particular the fires of 1938 and 1960 provide an opportunity to investigate the effect of fire and the differential response of streamflow after each of these fires. Immediately after the fires the well known fire-flood response of chaparral watersheds is noted with extremely large flood peaks possibly due to the combined effects of removal of vegetation and litter by fire as well as the presence of hydrophobic soils. However longer term impacts of fire are notciable, lasting as long as 20 years and are most likely related to decreases in vegetation coverage and the linked decrease in evapotranspiration. After the 1960 fire several watersheds were type converted to annual and perrenial grasslands from their native chaparral. The increased streamflow caused by these conversions is still observable during both storm and baseflow periods. The known fire history and streamflow records of the forest permit continuing study on the effect of fire frequency on watershed hydrology, biogeochemistry, and geomorphology. >http://www.rfl.psw.fs.fed.us/prefire/sdefhtml/

  13. Long-Term Mortality in Patients Diagnosed with Meningococcal Disease: A Danish Nationwide Cohort Study

    PubMed Central

    Roed, Casper; Omland, Lars Haukali; Engsig, Frederik Neess; Skinhoj, Peter; Obel, Niels

    2010-01-01

    Background In contrast to the case fatality rate of patients diagnosed with meningococcal disease (MD) the long-term mortality in these patients is poorly documented. Methodology/Principal Findings We performed a nationwide, population-based cohort study including all Danish patients diagnosed with MD from 1977 through 2006 and alive one year after diagnosis. Data was retrieved from the Danish National Hospital Register, the Danish Civil Registration System and the Danish Register of Causes of Death. For each patient four age- and gender-matched individuals were identified from the population cohort. The siblings of the MD patients and of the individuals from the population cohort were identified. We constructed Kaplan-Meier survival curves and used Cox regression analysis, cumulative incidence function and subdistribution hazard regression to estimate mortality rate ratios (MRR) and analyze causes of death. We identified 4,909 MD patients, 19,636 individuals from the population cohort, 8,126 siblings of MD patients and 31,140 siblings of the individuals from the population cohort. The overall MRR for MD patients was 1.27 (95% confidence interval (CI), 1.12–1.45), adjusted MRR, 1.21 (95% CI, 1.06–1.37). MD was associated with increased risk of death due to nervous system diseases (MRR 3.57 (95% CI, 1.82–7.00). No increased mortality due to infections, neoplasms or cardiovascular diseases was observed. The MRR for siblings of MD patients compared with siblings of the individuals from the population cohort was 1.17 (95% CI, 0.92–1.48). Conclusions Patients surviving the acute phase of MD have increased long-term mortality, but the excess risk of death is small and stems mainly from nervous system diseases. PMID:20300639

  14. 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

  15. 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. PMID:27508113

  16. 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

  17. 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.

  18. A long-term cohort study of the atomic-bomb survivors.

    PubMed

    Kodama, K; Mabuchi, K; Shigematsu, I

    1996-08-01

    The Atomic Bomb Casualty Commission (ABCC), the predecessor of the Radiation Effects Research Foundation (RERF), was established in 1947 to conduct long-term, comprehensive epidemiological and genetic studies of the atomic-bomb (A-bomb) survivors. Today this study still depends upon the voluntary cooperation of several tens of thousands of survivors of the bombings of Hiroshima and Nagasaki. An in-depth follow-up study of mortality in the study population of 120,000 persons, including A-bomb survivors and controls, has continued since 1950. The study of tumor incidence was initiated through record linkage with a tumor registry system in Hiroshima and Nagasaki in 1958. In the same year, biennial medical examinations of 20,000 individuals began. Follow-up studies also have been conducted on in-utero-exposed persons and first-generation offspring of the survivors. On the basis of these studies spanning nearly half a century, we know that the occurrence of leukemia and cancers associated with A-bomb radiation is higher than among the non-exposed. Among the A-bomb survivors, radiation cataracts, hyperparathyroidism, delayed growth and development, and chromosomal aberrations also occur more often. However, to date no evidence exists of genetic effects in the children of A-bomb survivors. It should be kept in mind that such study results could never be obtained without the cooperation of A-bomb survivors.

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

    PubMed

    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

  20. 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

  1. Long-term in vivo study of vertebrate embryonic development using noninvasive harmonics optical microscopy

    NASA Astrophysics Data System (ADS)

    Chen, Szu-Yu; Hsieh, C.-S.; Chu, S.-W.; Lin, Cheng-Yung; Ko, C.-Y.; Chen, Y.-C.; Tsai, Huai-Jen; Hu, C.-H.; Sun, Chi-Kuang

    2005-03-01

    Harmonics optical microscopy (HOM) provides a truly "noninvasive" tool for in vivo and long-term study of vertebrate embryonic development. Based on the nonlinear natures, it provides sub-micrometer 3D spatial resolution and high 3D optical-sectioning power (~1μm axial resolution) without using invasive and toxic fluorophores. Since only virtual-level-transition is involved, HOM is known to leave no energy deposition and no photodamages. Combined with second harmonic generation, which is sensitive to specific structure such as nerve and muscle fibers, HOM can be used to do functional studies of early developmental dynamics of many vertebrate physiological systems. Recently, zebrafish has become a standard model for many biological and medical studies of vertebrates, due to the similarity between embryonic development of zebrafish and human being. Zebrafish embryos now have been used to study many vertebrate physiological systems. We have demonstrated an in vivo HOM study of developmental dynamics of several embryonic physiological systems in live zebrafish embryos, with focuses on the developments of brains, eyes, ears, and hearts. Based on a femtosecond Cr:forsterite laser, which provides the deepest penetration (~1.5mm) and least photodamage in the zebrafish embryo, complete developing processes of different physiological systems within a period of time longer than 20 hours can be non-invasively observed inside the same embryo.

  2. Long-term risk of vascular events after peripheral bypass surgery. A cohort study.

    PubMed

    Van Hattum, Eline S; Tangelder, Marco J D; Lawson, James A; Moll, Frans L; Algra, Ale

    2012-09-01

    Patients with peripheral arterial disease (PAD) are at high risk of major ischaemic events. Long-term data of all major ischaemic events in PAD patients are scarce and outdated, especially for patients with severe PAD requiring bypass surgery. Our objective was to define their long-term prognosis and develop a prediction model which quantifies this risk up to a decade after surgery. We conducted a retrospective cohort study in patients from the Dutch Bypass Oral anticoagulants or Aspirin (BOA) Study; a multicentre randomised trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery. The primary outcome was the composite event of non-fatal myocardial infarction, non-fatal ischaemic stroke, major amputation, and vascular death. Cumulative risks were assessed by Kaplan-Meier analysis and independent determinants by multivariable Cox regression models. From 1995 until 2009, 482 patients were followed for a median period of 7.8 years. Follow-up was complete in 94%. Overall 60% of patients experienced a primary outcome event, of which the majority was a vascular death (30%), followed by major amputations (12%). The primary cause of vascular death was a cardiovascular event (29%), whereas the minority was due to complications directly related to PAD (6%). Within five years after bypass surgery vascular death occurred in about a quarter of patients and within 10 years in nearly half of patients. This was double the rate as for non-vascular death. The primary outcome event occurred in over a third and over half of patients in 5 and 10 years after bypass surgery, respectively. From four independent determinants for the primary outcome event: age, diabetes, critical limb ischaemia, and prior vascular interventions, we developed a risk chart, which systematically classifies the 10-year risks of the primary outcome event, ranging from 25% to 85%. This study provided a detailed insight in the course of PAD long after peripheral bypass surgery and

  3. 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.

  4. 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

  5. [Psychological and neurologic long-term consequences of brain tumors in children. A pilot study].

    PubMed

    Fossen, A; Skjeldal, O H; Storm-Mathisen, I

    1989-11-30

    Brain tumor is one of the most common forms of cancer in children. The therapy includes surgical interventions, radiation of the central nervous system and chemotherapy. Combining these methods of treatment has remarkably improved the survival of children with certain brain tumours (e.g. medulloblastoma). However, long-term studies have revealed serious psychological and somatic consequences of the disease and the treatment. This paper presents the results of a pilot study of nine children with brain tumor. The patients were examined using a battery of neuropsychological methods (Luria's Neuropsychological Investigation, WISC-R), a semi-structured interview (Child Assessment Schedule), a parent report form (Achenbach Child Behaviour Checklist) and a clinical neurological examination. The most striking finding from this investigation was in the psychosocial field. Except for one child, all the patients showed an introvert reaction pattern with a tendency towards anxiety, depression and social withdrawal. All the children showed some neurological and neuropsychological deficits. Except in the case of two mentally retarded children, cognitive functions were within the lower normal range. Specific learning, memory and fine-motor disabilities were found in more than half of the patients. The investigation suggested that both fine-motor and mental performance was detrimentally affected by increased speed. This seems to be an area of special interest for further studies.

  6. Long-term disease dynamics for a specialized parasite of ant societies: a field study.

    PubMed

    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.

  7. The study on long-term toxicity of d-psicose in rats.

    PubMed

    Yagi, Kanako; Matsuo, Tatsuhiro

    2009-11-01

    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 (LD(50) = 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.

  8. Assessment of children's long-term exposure to magnetic fields (The Geomet study)

    SciTech Connect

    Koontz, M.D. ); Koontz, M.D.; Mehegan, L.L.; Dietrich, F.M.; Nagda, N.L. )

    1992-11-01

    Past epidemiologic studies have had conflicting results concerning a possible association between childhood cancer and magnetic field exposure, perhaps because indirect measures of exposure were used. This pilot study was conducted to assess day-today and seasonal variations in children's exposure, the contributions of different environments to total exposure, and the level of measurement/observational detail needed to accurately predict or classify children's exposures. Twenty-eight children in two age groups (8 to 11 years and under 4 years) were personally monitored for exposure to magnetic fields. All subjects were monitored for two consecutive days during winter or spring, and 12 of the subjects were monitored during both seasons. Surrogates for exposure were developed from observation of wiring configurations, indoor/outdoor spot measurements of field strength, and continuous stationary monitoring at selected indoor locations in parallel with personal monitoring. The results indicate that a single monitoring episode may be insufficient for characterization of long-term exposure, and spot measurements at one point in time may not be adequate to predict exposure. For this study, wire codes and measures based on parallel stationary monitoring in the child's bedroom were the best surrogates for personal exposure.

  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. 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

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. Study on the weediness of winter wheat in a long-term fertilization field experiment.

    PubMed

    Lehoczky, E; Kismányoky, A; Kismányoky, T

    2006-01-01

    The study was carried out in Keszthely, in the long-term fertilization field experiment in April of 2005. In the experiment we had opportunity to compare the weediness in NPK and NPK + FYM* treatments, and we could study the effect of increasing N dosis on the weeds and winter wheat. The weed survey was made on the 20th of April at the end of tillering. For the weed survey used the Balázs-Ujvárosi method. After that we collected all the weeds from the plots per 1 m2. We counted, measured the fresh and dry matter weight of aerial parts. Winter wheat sampels were taken also from all plots (1 running meter per plot). In the experiment 10 weed species were found, 9 annual: Ambrosia artemisiifolia, Consolida regalis, Galium aparine, Lamiunt amplexicaule, Matricaria inodora, Papaver rhoeas, Stellaria media, Veronica hederifolia, Veronica triphyllos, and 1 perennial: Cirsium arvense. Veronica hederifolia was the dominant species in both fertilized plots, Stellaria media has the second highest weed coverage. The manuring treatments, and the N-dosis has important and significantly effect to the weedeness and the biomass production of winter wheat. On the control plots was the relation of biomass weight of weeds the highest. This relation reduced to the effect of N treatments, wich had an favorable effect on the winter wheat. PMID:17390822

  17. Long-Term Association Between Developmental Assets and Health Behaviors: An Exploratory Study.

    PubMed

    Bleck, Jennifer; DeBate, Rita

    2016-10-01

    Introduction Based on internal and external assets, the positive youth development approach aims to increase the capacity among adolescents to overcome challenges as they transition to adulthood. Developmental assets have been found to be positively associated with academic achievement, a variety of health promoting behaviors, and improved physical and mental health. The purpose of this exploratory study was to assess the long-term association between positive youth developmental assets with health risk and promoting behaviors. Method A continuous scale of developmental assets was created using 30 items from Wave I of the National Longitudinal Study of Adolescent to Adult Health, when participants were in 7th to 12th grades. Health behavior outcomes including cigarette use, substance use, fast food consumption, and physical activity were measured at both Wave III (age 18-26) and Wave IV (age 24-32). Path analysis was employed to assess the relationship between these observed measures. Results The well-fitted path model revealed associations between developmental assets with each health behavior at Wave III. Developmental assets indirectly influenced each health behavior and direct associations were observed between assets with substance use and physical activity at Wave IV. Conclusion Findings provide additional support for the developmental assets approach to adolescent health. Implications include Healthy People 2020 objectives related to tobacco and alcohol use and nutrition and physical activity. PMID:26462541

  18. A comparative study on long-term MTX controlled release from intercalated nanocomposites for nanomedicine applications.

    PubMed

    Alexa, Iuliana Florentina; Pastravanu, Cristina Giorgiana; Ignat, Maria; Popovici, Evelini

    2013-06-01

    The feasibility of some mesoporous materials such as SBA-15 and MCM-41 silica, LDH (layered double hydroxide) (Mg3Al-NO3) and MC (mesoporous carbon) have been comparatively evaluated for oral drug delivery applications, in order to broaden the range of matrices and implicitly to develop the class of drug delivery systems based on diffusion mechanism. As well known, methotrexate (MTX) is used widely to treat various neoplastic diseases such as acute lymphoblast leukemia, lymphoma and solid cancers and autoimmune diseases such as psoriasis and rheumatoid arthritis. The commercially available formulations of this drug have disadvantages due to the traditional release process that occurs in the body. Thus, this work is focused on the long-term controlled MTX delivery because this one could eliminate over or underdosing, could maintain drug levels in desired range, could increase patient compliance and prevent the side effects. Therefore, the mesoporous materials are used and efficient MTX-delivery systems, based on above-mentioned mesoporous materials, are successfully prepared by intercalation. The obtained drug carriers were tested in the controlled MTX-drug release process and the influence of the pore morphology and geometry on MTX release profiles was extensively studied comparatively. The prepared MTX delivery systems were characterized by FTIR and UV-vis spectroscopy, N2 sorption measurements. Then, the data obtained from the in vitro release studies have been analyzed, and in order to evaluate the MTX-release mechanism and kinetics, the Korsmeyer-Peppas equation has been applied. PMID:23434702

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

    2014-11-01

    This paper describes the long-term, satellite-based visible snow cover extent 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 has a spatial resolution of 190.5 km at 60 ° latitude, are updated monthly, and span from 4 October 1966 to present. The data comprise the longest satellite-based CDR of any environmental variable. Access to the data are provided in netCDF format and are archived by the National Climatic Data Center (NCDC) of the National Oceanic and Atmospheric Administration (NOAA) under the satellite climate data record program (doi:10.7289/V5N014G9). The basic characteristics, history, and evolution of the dataset are presented herein. In general, the CDR provides similar spatial and temporal variability as its widely used predecessor product. Key refinements to the new CDR improve the product's grid accuracy and documentation, and bring metadata into compliance with current standards for climate data records.

  6. 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.

  7. Systemic and splanchnic hemodynamic changes after liver transplantation for cirrhosis: a long-term prospective study.

    PubMed

    Piscaglia, F; Zironi, G; Gaiani, S; Mazziotti, A; Cavallari, A; Gramantieri, L; Valgimigli, M; Bolondi, L

    1999-07-01

    The effect of orthotopic liver transplantation (OLT) on the systemic and splanchnic hemodynamic alterations of cirrhosis is still largely unknown. The aim of this study was to prospectively investigate the long-term changes induced by OLT on several hemodynamic parameters. In 28 patients undergoing OLT for cirrhosis, the following parameters were measured before surgery and subsequently at 6-month intervals (mean follow-up period, 17 months): cardiac index, mean arterial pressure (MAP), heart rate, total peripheral resistance (TPR), portal vein flow velocity and flow volume, spleen size, and Doppler ultrasound resistance or pulsatility indexes (RI or PI) in the: 1) interlobular renal, 2) superior mesenteric, 3) splenic, and 4) hepatic arteries. The same parameters were measured in 10 healthy controls. After OLT, cardiac index and heart rate significantly decreased (P <.01), while MAP and TPR increased (P <.001), so that any significant difference from controls disappeared. Renal RI progressively decreased, achieving a significant reduction (P <.05) to normal values at the 12th month of follow-up. Portal flow velocity and hepatic and splenic RI returned to values not significantly different from controls. Portal flow volume increased over normal values after OLT (P <.001), and SMA PI, lower than normal before OLT, did not show any statistically significant increase thereafter. Spleen size decreased significantly, but persisted to be larger than in controls. In conclusion, systemic, renal, and most, but interestingly not all, splanchnic circulatory alterations of cirrhosis are restored to normal after OLT.

  8. Long-term land application of biosolids-a case study.

    PubMed

    Surampalli, R Y; Lai, K C K; Banerji, S K; Smith, J; Tyagi, R D; Lohani, B N

    2008-01-01

    Impact of long-term land application of biosolids on groundwater and soil quality of an application site, which had been operated for 8-15 years, was evaluated in this study. During and after the biosolids application, biosolids-amended soil, groundwater, and background soil samples were collected mainly for pathogen, nitrogen, phosphorus, and heavy metal analyses. Soil test data showed that there was no heavy metal accumulation in the biosolids-amended soil even after 10 years of biosolids application. Similar results were also observed from the groundwater samples in which the heavy metal concentrations in all groundwater samples were well below the maximum contamination levels of the drinking water standards. In addition, bacteriological levels of the soil and groundwater samples were close to the background level and below the permissible limits, respectively, thereby showing no pathogen contamination. However, nitrate-nitrogen contamination of the groundwater was occasionally observed probably due to an excess loading of the biosolids in the past. This problem can be alleviated by applying biosolids at agronomic rates so that no excess nitrogen is available for leaching down to the groundwater.

  9. 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

  10. Monitored natural attenuation of a long-term petroleum hydrocarbon contaminated sites: a case study.

    PubMed

    Naidu, Ravi; Nandy, Subhas; Megharaj, Mallavarapu; Kumar, R P; Chadalavada, Sreenivasulu; Chen, Zuliang; Bowman, Mark

    2012-11-01

    This study evaluated the potential of monitored natural attenuation (MNA) as a remedial option for groundwater at a long-term petroleum hydrocarbon contaminated site in Australia. Source characterization revealed that total petroleum hydrocarbons (TPH) as the major contaminant of concern in the smear zone and groundwater. Multiple lines of evidence involving the geochemical parameters, microbiological analysis, data modelling and compound-specific stable carbon isotope analysis all demonstrated natural attenuation of hydrocarbons occurring in the groundwater via intrinsic biodegradation. Groundwater monitoring data by Mann-Kendall trend analysis using properly designed and installed groundwater monitoring wells shows the plume is stable and neither expanding nor shrinking. The reason for stable plume is due to the presence of both active source and natural attenuation on the edge of the plume. Assuming no retardation and no degradation the contaminated plume would have travelled a distance of 1,096 m (best case) to 11,496 m (worst case) in 30 years. However, the plume was extended only up to about 170 m from its source. The results of these investigations provide strong scientific evidence for natural attenuation of TPH in this contaminated aquifer. Therefore, MNA can be applied as a defensible management option for this site following significant reduction of TPH in the source zone.

  11. Long-term toxicity study on transgenic rice with Cry1Ac and sck genes.

    PubMed

    Zhang, Min; Zhuo, Qin; Tian, Yuan; Piao, Jianhua; Yang, Xiaoguang

    2014-01-01

    In the present work, we evaluated the chronic effects of the transgenic insect-resistant rice carrying Cry1Ac and sck genes on Sprague-Dawley (SD) rats through a 78-week feeding study. Based on the gender and weight, 180 SD rats were randomly and evenly assigned into three groups. GM rice and non-GM rice were separately formulated into diets at high levels. AIN-93 diet was used as a nutritional control. Body weight, food consumption, hematology and serum chemistry were monitored regularly. Rats were sacrificed for organ weight measurement and pathological examination at 52 weeks and 78 weeks. Body weight, food consumption, mortality rates, tumor incidences and pathological findings showed no significant difference among the three groups. Although certain differences in some hematology, serum chemistry parameters and relative organ weights were observed between GM rice group and control groups, they were not considered as treatment-related. Taken together, long-term intake of transgenic rice carrying Cry1Ac and sck genes at a high level exerts no unintended adverse effects on rats.

  12. 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

  13. 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

  14. 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

  15. 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

  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. The Effect of Long-Term Outcome Studies on the Therapy of Schizophrenia.

    ERIC Educational Resources Information Center

    Haley, Jay

    1989-01-01

    Claims since schizophrenia is reversible, professions involved in social control and those doing therapy face new responsibilities. Notes therapists can approach psychotic symptoms expecting the person to become normal. Describes goal as being to help people past periods of acute disturbance without doing them long-term harm. (Author/ABL)

  18. 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,…

  19. 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…

  20. 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…

  1. 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.

  2. 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

  3. Long-term results of MISTI gold breast implants: a retrospective study.

    PubMed

    Piza-Katzer, Hildegunde; Pülzl, Petra; Balogh, Brigitte; Wechselberger, Gottfried

    2002-11-01

    MISTI Gold breast implants (Bioplasty, St. Paul, Minn.) filled with polyvinylpyrrolidone-hydrogel were developed as a promising alternative to silicone-filled implants. Some studies have reported on the positive effects of the implant, such as improved radiolucency and biocompatibility of the gel; however, there are also reports that such implants increased in volume and were subject to capsular contracture in the human body, resulting in demands for their removal. The purpose of this retrospective study was to analyze the long-term results of a series of patients with MISTI Gold breast implants. Between 1991 and 1993, the authors inserted 83 MISTI Gold implants in 61 patients with an average age of 46 years (range, 16 to 69). The authors were able to follow up 48 patients with 71 MISTI Gold implants. The average follow-up was 68 months (range, 10 to 108 months). The retrospective study found that 59 percent of all MISTI Gold implants were removed after an average period of 4.14 years. The main reason for implant removal was an increase in volume of 38 percent, followed by capsular contracture in 14 percent of all 71 MISTI Gold implants. The average increase in volume of all removed MISTI Gold implants was 43 percent. Capsular contracture was graded as Baker I and II in 63 percent and as Baker III and IV in 37 percent. In conclusion, the authors believe that MISTI Gold implants do not fulfill the criteria of safe breast implants, and they agree with the December of 2000 opinion of the Medical Devices Agency of the Department of Health in London that the hydrogel-filled breast implants should not be used until more information about the filler material and its metabolic fate is available.

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. Full thickness cartilage palisade tympanoplasty with malleus interposition: a study of the long term results.

    PubMed

    Velepic, Marko M; Manestar, Dubravko; Starcević, Radan; Velepic, Barbara Cesnik; Velepic, Sanja Zubović; Linsak, Zeljko

    2014-03-01

    The aim of this retrospective study is to review long term results of full-thickness cartilage palisade tympanoplasty (FTCPT) with malleus head interposition performed on 51 patients (56 ears); 36 women and 15 men (7-73 years, 44 years average). The pathology of ears which encourages this technique of tympanoplasty is presented. On average 12 years after surgery we have elaborated anatomic and functional results. Anatomic results were categorized based on empiric evaluation of the new tympanic membrane status: 40 (71%) tympanic membranes without anatomic irregularities, 14 (25%) with irregularities and 2 (4%) with secondary perforation. Functional results (tonal audiogram) are based on pure tone average air-bone gap (PTA-ABG) at 4 frequencies. Main functional results of 51 ears (51 audiograms performed): pre- and post-operative average PTA-ABGs were 27.07 +/- 9.98 and 10.77 +/- 7.85 dB (t = 10.36; p < 0.001). In the group of ears with a tympanic membrane with no anatomic irregularities, pre- and post-operative average PTA-ABGs were 27.30 +/- 10.56 and 10.82 +/- 8.33 dB (t = 8.09; p < 0.001). In the group of ears with cartilage resorption, pre- and post-operative PTA-ABGs were 24.92 +/- 8.19 and 9.33 +/- 6.58 dB (t = 6.21; p < 0.001). The differences between the two groups are irrelevant. Postoperative PTA-ABG values of ears after first surgery (N = 34) and revision surgery (N = 17) was significantly different (8.75 +/- 5.75 and 15.16 +/- 9.62 dB) (t = 2.60; p = 0.016). In spite of the thickness of the new tympanal membrane, FTCPT is a successful technique for solving advanced ear pathology.

  10. Hydroxyapatite fully coated conic hip prosthetic stem: a long term animal study.

    PubMed

    Moroni, A; Rocca, M; Faldini, C; Stea, S; Giardino, R; Giannini, S

    1999-01-01

    The purpose of this paper is to evaluate in an animal model the long term results obtained with a prosthetic stem fully coated with hydroxyapatite. The cup was manufactured in polyethylene and was cemented. Six arthroplasties were performed in six sheep. After twelve months, the animals were euthanized and the femurs were harvested and processed for undecalcified sectioning. Twelve cross sections were cut perpendicularly to the longitudinal stem axis. Sections one to five corresponded to the area of the stem which, at the time of surgery, had a full initial contact between the bone and the prosthesis; sections six to ten corresponded to the area of the stem which, at the time of surgery, had a gap from 0 to 2 mm between the bone and the prosthesis; sections eleven and twelve had an initial gap larger than 2 mm. At one year after implantation, in the sections one to five, morphological analyses showed extensive direct contact between the bone and the hydroxyapatite coating. Bone prosthesis contact was lower in the sections six to ten. No contact was seen in sections eleven and twelve. Comparing bone to prosthesis contact of each subsequent section, from proximal to distal, the difference becomes significant with section five compared to section six (p < 0.00005). No detachment of the hydroxyapatite coating from the metallic substrate was observed in any section. In conclusion, this study shows that a conic shaped femoral stem, fully coated with hydroxyapatite gives very good histological and histomorphometric results at one year. Prosthesis osteointegration showed to be influenced by the initial bone to prosthesis contact. No direct bone to prosthesis contact was achieved if the initial bone to prosthesis gap was larger than 2 mm.

  11. An improved optical reference frame for long-term Earth rotation studies

    NASA Astrophysics Data System (ADS)

    Vondrák, J.; Ron, C.

    The Earth orientation parameters, based on optical astrometry observations of latitude/universal time variations and the HIPPARCOS Catalogue, covering the interval 1899.7 - 1992.0, were determined in past years at the Astronomical Institute in Prague, in close cooperation with the Czech Technical University in Prague. During the solution we discovered that not all HIPPARCOS stars are suitable for such a long-term study; many of them proved to have large errors in proper motions, mostly due to their multiplicity and shortness of the HIPPARCOS mission. Eventually, we had to improve about 20% of the proper motions from the same observations that we used to estimate the Earth orientation parameters. New catalogues have appeared recently that are based on the combination of the HIPPARCOS Catalogue with past ground-based observations: FK6, TYCHO 2, and most recently ARIHIP, being a selection of the Combination Catalogues FK6, GC+HIP, TYC2+HIP and HIP. We made the inventory of all stars observed in Earth orientation programs at 33 observatories during the 20th century, and found 4480 different stars. Out of these we constructed the Earth Orientation Catalogue (EOC) that is basically given in the International Celestial Reference Frame (ICRS). Whenever possible, we take over the positions, proper motions, parallaxes and radial velocities from the following catalogues, in the order of their importance: ARIHIP (3023 stars), TYCHO 2 (1271 stars), and HIPPARCOS (140 stars); 46 stars were identified in none of them. However, not all of these stars are astrometrically excellent in the sense of the classification introduced by Wielen et al.; only 1982 belong to categories 1-3. The positions and proper motions of the remaining 2498 stars will therefore be thoroughly checked and, if necessary, improved on the basis of the latitude/universal time observations.

  12. Effects of forest management on soil carbon: results of some long-term resampling studies.

    PubMed

    Johnson, D W; Knoepp, J D; Swank, W T; Shan, J; Morris, L A; Van Lear, D H; Kapeluck, P R

    2002-01-01

    The effects of harvest intensity (sawlog, SAW; whole tree, WTH; and complete tree, CTH) on biomass and soil C were studied in four forested sites in the southeastern US (mixed deciduous forests at Oak Ridge, TN and Coweeta, NC; Pinus taeda at Clemson, SC: and P. eliottii at Bradford, FL). In general, harvesting had no lasting effects on soil C. However, intensive temporal sampling at the NC and SC sites revealed short-term changes in soil C during the first few years after harvesting, and large, long-term increases in soil C were noted at the TN site in all treatments. Thus, changes in soil C were found even though lasting effects of harvest treatment were not. There were substantial differences in growth and biomass C responses to harvest treatments among sites. At the TN site, there were no differences in biomass at 15 years after harvest. At the SC site, greater biomass was found in the SAW than in the WTH treatment 16 years after harvest, and this effect is attributed to be due to both the N left on site in foliar residues and to the enhancement of soil physical and chemical properties by residues. At the FL site, greater biomass was found in the CTH than in the WTH treatment 15 years after harvest, and this effect is attributed to be due to differences in understory competition. Biomass data were not reported for NC. The effects of harvest treatment on ecosystem C are expected to magnify over time at the SC and FL sites as live biomass increases, whereas the current differences in ecosystem C at the TN site (which are due to the presence of undecomposed residues) are expected to lessen with time.

  13. 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

  14. Water and electrolyte studies during long-term missions onboard the space stations SALYUT and MIR.

    PubMed

    Grigoriev, A I; Morukov, B V; Vorobiev, D V

    1994-02-01

    This contribution summarizes the results of investigations of water-electrolyte metabolism and its hormonal regulation conducted in cosmonauts who performed long-term space flights (from 18 to 366 days) aboard the space stations Salyut and Mir and compares them with the results obtained during various NASA flights. The role of the kidneys in ion metabolism regulation was assessed by various water-salt load tests before and after flights. In addition, the results of a year-long space flight and of medical experiments performed during the 237- and 241-day missions by the physicians and cosmonaut-researchers Atkov and Polyakov are reviewed in detail. In spite of interindividual variations, metabolic, and endocrine studies during prolonged space flights showed a reduction in body mass, usually with a reduction in body water and electrolytes and considerable changes in blood hormone concentrations and urinary hormone excretion. These changes reflect the processes of extended adaptation to a new environment. It is likely that shifts in electrolyte metabolism in weightlessness are primarily due to metabolic changes that diminish the tissue ability for ion retention and to concomitant changes in the endocrine status. The postflight examinations revealed changes in fluid-electrolyte metabolism and in the function of the kidneys which indicated a hypohydration status and a stimulation of hormonal systems responsible for fluid-electrolyte homeostasis in order to readapt to the normal gravitation. Postflight decline in osmotic concentration of urine in cosmonauts was accompanied by an altered response to antidiuretic hormone and was probably caused by changes in the functional state of the kidneys. We conclude that detailed knowledge of the alterations in water-electrolyte metabolism and its hormonal regulation on different stages of space flight are important prerequisites for the development of countermeasures to space deconditioning and thus for increased human efficiency

  15. 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 ...

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. Instrument packages to study long-term sediment transport processes in a shallow bay

    USGS Publications Warehouse

    Strahle, William J.; Martini, Marinna A.; Davis, Ray E.

    1994-01-01

    Pressure and near-surface and near-bottom measurements of current, temperature, salinity and light transmission were required in Mobile Bay, a 3 m deep estuary on the Gulf of Mexico. This environment presented several obstacles to obtaining long term observations. Boat traffic, soft estuary bottom, heavy biofouling, rapid sample rates and large data storage were overcome by using instrumentation techniques that are applicable to other estuary systems. Nearly two years of continuous data was collected.

  1. 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.

  2. 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.

  3. Lower Risk of Stroke after Deformity Surgery: Long Term Benefit Demonstrated by a National Cohort Study

    PubMed Central

    Huang, Liang-Chung; Chung, Wu-Fu; Liu, Shih-Wei; Chang, Peng-Yuan; Chen, Li-Fu; Wu, Jau-Ching; Chen, Yu-Chun; Huang, Wen-Cheng; Liu, Laura; Cheng, Henrich; Lo, Su-Shun

    2015-01-01

    Objectives: This study aimed to investigate the long-term risk of stroke in adult patients with spinal deformity. Specifically, the study addressed the possible protective effect of surgery for spinal deformity against stroke. Methods: Using the National Health Insurance Research Database (NHIRD), a monopolistic national database in Taiwan, this retrospective cohort study analyzed the incidence of stroke in patients with adult spinal deformity (ASD) in a 11-year period. A total of 13,503 patients, between 55 and 75 years old, were identified for the diagnosis of ASD. The patients were grouped into two: the surgical group (n = 10,439) who received spinal fusion surgery, and the control group (n = 2124) who received other medical treatment. The incidence rates of all subsequent cerebrovascular accidents, including ischemic and hemorrhagic strokes, were calculated. Hazard ratios for stroke were calculated use a full cohort and a propensity score matched cohort. Adjustments for co-morbidities that may predispose to stroke, including hypertension, diabetes mellitus, arrhythmia and coronary heart disease were conducted. Kaplan-Meier and Cox regression analyses were performed to compare the risk of stroke between the two groups. Results: During the total observation period of 50,450 person-years, the incidence rate of stroke in the surgical group (15.55 per 1000 person-years) was significantly lower than that of the control group (20.89 per 1000 person-years, p < 0.001). Stroke was more likely to occur in the control group than in the surgical group (crude hazard ratio 1.34, p < 0.001; adjusted HR 1.28, p < 0.001, by a propensity score matched model). Conclusions: In this national cohort of more than 13,000 ASD patients covering 10 years, stroke was approximately 25% less likely to happen in patients who underwent spinal fusion surgery than those who received medical management. Therefore, spinal fusion surgery may provide a protective effect against stroke in adult

  4. 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.

  5. 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

  6. 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

  7. Burn injury and long-term nervous system morbidity: a population-based cohort study

    PubMed Central

    Vetrichevvel, Thirthar P; Randall, Sean M; Fear, Mark W; Wood, Fiona M; Boyd, James H; Duke, Janine M

    2016-01-01

    Objective To investigate if children and adults who are hospitalised for a burn injury have increased long-term hospital use for nervous system diseases. Design A population-based retrospective cohort study using linked administrative health data from the Western Australian Data Linkage System. Participants Records of 30 997 persons hospitalised for a first burn injury in Western Australia during the period 1980–2012, and 123 399 persons who were age and gender frequency matched with no injury admissions randomly selected from Western Australia's birth registrations and electoral roll. Main outcome measures Admission rates and summed length of stay for nervous system diseases. Negative binomial and Cox proportional hazards regression modelling were used to generate incidence rate ratios (IRRs) and HRs with 95% CIs, respectively. Results After adjustment for demographic factors and pre-existing health status, the burn injury cohort had 2.20 times (95% CI 1.86 to 2.61) as many nervous system admissions and 3.25 times the number of days in hospital (95% CI: 2.28 to 4.64) than the uninjured cohort. This increase was found for those who had sustained burns during childhood (<15 years: IRR, 95% CI: 1.97, 1.49 to 2.61) and early to mid-adulthood (15–45 years: IRR, 95% CI: 2.70, 2.06 to 3.55) and older adults (≥45 years: IRR, 95% CI: 1.62, 1.33 to 1.97). Significantly elevated first-time postburn admissions were observed for children for 15 years postburn discharge (0–5 years: HR, 95% CI: 1.97, 1.75 to 2.22; 5–15 years: HR, 95% CI: 1.44, 1.28 to 1.63) and for adults 45 years and older at index burn for 5 years postburn only (HR, 95% CI: 1.72, 1.42 to 2.09). Conclusions Burn injury appears to be associated with increased nervous system-related morbidity for many years after burn injury. Further work into the mechanisms and possible treatments to reduce this morbidity are warranted in light of these findings. PMID:27609857

  8. 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

  9. LONG TERM RESULTS AFTER STAPLED HEMORRHOIDOPEXY ALONE AND COMPLEMENTED BY EXCISIONAL HEMORRHOIDECTOMY: A RETROSPECTIVE COHORT STUDY

    PubMed Central

    ARAUJO, Sergio Eduardo Alonso; HORCEL, Lucas de Araujo; SEID, Victor Edmond; BERTONCINI, Alexandre Bruno; KLAJNER, Sidney

    2016-01-01

    ABSTRACT Background: Stapled hemorrhoidopexy is associated with less postoperative pain and faster recovery. However, it may be associated with a greater risk of symptomatic recurrence. We hypothesized that undertaking a limited surgical excision of hemorrhoid disease after stapling may be a valid approach for selected patients. Aim: To compare long-term results after stapled hemorrhoidopexy with and without complementation with closed excisional technique. Method: In a retrospective uni-institutional cohort study, sixty-five (29 men) patients underwent stapled hemorrhoidopexy and 21 (13 men) underwent stapled hemorrhoidopexy with excision. The same surgeons operated on all cases. Patients underwent stapled hemorrhoidectomy associated with excisional surgery if symptoms attributable to external hemorrhoid piles were observed preoperatively, or if residual prolapse or bulky external disease was observed after the firing of the stapler. A closed excisional diathermy hemorrhoidectomy without vascular ligation was utilized in all complemented cases. All clinical variables were obtained from a questionnaire evaluation obtained through e-mail, telephone interview, or office follow-up. Results: The median duration of postoperative follow-up was 48.5 (6-40) months. Patients with grades 3 and 4 hemorrhoid disease were operated on more frequently using stapled hemorrhoidopexy complemented with excisional technique (95.2% vs. 55.4%, p=0.001). Regarding respectively stapled hemorrhoidopexy and stapled hemorrhoidopexy complemented with excision, there was no difference between the techniques in relation to symptom recurrence (43% and 33%, p=0.45) and median interval between surgery and symptom recurrence (30 (8-84) and 38.8 (8-65) months, p=0.80). Eight (12.3%) patients were re-operated after stapled hemorrhoidopexy and 2 (9.6%), after hemorrhoidopexy with excision (p=0.78). Patient distribution in both groups according to the degree of postoperative satisfaction was similar (p

  10. 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

  11. 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

  12. 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…

  13. 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…

  14. 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…

  15. 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…

  16. 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

  17. Long-term safety and tolerability of saxagliptin add-on therapy in older patients (aged ≥65 years) with type 2 diabetes

    PubMed Central

    Iqbal, Nayyar; Allen, Elsie; Öhman, Peter

    2014-01-01

    Background Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk. The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged ≥65 years and <65 years. Methods Pooled adverse event data from three placebo-controlled trials of 76–206 weeks’ duration in older (≥65 years) and younger (<65 years) patients receiving saxagliptin 5 mg or matching placebo added to metformin, glyburide, or a thiazolidinedione were analyzed. Measurements were calculated from day of first dose to specified event or last dose and included time at risk for adverse events, treatment-related adverse events, serious adverse events, adverse events leading to discontinuation, and events of special interest. Weighted incidence rates (number of events/total time) and incidence rate ratios (saxagliptin/placebo) with 95% confidence intervals were calculated (Mantel-Haenszel test). Results A total of 205 older (mean age 69 years; saxagliptin, n=99; placebo, n=106) and 1,055 younger (mean age 52 years; saxagliptin, n=531; placebo, n=524) patients were assessed. Regardless of age category, the adverse event incidence rates were generally similar between treatments, with confidence intervals for incidence rate ratios bridging 1. Treatment-related adverse events occurred in 36 older patients receiving saxagliptin versus 32 receiving placebo (incidence rate 34.1 versus 27.1 per 100 person-years) and in 150 younger patients in both treatment groups (incidence rate 24.0 versus 27.8 per 100 person-years). With saxagliptin versus placebo, serious adverse events occurred in eight versus 14 older (incidence rate 5.7 versus 9.9 per 100 person-years) and 49 versus 44 younger patients (incidence rate 6.5 versus 6.6 per 100 person-years). There were two deaths (one patient ≥65 years) with saxagliptin and six (none aged ≥65 years

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

    PubMed

    Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

    2014-03-01

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

  19. 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

  20. A National Population Study of the Co-Occurrence of Multiple Long-Term Conditions in People With Multimorbidity, Denmark, 2013.

    PubMed

    Friis, Karina; Pedersen, Marie Hauge; Larsen, Finn Breinholt; Lasgaard, Mathias

    2016-01-01

    The objective of this study was to describe the prevalence of pairwise combinations of 17 long-term conditions. Data were obtained from a national, representative population-based study including 162,283 Danish citizens aged 16 years or older. We calculated the prevalence of each long-term condition given the presence of another long-term condition. Compared with the general population, people with angina pectoris had more than twice the odds of having 12 of the 16 other long-term conditions, and inversely, people with cancer, tinnitus, or cataracts did not have notably higher odds for any of the other long-term conditions.

  1. A National Population Study of the Co-Occurrence of Multiple Long-Term Conditions in People With Multimorbidity, Denmark, 2013

    PubMed Central

    Pedersen, Marie Hauge; Larsen, Finn Breinholt; Lasgaard, Mathias

    2016-01-01

    The objective of this study was to describe the prevalence of pairwise combinations of 17 long-term conditions. Data were obtained from a national, representative population-based study including 162,283 Danish citizens aged 16 years or older. We calculated the prevalence of each long-term condition given the presence of another long-term condition. Compared with the general population, people with angina pectoris had more than twice the odds of having 12 of the 16 other long-term conditions, and inversely, people with cancer, tinnitus, or cataracts did not have notably higher odds for any of the other long-term conditions. PMID:26820044

  2. 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 ...

  3. 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

  4. Long term performance studies of large oil-free bakelite resistive plate chamber

    NASA Astrophysics Data System (ADS)

    Ganai, R.; Roy, A.; Shiroya, M. K.; Agarwal, K.; Ahammed, Z.; Choudhury, S.; Chattopadhyay, S.

    2016-09-01

    Several high energy physics and neutrino physics experiments worldwide require large-size RPCs to cover wide acceptances. The muon tracking systems in the Iron calorimeter (ICAL) experiment in the India based Neutrino Observatory (INO), India and the near detector in Deep Underground Neutrino Experiment (DUNE) at Fermilab are two such examples. A single gap bakelite RPC of dimension 240 cm × 120 cm, with gas gap of 0.2 cm, has been built and tested at Variable Energy Cyclotron Centre, Kolkata, using indigenous materials procured from the local market. No additional lubricant, like oil has been used on the electrode surfaces for smoothening. The chamber is in operation for > 365 days. We have tested the chamber for its long term operation. The leakage current, bulk resistivity, efficiency, noise rate and time resolution of the chamber have been found to be quite stable during the testing peroid. It has shown an efficiency > 95% with an average time resolution of ~ 0.83 ns at the point of measurement at ~ 8700 V throughout the testing period. Details of the long term performance of the chamber have been discussed.

  5. 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

  6. [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].

    PubMed

    Klug, B; Reinhardt, J; Schröder, C

    2010-01-01

    Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.

  7. Orthostatic Hypotension and the Long-Term Risk of Dementia: A Population-Based Study

    PubMed Central

    Wolters, Frank J.; Mattace-Raso, Francesco U. S.; Hofman, Albert; Ikram, M. Arfan

    2016-01-01

    .00–1.17, p = 0.06). The risk of dementia was particularly increased in those with OH who lacked a compensatory increase in heart rate (within lowest quartile of heart rate response: aHR 1.39, 95% CI 1.04–1.85, p-interaction = 0.05). Limitations of this study include potential residual confounding despite rigorous adjustments, and potentially limited generalisability to populations not of European descent. Conclusions In this population predominantly of European descent, OH was associated with an increase in long-term risk of dementia. PMID:27727284

  8. 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

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

    PubMed Central

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

    2015-01-01

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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. Impacts of human activities on coral reef ecosystems of southern Taiwan: a long-term study.

    PubMed

    Liu, Pi-Jen; Meng, Pei-Jie; Liu, Li-Lian; Wang, Jih-Terng; Leu, Ming-Yih

    2012-06-01

    In July 2001, the National Museum of Marine Biology and Aquarium, co-sponsored by the Kenting National Park Headquarters and Taiwan's National Science Council, launched a Long-Term Ecological Research (LTER) program to monitor anthropogenic impacts on the ecosystems of southern Taiwan, specifically the coral reefs of Kenting National Park (KNP), which are facing an increasing amount of anthropogenic pressure. We found that the seawater of the reef flats along Nanwan Bay, Taiwan's southernmost embayment, was polluted by sewage discharge at certain monitoring stations. Furthermore, the consequently higher nutrient and suspended sediment levels had led to algal blooms and sediment smothering of shallow water corals at some sampling sites. Finally, our results show that, in addition to this influx of anthropogenically-derived sewage, increasing tourist numbers are correlated with decreasing shallow water coral cover, highlighting the urgency of a more proactive management plan for KNP's coral reefs.

  16. A long-term study of anterior cruciate ligament allograft reconstruction.

    PubMed

    Almqvist, K F; Willaert, Pieter; De Brabandere, S; Criel, K; Verdonk, R

    2009-07-01

    We retrospectively reviewed the long-term clinical outcome of unilateral arthroscopic anterior cruciate ligament (ACL) allograft reconstruction. From October 1995 to December 1997, 64 arthroscopic ACL reconstructions were performed. Multiligamentous knee injuries and ACL injuries in polytrauma patients were excluded and out of the remaining 60 patients 55 were available for follow-up. Three patients had suffered a rerupture caused by major trauma. One patient had a rerupture without significant trauma and one failure was caused by deep infection. These five patients were revised. Fifty patients (36 males, 14 females) were included in the final follow-up. At the time of evaluation, the mean duration of follow-up was 10 years and 6 months. All patients were examined by an independent examiner. Seven patients had an extension lag (<5 degrees) and all patients had a knee flexion of at least 120 degrees, with a mean flexion of 135 +/- 5 degrees compared to 135 +/- 8 degrees. At the time of follow-up, the median IKDC score was 97 (74-100). The Lysholm scoring scale had a median value of 95 (76-100). The median sports level on the Tegner scale was 6 (4-9). The one-leg-hop test showed a mean value of 95 +/- 5%. One patient did not perform the one-leg-hop test because of recent surgery to the Achilles tendon. In conclusion, the tibialis anterior or tibialis posterior tendon allograft ACL reconstruction produced good clinical results in the majority of patients at long-term follow-up.

  17. Treatment of Wilson's disease with zinc: XV long-term follow-up studies.

    PubMed

    Brewer, G J; Dick, R D; Johnson, V D; Brunberg, J A; Kluin, K J; Fink, J K

    1998-10-01

    Wilson's disease is an inherited disease of copper accumulation caused by a failure of biliary excretion of excess copper. Accumulated copper causes liver disease in these patients, and in perhaps two thirds of patients, it causes brain damage leading to clinical neurologic or psychiatric dysfunction. Maintenance treatment involves reversing the positive copper balance. The earliest approaches have used chelators, such as penicillamine or trientine, which increase the urinary excretion of copper. A more recent approach has used zinc, which blocks the absorption of copper and increases copper excretion in the stool. Because of the high level of endogenously secreted copper in alimentary secretions, the reabsorption of which is partially blocked by zinc therapy, zinc acts to remove accumulated copper from the body as well as prevent its reaccumulation. In the present article we present data on the long-term follow-up (up to 10 years) of maintenance zinc treatment of 141 patients with Wilson's disease. The data presented document that zinc is effective as a sole therapy in the long-term maintenance treatment of Wilson's disease and that it has a low toxicity. The results demonstrate the efficacy of zinc therapy in treating the presymptomatic patient from the beginning of therapy. We also present limited data on the use of zinc in the treatment of pregnant patients and children who have Wilson's disease; these data also indicate efficacy and low toxicity. The median follow-up period for the group as a whole is 4.8 years; for the presymptomatic patients it is 6.5 years; for the children it is 3.6 years.

  18. A long-term study of anterior cruciate ligament allograft reconstruction.

    PubMed

    Almqvist, K F; Willaert, Pieter; De Brabandere, S; Criel, K; Verdonk, R

    2009-07-01

    We retrospectively reviewed the long-term clinical outcome of unilateral arthroscopic anterior cruciate ligament (ACL) allograft reconstruction. From October 1995 to December 1997, 64 arthroscopic ACL reconstructions were performed. Multiligamentous knee injuries and ACL injuries in polytrauma patients were excluded and out of the remaining 60 patients 55 were available for follow-up. Three patients had suffered a rerupture caused by major trauma. One patient had a rerupture without significant trauma and one failure was caused by deep infection. These five patients were revised. Fifty patients (36 males, 14 females) were included in the final follow-up. At the time of evaluation, the mean duration of follow-up was 10 years and 6 months. All patients were examined by an independent examiner. Seven patients had an extension lag (<5 degrees) and all patients had a knee flexion of at least 120 degrees, with a mean flexion of 135 +/- 5 degrees compared to 135 +/- 8 degrees. At the time of follow-up, the median IKDC score was 97 (74-100). The Lysholm scoring scale had a median value of 95 (76-100). The median sports level on the Tegner scale was 6 (4-9). The one-leg-hop test showed a mean value of 95 +/- 5%. One patient did not perform the one-leg-hop test because of recent surgery to the Achilles tendon. In conclusion, the tibialis anterior or tibialis posterior tendon allograft ACL reconstruction produced good clinical results in the majority of patients at long-term follow-up. PMID:19421736

  19. 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

  20. 75 FR 77880 - Proposed Collection; Comment Request; GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ...: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers SUMMARY: Under the... Study for Oil Spill Clean-Up Workers and Volunteers. Type of Information Collection Request: New. Need...- and long-term health effects associated with oil spill clean-up activities and exposures...

  1. 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

  2. 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

  3. 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

  4. Comparative stereological studies on the effects of long term CRF and ACTH treatment on the cortex of the suprarenal gland.

    PubMed

    Miśkowiak, B; Kasprzak, A; Malendowicz, L K

    1986-06-01

    The aim of the study was to investigate by means of stereological and biochemical methods the effects of long-term CRF administration on the cortex of the suprarenal gland of adult male rats and to compare these effects with those of ACTH. Both CRF (administered into the lateral ventricle of the brain) and ACTH resulted after 8 days in an increase in weight of the suprarenal gland. Both treatments increased the volume of individual adrenocortical zones and the average volume of adrenocortical cells as well as enhancing the total number of parenchymal cells in the paired glands. There was also no significant difference in those functional parameters studied of the adrenocortical cells of CRF- and ACTH-treated rats. Thus, long term treatment of adult male rats with CRF evoked adrenocortical changes similar to those observed after ACTH administration.

  5. A national study of the impact of outpatient mental health services for children in long-term foster care.

    PubMed

    Bellamy, Jennifer L; Gopalan, Geetha; Traube, Dorian E

    2010-10-01

    Despite the tremendous mental health need evidenced by children in foster care and high rates of use of mental health services among children in foster care, little is known about the impact of outpatient mental health services on the behavioral health of this population. This study utilizes data from the National Survey of Child and Adolescent Well-being (NSCAW), the first nationally representative study of child welfare in the United States. A subsample of 439 children who have experienced long-term foster care were included in this study. These data were used to estimate the impact of outpatient mental health services on the externalizing and internalizing behavior problems of children in long-term foster care. A propensity score matching model was employed to produce a robust estimate of the treatment effect. Results indicate that children who have experienced long-term foster care do not benefit from the receipt of outpatient mental health services. Study results are discussed in the context of earlier research on the quality of mental health services for children in foster care.

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

    NASA Astrophysics Data System (ADS)

    Mortazavi, S. M. Javad; Cameron, J. R.; Niroomand-rad, A.

    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.

  7. 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.

  8. 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

  9. 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 ®.

  10. Stopping long-term dialysis. An empirical study of withdrawal of life-supporting treatment.

    PubMed

    Neu, S; Kjellstrand, C M

    1986-01-01

    Dialysis was discontinued in 155 (9 percent) of 1766 patients being treated for end-stage renal disease, accounting for 22 percent of all deaths. Treatment was withdrawn more frequently in older than in younger non-diabetic patients, and more often in young diabetic patients than in young nondiabetic patients. Withdrawal was twice as common in nondiabetic patients with other degenerative disorders (P less than 0.005); in patients receiving intermittent peritoneal dialysis (P less than 0.025); and in patients living in nursing homes (P less than 0.025). Half the patients were competent when the decision to withdraw was made, and 39 percent of this group had no new preceding medical complications. Among incompetent patients, the physician initiated the decision for withdrawal in 73 percent, and the patient's family in 27 percent; all patients had recent medical complications. In the early 1970s the physician initiated the decision in 66 percent of all patients; in the early 1980s this figure had decreased to 30 percent (P less than 0.0005). We conclude that stopping treatment is a common mode of death in patients receiving long-term dialysis, particularly in those who are old and those who have complicating degenerative diseases. Because of the increasing age of patients on dialysis, withdrawal of treatment will probably become more common in the future.

  11. 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

  12. The headgear effect of the Herbst appliance: a cephalometric long-term study.

    PubMed

    Pancherz, H; Anehus-Pancherz, M

    1993-06-01

    The short- and long-term effects of the Herbst appliance on the maxillary complex were evaluated in 45 patients who had Class II malocclusions. The patients were followed for 6.4 years (5 to 10 years) after treatment. Lateral cephalograms from before and after 7 months of treatment, 6 months, and 6.4 years after treatment were analyzed. During Herbst treatment the upper molars were distalized in 96% of the subjects (maximum 4.5 mm), and the upper molars were intruded in 69% of the subjects (maximum 3.5 mm). The maxillary occlusal plane was opened in 82% of the subjects (maximum 7.5 degrees). Sagittal maxillary jaw base position seemed unaffected by therapy. A downward tipping of the palatal plane was noted in 47% of the subjects (maximum 2 degrees). During the first 6 months after therapy most of the treatment changes reverted. During the following 5.9 years after treatment, normal growth developmental changes prevailed: the upper molars moved mesially, and the teeth extruded, the occlusal plane closed, the maxilla grew anteriorly, and the palatal plane tipped downward. In conclusion the Herbst appliance exhibited a pronounced high-pull headgear effect on the maxillary complex. Without proper retention, however, the effect seemed to be of a temporary nature.

  13. Effects of antipsychotic D2 antagonists on long-term potentiation in animals and implications for human studies.

    PubMed

    Price, Rae; Salavati, Bahar; Graff-Guerrero, Ariel; Blumberger, Daniel M; Mulsant, Benoit H; Daskalakis, Zafiris J; Rajji, Tarek K

    2014-10-01

    In people with schizophrenia, cognitive abilities - including memory - are strongly associated with functional outcome. Long-term potentiation (LTP) is a form of neuroplasticity that is believed to be the physiological basis for memory. It has been postulated that antipsychotic medication can impair long-term potentiation and cognition by altering dopaminergic transmission. Thus, a systematic review was performed in order to assess the relationship between antipsychotics and D2 antagonists on long-term potentiation. The majority of studies on LTP and antipsychotics have found that acute administration of antipsychotics was associated with impairments in LTP in wild-type animals. In contrast, chronic administration and acute antipsychotics in animal models of schizophrenia were not. Typical and atypical antipsychotics and other D2 antagonists behaved similarly, with the exception of clozapine and olanzapine. Clozapine caused potentiation independent of tetanization, while olanzapine facilitated tetanus-induced potentiation. These studies are limited in their ability to model the effects of antipsychotics in patients with schizophrenia as they were largely performed in wild-type animals as opposed to humans with schizophrenia, and assessed after acute rather than chronic treatment. Further studies using patients with schizophrenia receiving chronic antipsychotic treatment are needed to better understand the effects of these medications in this population.

  14. 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.

  15. Assessing the Uncertainty of Raman Lidar Independent Water Vapor Calibration Means for Long Term Water Vapor Trend Studies

    NASA Astrophysics Data System (ADS)

    Walker, M. N.; Whiteman, D. N.; Venable, D. D.

    2015-12-01

    The Network for the Detection of Atmospheric Composition Change (NDACC) and GCOS Reference Upper Air Network (GRUAN) both have lidar groups that desire to detect long term water vapor trends using Raman lidars. However, traditional calibration efforts make the lidar water vapor data dependent on water vapor measurements from other instruments. Also the traditional calibration efforts are known to be the largest source of systematic uncertainty to Raman Lidar water vapor data. Recently the lamp mapping technique (LMT) has been introduced as a source of independent calibration for Raman lidar water vapor data. However the systematic uncertainty from the LMT, as it applies to Raman Lidar water vapor data, needs to be investigated. Therefore the purpose of this research is to investigate the uncertainty and stability of the LMT as an independent calibration source and assess its capability to be used to support Raman Lidar long-term water vapor trend studies.

  16. 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.

  17. 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

  18. The Value of Median Nerve Sonography as a Predictor for Short- and Long-Term Clinical Outcomes in Patients with Carpal Tunnel Syndrome: A Prospective Long-Term Follow-Up Study

    PubMed Central

    Marschall, Alexander; Ficjian, Anja; Husic, Rusmir; Zauner, Dorothea; Seel, Werner; Simmet, Nicole E.; Klammer, Alexander; Heizer, Petra; Brickmann, Kerstin; Gretler, Judith; Fürst-Moazedi, Florentine C.; Thonhofer, Rene; Hermann, Josef; Graninger, Winfried B.; Quasthoff, Stefan; Dejaco, Christian

    2016-01-01

    Objectives To investigate the prognostic value of B-mode and Power Doppler (PD) ultrasound of the median nerve for the short- and long-term clinical outcomes of patients with carpal tunnel syndrome (CTS). Methods Prospective study of 135 patients with suspected CTS seen 3 times: at baseline, then at short-term (3 months) and long-term (15–36 months) follow-up. At baseline, the cross-sectional area (CSA) of the median nerve was measured with ultrasound at 4 levels on the forearm and wrist. PD signals were graded semi-quantitatively (0–3). Clinical outcomes were evaluated at each visit with the Boston Questionnaire (BQ) and the DASH Questionnaire, as well as visual analogue scales for the patient’s assessment of pain (painVAS) and physician’s global assessment (physVAS). The predictive values of baseline CSA and PD for clinical outcomes were determined with multivariate logistic regression models. Results Short-term and long-term follow-up data were available for 111 (82.2%) and 105 (77.8%) patients, respectively. There was a final diagnosis of CTS in 84 patients (125 wrists). Regression analysis revealed that the CSA, measured at the carpal tunnel inlet, predicted short-term clinical improvement according to BQ in CTS patients undergoing carpal tunnel surgery (OR 1.8, p = 0.05), but not in patients treated conservatively. Neither CSA nor PD assessments predicted short-term improvement of painVAS, physVAS or DASH, nor was any of the ultrasound parameters useful for the prediction of long-term clinical outcomes. Conclusions Ultrasound assessment of the median nerve at the carpal tunnel inlet may predict short-term clinical improvement in CTS patients undergoing carpal tunnel release, but long-term outcomes are unrelated to ultrasound findings. PMID:27662617

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. Perioperative and Long-term Outcomes of Carotid Endarterectomy for Japanese Asymptomatic Cervical Carotid Artery Stenosis: A Single Institution Study.

    PubMed

    Ishiguro, Taichi; Yoneyama, Taku; Ishikawa, Tatsuya; Yamaguchi, Koji; Kawashima, Akitsugu; Kawamata, Takakazu; Okada, Yoshikazu

    2015-01-01

    As the recently developed medical treatments for asymptomatic cervical carotid artery stenosis (ACCAS) have shown excellent stroke prevention, carotid endarterectomy (CEA) should be carried out for more selected patients and with lower complication rates and better long-term outcomes. We have performed CEA for Japanese ACCAS patients with a uniform surgical technique and strict perioperative management. In this study, we retrospectively investigated the perioperative complications and long-term outcomes of our CEA series. A total of 147 CEAs were carried out in 139 Japanese ACCAS patients. All patients were routinely checked for their cardiac function and high risk coronary lesions were preferentially treated before CEA. All CEAs were performed under general anesthesia using a shunt system. The postoperative cerebral blood flow was routinely measured under continued sedation to prevent postoperative hyperperfusion. The 30-day perioperative morbidity rate was 2.04%, including a perioperative stroke rate of 0.68%. There were no perioperative deaths. With regard to the long-term outcomes of the 134 followed-up patients, 9 patients were dead and 5 patients suffered from strokes, including 2 patients with ipsilateral hemispheric ischemia. The annual rates of death, all stroke and ipsilateral ischemic stroke were 1.15%, 0.64%, and 0.25%, respectively. These results showed that the perioperative morbidity and mortality rates of our CEAs were lower than those in the previous large trials. Furthermore, the long-term outcomes of this series were favorable to those reported in the latest medical treatment trials for ACCAS patients. CEA may be useful for preventing ischemic stroke in Japanese ACCAS patients. PMID:26458845

  7. Perioperative and Long-term Outcomes of Carotid Endarterectomy for Japanese Asymptomatic Cervical Carotid Artery Stenosis: A Single Institution Study

    PubMed Central

    ISHIGURO, Taichi; YONEYAMA, Taku; ISHIKAWA, Tatsuya; YAMAGUCHI, Koji; KAWASHIMA, Akitsugu; KAWAMATA, Takakazu; OKADA, Yoshikazu

    2015-01-01

    As the recently developed medical treatments for asymptomatic cervical carotid artery stenosis (ACCAS) have shown excellent stroke prevention, carotid endarterectomy (CEA) should be carried out for more selected patients and with lower complication rates and better long-term outcomes. We have performed CEA for Japanese ACCAS patients with a uniform surgical technique and strict perioperative management. In this study, we retrospectively investigated the perioperative complications and long-term outcomes of our CEA series. A total of 147 CEAs were carried out in 139 Japanese ACCAS patients. All patients were routinely checked for their cardiac function and high risk coronary lesions were preferentially treated before CEA. All CEAs were performed under general anesthesia using a shunt system. The postoperative cerebral blood flow was routinely measured under continued sedation to prevent postoperative hyperperfusion. The 30-day perioperative morbidity rate was 2.04%, including a perioperative stroke rate of 0.68%. There were no perioperative deaths. With regard to the long-term outcomes of the 134 followed-up patients, 9 patients were dead and 5 patients suffered from strokes, including 2 patients with ipsilateral hemispheric ischemia. The annual rates of death, all stroke and ipsilateral ischemic stroke were 1.15%, 0.64%, and 0.25%, respectively. These results showed that the perioperative morbidity and mortality rates of our CEAs were lower than those in the previous large trials. Furthermore, the long-term outcomes of this series were favorable to those reported in the latest medical treatment trials for ACCAS patients. CEA may be useful for preventing ischemic stroke in Japanese ACCAS patients. PMID:26458845

  8. 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.

  9. Predicting long-term outcomes for children affected by HIV and AIDS: perspectives from the scientific study of children's development.

    PubMed

    Stein, Alan; Desmond, Christopher; Garbarino, James; Van IJzendoorn, Marinus H; Barbarin, Oscar; Black, Maureen M; Stein, Aryeh D; Hillis, Susan D; Kalichman, Seth C; Mercy, James A; Bakermans-Kranenburg, Marian J; Rapa, Elizabeth; Saul, Janet R; Dobrova-Krol, Natasha A; Richter, Linda M

    2014-07-01

    The immediate and short-term consequences of adult HIV for affected children are well documented. Little research has examined the long-term implications of childhood adversity stemming from caregiver HIV infection. Through overviews provided by experts in the field, together with an iterative process of consultation and refinement, we have extracted insights from the broader field of child development of relevance to predicting the long-term consequences to children affected by HIV and AIDS. We focus on what is known about the impact of adversities similar to those experienced by HIV-affected children, and for which there is longitudinal evidence. Cautioning that findings are not directly transferable across children or contexts, we examine findings from the study of parental death, divorce, poor parental mental health, institutionalization, undernutrition, and exposure to violence. Regardless of the type of adversity, the majority of children manifest resilience and do not experience any long-term negative consequences. However, a significant minority do and these children experience not one, but multiple problems, which frequently endure over time in the absence of support and opportunities for recovery. As a result, they are highly likely to suffer numerous and enduring impacts. These insights suggest a new strategic approach to interventions for children affected by HIV and AIDS, one that effectively combines a universal lattice of protection with intensive intervention targeted to selected children and families. PMID:24991899

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

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

    PubMed Central

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

    2016-01-01

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

  19. 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

  20. Longitudinal study of long-term smoking behaviour by biomarker-supported determination of exposure to smoke

    PubMed Central

    2014-01-01

    Background Long-term studies of smokers who switch to lower nicotine yield cigarettes have been identified by the World Health Organization Study Group TobReg and the US Food and Drug Administration as one key area where new knowledge is required to guide science based regulation. The limited number of long-term switching studies have concluded that smokers who switch to lower nicotine yield cigarettes show evidence of partial compensation. Since the European Union tobacco product directive of 2001 introduced tar and nicotine yield ceilings, there has been no long-term observational switching study. To address the limitations of previous studies where smokers were forced switched for relatively short durations, we plan to undertake a long-term study of spontaneous switching which is appropriately powered and includes non-switchers as a control group. Methods/design Healthy adult smokers aged 21–64 years will be enrolled into this 5-year non-residential, multicentre study across 10 cities in Germany. They will be assessed at 10 timepoints with 6 month intervals during which inclusion criteria will be reassessed and spent cigarette filter tips, saliva and 24 h urine samples will be collected. These samples will be used to determine average daily cigarette consumption, estimate mouth-level exposure to tar and nicotine and measure selected biomarkers of exposure, respectively. Spontaneous changes in subjects’ preferred cigarette products and any consequent change in tar or nicotine yield will be monitored. Subjects will be required to complete questionnaires on quality of life, smoking behaviours, smoking-related sensory attributes and recent life changes. Discussion The planned study is anticipated to contribute to understanding smokers’ behaviours and their consequent exposure to smoke constituents. It will also allow assessment of compensatory changes in their behaviour following spontaneous switching of cigarette product smoked. Data from this study are

  1. 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.

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

    PubMed Central

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

    2015-01-01

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

  3. 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…

  4. Dump stability and soil fertility of a coal mine spoil in Indian dry tropical environment: a long-term study.

    PubMed

    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. PMID:22842748

  5. WI-38 cell long-term quiescence model system: a valuable tool to study molecular events that regulate growth.

    PubMed

    Soprano, K J

    1994-04-01

    A number of cell culture model systems have been used to study the regulation of cell cycle progression at the molecular level. In this paper we describe the WI-38 cell long-term quiescence model system. By modulating the length of time that WI-38 cells are density arrested, it is possible to proportionately alter the length of the prereplicative or G-1 phase which the cell traverses after growth factor stimulation in preparation for entry into DNA synthesis. Through studies aimed at understanding the cause and molecular nature of the prolongation of the prereplicative phase, we have determined that gene expression plays an important role in establishing growth factor "competence" and that once the cell becomes "competent" there is a defined order to the molecular events that follow during the remainder of G-1. More specifically, we have determined that the prolongation represents a delay in the ability of long term quiescent cells to become fully "competent" to respond to growth factors which regulate progression through G-1 into S. This prolongation appears to occur as a result of changes during long term quiescence in the ability of immediate early G-1 specific genes (such as c-myc) to activate the expression of early G-1 specific genes (such as ornithine decarboxylase). While ODC is the first and thus far only growth associated gene identified as a target of c-myc (and the Myc/Max protein complex), it is likely that further studies in this model system will reveal other early G-1 growth regulatory genes. We anticipate that future follow-up studies in this model system will provide additional valuable information about the function of growth-regulatory genes in controlling growth factor responsiveness and cell cycle progression.

  6. 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

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

    PubMed Central

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

    2015-01-01

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

  8. A Randomized Trial of Long-term Multivitamin Supplementation and Cognitive Function in Men: The Physicians’ Health Study II

    PubMed Central

    Grodstein, Francine; O’Brien, Jacqueline; Kang, Jae Hee; Dushkes, Rimma; Cook, Nancy R.; Okereke, Olivia; Manson, JoAnn E.; Glynn, Robert J.; Buring, Julie E.; Gaziano, J. Michael; Sesso, Howard D.

    2013-01-01

    Background Despite widespread use of multivitamin supplements, their effect on cognitive health – a critical issue with aging – remains inconclusive. To date, there have been no long-term clinical trials to study multivitamin use and cognitive decline in older persons. Objective To evaluate whether long-term multivitamin supplementation affects cognitive health in later-life. Design Randomized, double-blind, placebo-controlled trial of a multivitamin from 1997 to June 1, 2011. The cognitive function sub-study began in 1998; we completed up to four repeated cognitive assessments by telephone interview over 12 years. Setting The Physicians’ Health Study II. Patients 5,947 male physicians aged ≥ 65 years. Intervention Daily multivitamin, or placebo. Measurements A global composite score averaging 5 tests of global cognition, verbal memory, and category fluency. The secondary endpoint was a verbal memory score combining 4 tests of verbal memory, a strong predictor of Alzheimer disease. Results There was no difference in the mean cognitive change over time between the multivitamin and placebo groups, or in the mean level of cognition at any of the four assessments. Specifically, for the global composite score, the mean difference in cognitive change over follow-up was −0.01 (95% confidence interval [CI] −0.04, 0.02) standard units, comparing treatment versus placebo. Similarly, there was no difference in cognitive performance between the treated and placebo groups on the secondary outcome, verbal memory (e.g., mean difference in cognitive change over follow-up=−0.005, 95% CI −0.04, 0.03). Limitations Doses of vitamins may be too low, or population may be too well-nourished to benefit from multivitamin. Conclusions In male physicians aged ≥ 65 years, long-term use of a daily multivitamin did not provide cognitive benefits. Trial Registration http://www.clinicaltrials.gov identifier: NCT00270647 PMID:24490265

  9. 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

  10. 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

  11. 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

  12. Forecasting life: a study of activity cycles in low-mass stars: lessons from long-term stellar light curves.

    PubMed

    Kafka, Stella

    2012-06-01

    Magnetic activity cycles are indirect traces of magnetic fields and can provide an insight on the nature and action of stellar dynamos and stellar magnetic activity. This, in turn, can determine local space weather and activity effects on stellar habitable zones. Using photometric monitoring of low-mass stars, we study the presence and properties of their magnetic activity cycles. We introduce long-term light curves of our sample stars, and discuss the properties of the observed trends, especially at spectral types where stars are fully convective (later than M3).

  13. Long-term persistence with injectable therapy in relapsing-remitting multiple sclerosis: an 18-year observational cohort study.

    PubMed

    Zhornitsky, Simon; Greenfield, Jamie; Koch, Marcus W; Patten, Scott B; Harris, Colleen; Wall, Winona; Alikhani, Katayoun; Burton, Jodie; Busche, Kevin; Costello, Fiona; Davenport, Jeptha W; Jarvis, Scott E; Lavarato, Dina; Parpal, Helene; Patry, David G; Yeung, Michael; Metz, Luanne M

    2015-01-01

    Disease modifying therapies (DMTs) reduce the frequency of relapses and accumulation of disability in multiple sclerosis (MS). Long-term persistence with treatment is important to optimize treatment benefit. This long-term, cohort study was conducted at the Calgary MS Clinic. All consenting adults with relapsing-remitting MS who started either glatiramer acetate (GA) or interferon-β 1a/1b (IFN-β) between January 1st, 1996 and July 1st, 2011 were included. Follow-up continued to February 1st, 2014. Time-to-discontinuation of the initial and subsequently-prescribed DMTs (switches) was analysed using Kaplan-Meier survival analyses. Group differences were compared using log-rank tests and multivariable Cox regression models. Analysis included 1471 participants; 906 were initially prescribed GA and 565 were initially prescribed IFN-β. Follow-up information was available for 87%; 29 (2%) were lost to follow-up and 160 (11%) moved from Southern Alberta while still using DMT. Median time-to-discontinuation of all injectable DMTs was 11.1 years. Participants with greater disability at treatment initiation, those who started treatment before age 30, and those who started between 2006 and 2011 were more likely to discontinue use of all injectable DMTs. Median time-to-discontinuation of the initial DMT was 8.6 years. Those initially prescribed GA remained on treatment longer. Of 610 participants who discontinued injectable DMT, 331 (54%) started an oral DMT, or a second-line DMT, or resumed injectable DMT after 90 days. Persistence with injectable DMTs was high in this long-term population-based study. Most participants who discontinued injectable DMT did not remain untreated. Further research is required to understand treatment outcomes and outcomes after stopping DMT.

  14. Risk of Endophthalmitis and Other Long-Term Complications of Trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS)

    PubMed Central

    Zahid, Sarwar; Musch, David C.; Niziol, Leslie M.; Lichter, Paul R.

    2012-01-01

    Purpose To report the risk of endophthalmitis and other long-term complications in patients randomized to trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Design A longitudinal cohort study using data collected from a multicenter, randomized clinical trial. Methods Long-term post-operative complications in the 300 patients randomized to trabeculectomy in CIGTS were tabulated. Kaplan-Meier analyses were used to estimate the time-related probability of blebitis, hypotony, and endophthalmitis. Results 285 patients were included in the final trabeculectomy cohort after accounting for assignment refusal and other early events. Patients were followed for an average of 7.2 years. 163 patients (57%) received 5-fluorouracil (5-FU) intraoperatively. Of the 247 patients with at least 5 years of follow-up, 50 required further treatment for glaucoma. Cataract extraction was performed in 57 patients (20%). Forty patients (14%) required bleb revision at least once. Bleb-related complications included bleb leak (N = 15), blebitis (N = 8), and hypotony (N = 4). Three patients were noted to have endophthalmitis, although the diagnosis in two patients was presumptive. The occurrences of blebitis, hypotony, or endophthalmitis were not significantly associated with 5-FU use. The Kaplan-Meier calculated risks of blebitis and hypotony at 5 years were both 1.5%, while the risk of endophthalmitis was 1.1%. Conclusions The potential efficacy of trabeculectomy must be weighed against the long-term risk of complications, especially endophthalmitis, when selecting treatments for patients with open-angle glaucoma. We report a low 5-year risk of endophthalmitis (1.1%) and other bleb-related complications in the trabeculectomy cohort of the CIGTS. PMID:23246272

  15. 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

  16. 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

  17. 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

  18. Bogalusa Heart Study: a long-term community study of a rural biracial (Black/White) population.

    PubMed

    Berenson, G S

    2001-11-01

    The Bogalusa Heart Study, a long-term population study with a continued relationship with a community, addresses the problem of capacity building in minority health research. The study was originally funded as a Specialized Center of Research-Arteriosclerosis (SCOR-A) by the National Heart Lung and Blood Institute (NHLBI). These centers were to conduct research on atherosclerosis, coronary artery disease (CAD), hypertension, diabetes mellitus, and complications of cardiovascular-renal disease as the major causes of deaths in the United States. From earlier research on atherosclerosis, we became interested in the underlying characteristics in early life that would eventually lead to clinical morbidity and mortality from heart disease. An observation at autopsy showed the degree of atherosclerotic involvement in human aortas, from young to older individuals (Figure 1). For example, at age 40 years, marked individual variability occurred in the severity and involvement with atherosclerotic disease. Some individuals showed very little disease, while almost 70% of the surface was diseased in others. Further studies on arterial wall matrix showed aortas from young individuals varied with the extent of disease and its chemical composition. This background stimulated an interest in studying children for early clinical evidence of major adult heart diseases. The Bogalusa Heart Study was begun in 1972 as an epidemiology study of cardiovascular risk factors in children and adolescents; it eventually evolved into observations of young adults. Bogalusa, LA, is a biracial (black/white) rural community 70 miles north of New Orleans, comparable to many other communities in southeastern United States.

  19. Bogalusa Heart Study: a long-term community study of a rural biracial (black/white) population.

    PubMed

    Berenson, G S

    2001-11-01

    The Bogalusa Heart Study, a long-term population study with a continued relationship with a community, addresses the problem of capacity building in minority health research. The study was originally funded as a Specialized Center of Research-Arteriosclerosis (SCOR-A) by the National Heart Lung and Blood Institute (NHLBI). These centers were to conduct research on atherosclerosis, coronary artery disease (CAD), hypertension, diabetes mellitus, and complications of cardiovascular-renal disease as the major causes of deaths in the United States. From earlier research on atherosclerosis, we became interested in the underlying characteristics in early life that would eventually lead to clinical morbidity and mortality from heart disease. An observation at autopsy showed the degree of atherosclerotic involvement in human aortas, from young to older individuals (Figure 1). For example, at age 40 years, marked individual variability occurred in the severity and involvement with atherosclerotic disease. Some individuals showed very little disease, while almost 70% of the surface was diseased in others. Further studies on arterial wall matrix showed aortas from young individuals varied with the extent of disease and its chemical composition. This background stimulated an interest in studying children for early clinical evidence of major adult heart diseases. The Bogalusa Heart Study was begun in 1972 as an epidemiology study of cardiovascular risk factors in children and adolescents; it eventually evolved into observations of young adults. Bogalusa, LA, is a biracial (black/white) rural community 70 miles north of New Orleans, comparable to many other communities in southeastern United States.

  20. 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

  1. 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.

  2. Long-term effects of fire frequency on carbon storage and productivity of boreal forests: a modeling study.

    PubMed

    Thornley, J H M; Cannell, M G R

    2004-07-01

    Climate change is predicted to shorten the fire interval in boreal forests. Many studies have recorded positive effects of fire on forest growth over a few decades, but few have modeled the long-term effects of the loss of carbon and nitrogen to the atmosphere. We used a process-based, dynamic, forest ecosystem model, which couples the carbon, nitrogen and water cycles, to simulate the effects of fire frequency on coniferous forests in the climate of Prince Albert, Saskatchewan. The model was calibrated to simulate observed forest properties. The model predicted rapid short-term recovery of net primary productivity (NPP) after fire, but in the long term, supported the hypotheses that (1) current NPP and carbon content of boreal forests are lower than they would be without periodic fire, and (2) any increase in fire frequency in the future will tend to lower NPP and carbon storage. Lower long-term NPP and carbon storage were attributable to (1) loss of carbon on combustion, equal to about 20% of NPP over a 100-200 year fire cycle, (2) loss of nitrogen by volatilization in fire, equal to about 3-4 kg N ha(-1) year(-1) over a 100-200 year fire cycle, and (3) the fact that the normal fire cycle is much shorter than the time taken for the forest (especially the soil) to reach an equilibrium carbon and nitrogen content. It was estimated that a shift in fire frequency from 200 to 100 years over 1000 Mha of boreal forest would release an average of about 0.1 Gt C year(-1) over many centuries.

  3. 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

  4. Reduced Long-Term Relative Survival in Females and Younger Adults Undergoing Cardiac Surgery: A Prospective Cohort Study

    PubMed Central

    Enger, Tone Bull; Pleym, Hilde; Stenseth, Roar; Greiff, Guri; Wahba, Alexander; Videm, Vibeke

    2016-01-01

    Objectives To assess long-term survival and mortality in adult cardiac surgery patients. Methods 8,564 consecutive patients undergoing cardiac surgery in Trondheim, Norway from 2000 until censoring 31.12.2014 were prospectively followed. Observed long-term mortality following surgery was compared to the expected mortality in the Norwegian population, matched on gender, age and calendar year. This enabled assessment of relative survival (observed/expected survival rates) and relative mortality (observed/expected deaths). Long-term mortality was compared across gender, age and surgical procedure. Predictors of reduced survival were assessed with multivariate analyses of observed and relative mortality. Results During follow-up (median 6.4 years), 2,044 patients (23.9%) died. The observed 30-day, 1-, 3- and 5-year mortality rates were 2.2%, 4.4%, 8.2% and 13.8%, respectively, and remained constant throughout the study period. Comparing observed mortality to that expected in a matched sample from the general population, patients undergoing cardiac surgery showed excellent survival throughout the first seven years of follow-up (relative survival ≥ 1). Subsequently, survival decreased, which was more pronounced in females and patients undergoing other procedures than isolated coronary artery bypass grafting (CABG). Relative mortality was higher in younger age groups, females and patients undergoing aortic valve replacement (AVR). The female survival advantage in the general population was obliterated (relative mortality ratio (RMR) 1.35 (1.19–1.54), p<0.001). Increasing observed long-term mortality seen with ageing was due to population risk, and younger age was independently associated with increased relative mortality (RMR per 5 years 0.81 (0.79–0.84), p<0.001)). Conclusions Cardiac surgery patients showed comparable survival to that expected in the general Norwegian population, underlining the benefits of cardiac surgery in appropriately selected patients. The

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

    PubMed

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

    2011-01-01

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

  6. 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

  7. 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

  8. 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

  9. Hepatic and hematological adverse effects of long-term low-dose methotrexate therapy in rheumatoid arthritis: An observational study

    PubMed Central

    Dubey, Lily; Chatterjee, Suparna; Ghosh, Alakendu

    2016-01-01

    Objectives: Methotrexate (MTX) is the most commonly used cost-effective disease-modifying antirheumatoid drug (DMARD). Its main dose-limiting adverse effects are hepatic and hematopoietic. This cross-sectional, observational study evaluated the prevalence of hepatic and hematological adverse effects with long-term low-dose MTX therapy. Materials and Methods: Rheumatoid arthritis (RA) patients taking ≤15 mg/week MTX for at least 2 years were enrolled from the rheumatology outpatient department. Demographic, disease, drug treatment profiles, and hematological and hepatic enzyme levels were noted. Results: Of the 204 patients enrolled, the frequency of raised alanine transaminase level (≥3-fold rise above the upper limit of normal) was 6.37% (95% confidence interval of 3.76–10.59) including two biopsy-proven hepatic fibrosis cases. About 5.4% had severe anemia (<8 g/dl) and 4.4% had leukopenia. Conclusion: Long-term low-dose MTX is safe in RA patients in the Indian population. The patterns of adverse effects were similar to those documented in earlier studies. However, our study results suggest that disease duration, cumulative MTX dose, concomitant DMARD intake are not risk factors associated with hepatic or hematological adverse effects.

  10. PCR amplification from paraffin-embedded tissues: recommendations on fixatives for long-term storage and prospective studies.

    PubMed

    Greer, C E; Lund, J K; Manos, M M

    1991-08-01

    The development of polymerase chain reaction (PCR) DNA amplification methods has afforded molecular studies of fixed paraffin-embedded tissue samples and other archival material. Some fixation methods damage DNA, and thus deleteriously affect subsequent PCR analysis. This study addressed the effect of short- and long-term storage (2 hr to 30 days) in a variety of fixatives (10% buffered-neutral formalin [BNF], 95% ethanol, acetone, and OmniFix) before paraffin embedding. We tested the ability of prepared tissue sections to yield DNA amplification products ranging from 268 to 1327 bp. Results indicated that tissues fixed for 8 days in BNF were able to amplify 536-bp but very little 989-bp DNA fragments; after 30 days of BNF fixation only a 268-bp fragment was amplifiable. Samples fixed in OmniFix and acetone yielded products of 989 and 1327 bp, respectively, after 8 days of fixation; both fixatives yielded 989-bp amplification products after 30 days of fixation. Tissues fixed in 95% ethanol for up to 30 days efficiently produced DNA amplification fragments of up to 1327 bp in length. The results provide important information for prospective studies that involve PCR analysis from archival material. Furthermore, fixation and long-term storage in ethanol should prove particularly useful in remote areas where refrigeration or immediate sample-processing is unavailable.

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. Long-Term Safety of Subcutaneous Abatacept in Rheumatoid Arthritis: Integrated Analysis of Clinical Trial Data Representing More Than Four Years of Treatment

    PubMed Central

    Alten, Rieke; Kaine, Jeffrey; Keystone, Edward; Nash, Peter; Delaet, Ingrid; Genovese, Mark C

    2014-01-01

    Objective To investigate the safety of long-term subcutaneous (SC) abatacept treatment using integrated clinical trial data obtained in patients with rheumatoid arthritis refractory to traditional disease-modifying antirheumatic drugs. Methods Data from the double-blind and open-label phases of 5 clinical trials of SC abatacept were pooled. The overall and 6-month incidence rates were calculated as events per 100 patient-years of exposure. Results This analysis included 1,879 patients with 4,214.6 patient-years of exposure to SC abatacept. The mean ± SD length of exposure was 27.3 ± 9.1 months. The reported incidence rate of serious infections was 1.79 (95% confidence interval [95% CI] 1.42–2.24); the most frequent infections were pneumonia (incidence rate 0.36 [95% CI 0.22–0.59]), urinary tract infection (incidence rate 0.14 [95% CI 0.06–0.32]), and gastroenteritis (incidence rate 0.10 [95% CI 0.04–0.25]). Tuberculosis occurred rarely (incidence rate 0.09 [95% CI 0.04–0.25]). The reported incidence rate of malignancies was 1.32 (95% CI 1.01–1.72), and the most common was solid organ malignancy (incidence rate 0.69 [95% CI 0.48–0.99]). The incidence rate of autoimmune events was 1.37 (95% CI 1.06–1.78), and the most frequent events were psoriasis (incidence rate 0.33 [95% CI 0.20–0.56]) and Sjögren's syndrome (incidence rate 0.24 [95% CI 0.13–0.44]). The reported incidence rate of local injection site reactions was 1.72 (95% CI 1.36–2.17); these events occurred primarily during the first 6 months of treatment, and almost all were of mild or moderate intensity. The incidence rates of serious infections, malignancies, autoimmune events, and injection site reactions did not increase over time. Conclusion Long-term treatment with SC abatacept was associated with low incidence rates of serious infections, malignancies, and autoimmune events and was well tolerated, with infrequent injection site reactions. These findings are consistent with those

  16. 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.

  17. 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

  18. Long-term in vivo left ventricular assist device study for 284 days with Gyro PI pump.

    PubMed

    Ohtsuka, G; Nakata, K; Yoshikawa, M; Takano, T; Glueck, J; Sankai, Y; Takami, Y; Mueller, J; Sueoka, A; Letsou, G; Schima, H; Schmallegger, H; Wolner, E; Koyanagi, H; Fujisawa, A; Baldwin, J C; Nosé, Y

    1999-06-01

    A totally implantable centrifugal artificial heart has been developed. The plastic prototype, the Gyro PI 601, passed 2 day hemodynamic tests as a functional total artificial heart (TAH), 2 week screening tests for anti-thrombogenecity, and a 1 month system feasibility study. Based upon these results, a metallic prototype, the Gyro PI 700 series, was subjected to long-term in vivo left ventricular assist device (LVAD) studies of over 1 month. The Gyro PI 700 series has the same inner dimension and same characteristics of the Gyro PI 601 such as an eccentric inlet port, a double pivot bearing system, and a magnet coupling system. The PI metallic pump is also driven with the Vienna DC brushless motor actuator like the PI 601. The pump-actuator package was implanted in 3 calves in the preperitoneal space, bypassing from the left ventricular (LV) apex to the descending aorta. Case 1 achieved a 284 day survival. Case 2 was euthanized early at 72 postoperative days as a result of the functional obstruction of the inlet port due to the excessive growth of the calf. There was no blood clot inside the pumps of either case. Case 3 is on-going (22 days on July 24, 1998). During these periods, all cases showed no physiological abnormalities. In conclusion, the PI 700 series pump has excellent results as a long-term implantable LVAD.

  19. The long-term outcomes of alternating chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma: a multiinstitutional phase II study.

    PubMed

    Fuwa, Nobukazu; Kodaira, Takeshi; Daimon, Takashi; Yoshizaki, Tomokazu

    2015-08-01

    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/m(2) per 24 h on days 1-5) and cisplatin (100 mg/m(2) 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.

  20. Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis.

    PubMed

    Reece, Donna E; Hegenbart, Ute; Sanchorawala, Vaishali; Merlini, Giampaolo; Palladini, Giovanni; Bladé, Joan; Fermand, Jean-Paul; Hassoun, Hani; Heffner, Leonard; Kukreti, Vishal; Vescio, Robert A; Pei, Lixia; Enny, Christopher; Esseltine, Dixie-Lee; van de Velde, Helgi; Cakana, Andrew; Comenzo, Raymond L

    2014-10-16

    CAN2007 was a phase 1/2 study of once- and twice-weekly single-agent bortezomib in relapsed primary systemic amyloid light chain amyloidosis (AL) amyloidosis. Seventy patients were treated, including 18 and 34 patients at the maximum planned doses on the once- and twice-weekly schedules. This prespecified final analysis provides mature response and long-term outcomes data after 3-year additional follow-up since the last report. In the once-weekly 1.6 mg/m(2) and twice-weekly 1.3 mg/m(2) bortezomib groups, final hematologic response rates were 68.8% and 66.7%; 80% of patients in each group sustained their response for ≥1 year. One-year progression-free rates were 72.2% and 76.8%. Median overall survival (OS) was 62.1 months and not reached; 4-year OS rates were 75.0% and 63.0%. Low baseline difference in κ/λ free light-chain level was associated with higher hematologic complete response rates and longer OS. At data cutoff, 40 (57%) patients had received subsequent therapy, including 19 (27%) retreated with bortezomib, 11 (58%) of whom achieved complete or partial hematologic responses. Four patients received prolonged bortezomib for between 3.5 and 5.6 years, with no new safety concerns, highlighting the feasibility of long-term therapy. Single-agent bortezomib produced durable hematologic responses and promising long-term OS in relapsed AL amyloidosis. This trial was registered at www.clinicaltrials.gov as #NCT00298766. PMID:25202139

  1. Alternative treatments for withdrawing the long-term benzodiazepine user: a pilot study.

    PubMed

    Nathan, R G; Robinson, D; Cherek, D R; Sebastian, C S; Hack, M; Davison, S

    1986-02-01

    Anxiolytic therapy with benzodiazepines and their potential for dependence are reviewed. Relaxation training and biofeedback have been used for chemically dependent anxious patients. These techniques have been recommended for benzodiazepine-dependent patients, but not investigated. Previous withdrawal studies offer only limited follow-up data. Stress management treatment was based on a successful case study. Recruitment difficulties were encountered. However, seven patients were randomly assigned to stress management or brief psycho-therapy. All showed improvement, but three of four patients available for 1 year follow-up had returned to pretreatment dependence. These withdrawal difficulties suggest the need for more effective treatments and more adequate follow-up studies.

  2. Microstructural investigations of as-fabricated, long-term thermally aged and neutron irradiated RPV materials: An atom probe study

    SciTech Connect

    Pareige, P.J.; Miller, M.K.; Stoller, R.E.

    1995-09-01

    Atom probe field ton microscopy (APFIM) investigations of the microstructure of as-fabricated, long-term thermally aged ({approximately}100,000h. at 540{degrees}F (282{degrees}C)) and neutron-irradiated (6.6{times}10{sup 18} and 3.47{times}10{sup 19} n cm{sup {minus}2} (E>1 MeV) at {approximately}550{degrees}F (288{degrees}C)) surveillance materials from commercial reactor pressure vessel steels were performed This combination of materials and conditions permitted the investigation of potential thermal aging effects as well as the neutron-induced effects. The microstructural study focused on the quantification of the matrix chemistry and the detection and characterization of radiation-induced precipitates. The APFIM results indicate that there was no microstructural evolution after a long term-thermal exposure in weld (0.28 wt% Cu), plate (0.13 wt% Cu) or forging (0.02 wt% Cu) materials. Conversely, matrix depletion of copper and phosphorus solutes and the presence of Cu. P, Ni, Mn and Si rich clusters were observed in the neutron-irradiated weld material. These APFIM comparisons of materials in all three conditions are consistent with the measured change in mechanical properties (transition temperature shift).

  3. Biosynthetic hydrogels--studies on chemical and physical characteristics on long-term cellular response for tissue engineering.

    PubMed

    Thankam, Finosh Gnanaprakasam; Muthu, Jayabalan

    2014-07-01

    Biosynthetic hydrogels can meet the drawbacks caused by natural and synthetic ones for biomedical applications. In the current article we present a novel biosynthetic alginate-poly(propylene fumarate) copolymer based chemically crosslinked hydrogel scaffolds for cardiac tissue engineering applications. Partially crosslinked PA hydrogel and fully cross linked PA-A hydrogel scaffolds were prepared. The influence of chemical and physical (morphology and architecture of hydrogel) characteristics on the long term cellular response was studied. Both these hydrogels were cytocompatible and showed no genotoxicity upon contact with fibroblast cells. Both PA and PA-A were able to resist deleterious effects of reactive oxygen species and sustain the viability of L929 cells. The hydrogel incubated oxidative stress induced cells were capable of maintaining the intra cellular reduced glutathione (GSH) expression to the normal level confirmed their protective effect. Relatively the PA hydrogel was found to be unstable in the cell culture medium. The PA-A hydrogel was able to withstand appreciable cyclic stretching. The cyclic stretching introduced complex macro and microarchitectural features with interconnected pores and more structured bound water which would provide long-term viability of around 250% after the 24th day of culture. All these qualities make PA-A hydrogel form a potent candidate for cardiac tissue engineering.

  4. 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

  5. Impact of Long-Term Proton Pump Inhibitor Therapy on Gut Microbiota in F344 Rats: Pilot Study

    PubMed Central

    Shin, Cheol Min; Kim, Nayoung; Kim, Yong Sung; Nam, Ryoung Hee; Park, Ji Hyun; Lee, Dong Ho; Seok, Yeong-Jae; Kim, Yeon-Ran; Kim, Joo-Hyon; Kim, Jung Min; Kim, Joo Sung; Jung, Hyun Chae

    2016-01-01

    Background/Aims To evaluate changes in gut microbiota composition following long-term proton pump inhibitor (PPI) treatment. Methods Twenty-four-week-old F344 rats were fed diets with (n=6) or without (n=5) lansoprazole for 50 weeks. Profiles of luminal microbiota in the terminal ileum were then analyzed. Pyrosequencing of the 16S rRNA gene was performed using an FLX genome sequencer (454 Life Sciences/Roche). Results Rats treated with lansoprazole showed significantly reduced body weights compared to controls (lansoprazole-treated rats and controls, 322.3±15.3 g vs 403.2±5.2 g, respectively, p<0.001). However, stool frequencies and consistencies did not differ between the two groups. The composition of the gut microbiota in lansoprazole-treated rats was quite different from that of the controls. In the controls, the microbiota profiles obtained from the terminal ileum showed a predominance of Proteobacteria (93.9%) due to the abundance of Escherichia and Pasteurella genera. Conversely, lansoprazole-treated rats showed an elevated population of Firmicutes (66.9%), which was attributed to an increased ratio of Clostridium g4 to Lactobacillus genera. Conclusions This preliminary study suggests that long-term administration of PPI may cause weight loss and changes to the microbiota in the terminal ileum. PMID:27458177

  6. 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.

  7. Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies.

    PubMed

    Studerus, Erich; Kometer, Michael; Hasler, Felix; Vollenweider, Franz X

    2011-11-01

    Psilocybin and related hallucinogenic compounds are increasingly used in human research. However, due to limited information about potential subjective side effects, the controlled medical use of these compounds has remained controversial. We therefore analysed acute, short- and long-term subjective effects of psilocybin in healthy humans by pooling raw data from eight double-blind placebo-controlled experimental studies conducted between 1999 and 2008. The analysis included 110 healthy subjects who had received 1-4 oral doses of psilocybin (45-315 µg/kg body weight). Although psilocybin dose-dependently induced profound changes in mood, perception, thought and self-experience, most subjects described the experience as pleasurable, enriching and non-threatening. Acute adverse drug reactions, characterized by strong dysphoria and/or anxiety/panic, occurred only in the two highest dose conditions in a relatively small proportion of subjects. All acute adverse drug reactions were successfully managed by providing interpersonal support and did not need psychopharmacological intervention. Follow-up questionnaires indicated no subsequent drug abuse, persisting perception disorders, prolonged psychosis or other long-term impairment of functioning in any of our subjects. The results suggest that the administration of moderate doses of psilocybin to healthy, high-functioning and well-prepared subjects in the context of a carefully monitored research environment is associated with an acceptable level of risk.

  8. Potential long-term consequences of fad diets on health, cancer, and longevity: lessons learned from model organism studies.

    PubMed

    Ruden, Douglas M; Rasouli, Parsa; Lu, Xiangyi

    2007-06-01

    While much of the third world starves, many in the first world are undergoing an obesity epidemic, and the related epidemics of type II diabetes, heart disease, and other diseases associated with obesity. The amount of economic wealth being directly related to a decline in health by obesity is ironic because rich countries contribute billions of dollars to improve the health of their citizens. Nevertheless, nutritional experiments in model organisms such as yeast, C. elegans, Drosophila, and mice confirm that "caloric restriction" (CR), which is defined generally as a 30-40% decrease in caloric intake, a famine-like condition for humans seen only in the poorest of countries, promotes good health and increases longevity in model organisms. Because caloric restriction, and dieting in general, requires a great deal of will power to deal with the feelings of deprivation, many fad diets, such as the Atkins, South Beach, and Protein Power, have been developed which allow people to lose weight purportedly without the severe feelings of deprivation. However, the long-term effects of such fad diets are not known and few experiments have been performed in the laboratory to investigate possible side affects and adverse consequences. In this paper, we review studies with fad-like dietary conditions in humans and model organisms, and we propose a "Dietary Ames Test" to rapidly screen fad diets, dietary supplements, and drugs for potential long-term health consequences in model organisms.

  9. Double-blind study comparing the long-term efficacy of the COX-2 inhibitor nimesulide and naproxen in patients with osteoarthritis.

    PubMed

    Kriegel, W; Korff, K J; Ehrlich, J C; Lehnhardt, K; Macciocchi, A; Moresino, C; Pawlowski, C

    2001-10-01

    This double-blind one-year study compares the long-term efficacy and safety of nimesulide with naproxen in patients with osteoarthritis (OA) of the knee or hip. Patients were randomised to nimesulide 100 mg twice daily (n = 183) or naproxen 250 mg morning, 500 mg evening (n = 187). The primary efficacy variable was change in pain intensity (WOMAC A scale) at 6 months. Nimesulide tablets showed at least equivalent efficacy to naproxen tablets in reducing pain intensity at 6 and 12 months (nimesulide -22.5% at 6 and 12 months; naproxen -22.4% at 6 months, -19.9% at 12 months; non-inferiority proven). At 6 months the investigator assessed efficacy as 'good' or 'excellent' in 59.3% of nimesulide and 56.4% of naproxen-treated patients, with corresponding values for patient assessment of 57% and 52.7%. Both treatments were well tolerated, with fewer related gastrointestinal adverse events reported with nimesulide (77 cases, 47.5%) than with naproxen (96 cases, 54.5%). This study shows nimesulide to be as effective as naproxen in the long-term treatment of OA and to be associated with fewer gastrointestinal side-effects.

  10. Long-term anaerobic treatability studies on opium alkaloids industry effluents.

    PubMed

    Aydin, Ali F; Ersahin, Mustafa E; Dereli, Recep K; Sarikaya, Hasan Z; Ozturk, Izzet

    2010-01-01

    In this study, the anaerobic treatability of high strength opium alkaloids processing industry wastewaters was investigated. The wastewater was fed to a lab-scale anaerobic upflow sludge blanket reactor (UASBR) operating at mesophilic conditions. The UASB reactor (11.5 L) was operated for 825 days at different hydraulic retention times ranging from 0.85 to 1.62 days and at organic loading rates ranging from 3.40 to 12.25 kg COD/m(3).day. Anaerobic treatability studies indicated that 300 L CH(4) can be produced per kg COD removed. At the 445th day of the study an extreme irreversible inhibition caused by N,N-dimethylaniline was experienced. This paper demonstrated that opium alkaloid industry wastewater can be efficiently treated by UASB type reactors with more than 80% COD removal efficiency at high organic loading rates.

  11. Long-Term Benefits of Full-Day Kindergarten: A Longitudinal Population-Based Study

    ERIC Educational Resources Information Center

    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…

  12. Prospective study of long-term pulmonary manifestations of mantle irradiation

    SciTech Connect

    Shapiro, S.J.; Shapiro, S.D.; Mill, W.B.; Campbell, E.J. )

    1990-09-01

    Given the high cure rate of patients with Hodgkin's disease, the complications related to therapy take on great significance. Mantle irradiation to the thorax is used in virtually all patients with early stage Hodgkin's disease. Prior studies of patients receiving mantle irradiation demonstrated short-term (up to 24 months) abnormalities of pulmonary function. In the present study, we prospectively studied 13 patients for up to 60 months after irradiation only with serial pulmonary function tests, arterial blood gas tests, diffusing capacity of carbon monoxide, chest radiographs, and ventilation-perfusion scans. No respiratory symptoms attributable to therapy were noted. Frequent radiographic changes (62%) were found consisting of apical fibrosis, paramediastinal fibrosis, or pleural thickening. Two patients developed an asymptomatic spontaneous pneumothorax that resolved with conservative management. Ventilation-perfusion scans often (73%) revealed decreased perfusion to the lung apices with associated ventilatory deficits in one-half of these patients. Patients with intrathoracic disease had decreased lung volumes prior to therapy, and lung volumes did not change following irradiation. Lung mechanics were normal throughout the study. Gas exchange at rest was normal in patients with extrathoracic disease. Patients with intrathoracic disease often presented with an abnormal arterial PO2 and widened alveolar-arterial partial pressure gradient for oxygen. However, these parameters normalized by 9 months after therapy. Despite the frequent development of radiographic and V/Q scan abnormalities in the lung apices, patients tolerated mantle radiotherapy remarkably well. In fact, patients with intrathoracic disease demonstrated improved gas exchange at rest following therapy.

  13. Long term exposure to NO2 and diabetes incidence in the Black Women's Health Study.

    PubMed

    Coogan, Patricia F; White, Laura F; Yu, Jeffrey; Burnett, Richard T; Marshall, Julian D; Seto, Edmund; Brook, Robert D; Palmer, Julie R; Rosenberg, Lynn; Jerrett, Michael

    2016-07-01

    While laboratory studies show that air pollutants can potentiate insulin resistance, the epidemiologic evidence regarding the association of air pollution with diabetes incidence is conflicting. The purpose of the present study was to assess the association of the traffic-related nitrogen dioxide (NO2) with the incidence of diabetes in a longitudinal cohort study of African American women. We used Cox proportional hazards models to calculate hazard ratios and 95% confidence intervals (CI) for diabetes associated with exposure to NO2 among 43,003 participants in the Black Women's Health Study (BWHS). Pollutant levels at participant residential locations were estimated with 1) a land use regression model for participants living in 56 metropolitan areas, and 2) a dispersion model for participants living in 27 of the cities. From 1995 to 2011, 4387 cases of diabetes occurred. The hazard ratios per interquartile range of NO2 (9.7 ppb), adjusted for age, metropolitan area, education, vigorous exercise, body mass index, smoking, and diet, were 0.96 (95% CI 0.88-1.06) using the land use regression model estimates and 0.94 (95% CI 0.80, 1.10) using the dispersion model estimates. The present results do not support the hypothesis that exposure to NO2 contributes to diabetes incidence in African American women.

  14. Historical and Future Trends in Studying the Development of Long-Term Retention.

    ERIC Educational Resources Information Center

    Howe, Mark L.

    2000-01-01

    Considers the relative lack of research attention to retention in developmental psychology and recent findings on age differences in retention. Highlights unresolved issues and how Bauer and colleagues' work may help set the research agenda and contribute to a shift in how early childhood retention is studied. Discusses memory strength,…

  15. Correlates of Long-Term Breastfeeding: A Study of Social and Personal Factors.

    ERIC Educational Resources Information Center

    Isabella, Patrice H.; Isabella, Russell A.

    This study examined the degree to which mothers' perceptions of their marital relationships, the support provided to them by their mothers and others, and their adjustment to pregnancy and motherhood, were associated with success at initiating and maintaining lactation during the first year after their child's birth. The incidence and duration of…

  16. LONG-TERM STUDY OF EDUCATIONAL EFFECTIVENESS OF NEWLY FORMED CENTRALIZED SCHOOL DISTRICTS IN RURAL AREAS.

    ERIC Educational Resources Information Center

    KREITLOW, B.W.

    THE BASIC PURPOSES OF THIS STUDY WERE--(1) TO ASCERTAIN WHETHER OR NOT SCHOOL DISTRICT REORGANIZATION IS WORTHWHILE IN TERMS OF TIME, EFFORT, AND EXPENDITURE OF FUNDS, AND (2) TO DETERMINE THE EFFECTS OF SUCH SCHOOL DISTRICT REORGANIZATIONS ON THE EDUCATIONAL OUTCOMES OF THE SCHOOL. THE SAMPLING CONSISTED OF 10 WISCONSIN COMMUNITIES--5 WITH…

  17. Long-term follow-up mortality study of petroleum refinery and chemical plant employees.

    PubMed

    Tsai, S P; Gilstrap, E L; Cowles, S R; Snyder, P J; Ross, C E

    1996-01-01

    A previous report presented the 1948-1983 mortality patterns of the Shell Deer Park Manufacturing Complex employees who were employed for at least 3 months from 1948 through 1972. The present study updates the earlier investigation by extending the vital status follow-up through 1989 and by expanding the cohort to include employees hired after 1972. As in the previous study, the overall mortality and cancer mortality for both refinery and chemical employees were quite favorable compared to residents in the local population. Among refinery workers, cancers for which a suspicion of work-relatedness was raised in the previous study, i.e. leukemia and cancers of the central nervous system and biliary passage/liver, no supportive evidence was found in this update. For both refinery and chemical plant employees, the mortality rate due to cancers of all lymphopoietic tissue increased with increasing duration of employment; this finding was also noted by the original study. This was also evident for lymphoreticulosarcoma in refinery employees and for leukemia in chemical plant employees. However, elevations of cancers of all lymphatic and hematopoietic tissue are primarily confined to employees who started work at the complex before 1946. By contrast, deaths from cancer of all lymphatic and hematopoietic tissue for employees hired after 1945 were 22% lower than the comparison population. Seven deaths with mesothelioma mentioned on the death certificates were identified, with 3.2 deaths expected, resulting in a statistically nonsignificant SMR of 219.

  18. The Long-Term Personal and Professional Impacts of Participating in a Study Abroad Program

    ERIC Educational Resources Information Center

    DeGraaf, Don; Slagter, Cynthia; Larsen, Kelly; Ditta, Elisa

    2013-01-01

    "Something hidden. Go and find it. Go and look beyond the ranges--something lost… and waiting for you." Rudyard Kipling's words portray perfectly the wonder of studying abroad for many college students. The excitement that leads up to a new adventure in an unknown place invites students into exploration and new experiences. But Kipling's…

  19. A National Study of School Effectiveness for Language Minority Students' Long-Term Academic Achievement.

    ERIC Educational Resources Information Center

    Thomas, Wayne P.; Collier, Virginia P.

    This longitudinal study examined the education of language minority students in five school districts nationwide. Qualitative data included interviews, school visits, surveys, and source documents. Quantitative data included information from registration centers, language minority student databases, student information systems databases, testing…

  20. Barriers to Physical Activity for People with Long-Term Neurological Conditions: A Review Study

    ERIC Educational Resources Information Center

    Mulligan, Hilda F.; Hale, Leigh A.; Whitehead, Lisa; Baxter, G. David

    2012-01-01

    People with disability are insufficiently physically active for health. This study identified the volume, quality, and findings of research that exposes environmental and personal barriers of physical activity participation for people with neurological conditions. CINAHL, Sport Discus, EMBASE, Medline, and AMED were systematically searched between…

  1. Cessation of Long-Term Naltrexone Therapy and Self-Injury: A Case Study.

    ERIC Educational Resources Information Center

    Crews, W. David, Jr.; And Others

    1993-01-01

    This case study of a woman with profound mental retardation and a history of severe self-injurious behavior (SIB) found that the dramatic decrease in SIB following Naltrexone administration was maintained through placebo and no drug phases and at six-month follow-up. Findings are discussed in terms of endogenous opioid system theories of SIB. (DB)

  2. Long-Term Effects of Course-Embedded Undergraduate Research: The CASPiE Longitudinal Study

    ERIC Educational Resources Information Center

    Szteinberg, Gabriela A.

    2012-01-01

    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…

  3. Yale Child Study Center School Development Program: Developmental History and Long Term Effects.

    ERIC Educational Resources Information Center

    Comer, James P.; And Others

    Research findings indicate that the Yale Child Study Center School Development Program (SDP) has led to consistent progress in academic achievement and school attendance from 1969 to 1984 in the New Haven (Connecticut) schools in which it has been used. This report evaluates SDP, which attempts to strengthen student academic and social skills in…

  4. Levetiracetam extended release for the treatment of patients with partial-onset seizures: A long-term, open-label follow-up study.

    PubMed

    Chung, Steve; Ceja, Hugo; Gawłowicz, Jacek; McShea, Cindy; Schiemann, Jimmy; Lu, Sarah

    2016-02-01

    This was an open-label study (N01281 [NCT00419393]) assessing the long-term safety of extended-release levetiracetam (LEV XR) in patients with partial-onset seizures (POS); the study was a follow-up to a double-blind, randomized, historical controlled, multicenter, conversion to monotherapy study (N01280 [NCT00419094]). Eligible patients initially received LEV XR 2000 mg/day; dose adjustments and the addition of other antiepileptic drugs (AEDs) were permitted. Overall, 190 patients were enrolled, 189 (99.5%) received LEV XR (safety and efficacy populations) and 166 patients (87.4%) completed the study. The study duration in completed patients was 5.5-24.6 months. Mean daily dose of LEV XR was 2131 mg/day. Treatment-emergent adverse events (TEAEs) occurred in 126 patients (66.7%); most were of mild or moderate severity. Five patients (2.6%) had a TEAE that led to treatment discontinuation. Treatment-emergent serious adverse events occurred in 22 patients (11.6%). Twenty-six patients (13.8%) experienced a psychiatric TEAE. The median 7-day normalized POS frequency was: 1.38 at N01280 study baseline; 0.50 at the first visit of N01281 (last visit of N01280); and 0.00-0.36 between all subsequent visits. Overall, 171 patients (90.5%) entered the N01281 study on LEV XR monotherapy; 65.3% (32/49) of patients remained on monotherapy for 12 months and 47.1% (8/17) for 18 months. While remaining on LEV XR monotherapy, 27/139 patients (19.4%) were seizure-free at 6 months and 8/49 (16.3%) at 12 months. In conclusion, LEV XR was well tolerated when administered as long-term monotherapy or in combination with other AEDs in patients with inadequately controlled POS. PMID:26716580

  5. Tumors in long-term rat studies associated with microchip animal identification devices.

    PubMed

    Elcock, L E; Stuart, B P; Wahle, B S; Hoss, H E; Crabb, K; Millard, D M; Mueller, R E; Hastings, T F; Lake, S G

    2001-02-01

    Tumors surrounding implanted microchip animal identification devices were noted in two separate chronic toxicity/oncogenicity studies using F344 rats. The tumors occurred at a low incidence rate (approximately 1 percent), but did result in the early sacrifice of most affected animals, due to tumor size and occasional metastases. No sex-related trends were noted. All tumors occurred during the second year of the studies, were located in the subcutaneous dorsal thoracic area (the site of microchip implantation) and contained embedded microchip devices. All were mesenchymal in origin and consisted of the following types, listed in order of frequency: malignant schwannoma, fibrosarcoma, anaplastic sarcoma, and histiocytic sarcoma. The following diagnostic techniques were employed: light microscopy, scanning electron microscopy, and immunohistochemistry. The mechanism of carcinogenicity appeared to be that of foreign-body induced tumorigenesis.

  6. Studying an Agulhas ring's long-term pathway and decay with finite-time coherent sets

    NASA Astrophysics Data System (ADS)

    Froyland, Gary; Horenkamp, Christian; Rossi, Vincent; van Sebille, Erik

    2015-08-01

    Coherent sets in dynamical systems are regions in phase space that optimally "carry mass" with them under the system's evolution, so that these regions experience minimal leakage. The dominant tool for determining coherent sets is the transfer operator, which provides a complete description of Lagrangian mass transport. In this work, we combine existing transfer operator methods with a windowing scheme to study the spatial and temporal evolution of a so-called Agulhas ring: a large anticyclonic mesoscale eddy playing a key role in inter-ocean exchange of climate-relevant properties. Our focus is on ring decay over time and the windowing scheme enables us to study how the most coherent region (our estimate of the ring) varies in position and size over a period of more than two years. We compare the eddy-like structure and its spatio-temporal changes as revealed by our method and by a classical Eulerian approach.

  7. Long-term aging of elastomers: Chemical stress relaxation of fluorosilicone rubber and other studies

    NASA Technical Reports Server (NTRS)

    Kalfayan, S. H.; Mazzeo, A. A.; Silver, R. H.

    1971-01-01

    Aerospace applications of elastomers are considered, including: propellant binders, bladder materials for liquid propellant expulsion systems, and fuel tank sealants for high-speed aircraft. A comprehensive molecular theory for mechanical properties of these materials has been developed but has only been tested experimentally in cases where chemical degradation processes are excluded. Hence, a study is being conducted to ascertain the nature, extent, and rate of chemical changes that take place in some elastomers of interest. Chemical changes that may take place in the fluorosilicone elastomer, LS 420, which is regarded as a fuel and high-temperature-resistant rubber are investigated. The kinetic analysis of the chemical stress relaxation and gel permeation chromatography studies comprise the major portion of the report.

  8. Long term drift studies of Sandia H{sub 2} sensor in reducing atmospheres

    SciTech Connect

    JENKINS,MARK W.; HUGHES,ROBERT C.; PATEL,SANJAY V.

    2000-04-01

    A study of the drift in Pd/Ni alloy hydrogen sensitive resistor and transistor responses is presented. The sensors were monitored for a period of 6 months in a reducing atmosphere of 0.1% H{sub 2} in N{sub 2} with periodic calibration exposures. A comparison of a resistor film with an adhesion layer showed considerable improvement in diminishing the drift.

  9. Plasma clozapine concentration coefficients of variation in a long-term study.

    PubMed

    Diaz, Francisco J; de Leon, Jose; Josiassen, Richard C; Cooper, Thomas B; Simpson, George M

    2005-01-01

    Kurz et al. conducted the first study of the intra-individual variability of clozapine plasma concentrations but did not take into account the effect of smoking and co-medication. As patients were receiving varying doses, Kurz et al. standardized plasma levels by using a plasma level/dose/kg ratio. In 15 patients, the mean coefficient of variation (CV) was 53% (S.D. = 21). In this new study, plasma clozapine and norclozapine concentrations were measured every 2 weeks in 47 patients randomized to 100, 300, or 600 mg/day for 16-week double-blind clozapine trials under controlled conditions (stable smoking, limited co-medication and absence of caffeinated beverages). For 100, 300 and 600 mg/day, the respective mean CVs for plasma clozapine concentrations were 23% (S.D. = 14), 19% (S.D.= 11) and 18% (S.D. = 8). For the combined concentrations of clozapine and norclozapine, the respective mean CVs were 20% (S.D. = 13), 16% (S.D. = 9) and 15% (S.D. = 7). Under 100 mg/day, the mean CV for clozapine concentrations was significantly higher for heavy smokers than non-heavy smokers (32%, S.D. = 3 vs. 19%, S.D. = 8) (p = 0.03). Studies of CVs in other environments are needed. Clozapine CVs may be important in order to understand the importance of variations around the therapeutic range and to interpret drug interactions above the usual noise of measuring plasma concentrations.

  10. A study of the need for anticholinergic medication in patients treated with long-term antipsychotics.

    PubMed

    Caradoc-Davies, G; Menkes, D B; Clarkson, H O; Mullen, P E

    1986-06-01

    Studies on the withdrawal of anticholinergics from patients on antipsychotics have produced conflicting results. This 12-week study employed a double-blind crossover design on 39 adult in-patients selected from a total hospital population of 620. The Colombia Scale was used to determine extrapyramidal side effects (EPS). All patients were stabilised prior to the study on benztropine mesylate 2 mg b.i.d., and gradual withdrawal was employed. Benztropine withdrawal produced a significant increase in overall EPS scores. Ten patients (26%) required reinstatement of benztropine while on placebo. Sialorrhoea, rigidity and postural instability were the most prominent changes. Neither age, sex, nor diagnosis were significantly predictive of EPS. Depot medications and doses greater than 1000 mg/day chlorpromazine-equivalent were related to significant EPS increase. The intrinsic anticholinergic properties of the antipsychotics themselves and concomitant medications, such as antidepressants, appeared protective against development of EPS. Most patients on a combination of antipsychotics and anticholinergics can safely be withdrawn from the latter.

  11. Long-term degradation study of hyaluronic acid in aqueous solutions without protection against microorganisms.

    PubMed

    Simulescu, Vasile; Kalina, Michal; Mondek, Jakub; Pekař, Miloslav

    2016-02-10

    The degradation of hyaluronan (HA) of different molecular weights (Mw 14.3, 267.2 and 1160.6 kDa, measured for fresh solutions, before degradation) was studied in aqueous solutions by SEC-MALLS determination of molecular mass, polydispersity and conformation parameters. The solutions were stored either at laboratory or refrigerator temperatures for two months. After this period the weight average molecular weight decreased by 90% for 14.3 kDa, 95% for 267.2 kDa and 71% for 1160.6 kDa hyaluronan (room temperature) or 5.6% for 14.3 kDa, 6.2% for 267.2 kDa and 7.7% for 1160.6 kDa hyaluronan (refrigerator temperature). The hyaluronan aqueous solutions studied did not contain sodium azide or other protectants against microorganisms, because the aim of our study was to assess the degradation in solutions to be used in medicine or cosmetics (without any compounds that are poisonous or toxic for the human body). The solvent used to prepare the samples was pure water. The polydispersity of all the samples remained unaltered during the entire degradation at both temperatures. This indicates a non-random mechanism of degradation. PMID:26686177

  12. Rapid maxillary expansion. A study of the long-term effects.

    PubMed

    Velázquez, P; Benito, E; Bravo, L A

    1996-04-01

    A study was made to determine whether skeletal alterations usually produced by rapid maxillary expansion may be compensated for in time by growth and/or comprehensive orthodontic treatment. In 30 patients, orthodontic treatment was started with rapid maxillary expansion, followed by fixed appliances, not combined with any other form of orthopedic device. Mean treatment time was 3.1 years. Nine measurements from the Ricketts analysis were studied, based on lateral cephalometric radiographs. Records were taken before orthodontic treatment and after completion of active therapy. A statistical analysis was made of the nine variables used, reflecting the vertical and anteroposterior skeletal proportions of the face, contrasting the changes before and after treatment. Of all the variables studied, the four that change with age according to the Ricketts analysis (mandibular plane angle, maxillary height, facial depth and facial convexity), yielded statistically significant differences after treatment, indicative of normal growth. The five remaining variables that remain constant with age according to the Ricketts analysis (facial axis, lower facial height, total facial height, palatal plane inclination and maxillary depth) showed no significant changes after treatment, also indicative of normal growth.

  13. An axenic plant culture system for optimal growth in long-term studies.

    PubMed

    Henry, Amelia; Doucette, William; Norton, Jeanette; Jones, Scott; Chard, Julie; Bugbee, Bruce

    2006-01-01

    The symbiotic co-evolution of plants and microbes leads to difficulties in understanding which of the two components is responsible for a given environmental response. Plant-microbe studies greatly benefit from the ability to grow plants in axenic (sterile) culture. Several studies have used axenic plant culture systems, but experimental procedures are often poorly documented, the plant growth environment is not optimal, and axenic conditions are not rigorously verified. We developed a unique axenic system using inert components that promotes plant health and can be kept sterile for at least 70 d. Crested wheatgrass (Agropyron cristatum cv. CDII) plants were grown in sand within flow-through glass columns that were positively pressured with filtered air. Plant health was optimized by regulating temperature, light level, CO2 concentration, humidity, and nutrients. The design incorporates several novel aspects, such as pretreatment of the sand with Fe, graduated sand layers to optimize the air-water balance of the root zone, and modification of a laminar flow hood to serve as a plant growth chamber. Adaptations of several sterile techniques were necessary for maintenance of axenic conditions. Axenic conditions were verified by plating and staining leachates as well as a rhizoplane stain. This system was designed to study nutrient and water stress effects on root exudates, but is useful for assessing a broad range of plant-microbe-environment interactions. Based on total organic C analysis, 74% of exudates was recovered in the leachate, 6% was recovered in the bulk sand, and 17% was recovered in the rhizosphere sand. Carbon in the leachate after 70 d reached 255 microg d(-1). Fumaric, malic, malonic, oxalic, and succinic acids were measured as components of the root exudates.

  14. Modelling long term morphological changes with XBeach: case study of Kizilirmak River mouth, Turkey

    NASA Astrophysics Data System (ADS)

    Baykal, Cüneyt; Ergin, Aysen; Güler, Işıkhan; Özyurt Tarakcıoğlu, Gülizar; Söğüt, Erdinç; Gökhan Güler, Hasan; Güney Doğan, Gözde

    2015-04-01

    The Bafra alluvial plain, where the Kızılırmak River discharges into the Black Sea, is one of the most critical examples of severe coastal erosion problems in Turkey. The amount of sediment carried by the Kızılırmak River has decreased from approximately 23 million ton per year to 0.46 million tons/year starting from 1960s as a result of construction of flow regulatory structures in the following years. This drastic decrease in the amount of sediment carried by the river resulted in a severe shoreline retreat up to 1 km in the cross-shore direction since 1988 according to the Regional Directorate of State Hydraulic Works and local residents (Kökpınar et al., 2007). The first remedial measure against this severe coastal erosion problem at the river mouth was constructed in 2000 by State Hydraulic Works (DSİ). It was composed of two Y-type and one I-type groins constructed at the eastern shoreline of the river mouth. After construction of the first remedial system, the shoreline retreat slowed down between the groins and trapping of sediment initiated. Today, the gaps between the groins are almost completely filled with sediment. In this study, the shoreline changes between the groins of the first remedial system for the years 1999, 2003 and 2007 are studied using the open source numerical model called XBeach (Roelvink et al.2010) focusing on the hydrodynamics and tombolo formation around the groins. The numerical model has been developed mainly to model short term morphological changes such as nearshore responses under storm and hurricane conditions. Herein, the preparation of the wave data input to minimize the computational demand of the model and the effect of the sequence of the input wave directions are discussed in detail in this study. Finally, the shoreline changes obtained from numerical model simulations are compared with the field data. Keywords: Numerical modeling of shoreline changes, tombolo formation

  15. An Axenic Plant Culture System for Optimal Growth in Long-Term Studies: Design and Maintenance

    NASA Technical Reports Server (NTRS)

    Henry, Amelia; Doucette, William; Norton, Jeanette; Jones, Scott; Chard, Julie; Bugbee, Bruce

    2006-01-01

    The symbiotic co-evolution of plants and microbes leads to difficulties in understanding which of the two components is responsible for a given environmental response. Plant-microbe studies greatly benefit from the ability to grow plants in axenic (sterile) culture. Several studies have used axenic plant culture systems, but experimental procedures are often poorly documented, the plant growth environment is not optimal, and axenic conditions are not rigorously verified. We developed a unique axenic system using inert components that promotes plant health and can be kept sterile for at least 70 d. Crested wheatgrass (Agropyron cristatum cv. DII) plants were grown in sand within flow-through glass columns that were positively pressured with filtered air. Plant health was optimized by regulating temperature, light level, CO2 concentration, humidity, and nutrients. The design incorporates several novel aspects, such as pretreatment of the sand with Fe, graduated sand layers to optimize the air-water balance of the root zone, and modification of a laminar flow hood to serve as a plant growth chamber. Adaptations of several sterile techniques were necessary for maintenance of axenic conditions. Axenic conditions were verified by plating and staining leachates as well as rhizoplane stain. This system was designed to study nutrient and water stress effects on root exudates, but is useful for assessing a broad range of plant-microbe-environment interactions. Based on total organic C analysis, 74% of exudates was recovered in the leachate, 6% was recovered in the bulk sand, and 17% was recovered in the rhizosphere sand. Carbon in the leachate after 70 d reached 255 micro-g/d. Fumaric, malic, malonic, oxalic, and succinic acids were measured as components of the root exudates.

  16. Hail formation in pre-frontal environments: A long-term study over Switzerland

    NASA Astrophysics Data System (ADS)

    Schemm, Sebastian; Nisi, Luca; Martynov, Andrey; Martius, Olivia

    2015-04-01

    This study investigates the formation of hail in environments pre-conditioned by synopticscale cold fronts. In addition the link of pre-frontal dynamics as trigger for the hail cell initiation is characterized climatologically over Switzerland. The study is based on a high-resolution analysis dataset (COSMO-2/-7) for the extended hail season May-September between the years 2002 - 2013 and a radar-based hail identification and tracking scheme. An automated identification method for fronts is used to compile a climatology of fronts for the COSMO-2 domain, encompassing Switzerland and parts of its neighboring countries, e.g., the Italian Alpine foothills and the Black Forest in southwestern Germany. The informations are used to quantify the relative portion of hail cell initiation in a pre-frontal environment and to study in greater detail the temporal evolution of selected variables (CAPE, CIN, wind shear) in a 20 hour period prior. Pre-frontal hail initiations accounts for up to 40% of all hail formation in northwestern Switzerland, the southern Prealps, and upstream of the Jura and Black Forest mountains.We suggest that fronts trigger hail formation in particular in regions where hail is less frequently observed (with the exception of southern Switzerland). Adiabatic cooling due to pre-frontal lifting lead an increase of CAPE, a reduction of CIN and an increase of the wind shear. Additional lifting by flow convergence along the Alps or by the front itself above the level of free convection leads to the development of strong convection.

  17. The use of Na-22 as a tracer for long-term bone mineral turnover studies.

    NASA Technical Reports Server (NTRS)

    Palmer, H. E.; Rieksts, G. A.; Palmer, R. F.; Gillis, M. F.

    1979-01-01

    Sodium-22 has been studied as a tracer for bone mineral metabolism in rats and dogs. When incorporated into bone during growth from birth to adulthood, the bone becomes uniformly tagged with Na-22, which is released through the metabolic turnover of the bone. The Na-22 not incorporated in the bone matrix is rapidly excreted within a few days when animals are fed high, but nontoxic levels of NaCl. The Na-22 tracer can be used to measure bone mineral loss in animals during space flight and in research on bone disease.

  18. Long Term Storage of Dry versus Frozen RNA for Next Generation Molecular Studies

    PubMed Central

    Seelenfreund, Eric; Robinson, William A.; Amato, Carol M.; Tan, Aik-Choon; Kim, Jihye; Robinson, Steven E.

    2014-01-01

    The standard method for the storage and preservation of RNA has been at ultra-low temperatures. However, reliance on liquid nitrogen and freezers for storage of RNA has multiple downsides. Recently new techniques have been developed for storing RNA at room temperature utilizing desiccation and are reported to be an effective alternative for preserving RNA integrity. In this study we compared frozen RNA samples stored for up to one year to those which had been desiccated using RNAstable (Biomatrica, Inc., San Diego, CA) and stored at room temperature. RNA samples were placed in aliquots and stored after desiccation or frozen (at −80°C), and were analyzed for RNA Integrity Number (RIN), and by qPCR, and RNA sequencing. Our study shows that RNAstable is able to preserve desiccated RNA samples at room temperature for up to one year, and that RNA preserved by desiccation is comparable to cryopreserved RNA for downstream analyses including real-time-PCR and RNA sequencing. PMID:25380187

  19. Clinical evaluation of direct composite restoration done for midline diastema closure – long-term study

    PubMed Central

    Prabhu, R.; Bhaskaran, S.; Geetha Prabhu, K. R.; Eswaran, M. A.; Phanikrishna, G.; Deepthi, B.

    2015-01-01

    Purpose of the Study: The aim of this study was to evaluate clinically the performance of composite resin used to restore midline diastema between the maxillary and mandibular central incisors. Methodology: Direct composite restorations were done for 45 patients with midline diastema between the maxillary and mandibular central incisors. Standard protocols were followed for the placement of composite resin for the diastema closure, and recall visits were made for every 6 months for a period of 60 months for evaluation of the success of these restorations made. Qualified dental personnel examined the restorations made. Results: Clinical evaluations were done after the restorations had been in place for an average of 6 months. Results indicate that none of the restorations were totally lost, and resulting in a 91% overall retention rate for the period of 60 months. About 62% of the restorations made had no noticeable color difference with that of the adjacent tooth, and gingival health indicated 73% of the sample was without any signs of inflammation. Conclusions: Composites restored for diastemas exhibit satisfactory survival rates placed with recommended placement protocols and without occlusal loading. PMID:26538917

  20. Impact of agricultural management practices on DOC leaching - results of a long-term lysimeter study

    NASA Astrophysics Data System (ADS)

    Wagner, A.; Ollesch, G.; Seeger, J.; Meißner, R.; Rode, M.

    2009-04-01

    Dissolved organic carbon (DOC) fluxes are recently increasing in surface waters of humid climate regions. Due to its substantial importance for leaching processes, aquatic foodwebs, and drinking water purification a better understanding of sources and pathways of DOC is needed. Therefore this study aims to analyse and simulate DOC fluxes in agricultural ecosystems with selected crop rotations. A data set of 24 lysimeters of the UFZ Lysimeter station at Falkenberg (Saxony-Anhalt) covering nine years of DOC investigation has been selected and examined. The data set covers a wide range of climatic conditions with deviating management practices for grasslands and agricultural crop rotations. The monthly DOC concentrations assessed in the leached water range from 2.4 to 34.1 mg /l. DOC concentrations depend on temperature, precipitation and discharge. The type of crop grown on the lysimeter is an important trigger for DOC leaching - especially lysimeters used as pasture, or planted with rape and carrots exhibit high DOC concentrations. Management practices and fertilizer application modify the leaching of DOC and offer potentials to reduce DOC losses. The results form the basis of further process simulation studies and upscaling of the results to the small catchment scale.

  1. A long term (1999-2008) study of radar anomalous propagation conditions in the Western Mediterranean

    NASA Astrophysics Data System (ADS)

    Magaldi, A. V.; Mateu, M.; Bech, J.; Lorente, J.

    2016-03-01

    In this paper a study of the radio propagation environment of electromagnetic waves prevailing in the lower troposphere of the Western Mediterranean basin is presented. Deviations from atmospheric average or standard radio propagation conditions (anomalous propagation or AP) can affect significantly the quality of weather radar observations and other telecommunication systems. This is particularly important when ducting or superrefraction is present and spurious echoes resulting from the interaction of the beam with the ground or sea surface may appear. These AP conditions occur mainly when temperature inversions or strong moisture gradients are present. The period covered in this study ranges from 1999 to 2008 and conditions were derived from the Weather Research and Forecasting (WRF) modeling system, using the Japanese 25-year Reanalysis (JRA25) dataset as initial and boundary data. From the WRF model, we use the temperature, moisture, and pressure fields with a grid length of 30-km horizontal resolution and 250 m vertical resolution to compute several indices such as the Vertical Refractivity Gradient, Vertical Modified Refractivity Gradient and a Ducting Index. Results obtained show that on the Western Mediterranean coast the most favorable conditions for superrefraction are found in summer, while the most affected areas are the Gulf of Valencia, the Strait of Gibraltar and the Northern Gulf of Lion. Additionally, a comparison with radiosonde data recorded in Barcelona (NE Spain) is also performed indicating an overall agreement between model and observational data despite a tendency to decrease subrefractive events by the WRF model.

  2. [Long-term effect of extracorporeal shockwave lithotripsy on kidney. A preliminary study].

    PubMed

    Zhang, Y F

    1992-09-01

    We studied 139 patients with upper urinary tract calculi who were treated by JT-ESWL-I and III type extra corporeal shock wave lithotripter (ESWL) for an average of 4 years and 11 months. These patients aged below 45 had no history or family history of hypertension. Hypertension was found in 1 patient (0.7%) and elevated diastolic pressure in 6 (4.3%). The recurrence rate of calculi was 5%. Before and after ESWL, Bun, Cr, B2-mG (of blood and urine), activity of blood plasma renin AT-II, -GT, NAG, mucoprotein of plasma, etc were also determined. The differences in their values were not significant. We concluded that if the indications for ESWL are strictly considered including patient selection and number of wave pulsation and energy, ESWL is still an ideal method of treatment.

  3. Long-term mortality in miners with coal workers' pneumoconiosis in The Netherlands: A pilot study

    SciTech Connect

    Meijers, J.M.; Swaen, G.M.; Slangen, J.J.; van Vliet, K.; Sturmans, F. )

    1991-01-01

    In order to investigate whether the prolonged exposure to coal mine dust increases the cancer risk for coal miners, a pilot study in a selected cohort of 334 Dutch miners with coal work