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Sample records for long-term safety study

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

    PubMed Central

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

    2016-01-01

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

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

    SciTech Connect

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

    2007-12-01

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

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

    PubMed

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

    2015-10-01

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

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

    PubMed

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

    2014-10-01

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

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

    PubMed

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

    1999-05-01

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

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

    PubMed

    Acorn, Jonathan R

    2010-01-01

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

  8. 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.

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

    PubMed

    Brattström, Axel

    2009-04-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-06-07

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

  12. 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.

  13. 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.

  14. Long-term studies of dopamine agonists.

    PubMed

    Hubble, Jean P

    2002-02-26

    Dopamine agonists have long been used as adjunctive therapy for the treatment of Parkinson's disease (PD). In more recent years these drugs have also been proved safe and effective as initial therapy in lieu of levodopa in the treatment of PD. Long-term levodopa therapy is associated with motor complications, including fluctuating response patterns and dyskinesia. By initially introducing a dopamine agonist as symptomatic drug therapy, it may be possible to postpone the use of levodopa and delay or prevent the development of motor complications. Recently, four clinical trials have explored this hypothesis by comparing the long-term response and side effects of levodopa with dopamine agonist therapy. The drugs studied have included ropinirole, pramipexole, cabergoline, and pergolide. In each of these projects, the occurrence of motor complications, such as wearing off and dyskinesia, was significantly less in the subjects assigned to initiation of therapy with a dopamine agonist. The addition of levodopa could be postponed by many months or even several years. Therefore, these long-term studies of dopamine agonists support the initiation of a dopamine agonist instead of levodopa in an effort to postpone levodopa-related motor complications. This therapeutic approach may be particularly appropriate in PD patients with a long treatment horizon on the basis of age and general good health. The extension phase of the long-term study comparing pramipexole with levodopa is ongoing, and follow-up information may help to establish the value of this treatment strategy.

  15. 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

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

    PubMed

    Smilde, J G

    2000-11-01

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

  17. Long term cryogenic storage facility systems study

    NASA Technical Reports Server (NTRS)

    Schuster, John R.

    1987-01-01

    The Long Term Cryogenic Storage Facility Systems Study (LTCSFSS) is a Phase A study of a large capacity propellant depot for the space based, cryogenic orbital transfer vehicle. The study is being performed for Marshall Space Flight Center by General Dynamics Space Systems Division and has five principal objectives: (1) Definition of preliminary concept designs for four storage facility concepts; (2) Selection of preferred concepts through the application of trade studies to candidate propellant management system components; (3) Preparation of a conceptual design for an orbital storage facility; (4) Development of supporting research and technology requirements; and (5) Development of a test program to demonstrate facility performance. The initial study has been completed, and continuation activities are just getting under way to provide greater detail in key areas and accommodate changes in study guidelines and assumptions.

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

    PubMed Central

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

    2017-01-01

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

  19. Neurotoxicity testing during long-term studies.

    PubMed

    Ivens, I

    1990-01-01

    Several tests and methods for the investigation of neurotoxicity were performed with female Wistar rats for up to 187 days. The methods were validated by testing 10 rats treated with beta,beta'-iminodipropionitrile (IDPN) and 10 control rats. Cage side observation of the animals revealed signs of altered behavior and motor dysfunction of the IDPN-treated rats. Results of a neuromuscular screen indicated changes in gait, righting reflex, grip strength and performance of the negative geotropism test. Investigation of the animals in activity monitors and on the accelerating rotarod showed changes of several parameters. The motor nerve conduction velocity, measured 6 months after the first treatment, was reduced by 6.7 meters per second in the IDPN group compared to controls. From the results of the tests it can be concluded that the methods chosen can be used during long-term studies but may be most useful for animals not older than 12 months.

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

    PubMed

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

    2000-04-01

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

  1. 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.

  2. 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)

  3. 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

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

    SciTech Connect

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

    2013-07-01

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

  5. 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

  6. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  9. 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.

  10. 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…

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

    PubMed Central

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

    2014-01-01

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

  12. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study.

    PubMed

    McDonnell, David P; Landry, John; Detke, Holland C

    2014-11-01

    The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18-76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2-4 weeks. The mean duration of exposure was ∼3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome).

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

    PubMed

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

    1991-11-01

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

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

    PubMed

    Zimmer, J G

    1979-02-01

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

  15. 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.

  16. 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.

  17. The Long-Term Safety, Public Health Impact, and Cost-Effectiveness of Routine Vaccination with a Recombinant, Live-Attenuated Dengue Vaccine (Dengvaxia): A Model Comparison Study

    PubMed Central

    Longini, Ira; Lourenco, Jose; Pearson, Carl A. B.; Reiner, Robert C.; Mier-y-Terán-Romero, Luis; Vannice, Kirsten

    2016-01-01

    Background Large Phase III trials across Asia and Latin America have recently demonstrated the efficacy of a recombinant, live-attenuated dengue vaccine (Dengvaxia) over the first 25 mo following vaccination. Subsequent data collected in the longer-term follow-up phase, however, have raised concerns about a potential increase in hospitalization risk of subsequent dengue infections, in particular among young, dengue-naïve vaccinees. We here report predictions from eight independent modelling groups on the long-term safety, public health impact, and cost-effectiveness of routine vaccination with Dengvaxia in a range of transmission settings, as characterised by seroprevalence levels among 9-y-olds (SP9). These predictions were conducted for the World Health Organization to inform their recommendations on optimal use of this vaccine. Methods and Findings The models adopted, with small variations, a parsimonious vaccine mode of action that was able to reproduce quantitative features of the observed trial data. The adopted mode of action assumed that vaccination, similarly to natural infection, induces transient, heterologous protection and, further, establishes a long-lasting immunogenic memory, which determines disease severity of subsequent infections. The default vaccination policy considered was routine vaccination of 9-y-old children in a three-dose schedule at 80% coverage. The outcomes examined were the impact of vaccination on infections, symptomatic dengue, hospitalised dengue, deaths, and cost-effectiveness over a 30-y postvaccination period. Case definitions were chosen in accordance with the Phase III trials. All models predicted that in settings with moderate to high dengue endemicity (SP9 ≥ 50%), the default vaccination policy would reduce the burden of dengue disease for the population by 6%–25% (all simulations: –3%–34%) and in high-transmission settings (SP9 ≥ 70%) by 13%–25% (all simulations: 10%– 34%). These endemicity levels are

  18. Planning long-term vegetation studies at landscape scales

    USGS Publications Warehouse

    Stohlgren, Thomas J.

    1995-01-01

    Long-term ecological research is receiving more attention now than ever before. Two recent books, Long-term Studies in Ecology: Approaches and Alternatives, edited by Gene Likens (1989), and Long-term Ecological Research: An International Perspective, edited by Paul Risser (1991), prompt the question, “Why are these books so thin?” Except for data from paleoecological, retrospective studies (see below), there are exceptionally few long-term data sets in terrestrial ecology (Strayer et al. 1986; Tilman 1989; this volume). In a sample of 749 papers published in Ecology, Tilman (1989) found that only 1.7% of the studies lasted at least five field seasons. Only one chapter in each of the review books dealt specifically with expanding both the temporal and the spatial scales of ecological research (Berkowitz et al. 1989; Magnuson et al. 1991). Judging by the growing number of landscape-scale long-term studies, however, such as the Long-Term Ecological Research (LTER) Program (Callahan 1991), the U.S. Environmental Protection Agency’s Environmental Monitoring and Assessment Program (EMAP; Palmer et al. 1991), the U.S. Army’s Land Condition-Trend Analysis (LCTA) Program (Diersing et al. 1992), and various agencies’ global change research programs (CEES 1993), there is a growing interest to expand ecological research both temporally and spatially.

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

    PubMed

    Ramirez-Castaneda, Juan; Jankovic, Joseph

    2013-02-04

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

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

    PubMed

    Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-02-02

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

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

    PubMed Central

    Anderson, Paul A.; Hashimoto, Robin

    2012-01-01

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

  2. 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.

  3. 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

  4. 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

  5. Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

    PubMed Central

    El-Agroudy, A. E.; Alarrayed, S. M.; Al-Ghareeb, S. M.; Farid, E.; Alhelow, H.; Abdulla, S.

    2017-01-01

    We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival. PMID:28182044

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

    PubMed

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

    2014-10-01

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

  7. 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

  8. Long-term cardiac (valvulopathy) safety of cabergoline in prolactinoma

    PubMed Central

    Khare, Shruti; Lila, Anurag R.; Patil, Rishikesh; Phadke, Milind; Kerkar, Prafulla; Bandgar, Tushar; Shah, Nalini S.

    2017-01-01

    Background: Clinical relevance of association of cabergoline use for hyperprolactinemia and cardiac valvulopathy remains unclear. Objective: The aim of the study was to determine the prevalence of valvular heart abnormalities in patients taking cabergoline for the treatment of prolactinoma and to explore any associations with the cumulative dose of drug used. Design: A cross-sectional echocardiographic study was performed in patients who were receiving cabergoline therapy for prolactinoma. Results: Hundred (61 females, 39 males) prolactinoma cases (81 macroprolactinoma and 19 microprolactinoma) were included in the study. The mean age at presentation was 33.9 ± 9.0 years (range: 16–58 years). The mean duration of treatment was 53.11 ± 43.15 months (range: 12–155 months). The mean cumulative dose was 308.6 ± 290.2 mg (range: 26–1196 mg; interquartile range: 104–416 mg). Mild mitral regurgitation was present in one patient (cumulative cabergoline dose 104 mg). Mild tricuspid regurgitation was present in another two patients (cumulative cabergoline dose 52 mg and 104 mg). Aortic and pulmonary valve functioning was normal in all the cases. There were no cases of significant valvular regurgitation (moderate to severe, Grade 3–4). None of the patients had morphological abnormalities such as thickening, calcification, and restricted mobility of any of the cardiac valves. Conclusion: Cabergoline appears to be safe in patients with prolactinoma up to the cumulative dose of ~300 mg. The screening for valvulopathy should be restricted to those with higher cumulative cabergoline exposure. PMID:28217516

  9. 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.

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

    PubMed

    Strier, Karen B

    2010-09-01

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

  11. 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…

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

    PubMed Central

    DiVall, Sara A.; Radovick, Sally

    2013-01-01

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

  13. 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.

  14. 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

  15. 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

  16. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy.

    PubMed

    Taniwaki, Masanori; Radu, Maria D; Garcia-Garcia, Hector M; Heg, Dik; Kelbæk, Henning; Holmvang, Lene; Moschovitis, Aris; Noble, Stephane; Pedrazzini, Giovanni; Saunamäki, Kari; Dijkstra, Jouke; Landmesser, Ulf; Wenaweser, Peter; Meier, Bernhard; Stefanini, Giulio G; Roffi, Marco; Lüscher, Thomas F; Windecker, Stephan; Räber, Lorenz

    2015-06-01

    We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared with the results from a cohort of 485 STEMI patients undergoing primary PCI without additional imaging. Imaging of the infarct-related artery at baseline (and follow-up) was successful in 92.2% (96.6%) of patients using OCT and in 93.2% (95.5%) using IVUS. Imaging of the non-infarct-related vessels was successful in 88.7% (95.6%) using OCT and in 90.5% (93.3%) using IVUS. Periprocedural complications occurred <2.0% of OCT and none during IVUS. There were no differences throughout 2 years between the imaging and control group in terms of MACE (16.7 vs. 13.3%, adjusted HR1.40, 95% CI 0.77-2.52, p = 0.27). Multi-modality three-vessel i.c. imaging in STEMI patients undergoing primary PCI is consistent a high degree of success and can be performed safely without impact on cardiovascular events at long-term follow-up.

  17. 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.

  18. Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

    PubMed

    Resnik, David B

    2007-10-01

    Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

  19. Myocardial injury after electrical burns: short and long term study.

    PubMed

    Guinard, J P; Chiolero, R; Buchser, E; Delaloye-Bischof, A; Payot, M; Grbic, A; Krupp, S; Freeman, J

    1987-01-01

    Miscellaneous cardiac abnormalities can occur after electrical burns. The long term outcomes are still unknown. We studied 10 patients, 9 of whom suffered high-voltage electrocution, and one of whom was struck by lightning. Serial electrocardiograms (ECG) and serum MB creatine phosphokinase isoenzyme (MB-CPK) activities were obtained during their stay in hospital. ECG and thallium 201 cardiac scintigraphy at rest, as well as echocardiograms were obtained in all patients 4 to 48 months after discharge. In hospital, 9 patients showed one or more abnormal findings at physical examination (4 cases), ECG (8 cases), MB-CPK (1 case). At long term follow-up, 5 patients had one or more myocardial functions or conduction abnormalities, with or without symptoms. One patient had compensated heart failure. Nine patients were asymptomatic. Abnormal ECG findings persisted in 3 patients. Three cardiac scans showed evidence of regional myocardial hypoperfusion. Decreases in left ventricular indices measured by echocardiogram were found in 3 patients. We conclude that high-voltage electrocution is associated with a high incidence of cardiac abnormalities, which may persist. Long term evaluation, requiring cardiac T1 201 scintigraphy and echocardiogram, may be justified.

  20. 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%.

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

    PubMed Central

    Kissin, Igor

    2013-01-01

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

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

    SciTech Connect

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

    1995-02-01

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

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

    NASA Astrophysics Data System (ADS)

    Vasudevan, Srikanth; Patel, Kunal; Welle, Cristin

    2017-02-01

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

  4. 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.

  5. 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.

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

    PubMed Central

    Watanabe, Yoshinori; Hongo, Seiji

    2017-01-01

    Background We investigated whether the long-term efficacy and safety of lamotrigine (LTG) for bipolar disorder (BP) differs between disease types (BP-I, BP-II, or BP not otherwise specified [BP-NOS]), and the efficacy of the concomitant use of antidepressants (ADs). Methods For >1 year, we observed 445 outpatients with BP (diagnosed by DSM-IV criteria) who initiated LTG treatment between July 1 and October 31, 2011, using the Himorogi Self-rating Depression (HSDS) and Anxiety Scales and the Clinical Global Impression-Improvement scale and also recorded adverse events. Results Treatment efficacy was observed at week 4, with the improved HSDS scores sustained until week 52 for all types of BP; 50% of the patients with any type of BP could be treated with LTG for 1 year, whereas ~40% could be treated for >1.5 years. However, 25% of the patients were withdrawn within the first 4 weeks. The overall incidence of adverse events was 22.9% (104/455): 34.1% (14/41) for BP-I, 22.7% (15/66) for BP-II, and 22.2% (75/338) for BP-NOS. The most common adverse event was skin rash: 22.0% for BP-I, 16.7% for BP-II, and 12.1% for BP-NOS. Limitations There was no control group. Data were collected retrospectively. Conclusion With careful and adequate titration, long-term treatment with LTG is possible for any type of BP, with BP-NOS patients, the largest population in clinical practice, responding particularly well. Symptoms can improve with or without ADs. Large-scale prospective studies of the efficacy of ADs in bipolar treatment are warranted. PMID:28360522

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  10. Antihypertensive efficacy and safety of benidipine and its effects on cardiac structure and function in elderly Chinese patients with mild to moderate hypertension: an open-label, long-term study.

    PubMed

    Qi, Weilin; Fan, Weihu

    2011-01-01

    Benidipine (CAS 91599-74-5) has been reported as an effective antihypertensive treatment and its cardioprotective effects have been shown in several basic and clinical studies. However, the long-term efficacy and safety of benidipine remain unknown in elderly Chinese patient with hypertension. In this prospective, multicenter, open-label clinical trial, 152 eligible patients aged 60 to 75 years with mild to moderate essential hypertension (sitting systolic blood pressure (BP) > or = 140 mmHg and/or sitting diastolic BP > or = 90 mmHg) entered a 52-week study. All patients initially received benidipine 2-4 mg once a day, followed by titration to benidipine 8 mg/day to achieve the target BP (< 140/90 mmHg in non-diabetics and <130/80 mmHg in diabetics). Add-on hydrochlorothiazide (CAS 58-93-5) and/or metoprolol tartaric acid (CAS 3750-58-6) were permitted during the study. Overall, 132 patients completed the 52-week treatment with benidipine as monotherapy or combination therapy. It showed that the regimen based on benidipine provided an obvious mean trough BP reduction of 13.8 +/- 12.4/8.3 +/- 9.2 mmHg (p < 0.001), and 62.5% of patients reached the target BP. In patients with left ventricular hypertrophy, the left ventricular mass index significantly decreased from 147.1 +/- 27.6 g/m2 at baseline to 136.0 +/- 17.5 g/m2 at 52 weeks (p = 0.036). Clinical adverse events (AEs) were found in 15.1% of all patients, and six patients discontinued the treatment due to drug-related AEs during the entire trial. Patients' compliance was an average of 98.7%. Benidipine, with a favorable tolerability profile, provides a long-term antihypertensive effect and potential benefit for the heart in elderly patients with mild to moderate hypertensive, suggesting that it is suitable for elderly patients with hypertension.

  11. 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

  12. 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

  13. 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.

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

    SciTech Connect

    Rowat, J.; Metcalf, P.

    2007-07-01

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

  15. Long-term 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

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

    PubMed

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

    2002-08-01

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

  17. 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

  18. 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.

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

    PubMed Central

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

    2016-01-01

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

  20. The efficacy and safety of reinstitution of tocilizumab in patients with relapsed active rheumatoid arthritis after long-term withdrawal of tocilizumab: retreatment of patients with rheumatoid arthritis with novel anti-IL-6 receptor antibody after a long-term interval following SAMURAI: the RONIN study.

    PubMed

    Sagawa, Akira

    2011-08-01

    We have evaluated the efficacy and safety of tocilizumab (TCZ) re-administration in patients with active rheumatoid arthritis (RA) who had previously received TCZ treatment for about 31 months. Four patients whose RA had been well-controlled with 8 mg/kg TCZ treatment every 4 weeks and had withdrawn from the treatment were enrolled. They resumed TCZ treatment after TCZ was authorized for RA treatment in Japan. Disease activity was assessed by the Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR), and synovitis in the wrists and elbows was measured by ultrasonography at baseline and during follow-up. The mean DAS28-ESR was 6.32 before the first TCZ infusion. After fewer than 20 months of initial TCZ treatment, the mean DAS28-ESR decreased to 1.87. However, after withdrawal of TCZ treatment, the disease activity could not be sufficiently controlled with conventional disease-modifying antirheumatic drugs or biologic agents. The maximum interval between TCZ treatments was approximately 34 months. Following reinstatement of the TCZ treatment, within 12 months the mean DAS28-ESR improved from 5.21 to 2.87, with the synovitis in the wrists and elbow joints also showing great improvement. These findings demonstrate that TCZ retreatment in active RA patients who had relapsed after long-term discontinuation of TCZ treatment led to an improvement in the signs and symptoms of RA and in synovitis without any severe adverse events.

  1. Related studies in long term lithium battery stability

    NASA Astrophysics Data System (ADS)

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

    1984-09-01

    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.

  2. 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.

  3. Long-term Studies of Marine Halogen Release

    NASA Astrophysics Data System (ADS)

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

    2009-04-01

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

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

    PubMed

    Bishu, Kalkidan; Agarwal, Rajiv

    2006-09-01

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

  5. 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

  6. 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

  7. 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

  8. Long-Term Outcome of Endoscopic Balloon Dilation in Obstructive Gastrointestinal Crohn's Disease: A Prospective Long-Term Study

    PubMed Central

    Ikeda, Keisuke; Tsuda, Sumio; Yao, Kenshi; Sou, Suketo; Satoh, Shigeru; Hatakeyama, Sadamune; Matake, Hiroaki; Sakurai, Toshihiro; Yao, Tsuneyoshi

    2000-01-01

    Background The short- and long-term results of balloon dilation therapy in Crohn's patients with non-anastomotic obstructive gastrointestinal lesions are investigated. Materials and methods Fifty-five patients with Crohn's disease who had obstructive gastrointestinal lesions were treated prospectively by endoscopic balloon dilation. Short-term results Eight of the initial dilations were unsuccessful giving no symptomatic relief (14.5%). Long-term results The subjects of the long-term prognosis were 40 cases followed up for more than 6 months (average 37 months) and their strictures were non-anastomotic in more than half (59%). Avoidance of surgery, was possible in 31 of 40 patients (78%). Surgery was avoided in 92%, 81% and 77% of patients after one, two, and three years, respectively (Kaplan–Meier's method). There was no difference in long-term outcome between anastomotic strictures and strictures in the absence of prior surgery. Conclusion Our results suggest that, (1) strictures in the absence of prior surgery might be treated in this way as well as anastomotic strictures; (2) if followed for a prolonged time period, more than 70% of patients, who have undergone balloon dilation for obstructive gastrointestinal Crohn's disease, may be able to avoid surgery. PMID:18493528

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

    PubMed

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

    2012-11-01

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

  10. 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.

  11. 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.

  12. 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…

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

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

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

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

    PubMed

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

    2015-05-01

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

  15. 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

  16. A long-term open-label extension study assessing cognition and behavior, tolerability, safety, and efficacy of adjunctive levetiracetam in children aged 4 to 16 years with partial-onset seizures.

    PubMed

    Schiemann-Delgado, Jimmy; Yang, Haichen; Loge, Christine de la; Stalvey, Tracy J; Jones, John; Legoff, Daniel; Mintz, Mark

    2012-01-01

    The objective of this study was to assess cognition and behavior in children (4-16 years; n = 103) with partial-onset seizures using the Leiter-R International Performance Scale and Achenbach Child Behavior Checklist. The study was a multicenter, open-label, noncomparative 48-week extension study (NCT00152516) of adjunctive levetiracetam (20-100 mg/kg/d, mean 50.2 mg/kg/d). Improvement from baseline in Leiter-R Memory Screen composite score at weeks 24 and 48 (mean [SD] change, +4.8 [12.6] and +4.5 [15.3]) was similar to changes observed with levetiracetam and placebo in a prior study. Child Behavior Checklist Syndrome scores improved from baseline at weeks 24 and 48 (total problems mean [SD] change, -9.3 [22.2] and -10.4 [23.4]). Adjunctive levetiracetam was well tolerated (most frequently reported central nervous system-related treatment-emergent adverse events: headache [24.3%], aggression [7.8%], irritability [7.8%]). Of the patients, 4.9% discontinued because of treatment-emergent adverse events. Levetiracetam provided good and sustained seizure control (median percentage reduction from baseline in partial-onset seizure frequency/wk during maintenance: 86.4%); 24.7% of patients had continuous seizure freedom from all seizure types for ≥40 weeks. In children, adjunctive levetiracetam was associated with long-term stability in cognitive functioning and improvement in emotional/behavioral functioning over time.

  17. 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…

  18. 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.

  19. 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…

  20. 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

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2008-04-01

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

  3. 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.

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

    PubMed

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

    2013-07-01

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

  5. 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.

  6. A long term experimental study of canine visceral leishmaniasis.

    PubMed

    Rodríguez-Cortés, Alhelí; Ojeda, Ana; López-Fuertes, Laura; Timón, Marcos; Altet, Laura; Solano-Gallego, Laia; Sánchez-Robert, Elisenda; Francino, Olga; Alberola, Jordi

    2007-05-01

    Previous studies on Leishmania infantum and the canine immune response are derived mainly from short-term studies. To date, there have been no longitudinal studies that perform a serial analysis of the intensity of infection in conjunction with immunological parameters and clinical signs in Leishmania-infected dogs. For this purpose, six dogs were infected experimentally by the i.v. route and were monitored for 1 year. Clinical, immunological (humoral and cellular response) and parasitological (parasitaemia) parameters were evaluated monthly. Four dogs developed clinico-pathological signs compatible with leishmaniasis, whereas two dogs showed few abnormalities during the study. Evaluation of clinical, immunological and parasitological parameters showed that the intensity of Leishmania infection in blood samples, as indicated by the amount of Leishmania DNA, was correlated significantly with IgG, IgG1, IgG2, IgA, and IgM concentrations and with clinical signs. Parasitaemia and Leishmania-specific cell-mediated immunity were inversely correlated. Moreover, higher quantities of Leishmania DNA were detected in the liver, spleen, lymph node, skin and bone marrow of dogs exhibiting clinical signs than those exhibiting few such signs. These findings suggest that progressive disease in experimental canine leishmaniasis is associated with specific T-cell unresponsiveness and unprotective humoral responses which allow the dissemination and multiplication of L. infantum in different tissues.

  7. 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…

  8. Long-Term Operating System Maintenance. A Linux Case Study

    DTIC Science & Technology

    2008-01-01

    when maintaining an operating system for long periods. Therefore, this report serves as an introduction and a simple methodology for performing...and necessary reconfiguration capabilities have been established, an appropriate methodology could be developed for upgrading and updating an...this study proposes a methodology for upgrading and updating an operating system so that installing a newer operating system is not required in order

  9. [Methodology of a long-term study of senile dementia].

    PubMed

    Wertheimer, J; Brull, J

    1977-01-01

    The longitudinal method aims to point out phenomena that are bound with time. It is thus particularly fit for the study of ageing as it is proved by many large American research programs. It is also useful to follow during a limited period (short term) the natural history of pathologic entities as degenerative illnesses. After mentioning the fundamental conditions of any longitudinal approach, the program of this study on senile dementia is described. Each case is followed for 2 years, with an examination every 6 months. This later is based on anamnestic, psychiatric, neurologic and functional items as well as on intellectual functions and EEG. A sample of 50 cases should be collected. After a period of 3 years prospection 91 cases were found of which on 31 fitted. The difficulty of recruitement is bound to several factors: the little knowledge of senile dementia frequency in the general population, the poor criteria used in their choices by non-specialists as the directors of homes, the refusals and the withdrawals. Difficulties in establishing contact with patients showing behavioral troubles are underlined as well as cooperative problems with the surroundings. The repetition, at regular periods, of psychological tests sets the problem of learning. In the way of senile dementia it should decrease with the illness evolution thus bringing the overestimation of initial capacities, the gap becomming artifically greater between performances at the beginning and at the end of the observation.

  10. 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.

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

    PubMed

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

    2014-03-01

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

  12. [Elbow dislocation in childhood. Long-term observational study].

    PubMed

    Frongia, G; Günther, P; Romero, P; Kessler, M; Holland-Cunz, S

    2012-02-01

    Traumatic dislocation of the elbow is rare in children with an incidence of 3-6% of all elbow injuries. In the literature the outcome after elbow dislocation in childhood is rarely discussed. In the present study 33 children treated in our clinic from 2001 to 2008 with an acute traumatic dislocation of the elbow were retrospectively included. All events were unilateral whereby 1 child (3%) showed a recurrence of elbow dislocation after 9 weeks, 30% had a pure dislocation, 70% had a concomitant fracture, 55% showed a fracture of the medial epicondyle, 6% a fracture of the lateral epicondyle and 9% a further fracture. Of the fractures 83% required open reduction with osteosynthesis. After an average of 4.5 years 20 children (61%) were clinically examined. There were no instabilities of the joint and only minor clinical limitations of the range of motion. The established Mayo elbow performance score showed good to excellent results for all children. Despite severe joint trauma with frequently accompanying fractures, post-traumatic functional deficits are rarely limiting, independent of the accompanying fracture. The frequency of recurrence is low and instabilities were not seen.

  13. 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

  14. Leaching of microelement contaminants: a long-term field study.

    PubMed

    Németh, Tamás; Kádár, Imre

    2005-01-01

    A field experiment with microelement loads was set up on loamy textured, calcareous chernozem soil formed on loess. The ploughed layer contained ca. 5% CaCO3 and 3% humus. The soil was well supplied with Ca, Mg, Mn and Cu, moderately supplied with N and K, and weakly supplied with P and Zn. The water table is at the depth of 15 m, the water balance of the area is negative, and the site is drought sensitive. Salts of the 13 examined microelements were applied at 4 doses in the spring of 1991. Treatments were arranged in a split-plot design, in a total of 104 plots with two replications. Loading rates were 0, 90, 270 and 810 kg/ha per element in the form of AlCl3, NaAsO2, BaCl2, CdSO4, K2CrO4, CuSO4, HgCl2, (NH4)6Mo7O24, NiSO4, Pb(NO3)2, Na2SeO3, SrSO4, ZnSO4. Soil profiles of the control and the 810 kg/ha treated plots were sampled in the 3rd, 6th and 10th year of the trial. The mixed samples, consisting of 5 cores/plot were taken in 30 cm steps to 60 cm (year 1993), 90 cm (year 1996), and 290 cm (year 2000). Ammonium acetate + EDTA-soluble element content was determined. The main conclusions of the study are: (1) In soils contaminated with 810 kg/ha load rates As, Hg, Ni, Cu, Pb, Ba and Sr displayed no significant vertical movement. There is little uptake and translocation in plants of these elements: their concentration in the above-ground plant parts usually remains below 5-10 mg/kg dry mass with the exception of Ba and Sr showing a somewhat higher accumulation. Under our conditions the above elements did not behave as dangerous contaminants to the soil, groundwater, or plants. (2) Moderate leaching of Zn and Cd was detected when applied at higher doses. Their accumulation was also moderate in the above-ground plants parts. Zn is not a dangerous pollutant for soil, plants or groundwater at our site. Cd, however, is a very dangerous element because of its high toxicity to mammals, soil life and crops. (3) Cr, Se, and Mo (in the form of chromate, selenate and

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

    PubMed Central

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

    2016-01-01

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

  16. Environmental Perturbations, Behavioral Change, and Population Response in a Long-Term Northern Elephant Seal Study

    DTIC Science & Technology

    2013-09-30

    Population Response in a Long-Term Northern Elephant Seal Study Daniel P. Costa University of California, Santa Cruz 100 Shaffer Rd. Santa Cruz, CA...grant has allowed us to extend and improve a four-decade study of northern elephant seal populations in California, aiming specifically to quantify...in a Long-Term Northern Elephant Seal Study 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e

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

    PubMed

    Tanner, Rachel; Bercaw, Lawren

    2005-12-31

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

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

    PubMed Central

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

    2008-01-01

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

  19. 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

  20. 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.

  1. Long-term open-label study of pramipexole in patients with primary restless legs syndrome.

    PubMed

    Inoue, Yuichi; Kuroda, Kenji; Hirata, Koichi; Uchimura, Naohisa; Kagimura, Tatsuo; Shimizu, Tetsuo

    2010-07-15

    A phase III, open-label, long-term clinical study was performed to evaluate the safety and efficacy of pramipexole in a cohort of 141 Japanese patients with primary restless legs syndrome (RLS). The patients were started on pramipexole 0.25 mg/day and were subsequently maintained on that dose or switched to 0.125, 0.5, or 0.75 mg/day to achieve optimal efficacy and tolerability. The International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome (IRLS) score improved from 22.3+/-4.7 at baseline to 11.1+/-7.7 at week 8 and 4.9+/-5.9 at week 52. IRLS responders, defined as patients whose IRLS total score decreased by > or =50% from baseline, accounted for 67.4% at week 12 and 86.6% at week 52. Over 90% of patients were Clinical Global Impression-global improvement (CGI-I) and Patient Global Impression (PGI) responders. The Pittsburgh Sleep Quality Index (PSQI) score decreased from 7.9+/-3.1 at baseline to 4.6+/-2.9 at week 52. Similarly, the Japanese version of the Epworth Sleepiness Scale score decreased from 9.3+/-5.2 to 4.9+/-3.8. Baseline IRLS score < or =20 was significantly associated with a complete IRLS response in this long-term study. Adverse events were typical of nonergot dopamine agonists, mild in intensity, and decreased in frequency as the study progressed. RLS augmentation was not observed. Pramipexole 0.25-0.75 mg/day is efficacious, safe, and well tolerated in patients with RLS. Pramipexole showed good efficacy, particularly in patients with an IRLS total score <20.

  2. 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

  3. Intervention Program for Long-Term English Learners: A Study of Long-Term English Learners' Literacy Performance in a Reading Intervention Program at Falcon School District

    ERIC Educational Resources Information Center

    Ayala, Erika

    2016-01-01

    The purpose of this sequential explanatory embedded mixed methods study was to: (a) investigate and describe the academic performance of eighth grade students in the Falcon School District (FSD) who were designated as Long Term English Learners (LTELs) and participants in FSD's reading intervention program during their fourth through eighth grade…

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

    PubMed

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

    2012-04-01

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

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

    PubMed

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

    2013-05-28

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

  6. 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…

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2016-11-17

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

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

    PubMed

    Müller, E; Münch, K

    1996-01-01

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

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

    PubMed

    Dinsmore, Wallace W; Wyllie, Michael G

    2012-07-01

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

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

    PubMed Central

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

    2017-01-01

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

  12. Long-Term Engagement in Formal Volunteering and Well-Being: An Exploratory Indian Study.

    PubMed

    Elias, Jereesh K; Sudhir, Paulomi; Mehrotra, Seema

    2016-09-27

    Sustained engagement in volunteering and its correlates have been examined in many studies across the globe. However, there is a dearth of research that explores the perspectives of long-term formal volunteers on the nature of changes perceived in oneself as a result of volunteering. Moreover, the linkages between psychological well-being and volunteering have been insufficiently explored. The present study was aimed at addressing these gaps. A heterogeneous sample of 20 long-term formal volunteer engaged in volunteering across different voluntary organisations in a southern metropolitan Indian city formed the primary sample for the study. In addition, a group of 21 short-term volunteers, matched on age, income and gender, was utilised for comparison with long-term volunteers on well-being indices. A semi structured interview schedule was used to explore self-perceived changes attributable to volunteering experience. In addition, a few standardised measures were used to comprehensively assess subjective well-being and psychological well-being. The interview data provided rich descriptions of perceived positive changes in self across cognitive, behavioral and emotional domains. Mirroring these patterns, the quantitative analyses indicated that long-term volunteers experienced higher levels of psychological well-being (sense of mastery and competence, self-acceptance and sense of engagement and growth) than short-term volunteers. The potential mechanisms involved in beneficial outcomes of long-term volunteering and implications for further research are highlighted.

  13. Long-Term Engagement in Formal Volunteering and Well-Being: An Exploratory Indian Study

    PubMed Central

    Elias, Jereesh K.; Sudhir, Paulomi; Mehrotra, Seema

    2016-01-01

    Sustained engagement in volunteering and its correlates have been examined in many studies across the globe. However, there is a dearth of research that explores the perspectives of long-term formal volunteers on the nature of changes perceived in oneself as a result of volunteering. Moreover, the linkages between psychological well-being and volunteering have been insufficiently explored. The present study was aimed at addressing these gaps. A heterogeneous sample of 20 long-term formal volunteer engaged in volunteering across different voluntary organisations in a southern metropolitan Indian city formed the primary sample for the study. In addition, a group of 21 short-term volunteers, matched on age, income and gender, was utilised for comparison with long-term volunteers on well-being indices. A semi structured interview schedule was used to explore self-perceived changes attributable to volunteering experience. In addition, a few standardised measures were used to comprehensively assess subjective well-being and psychological well-being. The interview data provided rich descriptions of perceived positive changes in self across cognitive, behavioral and emotional domains. Mirroring these patterns, the quantitative analyses indicated that long-term volunteers experienced higher levels of psychological well-being (sense of mastery and competence, self-acceptance and sense of engagement and growth) than short-term volunteers. The potential mechanisms involved in beneficial outcomes of long-term volunteering and implications for further research are highlighted. PMID:27690114

  14. 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

  15. 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…

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

    PubMed

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

    2004-06-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2013-01-01

    To date, anti-tumor necrosis factor alfa (anti-TNF-α) therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, hematologic disorders like aplastic anemia and pancytopenia, vasculitis, immunogenicity, and exacerbation or induction of psoriasis are class effects of all the anti-TNF drugs, and have been seen in patients with ankylosing spondylitis. However, etanercept is less likely to induce reactivation of tuberculosis than the other anti-TNF drugs and it has been suggested that etanercept might be less immunogenic, especially in ankylosing spondylitis. Acute uveitis, Crohn’s disease, and sarcoidosis are other adverse events that have been rarely associated with etanercept

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

    PubMed Central

    2009-01-01

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

  20. 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

  1. A long-term in vitro biocompatibility study of a biodegradable polyurethane and its degradation products.

    PubMed

    van Minnen, B; Stegenga, B; van Leeuwen, M B M; van Kooten, T G; Bos, R R M

    2006-02-01

    The biological safety of degradation products from degradable biomaterials is very important. In this study a new method is proposed to test the cytotoxicity of these degradation products with the aim to save time, laboratory animals, and research funds. A biodegradable polyurethane (PU) foam was subjected to this test method. The PU had soft segments of DL-lactide/epsilon-caprolactone and hard segments synthesized from butanediol and 1,4-butanediiosocyanate. Copolymer foams without urethane segments, consisting of DL-lactide/epsilon-caprolactone, were tested as well. Accumulated degradation products were collected by degrading the foams in distilled water at 60 degrees C up to 52 weeks. Cell-culture medium was prepared from powder medium with this water. In different tests the cytotoxicity of this medium was established. The first signs of cytotoxicity were observed after 3-5 weeks of degradation. This accounts for both materials and reestablishes the good short-term biocompatibility of these materials. The PU showed more toxicity toward the end stages of degradation in comparison with the copolymer. This is probably related to the accumulation of degradation products of the urethane segments. In the in vivo situation the degradation of the PU and the metabolism and excretion of degradation products may differ. Therefore, long-term in vivo studies will have to establish whether these in vitro results are representative for the in vivo behavior of the degrading PU.

  2. Barnidipine monotherapy and combination therapy in older patients with essential hypertension: a long-term study.

    PubMed

    Naber, F B; Häge, R; Mortelmans, J

    2000-11-01

    The long-term (2 year) safety and efficacy of barnidipine was assessed in an open-label, dose-titration, multicentre study of 236 patients aged > or = 75 years with a sitting diastolic blood pressure (DBP) > or = 95 mmHg. All eligible patients started treatment with barnidipine 10 mg once daily. After at least 4 weeks treatment, the dose of barnidipine was titrated upwards to 20 mg daily in patients who did not achieve normalisation of blood pressure (sitting DBP < 90 mmHg). After at least another 4 weeks of treatment an ACE inhibitor or diuretic was added if necessary. Barnidipine monotherapy was the final treatment in 74% of patients in the ITT population (50% barnidipine 10 mg, 24% barnidipine 20 mg). The overall response rate was 84.1% at endpoint. Overall mean sitting DBP decreased by 18.4 mmHg from 102.1 mmHg at baseline to 83.7 mmHg at endpoint. Although a total of 82.2% of patients reported at least one adverse event, only 37.4% of patients experienced an adverse event that was possibly or probably related to the study medication. Many patients experienced adverse events associated with co-existing diseases common in older people. It can be concluded that barnidipine as monotherapy or in combination with ACE inhibitors or diuretics is safe and effective in older patients with essential hypertension.

  3. 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,…

  4. A randomized, naturalistic, parallel-group study for the long-term treatment of panic disorder with clonazepam or paroxetine.

    PubMed

    Nardi, Antonio E; Freire, Rafael C; Mochcovitch, Marina D; Amrein, Roman; Levitan, Michelle N; King, Anna L; Valença, Alexandre M; Veras, André B; Paes, Flávia; Sardinha, Aline; Nascimento, Isabella; de-Melo-Neto, Valfrido L; Dias, Gisele P; E Silva, Adriana Cardoso de O; Soares-Filho, Gastão L; da Costa, Rafael T; Mezzasalma, Marco A; de Carvalho, Marcele R; de Cerqueira, Ana C; Hallak, Jaime E; Crippa, José A; Versiani, Marcio

    2012-02-01

    This long-term extension of an 8-week randomized, naturalistic study in patients with panic disorder with or without agoraphobia compared the efficacy and safety of clonazepam (n = 47) and paroxetine (n = 37) over a 3-year total treatment duration. Target doses for all patients were 2 mg/d clonazepam and 40 mg/d paroxetine (both taken at bedtime). This study reports data from the long-term period (34 months), following the initial 8-week treatment phase. Thus, total treatment duration was 36 months. Patients with a good primary outcome during acute treatment continued monotherapy with clonazepam or paroxetine, but patients with partial primary treatment success were switched to the combination therapy. At initiation of the long-term study, the mean doses of clonazepam and paroxetine were 1.9 (SD, 0.30) and 38.4 (SD, 3.74) mg/d, respectively. These doses were maintained until month 36 (clonazepam 1.9 [SD, 0.29] mg/d and paroxetine 38.2 [SD, 3.87] mg/d). Long-term treatment with clonazepam led to a small but significantly better Clinical Global Impression (CGI)-Improvement rating than treatment with paroxetine (mean difference: CGI-Severity scale -3.48 vs -3.24, respectively, P = 0.02; CGI-Improvement scale 1.06 vs 1.11, respectively, P = 0.04). Both treatments similarly reduced the number of panic attacks and severity of anxiety. Patients treated with clonazepam had significantly fewer adverse events than those treated with paroxetine (28.9% vs 70.6%, P < 0.001). The efficacy of clonazepam and paroxetine for the treatment of panic disorder was maintained over the long-term course. There was a significant advantage with clonazepam over paroxetine with respect to the frequency and nature of adverse events.

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

    PubMed

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

    2015-02-01

    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.

  6. 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.

  7. 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.

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

    PubMed

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

    2013-10-01

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

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

    PubMed

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

    2004-09-01

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

  10. Long-term efficacy follow-up on two cryolipolysis case studies: 6 and 9 years post-treatment.

    PubMed

    Bernstein, Eric F

    2016-12-01

    Cryolipolysis is a noninvasive esthetic procedure that utilizes controlled cooling to reduce subcutaneous fat. Clinical studies have established its safety, efficacy, and tolerability for fat reduction in a variety of areas including the abdomen, flanks, thighs, submental area, arms, back, and chest. Because of obvious esthetic concerns, long-term unilateral studies leaving an untreated flank, thigh, or arm are not performed, but serve as ideal controls for weight gain or loss or re-distribution of fat for other reasons. This article follows two patients previously documented in a case report to demonstrate their ongoing treatment efficacy at 6 and 9 years after treatment. Clinical photographs of the treated flanks and untreated contralateral controls demonstrate long-term durability in these two subjects.

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  13. 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…

  14. 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…

  15. 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.

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

    PubMed Central

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

    2012-01-01

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

  17. 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.

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

    PubMed

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

    2010-06-01

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

  19. 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…

  20. A Pilot Study of CME on Risk Management in Long-Term Care

    ERIC Educational Resources Information Center

    Powers, James; Pichert, James W.; Habermann, Ralf; Ribble, Rachel

    2004-01-01

    This pilot study's purpose was to evaluate behavioral changes among medical directors and physicians following CME on risk management in long-term care (LTC) facilities. The setting was a satellite conference at the AGS Meeting Symposium 2000. CME participants included 51 medical directors, attending physicians, and nurses. Evaluations were based…

  1. 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…

  2. 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…

  3. How Students Structure Their Investigations and Learn Mathematics: Insights from a Long-Term Study

    ERIC Educational Resources Information Center

    Maher, Carolyn A.

    2005-01-01

    This paper reports on the mathematical thinking of participants of a long-term study, now in its 17th year, who did mathematics together through their public school and early university years. In particular, it describes how fundamental ideas and images of a cohort group of students are elaborated and presented in symbolic expressions of…

  4. 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)

  5. Broadening the Knowledge of the LPN Long-Term Care Provider: A Pilot Study

    ERIC Educational Resources Information Center

    Faulk, Debbie; Parker, Francine; Lazenby, Ramona; Morris, Arlene

    2008-01-01

    There are little data regarding Licensed Practical Nurse (LPN) roles in long-term care settings and how the roles might be expanded or changed to meet the unique needs of the elderly. The purpose of this quantitative descriptive study was to determine if an increase in knowledge occurred in LPN care providers after implementation of a 32-hour…

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  7. Naturalistic Studies of the Long-Term Effects of Television Violence.

    ERIC Educational Resources Information Center

    Turner, Charles W.; And Others

    1986-01-01

    Argues that field research can provide evidence about the long-term socialization and developmental effects of media violence on viewer's behavior. Summarizes findings from a number of quasi-experimental studies about the effects of naturally occurring media violence. Concludes that these findings are often consistent with the hypothesis that…

  8. Comparative study of different stochastic weather generators for long-term climate data simulation

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Climate is one of the single most important factors affecting watershed ecosystems and water resources. The effect of climate variability and change has been studied extensively in some places; in many places, however, assessments are hampered by limited availability of long term continuous climate ...

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

    PubMed Central

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

    2017-01-01

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

  10. 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.

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

    PubMed

    Cohen, Donna; Hays, Teresa; Molinari, Victor

    2011-09-01

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

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

    PubMed Central

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

    1997-01-01

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

  14. Distinctiveness of long-term pain that does not interfere with life: An observational cohort study

    PubMed Central

    Jordan, KP; Sim, J; Moore, A; Bernard, M; Richardson, J

    2012-01-01

    Background Reporting of pain that does not interfere with life is common in the older population but little is known about people with such long-term non-interfering pain. Objectives To assess whether non-interfering pain can be a long-term state, and to compare this group with those who continuously report no pain, and with those with chronic pain that interferes with life. Methods This was a prospective general population cohort study set within the North Staffordshire Osteoarthritis Project (NorStOP). People aged 50 plus were sent baseline, 3-year and 6-year questionnaires. Those who reported the same pain status (no pain, non-interfering pain, interfering pain) at each time point were compared on pain intensity, widespread pain and medication, and on sociodemographic and co-morbid characteristics at 6 years. Results Forty percent of responders reported the same pain status at each time point; 12% reported long-term non-interfering pain. Fifty-nine percent of those with non-interfering pain reported at least one site of high pain intensity, 33% reported widespread pain, and 90% had used pain medication in the past 4 weeks. This group was similar to the no-pain group but distinct on sociodemographic and co-morbid measures from those with pain that interfered. Conclusions Long-term non-interfering pain is common, but despite often suffering from high pain intensity and widespread pain, those within this group seem to be able to control their pain without allowing it to affect their everyday lives. Future work is needed to assess how people with long-term pain ensure it does not cause interference with life. PMID:22887341

  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. 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.

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

    PubMed

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

    2015-03-01

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

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

    PubMed

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

    2011-03-01

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

  20. 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

  1. Insights into population ecology from long-term studies of red grouse Lagopus lagopus scoticus.

    PubMed

    Martínez-Padilla, Jesus; Redpath, Steve M; Zeineddine, Mohammed; Mougeot, François

    2014-01-01

    Long-term studies have been the backbone of population ecology. The red grouse Lagopus lagopus scoticus is one species that has contributed widely to this field since the 1950s. This paper reviews the trajectory and profound impact that these studies have had. Red grouse research has combined long-term studies of marked individuals with demographic studies over wide geographical areas and replicated individual- and population-level manipulations. A main focus has been on understanding the causes of population cycles in red grouse, and in particular the relative importance of intrinsic (behaviour) and extrinsic (climate, food limitation and parasite) mechanisms. Separate studies conducted in different regions initially proposed either the nematode parasite Trichostrongylus tenuis or changes in male aggressiveness in autumn as drivers of population cycles. More recent experiments suggest that parasites are not a necessary cause for cycles and have highlighted that behavioural and parasite-mediated mechanisms are interrelated. Long-term experiments show that parasites and aggressiveness interact. Two outstanding questions remain to be tested experimentally. First, what intrinsic mechanism causes temporal variation in patterns of male aggressiveness? The current favoured mechanism is related to patterns of kin structuring although there are alternative hypotheses. Second, how do the dual, interacting mechanisms, affect population dynamics? Red grouse studies have had an important impact on the field of population ecology, in particular through highlighting: (1) the impact of parasites on populations; (2) the role of intrinsic mechanisms in cyclic dynamics and (3) the need to consider multiple, interacting mechanisms.

  2. Long-term e-cigarette use and smoking cessation: a longitudinal study with US population

    PubMed Central

    Zhuang, Yue-Lin; Cummins, Sharon E; Y Sun, Jessica; Zhu, Shu-Hong

    2016-01-01

    Background E-cigarettes have grown popular. The most common pattern is dual use with conventional cigarettes. Dual use has raised concerns that it might delay quitting of cigarette smoking. This study examined the relationship between long-term use of e-cigarettes and smoking cessation in a 2-year period. Methods A nationally representative sample of 2028 US smokers were surveyed in 2012 and 2014. Long-term e-cigarette use was defined as using e-cigarettes at baseline and follow-up. Use of e-cigarettes only at baseline or at follow-up was defined as short-term use. Non-users did not use e-cigarettes at either survey. Quit attempt rates and cessation rates (abstinent for 3 months or longer) were compared across the three groups. Results At 2-year follow-up, 43.7% of baseline dual users were still using e-cigarettes. Long-term e-cigarette users had a higher quit attempt rate than short-term or non-users (72.6% vs 53.8% and 45.5%, respectively), and a higher cessation rate (42.4% vs 14.2% and 15.6%, respectively). The difference in cessation rate between long-term users and non-users remained significant after adjusting for baseline variables, OR=4.1 (95% CI 1.5 to 11.4) as did the difference between long-term users and short-term users, OR=4.8 (95% CI 1.6 to 13.9). The difference in cessation rate between short-term users and non-users was not significant, OR=0.9 (95% CI 0.5 to 1.4). Among those making a quit attempt, use of e-cigarettes as a cessation aid surpassed that of FDA-approved pharmacotherapy. Conclusions Short-term e-cigarette use was not associated with a lower rate of smoking cessation. Long-term use of e-cigarettes was associated with a higher rate of quitting smoking. PMID:27697953

  3. Long-Term Results of Bariatric Restrictive Procedures: A Prospective Study

    PubMed Central

    Wiryasaputra, Dorothee C.; van Dielen, Francois M. H.; van Gemert, Wim G.; Greve, Jan Willem M.

    2010-01-01

    Laparoscopic adjustable gastric banding (LAGB) and vertical-banded gastroplasty (VBG) are surgical treatment modalities for morbid obesity. This prospective study describes the long-term results of LAGB and VBG. One hundred patients were included in the study. Fifty patients underwent LAGB and 50 patients, open VBG. Study parameters were weight loss, changes in obesity-related comorbidities, long-term complications, re-operations including conversions to other bariatric procedures and laboratory parameters including vitamin status. From 91 patients (91%), data were obtained with a mean follow-up duration of 84 months (7 years). Weight loss [percent excess weight loss (EWL)] was significantly more after VBG compared with LAGB, 66% versus 54%, respectively. All comorbidities significantly decreased in both groups. Long-term complications after VBG were mainly staple line disruption (54%) and incisional hernia (27%). After LAGB, the most frequent complications were pouch dilatation (21%) and anterior slippage (17%). Major re-operations after VBG were performed in 60% of patients. All re-operations following were conversions to Roux-en-Y gastric bypass (RYGB). In the LAGB group, 33% of patients had a refixation or replacement of the band, and 11% underwent conversion to another bariatric procedure. There were no significant differences in weight loss between patients with or without re-interventions. No vitamin deficiencies were present after 7 years, although supplement usage was inconsistent. This long-term follow-up study confirms the high occurrence of late complications after restrictive bariatric surgery. The failure rate of 65% after VBG is too high, and this procedure is not performed anymore in our institution. The re-operation rate after LAGB is decreasing as a result of new techniques and materials. Results of the re-operations are good with sustained weight loss and reduction in comorbidities. However, in order to achieve these results, a durable and

  4. 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

  5. Long-term effects of traumatic experience: Comparison study in the adolescent IDPs in Serbia.

    PubMed

    Matsunaga, Chieko; Ristic, Dragana; Niregi, Mitsuki

    2006-12-01

    The purpose of this study is to examine the long term psychological effects of war stress regarded as traumatic experience. The subjects are Serbian internally displaced people (IDP) of adolescent population from Kosovo. It is a very big concern whether the adolescents would overcome the social and psychological difficulties caused by the war stress in order to reconstruct the better society. The result came out that the long-term effects still exist in PTSD, depression and hopelessness, which affects self-esteem and the attitude in purpose in life that are important factors for personality development. This paper also examines the difference between IDPs with war stress and the adolescent sufferers of the big earthquake in Japan.

  6. Chikungunya Virus-associated Long-term Arthralgia: A 36-month Prospective Longitudinal Study

    PubMed Central

    Madec, Yoann; Carpentier, Florence; Kassab, Somar; Albert, Matthew L.; Lecuit, Marc; Michault, Alain

    2013-01-01

    Background Arthritogenic alphaviruses, including Chikungunya virus (CHIKV), are responsible for acute fever and arthralgia, but can also lead to chronic symptoms. In 2006, a Chikungunya outbreak occurred in La Réunion Island, during which we constituted a prospective cohort of viremic patients (n = 180) and defined the clinical and biological features of acute infection. Individuals were followed as part of a longitudinal study to investigate in details the long-term outcome of Chikungunya. Methodology/Principal Findings Patients were submitted to clinical investigations 4, 6, 14 and 36 months after presentation with acute CHIKV infection. At 36 months, 22 patients with arthralgia and 20 patients without arthralgia were randomly selected from the cohort and consented for blood sampling. During the 3 years following acute infection, 60% of patients had experienced symptoms of arthralgia, with most reporting episodic relapse and recovery periods. Long-term arthralgias were typically polyarthralgia (70%), that were usually symmetrical (90%) and highly incapacitating (77%). They were often associated with local swelling (63%), asthenia (77%) or depression (56%). The age over 35 years and the presence of arthralgia 4 months after the disease onset are risk factors of long-term arthralgia. Patients with long-term arthralgia did not display biological markers typically found in autoimmune or rheumatoid diseases. These data helped define the features of CHIKV-associated chronic arthralgia and permitted an estimation of the economic burden associated with arthralgia. Conclusions/Significance This study demonstrates that chronic arthralgia is a frequent complication of acute Chikungunya disease and suggests that it results from a local rather than systemic inflammation. PMID:23556021

  7. 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.

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

    PubMed

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

    2010-12-01

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

  9. Long-Term Outcome of the Management of Chronic Neuropathic Pain: A Prospective Observational Study.

    PubMed

    Moulin, Dwight E; Clark, A John; Gordon, Allan; Lynch, Mary; Morley-Forster, Patricia K; Nathan, Howard; Smyth, Cathy; Toth, Cory; VanDenKerkhof, Elizabeth; Gilani, Ammar; Ware, Mark A

    2015-09-01

    This prospective observational cohort study addressed the long-term clinical effectiveness of the management of chronic neuropathic noncancer pain at 7 Canadian tertiary pain centers. Patients were treated according to standard guidelines and were followed at 3, 6, 12, 18, and 24 months. Standard outcome measures for pain, mood, quality of life, and overall treatment satisfaction were administered, with the primary outcome measure designated as the composite of 30% reduction in average pain intensity and 1-point decrease in the mean Interference Scale Score (0-10) of the Brief Pain Inventory at 12 months relative to baseline. Of 789 patients recruited, mean age was 53.5 ± 14.2 years (55% female) and mean duration of pain was 4.88 ± 5.82 years. Mean average pain intensity (0-10) at baseline was 6.1 ± 1.9. All standard outcome measures showed statistically significant improvement at 12 months relative to baseline (P < .001). However, only 23.7% attained clinically significant improvement in pain and function at 12 months as the primary outcome measure. Univariable analyses showed poorer outcomes at 12-month follow-up with longer duration of pain (P = .002), greater cigarette use (P = .01), more disability compensation (P = .001), and higher opioid doses at baseline and at 12 months (P < .02). Our present treatment modalities provide significant long-term benefit in only about a quarter of patients with neuropathic pain managed at tertiary care pain clinics. Opioid therapy may not be beneficial for the long term. Perspective: Evidence-based treatment of chronic neuropathic pain provides long-term benefit in only about one-quarter of patients seen in tertiary care centers. Opioid therapy may not be beneficial.

  10. Long term efficacy of paroxetine in major depression: A study with plasma levels.

    PubMed

    Mauri, M C; Laini, V; Bitetto, A; Boscati, L; Scalvini, M; Mapelli, L; Rudelli, R

    1999-01-01

    Depressive disorders can be regarded as recurrent and chronic conditions that may reduce the quality of life and work output of patients. Data on the long-term efficacy of paroxetine appear to indicate that it is an effective maintenance treatment. Our aim was to measure paroxetine concentrations in plasma in order to optimize its clinical efficacy and tolerability during long-term treatment. We studied 35 patients aged 23-70 years, suffering from Major Depressive Disorder (recurrent). These patients received 10-50 mg of paroxetine once a day for one year; they were evaluated at baseline, after 2 weeks and then after 1,2,6,9 and 12 months by BPRS, HRS-D and HRS-A rating scales, and at the same time, any side-effects were assessed and samples for paroxetine plasma determination were also collected. Results confirmed the efficacy and tolerability of paroxetine for long-term treatment. We observed a curvilinear relationship between plasma paroxetine levels and improvement on the HRS-D with greater clinical amelioration at plasma levels between 20 and 70 ng/ml.

  11. Long-term exercise maintenance in COPD via telerehabilitation: a two-year pilot study.

    PubMed

    Zanaboni, Paolo; Hoaas, Hanne; Aarøen Lien, Linda; Hjalmarsen, Audhild; Wootton, Richard

    2017-01-01

    Introduction Pulmonary rehabilitation (PR) is an integral part of the management of chronic obstructive pulmonary disease (COPD). However, many patients do not access or complete PR, and long-term exercise maintenance has been difficult to achieve after PR. This study aimed to investigate feasibility, long-term exercise maintenance, clinical effects, quality of life and use of hospital resources of a telerehabilitation intervention. Methods Ten patients with COPD were offered a two-year follow-up via telerehabilitation after attending PR. The intervention consisted of home exercise, telemonitoring and self-management via a webpage combined with weekly videoconferencing sessions. Equipment included a treadmill, a pulse oximeter and a tablet. Data collected at baseline, one year and two years were six-minute walking distance (6MWD), COPD assessment test (CAT), EuroQol 5 dimensions (EQ-5D), hospitalisations and outpatient visits. Results No dropout occurred. Physical performance, lung capacity, health status and quality of life were all maintained at two years. At one year, 6MWD improved by a mean of 40 metres from baseline, CAT decreased by four points and EQ visual analogue scale (EQ VAS) improved by 15.6 points. Discussion Long-term exercise maintenance in COPD via telerehabilitation is feasible. Results are encouraging and suggest that telerehabilitation can prevent deterioration and improve physical performance, health status and quality of life.

  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 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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…

  19. 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…

  20. 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.

  1. 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.

  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.

  3. 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

  4. 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.

  5. 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.

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

    PubMed

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

    1976-02-01

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

  7. Measuring forgetting: a critical review of accelerated long-term forgetting studies.

    PubMed

    Elliott, Gemma; Isaac, Claire L; Muhlert, Nils

    2014-05-01

    Accelerated long-term forgetting (ALF) refers to abnormal forgetting over hours to weeks despite normal acquisition or initial consolidation. Since standardised assessments of memory typically only test at delays of up to 40-minutes, ALF may go undetected in clinical practice. The memory difficulties associated with ALF can however cause considerable distress to patients. It is important therefore that clinicians are aware that ALF may represent a distinct phenomenon that will require additional and careful assessment to aid patients' understanding of the condition and assist in developing strategies to address its effects. At the same time, ALF may also provide insight into long-term memory processes. Studies of ALF in patients with epilepsy have so far demonstrated mixed results, which may reflect differences in methodology. This review explores the methodological issues that can affect forgetting, such as the effects of age, general cognitive function, test sensitivity and initial learning. It then evaluates the extent to which existing studies have considered these key issues. We outline the points to consider when designing ALF studies that can be used to help improve their validity. These issues can also help to explain some of the mixed findings in studies of ALF and inform the design of standardised tests for assessing ALF in clinical practice.

  8. 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.

  9. Retrospective study of long-term outcome after brain arteriovenous malformation rupture: the RAP score.

    PubMed

    Shotar, Eimad; Debarre, Matthieu; Sourour, Nader-Antoine; Di Maria, Federico; Gabrieli, Joseph; Nouet, Aurélien; Chiras, Jacques; Degos, Vincent; Clarençon, Frédéric

    2017-01-20

    OBJECTIVE The authors aimed to design a score for stratifying patients with brain arteriovenous malformation (BAVM) rupture, based on the likelihood of a poor long-term neurological outcome. METHODS The records of consecutive patients with BAVM hemorrhagic events who had been admitted over a period of 11 years were retrospectively reviewed. Independent predictors of a poor long-term outcome (modified Rankin Scale score ≥ 3) beyond 1 year after admission were identified. A risk stratification scale was developed and compared with the intracranial hemorrhage (ICH) score to predict poor outcome and inpatient mortality. RESULTS One hundred thirty-five patients with 139 independent hemorrhagic events related to BAVM rupture were included in this analysis. Multivariate logistic regression followed by stepwise analysis showed that consciousness level according to the Glasgow Coma Scale (OR 6.5, 95% CI 3.1-13.7, p < 10(-3)), hematoma volume (OR 1.8, 95% CI 1.2-2.8, p = 0.005), and intraventricular hemorrhage (OR 7.5, 95% CI 2.66-21, p < 10(-3)) were independently associated with a poor outcome. A 12-point scale for ruptured BAVM prognostication was constructed combining these 3 factors. The score obtained using this new scale, the ruptured AVM prognostic (RAP) score, was a stronger predictor of a poor long-term outcome (area under the receiver operating characteristic curve [AUC] 0.87, 95% CI 0.8-0.92, p = 0.009) and inpatient mortality (AUC 0.91, 95% CI 0.85-0.95, p = 0.006) than the ICH score. For a RAP score ≥ 6, sensitivity and specificity for predicting poor outcome were 76.8% (95% CI 63.6-87) and 90.8% (95% CI 81.9-96.2), respectively. CONCLUSIONS The authors propose a new admission score, the RAP score, dedicated to stratifying the risk of poor long-term outcome after BAVM rupture. This easy-to-use scoring system may help to improve communication between health care providers and consistency in clinical research. Only external prospective cohorts and population

  10. 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

  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. The Scorpion An ideal animal model to study long-term microgravity effects on circadian rhythms

    NASA Astrophysics Data System (ADS)

    Riewe, Pascal C.; Horn, Eberhard R.

    2000-01-01

    The temporal pattern of light and darkness is basic for the coordination of circadian rhythms and establishment of homoeostasis. The 24th frequency of zeitgebers is probably a function of the Earth's rotation. The only way to eliminate its influence on organisms is to study their behavior in space because the reduced day length during orbiting the Earth might disrupt synchronizing mechanisms based on the 24th rhythm. The stability of microgravity induced disturbances of synchronization as well as the extent of adaptation of different physiological processes to this novel environment can only be studied during long-term exposures to microgravity, i.e., on the International Space Station. Biological studies within the long-term domain on ISS demand the use of experimental models which can be exposed to automatic handling of measurements and which need less or no nutritional care. Scorpions offer these features. We describe a fully automatic recording device for the simultaneous collection of data regarding the sensorimotor system and homoeostatic mechanisms. In particular, we record sensitivity changes of the eyes, motor activity and heart beat and/or respiratory activity. The advantage of the scorpion model is supported by the fact that data can be recorded preflight, inflight and postflight from the same animal. With this animal model, basic insights will be obtained about the de-coupling of circadian rhythms of multiple oscillators and their adaptation to the entraining zeitgeber periodicity during exposure to microgravity for at least three biological parameters recorded simultaneously. .

  13. Multicenter study on the long-term (3-year) efficacy of lanthanum carbonate in dialysis patients.

    PubMed

    Ando, Ryoichi; Yama, Satomi; Ohnishi, Tsuyoshi; Iwamoto, Shunsuke; Kimura, Hitoshi; Chida, Yoshiko; Ishida, Yuji; Yamada, Kouei; Inagaki, Yuichiro; Takayama, Masanobu; Tachibana, Ken; Kikuchi, Kan; Inoue, Atsushi; Ohtsuka, Masakazu

    2014-06-01

    We previously conducted a multicenter study enrolling 101 dialysis patients with hyperphosphatemia in which lanthanum carbonate (LC) was administered for 2 years. In this study, the administration has been continued for an additional year, and we have evaluated the long-term (a total of 3 years) effects of LC. The average serum phosphorus (P) level was 6.05 mg/dL at the start and decreased to 5.84 mg/dL after 3 years, but no significant differences were observed at both points. The average serum corrected calcium (Ca) level significantly reduced after 3 years (P < 0.001). As results of evaluating the achievement rates with the management target values of serum P, Ca and intact parathyroid hormone (PTH) stated in the Japanese guideline, the achievement rates increased after 3 years. From these results, LC is considered to be a useful P binder that can be used for long-term treatment of hyperphosphatemia, without causing a Ca load.

  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 Central

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

    2015-01-01

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

  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. Long-term effects of political imprisonment: a group comparison study.

    PubMed

    Maercker, A; Schützwohl, M

    1997-11-01

    The study investigated the long-term effects of political imprisonment in the former German Democratic Republic. A group of non-treatment-seeking former political prisoners (n = 146) was compared with an age- and sex-matched group (n = 75). Assessments included the structured Diagnostic Interview for Psychiatric Disorders (German abbreviation: DIPS) for DSM-III-R/-IV diagnoses, a checklist of persecution and maltreatment, and other self-rated measures of post-traumatic stress disorder (PTSD), anxiety, depression, and dissociation. PTSD was assessed by the DIPS as current and lifetime diagnoses. Former political prisoners were imprisoned for 38 months on average. The former prisoners had a lower educational and lifetime occupational level than the comparison group. Results regarding diagnoses show a frequency of 30% current and 60% lifetime PTSD in the former prisoners group. Other anxiety disorders (e.g., claustrophobia, social phobia) outnumbered comorbid affective disorders. The level of dissociation was elevated in the former prisoners group. Intrusive recollections and hyperarousal were more common than avoidance/numbing symptoms. Despite differences in imprisonment duration between three historically defined eras of persecution, no differences appeared in the level of symptomatology. The results suggest that political imprisonment in the former German Democratic Republic had long-term psychological effects. Compared with an age- and sex-matched comparison group, the former political prisoners showed higher levels not only of post-traumatic symptomatology but also of other anxiety disorders and dissociation.

  19. ALTERATIONS IN BRAIN CREATINE CONCENTRATIONS UNDER LONG-TERM SOCIAL ISOLATION (EXPERIMENTAL STUDY).

    PubMed

    Koshoridze, N; Kuchukashvili, Z; Menabde, K; Lekiashvili, Sh; Koshoridze, M

    2016-02-01

    Stress represents one of the main problems of modern humanity. This study was done for understanding more clearly alterations in creatine content of the brain under psycho-emotional stress induced by long-term social isolation. It was shown that under 30 days social isolation creatine amount in the brain was arisen, while decreasing concentrations of synthesizing enzymes (AGAT, GAMT) and creatine transporter protein (CrT). Another important point was that such changes were accompanied by down-regulation of creatine kinase (CK), therefore the enzyme's concentration was lowered. In addition, it was observed that content of phosphocreatine (PCr) and ATP were also reduced, thus indicating down-regulation of energy metabolism of brain that is really a crucial point for its normal functioning. To sum up the results it can be underlined that long-term social isolation has negative influence on energy metabolism of brain; and as a result reduce ATP content, while increase of free creatine concentration, supposedly maintaining maximal balance for ATP amount, but here must be also noted that up-regulated oxidative pathways might have impact on blood brain barrier, resulting on its permeability.

  20. Acupuncture for the treatment of chronic painful peripheral diabetic neuropathy: a long-term study.

    PubMed

    Abuaisha, B B; Costanzi, J B; Boulton, A J

    1998-02-01

    Forty-six diabetic patients with chronic painful peripheral neuropathy were treated with acupuncture analgesia to determine its efficacy and long-term effectiveness. Twenty-nine (63%) patients were already on standard medical treatment for painful neuropathy. Patients initially received up to six courses of classical acupuncture analgesia over a period of 10 weeks, using traditional Chinese Medicine acupuncture points. Forty-four patients completed the study with 34 (77%) showing significant improvement in their primary and/or secondary symptoms (P < 0.01). These patients were followed up for a period of 18-52 weeks with 67% were able to stop or reduce their medications significantly. During the follow-up period only eight (24%) patients required further acupuncture treatment. Although 34 (77%) patients noted significant improvement in their symptoms, only seven (21%) noted that their symptoms cleared completely. All the patients but one finished the full course of acupuncture treatment without reported or observed side effects. There were no significant changes either in the peripheral neurological examination scores, VPT or in HbA1c during the course of treatment. These data suggest that acupuncture is a safe and effective therapy for the long-term management of painful diabetic neuropathy, although its mechanism of action remains speculative.

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

    PubMed Central

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

    2016-01-01

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

  2. The efficacy and long-term safety of a triple combination of 80 mg telmisartan, 5 mg amlodipine and 12.5 mg hydrochlorothiazide in Japanese patients with essential hypertension: a randomized, double-blind study with open-label extension

    PubMed Central

    Higaki, Jitsuo; Komuro, Issei; Shiki, Kosuke; Ugai, Hiroyuki; Taniguchi, Atsushi; Ikeda, Hiroshi; Kuroki, Daisuke; Nishimura, Seiichiro; Ogihara, Toshio

    2017-01-01

    The aim of this study was to compare 80 mg telmisartan/5 mg amlodipine/12.5 mg hydrochlorothiazide (T80/A5/H12.5) with 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5) to determine their relative blood pressure (BP) lowering effects in essential hypertensive patients with inadequate control and to evaluate the long-term safety of T80/A5/H12.5 in a 52-week extension period. Patients (n=132) were randomly assigned to receive double-blind treatment with T80/A5/H12.5 or T80/H12.5 for 8 weeks after a 6-week run-in-period of T80/H12.5. All 126 patients who completed the double-blind period entered the 52-week open-label extension and received T80/A5/H12.5. The adjusted mean changes from the reference baseline of the trough-seated systolic and diastolic BP (SBP/DBP) at week 8 were significantly larger in the T80/A5/H12.5 group (−10.6/−8.8 mm Hg) than in the T80/H12.5 group (−2.3/−1.3 mm Hg) (P<0.0001). The BP-lowering effect of T80/A5/H12.5 was maintained over the 52-week extension period. The adverse events (AEs) during both treatment periods were generally mild. Drug-related AEs were reported in one patient in each group in the double-blind period and in five patients exposed to T80/A5/H12.5 in the double-blind and/or open-label extension period. T80/A5/H12.5 therapy was clinically and statistically superior to T80/H12.5 therapy for the reduction of BP in patients with essential hypertension uncontrolled with T80/H12.5, and its BP-lowering effect was maintained in the long term. T80/A5/H12.5 was generally well-tolerated. PMID:27581533

  3. 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.

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

    PubMed Central

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

    2015-01-01

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

  5. 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.

  6. 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.

  7. Corn and soybean grain yields in a long-term tillage and cropping systems study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Reports on the long-term effects of tillage and cropping systems on corn and soybean yields are limited. Yields have been measured in a long-term experiment (30+ years) with three cropping systems [continuous corn (CC), continuous soybean (CSB), and soybean-corn (SB-C)] in six primary tillage system...

  8. A Prospective, Open-label Study of Long-term Intrathecal Ziconotide for Chronic Nonmalignant Back Pain: A Case Report.

    PubMed

    Ver Donck, Ann; Dissanayake, Sanjeeva; Bostyn, An; Vercruysse, Piet

    2006-01-01

    Ziconotide is an N-type calcium channel (NCC) blocking conopeptide, acting primarily at the NCC-rich dorsal horn. Reported here is an early experience with intrathecal ziconotide in a 55-year-old man with chronic pain resulting from failed back surgery. All conservative and surgical treatments, in addition to IT morphine, failed prior to enrollment in a short-term, placebo-controlled trial testing ziconotide efficacy and safety. Following successful short-term treatment, the patient was enrolled in a long-term follow-up study. The dosing regimen, onset and resolution of adverse events, and improvement on the primary efficacy measure, the Visual Analog Scale of Pain Intensity, are discussed. Overall, the patient responded positively to ziconotide.

  9. 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

  10. Long-term experiment to study the development, interaction, and influencing factors of DEXA parameters.

    PubMed

    Fuchs, Helmut; Gau, Christine; Hans, Wolfgang; Gailus-Durner, Valerie; Hrabě de Angelis, Martin

    2013-10-01

    Dual-energy X-ray absorption (DEXA) is commonly used to measure bone mineral density (BMD), bone mineral content (BMC), and body composition data (fat mass and lean mass) for phenotype assessment in mice. We were interested in the long-term development of BMD, BMC, lean mass, and fat mass of mice, also taking into account sex and genetic background. The dataset was used to analyze correlations among the different parameters. We analyzed males and females from inbred strains C3HeB/FeJ and C57BL/6J, starting from 42 until 528 days of age. To evaluate the effect of husbandry systems, we repeated a part of the study in a second facility with a different caging system. We also assessed different DEXA settings and repeatability of the scans. The results of this study were used to draw conclusions for the use of DEXA analysis in mouse phenotyping approaches.

  11. 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

  12. 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

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

    PubMed

    Lee, Cheng-Ling; Kuo, Hann-Chorng

    2015-10-22

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

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

    PubMed

    2008-08-13

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

  15. Long-term treatment of transthyretin familial amyloid polyneuropathy with tafamidis: a clinical and neurophysiological study.

    PubMed

    Planté-Bordeneuve, Violaine; Gorram, Farida; Salhi, Hayet; Nordine, Tarik; Ayache, Samar S; Le Corvoisier, Philippe; Azoulay, Daniel; Feray, Cyrille; Damy, Thibaud; Lefaucheur, Jean-Pascal

    2017-02-01

    Tafamidis is a transthyretin (TTR) stabilizer recently approved to slow the neurologic impairment in TTR familial amyloid polyneuropathy (TTR-FAP). The pivotal studies on Tafamidis reported encouraging results on the short term, in the early onset Val30Met-TTR-FAP patients at an early stage of the neuropathy. However, the effect of the drug in the non-Val30Met patients, at a more advanced stage of the disease and on the long term, is less known. In this study, we report the effect of Tafamidis in 43 TTR-FAP patients with a variety of pathogenic mutations, including 53% of non-Val30Met variants, at different stages of neuropathy followed on the long term. General and neurological assessment was performed in a standardized protocol every 6-12 months along with neurophysiological variables, including testing of small nerve fibres. The mean follow-up under treatment was 2 years with a subset of 26 patients treated for 3 years. Overall, Tafamidis was well tolerated. A significant clinical deterioration of the neuropathy and the patient's general condition was observed across the 3 years follow-up, although neurophysiological parameters remained stable for the first 2 years. In contrast, patients had a significant increase of BMI under treatment. Deterioration of the neuropathy correlated to an older age at disease onset or treatment initiation and to poor clinical status at baseline. A higher BMI at baseline was associated with a lower progression of the neuropathy. About one-third of the patients who received 3 years of tafamidis had still preserved walking capacity or good clinical condition, suggesting that tafamidis slowed the disease progression in some patients. Overall, our work shows that tafamidis is well tolerated in TTR-FAP but does not prevent the steady progression of the neuropathy on the long term. Age, neurologic status, and general condition at baseline appear to be best predictors of tafamidis efficacy on the neurological function.

  16. A long-term efficacy study of gene replacement therapy for RPGR-associated retinal degeneration

    PubMed Central

    Wu, Zhijian; Hiriyanna, Suja; Qian, Haohua; Mookherjee, Suddhasil; Campos, Maria M.; Gao, Chun; Fariss, Robert; Sieving, Paul A.; Li, Tiansen; Colosi, Peter; Swaroop, Anand

    2015-01-01

    Mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene account for >70% of X-linked retinitis pigmentosa (XLRP) and 15–20% of all inherited retinal degeneration. Gene replacement therapy for RPGR-XLRP was hampered by the relatively slow disease progression in mouse models and by difficulties in cloning the full-length RPGR-ORF15 cDNA that includes a purine-rich 3′-coding region; however, its effectiveness has recently been demonstrated in four dogs with RPGR mutations. To advance the therapy to clinical stage, we generated new stable vectors in AAV8 or AAV9 carrying mouse and human full-length RPGR-ORF15-coding sequence and conducted a comprehensive long-term dose-efficacy study in Rpgr-knockout mice. After validating their ability to produce full-length proteins that localize to photoreceptor connecting cilia, we evaluated various vector doses in mice during a 2-year study. We demonstrate that eyes treated with a single injection of mouse or human RPGR-ORF15 vector at an optimal dose maintained the expression of RPGR-ORF15 throughout the study duration and exhibited higher electroretinogram amplitude, thicker photoreceptor layer and better targeting of opsins to outer segments compared with sham-treated eyes. Furthermore, mice that received treatment at an advanced age also showed remarkable preservation of retinal structure and function. Retinal toxicity was observed at high vector doses, highlighting the importance of careful dose optimization in future clinical experiments. Our long-term dose-efficacy study should facilitate the design of human trials with human RPGR-ORF15 vector as a clinical candidate. PMID:25877300

  17. 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.

  18. Air Traffic Controllers’ Long-Term Speech-in-Noise Training Effects: A Control Group Study

    PubMed Central

    Zaballos, María T.P.; Plasencia, Daniel P.; González, María L.Z.; de Miguel, Angel R.; Macías, Ángel R.

    2016-01-01

    Introduction: Speech perception in noise relies on the capacity of the auditory system to process complex sounds using sensory and cognitive skills. The possibility that these can be trained during adulthood is of special interest in auditory disorders, where speech in noise perception becomes compromised. Air traffic controllers (ATC) are constantly exposed to radio communication, a situation that seems to produce auditory learning. The objective of this study has been to quantify this effect. Subjects and Methods: 19 ATC and 19 normal hearing individuals underwent a speech in noise test with three signal to noise ratios: 5, 0 and −5 dB. Noise and speech were presented through two different loudspeakers in azimuth position. Speech tokes were presented at 65 dB SPL, while white noise files were at 60, 65 and 70 dB respectively. Results: Air traffic controllers outperform the control group in all conditions [P<0.05 in ANOVA and Mann-Whitney U tests]. Group differences were largest in the most difficult condition, SNR=−5 dB. However, no correlation between experience and performance were found for any of the conditions tested. The reason might be that ceiling performance is achieved much faster than the minimum experience time recorded, 5 years, although intrinsic cognitive abilities cannot be disregarded. Discussion: ATC demonstrated enhanced ability to hear speech in challenging listening environments. This study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions, although good cognitive qualities are likely to be a basic requirement for this training to be effective. Conclusion: Our results show that ATC outperform the control group in all conditions. Thus, this study provides evidence that long-term auditory training is indeed useful in achieving better speech-in-noise understanding even in adverse conditions. PMID:27991470

  19. Magnetic approaches to study collective three-dimensional cell mechanics in long-term cultures (invited)

    PubMed Central

    Zhao, Ruogang; Boudou, Thomas; Wang, Wei-Gang; Chen, Christopher S.; Reich, Daniel H.

    2014-01-01

    Contractile forces generated by cells and the stiffness of the surrounding extracellular matrix are two central mechanical factors that regulate cell function. To characterize the dynamic evolution of these two mechanical parameters during tissue morphogenesis, we developed a magnetically actuated micro-mechanical testing system in which fibroblast-populated collagen microtissues formed spontaneously in arrays of microwells that each contains a pair of elastomeric microcantilevers. We characterized the magnetic actuation performance of this system and evaluated its capacity to support long-term cell culture. We showed that cells in the microtissues remained viable during prolonged culture periods of up to 15 days, and that the mechanical properties of the microtissues reached and maintained at a stable state after a fast initial increase stage. Together, these findings demonstrate the utility of this microfabricated bio-magneto-mechanical system in extended mechanobiological studies in a physiologically relevant 3D environment. PMID:24803684

  20. 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.

  1. Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study).

    PubMed

    Castillo, Renan C; Raja, Srinivasa N; Frey, Katherine P; Vallier, Heather A; Tornetta, Paul; Jaeblon, Todd; Goff, Brandon J; Gottschalk, Allan; Scharfstein, Daniel O; OʼToole, Robert V

    2017-04-01

    Poor pain control after orthopaedic trauma is a predictor of physical disability and numerous negative long-term outcomes. Despite increased awareness of the negative consequences of poorly controlled pain, analgesic therapy among hospitalized patients after orthopaedic trauma remains inconsistent and often inadequate. The Pain study is a 3 armed, prospective, double-blind, multicenter randomized trial designed to evaluate the effect of standard pain management versus standard pain management plus perioperative nonsteroidal anti-inflammatory drugs or pregabalin in patients of ages 18-85 with extremity fractures. The primary outcomes are chronic pain, opioid utilization during the 48 hours after definitive fixation and surgery for nonunion in the year after fixation. Secondary outcomes include preoperative and postoperative pain intensity, adverse events and complications, physical function, depression, and post-traumatic stress disorder. One year treatment costs are also compared between the groups.

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

    PubMed

    Ignatova, M; Karadzhov, I

    1982-01-01

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

  3. Long term study of the effect of sodium cromoglycate on non-specific bronchial hyperresponsiveness.

    PubMed Central

    Jenkins, C J; Breslin, A B

    1987-01-01

    A double blind, crossover study was undertaken to determine whether non-specific hyperresponsiveness in subjects with asthma was reduced by long term treatment with sodium cromoglycate and, if so, whether this was related to change in lung function. Forty four adult asthmatic subjects (41 atopic, three non-atopic) entered the one year study at intervals staggered over six months. After a baseline period to ensure that asthma control was stable subjects entered the treatment period, during which they inhaled sodium cromoglycate 20 mg four times daily or matching placebo four times daily for 16 weeks each, in random order. Response was assessed at four weekly intervals by measurement of lung function and histamine inhalation tests, from which the provocative concentration of histamine causing a 20% fall in FEV1 (PC20H) was calculated. The assessment included daily symptom score, morning and evening Airflow-meter readings and treatment; mean values for each treatment period and also for the final four weeks of each period were compared. There were no significant differences between placebo and sodium cromoglycate treatment for PC20H, FEV1, morning or evening flow meter readings, bronchodilator usage, or symptom scores for the group as a whole, for the 16 week period or for the final four weeks of each period. Thirteen subjects showed better morning and evening flow meter readings while taking sodium cromoglycate than while taking placebo and eight better readings with placebo than with sodium cromoglycate (p less than 0.05). Improvement in lung function did not correlate with baseline lung function or baseline PC20H, or with features of atopy. These results suggest that long term sodium cromoglycate treatment does not alter non-specific bronchial responsiveness in adult asthmatic subjects. PMID:3120345

  4. Monitoring of patients on long-term glucocorticoid therapy: a population-based cohort study.

    PubMed

    Fardet, Laurence; Petersen, Irene; Nazareth, Irwin

    2015-04-01

    About 1% of the general population receives long-term systemic glucocorticoids. The monitoring provided to these patients is unknown. We conducted a population-based cohort study using The Health Improvement Network database. A total of 100,944 adult patients prescribed systemic glucocorticoids for >3 months between January 2000 and December 2012 were studied. The monitoring done before prescribing glucocorticoid therapy and during exposure to the drug was examined. This included measurement of body weight, blood pressure, lipids, glucose and potassium levels, referrals for dual-energy X-ray absorptiometry (DEXA-scan) or to an ophthalmologist/optician, and vaccinations. We assessed factors associated with the odds of being monitored before and during exposure. Before glucocorticoid initiation, weight and blood pressure were monitored in < 20% and < 50% of patients, respectively. Glucose and lipid levels were monitored in less than one-third of the patients, while DEXA-scan and eye monitoring were offered to <15% of them. Vaccination against flu and pneumococcus was given to 57% and 46% of the patients, respectively. During exposure to the drug, <60% of patients who were prescribed the drug for more than a year had their weight, glucose, or lipid levels recorded at least once and <25% of patients were referred at least once for DEXA-scan or screening for eye diseases. Overall, the odds of being monitored were higher in older patients and in those with comorbidities. There were variations in the level of monitoring provided across the UK, but the monitoring has improved over the last 12 years. Although the extent of monitoring of people on long-term glucocorticoids has improved over time, the overall monitoring provided is not satisfactory, particularly in young patients and those without comorbidities.

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

    PubMed Central

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

    2014-01-01

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

  6. 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

  7. 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.

  8. 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.

  9. Prospective, long-term study of the effect of cabergoline on valvular status in patients with prolactinoma and idiopathic hyperprolactinemia.

    PubMed

    Vroonen, Laurent; Lancellotti, Patrizio; Garcia, Monica Tomé; Dulgheru, Raluca; Almanza, Matilde; Maiga, Ibrahima; Magne, Julien; Petrossians, Patrick; Auriemma, Renata; Daly, Adrian F; Beckers, Albert

    2017-01-01

    Since the 1990's cabergoline has been the treatment of choice in prolactinoma, as it permits rapid and effective hormonal and tumor control in most cases. Evidence of cardiac valvulopathy was demonstrated in Parkinson's disease patients treated with dopamine agonists. Retrospective studies in prolactinoma patients treated with cabergoline at lower doses did not show such an effect. However, few prospective data with long-term follow-up are available. The aim of this study was to assess the safety of cabergoline regarding cardiac valvular status during prospective follow-up in patients treated for prolactinoma or idiopathic hyperprolactinemia. We report here a series of 100 patients (71F; median age at diagnosis: 41.5 years) treated with cabergoline for endocrine diseases (prolactinoma n = 89, idiopathic hyperprolactinemia n = 11). All patients underwent complete transthoracic echocardiographic studies at baseline and during long-term prospective surveillance using the same equipment and performed by the same technicians. The median interval between baseline and last follow-up echocardiographic studies while on cabergoline was 62.5 months (interquartile range: 34.75-77.0). The median total duration of cabergoline treatment was 124.5 months (interquartile range: 80.75-188.75) and the median cumulative total dose of cabergoline was 277.8 mg (interquartile range : 121.4-437.8 mg) at last follow-up. We found no clinically relevant alterations in cardiac valve function or valvular calcifications with cabergoline treatment. Our data suggest that findings from retrospective analyses are correct and that cabergoline is a safe chronic treatment at the doses used typically in endocrinology.

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

    PubMed Central

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

    2017-01-01

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

  11. Use of Tradescantia clone 4430 for direct long-term soil mutagenicity studies.

    PubMed

    Cėsnienė, Tatjana; Kleizaitė, Violeta; Rančelis, Vytautas; Zvingila, Donatas; Svabauskas, Kęstutis; Taraškevičius, Ričardas

    2014-07-01

    Soil mutagens permanently and directly affect terrestrial plants, soil microorganisms and invertebrates and indirectly impact vertebrate and human populations. However, the dynamic response to soil mutagens under conditions of long-term exposure has been studied insufficiently. The clonal nature of Tradescantia #4430 and the well-developed associated test systems for evaluation of genotoxicity allow investigation of the permanent effects of direct exposure to the soil not only on plants of the same genotype, but even with the same individual plants, as was done in the present study. Twenty soil samples of different origin were studied in Tradescantia after 0.5, 1 and 2 years of direct exposure to the soil, in order to examine the induction of pink cells (PC), colorless cells (CC) and branched hairs (BH). Additionally, after 0.5 years, micronucleus (MN) formation was assessed, and after 1 year, the variation of random amplified polymorphic DNA (RAPD) markers was evaluated. Nine soil samples were of urban origin, and the others came from different soils from former military grounds. The results of the 0.5-year exposure were compared with the effects of aqueous/DMSO extracts tested in previous work. The long-term exposure period allowed not only a better differentiation of the soils within territories, but also permitted detection of differences between soils of urban and military origin. The results also depended on the test used to evaluate genotoxicity. The 'burst' phenomenon, consisting of a sudden increase of BH variation and, especially, of CC, was observed only in tests of samples from several military sites, mainly after a 2-year exposure. MN formation was less frequent after 0.5 years of exposure compared with the results from aqueous extracts, and this difference was highly significant. The variation of the RAPD markers in a significant portion of the soil samples coincided with a higher level of variation according to other tests (PC, CC, BH), but

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

    NASA Astrophysics Data System (ADS)

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

    2015-04-01

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

  13. 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.

  14. 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.

  15. 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

  16. Long-term economic consequences of child maltreatment: a population-based study.

    PubMed

    Thielen, Frederick W; Ten Have, Margreet; de Graaf, Ron; Cuijpers, Pim; Beekman, Aartjan; Evers, Silvia; Smit, Filip

    2016-12-01

    Child maltreatment is prognostically associated with long-term detrimental consequences for mental health. These consequences are reflected in higher costs due to health service utilization and productivity losses in adulthood. An above-average sense of mastery can have protective effects in the pathogenesis of mental disorders and thus potentially cushion adverse impacts of maltreatment. This should be reflected in lower costs in individuals with a history of child maltreatment and a high sense of mastery. The aims of the study were to prognostically estimate the excess costs of health service uptake and productivity losses in adults with a history of child maltreatment and to evaluate how mastery may act as an effect modifier. Data were used on 5618 individuals participating in the Netherlands Mental Health Survey and Incidence Study (NEMESIS). We focussed on measures of child maltreatment (emotional neglect, physical, psychological and sexual abuse) and economic costs owing to health-care uptake and productivity losses when people with a history of abuse have grown into adulthood. We evaluated how mastery acted as an effect modifier. Estimates were adjusted for demographics and parental psychopathology. Post-stratification weights were used to account for initial non-response and dropout. Due to the non-normal distribution of the costs data, sample errors, 95 % confidence intervals, and p values were calculated using non-parametric bootstrapping (1000 replications). Exposure to child maltreatment occurs frequently (6.9-24.8 %) and is associated with substantial excess costs in adulthood. To illustrate, adjusted annual excess costs attributable to emotional neglect are €1,360 (95 % CI: 615-215) per adult. Mastery showed a significant effect on these figures: annual costs were €1,608 in those with a low sense of mastery, but only €474 in those with a firmer sense of mastery. Child maltreatment has profound mental health consequences and is associated with

  17. 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.

  18. Bone Density in Chronic Schizophrenia with Long-Term Antipsychotic Treatment: Preliminary Study

    PubMed Central

    Lee, Tae-Young; Chung, Hae-Kyung; Choi, Jin-Hee; Kim, Tae-Yong; So, Hyung-Seok

    2010-01-01

    Objective Decreased bone mineral density has been found in the chronic schizophrenic patients who have been given a long-term administration of antipsychotics. Hyperprolactinemia from the antipsychotics and the negative symptom of schizophrenia were considered as the causes for this finding. In this study, the effect of hyperprolactinemia and the negative symptom of schizophrenia on bone mineral density was investigated on male schizophrenic patients. Methods The cross-sectional study was carried out with the subjects of 45 male schizophrenic patients who have undertaken the monotherapy with risperidone, olanzapine and clozapine for at least one year. The demographic factors, clinical symtoms, bone mineral density and hematological test were examined for all the subjects. Results No significant relationship was found between hyperprolactinemia and the decreased bone mineral density in the subjects. The negative schizophrenia symptom of the subjects showed a significant effect on the decreased bone mineral density. Conclusion The decreased bone mineral density finding in the male schizophrenic patients may be caused by the negative schizophrenia symptom rather than the hyperprolactinemia due to the antipsychotics. Additional studies are further required regarding other factors that may affect the decreased bone mineral density such as activity, calcium intake and exposure to sunlight. PMID:21253412

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

    NASA Astrophysics Data System (ADS)

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

    2010-03-01

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

  20. 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

  1. Long Term Stability and Relapse Following Mandibular Advancement and Mandibular Setback Surgeries: A Cephalometric Study

    PubMed Central

    Darshan, S Vinay; Ronad, Yusuf Ahammed; Kishore, M S V; Shetty, K Sadashiva; Rajesh, M; Suman, S D

    2014-01-01

    Background: The aim was to evaluate the long-term hard and soft tissue changes following mandibular advancement and setback surgeries. Materials and Methods: A total of 16 subjects each were selected who underwent bilateral sagittal split osteotomy mandibular advancement and mandibular setback groups. Pre-surgical (T1), immediate post-surgical (T2) and long-term post-surgical (T3) cephalograms were compared for hard and soft tissue changes. After cephalometric measurements, the quantity of changes between T1-T2 and T1-T3 were determined for each patient. The mean difference between T1-T2 and T1-T3 was compared with assess the long-term changes and stability. Results: In mandibular advancement the mean difference between immediate post-surgical and long term post-surgical is 7%, which accounts for a relapse of 7%. In mandibular setback, the mean difference between immediate post-surgical and long-term post-surgical is 29%, which accounts for a relapse of 29%. Conclusion: Mandibular advancement remained stable over the long period when compared to mandibular setback. PMID:25395792

  2. Long Term Multiplication Behavior Studies of the 30cmx 30cm prototype Gas electron Multiplier

    NASA Astrophysics Data System (ADS)

    Ng, Ying Wun Yvonne; Yu, Jaehoon; Park, Seongtae; White, Andy

    2014-03-01

    The Gas Electron Multiplier (GEM) technology is one of the next generation radiation detector technologies that utilized the ionization in gaseous medium and the electron avalanche to detect a magnified charge value from various radiation and charge particles. With its low building cost, low discharge rate and high resolution, GEM is currently being considered to be one of the candidate gap detectors for the International Linear Collider (ILC) in Japan. It is therefore of crucial for us to study the long term stability of amplification power of the detector. Using cosmic radiation as our radiation source, data has been taken continuously in the past 2 years by the high energy physics group in University of Texas at Arlington to characterize the stability of the 30cmx30cm detector. Effect of atmospheric pressure to the detector amplification is eliminated by a correction algorithm. Noise study has been done to eliminate excessive noise produced by the detector as well as its readout chip. Result shows that the detector gives us a stable 35fC average MPV for the cosmic MIPs with few fC of chamber noise and about 0.5 of chip noise. GEM should work well as a digital calorimeter for uses in the ILC project.

  3. 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.

  4. 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.

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

    PubMed Central

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

    1998-01-01

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

  6. Long-term in vivo left ventricular assist device study with a titanium centrifugal pump.

    PubMed

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

    1998-01-01

    A totally implantable centrifugal artificial heart has been developed. The plastic prototype, Gyro PI 601, passed 2 day hemodynamic tests as a functional total artificial heart, 2 week screening tests for antithrombogenicity, and 1 month system feasibility. Based on these results, a metallic prototype, Gyro PI 702, was subjected to in vivo left ventricular assist device (LVAD) studies. The pump system employed the Gyro PI 702, which has the same inner dimensions and the same characteristics as the Gyro PI 601, including an eccentric inlet port, a double pivot bearing system, and a magnet coupling system. The PI 702 is driven with the Vienna DC brushless motor actuator. For the in vivo LVAD study, the pump actuator package was implanted in the preperitoneal space in two calves, from the left ventricular apex to the descending aorta. Case 1 achieved greater than 9 month survival without any complications, at an average flow rate of 6.6 L/min with 10.2 W input power. Case 2 was killed early due to the excessive growth of the calf, which caused functional obstruction of the inlet port. There was no blood clot inside the pump. During these periods, neither case exhibited any physiologic abnormalities. The PI 702 pump gives excellent results as a long-term implantable LVAD.

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

    PubMed

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

    2016-10-01

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

  8. Inducible molecular switches for the study of long-term potentiation.

    PubMed

    Hédou, Gaël; Mansuy, Isabelle M

    2003-04-29

    This article reviews technical and conceptual advances in unravelling the molecular bases of long-term potentiation (LTP), learning and memory using genetic approaches. We focus on studies aimed at testing a model suggesting that protein kinases and protein phosphatases balance each other to control synaptic strength and plasticity. We describe how gene 'knock-out' technology was initially exploited to disrupt the Ca(2+)/calmodulin-dependent protein kinase IIalpha (CaMKIIalpha) gene and how refined knock-in techniques later allowed an analysis of the role of distinct phosphorylation sites in CaMKII. Further to gene recombination, regulated gene expression using the tetracycline-controlled transactivator and reverse tetracycline-controlled transactivator systems, a powerful new means for modulating the activity of specific molecules, has been applied to CaMKIIalpha and the opposing protein phosphatase calcineurin. Together with electro-physiological and behavioural evaluation of the engineered mutant animals, these genetic methodologies have helped gain insight into the molecular mechanisms of plasticity and memory. Further technical developments are, however, awaited for an even higher level of finesse.

  9. 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

  10. 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.

  11. 241Am migration in a sandy aquifer studied by long-term column experiments.

    PubMed

    Artinger, Robert; Schuessler, Wolfram; Scherbaum, Franz; Schild, Dieter; Kim, Jae-Il

    2002-11-15

    The migration behavior of 241Am(III) in a sandy aquifer was studied under near-natural conditions by long-term column experiments of more than 1 year duration. Columns with 50 cm length and 5 cm in diameter were packed with aeolian quartz sand and equilibrated with two different groundwaters having an original dissolved organic carbon concentration (DOC) of 1.1 and 7.2 mg x dm(-3), respectively,from the Gorleben site (Lower Saxony, Germany). In each experiment, 1 cm3 of Am-spiked groundwater ([Am] = 0.2 to 2 micromol x dm(-3)) was injected into the column. The flow rate of the groundwater was adjusted to 0.28 m x d(-1). A small colloid-borne Am fraction was found to elute together with tritiated water. After 414 and 559 days, respectively, the experiments were terminated. Whereas the nonsorbing tracer of tritiated water would have covered a distance of about 350 m in that time period, the maximum of the Am activity was detected between 32 and 40 mm column length. Applying selective dissolution analysis to the sand surface, Am was found to be preferentially bound to iron hydroxide/oxide sites. From this Am distribution, a retardation factor R of about 10(4) was determined and compared to static batch experiments. The Am breakthrough was calculated forthe conditions of the column experiment

  12. 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.

  13. 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.

  14. 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.

  15. Living with the long-term consequences 11-13 years after stroke: A phenomenological study.

    PubMed

    Erikson, Anette; Karlsson, Gunnar; Tham, Kerstin

    2016-11-11

    To follow up an original research project of persons 11-13 years after stroke, in order to describe and understand the impact of stroke on everyday life experienced during these years. Eleven persons who had had a stroke were interviewed 11-13 years after the original research project. Data were collected and analysed using the empirical phenomenological psychological method. Three main characteristics were identified from analysis of participants' experiences during the years after stroke: () going through the loss of the previous life; () struggling to reclaim the former existence; () finding meaning in a "new" and different world. This study provides an understanding of the complexity of the lost connection between body and world occurring for a long time after stroke. This understanding provides support for the need for long-term and intermittent support and guidance to enable the re-creation of meaning and participation in everyday life in order to find a "new" self-identity after stroke, especially among persons with residual cognitive impairment.

  16. [Study of immunization promotion against influenza in nursing homes and long term care facilities in Quebec].

    PubMed

    De Wals, P; Drapeau, J

    1996-01-01

    This study measured the rate of influenza immunization in nursing homes and long-term care facilities, and evaluated the effectiveness of a promotion program in reaching the national objective of 95% coverage. At the end of 1993, data were provided by 55 of the 79 nursing homes in the region of Montérégie, Quebec. The mean reported immunization rate was 78%, minimum 19% and maximum 100%. In 70% of cases, non-vaccination was due to patient refusal. In 1994, an intervention was carried out in a random sample of 28 nursing homes. Directors, chiefs of nursing and consulting physicians were informed of the coverage achieved in their institution in relation to the national objective. In addition, presentations were given to the nursing personnel and residents. These presentations were made by post-graduate medical students in 22 of the 28 nursing homes in the experimental group. No increase in the mean immunization rate was observed, indicating that it will be more difficult than expected to reach the desired level of coverage.

  17. Isolated arthroscopic meniscal repair: a long-term outcome study (more than 10 years).

    PubMed

    Johnson, M J; Lucas, G L; Dusek, J K; Henning, C E

    1999-01-01

    A single surgeon's consecutive series of 50 arthroscopically repaired meniscal tears in 48 patients was retrospectively reviewed. None of these patients had concomitant ligament damage to the knee. The average follow-up period was 10 years, 9 months. Criteria for clinical success included 1) history of pain of grade 1 or less and absence of locking, catching, or giving way; 2) a physical examination demonstrating no significant effusion and a painless and negative jump sign; and 3) no subsequent surgical procedures on the repaired meniscus. Patient satisfaction was quite high, although clinical confirmation was possible in only 38 knees, indicating a clinical success rate of 76%. Bilateral standing radiographs were obtained on these 38 operated knees and were evaluated using Fairbank's classification. Evaluation of the radiographs revealed that 8% of the operated knees had minimal joint changes, as compared with 3% in the contralateral, nonoperated knee. This study demonstrates that arthroscopic meniscal repair in knees with isolated meniscal tears has the potential for a long-term successful clinical and radiographic outcome.

  18. 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.

  19. 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.

  20. 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

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

    PubMed

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

    2013-03-01

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

  2. A microfluidic system for long-term time-lapse microscopy studies of mycobacteria.

    PubMed

    Golchin, Solmaz A; Stratford, James; Curry, Richard J; McFadden, Johnjoe

    2012-11-01

    Phenotypic heterogeneity in bacterial populations is thought to contribute to a number of important phenomena including sporulation and persistence. The latter has clinical implications in many diseases such as tuberculosis, where persistence of Mycobacterium tuberculosis within the human host is believed to be the root cause of latent tuberculosis and the ability of a minority population of cells to survive antibiotic exposure, despite being genetically identical to the bulk population that are killed. However, phenotypic variations caused by non-genetic mechanisms are difficult to study because of the transient nature of the persistent state and thereby the requirement to observe individual cells in real-time. Recently, microfluidics, combined with time-lapse microscopy, has become a powerful tool for studying population heterogeneity in bacteria. However, growth and replication of mycobacterial cells provide particular problems for the development of microfluidic systems due to their tendency to grow in three dimensions. We here describe a novel microfluidic device for the observation of growth and antibiotic killing in individual mycobacterial cells. We constructed a microfluidic device suitable for studying single cell behavior in mycobacteria. The growth of single cells of Mycobacterium smegmatis expressing green fluorescent protein was monitored using a confocal laser scanning microscope. Within the device M. smegmatis cells were tightly confined within a hydrogel matrix thus promoting planar growth. Cell growth and killing was observed in the device with dead cells highlighted by uptake of propidium iodide. Conclusions/Significance. We demonstrate that our device allows real-time analysis and long-term culture of single cells of mycobacteria, and is able to support the study of cell death during the application of antibiotics. The device will allow observation of individual cells' cell genealogy to be determined and direct observation of rare states, such

  3. 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...

  4. 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)

  5. 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,…

  6. 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…

  7. Leisure time physical activity and long-term cardiovascular and cancer outcomes: the Busselton Health Study.

    PubMed

    Gunnell, Anthony S; Knuiman, Matthew W; Divitini, Mark L; Cormie, Prue

    2014-11-01

    The study aimed to investigate whether meeting leisure time physical activity recommendations was associated with reduced incident and fatal cancer or cardiovascular disease (CVD) in a community-based cohort of middle- to late-aged adults with long-term follow-up. At baseline, 2,320 individuals were assessed on a large number of lifestyle and clinical parameters including their level of physical activity per week, other risk factors (e.g. smoking and alcohol use) various anthropometric measures, blood tests and medical history. Individuals were linked to hospital and mortality registry data to identify future cancer and cardiovascular events (fatal and non-fatal) out to 15 years of follow-up. Cox regression analyses adjusted for relevant confounders identified a priori were used to estimate risk for all-cause, cancer-specific and CVD-specific mortality. In the full cohort an estimated 21 % decreased risk for all-cause mortality (HR 0.79; 95 % CI 0.66-0.96) and 22 % decreased risk for fatal/non-fatal CVD events (HR 0.78; 95 % CI 0.66-0.92) was associated with baseline self-reported physical activity levels of 150 min or more. After exclusion of those with chronic co-morbidities (CVD, cancer, diabetes, chronic obstructive pulmonary disease, hypertension treatment) at baseline, lower risk for fatal/non-fatal CVD events remained significantly associated with 150 min or more of physical activity (HR 0.77; 95 % CI 0.62-0.96). Results from this well established prospective community-based cohort study support the role of leisure time physical activity in reducing all-cause mortality and CVD events (fatal/nonfatal) in the broader population studied. The data also suggest that physical activity associated reductions in risk for CVD events (fatal/nonfatal) were not overly impacted by prevalent key non-communicable diseases.

  8. 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

  9. Tolerability of long-term prophylaxis with fansidar: a randomized double-blind study in Nigeria.

    PubMed

    Stemberger, H; Leimer, R; Wiedermann, G

    1984-12-01

    A randomized double-blind study was performed to compare the side effects of long-term chemoprophylaxis of malaria with Fansidar (1 tablet a week) with those of a 300-mg weekly chloroquine regimen. This study was designed as a field trial with Austrian industrial workers in Nigeria and included 173 volunteers, 86 taking Fansidar and 87 taking chloroquine for 6 to 22 months. Only a few complaints were reported during that time, gastrointestinal disorders predominating in the Fansidar group and insomnia in the chloroquine group (3 cases each). The other complaints in both groups included one case each of skin rash and of visual disturbance, as well as one case of facial erythema after alcohol consumption in the Fansidar group and one of hair loss in the chloroquine group. Laboratory checks were performed at 3-monthly intervals, and included white and red cell counts, platelet counts and determination of GOT, GPT and alkaline phosphatase. There were no signs of drug-associated liver damage. In the Fansidar group there occurred a slight and transient decrease in the red cell count and in the chloroquine group a slight and transient decrease in the white cell count. Although statistically significant, these changes were without clinical significance. It is noteworthy that there were no cases of leucopenia in the Fansidar group. With the exception of one volunteer, who had discontinued his prophylactic drug regimen, malaria did not occur. Antibodies against blood stage parasites as determined by the indirect immunofluorescence test (IIFT), however, could be found at different stages of the study, which indicates that these two antimalarials are not causal prophylactic agents.

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

    PubMed Central

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

    2015-01-01

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

  11. Long-Term Study Of Health And Quality Of Life After Burn Injury

    PubMed Central

    Moi, A.L.; Haugsmyr, E.; Heisterkamp, H.

    2016-01-01

    Summary The aim of the present study was to examine burn patient health status, quality of life and work status 16.2 (1.7) [mean (SD)] years after burn injury, and to compare the findings with similar questionnaire data from the same people obtained 11.5 years earlier. Data on burn-specific health (BSHS-N), generic health (SF-36), overall quality of life (QOLS), injury characteristics, socio-demography and work were obtained in 2001 from 95 adult burn patients. In 2013, 78 participants were still eligible, and 34 of them (age: 53.4 [9.4] [mean (SD)], total body surface burn: 17.8% [12.7%]; full thickness injury: 4.4% [5.1%]) answered a follow up study. In 2001, the burn patients reported impaired health status, but an overall quality of life comparable to the Norwegian general population. In particular, the participants were satisfied with their close relationships. At follow up 11.5 years later, the perceived burn-specific and generic health remained unchanged, whereas overall quality of life had improved significantly (QOLS score 77.2 (10.2) vs. 73.1 (12.1), p=0.003), with the largest improvements in the items related to satisfaction with helping others, work, physical active pastimes and independence. The results indicate that self-perceived functioning and wellbeing expressed by burn-specific and generic health status remain stable after the first years post injury. The improvement in overall quality of life 16.2 years post injury suggests long-term processes of growth. PMID:28289366

  12. 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.

  13. Long-Term Study Of Health And Quality Of Life After Burn Injury.

    PubMed

    Moi, A L; Haugsmyr, E; Heisterkamp, H

    2016-12-31

    The aim of the present study was to examine burn patient health status, quality of life and work status 16.2 (1.7) [mean (SD)] years after burn injury, and to compare the findings with similar questionnaire data from the same people obtained 11.5 years earlier. Data on burn-specific health (BSHS-N), generic health (SF-36), overall quality of life (QOLS), injury characteristics, socio-demography and work were obtained in 2001 from 95 adult burn patients. In 2013, 78 participants were still eligible, and 34 of them (age: 53.4 [9.4] [mean (SD)], total body surface burn: 17.8% [12.7%]; full thickness injury: 4.4% [5.1%]) answered a follow up study. In 2001, the burn patients reported impaired health status, but an overall quality of life comparable to the Norwegian general population. In particular, the participants were satisfied with their close relationships. At follow up 11.5 years later, the perceived burn-specific and generic health remained unchanged, whereas overall quality of life had improved significantly (QOLS score 77.2 (10.2) vs. 73.1 (12.1), p=0.003), with the largest improvements in the items related to satisfaction with helping others, work, physical active pastimes and independence. The results indicate that self-perceived functioning and wellbeing expressed by burn-specific and generic health status remain stable after the first years post injury. The improvement in overall quality of life 16.2 years post injury suggests long-term processes of growth.

  14. 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

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

    PubMed Central

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

    2008-01-01

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

  17. Long-Term Exposure to Road Traffic Noise and Incident Diabetes: A Cohort Study

    PubMed Central

    Andersen, Zorana J.; Nordsborg, Rikke B.; Becker, Thomas; Tjønneland, Anne; Overvad, Kim; Raaschou-Nielsen, Ole

    2012-01-01

    Background: Road traffic noise at normal urban levels can lead to stress and sleep disturbances. Both excess of stress hormones and reduction in sleep quality and duration may lead to higher risk for type 2 diabetes. Objective: We investigated whether long-term exposure to residential road traffic noise is associated with an increased risk of diabetes. Methods: In the population-based Danish Diet, Cancer and Health cohort of 57,053 people 50–64 years of age at enrollment in 1993–1997, we identified 3,869 cases of incident diabetes in a national diabetes registry between enrollment and 2006. The mean follow-up time was 9.6 years. Present and historical residential addresses from 1988 through 2006 were identified using a national register, and exposure to road traffic noise was estimated for all addresses. Associations between exposure to road traffic noise and incident diabetes were analyzed in a Cox regression model. Results: A 10-dB higher level of average road traffic noise at diagnosis and during the 5 years preceding diagnosis was associated with an increased risk of incident diabetes, with incidence rate ratios (IRR) of 1.08 (95% CI: 1.02, 1.14) and 1.11 (95% CI: 1.05, 1.18), respectively, after adjusting for potential confounders including age, body mass index, waist circumference, education, air pollution (nitrogen oxides), and lifestyle characteristics. After applying a stricter definition of diabetes (2,752 cases), we found IRRs of 1.11 (95% CI: 1.03, 1.19) and 1.14 (95% CI: 1.06, 1.22) per 10-dB increase in road traffic noise at diagnosis and during the 5 years preceding diagnosis, respectively. Conclusion: Exposure to residential road traffic noise was associated with a higher risk of diabetes. This study provides further evidence that urban noise may adversely influence population health. PMID:23229017

  18. Long-term studies on the effects of nonvolatile organic compounds on porous media surface areas.

    PubMed

    Khachikian, Crist S; Harmon, Thomas C

    2002-01-01

    This paper investigates the long-term behavior of porous media contaminated by nonvolatile organic compounds (NVOC) in terms of specific interfacial surface area. Specifically, a natural sand, Moffett sand (MS), was contaminated with naphthalene and the surface area was measured repeatedly over time using nitrogen adsorption-desorption techniques. A field-contaminated sand affected by lamp-black material (LB) from former manufactured gas plant operations was also studied. Lampblack is a carbonaceous skeleton containing polycyclic aromatic hydrocarbons (PAHs) and other hydrocarbons. It is hypothesized that soils contaminated by these types of chemicals will exhibit significantly less surface area than their clean counterparts. The surface areas for the contaminated MS samples increased toward their clean-MS values during the 700-h aging period, but achieved the clean values only after pentane extraction or heating at 60 degrees C. Heating at 50 degrees C failed to achieve a similar recovery of the clean-MS surface area value. Nonspecific mass loss tracked the increase in surface area as indirect evidence that naphthalene loss was the cause of the surface area increase. For the LB samples, aging at 100 degrees C produced a slight decrease in surface area and mass while aging at 250 degrees C caused the surface area to increase roughly threefold while the mass decreased by approximately 1%. These results suggest that, under moderate heating and over the time scale of this investigation, there is a redistribution of the complex contaminant mixture on the solid matrix. Greater temperatures remove mass more efficiently and therefore exhibited the surface area increase expected in this experiment.

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

    PubMed

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

    2016-01-01

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

  20. Long-term trajectories of back pain: cohort study with 7-year follow-up

    PubMed Central

    Dunn, Kate M; Campbell, Paul; Jordan, Kelvin P

    2013-01-01

    Objective To describe long-term trajectories of back pain. Design Monthly data collection for 6 months at 7-year follow-up of participants in a prospective cohort study. Setting Primary care practices in Staffordshire, UK. Participants 228 people consulting their general practitioners with back pain, on whom information on 6-month back pain trajectories had been collected during 2001–2003, and who had valid consent and contact details in 2009–2010, were contacted. 155 participants (68% of those contacted) responded and provided sufficient data for primary analyses. Outcome measures Trajectories based on patients’ self-reports of back pain were identified using longitudinal latent class analysis. Trajectories were characterised using information on disability, psychological status and presence of other symptoms. Results Four clusters with different back pain trajectories at follow-up were identified: (1) no or occasional pain, (2) persistent mild pain, (3) fluctuating pain and (4) persistent severe pain. Trajectory clusters differed significantly from each other in terms of disability, psychological status and other symptoms. Most participants remained in a similar trajectory as 7 years previously (weighted κ 0.54; 95% CI 0.42 to 0.65). Conclusions Most people with back pain appear to follow a particular pain trajectory over long time periods, and do not have frequently recurring or widely fluctuating patterns. The results are limited by lack of information about the time between data collection periods and by loss to follow-up. However, findings do raise questions about standard divisions into acute and chronic back pain. A new framework for understanding the course of back pain is proposed. PMID:24334157

  1. Idiopathic intracranial hypertension is not benign: a long-term outcome study.

    PubMed

    Yri, Hanne M; Wegener, Marianne; Sander, Birgit; Jensen, Rigmor

    2012-05-01

    Idiopathic intracranial hypertension (IIH) primarily affects young obese females, and potentially causes visual loss and severe headache. The aim of this experiment is to examine relapse rate and long-term outcome in IIH patients. The methods involved in this experiment include a prospective controlled study of 18 newly diagnosed IIH patients followed for a mean observation period of 21.1 (±8.0) months. Treatment regime included diuretics, dietary recommendations and check-up visits at a dietician. Baseline and follow-up included neurological examination, detailed headache history and comprehensive neuro-ophthalmological examination, including fundus photography, Humphrey visual fields, and measurement of the retinal thickness (RT) and retinal nerve fiber layers (RNFL) by optical coherence tomography (OCT). Relapse was defined as recurrence of either: (1) papilledema or (2) symptoms and demonstrated raised ICP. The result of this experiment is that relapse was found in 28%. Visual function improved from baseline to follow-up and was generally favorable. In patients without relapse of papilledema RT and RNFL were significantly thinner than in healthy controls (p = 0.003 and 0.02), although atrophy was clinically detectable in only one patient. Headache was still present in 67% of the patients at follow-up. Headache was heterogenic and unrelated to relapse. After an initial reduction, weight increased again in the relapse group compared to reduced weight in the non-relapse group (p = 0.013). Thus, the conclusions drawn are that headache was persistent, difficult to classify, and equally represented in relapse and non-relapse patients. Headache was thus a poor marker of active disease. Relapse rate was high and clinically undetectable optic disc atrophy was discovered in apparently well treated IIH patients.

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

    PubMed Central

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

    2013-01-01

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

  3. Long-term safety and efficacy of taliglucerase alfa in pediatric Gaucher disease patients who were treatment-naïve or previously treated with imiglucerase.

    PubMed

    Zimran, Ari; Gonzalez-Rodriguez, Derlis Emilio; Abrahamov, Aya; Cooper, Peter A; Varughese, Sheeba; Giraldo, Pilar; Petakov, Milan; Tan, Ee Shien; Chertkoff, Raul

    2016-10-20

    Taliglucerase alfa is an enzyme replacement therapy approved for treatment of Gaucher disease (GD) in children and adults in several countries. This multicenter extension study assessed the efficacy and safety of taliglucerase alfa in pediatric patients with GD who were treatment-naïve (n=10) or switched from imiglucerase (n=5). Patients received taliglucerase alfa 30 or 60U/kg (treatment-naïve) or the same dose as previously treated with imiglucerase every other week. In treatment-naïve patients, taliglucerase alfa 30 and 60U/kg, respectively, reduced mean spleen volume (-18.6 multiples of normal [MN] and -26.0MN), liver volume (-0.8MN and -0.9MN), and chitotriosidase activity (-72.7% and -84.4%), and increased mean Hb concentration (+2.0g/dL and +2.3g/dL) and mean platelet count (+38,200/mm(3) and +138,250/mm(3)) from baseline through 36 total months of treatment. In patients previously treated with imiglucerase, these disease parameters remained stable through 33 total months of treatment with taliglucerase alfa. Most adverse events were mild/moderate; treatment was well tolerated. These findings extend the taliglucerase alfa safety and efficacy profile and demonstrate long-term clinical improvement in treatment-naïve children receiving taliglucerase alfa and maintenance of disease stability in children switched to taliglucerase alfa. Treatment was well-tolerated, with no new safety signals. This study is registered at www.clinicaltrials.gov as NCT01411228.

  4. HOW DO WORK HIERARCHIES AND STRICT DIVISIONS OF LABOUR IMPACT CARE WORKERS’ EXPERIENCES OF HEALTH AND SAFETY? CASE STUDIESOF LONG TERM CARE IN TORONTO

    PubMed Central

    SYED, I.; DALY, T.; ARMSTRONG, P.; LOWNDES, R.; CHADOIN, M.; NAIDOO, V.

    2016-01-01

    Background According to the Canadian Health Care Association (1), there are 2,577 long-term care (“LTC”) facilities across Canada, with the largest proportion (33.4%) located in Ontario. Most studies focus on residents’ health, with less attention paid to the health and safety experiences of staff. Given that the work performed in Ontario LTC facilities is very gendered, increasingly racialized, task-oriented, and with strict divisions of labour, this paper explores in what ways some of these factors impact workers’ experiences of health and safety. Objectives The study objectives included the following research question: How are work hierarchies and task orientation experienced by staff? Design and Setting This paper draws on data from rapid team-based ethnographies of the shifting division of labour in LTC due to use of informal carers in six non-profit LTC facilities located in Toronto, Ontario. Methods Our method involved conducting observations and key informant interviews (N=167) with registered nurses, registered practical nurses, personal support workers, dietary aides, recreation therapists, families, privately paid companions, students, and volunteers. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed. For observations, researchers were paired and covered shifts between 7 a.m. and 11 p.m., as well as into the late night over six days, at each of the six sites. Detailed ethnographic field notes were written during and immediately following observational fieldwork. Results Our results indicate that employee stress is linked to the experiences of care work hierarchies, task orientation, and strict divisions of labour between and among various staff designations. Conclusion Findings from this project confirm and extend current research that demonstrates there are challenging working conditions in LTC, which can result in occupational health and safety problems, as well as stress for individual workers. PMID:28066839

  5. Short-, middle- and long-term safety of superparamagnetic iron oxide-labeled allogeneic bone marrow stromal cell transplantation in rat model of lacunar infarction.

    PubMed

    Tan, Chengbo; Shichinohe, Hideo; Abumiya, Takeo; Nakayama, Naoki; Kazumata, Ken; Hokari, Masaaki; Hamauchi, Shuji; Houkin, Kiyohiro

    2015-06-01

    Recently, both basic and clinical studies demonstrated that bone marrow stromal cell (BMSC) transplantation therapy can promote functional recovery of patients with CNS disorders. A non-invasive method for cell tracking using MRI and superparamagnetic iron oxide (SPIO)-based labeling agents has been applied to elucidate the behavior of transplanted cells. However, the long-term safety of SPIO-labeled BMSCs still remains unclear. The aim of this study was to investigate the short-, middle- and long-term safety of the SPIO-labeled allogeneic BMSC transplantation. For this purpose, BMSCs were isolated from transgenic rats expressing green fluorescent protein (GFP) and were labeled with SPIO. The Na/K ATPase pump inhibitor ouabain or vehicle was stereotactically injected into the right striatum of wild-type rats to induce a lacunar lesion (n = 22). Seven days after the insult, either BMSCs or SPIO solution were stereotactically injected into the left striatum. A 7.0-Tesla MRI was performed to serially monitor the behavior of BMSCs in the host brain. The animals were sacrificed after 7 days (n = 7), 6 weeks (n = 6) or 10 months (n = 9) after the transplantation. MRI demonstrated that BMSCs migrated to the damage area through the corpus callosum. Histological analysis showed that activated microglia were present around the bolus of donor cells 7 days after the allogeneic cell transplantation, although an immunosuppressive drug was administered. The SPIO-labeled BMSCs resided and started to proliferate around the route of the cell transplantation. Within 6 weeks, large numbers of SPIO-labeled BMSCs reached the lacunar infarction area from the transplantation region through the corpus callosum. Some SPIO nanoparticles were phagocytized by microglia. After 10 months, the number of SPIO-positive cells was lower compared with the 7-day and 6-week groups. There was no tumorigenesis or severe injury observed in any of the animals. These findings suggest that

  6. 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.

  7. 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

  8. Long-term use of oxcarbazepine oral suspension in childhood epilepsy: open-label study.

    PubMed

    Rufo-Campos, Miguel; Casas-Fernández, Carlos; Martínez-Bermejo, Antonio

    2006-06-01

    Studies designed specifically for the pediatric population are needed to assess the tolerability and safety of the new antiepileptic drugs. The purpose of this study was to document the safety, ease of dosing, and acceptance of oxcarbazepine oral suspension in pediatric patients in monotherapy and polytherapy. A prospective, multicenter, open-label study was conducted at the neurology services of three pediatric university hospitals over 12 months. After obtaining signed informed consent, we enrolled a series of 62 patients with epilepsy aged between 2 months and 14 years who began oxcarbazepine treatment in monotherapy or in combination with other antiepileptic drugs to assess the seizure frequency, safety (adverse events), and acceptance of the pharmaceutical form by the patient's family. Fifty patients (80.6%) reduced seizures by at least 50%, 44 (71%) saw a reduction in seizure frequency of over 75%, and 29 (46.8%) were seizure free at the end of the study. The difference in the number of seizures before and after the study was statistically significant, both overall and by type of pathology. Adverse events occurred in four patients (6.4%) and required withdrawal of the drug in two cases (skin rash); three patients (4.8%) withdrew for inefficacy. Five patients (8.1%) withdrew from the treatment. We concluded that, in this series of patients, oxcarbazepine in oral suspension form was seen to help reduce seizure frequency, to have few side effects, and to be accepted by parents and patients.

  9. Environmental Perturbations, Behavioral Change, and Population Response in a Long-Term Northern Elephant Seal Study

    DTIC Science & Technology

    2014-09-30

    of transfer functions which describe how behavioral responses to sound affect life functions, how life functions are linked to vital population...Resource Sound Research Requirements, specifically within the “Response to Naval Sounds ” requirement #5: Determine biologically significant behavioral...responses from Navy sound sources on individuals representing marine mammal species of concern with respect to ... determining long-term effects of

  10. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

    PubMed Central

    González-Rodríguez, Alexandre; Catalán, Rosa; Penadés, Rafael; Garcia-Rizo, Clemente; Bioque, Miquel; Parellada, Eduard; Bernardo, Miquel

    2015-01-01

    Background and objectives Short-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations. Method Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available. Results Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted. Conclusion Several studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release. PMID:26082620

  11. Development of long-term event memory in preverbal infants: an eye-tracking study.

    PubMed

    Nakano, Tamami; Kitazawa, Shigeru

    2017-03-08

    The development of long-term event memory in preverbal infants remains elusive. To address this issue, we applied an eye-tracking method that successfully revealed in great apes that they have long-term memory of single events. Six-, 12-, 18- and 24-month-old infants watched a video story in which an aggressive ape-looking character came out from one of two identical doors. While viewing the same video again 24 hours later, 18- and 24-month-old infants anticipatorily looked at the door where the character would show up before it actually came out, but 6- and 12-month-old infants did not. Next, 12-, 18- and 24-month-old infants watched a different video story, in which a human grabbed one of two objects to hit back at the character. In their second viewing after a 24-hour delay, 18- and 24-month-old infants increased viewing time on the objects before the character grabbed one. In this viewing, 24-month-old infants preferentially looked at the object that the human had used, but 18-month-old infants did not show such preference. Our results show that infants at 18 months of age have developed long-term event memory, an ability to encode and retrieve a one-time event and this ability is elaborated thereafter.

  12. Development of long-term event memory in preverbal infants: an eye-tracking study

    PubMed Central

    Nakano, Tamami; Kitazawa, Shigeru

    2017-01-01

    The development of long-term event memory in preverbal infants remains elusive. To address this issue, we applied an eye-tracking method that successfully revealed in great apes that they have long-term memory of single events. Six-, 12-, 18- and 24-month-old infants watched a video story in which an aggressive ape-looking character came out from one of two identical doors. While viewing the same video again 24 hours later, 18- and 24-month-old infants anticipatorily looked at the door where the character would show up before it actually came out, but 6- and 12-month-old infants did not. Next, 12-, 18- and 24-month-old infants watched a different video story, in which a human grabbed one of two objects to hit back at the character. In their second viewing after a 24-hour delay, 18- and 24-month-old infants increased viewing time on the objects before the character grabbed one. In this viewing, 24-month-old infants preferentially looked at the object that the human had used, but 18-month-old infants did not show such preference. Our results show that infants at 18 months of age have developed long-term event memory, an ability to encode and retrieve a one-time event and this ability is elaborated thereafter. PMID:28272489

  13. 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.

  14. [Long-Term Care Preferences Among Individuals of Advanced Age in Germany: Results of a Population-Based Study].

    PubMed

    Hajek, André; Lehnert, Thomas; Wegener, Annemarie; Riedel-Heller, Steffi G; König, Hans-Helmut

    2017-03-07

    The need for long-term care is expected to increase markedly in the next decades as a result of demographic ageing. Consequently, it is important to know the long-term care preferences. This study investigated the long-term care preferences among older individuals in Germany. Based on a systematic review and expert interviews, a questionnaire was designed to assess long-term care preferences. Data were gathered from a representative telephone survey of the German population (n=1,006; 65 years and above) in 2015. The mean age was 75.2 years (±6.6 years, ranging from 65 to 96 years). While nearly 90% of the individuals preferred home care, other care settings such as nursing care abroad were mostly undesired. In case of home care, most of the individuals preferred care provided by friends/family or formal caregivers, whereas the idea of all-day care services (such as employed private caregivers) was less popular. With respect to home care, additional services such as household assistance, transportation services, and emergency call systems were highly valued by the study participants, whereas continual supervision throughout the day was seen as less important. In case of inpatient care, more than 90% of the individuals preferred a private room, with the inpatient facility located near home or close to relatives' homes. A wide range of activities was appreciated. Given these preferences, it is assumed that there is a gap between expectations (preferences) and reality (utilization) regarding long-term care in Germany. Interventions aimed at minimizing this gap are urgently needed. For example, strategies to raise the awareness of private long-term care provision might be fruitful.

  15. 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.

  16. 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.

  17. 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

  18. Hepatobiliary complications of alveolar echinococcosis: A long-term follow-up study

    PubMed Central

    Graeter, Tilmann; Ehing, Franziska; Oeztuerk, Suemeyra; Mason, Richard Andrew; Haenle, Mark Martin; Kratzer, Wolfgang; Seufferlein, Thomas; Gruener, Beate

    2015-01-01

    AIM: To determine the long-term hepatobiliary complications of alveolar echinococcosis (AE) and treatment options using interventional methods. METHODS: Included in the study were 35 patients with AE enrolled in the Echinococcus Multilocularis Data Bank of the University Hospital of Ulm. Patients underwent endoscopic intervention for treatment of hepatobiliary complications between 1979 and 2012. Patients’ epidemiologic data, clinical symptoms, and indications for the intervention, the type of intervention and any additional procedures, hepatic laboratory parameters (pre- and post-intervention), medication and surgical treatment (pre- and post-intervention), as well as complications associated with the intervention and patients‘ subsequent clinical courses were analyzed. In order to compare patients with AE with and without history of intervention, data from an additional 322 patients with AE who had not experienced hepatobiliary complications and had not undergone endoscopic intervention were retrieved and analyzed. RESULTS: Included in the study were 22 male and 13 female patients whose average age at first diagnosis was 48.1 years and 52.7 years at the time of intervention. The average time elapsed between first diagnosis and onset of hepatobiliary complications was 3.7 years. The most common symptoms were jaundice, abdominal pains, and weight loss. The number of interventions per patient ranged from one to ten. Endoscopic retrograde cholangiopancreatography (ERCP) was most frequently performed in combination with stent placement (82.9%), followed by percutaneous transhepatic cholangiodrainage (31.4%) and ERCP without stent placement (22.9%). In 14.3% of cases, magnetic resonance cholangiopancreatography was performed. A total of eight patients received a biliary stent. A comparison of biochemical hepatic function parameters at first diagnosis between patients who had or had not undergone intervention revealed that these were significantly elevated in six

  19. Long-Term Study of Vascularized Free-Draining Intraperitoneal Pancreatic Segmental Allografts in Beagle Dogs

    PubMed Central

    Kyriakides, George K.; Rabinovitch, Alexander; Mintz, Daniel; Olson, Les; Rapaport, Felix T.; Miller, Joshua

    1981-01-01

    islets in both groups I and II, but with less fibrosis in group I (immunosuppressed). These results indicate that (a) pancreatic islets in vascularized grafts (FDPS) may survive indefinitely in the presence of a good tissue match best predicted by MLC testing, (b) tissue specific histocompatibility factors appear to be common enough between kidney and pancreas to allow for long-term survival of both organs transplanted from the same donor, at least in appropriate recipients (group II), and (c) immunosuppression is associated with less fibrosis in FDPS allografts. Images PMID:6450223

  20. A longitudinal, multicentre, cohort study of community rehabilitation service delivery in long-term neurological conditions

    PubMed Central

    Siegert, Richard J; Jackson, Diana M; Playford, E Diane; Fleminger, Simon; Turner-Stokes, Lynne

    2014-01-01

    Objectives Part A: To pilot the use of a register to identify and monitor patients with complex needs arising from long-term neurological conditions. Part B: To determine the extent to which patients’ needs for health and social services are met following discharge to the community after inpatient rehabilitation; to identify which factors predict unmet needs and to explore the relationship between service provision and outcomes at 12 months. Design A multicentre, prospective, cohort study surveying participants at 1, 6 and 12 months using postal/online questionnaires and telephone interview. Setting Consecutive discharges to the community from all nine tertiary, specialist, inpatient neurorehabilitation services in London over 18 months in 2010–2011. Participants Of 576 admissions 428 patients were recruited at discharge: 256 responded at 4 weeks, 212 at 6 months and 190 at 12 months. Measures Neurological Impairment Scale, The Needs and Provision Complexity Scale, The Northwick Park Dependency Scale, Community Integration Questionnaire, Zarit Burden Inventory. Results n=322 (75%) expressed willingness to be registered, but in practice less than half responded to questionnaires at 6 and 12 months (49% and 44%, respectively), despite extensive efforts to contact them, with no significant differences between responders and non-responders. Significant unmet needs were identified within the first year following discharge, particularly in rehabilitation, social work support and provision of specialist equipment. Dependency for basic care and motor and cognitive impairment predicted services received, together accounting for 40% of the variance. Contra to expectation, patients whose rehabilitation needs were met were more dependent and less well integrated at 12 months post discharge than those with unmet needs. Conclusions Registration is acceptable to most patients, but questionnaires/telephone interviews may not be the most efficient way to reach

  1. Bone induction using demineralized bone in the rabbit femur: a long-term study.

    PubMed

    Concannon, M J; Boschert, M T; Puckett, C L

    1997-06-01

    While traditional bone grafting is the standard for replacement of segmental bony defects, alternative options (avoiding morbidity of autologous grafts) are attractive and continue to be sought. This study attempted to determine whether demineralized bone powder could be used reliably to replace a significant bony deficit at a weight-bearing site. The long-term functional characteristics of this induced bone were analyzed to determine whether it maintained its strength and shape and reacted normally to physiologic stress over an extended period of time (12 months). In 55 New Zealand White rabbits, a 1-cm length of femur was removed (approximately 20 percent of the total length of the rabbit femur). The femur was then reconstructed with a titanium mandibular plate, leaving the gap intact. In 38 of the animals, this gap was filled with demineralized bone powder in an attempt to induce bone to form across the defect. In group 1 (n = 23), the mandibular plate remained in place for the duration of the study (12 months). In group 2 (n = 15), the plate was removed 8 weeks after placement of the demineralized bone powder, and the animals were followed for an additional 12 months. In group 3 (n = 10), nothing was placed within the bony gap. In group 4 (n = 7), the gap was repaired with autologous bone graft. All the animals that received demineralized bone powder completely filled the osteotomy gap with new bone within 6 to 8 weeks after implantation. None of control group 3 formed bone across the gap (p < 0.001). Eighty-six percent of control group 4 (autologous bone graft) successfully formed bone across the osteotomy gap. In addition, 90 percent of control group 3 had hardware failure within 8 weeks after surgery compared with 0 percent (0 of 38) of the group that received demineralized bone powder (p < 0.001). In group 1, analysis after 12 months revealed that the bone formed ultimately became thin and easily fractured, most likely because of shielding from stress

  2. 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

  3. 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

  4. Post-Stroke Epilepsy in Young Adults: A Long-Term Follow-Up Study

    PubMed Central

    Arntz, Renate; Rutten-Jacobs, Loes; Maaijwee, Noortje; Schoonderwaldt, Hennie; Dorresteijn, Lucille; van Dijk, Ewoud; de Leeuw, Frank-Erik

    2013-01-01

    Background Little is known about the incidence and risk of seizures after stroke in young adults. Especially in the young seizures might dramatically influence prognosis and quality of life. We therefore investigated the long-term incidence and risk of post-stroke epilepsy in young adults with a transient ischemic attack (TIA), ischemic stroke (IS) or intracerebral hemorrhage (ICH). Methods and Findings We performed a prospective cohort study among 697 consecutive patients with a first-ever TIA, IS or ICH, aged 18–50 years, admitted to our hospital between 1-1-1980 till 1-11-2010. The occurrence of epilepsy was assessed by standardized questionnaires and verified by a neurologist. Cumulative risks were estimated with Kaplan-Meier analysis. Cox proportional hazard models were used to calculate relative risks. After mean follow-up of 9.1 years (SD 8.2), 79 (11.3%) patients developed post-stroke epilepsy and 39 patients (5.6%) developed epilepsy with recurrent seizures. Patients with an initial late seizure more often developed recurrent seizures than patients with an initial early seizure. Cumulative risk of epilepsy was 31%, 16% and 5% for patients with an ICH, IS and TIA respectively (Logrank test ICH and IS versus TIA p<0.001). Cumulative risk of epilepsy with recurrent seizures was 23%, 8% and 4% respectively (Logrank ICH versus IS p = 0.05, ICH versus TIA p<0.001, IS versus TIA p = 0.01). In addition a high NIHSS was a significant predictor of both epilepsy and epilepsy with recurrent seizures (HR 1.07, 95% CI 1.03–1.11 and 1.08, 95% CI 1.02–1.14). Conclusions Post-stroke epilepsy is much more common than previously thought. Especially patients with an ICH and a high NIHSS are at high risk. This calls upon the question whether a subgroup could be identified which benefits from the use of prophylactic antiepileptic medication. Future studies should be executed to investigate risk factors and the effect of post-stroke epilepsy on quality of life

  5. An observational study on the effect of premature ventricular complex burden on long-term outcome

    PubMed Central

    Lin, Chin-Yu; Chang, Shih-Lin; Lin, Yenn-Jiang; Chen, Yun-Yu; Lo, Li-Wei; Hu, Yu-Feng; Tuan, Ta-Chuan; Chao, Tze-Fan; Chung, Fa-Po; Liao, Jo-Nan; Chang, Yao-Ting; Lin, Chung-Hsing; Walia, Rohit; Te, Abigail Louise D.; Yamada, Shinya; Chiou, Chuen-Wang; Tsao, Hsuan-Ming; Chen, Shih-Ann

    2017-01-01

    Abstract The long-term clinical impact of premature ventricular complexes (PVCs) on mortality and morbidity has not been fully studied. This study aimed to investigate the association between the burden of PVCs and adverse clinical outcome. A total of 5778 subjects, who were pacemaker-free and ventricular tachycardia-free at baseline, received 24-hour electrocardiography monitoring between January 1, 2002 and December 31, 2004. Clinical event data were retrieved from the Bureau of National Health Insurance of Taiwan. Multivariate Cox hazards regression models and propensity-score matching were applied to assess the association between PVCs and adverse clinical outcome. Average follow-up time was 10�± 1 year. In all, 1403 subjects expired, 1301 subjects were hospitalized in the cardiovascular (CV) ward, 3384 were hospitalized for any reason, and 631 subjects developed new-onset heart failure (HF). The optimal cut-off PVC frequency (12 beats per day) was obtained through receiver operator characteristic curves, with a sensitivity of 58.4% and specificity of 59.8%. Upon multivariate analysis, a PVC frequency >12 beats per day was an independent predictor for all mortality (hazard ratio [HR]: 1.429, 95% confidence interval [CI]: 1.284–1.590), CV hospitalization (HR: 1.127, 95% CI: 1.008–1.260), all-cause hospitalization (HR 1.094, 95% CI: 1.021–1.173), and new-onset HF (HR: 1.411, 95% CI: 1.203–1.655). Subjects with a PVC frequency >12 beats per day had an increased risk of cardiac death attributable to HF and sudden cardiac death. The incidence rates for mortality and HF were significantly increased in cases of raised PVC frequency. Propensity-score matching analysis also echoed the main findings. Increased PVC burden was associated with a higher incidence of all-cause mortality, CV hospitalization, all-cause hospitalization, and new-onset HF which was independent of other clinical risk factors. PMID:28072689

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-02-13

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

  8. Long-term study of air urban quality together with mixing layer height

    NASA Astrophysics Data System (ADS)

    Schäfer, Klaus; Ling, Hong; Münkel, Christoph; Emeis, Stefan

    2013-10-01

    Air pollution episodes in urban areas often occur during low wind speeds and low mixing layer height (MLH) and can not only be ascribed to increased local anthropogenic emissions. The continuous knowledge of MLH is supporting the understanding of processes directing air quality. If the MLH is located near to the ground, which occurs mainly during winter and night-time, air pollution can be high due to a strongly limited air mass dilution. The Vaisala ceilometer CL31, which is an eye-safe commercial mini-lidar system, is used for long-term continuous remote sensing of MLH. The ceilometer measurements provide information about the range-dependent aerosol concentration; gradient minima within this profile mark the borders of mixed layers. Special software for this ceilometer developed with MATLAB provides routine retrievals of lower atmosphere layering from vertical profiles of laser backscatter data. To study the gaseous pollutants and those compounds important for secondary aerosol formation like NO and NO2 as well as O3 The data retrieval software is extended to improve remote sensing of MLH. The original 10-minute-interval values are used to calculate continuous 1-hour-mean values. Gaps and strong variations of the original data are considered. The results of investigations of the meteorological influences and the role of emissions within the context of the air quality in Augsburg are discussed. a DOAS is operated since March 2012 in Augsburg. Information about different road traffic emissions is provided by this one instrument i.e. by path-integrated air pollution information in different directions. The DOAS contains an analyser and an emitter/receiver unit pointing to three retroreflectors. The retroreflectors were installed at lamp masts so that the paths were about 10 m above street level and perpendicular across the streets. The emitter/receiver unit was in a distance of about 20 m to an in situ air pollution measurement station at the ground. Ground

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

    PubMed Central

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

    2016-01-01

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

  10. 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

  11. 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…

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  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. Relative Impact of Course Components at Outward Bound Singapore: A Retrospective Study of Long-Term Outcomes

    ERIC Educational Resources Information Center

    Gassner, Michael E.; Russell, Keith C.

    2008-01-01

    This study examined the long-term impact of specific course components on participants who attended a 21-day Outward Bound Singapore course between 1997 and 2005. In total, 1029 questionnaires were sent out by mail. Participants were given a choice to complete the questionnaire on paper or online. A total of 318 questionnaires were successfully…

  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. Sacroiliac joint dysfunction: a long-term follow-up study.

    PubMed

    Sasso, R C; Ahmad, R I; Butler, J E; Reimers, D L

    2001-05-01

    Sixty-nine patients with sacroiliac joint dysfunction were prospectively evaluated and treated with a structured physical therapy program. Follow-up clinical outcome was obtained from a patient questionnaire administered by an independent reviewer a minimum of 2 years after treatment. Average patient age was 40 years, and 80% were women. Ninety-five percent rated their result as good or excellent, while 5% believed their outcome was fair or poor. A structured physical therapy program can produce good long-term results in most patients; however, 5% continue to be symptomatic. This small subset may be candidates for more invasive evaluation.

  18. 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

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

    MedlinePlus

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

  20. Long-term pharmacokinetic efficacy and safety of low-dose ritonavir as a booster and atazanavir pharmaceutical formulation based on solid dispersion system in rats.

    PubMed

    Fukushima, Keizo; Haraya, Kenta; Terasaka, Shuichi; Ito, Yukako; Sugioka, Nobuyuki; Takada, Kanji

    2008-06-01

    Atazanavir (ATV) is clinically coadministered with low-dose ritonavir (RTV), which boosts the oral bioavailability (BA) of ATV by inhibiting cytochrome P450 (CYP) 3A, and P-glycoprotein (Pgp) via the same metabolic pathway; however, it is well known that in the chronic phase, the inhibition effect of RTV on Pgp and CYP3A becomes an induction effect. In this study, we investigated the long-term efficacy and safety of RTV-boosted ATV in rats with a clinical relevant dosage of ATV and RTV, 7 mg/kg and 2 mg/kg, respectively, and drew a direct comparison with RTV-boosted ATV and the previously reported ATV pharmaceutical formulation based on a solid dispersion system (ATV-SLS SD+G). Rats received RTV-boosted ATV or ATV-SLS SD+G for 14 d in the pharmacokinetic study. In addition, after 14-d repeated administration of each formulation, cyclosporine A (CyA) was administered to rats and Western blot analysis of Pgp and CYP3A was performed to investigate the impact on pharmacokinetic interaction of each ATV formulation. After repeated administration of both formulations, there was no significant difference between ATV pharmacokinetic parameters on day 1 and 14; therefore, it was considered that the long-term efficacy of both ATV formulations was maintained. However, after treatment with RTV-boosted ATV, the Cmax and AUC0-infinity of the following CyA significantly decreased to 49% and 47% in comparison to the control, respectively, and the Pgp expression in the small intestine by Western blot analysis was approximately 2-fold higher than the control, whereas after treatment with ATV pharmaceutical formulation, neither significant alteration of CyA nor notable change in the expression of intestinal Pgp and hepatic CYP3A was observed. Therefore, it was considered that the BA of CyA after treatment with RTV-boosted ATV would decrease by the induction effect of RTV in chronic phase as described above. The results of this study revealed that the chronic use of low-dose RTV as a

  1. 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

  2. Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized, parallel-group, multicenter, extension clinical trial.

    PubMed

    Fujishiro, Mitsuhiro; Higuchi, Kazuhide; Kato, Mototsugu; Kinoshita, Yoshikazu; Iwakiri, Ryuichi; Watanabe, Toshio; Takeuchi, Toshihisa; Sugisaki, Nobuyuki; Okada, Yasushi; Ogawa, Hisao; Arakawa, Tetsuo; Fujimoto, Kazuma

    2015-05-01

    A 24-week, double-blind, clinical trial of rabeprazole for the prevention of recurrent peptic ulcers caused by low-dose aspirin (LDA) has been reported, but trials for longer than 24 weeks have not been reported. The aim of this study is to assess the long-term efficacy and safety of rabeprazole for preventing peptic ulcer recurrence on LDA therapy. Eligible patients had a history of peptic ulcers on long-term LDA (81 or 100 mg/day) therapy. Patients with no recurrence of peptic ulcers at the end of the 24-week double-blind phase with rabeprazole (10- or 5-mg once daily) or teprenone (50 mg three times daily) entered the extension phase. Rabeprazole doses were maintained for a maximum of 76 weeks, including the double-blind 24-week period and the extension phase period (long-term rabeprazole 10- and 5-mg groups). Teprenone was randomly switched to rabeprazole 10 or 5 mg for a maximum of 52 weeks in the extension phase (newly-initiated rabeprazole 10- and 5-mg groups). The full analysis set consisted of 151 and 150 subjects in the long-term rabeprazole 10- and 5-mg groups, respectively, and the cumulative recurrence rates of peptic ulcers were 2.2 and 3.7%, respectively. Recurrent peptic ulcers were not observed in the newly-initiated rabeprazole 10- and 5-mg groups. No bleeding ulcers were reported. No clinically significant safety findings, including cardiovascular events, emerged. The use of long-term rabeprazole 10- and 5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-dose aspirin therapy, and both were well-tolerated.

  3. The long-term effects of child sexual abuse by female perpetrators: a qualitative study of male and female victims.

    PubMed

    Denov, Myriam S

    2004-10-01

    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 abuse by females. Most respondents reported severe sexual abuse by their mothers. The vast majority of participants reported that the experience of female-perpetrated sexual abuse was harmful and damaging. As a result of the sexual abuse, male and female respondents reported long-term difficulties with substance abuse, self-injury, suicide, depression, rage, strained relationships with women, self-concept and identity issues, and a discomfort with sex. In light of the popular and professional perceptions that sexual abuse by women is relatively harmless as compared to sexual abuse by men, the implications of these long-term effects are discussed, particularly in relation to professionals working in the area of child sexual abuse.

  4. Depression, social support, and long-term risk for coronary heart disease in a 13-year longitudinal epidemiological study.

    PubMed

    Liu, Richard T; Hernandez, Evelyn M; Trout, Zoë M; Kleiman, Evan M; Bozzay, Melanie L

    2017-02-06

    Depression has been linked with long-term risk for a variety of physical health ailments, including coronary heart disease (CHD). Little is known about resilience factors that may attenuate this relationship. The current study assessed whether social support moderates the long-term risk for CHD associated with this disorder. Data were drawn from the Americans' Changing Lives study, a nationally representative longitudinal survey of adults in the United States. Participants (unweighted n=1636) completed initial assessments of functional social support, body mass index, recent history of major depression, CHD, hypertension, and diabetes. Participants were again assessed for CHD at a follow-up assessment 13 years later. Social support was found to moderate the relationship between depression and the occurrence of CHD 13 years later. Specifically, among individuals with low social support, depression was prospectively associated with CHD. In contrast, depression was not prospectively associated with CHD among individuals with high social support. The results indicate that social support may function as a resilience factor against the long-term cardiovascular risk associated with depression. Clinical interventions focusing on the development of social support systems are important not only for addressing depression itself, but also for associated long-term physical health outcomes.

  5. 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.

  6. Viscosupplementation in haemophilic arthropathy: a long-term follow-up study.

    PubMed

    Carulli, C; Civinini, R; Martini, C; Linari, S; Morfini, M; Tani, M; Innocenti, M

    2012-05-01

    Haemophilic arthropathy is the most common clinical manifestation of haemophilia, secondary to recurrent haemarthroses and chronic synovitis. Modern bleeding-preventing drugs have limited significantly the incidence of severe arthropathy, and primary approach is usually conservative. Use of intra-articular injections of hyaluronan acid is considered one of the most efficient treatments for early stages of articular degenerative diseases. Assessment of long-term effectiveness of intra-articular administration of hyaluronic acid (HA) in knees, ankles and elbows of patients affected by haemophilic arthropathy was done for 46 patients (10 elbows, 24 knees and 25 ankles) affected by haemophilic arthropathy. They received injections of HA and were evaluated with Visual Analogue Scale, Short Form-36, World Federation of Haemophilia score and Petterson score with a 6-year mean follow-up. Most of the patients showed improvement in pain relief and functional recovery without any complications: only a limited number of patients (8.6%) found poor results, undergoing surgery or other further treatments in the follow-up period for persistent pain or limitation. Viscosupplementation is an effective therapeutic strategy in early stages of haemophilic arthropathy, with no complications and long-term good clinical results.

  7. Factors associated with long-term survival after liver transplantation: A retrospective cohort study

    PubMed Central

    Pischke, Sven; Lege, Marie C; von Wulffen, Moritz; Galante, Antonio; Otto, Benjamin; Wehmeyer, Malte H; Herden, Uta; Fischer, Lutz; Nashan, Björn; Lohse, Ansgar W; Sterneck, Martina

    2017-01-01

    AIM To identify predictive factors associated with long-term patient and graft survival (> 15 years) in liver transplant recipients. METHODS Medical charts of all de novo adult liver transplant recipients (n = 140) who were transplanted in Hamburg between 1997 and 1999 were retrospectively reviewed. In total, 155 transplantations were identified in this time period (15 re-transplantations). Twenty-six orthotopic liver transplant (OLT) recipients were early lost to follow-up due to moving to other places within 1 year after transplantation. All remaining 114 patients were included in the analysis. The following recipient factors were analysed: Age, sex, underlying liver disease, pre-OLT body mass index (BMI), and levels of alanine aminotransferase (ALT), bilirubin, creatinine and gamma-glutamyltransferase (gamma-GT), as well as warm and cold ischemia times. Furthermore, the following donor factors were assessed: Age, BMI, cold ischemia time and warm ischemia time. All surviving patients were followed until December 2014. We divided patients into groups according to their underlying diagnosis: (1) hepatocellular carcinoma (n = 5, 4%); (2) alcohol toxic liver disease (n = 25, 22.0%); (3) primary sclerosing cholangitis (n = 6, 5%); (4) autoimmune liver diseases (n = 7, 6%); (5) hepatitis C virus cirrhosis (n = 15, 13%); (6) hepatitis B virus cirrhosis (n = 21, 19%); and (7) other (n = 35, 31%). The group “other” included rare diagnoses, such as acute liver failure, unknown liver failure, stenosis and thrombosis of the arteria hepatica, polycystic liver disease, Morbus Osler and Caroli disease. RESULTS The majority of patients were male (n = 70, 61%). Age and BMI at the time point of transplantation ranged from 16 years to 69 years (median: 53 years) and from 15 kg/m2 to 33 kg/m2 (median: 24), respectively. Sixty-six OLT recipients (58%) experienced a follow-up of 15 years after transplantation. Recipient’s age (P = 0.009) and BMI (P = 0.029) were identified as

  8. 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

  9. 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

  10. 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

  11. Orthodontic treatment outcomes in the long term: findings from a longitudinal study of New Zealanders.

    PubMed

    Thomson, W M

    2002-10-01

    The aim of this study was to use a health services research (HSR) approach to examine the longer-term outcomes of orthodontic treatment. Participants in a longstanding population-based New Zealand cohort study (the Dunedin Multidisciplinary Health and Development Study) were allocated to one of four malocclusion severity categories on the basis of orthodontic data collected at age 12. The outcome of that care by age 26 was evaluated using the key indicators of equity (was it fair?); efficacy (did it work?); effectiveness (did it work in the longer term?); and safety (was it associated with a greater subsequent experience of caries, periodontal disease, or tooth loss?). Data were available for 452 Study members, of whom 56.2% were in the minor/none category, 29.0% were in the definite category, 10.2% were in the severe category, and 4.6% were in the handicapping treatment-need category. No clear differences in treatment uptake by socioeconomic status were apparent, and the proportion treated increased across the malocclusion severity categories, as did the proportion that showed an improvement following treatment. By age 26 a difference between those who had and those who had not been treated was evident, with the percentage of those rating their dental appearance as above average increasing with increasing severity of the age-12 orthodontic treatment need. This was also true for the percentage that considered their orthodontic treatment to have been successful. There were no significant differences in caries experience, periodontal disease occurrence, or tooth loss between those who had and had not been treated by age 26. This study has found the equity, efficacy, effectiveness, and safety of orthodontic treatment in the Dunedin cohort to be acceptable.

  12. 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

  13. 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...

  14. 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

  15. Adalimumab treatment optimization for psoriasis: Results of a long-term phase 2/3 Japanese study.

    PubMed

    Asahina, Akihiko; Ohtsuki, Mamitaro; Etoh, Takafumi; Gu, Yihua; Okun, Martin M; Teixeira, Henrique D; Yamaguchi, Yuji; Nakagawa, Hidemi

    2015-11-01

    The tumor necrosis factor-α inhibitor, adalimumab, is approved to treat moderate-to-severe plaque psoriasis (40 mg every-other-week or 80 mg every-other-week following inadequate response at 40 mg in Japan). This open-label extension (OLE) trial evaluated the optimal adalimumab dose for long-term efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis following a prior 24-week, phase 2/3, randomized, double-blind study. Of the 169 patients from the phase 2/3 trial, 147 entered the OLE on 40 mg (n = 89) or 80 mg (n = 58) adalimumab every-other-week. Patients on 40 mg with Psoriasis Area and Severity Index (PASI) of less than 50 could escalate to 80 mg. At week 52 (28 of OLE), patients entering the OLE on 80 mg were reduced to 40 mg, with the option to re-escalate. For patients entering the OLE on 40 mg, final PASI 50/75/90 response rates were 85.1%/73.3%/60.4%, respectively, including effects of dose escalation. Among patients whose dose was escalated, final PASI 50/75/90 response rates were 70.0%/53.3%/36.7%, respectively. For patients entering the OLE on 80 mg, final PASI 50/75/90 response rates were 92.5%/84.9%/73.6%, respectively, including effects of dose re-escalation. Overall incidence rates of adverse events (AE) and injection-site reaction AE declined over time; rates for serious AE and infections were generally stable. Clinically meaningful efficacy of adalimumab was sustained to 4 years. Dose escalation to 80 mg every-other-week for patients with suboptimal response to 40 mg every-other-week, and dose reduction to 40 mg every-other-week for patients satisfactorily controlled on 80 mg every-other-week, are viable strategies for adalimumab optimization.

  16. 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

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

    PubMed

    Lecrubier, Y; Judge, R

    1997-02-01

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

  18. 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

  19. Long-Term Efficacy of First Line Antiretroviral Therapy in Indian HIV-1 Infected Patients: A Longitudinal Cohort Study

    PubMed Central

    Neogi, Ujjwal; Heylen, Elsa; Shet, Anita; Chandy, Sara; Shamsunder, Ranjani; Sönnerborg, Anders; Ekstrand, Maria L.

    2013-01-01

    Background Short term efficacy of combination antiretroviral therapy (cART) in resource-constrained settings is comparable to that found in western studies. However, long term data are limited. India has the third largest HIV infected population in the world but the long-term outcome of first line therapy according to the national guidelines has not been evaluated yet. Therefore, we conducted a long-term longitudinal analysis of the efficacy of the national first-line therapy in India from an observational cohort of Indian patients in two different clinical settings. Methodology/Principal Findings A total 323 patients who had been on ART for a median of 23 months and achieved virological suppression <100 copies/ml by their study baseline visit, were included and followed for two years. Blood samples were collected every six months for viral load and CD4 count. Drug resistance genotyping was performed when the viral load was >2000 copies/mL. Adherence and treatment interruptions (>48 h) were assessed via self-report. In the studied patients, the median duration of viral suppression was 44 months; 15.8% of patients showed viral rebound, and 2.8% viral failure. Viral rebound or failure was significantly negatively related to perfect adherence (100% adherence and no treatment interruption >48 hrs). Virological re-suppression in the subsequent visit was observed in three patients without any change in therapy despite the presence of key mutations. Conclusion/Significance Our study reports for the first time, a good long-term response to the first line therapy for a median of nearly four years although a less than perfect adherence increases the risk for treatment failure and subsequent drug resistance development. The empirical findings in this study also indicate the overall success of the Indian ART program in two different settings which likely are representative of other clinics that operate under the national guidelines. PMID:23383185

  20. 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.

  1. Organic brain syndrome and long-term exposure to toluene: a clinical, psychiatric study of vocationally active printing workers

    SciTech Connect

    Larsen, F.; Leira, H.L.

    1988-11-01

    This study addresses the prevalence of organic brain syndrome (OBS) among long-term toluene-exposed rotogravure workers who are still working. The prevalence of OBS in 22 workers exposed to toluene for a minimum of 12 years and 19 unexposed control subjects, matched for age and employment status, was assessed with a comprehensive clinical psychiatric interview. There was a significantly greater prevalence of mild chronic encephalopathy and organic affective syndrome in the toluene-exposed group.

  2. Long-term outcome of acute pancreatitis: a prospective study with 118 patients.

    PubMed

    Angelini, G; Cavallini, G; Pederzoli, P; Bovo, P; Bassi, C; Di Francesco, V; Frulloni, L; Sgarbi, D; Talamini, G; Castagnini, A

    1993-01-01

    118 patients who had recovered from acute pancreatitis underwent endoscopic retrograde pancreatography (ERCP) during a long-term follow-up (mean 4.4 years, range 1-17) to investigate the frequency and features of residual ductal lesions. Oedematous and necrohaemorrhagic pancreatitis occurred in 35 and in 83 patients, respectively. The aetiology was biliary (39 patients), alcoholic (32), biliary-alcoholic (18) and miscellaneous (29). After oedematous pancreatitis, ERCP was normal in 31, showed obstructive pancreatitis in 2 and a slight localized and smooth stricture of the main duct in 2 patients. After necrotizing pancreatitis, 29 patients showed ductal changes without features of chronic pancreatitis, 7 obstructive, 3 chronic calcifying pancreatitis and 44 normal pictures. In 17 patients submitted to two or three ERCPs during a mean 10-year follow-up, the ductal appearance was unchanged in 12, worsened in 3, and improved in 2 patients. The aetiology of pancreatitis and frequency of recurrences was similar in patients with or without scarring lesions. We conclude that residual ductal lesions are common after acute necrotizing pancreatitis.

  3. Multicenter study of long-term (two-year) efficacy of lanthanum carbonate.

    PubMed

    Ando, Ryoichi; Kimura, Hitoshi; Sato, Hidehiko; Iwamoto, Shunsuke; Yoshizaki, Yuki; Chida, Yoshiko; Ishida, Yuji; Takayama, Masanobu; Yamada, Kouei; Tachibana, Ken; Ohtsuka, Masakazu; Kikuchi, Kan; Inoue, Atsushi

    2013-04-01

    Long-term efficacy of lanthanum carbonate on hyperphosphatemia was examined in multicenter dialysis patients. Outcome and efficacy after 2 years was investigated in 101 patients who had undergone lanthanum carbonate administration. Thirty-three cases dropped out by the 2-year point; patients undergoing at least 2 years of administration totaled 68. Reasons for dropping out were as follows: improvement of hyperphosphatemia, nine cases; changing hospitals, seven cases; medical complications, five cases; digestive symptoms, four cases; poor compliance, four cases; parathyroidectomy, two cases; death, two cases. The mean dosage was increased from initial daily dosage of 744 mg to 1266 mg after 1 year, and to 1246 mg after 2 years. Serum phosphate concentration decreased significantly from the initial 6.15 mg to 5.57 mg/dL after 1 year, and to 5.45 mg/dL after 2 years. Although a lowering trend was observed in corrected calcium levels, the difference was not significant. Parathyroid hormone was unchanged. Achievement rate of Japanese Society for Dialysis Therapy (JSDT) management target values for both phosphorus and calcium improved from 32.7% to 50.0% after 1 year, and to 56.5% after 2 years. Lanthanum carbonate is useful as a therapeutic tool for hyperphosphatemia over long durations.

  4. Nanotechnology for sustainable wastewater treatment and use for agricultural production: A comparative long-term study.

    PubMed

    De La Cueva Bueno, Patricia; Gillerman, Leonid; Gehr, Ronald; Oron, Gideon

    2017-03-01

    Nanotechnology applications can be used for filtering low quality waters, allowing under given conditions, the removal of salts and other micropollutants from these waters. A long-term field experiment, implementing nanotechnology in the form of UltraFiltration (UF) and Reverse Osmosis (RO) for salt removal from treated wastewater, was conducted with secondary effluents, aiming to prove the sustainability of agricultural production using irrigation with treated wastewater. Six outdoor field treatments, each under four replications, were conducted for examining the salt accumulation effects on the soil and the crops. The field experiments proved that crop development is correlated with the water quality as achieved from the wastewater filtration capability of the hybrid nanotechnology system. The key goal was to maintain sustainable food production, despite the low quality of the waters. Of the six treatment methods tested, irrigation with RO-treated effluent produced the best results in terms of its effect on soil salinity and crop yield. Nevertheless, it must be kept in mind that this process is not only costly, but it also removes all organic matter content from the irrigation water, requiring the addition of fertilizers to the effluent.

  5. Effectiveness of a therapeutic community treatment in Spain: a long-term follow-up study.

    PubMed

    Fernández-Hermida, José-Ramón; Secades-Villa, Roberto; Fernández-Ludeña, José-Javier; Marina-González, Pedro-Antonio

    2002-01-01

    In this paper, the effectiveness of the treatment program developed by Proyecto Hombre ('Project Mankind') in Asturias, Spain, is evaluated. In a long-term follow-up (range from 73 days to 8 years) with a sample of 249 subjects, the results obtained by subjects completing the treatment (194) were compared with pre-treatment results and with those of the group that dropped out (55). The measurements used were relapses in illegal drugs, alcohol, changes in family situation, educational level, employment, criminal involvement and state of health. External validation of self-report measures given in the questionnaire was carried out. Findings support the effectiveness of the treatment in all measures and the validity of self-report items. Relapse rate in 'treatment-completed' group was 10.3%, whilst in the non-completers group it reached 63.6% (significant difference, p < 0.001). Relapses of non-completers were more severe, occurred sooner after leaving the program (they stayed abstinent for shorter periods) and lasted longer than those of subjects completing the treatment.

  6. 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.

  7. Executive Functioning Skills in Long-Term Users of Cochlear Implants: A Case Control Study

    PubMed Central

    Pisoni, David B.; Henning, Shirley C.; Colson, Bethany G.

    2013-01-01

    Objective To investigate differences in executive functioning between deaf children with cochlear implants (CIs) and normal-hearing (NH) peers. The cognitive effects of auditory deprivation in childhood may extend beyond speech–language skills to more domain-general areas including executive functioning. Methods Executive functioning skills in a sample of 53 prelingually deaf children, adolescents, and young adults who received CIs prior to age 7 years and who had used their CIs for ≥7 years were compared with age- and nonverbal IQ-matched NH peers and with scale norms. Results Despite having above average nonverbal IQ, the CI sample scored lower than the NH sample and test norms on several measures of short-term/working memory, fluency–speed, and inhibition–concentration. Executive functioning was unrelated to most demographic and hearing history characteristics. Conclusions Prelingual deafness and long-term use of CIs was associated with increased risk of weaknesses in executive functioning. PMID:23699747

  8. Long-term corrosion/oxidation studies under controlled humidity conditions

    SciTech Connect

    Gdowski, G.

    1997-10-13

    Independent of thermal loading scenarios, the waste packages at the potential repository at Yucca Mountain, Nevada will be exposed to environmental conditions where there is the possibility of significant water film formation occurring on the waste packages. Water films can cause aggressive aqueous film electrochemical corrosion on susceptible metals or alloys. Water film formation will be facilitated when relative humidities are high, when hygroscopic salts are present on the surfaces, when corrosion products are hygroscopic, and when particles form crevices with the surfaces (capillary effect). Also certain gaseous contaminants, such as, NO{sub x} and SO{sub 2}, can facilitate water film formation. It should be noted that water film formation can occur at isolated spots (e.g. surface defects and salt particles) and need not cover the entire surface for electrochemical corrosion to occur. This activity will characterize the long term corrosion of metal specimens at two nominal relative humidities (50 and 85%) and at 80 C. Under the low relative humidity (50%) condition, water film formation is expected to be limited and therefore aqueous film electrochemical corrosion is expected also to be limited. Under the high relative humidity (85%) condition, significant water film formation is expected to occur under some test conditions, and subsequently aqueous film electrochemical corrosion will occur on susceptible materials.

  9. Long-term clinical toxicity studies with clofazimine (B663) in leprosy.

    PubMed

    Hastings, R C; Jacobson, R R; Trautman, J R

    1976-01-01

    Fifty-one leprosy patients receiving long-term clofazimine have undergone systematic clinical laboratory testing in a search for any toxicity secondary to the drug. In approximately 220 patient-years of observation and in analyzing approximately 40,000 test results, no statistically significant changes in the direction of abnormality have been observed in SGOT, thymol turbidity, serum globulins, uric acid, alkaline phosphatase, white blood cell count or differential, hematocrit, hemoglobin, BUN, serum creatinine, serum cholesterol, serum albumin, serum potassium, serum calcium, stool for occult blood, routine urinalysis, or reticulocyte count. Statistically significant changes toward abnormality were found in fasting blood sugar and total serum bilirubin. These statistically significant changes in the direction of abnormality were of a small magnitude, were not associated with related clinical signs or symptoms, and do not seem to be of major clinical significance. Despite the accumulation of relatively massive amounts of the drug in various tissues, clofazimine appears remarkably free of serious or life-threatening toxicity clinically. Although the skin and gastrointestinal side effects of clofazimine limit its usefulness, on the evidence to date, its advantages outweigh its disadvantages in those leprosy patients for whom it is indicated.

  10. 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 ®.

  11. Long-term effectiveness of CBT for anxiety disorders in an adult outpatient clinic sample: a follow-up study.

    PubMed

    DiMauro, Jennifer; Domingues, Janine; Fernandez, Geraldine; Tolin, David F

    2013-02-01

    The short-term efficacy and effectiveness of Cognitive-Behavioral Therapy (CBT) for treating anxiety disorders in adults has been well established by a multitude of clinical studies and well-controlled randomized trials. However, though the long-term efficacy of CBT as a treatment modality is fairly well established, the degree of its long-term effectiveness has yet to be fully evaluated. Thus, the present study sought to assess both the immediate and long-term effectiveness of individually-administered CBT for the treatment of anxiety disorders in an outpatient psychological clinic. Individuals with a primary diagnosis of Panic Disorder, Social Phobia, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, or Obsessive-Compulsive Disorder who had received 3 or more sessions of CBT were assessed for symptom severity and improvement prior to initiating treatment, at posttreatment, and at one-year follow-up. Symptom severity and improvement ratings were used to categorize patients as "responders" or "remitters" at posttreatment, and "maintained responders" or "maintained remitters" at follow-up. Findings demonstrated that posttreatment success as responder and remitter was significantly maintained at one-year follow-up. Additionally, pre- and posttreatment severity and posttreatment improvement scores were also predictive of maintenance. Furthermore, effect sizes were used to compare the effectiveness of CBT in the present clinical sample to research treatment outcomes demonstrated by previous efficacy studies.

  12. Long-term mobile phone use and the risk of vestibular schwannoma: a Danish nationwide cohort study.

    PubMed

    Schüz, Joachim; Steding-Jessen, Marianne; Hansen, Søren; Stangerup, Sven-Eric; Cayé-Thomasen, Per; Poulsen, Aslak Harbo; Olsen, Jørgen H; Johansen, Christoffer

    2011-08-15

    Vestibular schwannomas grow in the region within the brain where most of the energy by radiofrequency electromagnetic fields from using mobile phones is absorbed. The authors used 2 Danish nationwide cohort studies, one a study of all adult Danes subscribing for a mobile phone in 1995 or earlier and one on sociodemographic factors and cancer risk, and followed subjects included in both cohorts for occurrence of vestibular schwannoma up to 2006 inclusively. In this study including 2.9 million subjects, a long-term mobile phone subscription of ≥11 years was not related to an increased vestibular schwannoma risk in men (relative risk estimate = 0.87, 95% confidence interval: 0.52, 1.46), and no vestibular schwannoma cases among long-term subscribers occurred in women versus 1.6 expected. Vestibular schwannomas did not occur more often on the right side of the head, although the majority of Danes reported holding their mobile phone to the right ear. Vestibular schwannomas in long-term male subscribers were not of larger size than expected. Overall, no evidence was found that mobile phone use is related to the risk of vestibular schwannoma. Because of the usually slow growth of vestibular schwannoma and possible diagnostic delay, further surveillance is indicated.

  13. Long-term care residents' views about the contributions of Christian-based volunteers in Taiwan: a pilot study.

    PubMed

    Liu, Yi-Jung

    2012-09-01

    This pilot study explored the view from six long-term care residents on the contributions of religious volunteers. The findings suggest that religious volunteers may contribute to long-term care residents' religious or spiritual health more than non-religious volunteers. However, since religious volunteers lack professional training and competence to attend to patients' religious needs, they may not afford in-depth spiritual and religious services. Under certain conditions when qualified chaplains are not available, inadequate religious services performed by religious volunteers are still better than no such care at all. However, in order to provide this important aspect of holistic care, we propose that health care policy makers should pay more attention to this topic.

  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. 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

  16. Fifty-two-week long-term clinical study of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.

    PubMed

    Seino, Yutaka; Kaku, Kohei; Inagaki, Nobuya; Haneda, Masakazu; Sasaki, Takashi; Fukatsu, Atsushi; Ubukata, Michito; Sakai, Soichi; Samukawa, Yoshishige

    2015-01-01

    Luseogliflozin, a selective sodium glucose cotransporter 2 inhibitor, was demonstrated in a previous 24-week study of type 2 diabetic patients to be efficacious and well tolerated. This study mainly aimed to evaluate the long-term safety of luseogliflozin monotherapy in Japanese type 2 diabetic patients based on the Japanese guidelines. Additionally, long-term efficacy was also evaluated. Patients on diet and exercise therapy alone with an HbA1c of 6.9-10.5% received luseogliflozin 2.5 mg once daily for 52 weeks. For patients with insufficient glycemic control, this dose was able to be increased to 5 mg at Week 24. Adverse events (AEs), clinical laboratory tests, vital signs and 12-lead electrocardiograms were used to assess safety. Efficacy endpoints consisted of changes in HbA1c, fasting plasma glucose (FPG), and body weight from baseline. Of 299 patients who received luseogliflozin, 279 completed the study. Most AEs were mild in severity with incidences of AEs and adverse drug reactions at 75.3% and 16.7%, respectively. Although hypoglycemia was observed in 7 patients (2.3%), no major hypoglycemic episodes occurred. The incidences of AEs of special interest, including pollakiuria, volume depletion and urinary tract/genital infections, were at acceptable levels. Luseogliflozin significantly lowered HbA1c (-0.50%, P< 0.001), FPG (-16.3 mg/dL, P< 0.001) and body weight (-2.68 kg, P< 0.001) at Week 52 compared to baseline. Up-titration to 5 mg further improved glycemic control. In this long-term study of Japanese type 2 diabetic patients, luseogliflozin monotherapy was well tolerated for 52 weeks and provided a sustained glycemic lowering effect and reduced body weight.

  17. 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

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

    PubMed Central

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

    2017-01-01

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

  19. 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

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

    PubMed

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

    2016-01-01

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

  1. Value of Superficial Cultures for Prediction of Catheter-Related Bloodstream Infection in Long-Term Catheters: a Prospective Study

    PubMed Central

    Martín-Rabadán, P.; Echenagusia, A.; Camúñez, F.; Rodríguez-Rosales, G.; Simó, G.; Echenagusia, M.; Bouza, E.

    2013-01-01

    Cultures taken from the skin and from the hubs of short-term central venous catheters can help us to predict catheter-related bloodstream infections (C-RBSIs). The value of these cultures for such predictions has not been assessed in long-term catheters. Our objective was to assess the value of superficial cultures for the prediction of C-RBSI among patients with long-term catheters. Over a 2-year period, we prospectively obtained cultures from the skin overlying reservoir ports (group A) and from the skin insertion site and hubs of all tunneled catheters (group B). This routine was performed by vascular and interventional radiologists immediately before catheter removal (irrespective of the reason for withdrawal). Swabs were processed semiquantitatively. Catheter tips from both groups were cultured using Maki's semiquantitative technique and sonication. We also performed cultures of the reservoir ports at different sites. C-RBSI was defined as the isolation of the same species of microorganism(s) both in the colonized catheter and in at least 1 peripheral blood culture. We included 372 catheters (group A, 223; group B, 149) during the study period. The catheter colonization rate was 23.4% (87/372), and 28 patients had C-RBSI. Validity index values for the capacity of surface cultures to predict C-RBSI in groups A and B were, respectively, as follows: sensitivity, 23.5% and 45.5%; specificity, 59.7% and 63.0%; positive predictive value, 4.6% and 8.9%; and negative predictive value, 90.4% and 93.5%. Superficial cultures of patients with long-term catheters could help us to rule out the catheter as the portal of entry of bloodstream infections. Superficial cultures (from skin and hubs) proved to be a useful conservative diagnostic tool for ruling out C-RBSI among patients with long-term tunneled catheters and totally implantable venous access ports. PMID:23850957

  2. Who Receives Rehabilitation in Canadian Long-Term Care Facilities? A Cross-Sectional Study

    PubMed Central

    Hirdes, John; Berg, Katherine; Giangregorio, Lora

    2015-01-01

    ABSTRACT Purpose: To describe the proportion of residents receiving occupational therapy (OT) and physical therapy (PT) and the factors associated with receiving PT in long-term care (LTC) facilities across five provinces and one territory in Canada. Methods: Using a population-based, retrospective analysis of cross-sectional data, the proportion of LTC facility residents in each province or territory receiving three different amounts (time and frequency) of PT, OT, or both before July 1, 2013, was calculated according to the Resource Utilization Groups–III rehabilitation classifications. Twenty-three variables from the Resident Assessment Instrument 2.0, such as age and cognition, were examined as correlates; those significant at p<0.01 were included in a multivariate logistic regression. Results: Between 63.7% and 88.6% of residents did not receive any PT or OT; 0.8%–12.6% received both PT and OT; 5.8%–29.5% received an unspecified amount of PT; 1.9%–7.0% received 45 minutes or more of PT 3 days or more per week; and fewer than 1% received 150 minutes or more of PT on 5 or more days per week. Province, age, cognitive status, depression, clinical status, fracture, multiple sclerosis, and self-rated potential for improvement were associated with PT irrespective of time intensity. Conclusions: The proportion of LTC residents receiving rehabilitation services varies across Canada and appears to be associated with physical impairments and the potential for improvement; older residents with cognitive impairment or mood disorders are less likely to receive rehabilitation services. Future recommendations should consider what is driving the patterns of service use, determine whether the resources available are appropriate, and address the most appropriate goals for residents in LTC. PMID:25931661

  3. The chemical durability of tektites - A laboratory study and correlation with long-term corrosion behavior

    NASA Astrophysics Data System (ADS)

    Barkatt, A.; Boulos, M. S.; Barkatt, A.; Sousanpour, W.; Boroomand, M. A.; Macedo, P. B.; O'Keefe, J. A.

    1984-02-01

    Leach tests carried out on tektite specimens (indochinites and australites) under high-dilution conditions show a common behavior characterized by low leach rates (0.00018 g/sq m per d, or 7.2 x 10 to the -12th m/d at 23 C) and an activation energy of (79,600 + or - 700 J/mol). The extent of selective leaching is very small, of the order of 10 to the -8th m. Extrapolation of test results over the lifetime of the tektites gives an excellent agreement with field observations on the extent of corrosion, and this is an important step in establishing the validity of laboratory tests as a basis for the development of models and predictions concerning long-term durabilities at least in the limiting case of high dilution or rapid flow. The results are also shown to be in agreement with various previous observations on the corrosion resistance of tektites. The chemical durability of tektites is observed to be consistent with their composition, highlighting requirements of high corrosion resistance in glasses; these requirements include a silica content in excess of 67 mol percent, an extremely low water content, and an alkali content which is low both absolutely and relative to the di- and poly-valent metal oxide levels. It is shown that artificial glasses which fulfil these criteria are no less corrosion-resistant than the corresponding natural glasses. These conclusions have bearing on the development, as well as on the evaluation, of glasses intended for very long service, such as radioactive waste vitrification media.

  4. 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

  5. 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.

  6. 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

  7. 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.

  8. Long-term outcome of patients after a single interruption of antiretroviral therapy: a cohort study

    PubMed Central

    2012-01-01

    Background To describe the long term outcome of patients who interrupted highly active antiretroviral therapy (HAART) once, identify the variables associated with earlier need to re-start HAART, and the response when therapy was resumed. A retrospective observational cohort of 66 adult patients with HIV-1 infection who interrupted HAART with a CD4+cell count ≥350 cells/μL and undetectable viral load (VL) was performed. The pre-established CD4+ cell count for restarting therapy was 300cells/μL. Cox regression was used to analyse the variables associated with earlier HAART reinitiation. Results The median follow-up was 209 weeks (range, 64–395). Rates of HIV-related or possible HIV-related events were 0.37 (one case of acute retroviral syndrome) and 1.49 per 100 patient-years, respectively. Two patients died after re-starting therapy and having reached undetectable VL. Three patients suffered a sexually transmitted disease while off therapy. Fifty patients (76%) resumed therapy after a median of 97 weeks (range, 17–267). Age, a nadir of CD4+ <250 cells/μL, and a mean VL during interruption of >10,000 copies/ml were independent predictors for earlier re-start. The intention-to-treat success rate of the first HAART resumed regimen was 85.4%. There were no differences by regimen used, nor between regimens that were the same as or different from the one that had been interrupted. Conclusions Our data suggest highly active antiretroviral therapy may be interrupted in selected patients because in these patients, when the HAART is restarted, the viral and clinical response may be achieved. PMID:23095460

  9. 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.

  10. Long-term effect of nitrate on Cr(VI) removal by Fe(0): column studies.

    PubMed

    Wei, Minghai; Yuan, Fang; Huang, Guoxin; Chen, Honghan; Liu, Fei

    2016-05-01

    Lab-scale parallel continuous-flow column experiments were performed to assess the long-term effect of nitrate (NO3 (-)) on hexavalent chromium (Cr(VI)) removal by scrap iron (Fe(0)). The first column (L1) was fed with the Cr(VI) solution and the second column (L2) was loaded with the Cr(VI) + NO3 (-) solution. Raman spectroscopy and scanning electron microscopy energy-dispersive X-ray analyses (SEM-EDS) were conducted to investigate the changes of the iron oxides on Fe(0). The results showed that the process of Cr(VI) removal by Fe(0) was divided into three different stages in the presence of NO3 (-): inhibition period (<198 pore volumes (PVs)); promotion period (198∼1025 PVs); and complete passivation period (1025∼1300 PVs). During the 462∼1025 PVs, Cr(VI) removal capacity in L2 was about 2.5 times higher than that in L1, and the longevity of L2 than L1 was 275PVs longer. NO3 (-) exhibited the most dominant effect on the Cr(VI) removal by Fe(0) in the last two stages. New magnetite (Fe3O4) produced by the redox reaction of NO3 (-) and Fe(0) was discovered on the surface of the Fe(0) obtained from L2. The new generated Fe3O4 could directly reduce the Cr(VI) and could also act as an inhibitor for the formation of passive film on the Fe(0) surface as well as an electron mediator that facilitated electron transport from Fe(0) to adsorbed Cr(VI).

  11. Stability and relapse after orthodontic treatment of deep bite cases-a long-term follow-up study.

    PubMed

    Danz, J C; Greuter, C; Sifakakis, I; Fayed, M; Pandis, N; Katsaros, C

    2014-10-01

    The purpose of this long-term follow-up study was twofold-firstly, to assess prevalence of relapse after treatment of deep bite malocclusion and secondly, to identify risk factors that predispose patients with deep bite malocclusion to relapse. Sixty-one former patients with overbite more than 50% incisor overlap before treatment were successfully recalled. Clinical data, morphometrical measurements on plaster casts before treatment, after treatment and at long-term follow-up, as well as cephalometric measurements before and after treatment were collected. The median follow-up period was 11.9 years. Patients were treated by various treatment modalities, and the majority of patients received at least a lower fixed retainer and an upper removable bite plate during retention. Relapse was defined as increase in incisor overlap from below 50% after treatment to equal or more than 50% incisor overlap at long-term follow-up. Ten per cent of the patients showed relapse to equal or larger than 50% incisor overlap, and their amount of overbite increase was low. Among all cases with deep bite at follow-up, gingival contact and palatal impingement were more prevalent in partially corrected noncompliant cases than in relapse cases. In this sample, prevalence and amount of relapse were too low to identify risk factors of relapse.

  12. 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.

  13. 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.

  14. 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

  15. Influence of long-term Sahaja Yoga meditation practice on emotional processing in the brain: An ERP study.

    PubMed

    Reva, N V; Pavlov, S V; Loktev, K V; Korenyok, V V; Aftanas, L I

    2014-12-05

    Despite growing interest in meditation as a tool for alternative therapy of stress-related and psychosomatic diseases, brain mechanisms of beneficial influences of meditation practice on health and quality of life are still unclear. We propose that the key point is a persistent change in emotional functioning, specifically the modulation of the early appraisal of motivational significance of events. The main aim was to study the effects of long-term meditation practice on event-related brain potentials (ERPs) during affective picture viewing. ERPs were recorded in 20 long-term Sahaja Yoga meditators and 20 control subjects without prior experience in meditation. The meditators' mid-latency (140-400ms) ERPs were attenuated for both positive and negative pictures (i.e. there were no arousal-related increases in ERP positivity) and this effect was more prominent over the right hemisphere. However, we found no differences in the long latency (400-800ms) responses to emotional images, associated with meditation practice. In addition we found stronger ERP negativity in the time window 200-300ms for meditators compared to the controls, regardless of picture valence. We assume that long-term meditation practice enhances frontal top-down control over fast automatic salience detection, based on amygdala functions.

  16. Long-Term Exposure to Traffic-Related Air Pollution and Risk of Incident Atrial Fibrillation: A Cohort Study

    PubMed Central

    Monrad, Maria; Sajadieh, Ahmad; Christensen, Jeppe Schultz; Ketzel, Matthias; Raaschou-Nielsen, Ole; Tjønneland, Anne; Overvad, Kim; Loft, Steffen; Sørensen, Mette

    2016-01-01

    Background: Atrial fibrillation is the most common sustained arrhythmia and is associated with cardiovascular morbidity and mortality. The few studies conducted on short-term effects of air pollution on episodes of atrial fibrillation indicate a positive association, though not consistently. Objectives: The aim of this study was to evaluate the long-term impact of traffic-related air pollution on incidence of atrial fibrillation in the general population. Methods: In the Danish Diet, Cancer, and Health cohort of 57,053 people 50–64 years old at enrollment in 1993–1997, we identified 2,700 cases of first-ever hospital admission for atrial fibrillation from enrollment to end of follow-up in 2011. For all cohort members, exposure to traffic-related air pollution assessed as nitrogen dioxide (NO2) and nitrogen oxides (NOx) was estimated at all present and past residential addresses from 1984 to 2011 using a validated dispersion model. We used Cox proportional hazard model to estimate associations between long-term residential exposure to NO2 and NOx and risk of atrial fibrillation, after adjusting for lifestyle and socioeconomic position. Results: A 10 μg/m3 higher 10-year time-weighted mean exposure to NO2 preceding diagnosis was associated with an 8% higher risk of atrial fibrillation [incidence rate ratio: 1.08; 95% confidence interval (CI): 1.01, 1.14] in adjusted analysis. Though weaker, similar results were obtained for long-term residential exposure to NOx. We found no clear tendencies regarding effect modification of the association between NO2 and atrial fibrillation by sex, smoking, hypertension or myocardial infarction. Conclusion: We found long-term residential traffic-related air pollution to be associated with higher risk of atrial fibrillation. Accordingly, the present findings lend further support to the demand for abatement of air pollution. Citation: Monrad M, Sajadieh A, Christensen JS, Ketzel M, Raaschou-Nielsen O, Tjønneland A, Overvad K

  17. 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

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

    PubMed

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

    1987-01-01

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

  19. 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

  20. 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

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

    NASA Astrophysics Data System (ADS)

    Solano Barajas, Ramon

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

  2. 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

  3. Video capture of the circumstances of falls in elderly people residing in long-term care: an observational study

    PubMed Central

    Robinovitch, Stephen N; Feldman, Fabio; Yang, Yijian; Schonnop, Rebecca; Lueng, Pet Ming; Sarraf, Thiago; Sims-Gould, Joanie; Loughin, Marie

    2012-01-01

    Summary Background Falls in elderly people are a major health burden, especially in the long-term care environment. Yet little objective evidence is available for how and why falls occur in this population. We aimed to provide such evidence by analysing real-life falls in long-term care captured on video. Methods We did this observational study between April 20, 2007, and June 23, 2010, in two long-term care facilities in British Columbia, Canada. Digital video cameras were installed in common areas (dining rooms, lounges, hallways). When a fall occurred, facility staff completed an incident report and contacted our teams so that we could collect video footage. A team reviewed each fall video with a validated questionnaire that probed the cause of imbalance and activity at the time of falling. We then tested whether differences existed in the proportion of participants falling due to the various causes, and while engaging in various activities, with generalised linear models, repeated measures logistic regression, and log-linear Poisson regression. Findings We captured 227 falls from 130 individuals (mean age 78 years, SD 10). The most frequent cause of falling was incorrect weight shifting, which accounted for 41% (93 of 227) of falls, followed by trip or stumble (48, 21%), hit or bump (25, 11%), loss of support (25, 11%), and collapse (24, 11%). Slipping accounted for only 3% (six) of falls. The three activities associated with the highest proportion of falls were forward walking (54 of 227 falls, 24%), standing quietly (29 falls, 13%), and sitting down (28 falls, 12%). Compared with previous reports from the long-term care setting, we identified a higher occurrence of falls during standing and transferring, a lower occurrence during walking, and a larger proportion due to centre-of-mass perturbations than base-of-support perturbations. Interpretation By providing insight into the sequences of events that most commonly lead to falls, our results should lead to

  4. 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

  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. 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.

  7. 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…

  8. An early oral health care program starting during pregnancy: results of a prospective clinical long-term study.

    PubMed

    Meyer, Karen; Geurtsen, Werner; Günay, Hüsamettin

    2010-06-01

    This study covers phase IV of a prospective clinical long-term study. Objective of this clinical investigation was to analyze the effects of a long-term prevention program on dental and oral health of teenagers at the age of 13 to 14 years. The entire study was subdivided into four phases. Phase I comprised an individual preventive care during pregnancy ("primary-primary prevention"); phase II assessed mothers and their young children until the age of 3 years ("primary prevention"); and in phase III, mothers and children at the age of 6 years were investigated. In phase IV of the study, the oral health of 13- to 14-year-old teenagers was examined (13.4 +/- 0.5 years; n = 29). All phases consisted of an examination, education about oral health care, and treatment based on the concept of an early oral health care promotion. The control group consisted of randomly selected adolescents at the same age (n = 30). The following clinical parameters were assessed: decayed/missing/filled teeth (DMF-T)/decayed, missing, and filled surface teeth index, hygiene index, papilla bleeding index, Periodontal Screening Index, and Streptococcus mutans/Lactobacillus concentration in saliva. The teenagers of the "prevention" group of phase IV of our prospective study revealed a share of 89.7% caries-free dentitions (65.5% sound; 24.2% caries-free with fillings). Mean DMF-T was 0.55 +/- 1.0. The control group showed a significantly higher mean DMF-T of 1.5 +/- 1.5 (p < 0.05) and revealed 56.7% of caries-free dentitions (30% sound, 26.7% caries-free with restorations). Our data clearly document that an early oral health care promotion starting during pregnancy may cause a sustained and long-term improvement of the oral health of children.

  9. 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

  10. A Study of the Wide Main Sequence: The Long-Term Photometric Variability of Low Mass Stars

    NASA Astrophysics Data System (ADS)

    Pewett, Tiffany; Henry, Todd J.; Hosey, Altonio D.; Dieterich, Sergio; Jao, Wei-Chun; Winters, Jennifer G.; Riedel, Adric R.; RECONS Team

    2016-01-01

    The RECONS (REsearch Consortium On Nearby Stars, www.recons.org) team has carried out a long-term photometric variability study using the SMARTS 0.9m telescope at the Cerro Tololo Inter-American Observatory (CTIO). The program has obtained up to 15 years of observations in the V band for hundreds of M dwarf stars. This unique study has provided insight into how the ubiquitous M dwarfs change over decadal timescales, revealing their long-term magnetic cycles and how the presence or lack of such activity may affect their sizes and consequent luminosities, and thus their positions on the H-R Diagram.Using carefully vetted parallaxes and photometric colors, many measured by the RECONS team, we have created a highly accurate H-R Diagram of the nearest (within 25pc) stars using their V-K colors to represent temperatures and absolute V magnitudes as proxies for luminosities. We find that for M dwarfs, the main sequence widens significantly, by up to four magnitudes in MV, corresponding to a factor of almost 40 in optical flux. This spread implies a wide range of stellar radii for M dwarfs of the same temperature. Our study of long-term photometric variability indicates that there is a trend in cyclic activity that is highest for the most luminous red dwarfs and lowest for the rare, cool red subdwarfs. This provides valuable insight into the complex interplay of age, metallicity, and magnetic fields that molds the character of the red dwarfs.This effort has been supported by the NSF through grants AST-0908402, AST-1109445, and AST-1412026, STScI grant HST-GO-13724.001-A, and via observations made possible by the SMARTS Consortium.

  11. Socioeconomic position predicts long-term depression trajectory: a 13-year follow-up of the GAZEL cohort study.

    PubMed

    Melchior, M; Chastang, J-F; Head, J; Goldberg, M; Zins, M; Nabi, H; Younès, N

    2013-01-01

    Individuals with low socioeconomic position have high rates of depression; however, it is not clear whether this reflects higher incidence or longer persistence of disorder. Past research focused on high-risk samples, and risk factors of long-term depression in the population are less well known. Our aim was to test the hypothesis that socioeconomic position predicts depression trajectory over 13 years of follow-up in a community sample. We studied 12 650 individuals participating in the French GAZEL study. Depression was assessed by the Center for Epidemiological Studies-Depression scale in 1996, 1999, 2002, 2005 and 2008. These five assessments served to estimate longitudinal depression trajectories (no depression, decreasing depression, intermediate/increasing depression, persistent depression). Socioeconomic position was measured by occupational grade. Covariates included year of birth, marital status, tobacco smoking, alcohol consumption, body mass index, negative life events and preexisting psychological and non-psychological health problems. Data were analyzed using multinomial regression, separately in men and women. Overall, participants in intermediate and low occupational grades were significantly more likely than those in high grades to have an unfavorable depression trajectory and to experience persistent depression (age-adjusted ORs: respectively 1.40, 95% confidence interval (CI) 1.16-1.70 and 2.65, 95% CI 2.04-3.45 in men, 2.48, 95% CI 1.36-4.54 and 4.53, 95% CI 2.38-8.63 in women). In multivariate models, the socioeconomic gradient in long-term depression decreased by 21-59% in men and women. Long-term depression trajectories appear to follow a socioeconomic gradient; therefore, efforts aiming to reduce the burden of depression should address the needs of the whole population rather than exclusively focus on high-risk groups.

  12. 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.

  13. 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

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

    PubMed

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

    2016-07-01

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

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

    SciTech Connect

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

    2013-07-01

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

  16. 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).

  17. The Importance of Data Quality on Studies of Short-term and Long-Term Ionospheric Processes

    NASA Astrophysics Data System (ADS)

    Weatherhead, E. C.; Araujo-Pradere, E.

    2004-12-01

    The 50-year record of ionospheric observations from ground-based stations worldwide provides a valuable data set for several applications, including studies of short-term processes and detection of long-term environmental change. The ionospheric region is subject to large natural variability as a result of numerous influences including solar and geomagnetic activity. These variations occur on both short and long timescales and must be well understood before a clear trend or signal can be identified. Previous analyses of the layer heights and critical frequencies have provided conflicting results, and an evaluation of various approaches suggests that data quality has a significant influence on studies of both short- and long-term ionospheric behavior. Exploring the quality of the observations brought to light three main areas that must be addressed before the data are suitable for analysis. First, changes in instrumentation, including the switch from analog to digital technology, have resulted in observable shifts in the data records. Understanding and accounting for these shifts can reduce biases that may result when analyzing the time series of observations. Second, many of the records contained time periods during which no data were reported. These gaps, if not properly addressed in the data analysis, can affect the evaluation of both trends and forcing mechanisms. Third, changes in how parameters (particularly peak layer heights and virtual heights) are inferred can also affect the analysis. These problems have been carefully addressed for four ionosonde stations and have resulted in a corrected, more robust data set for analyzing storms and other short-term processes and for assessing long-term trends. We will summarize some of the issues affecting the data record and will present preliminary results from analyses of the improved data set.

  18. 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.

  19. The FP7 ULTimateCO2 project: a study of the long term fate of CO2

    NASA Astrophysics Data System (ADS)

    Audigane, Pascal; Waldmann, Svenja; Pearce, Jonathan; Dimier, Alain; Le Gallo, Yann; Frykman, Peter; Maurand, Nicolas; Gherardi, Fabrizio; Yalamas, Thierry; Cremer, Holger; Spiers, Chris; Nussbaum, Christophe

    2014-05-01

    The objectives of the European FP7 ULTimateCO2 project are to study specific processes that could influence the long-term fate of geologically stored CO2, mainly: the trapping mechanisms occurring in the storage reservoir, the influence of fluid-rock interactions on mechanical integrity of caprock and well vicinity, and also the modifications induced at the regional scale (brine displacement, fault reactivation, hydrogeology changes...). A comprehensive approach combining laboratory experiments, numerical modeling and natural analogue studies is developed to assess all the processes mentioned above. A collection of data has been generated from natural and industrial (oil industry) analogues on the fluid flow and mechanical properties, structure, and mineralogy of faults and fractures that could affect the long-term storage capacity of underground CO2 storage sites. To address geochemical trapping at reservoir scale, an experimental approach is developed using sandstone core materials in batch reactive mode with CO2 and impurities at reservoir pressure and temperature conditions. Three inter-related lines of laboratory experiments investigate the long-term evolution of the mechanical properties and sealing integrity of fractured and faulted caprocks using Opalinus clay of Mont Terri Gallery (Switzerland), an analogue for caprock well investigated in the past for nuclear waste disposal purpose. To evaluate the interactions between CO2 (and formation fluid) and the well environment (formation, cement, casing) and to assess the consequences of these interactions on the transport properties of well materials, a 1 to 1 scale experiment has been set in the Mont Terri Gallery Opalinus clay to reproduce classical well objects (cemented annulus, casing and cement plug) perforating caprock formations. An extensive program of numerical modeling is also developed to calibrate, to reproduce and to extrapolate the experimental results at longer time scales including uncertainty

  20. ISR II study: a long-term evaluation of sirolimus-eluting stent in the treatment of patients with in-stent restenotic native coronary artery lesions.

    PubMed

    Commeau, Philippe; Barragan, Paul T; Roquebert, Pierre O; Siméoni, Jean B

    2005-10-01

    The aim of this pilot study was to determine the safety and long-term efficacy of treating intrastent restenosis (ISR) with the slow-release sirolimus-eluting stent Bx Velocity (Cypher stent) without intravascular ultrasound (IVUS) guidance. Of patients who received a bare metal stent implantation and presented an ISR, 30-80% of the patients will develop a second restenosis within the stent, at the stent edges or both. To date, intravascular brachytherapy using beta- and gamma-radiation has been the only effective treatment for ISR. Twenty-three patients with ISR and evidence of ischemia were treated with Cypher stent. Clinical information was collected 1, 8, 12, and 24 months after stent implantation. During the first 8 months of the study, in-stent lumen diameter remained essentially unchanged from postprocedure in 80% of the case. The target lesion repeat revascularization (TLR) was 17%, of which 50% were oculostenotic reflexes. Only one patient presented a restenosis greater than 70%. During the 2-year study period, the TLR rate was 17%; the major adverse coronary event rate was 26%, and the non-Q-wave myocardial infarction (MI) rate was 9%. There were no reports of death, coronary artery bypass grafting, or Q-wave MI during the study. This study demonstrates the feasibility of using sirolimus-eluting stents without IVUS guidance for the treatment of ISR, providing long-term stability of immediate results.

  1. 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

  2. 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

  3. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia

    PubMed Central

    2013-01-01

    Introduction The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a prospective, multicenter, open-label, extension study in patients completing 1 of 2 phase 3 randomized, double-blind, controlled, 14-week trials that examined the efficacy and safety of SXB 4.5 g, SXB 6 g, and placebo for treatment of FM. Methods This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries. Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged ≥ 18 years met the American College of Rheumatology 1990 criteria for FM, had a body mass index (BMI) < 40 kg/m2, and had a score ≥ 50 on a 100-mm pain visual analog scale (VAS) at baseline. All patients began treatment in the extension study with SXB 4.5 g/night (administered in 2 equally divided doses) for at least 1 week, followed by possible serial 1.5 g/night dose increases to 9 g/night (maximum) or reductions to 4.5 g/night (minimum). Results Of the 560 FM patients enrolled in this extension study, 319 (57.0%) completed the study. The main reason for early discontinuation was adverse events (AEs; 23.0% of patients). Patients were primarily middle-aged (mean 46.9 ± 10.8 years), female (91.1%), white (91.4%), with a mean duration of FM symptoms of 9.9 ± 8.7 years. Serious AEs were experienced by 3.6% of patients. The most frequently reported AEs (incidence ≥ 5% at any dose or overall) were nausea, headache, dizziness, nasopharyngitis, vomiting, sinusitis, diarrhea, anxiety, insomnia, influenza, somnolence, upper respiratory tract infection, muscle spasms, urinary tract infection, and gastroenteritis viral. Maintenance of SXB therapeutic response was demonstrated with continued improvement from controlled-study baseline in pain VAS, Fibromyalgia Impact Questionnaire (FIQ) total scores, and other measures

  4. PleurX drain use in the management of malignant ascites: safety, complications, long-term patency and factors predictive of success

    PubMed Central

    Tapping, C R; Ling, L; Razack, A

    2012-01-01

    Objectives The aim of this article was to assess the success, safety, complication profile and factors associated with long-term patency of tunnelled peritoneal drains (PleurX) in the treatment of refractory malignant ascites. Methods Over a 4-year period, 28 consecutive patients (32 drain insertions) with refractory malignant ascites were treated with a PleurX drain. The study group comprised 7 males and 21 females (mean age, 61 years). A combination of fluoroscopic and ultrasound guidance was used to insert 4 drains; the remaining 28 drains were inserted under ultrasound guidance alone. Patient history, biochemical profiles, pathological and procedural records and clinical follow-up until death were reviewed. Statistical analysis included multivariate logistic regression analysis and Kaplan–Meier curves (p<0.05 was considered significant). Results There was a 100% technical success rate for the insertion of the drain; there were no procedure-related deaths and no major complications. Only minor complications were reported: three (10%) immediate; three (10%) early; and two (7%) late. Factors significantly associated with these complications included current chemotherapy, low haemoglobin levels, low albumin levels, high white cell count and high c-reactive protein levels. The length of time the drains remained in situ, and therefore patent, ranged from 5 to 365 days (mean, 113 days). Out of the original 28 tunnelled drains, 24 (86%) remained in situ and functioning until the patients’ death. Four (14%) drains dislodged and a subsequent PleurX drain was inserted on the opposite side of the abdominal wall. These new drains remained patent until the patient’s death. The annual event rate was 0.45 events per year. A comorbid diagnosis of renal disease or chemotherapy was significantly related to a decreased length of patency. Conclusion The use of tunnelled peritoneal drains is safe and effective and we would advocate their use as a first-line approach in

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

    PubMed

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

    2015-12-01

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

  6. 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

  7. Direct adsorption of low-density lipoprotein and lipoprotein(a) from whole blood: results of the first clinical long-term multicenter study using DALI apheresis.

    PubMed

    Bosch, T; Lennertz, A; Schenzle, D; Dräger, J

    2002-01-01

    Direct adsorption of lipoproteins (DALI) is the first low-density lipoprotein (LDL)-apheresis technique by which atherogenic LDL and lipoprotein(a) (Lp(a)) can be selectively removed from whole blood without plasma separation. The present study was performed to evaluate the efficacy, selectivity and safety of long-term DALI apheresis. Sixty-three hypercholesterolemic coronary patients were treated by weekly DALI sessions. Initial LDL-cholesterol (C) plasma levels averaged 238 +/- 87 mg/dl (range 130-681 mg/dl). On average, 34 sessions (1-45) were performed processing 1.5 patient blood volumes. The primary aim was to acutely reduce LDL-C by >or=60% per session. To this end, three different adsorber sizes could be employed, i.e., DALI 500, 750, and 1000, which were used in 4, 73, and 23% of the 2156 sessions, respectively. On average, 7387 ml of blood were processed in 116 min per session. This resulted in the following mean acute changes: LDL-C 198 --> 63 mg/dl (-69%), Lp(a) 86 --> 32 mg/dl (-64%), triglycerides 185 --> 136 mg/dl (-27%). HDL-C (-11%) and fibrinogen (-15%) were not significantly influenced. The mean long-term reduction of LDL-C was 42% compared to baseline while HDL-C slightly increased in the long run (+4%). The selectivity of LDL removal was good as recoveries of albumin, immunoglobulins, and other proteins exceeded 85%. Ninety-five percent of 2156 sessions were completely uneventful. The most frequent adverse effects were hypotension (1.2% of sessions) and paresthesia (1.1%), which were probably due to citrate anticoagulation. Access problems had to be overcome in 1.5%, adsorber and hardware problems in 0.5% of the sessions. In this multicenter long-term study, DALI apheresis proved to be an efficient, safe, and easy procedure for extracorporeal LDL and Lp(a) elimination.

  8. Long-term effects of acute low-dose ionizing radiation on the neonatal mouse heart: a proteomic study.

    PubMed

    Bakshi, Mayur V; Barjaktarovic, Zarko; Azimzadeh, Omid; Kempf, Stefan J; Merl, Juliane; Hauck, Stefanie M; Eriksson, Per; Buratovic, Sonja; Atkinson, Michael J; Tapio, Soile

    2013-11-01

    Epidemiological studies establish that children and young adults are especially susceptible to radiation-induced cardiovascular disease (CVD). The biological mechanisms behind the elevated CVD risk following exposure at young age remain unknown. The present study aims to elucidate the long-term effects of ionizing radiation by studying the murine cardiac proteome after exposure to low and moderate radiation doses. NMRI mice received single doses of total body (60)Co gamma-irradiation on postnatal day 10 and were sacrificed 7 months later. Changes in cardiac protein expression were quantified using isotope-coded protein label and tandem mass spectrometry. We identified 32, 31, 66, and 34 significantly deregulated proteins after doses of 0.02, 0.1, 0.5, and 1.0 Gy, respectively. The four doses shared 9 deregulated proteins. Bioinformatics analysis showed that most of the deregulated proteins belonged to a limited set of biological categories, including metabolic processes, inflammatory response, and cytoskeletal structure. The transcription factor peroxisome proliferator-activated receptor alpha was predicted as a common upstream regulator of several deregulated proteins. This study indicates that both adaptive and maladaptive responses to the initial radiation damage persist well into adulthood. It will contribute to the understanding of the long-term consequences of radiation-induced injury and developmental alterations in the neonatal heart.

  9. The Association between Obstructive Sleep Apnea and Neurocognitive Performance—The Apnea Positive Pressure Long-term Efficacy Study (APPLES)

    PubMed Central

    Quan, Stuart F.; Chan, Cynthia S.; Dement, William C.; Gevins, Alan; Goodwin, James L.; Gottlieb, Daniel J.; Green, Sylvan; Guilleminault, Christian; Hirshkowitz, Max; Hyde, Pamela R.; Kay, Gary G.; Leary, Eileen B.; Nichols, Deborah A.; Schweitzer, Paula K.; Simon, Richard D.; Walsh, James K.; Kushida, Clete A.

    2011-01-01

    Study Objectives: To determine associations between obstructive sleep apnea (OSA) and neurocognitive performance in a large cohort of adults. Study Design: Cross-sectional analyses of polysomnographic and neurocognitive data from 1204 adult participants with a clinical diagnosis of obstructive sleep apnea (OSA) in the Apnea Positive Pressure Long-term Efficacy Study (APPLES), assessed at baseline before randomization to either continuous positive airway pressure (CPAP) or sham CPAP. Measurements: Sleep and respiratory indices obtained by laboratory polysomnography and several measures of neurocognitive performance. Results: Weak correlations were found for both the apnea hypopnea index (AHI) and several indices of oxygen desaturation and neurocognitive performance in unadjusted analyses. After adjustment for level of education, ethnicity, and gender, there was no association between the AHI and neurocognitive performance. However, severity of oxygen desaturation was weakly associated with worse neurocognitive performance on some measures of intelligence, attention, and processing speed. Conclusions: The impact of OSA on neurocognitive performance is small for many individuals with this condition and is most related to the severity of hypoxemia. Citation: Quan SF; Chan CS; Dement WC; Gevins A; Goodwin JL; Gottlieb DJ; Green S; Guilleminault C; Hirshkowitz M; Hype PR; Kay GG; Leary EB; Nichols DA; Schweitzer PK; Simon RD; Walsh JK; Kushida CA. The association between obstructive sleep apnea and neurocognitive performance—the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2011;34(3):303-314. PMID:21358847

  10. 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

    2015-02-03

    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.

  11. Plutonium Isotopes in the Terrestrial Environment at the Savannah River Site, USA. A Long-Term Study

    DOE PAGES

    Armstrong, Christopher R.; Nuessle, Patterson R.; Brant, Heather A.; ...

    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. Pulmonary response after exposure to inhaled nickel hydroxide nanoparticles: short and long-term studies in mice

    PubMed Central

    Gillespie, Patricia A.; Kang, Gi Soo; Elder, Alison; Gelein, Robert; Chen, Lu; Moreira, Andre L.; Koberstein, Jeffrey; Tchou-Wong, Kam-Meng; Gordon, Terry; Chen, Lung Chi

    2010-01-01

    Short and long-term pulmonary response to inhaled nickel hydroxide nanoparticles (nano-Ni(OH)2, CMD = 40 nm) in C57BL/6 mice was assessed using a whole body exposure system. For short-term studies mice were exposed for 4 h to nominal concentrations of 100, 500, and 1000 mg/m3. For long-term studies mice were exposed for 5 h/d, 5 d/w, for up to 5 months (m) to a nominal concentration of 100 mg/m3. Particle morphology, size distribution, chemical composition, solubility, and intrinsic oxidative capacity were determined. Markers of lung injury and inflammation in bronchoalveolar lavage fluid (BALF); histopathology; and lung tissue elemental nickel content and mRNA changes in macrophage inflammatory protein-2 (Mip-2), chemokine ligand 2 (Ccl2), interleukin 1-alpha (Il-1α), and tumor necrosis factor-alpha (Tnf-α) were assessed. Dose-related changes in BALF analyses were observed 24 h after short-term studies while significant changes were noted after 3 m and/or 5 m of exposure (24 h). Nickel content was detected in lung tissue, Ccl2 was most pronouncedly expressed, and histological changes were noted after 5 m of exposure. Collectively, data illustrates nano-Ni(OH)2 can induce inflammatory responses in C57BL/6 mice. PMID:20730025

  14. [Assessment of immunoglobulins in a long-term non-interventional study (SIGNS Study). Rationale, design, and methods].

    PubMed

    Kirch, Wilhelm; Gold, Ralf; Hensel, Manfred; Fasshauer, Maria; Pittrow, David; Huscher, Dörte; Reiser, Marcel; Stangel, Martin; Baumann, Ulrich; Borte, Michael

    2010-09-01

    Non-modified human immunoglobulins (IgG) are standard of care for replacement therapy with primary (inherited) immunodeficiencies, and secondary immunodeficiencies due to multiple myeloma (MM) or chronic lymphocytic leukemia (CLL). Further, they have effectively been used as immunomodulation in neurological autoimmune diseases such as Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN). A variety of IgG preparations for intravenous and subcutaneous use are available. In view of the broad range of indications, data on the utilization of the IgG preparations in everyday clinical care are of high clinical interest. Furthermore, data on the outcomes of IgG therapy outside the setting of controlled clinical trials are needed. Therefore, the SIGNS study (Assessment of Immunoglobulins in a Long-Term Non-Interventional Study) was set up as a non-interventional prospective open-label cohort study and was approved by the ethics committee. Led by an interdisciplinary steering board, hospital- and office-based investigators in 30-40 centers throughout Germany (neurologists, pediatricians, oncologists, other) will document approximately 300 patients, and will follow them for at least 2 years. Patients of both genders and any age are eligible if they have received, or are scheduled for, IgG therapy for primary or severe secondary immunodeficiency or neurological autoimmune diseases, and have provided written informed consent. No exclusion criteria have been defined in order to minimize selection bias. Long-term outcome data will be collected on patient characteristics in the various indications, drug utilization (e.g., treatment and dosing patterns), effectiveness (i.e., number of infections), tolerability, health-related quality of life, and economic variables (number of hospitalizations, sick-leave days, etc.) with the possibility to estimate direct costs. For the neurological autoimmune diseases

  15. Atherosclerotic effects of long-term old and new antiepileptic drugs monotherapy: a cross-sectional comparative study.

    PubMed

    El-Farahaty, Reham M; El-Mitwalli, Ashraf; Azzam, Hanan; Wasel, Yasser; Elrakhawy, Mohamed M; Hasaneen, Bothina Mohammed

    2015-03-01

    This work aimed to evaluate the metabolic and atherogenic effects of long-term antiepileptic drugs in a group of Egyptian epileptic patients. Sixty-nine epileptic patients on antiepileptic drug monotherapy for at least 2 years and 34 control subjects were recruited in this study. Patients were divided into 5 subgroups according to antiepileptic drugs used (valproate, carbamazepine, lamotrigine, topiramate, and levetiracetam). Fasting lipid profile (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol), lipoprotein(a), homocysteine, free thyroxine, thyroid-stimulating hormone, and common carotid artery intima-media thickness were measured for all subjects. Significant higher mean values of low-density lipoprotein cholesterol, low-density lipoprotein / high-density lipoprotein ratio, lipoprotein(a), homocysteine, significantly lower mean value of high-density lipoprotein cholesterol, and significantly larger diameter of common carotid artery intima-media thickness were observed in each drug-treated group versus control group. Our study supports that long-term monotherapy treatment with valproate, carbamazepine, lamotrigine, and topiramate had altered markers of vascular risk that might enhance atherosclerosis, whereas levetiracetam exerted minimal effect.

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

    PubMed

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

    2008-01-01

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

  18. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study

    PubMed Central

    2011-01-01

    Background There is a lack of data on the long-term outcome of total hip arthroplasty procedures, as assessed by validated tools. Methods We conducted a follow-up study to evaluate the quality of life and functionality of 250 patients an average of 16 years (range: 11-23 years) after total hip arthroplasty using a validated assessment set including the SF-36 questionnaire, Harris Hip Score, WOMAC score, Functional Comorbidity Index, and a study specific questionnaire. Models of multiple stepwise linear and logistic regression analysis were constructed to evaluate the relationships between several explanatory variables and these functional outcomes. Results The SF-36 physical indexes of these patients compared negatively with the normative values but positively with the results obtained in untreated subjects with severe hip osteoarthritis. Similar results were detected for the Harris Hip Score and WOMAC score. There was a 96% rate of post-surgical satisfaction. Hip functionality and comorbidities were the most important determinants of physical measures on the SF-36. Conclusions Patients who had undergone total hip arthroplasty have impaired long-term self-reported physical quality of life and hip functionality but they still perform physically better than untreated patients with advanced hip osteoarthritis. However, the level of post-surgical satisfaction is high. PMID:21978244

  19. 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.

  20. Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up.

    PubMed

    Frimat, L; Cassuto-Viguier, E; Provôt, F; Rostaing, L; Charpentier, B; Akposso, K; Moal, M C; Lang, P; Glotz, D; Caillard, S; Ducloux, D; Pouteil-Noble, C; Girardot-Seguin, S; Kessler, M

    2010-01-01

    Calcineurin inhibitor (CNI) toxicity contributes to chronic allograft nephropathy (CAN). In the 2-year, randomized, study, we showed that 50% cyclosporin (CsA) reduction in combination with mycophenolate mofetil (MMF) treatment improves kidney function without increasing the risk for graft rejection/loss. To investigate the long-term effect of this regimen, we conducted a follow up study in 70 kidney transplant patients until 5 years after REFERENCE initiation. The improvement of kidney function was confirmed in the MMF group but not in the control group (CsA group). Four graft losses occurred, 2 in each group (graft survival in the MMF group 95.8% and 90.9% in control group). One death occurred in the control group. There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections. A limitation is the weak proportion of patient still remaining within the control group. On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated. In conclusion, CsA reduction in the presence of MMF treatment seems to maintain kidney function and is well tolerated in the long term.

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

    PubMed Central

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

    2016-01-01

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

  2. Correction: Prospective pilot study of fully covered self-expandable metal stents for refractory benign pancreatic duct strictures: long-term outcomes

    PubMed Central

    Matsubara, Saburo; Sasahira, Naoki; Isayama, Hiroyuki; Takahara, Naminatsu; Mizuno, Suguru; Kogure, Hirofumi; Yamamoto, Natsuyo; Nakai, Yousuke; Tada, Minoru; Koike, Kazuhiko

    2016-01-01

    Background and study aims: Background and study aims: Temporary placement of a fully covered self-expandable metal stent (FCSEMS) has recently emerged as a treatment option for pancreatic duct strictures due to chronic pancreatitis refractory to conventional plastic stenting. However, there are no data about long-term outcomes with this therapeutic option. The aims of the current study were to estimate the feasibility, safety, efficacy, and long-term outcomes of temporary FCSEMS placement for refractory pancreatic duct strictures. Patients and methods: This was a prospective, single-center feasibility study. Ten patients with refractory pancreatic duct strictures due to chronic pancreatitis underwent FCSEMS placement for 3 months. We evaluated the rate of recurrent symptoms after stent removal during long-term follow-up, as well as adverse events (AEs). Results: Two patients required early (within 1 week) stent removal because of intolerable pain or pancreatitis. In the remaining 8 patients, the recurrence rate of any symptoms after FCSEMS removal was 63% during 35 months of follow up. The causes of recurrent symptoms were as follows: recurrence of stricture in 2; stent-induced stricture in 1; impaction of pancreatic stones in 1; and development of a pseudocyst in 1. When limited to stricture, the recurrence rate was 38%. Additional endoscopic treatments were required in 4 patients: a second FCSEMS placement in 1; plastic stent (PS) placement in 1; stone extraction in 1; and endoscopic ultrasound–guided pseudocyst drainage in 1. Asymptomatic stent migration occurred in 2 patients. Suppurative pancreatic ductitis due to food impaction in the FCSEMS occurred in 2 patients, and endoscopic pancreatic duct drainage was performed. Stent-induced ductal changes developed in 2 patients and PS treatment was required in 1 patient for pain relief. Conclusion: The FCSEMS appears to be a feasible and potentially effective option for the management of refractory pancreatic duct

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. Theoretical estimation and experimental studies on gas dissociation in TEA CO2 laser for long term arc free operation

    NASA Astrophysics Data System (ADS)

    Kumar, Manoj; Biswas, A. K.; Bhargav, Pankaj; Reghu, T.; Sahu, Shashikiran; Pakhare, J. S.; Bhagat, M. S.; Kukreja, L. M.

    2013-11-01

    Gas dissociation in a high energy, high repetition rate Transversely Excited Atmospheric (TEA) CO2 laser in both sealed-off and gas replenishment modes were studied for nitrogen lean gas mixture. A comprehensive theoretical model based on the Boltzmann transport equation and the discharge excitation circuit equations was adopted to calculate the amount of CO2 dissociated during a single discharge pulse. Theoretically it is shown that inclusion of superelastic collisions in the Boltzmann transport equation is necessary for precise estimation of dissociation per pulse, particularly at high discharge energy loadings and for nitrogen rich gas mixtures. Gas lifetime for repetitively pulsed operations was found experimentally by measuring the amount of CO formed when frequent arcing sets in under sealed off operation. Using this model, the optimum replenishment rate of CO2 either by gas purging and/or by catalytic regeneration needed for arc free long term operation of the laser was estimated. The measured saturation values of CO concentration in the laser chamber agreed well with the calculated values for various operating conditions. Arc free, long term repetitively pulsed operation of the laser was achieved in the gas replenishment mode with gas purging and/or catalytic regeneration.

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

    PubMed

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

    2014-12-01

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

  9. A Long Term Study of the Water Content Changes in Three Types of Hydrogel Contact Lenses.

    DTIC Science & Technology

    1987-05-01

    in visual acuity , keratometric readings, and post-lens removal refractions? Appropriate statistical analysis of the data would be used to determine the...study. Visual acuities had to be correctable to 20/20 or better in each eye by both spectacles and contact lens. Participation in this study required...eye. This was done before and after lens removal. 4. Distant Snellen visual acuity --measured through contact lenses with a • -: Meanco projector and an

  10. European studies on long-term exposure to ambient particulate matter and lung cancer.

    PubMed

    Gallus, Silvano; Negri, Eva; Boffetta, Paolo; McLaughlin, Joseph K; Bosetti, Cristina; La Vecchia, Carlo

    2008-06-01

    European epidemiological studies on ambient air pollution and cancer published before December 2006 are reviewed, with focus on five analytic studies providing data on the association between various measures of particulate matter (PM) and lung cancer. A case-control study of 755 men who died from lung cancer in Trieste, Italy, reported that, compared with less than 0.18 g/m/day of deposition of particulate, the relative risk (RR) was 1.1 [95% confidence interval (CI): 0.8-1.5] for 0.18-0.30 and 1.4 (95% CI: 1.1-1.8) for more than 0.30 g/m/day. In the Netherlands Cohort Study on Diet and Cancer with 60 deaths from lung cancer, the RR was 1.06 (95% CI: 0.43-2.63) for an increase of 10 mug/m in black smoke. In the French Pollution Atmospherique et Affections Respiratoires Chroniques study cohort based on 178 deaths from lung cancer, the RR associated with an increase in exposure to 10 mug/m of total suspended particulate was 0.97 (95% CI: 0.94-1.01). A nested case-control study within the European Prospective Investigation on Cancer and Nutrition included 113 nonsmokers or exsmokers diagnosed with lung cancer and 312 controls. The RRs were 0.91 (95% CI: 0.70-1.18) for an increase in PM with diameter study, based on 1453 lung cancer deaths, no significant excess risk was found for men, and a modest association was observed for women. European studies of PM exposure and lung cancer do not show a clear association, but uncertainties remain for the measurement of exposure and latency.

  11. Vegetation cover and long-term conservation of radioactive waste packages: the case study of the CSM waste disposal facility (Manche District, France).

    PubMed

    Petit-Berghem, Yves; Lemperiere, Guy

    2012-03-01

    The CSM is the first French waste disposal facility for radioactive waste. Waste material is buried several meters deep and protected by a multi-layer cover, and equipped with a drainage system. On the surface, the plant cover is a grassland vegetation type. A scientific assessment has been carried out by the Géophen laboratory, University of Caen, in order to better characterize the plant cover (ecological groups and associated soils) and to observe its medium and long term evolution. Field assessments made on 10 plots were complemented by laboratory analyses carried out over a period of 1 year. The results indicate scenarios and alternative solutions which could arise, in order to passively ensure the long-term safety of the waste disposal system. Several proposals for a blanket solution are currently being studied and discussed, under the auspices of international research institutions in order to determine the most appropriate materials for the storage conditions. One proposal is an increased thickness of these materials associated with a geotechnical barrier since it is well adapted to the forest plants which are likely to colonize the site. The current experiments that are carried out will allow to select the best option and could provide feedback for other waste disposal facility sites already being operated in France (CSFMA waste disposal facility, Aube district) or in other countries.

  12. A retrospective long term study of teeth restored with prefabricated carbon fiber reinforced epoxy resin posts.

    PubMed

    Segerström, Susanna; Astbäck, Johnny; Ekstrand, Karl D

    2006-01-01

    The Composipost endodontic post, made of stretched aligned carbon fibers embedded in an epoxy-resin matrix, has since the beginning of the nineties been widely used for the restoration of endodontically treated teeth. The aim of this retrospective study was to evaluate the treatment outcome of the Composipost system up to 7 years. In a study published 1998, 236 patients treated during 1992-93 by seven Swedish general dental private practitioners were studied. Five of the former seven private practitionersi consented to participate in this follow up of that study. Thus the material was reduced to 138 patients. Thirty-nine of these were excluded due to insufficient data. For the remaining 99 patients, data were collected from dental records. All patients were offered a clinical examination but only 25 accepted. Data were collected from dental records for the remaining 74 patients. The mean follow up time was 6,7 years with a range from 1 month to 10 years (median 7.6 years, SD 2.5 years), (five teeth were extracted during the previous study). The outcome was considered successful if the post and core was in situ and showed no clinical or radiographic signs of technical failures. Sixty-four teeth (65%) restored with the Composipost system were successful after a mean time of 6.7 years. Thirty-two teeth were extracted due to fractures, periapical lesions and periodontitis. Dislodgment of post was observed in three cases. In conclusion, within the limitations of this study, after a mean time of 6.7 years, the Composipost restored teeth had shorter survival times than those of previously documented cast posts.

  13. A long-term study of burning effects on a plant pathogen in tallgrass prairie

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Tallgrass prairie species have evolved with regular exposure to fire. Yet burning has been used as a management tool for reducing plant disease in agricultural systems, posing the question of how plant pathogens of tallgrass prairie will be affected by burning. We studied the rust fungus Puccinia ...

  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. 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)

  16. 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…

  17. 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…

  18. 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…

  19. Long-Term Follow-up Study of Children Developmentally Retarded by Early Environmental Deprivation.

    ERIC Educational Resources Information Center

    Fujinaga, Tamotsu; And Others

    This paper reports on a 14-year follow-up study of two developmentally retarded Japanese children, a brother and sister, who had been kept shut up in a small shack before being rescued (at ages 5 and 6 respectively). Following birth they consistently suffered malnutrition, maternal deprivation, social isolation from adults, language deprivation,…

  20. Revisiting soil terrain relationships at a long-term agroecosystem study site

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Landscape topography is considered a major controlling factor in soil development and, therefore, several attempts have been made to relate various soil properties to terrain attributes. The often cited study of Moore et al. (1993) related soil attributes to the terrain based on a 15.24-m grid of e...

  1. 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…

  2. 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…

  3. 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