Sample records for long-term safety efficacy

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

    PubMed Central

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

    2014-01-01

    In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines – bivalent (bHPV) and quadrivalent (qHPV) – are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman’s sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish systems for continued monitoring of vaccine immunogenicity, efficacy, and safety over time. PMID:25587221

  2. Efficacy and Safety of Long-Term Thiopurine Maintenance Treatment in Japanese Patients With Ulcerative Colitis

    PubMed Central

    Yamada, Satoshi; Yoshino, Takuya; Matsuura, Minoru; Kimura, Masamichi; Koshikawa, Yorimitsu; Minami, Naoki; Toyonaga, Takahiko; Honzawa, Yusuke

    2015-01-01

    Background/Aims The long-term clinical outcomes of patients with bio-naive ulcerative colitis (UC) who maintain remission with thiopurine are unclear. The aim of this study was to assess the long-term efficacy and safety of maintenance treatment with thiopurine in UC patients. Methods This was a retrospective observational cohort analysis conducted at a single center. Between December 1998 and August 2013, 59 of 87 patients with bio-naive UC who achieved remission after induction with treatments other than biologics were enrolled. Remission maintenance with thiopurine was defined as no concomitant treatment needed other than 5-aminosalicylate without relapse. We assessed the remission-maintenance rate, mucosal healing rate, colectomy-free rate, and treatment safety in UC patients who received thiopurine as maintenance treatment. Results The 84-month cumulative remission-maintenance and colectomy-free survival rates in the UC patients who were receiving maintenance treatment with thiopurine and 5-aminosalicylate were 43.9% and 88.0%, respectively. Of the 38 patients who underwent colonoscopy during thiopurine maintenance treatment, 23 (60.5%) achieved mucosal healing. Of the 59 patients who achieved clinical remission with thiopurine, 6 patients (10.2%) discontinued the thiopurine therapy because of adverse events. Conclusions Our study demonstrates the long-term efficacy and safety of thiopurine treatment in patients with bio-naive UC. PMID:26131000

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

    Microsoft Academic Search

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

    2009-01-01

    The long-term safety and efficacy of products used in the correction of HIV-associated facial lipoatrophy (FLA) are largely unknown. The purpose of this study was to describe the long-term efficacy and safety of polyalkylimide gel (PAIG) in the treatment of HIV-associated FLA. In this open-label, randomized, single-center study, 31 HIV-positive individuals (median age 48 years (interquartile ranges (IQR) 45, 55,

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

    PubMed Central

    Iborra, Marisa; Álvarez-Sotomayor, Diego; Nos, Pilar

    2014-01-01

    Ulcerative colitis (UC) is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon). Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide’s usefulness in treating active mild to moderate ileocecal Crohn’s disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide’s efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX) to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide’s long-term safety and efficacy in treating UC. PMID:24523594

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

    PubMed Central

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

    2015-01-01

    Several second-generation bisphosphonates (BPs) are approved in osteoporosis treatment. Efficacy and safety depends on potency of farnesyl pyrophosphate synthase (FPPS) inhibition, hydroxyapatite affinity, compliance and adherence. The latter may be influenced by frequency and route of administration. A literature search using “ibandronate”, “postmenopausal osteoporosis”, “fracture”, and “bone mineral density” (BMD) revealed 168 publications. The Phase III BONE study, using low dose 2.5 mg daily oral ibandronate demonstrated 49% relative risk reduction (RRR) in clinical vertebral fracture after 3 years. Non-vertebral fracture (NVF) reduction was demonstrated in a subgroup (pretreatment T-score ? ?3.0; RRR 69%) and a meta-analysis of high annual doses (150 mg oral monthly or intravenous equivalent of ibandronate; RRR 38%). Hip fracture reduction was not demonstrated. Long-term treatment efficacy has been confirmed over 5 years. Long term safety is comparable to placebo over 3 years apart from flu-like symptoms which are more common with oral monthly and intravenous treatments. No cases of atypical femoral fracture or osteonecrosis of the jaw have been reported in randomized controlled trial studies. Ibandronate inhibits FPPS more than alendronate but less than other BPs which could explain rate of action onset. Ibandronate has a higher affinity for hydroxyapatite compared with risedronate but less than other BPs which could affect skeletal distribution and rate of action offset. High doses (150 mg oral monthly or intravenous equivalent) were superior to low doses (oral 2.5 mg daily) according to 1 year BMD change. Data are limited by patient selection, statistical power, under-dosing, and absence of placebo groups in high dose studies. Ibandronate treatment offers different doses and modalities of administration which could translate into higher adherence rates, an important factor when the two main limitations of BP treatment are initiation and adherence rates. However, lack of consistency in NVF reduction and absence of hip fracture data limits more generalized use of this agent. PMID:25565901

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

    PubMed

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

    2015-01-01

    Several second-generation bisphosphonates (BPs) are approved in osteoporosis treatment. Efficacy and safety depends on potency of farnesyl pyrophosphate synthase (FPPS) inhibition, hydroxyapatite affinity, compliance and adherence. The latter may be influenced by frequency and route of administration. A literature search using "ibandronate", "postmenopausal osteoporosis", "fracture", and "bone mineral density" (BMD) revealed 168 publications. The Phase III BONE study, using low dose 2.5 mg daily oral ibandronate demonstrated 49% relative risk reduction (RRR) in clinical vertebral fracture after 3 years. Non-vertebral fracture (NVF) reduction was demonstrated in a subgroup (pretreatment T-score ? -3.0; RRR 69%) and a meta-analysis of high annual doses (150 mg oral monthly or intravenous equivalent of ibandronate; RRR 38%). Hip fracture reduction was not demonstrated. Long-term treatment efficacy has been confirmed over 5 years. Long term safety is comparable to placebo over 3 years apart from flu-like symptoms which are more common with oral monthly and intravenous treatments. No cases of atypical femoral fracture or osteonecrosis of the jaw have been reported in randomized controlled trial studies. Ibandronate inhibits FPPS more than alendronate but less than other BPs which could explain rate of action onset. Ibandronate has a higher affinity for hydroxyapatite compared with risedronate but less than other BPs which could affect skeletal distribution and rate of action offset. High doses (150 mg oral monthly or intravenous equivalent) were superior to low doses (oral 2.5 mg daily) according to 1 year BMD change. Data are limited by patient selection, statistical power, under-dosing, and absence of placebo groups in high dose studies. Ibandronate treatment offers different doses and modalities of administration which could translate into higher adherence rates, an important factor when the two main limitations of BP treatment are initiation and adherence rates. However, lack of consistency in NVF reduction and absence of hip fracture data limits more generalized use of this agent. PMID:25565901

  7. Kinetics, safety, and efficacy of ramipril after long-term administration in hemodialyzed patients.

    PubMed

    Fillastre, J P; Baguet, J C; Dubois, D; Vauquier, J; Godin, M; Legallicier, B; Luus, H G; de la Rey, N; Carcone, N; Genthon, R

    1996-02-01

    We studied the efficacy and safety of ramipril and the kinetics of its active moiety ramiprilat in 12 hypertensive patients receiving regular hemodialysis, after a single dose and after long-term (28 days) administration. Patients received 2.5 mg ramipril after each hemodialysis. On days 1 and 29, ramipril was administered 4 h before the hemodialysis and serial blood samples were obtained for 9 h for determination of pharmacokinetic parameters. Tolerability was good, and all patients completed the study. There was a high degree of angiotensin-converting enzyme (ACE) inhibition throughout the study. Ramipril had a clear-cut antihypertensive effect. Long-term administration of ramipril did not modify the time to peak ramiprilat concentration, but increased the mean maximal concentration significantly: 20.2 +/- 12.7 vs. 10.4 +/- 7.1 ng center dot ml-1. The mean accumulation ratio was 2.2. Ramiprilat hemodialysis clearance was 31.7 ml/min (range 4.2-64.9 ml/min) on day 1 and 21.0 ml/min (range 7.9-56.5 ml/min) on day 29. Ramipril 2.5 mg, administered after hemodialysis, appears to be safe and effective in hypertensive patients receiving periodic hemodialysis. Despite an increase in ramiprilat concentration from day 1 to day 29, the steady state was reached. We describe the role of nonrenal clearance of ramiprilat. PMID:8720427

  8. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: Efficacy, safety, and influence on gastric mucosa

    Microsoft Academic Search

    Elly C. Klinkenberg-Knol; Frits Nelis; John Dent; Pleun Snel; Brent Mitchell; Peter Prichard; David Lloyd; Niilo Havu; Madeline H. Frame; Jonas Romàn; Anders Walan

    2000-01-01

    Background & Aims: The efficacy and safety of long-term acid suppression remains a subject for debate. We report data from patients with refractory reflux esophagitis who were undergoing maintenance therapy with ?20 mg omeprazole daily for a mean period of 6.5 years (range, 1.4–11.2 years). Methods: Patients with severe reflux esophagitis resistant to long-term therapy with H2-receptor antagonists and who

  9. Calcium Hydroxylapatite (Radiesse) for Treatment of Nasolabial Folds: Long-Term Safety and Efficacy Results

    Microsoft Academic Search

    Lawrence S. Bass; Stacy Smith; Mariano Busso; Marla McClaren

    2010-01-01

    Background: Calcium hydroxylapatite (CaHA, Radiesse) is approved by the Food and Drug Administration for treatment of moderate to severe wrinkles and folds, including nasolabial folds (NLF). A pivotal NLF split-face study previously compared the performance of Radiesse to human-based collagen at six months and safety of Radiesse through one year.Objective: The authors assess the long-term safety and effectiveness of Radiesse

  10. Long-term efficacy and safety of modafinil (PROVIGIL ®) for the treatment of excessive daytime sleepiness associated with narcolepsy

    Microsoft Academic Search

    Merrill M Mitler; John Harsh; Max Hirshkowitz; Christian Guilleminault

    2000-01-01

    Objectives: To assess the long-term efficacy and safety of modafinil in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.Background: Modafinil has been shown to be effective and well tolerated for treating EDS associated with narcolepsy in two large-scale, well-controlled, 9-week clinical trials.Methods: Four hundred and seventy eight adult patients with a diagnosis of narcolepsy who had completed one of

  11. Assessment of the efficacy and safety of Viagra® (sildenafil citrate) in men with erectile dysfunction during long-term treatment

    Microsoft Academic Search

    W Steers; AT Guay; A Leriche; C Gingell; TB Hargreave; PJ Wright; DE Price; RA Feldman

    2001-01-01

    Long-term efficacy and safety of sildenafil was assessed in 1008 patients with erectile dysfunction (ED) enrolled in four flexible-dose (25–100 mg), open-label, 36- or 52-week extension studies. After 36 and 52 weeks, 92% and 89% of patients felt that treatment with sildenafil had improved their erections. Responses to a Sexual Function Questionnaire indicated that 52 weeks of sildenafil treatment resulted

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

    Microsoft Academic Search

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

    2002-01-01

    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

  13. 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

  14. Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study.

    PubMed

    Rostaing, L; Vincenti, F; Grinyó, J; Rice, K M; Bresnahan, B; Steinberg, S; Gang, S; Gaite, L E; Moal, M-C; Mondragón-Ramirez, G A; Kothari, J; Pupim, L; Larsen, C P

    2013-11-01

    The Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial randomized patients receiving a living or standard criteria deceased donor kidney transplant to a more (MI) or less intensive (LI) regimen of belatacept or cyclosporine A (CsA). The 5-year results of the long-term extension (LTE) cohort are reported. A total of 456 (68.5% of intent-to-treat) patients entered the LTE at 36 months; 406 patients (89%) completed 60 months. Between Months 36 and 60, death occurred in 2%, 1% and 5% of belatacept MI, belatacept LI and CsA patients, respectively; graft loss occurred in 0% belatacept and 2% of CsA patients. Acute rejection between Months 36 and 60 was rare: zero belatacept MI, one belatacept LI and one CsA. Rates for infections and malignancies for Months 36-60 were generally similar across belatacept groups and CsA, respectively: fungal infections (14%, 15%, 12%), viral infections (21%, 18%, 16%) and malignancies (6%, 6%, 9%). No new posttransplant lymphoproliferative disorder cases occurred after 36 months. Mean calculated GFR (MDRD, mL/min/1.73?m(2) ) at Month 60 was 74 for belatacept MI, 76 for belatacept LI and 53 for CsA. These results show that the renal function benefit and safety profile observed in belatacept-treated patients in the early posttransplant period was sustained through 5 years. PMID:24047110

  15. Long-Term Efficacy and Safety of Celecoxib in Alzheimer’s Disease

    Microsoft Academic Search

    Hilkka Soininen; Christine West; Jeffery Robbins; Liviu Niculescu

    2007-01-01

    Background\\/Aims: Cyclooxygenase-2 (COX-2) may play an important role in the neuropathology of Alzheimer’s disease (AD). The efficacy and safety of celecoxib (200 mg bid), a COX-2 selective inhibitor, were assessed in patients ?50 years with established mild-to-moderate AD to determine whether treatment was effective in retarding deterioration of cognitive function. Methods: This was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group

  16. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy.

    PubMed

    Kuter, David J; Bussel, James B; Newland, Adrian; Baker, Ross I; Lyons, Roger M; Wasser, Jeffrey; Viallard, Jean-Francois; Macik, Gail; Rummel, Mathias; Nie, Kun; Jun, Susie

    2013-05-01

    Romiplostim was effective, safe, and well-tolerated over 6-12 months of continuous treatment in Phase 3 trials in patients with immune thrombocytopenia (ITP). This report describes up to 5 years of weekly treatment with romiplostim in 292 adult ITP patients in a long-term, single-arm, open-label study. Outcome measures included adverse events (including bleeding, thrombosis, malignancy, and reticulin/fibrosis), platelet response (platelet count >50 × 10(9) per litre), and the proportion of patients requiring rescue treatments. Treatment-related serious adverse events were infrequent and did not increase with longer treatment. No new classes of adverse events emerged. Thrombotic events occurred in 6.5% of patients and were not associated with platelet count. Median platelet counts of 50-200 × 10(9) per litre were maintained with stable doses of romiplostim (mean 5-8 ?g/kg; generally self-administered at home) throughout the study. A platelet response was achieved at least once by 95% of patients, with a platelet response maintained by all patients on a median 92% of study visits. There was a low rate of bleeding and infrequent need for rescue treatments. In conclusion, this study demonstrated that romiplostim was safe and well-tolerated over 614 patient-years of exposure in ITP patients, and that efficacy was maintained with stable dosing for up to 5 years of continuous treatment. PMID:23432528

  17. Long-Term Safety and Efficacy of Factor IX Gene Therapy in Hemophilia B

    PubMed Central

    Nathwani, A.C.; Reiss, U.M.; Tuddenham, E.G.D.; Rosales, C.; Chowdary, P.; McIntosh, J.; Della Peruta, M.; Lheriteau, E.; Patel, N.; Raj, D.; Riddell, A.; Pie, J.; Rangarajan, S.; Bevan, D.; Recht, M.; Shen, Y.-M.; Halka, K.G.; Basner-Tschakarjan, E.; Mingozzi, F.; High, K.A.; Allay, J.; Kay, M.A.; Ng, C.Y.C.; Zhou, J.; Cancio, M.; Morton, C.L.; Gray, J.T.; Srivastava, D.; Nienhuis, A.W.; Davidoff, A.M.

    2014-01-01

    BACKGROUND In patients with severe hemophilia B, gene therapy that is mediated by a novel self-complementary adeno-associated virus serotype 8 (AAV8) vector has been shown to raise factor IX levels for periods of up to 16 months. We wanted to determine the durability of transgene expression, the vector dose–response relationship, and the level of persistent or late toxicity. METHODS We evaluated the stability of transgene expression and long-term safety in 10 patients with severe hemophilia B: 6 patients who had been enrolled in an initial phase 1 dose-escalation trial, with 2 patients each receiving a low, intermediate, or high dose, and 4 additional patients who received the high dose (2×1012 vector genomes per kilogram of body weight). The patients subsequently underwent extensive clinical and laboratory monitoring. RESULTS A single intravenous infusion of vector in all 10 patients with severe hemophilia B resulted in a dose-dependent increase in circulating factor IX to a level that was 1 to 6% of the normal value over a median period of 3.2 years, with observation ongoing. In the high-dose group, a consistent increase in the factor IX level to a mean (±SD) of 5.1±1.7% was observed in all 6 patients, which resulted in a reduction of more than 90% in both bleeding episodes and the use of prophylactic factor IX concentrate. A transient increase in the mean alanine aminotransferase level to 86 IU per liter (range, 36 to 202) occurred between week 7 and week 10 in 4 of the 6 patients in the high-dose group but resolved over a median of 5 days (range, 2 to 35) after prednisolone treatment. CONCLUSIONS In 10 patients with severe hemophilia B, the infusion of a single dose of AAV8 vector resulted in long-term therapeutic factor IX expression associated with clinical improvement. With a follow-up period of up to 3 years, no late toxic effects from the therapy were reported. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00979238.) PMID:25409372

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

    PubMed Central

    Billecke, Scott S; Marcovitz, Pamela A

    2013-01-01

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

  19. Long-term efficacy and safety of atenolol for supraventricular tachycardia in children

    Microsoft Academic Search

    A. V. Mehta; A. B. Subrahmanyam; R. Anand

    1996-01-01

    Propranolol, a first-generation nonselective ?-adrenoceptor blocking agent, is commonly used to treat pediatric arrhythmias.\\u000a Atenolol, relatively longacting, cardioselective ?-adrenoceptor blocking agent, has been successfully used in adults with\\u000a supraventricular tachycardia (SVT). There is only one report on the use of atenolol in children with SVT, and our report is\\u000a on the first long-term prospective study to evaluate the use of

  20. The Long-Term Safety and Efficacy of Intrathecal Therapy Using Sufentanil in Chronic Intractable Non-Malignant Pain

    PubMed Central

    Monsivais, Diane Burn

    2014-01-01

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

  1. Efficacy and safety of long-term antibiotics (macrolides) for the treatment of chronic rhinosinusitis.

    PubMed

    Cervin, Anders; Wallwork, Ben

    2014-03-01

    Long-term treatment of airway inflammation/infection with macrolide antibiotics has now been in use for almost 30 years. Whereas the beneficial clinical effect in cystic fibrosis and COPD have been backed up by randomized controlled trials, the evidence from the upper airways is not as strong. We have identified 22 open studies in chronic rhinosinusitis, with and without polyps, but only 2 randomized controlled trials. Of the controlled trials, the one including CRS patients just without polyps, showed a significant effect in sino-nasal outcome test, saccharine transit time, nasal endoscopy, and IL-8 levels in lavage fluid after 12 weeks of roxithromycin, whereas, in the other RCT with a mixed study group of CRS patients with and without polyps, 12 weeks of azithromycin showed no effect compared to placebo. Concerns regarding the risk of macrolides to induce arrhythmia have been raised. Recent FDA guidelines changes has recommended caution in patients with risk factors such as long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia. Ototoxicity is another concern. Long-term macrolide antibiotics in the treatment of CRS patients is still a viable option in a select group of patients. PMID:24429901

  2. Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease

    PubMed Central

    Hauser, R A; Schapira, A H V; Barone, P; Mizuno, Y; Rascol, O; Busse, M; Debieuvre, C; Fraessdorf, M; Poewe, W; Pramipexole ER Studies Group

    2014-01-01

    Background and purpose To assess the long-term safety and efficacy of pramipexole as a once-daily (q.d.) extended-release oral formulation in early or advanced Parkinson's disease (PD). Methods In two double-blind (DB) studies of early PD and one of advanced PD, active-treatment arms received pramipexole immediate release (IR) or extended release (ER), with exposure lasting up to 33 weeks. In open-label (OL) extensions that followed immediately, subjects took ER q.d. for up to 80 weeks, with dosage adjustment permitted (range 0.375–4.5 mg q.d.). Results Of 590 subjects completing an early-PD DB study, 511 entered the early-PD OL extension; 408 completed it. Reported adverse events (AEs) with incidence ?10.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain (10.6%). Of 465 subjects completing the advanced-PD DB study, 391 entered the advanced-PD OL extension; 329 completed it. Reported AEs with incidence ?10.0% were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders were identified by semi-structured interview in 13 subjects (1.4% of 902). In exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores (excluding ex-placebo recipients) remained substantially improved from DB baseline scores prior to pramipexole introduction, at ?6.6 and ?6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole (33 DB plus 80 OL) in early PD, and ?11.5 and ?9.1 after up to 113 weeks (up to 33 DB plus 80 OL) in advanced PD. Conclusions These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit. PMID:24834511

  3. Long-term hypnotic efficacy and safety of triazolam and flurazepam.

    PubMed

    Leibowitz, M; Sunshine, A

    1978-01-01

    Both triazolam and flurazepam are effective hypnotics when administered nightly for 12 consecutive weeks. However, at the dosages tested, 0.6 mg triazolam had a significantly faster onset of activity than 30 mg flurazepam. Long-term administration of either treatment did not influence the patient's capability to recognize the difference between active drug and placebo. This supports the conclusion that there was no tolerance development on either treatment. There were no deleterious effects attributable to either treatment as measured by the 35-Item Hopkins Symptom Checklist or by physical examinations, laboratory tests, ECGs, and ophthalmologic examinations. Side effects occurred more often on flurazepam than on triazolam, and the number of patients experiencing side effects was significantly higher in the flurazepam group. Drowsiness and grogginess were reported most frequently on both treatments, and the number of patients reporting drowsiness or grogginess was also significantly higher in the flurazepam group. PMID:25288

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

    Microsoft Academic Search

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

    2008-01-01

    Background: Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 ?g\\/g plus betamethasone dipropionate 0.5 mg\\/g) for scalp psoriasis. Methods: In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429)

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

    PubMed Central

    Planas, Raquel; Martin, Roland; Sospedra, Mireia

    2014-01-01

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

  6. Long-term safety and efficacy of raloxifene in the prevention and treatment of postmenopausal osteoporosis: an update

    PubMed Central

    Messalli, Enrico M; Scaffa, Cono

    2010-01-01

    The integrity of bone tissue and its remodeling that occurs throughout life requires a coordinated activity of osteoblasts and osteoclasts. The decreased estrogen circulating level during postmenopausal transition, with a prevalence of osteoclastic activity over osteoblastic activity, represents the main cause of bone loss and osteoporosis. Osteoporosis is a chronic disease requiring long-term therapy and it is important to evaluate the efficacy and safety of treatments over several years, as the fear of health risks is a common reason for discontinuing therapy. Raloxifene is a selective estrogen receptor modulator (SERM) leading to estrogen-agonist effects in some tissues and estrogen-antagonist effects in others. Raloxifene is effective to prevent and treat postmenopausal vertebral osteoporosis, with reduction of spine fractures and, in post-hoc analyses, non-spine fractures in high-risk subjects. Moreover, raloxifene reduces the risk of invasive breast cancer and improves the levels of serum lipoprotein but with an increased risk of venous thromboembolism and fatal stroke, without significant change in the incidence of coronary events. For these reasons the overall risk-benefit profile is favorable. Therefore, when considering the use of raloxifene in a postmenopausal woman, we should take into account the osteoporosis-related individual risk and weigh the potential benefits, skeletal and extra-skeletal, against the health risks. PMID:21072271

  7. 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 96% found it to be cosmetically acceptable. There is no clinically significant risk of testosterone transfer from Striant SR, as any testosterone that may be present in the saliva when swallowed is subject to extensive first-pass hepatic metabolism. It is pertinent to note that the saliva of eugonadal men contains similar levels of endogenous testosterone. Buccal delivery is particularly suitable where easy and rapid reversal of treatment might be required (such as in late-onset hypogonadism) and where there is a need to avoid the potential for transfer of testosterone to women and young children. PMID:22288877

  8. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects

    Microsoft Academic Search

    J Wilding; L Van Gaal; A Rissanen; F Vercruysse; M Fitchet

    2004-01-01

    BACKGROUND: Treatment of obese subjects with topiramate has recently been associated with significant weight loss in a 6-month dose-ranging study.OBJECTIVE: To investigate the long-term efficacy and safety of topiramate in obese subjects.DESIGN: Randomised, double-blind, placebo-controlled study investigating three doses of topiramate: 96, 192, and 256 mg\\/day. All subjects also participated in a nonpharmacological weight-loss programme.SUBJECTS: The study included 1289 subjects

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed Central

    Triantafillidis, John K; Malgarinos, George

    2014-01-01

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

  11. [Study of clinical efficacy and safety of long-term cinoxacin therapy of chronic urogenital organ infection].

    PubMed

    Hayashi, Y; Terao, E; Yamasaki, I

    1987-05-01

    Thirty-five patients with chronic simple and complicated urogenital organ infections were treated with 400 mg/day Cinoxacin for 60 to 284 days. The effects were judged according to improvements of subjective symptoms, bacteriuria and pyuria before and after the complete administration. Overall clinical efficacy in 35 cases with urogenital organ infections was estimated as excellent: 54%, good: 26%, poor: 17%, and effectiveness rate: 80%. The clinical effectiveness rate in 12 cases of chronic simple urinary tract infection was 100%, and in 14 cases of chronic complicated urinary tract infections was 64%, and in 6 cases of chronic prostatitis the rate of effectiveness was 83%. No recurrence was observed during the treatment. No side-effects or toxicity were seen. Accordingly long-term Cinoxacin therapy seems to be useful in preventing recurrence in chronic infections encountered in the department of urology. PMID:3661347

  12. 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. [Department of Microbiology, Molecular Genetics, and Immunology, University of Kansas Medical Center, 3025 WHW - MS 3029, 3901 Rainbow Boulevard, Kansas City, KS 66160 (United States)], E-mail: tyankee@kumc.edu; Sheffer, Darlene; Liu Zhengian; Dhillon, Sukhbir; Jia Fenglan; Chebloune, Yahia [Department of Microbiology, Molecular Genetics, and Immunology, University of Kansas Medical Center, 3025 WHW - MS 3029, 3901 Rainbow Boulevard, Kansas City, KS 66160 (United States); Stephens, Edward B. [Department of Microbiology, Molecular Genetics, and Immunology, University of Kansas Medical Center, 3025 WHW - MS 3029, 3901 Rainbow Boulevard, Kansas City, KS 66160 (United States); Department of Anatomy and Cell Biology, University of Kansas Medical Center, Kansas City, KS 66160 (United States); Narayan, Opendra [Department of Microbiology, Molecular Genetics, and Immunology, University of Kansas Medical Center, 3025 WHW - MS 3029, 3901 Rainbow Boulevard, Kansas City, KS 66160 (United States)

    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.

  13. 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 ?-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 efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer. Trial registration ClinicalTrials.gov identifier NCT00595517. PMID:23530709

  14. Rituximab in previously treated primary immune thrombocytopenia patients: evaluation of short- and long-term efficacy and safety.

    PubMed

    Santoro, Cristina; Biondo, Francesca; Baldacci, Erminia; De Propris, Maria Stefania; Guarini, Anna; Paoloni, Francesca; Foà, Roberto; Mazzucconi, Maria Gabriella

    2014-01-01

    The anti-CD20 chimeric monoclonal antibody rituximab has been effectively used in the treatment of patients with primary immune thrombocytopenia (pITP). We retrospectively evaluated 19 patients affected by pITP resistant to 2 or more lines of therapy who were treated with rituximab. Nine of the 19 patients showed an initial response (47.4%). The sustained response rate was 31.6% (6/19). The median follow-up of the patients was 53.2 months (range 9.2-92.9). Disease-free survival at 48 months was 62.2%. Following rituximab treatment, a proportion of patients (42%) recovered a normal B lymphocyte number. During the follow-up, no opportunistic or severe infectious complications were observed. These data confirm, over a long period of observation, the efficacy and safety of rituximab treatment in the management of patients with resistant pITP. PMID:24356282

  15. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis

    PubMed Central

    Lai, Tianwen; Wang, Shaobin; Xu, Zhiwei; Zhang, Chao; Zhao, Yun; Hu, Yue; Cao, Chao; Ying, Songmin; Chen, Zhihua; Li, Wen; Wu, Bin; Shen, Huahao

    2015-01-01

    Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ?52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749). Omalizumab was associated with significant improvements in quality of life and the Global Evaluation of Treatment Effectiveness. Omalizumab also allowed patients to completely withdraw from inhaled corticosteroid therapy and did not increase the overall incidence of adverse events. However, there was insufficient evidence that omalizumab reduced the incidence of exacerbations, and the cost-effectiveness of omalizumab varied across studies. Our data indicated that omalizumab use for at least 52 weeks in patients with persistent uncontrolled allergic asthma was accompanied by an acceptable safety profile, but it lacked effect on the asthma exacerbations. Use of omalizumab was associated with a higher cost than conventional therapy, but these increases may be cost-effective if the medication is used in patients with severe allergic asthma. PMID:25645133

  16. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis.

    PubMed

    Lai, Tianwen; Wang, Shaobin; Xu, Zhiwei; Zhang, Chao; Zhao, Yun; Hu, Yue; Cao, Chao; Ying, Songmin; Chen, Zhihua; Li, Wen; Wu, Bin; Shen, Huahao

    2015-01-01

    Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ?52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749). Omalizumab was associated with significant improvements in quality of life and the Global Evaluation of Treatment Effectiveness. Omalizumab also allowed patients to completely withdraw from inhaled corticosteroid therapy and did not increase the overall incidence of adverse events. However, there was insufficient evidence that omalizumab reduced the incidence of exacerbations, and the cost-effectiveness of omalizumab varied across studies. Our data indicated that omalizumab use for at least 52 weeks in patients with persistent uncontrolled allergic asthma was accompanied by an acceptable safety profile, but it lacked effect on the asthma exacerbations. Use of omalizumab was associated with a higher cost than conventional therapy, but these increases may be cost-effective if the medication is used in patients with severe allergic asthma. PMID:25645133

  17. Update on long-term efficacy and safety of dapagliflozin in patients with type 2 diabetes mellitus.

    PubMed

    Liakos, Aris; Karagiannis, Thomas; Bekiari, Eleni; Boura, Panagiota; Tsapas, Apostolos

    2015-04-01

    Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a novel class of antihyperglycaemic agents with an insulin-independent mode of action. Dapagliflozin is a member of the SGLT2 inhibitors class that has received marketing authorization in Europe and the US for use in patients with type 2 diabetes. This review summarizes current evidence from clinical trials assessing the clinical efficacy and safety of dapagliflozin, and presents data regarding its cost-effectiveness. Treatment with dapagliflozin results in similar reduction in haemoglobin A1c with other oral antihyperglycaemic drugs, which is preserved over 4 years of treatment. However, compared with most antidiabetic agents, dapagliflozin provides additional clinical benefits including body weight loss and blood pressure reduction. Moreover, treatment with dapagliflozin does not increase risk for hypoglycaemia, but is associated with increased incidence of mild to moderate urinary and genital tract infections. A pivotal outcomes trial of dapagliflozin is expected to clarify its effect on cardiovascular endpoints, whilst a causative relationship between dapagliflozin and select malignancies is unlikely. Finally, based on recent economic evaluations dapagliflozin seems to be a cost-effective option for type 2 diabetes in some settings. PMID:25941564

  18. Outcome predictors, efficacy and safety of Botox and Dysport in the long-term treatment of hemifacial spasm

    Microsoft Academic Search

    A. R. Bentivoglio; A. Fasano; T. Ialongo; F. Soleti; S. Lo Fermo; A. Albanese

    2009-01-01

    Background and purpose: To review the clinical characteristics and the long-term outcome of patients with hemifacial spasm (HFS) who received botulinum neurotoxin (BoNT) over the past 10 years. Results: A total of 108 patients received 665 treat- ments. Mean latency of clinical effect was 5.4 ± 5.3 days for Botox and 4.9 ± 4.6 days for Dysport (P > 0.05).

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

    PubMed Central

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

    2013-01-01

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

  20. 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.

  1. Patient Self-Management of Oral Anticoagulation with Vitamin K Antagonists in Everyday Practice: Efficacy and Safety in a Nationwide Long-Term Prospective Cohort Study

    PubMed Central

    Nagler, Michael; Bachmann, Lucas M.; Schmid, Pirmin; Raddatz Müller, Pascale; Wuillemin, Walter A.

    2014-01-01

    Patient self-management (PSM) of oral anticoagulation is under discussion, because evidence from real-life settings is missing. Using data from a nationwide, prospective cohort study in Switzerland, we assessed overall long-term efficacy and safety of PSM and examined subgroups. Data of 1140 patients (5818.9 patient-years) were analysed and no patient were lost to follow-up. Median follow-up was 4.3 years (range 0.2–12.8 years). Median age at the time of training was 54.2 years (range 18.2–85.2) and 34.6% were women. All-cause mortality was 1.4 per 100 patient-years (95% CI 1.1–1.7) with a higher rate in patients with atrial fibrillation (2.5; 1.6–3.7; p<0.001), patients>50 years of age (2.0; 1.6–2.6; p<0.001), and men (1.6; 1.2–2.1; p?=?0.036). The rate of thromboembolic events was 0.4 (0.2–0.6) and independent from indications, sex and age. Major bleeding were observed in 1.1 (0.9–1.5) per 100 patient-years. Efficacy was comparable to standard care and new oral anticoagulants in a network meta-analysis. PSM of properly trained patients is effective and safe in a long-term real-life setting and robust across clinical subgroups. Adoption in various clinical settings, including those with limited access to medical care or rural areas is warranted. PMID:24748062

  2. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study.

    PubMed

    Saleh, Mansoor N; Bussel, James B; Cheng, Gregory; Meyer, Oliver; Bailey, Christine K; Arning, Michael; Brainsky, Andres

    2013-01-17

    Patients with chronic immune thrombocytopenia may have bleeding resulting from low platelet counts. Eltrombopag increases and maintains hemostatic platelet counts; however, to date, outcome has been reported only for treatment lasting ? 6 months. This interim analysis of the ongoing open-label EXTEND (Eltrombopag eXTENded Dosing) study evaluates the safety and efficacy of eltrombopag in 299 patients treated up to 3 years. Splenectomized and nonsplenectomized patients achieved platelets ? 50 000/?L at least once (80% and 88%, respectively). Platelets ? 50 000/?L and 2 × baseline were maintained for a median of 73 of 104 and 109 of 156 cumulative study weeks, respectively. Bleeding symptoms (World Health Organization Grades 1-4) decreased from 56% of patients at baseline to 20% at 2 years and 11% at 3 years. One hundred (33%) patients were receiving concomitant treatments at study entry, 69 of whom attempted to reduce them; 65% (45 of 69) had a sustained reduction or permanently stopped ? 1 concomitant treatment. Thirty-eight patients (13%) experienced ? 1 adverse events leading to study withdrawal, including patients meeting protocol-defined withdrawal criteria (11 [4%] thromboembolic events, 5 [2%] exceeding liver enzyme thresholds). No new or increased incidence of safety issues was identified. Long-term treatment with eltrombopag was generally safe, well tolerated, and effective in maintaining platelet counts in the desired range. PMID:23169778

  3. Pharmacokinetics, pharmacodynamics, long-term efficacy and safety of oral 1-deamino-8-d-arginine vasopressin in adult patients with central diabetes insipidus

    PubMed Central

    LAM, K. S. L.; WAT, M. S.; CHOI, K. L.; IP, T. P.; PANG, R. W. C.; KUMANA, C. R.

    1996-01-01

    1The pharmacokinetics and pharmacodynamics of intranasal (IN) and oral 1-deamino-8-d-arginine vasopressin (DDAVP) were compared in 10 Chinese adults with central diabetes insipidus previously controlled on IN DDAVP. This was followed by comparison of the acute pharmacodynamics of commonly used oral preparations (containing 100, 200 and 400??g per tablet) and a 1 year prospective evaluation of the long-term safety and efficacy of oral DDAVP. 2Following 20??g IN and 200??g orally, respective plasma DDAVP concentrations peaked after 45.6±7.3 and 93.3±3.3 (mean±s.e.mean) min, reaching 24.1±4.7 and 15.1±3.2?pmol l?1 and respective terminal half-lives were 2.2±0.1 and 2.0±0.1?h. Based on the area under the concentration-time-curve, the bioequivalent IN/oral ratio was 1:16. 3As judged by changes in urine flow rate and osmolality after IN or oral (100, 200 or 400??g) DDAVP, antidiuretic activity increased rapidly during the second hour and peaked at 4 h. The antidiuresis duration and magnitude correlated with the oral dose (P<0.001 and <0.05 respectively), and was least following 100??g (P<0.01 vs 200 or 400??g). Increasing the dose from 200 to 400??g did not increase maximal antidiuretic activity significantly, but there was a trend towards a longer duration of action (P=0.076). 4During the 1-year prospective study with oral DDAVP 300–600??g per day in two to three doses, stable and satisfactory antidiuresis (comparable with that on previous IN therapy) was maintained; tablets were well-tolerated and no side-effect warranted drug withdrawal. 5These findings suggest that the 100 and 200??g preparations of oral DDAVP are adequate for the long-term control of central diabetes insipidus in our population, and that the 400??g preparation may have a role if the frequency of administration is to be reduced. PMID:8877030

  4. Pharmacokinetics, pharmacodynamics, long-term efficacy and safety of oral 1-deamino-8-D-arginine vasopressin in adult patients with central diabetes insipidus.

    PubMed

    Lam, K S; Wat, M S; Choi, K L; Ip, T P; Pang, R W; Kumana, C R

    1996-09-01

    1. The pharmacokinetics and pharmacodynamics of intranasal (IN) and oral 1-deamino-8-D-arginine vasopressin (DDAVP) were compared in 10 Chinese adults with central diabetes insipidus previously controlled on IN DDAVP. This was followed by comparison of the acute pharmacodynamics of commonly used oral preparations (containing 100, 200 and 400 micrograms per tablet) and a 1 year prospective evaluation of the long-term safety and efficacy of oral DDAVP. 2. Following 20 micrograms IN and 200 micrograms orally, respective plasma DDAVP concentrations peaked after 45.6 +/- 7.3 and 93.3 +/- 3.3 (mean +/- s.e.mean) min, reaching 24.1 +/- 4.7 and 15.1 +/- 3.2 pmol 1(-1) and respective terminal half-lives were 2.2 +/- 0.1 and 2.0 +/- 0.1 h. Based on the area under the concentration-time-curve, the bioequivalent IN/oral ratio was 1:16. 3. As judged by changes in urine flow rate and osmolality after IN or oral (100, 200 or 400 micrograms) DDAVP, antidiuretic activity increased rapidly during the second hour and peaked at 4 h. The antidiuresis duration and magnitude correlated with the oral dose (P < 0.001 and < 0.05 respectively), and was least following 100 micrograms (P < 0.01 vs 200 or 400 micrograms). Increasing the dose from 200 to 400 micrograms did not increase maximal antidiuretic activity significantly, but there was a trend towards a longer duration of action (P = 0.076). 4. During the 1-year prospective study with oral DDAVP 300-600 micrograms per day in two to three doses, stable and satisfactory antidiuresis (comparable with that on previous IN therapy) was maintained; tablets were well-tolerated and no side-effect warranted drug withdrawal. 5. These findings suggest that the 100 and 200 micrograms preparations of oral DDAVP are adequate for the long-term control of central diabetes insipidus in our population, and that the 400 micrograms preparation may have a role if the frequency of administration is to be reduced. PMID:8877030

  5. Long-term efficacy of biologics in dermatology

    PubMed Central

    Castelo-Soccio, Leslie; Van Voorhees, Abby S.

    2010-01-01

    Chronic dermatologic diseases affect millions of people. The long-term nature of these diseases creates psychological and financial burden as well as substantially impacts patients' quality of life. Biologics, including adalimumab, etanercept, alefacept, efalizumab, and infliximab, are the newest therapeutic agents in the treatment of moderate-to-severe psoriasis and psoriatic arthritis and have been used in a variety of other dermatologic diseases. These agents act relatively quickly and effectively in 12-week clinical trials. Because these agents are used to treat patients for longer than 12 weeks, there is a need to review the safety and efficacy of these agents over longer periods of time. Many levels of evidence are available for biologics including high level of evidence from large, randomized, double-blind, placebo-controlled clinical studies. This review focuses on the available data for efficacy and safety for greater than 24 weeks of therapy. The studies supporting the use of rituximab and intravenous immunoglobulin in autoimmune blistering diseases are also presented in this review. PMID:19222514

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

    Landry, John; Detke, Holland C.

    2014-01-01

    The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18–76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2–4 weeks. The mean duration of exposure was ?3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome). PMID:24850228

  8. 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). PMID:24850228

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

    PubMed Central

    2014-01-01

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

  10. The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease.

    PubMed

    Barker, Roger A; Mason, Sarah L; Harrower, Timothy P; Swain, Rachel A; Ho, Aileen K; Sahakian, Barbara J; Mathur, Raj; Elneil, Sohier; Thornton, Steven; Hurrelbrink, Carrie; Armstrong, Richard J; Tyers, Pam; Smith, Emma; Carpenter, Adrian; Piccini, Paola; Tai, Yen F; Brooks, David J; Pavese, Nicola; Watts, Colin; Pickard, John D; Rosser, Anne E; Dunnett, Stephen B

    2013-06-01

    Huntington's disease (HD) is a fatal autosomal dominant neurodegenerative disease involving progressive motor, cognitive and behavioural decline, leading to death approximately 20 years after motor onset. The disease is characterised pathologically by an early and progressive striatal neuronal cell loss and atrophy, which has provided the rationale for first clinical trials of neural repair using fetal striatal cell transplantation. Between 2000 and 2003, the 'NEST-UK' consortium carried out bilateral striatal transplants of human fetal striatal tissue in five HD patients. This paper describes the long-term follow up over a 3-10-year postoperative period of the patients, grafted and non-grafted, recruited to this cohort using the 'Core assessment program for intracerebral transplantations-HD' assessment protocol. No significant differences were found over time between the patients, grafted and non-grafted, on any subscore of the Unified Huntington's Disease Rating Scale, nor on the Mini Mental State Examination. There was a trend towards a slowing of progression on some timed motor tasks in four of the five patients with transplants, but overall, the trial showed no significant benefit of striatal allografts in comparison with a reference cohort of patients without grafts. Importantly, no significant adverse or placebo effects were seen. Notably, the raclopride positron emission tomography (PET) signal in individuals with transplants, indicated that there was no obvious surviving striatal graft tissue. This study concludes that fetal striatal allografting in HD is safe. While no sustained functional benefit was seen, we conclude that this may relate to the small amount of tissue that was grafted in this safety study compared with other reports of more successful transplants in patients with HD. PMID:23345280

  11. Long term efficacy and safety of cyclosporin versus parenteral gold in early rheumatoid arthritis: a three year study of radiographic progression, renal function, and arterial hypertension

    PubMed Central

    Kvien, T; Zeidler, H; Hannonen, P; Wollheim, F; Forre, O; Hafstrom, I; Kaltwasser, J; Leirisalo-Repo, M; Manger, B; Laasonen, L; Prestele, H; Kurki, P

    2002-01-01

    Objective: To compare the three year safety and efficacy of cyclosporin and parenteral gold in the treatment of early, active, severe rheumatoid arthritis (RA), and to study the reversibility of cyclosporin associated renal dysfunction in patients who discontinued cyclosporin treatment. Methods: The patients continued to receive cyclosporin or parenteral gold in an 18 month open extension to an 18 month randomised, parallel group study. The main efficacy variable was blinded evaluation of radiographic progression of joint damage. Safety variables included serum creatinine, calculated creatinine clearance, and blood pressure. Results: Radiographic progression during follow up was similar in both groups. About 60% of the patients in the intention to treat groups (n=272) and about half of the patients in the completer groups (n=114) had definite radiographic progression in joint damage (increases >6 in the Larsen-Dale score), and about one in three also had substantial progression (>18 increase in Larsen-Dale score). Both systolic and diastolic blood pressure were significantly increased in the cyclosporin group compared with the gold group, and 12/139 (9%) versus 3/139 (2%) (p=0.03) had notably raised blood pressure. The mean serum creatinine increased by 28% at the treatment end point in the cyclosporin group as compared with 7% in the gold group. The mean calculated creatinine clearance was reduced by 16% and increased by 1% in the cyclosporin and gold groups, respectively, at the end of the study. At the final follow up visit after discontinuation of cyclosporin (at least three months after treatment was stopped) the mean serum creatinine was increased by 15% and creatinine clearance reduced by 16%. Sustained increases in serum creatinine at this post-treatment end point were mostly seen in patients with a raised serum creatinine during treatment of at least 50%. Conclusion: Three year changes in radiographic damage during cyclosporin and parenteral gold were similar in patients with early, active RA. Abnormal renal function and raised blood pressure were often seen in the cyclosporin treated patients. PMID:12006323

  12. Long-term safety and efficacy of Pitavastatin in patients with acute myocardial infarction (from the Livalo Acute Myocardial Infarction Study [LAMIS]).

    PubMed

    Suh, Soon Yong; Rha, Seung-Woon; Ahn, Tae Hoon; Shin, Eak Kyun; Choi, Cheol Ung; Oh, Dong Joo; Bae, Jang-Ho; Hur, Seung-Ho; Yun, Kyeong Ho; Yoon, Kyung Ho; Oh, Seok-Kyu; Kim, Jong Hyun; Kim, Sang Wook; Chae, In Ho; Kim, Kee-Sik; Hong, Young Joon; Jeong, Myung Ho

    2011-12-01

    Pitavastatin is a potent lipophilic statin and may play an important role in acute myocardial infarction (AMI) but there have been limited data on the safety and efficacy of pitavastatin in AMI. This study consisted of 1,039 consecutive patients with AMI (74.0% men, mean age 61.4 ± 12.6 years) who presented in 10 major percutaneous coronary intervention centers in Korea from February 2007 through September 2009. Pitavastatin 2 mg/day was routinely administered in patients with AMI from time of presentation. We investigated changes of lipid profiles, biochemical markers, adverse events, and clinical outcomes up to 12 months. During the study 318 events overall occurred in 220 patients (21.2%) who reported ?1 treatment emergent adverse event, although 20 events in 14 patients (1.4%) were treatment-related adverse events. Low-density lipoprotein (LDL) cholesterol percent change was -25.6% and LDL cholesterol target attainment was 70.5% at 12-month follow-up. Levels of creatinine phosphokinase, serum glutamic oxaloacetic transaminase, glutamic pyruvic transaminase, and high-sensitivity C-reactive protein decreased significantly during the first 1 month of pitavastatin treatment and were sustained to 12-month follow-up. Major adverse cardiac events occurred in 66 patients (7.3%). All-cause deaths occurred in 32 patients (3.5%) including 19 (2.1%) cardiac deaths and recurrent MIs occurred in 14 (1.6%) and target lesion revascularizations in 42 (4.7%). In conclusion, administration of pitavastatin 2 mg/day in patients with AMI showed 70.5% LDL cholesterol target attainment with good tolerance and was associated with favorable clinical outcomes up to 12 months. PMID:21890083

  13. 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 under field conditions. Therefore, it can be used as sustainable long-term preventative, covering the whole flea and tick season. PMID:22463745

  14. Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study)

    PubMed Central

    Zaitsu, Masayoshi; Mikami, Koji; Ishida, Noriko; Takeuchi, Takumi

    2011-01-01

    Objectives. Overactive bladder (OAB) is a chronic disease, but comparative trials of anticholinergics, which are commonly used for treatment of OAB, have generally been performed for up to 12 weeks only. There is no comparative study of a long-term intervention. Methods. We conducted a 52-week prospective randomized comparative study to evaluate the efficacy and tolerability of two anticholinergics. Results. Forty-one Japanese patients with untreated OAB were randomly assigned to imidafenacin and solifenacin groups. There was no difference in OABSS and KHQ scores between the two groups, but the severity and incidence of adverse events caused by the anticholinergics showed increased differences between the groups with time. The severity of dry mouth and the incidence of constipation were significantly lower in the imidafenacin group (P = 0.0092 and P = 0.0013, resp.). Conclusions. This study is the first long-term trial to show differences in the properties of anticholinergics that were not detected in short-term studies. Since OAB is a chronic disease, we conclude that imidafenacin is preferable to solifenacin from a perspective of safety. PMID:22046182

  15. Efficacy and safety of long-term tadalafil 5 mg once daily combined with sildenafil 50 mg as needed at the early stage of treatment for patients with erectile dysfunction.

    PubMed

    Cui, H; Liu, B; Song, Z; Fang, J; Deng, Y; Zhang, S; Wang, H; Wang, Z

    2015-02-01

    This study aimed to evaluate the efficacy and safety of long-term and low-dose tadalafil combined with sildenafil as needed at the early stage of treatment for erectile dysfunction (ED). We enrolled 180 patients with ED 1 : 1 to tadalafil 5 mg once daily or once-a-day tadalafil 5 mg combined with sildenafil 50 mg as needed. The efficacy measures included the 5-item version of the International Index of Erectile Function (IIEF-5) and the Sexual Encounter Profile (SEP). The safety was assessed by observing drug tolerability and adverse events. Total IIEF-5 scores of patients with severe ED in combined medication group were significantly higher than in tadalafil alone group. Question 2 scores of IIEF-5 of patients with moderate and severe ED in combined medication group were significantly higher than in tadalafil alone group. The significant improvement in question 3 scores of IIEF-5 existed only in patients with severe ED receiving combined medication. The percentage of 'yes' responses to SEP4, SEP5 and partner's SEP3 were improved significantly in combined medication group. There was no difference between two groups in the incidence of adverse events. Our results suggest that combined medication can better improve erectile function, especially for patients with severe ED. PMID:24387078

  16. Session 6: Infant nutrition: future research developments in Europe EARNEST, the early nutrition programming project: EARly Nutrition programming - long-term Efficacy and Safety Trials and integrated epidemiological, genetic, animal, consumer and economic research.

    PubMed

    Fewtrell, M S

    2007-08-01

    Increasing evidence from lifetime experimental studies in animals and observational and experimental studies in human subjects suggests that pre- and postnatal nutrition programme long-term health. However, key unanswered questions remain on the extent of early-life programming in contemporary European populations, relevant nutritional exposures, critical time periods, mechanisms and the effectiveness of interventions to prevent or reverse programming effects. The EARly Nutrition programming - long-term Efficacy and Safety Trials and integrated epidemiological, genetic, animal, consumer and economic research (EARNEST) consortium brings together a multi-disciplinary team of scientists from European research institutions in an integrated programme of work that includes experimental studies in human subjects, modern prospective observational studies and mechanistic animal work including physiological studies, cell-culture models and molecular techniques. Theme 1 tests early nutritional programming of disease in human subjects, measuring disease markers in childhood and early adulthood in nineteen randomised controlled trials of nutritional interventions in pregnancy and infancy. Theme 2 examines associations between early nutrition and later outcomes in large modern European population-based prospective studies, with detailed measures of diet in pregnancy and early life. Theme 3 uses animal, cellular and molecular techniques to study lifetime effects of early nutrition. Biomedical studies are complemented by studies of the social and economic importance of programming (themes 4 and 5), and themes encouraging integration, communication, training and wealth creation. The project aims to: help formulate policies on the composition and testing of infant foods; improve the nutritional value of infant formulas; identify interventions to prevent and reverse adverse early nutritional programming. In addition, it has the potential to develop new products through industrial partnerships, generate information on the social and economic cost of programming in Europe and help maintain Europe's lead in this critical area of research. PMID:17637096

  17. Efficacy and long-term safety of dexibuprofen [S(+)-ibuprofen]: a short-term efficacy study in patients with osteoarthritis of the hip and a 1-year tolerability study in patients with rheumatic disorders.

    PubMed

    Mayrhofer, F

    2001-11-01

    The efficacy study was performed to prove the equivalent efficacy of dexibuprofen compared to the double dose of racemic ibuprofen and to show a clinical dose-response relationship of dexibuprofen. The 1-year tolerability study was carried out to investigate the tolerability of dexibuprofen. In the efficacy study 178 inpatients with osteoarthritis of the hip were assigned to 600 or 1200 mg of dexibuprofen or 2400 mg of racemic ibuprofen daily. The primary end-point was the improvement of the WOMAC OA index. A 1-year open tolerability study included 223 outpatients pooled from six studies. The main parameter was the incidence of clinical adverse events. In the efficacy study the evaluation of the improvement of the WOMAC OA index showed equivalence of dexibuprofen 400 mg t.i.d. compared to racemic ibuprofen 800 mg t.i.d., with dexibuprofen being borderline superior (P = 0.055). The comparison between the 400 mg t.i.d. and 200 mg t.i.d. doses confirmed a significant superior efficacy of dexibuprofen 400 mg (P = 0.023). In the tolerability study the overall incidence of clinical adverse events was 15.2% (GI tract 11.7%, CNS 1.3%, skin 1.3%, others 0.9%). The active enantiomer dexibuprofen proved to be an effective NSAID with a significant dose-response relationship. Compared to the double dose of racemic ibuprofen, dexibuprofen was at least equally efficient, with borderline superiority over dexibuprofen (P = 0.055). The tolerability study in 223 patients on dexibuprofen showed an incidence of clinical adverse events of 15.2% after 12 months. The results of the studies suggest that dexibuprofen is an effective NSAID with good tolerability. PMID:11771571

  18. Tamsulosin: 3Year Long-Term Efficacy and Safety in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Obstruction: Analysis of a European, Multinational, Multicenter, Open-Label Study

    Microsoft Academic Search

    C. C. Schulman; J. Cortvriend; U. Jonas; T. M. T. W. Lock; S. Vaage; M. J. Speakman

    1999-01-01

    Objective: This open-label extension study evaluated the efficacy and safety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) treated for up to 3 years. Methods: Patients were enrolled from two European, 12-week, placebo-controlled trials. This analysis reports on 355 patients randomized originally to

  19. Long-Term Efficacy of Three Contraceptive Approaches for Population Control of Wild Horses

    Microsoft Academic Search

    Gary Killian; Nancy K. Diehl; Lowell Miller; Jack Rhyan

    Controlling fertility of feral horses through the use of long-acting contraceptives or sterilization approaches has been championed as a reasonable and humane solution for addressing overpopulation problems in several western states. However, methods to accomplish long-term contraceptive efficacy of horses following a single treatment have been lacking. In fall 2002 and spring 2003, we initiated a study to compare the

  20. Phosphorus Efficacy in Four Chinese Long?Term Experiments with Different Soil Properties and Climate Characteristics

    Microsoft Academic Search

    Linping Zhao; Yibing Ma; Guoqing Liang; Shutian Li; Lishu Wu

    2009-01-01

    Four long?term experiments in China were used to study the efficacy of phosphorus (P) fertilizers in soils. The results showed that the increased yield by P fertilization varied with different crops: early rice > late rice. We suggest applying the P fertilizer heavily on winter wheat and early rice. The P agronomic efficiency was about 27 kg rice grain kg and

  1. 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

  2. Tolerability and Efficacy of Almotriptan in the Long-Term Treatment of Migraine

    Microsoft Academic Search

    J. Pascual; R. Falk; R. Docekal; A. Prusinski; J. Jelencsik; X. Cabarrocas; X. Segarra; X. Luria; P. Ferrer

    2001-01-01

    Background: Almotriptan is a highly specific 5-HT1B\\/1D receptor agonist, which acts selectively on blood vessels of the brain. Short-term studies have demonstrated that almotriptan provides rapid, effective and reliable relief of migraine attacks, while offering excellent tolerability. Purpose: To assess the long-term tolerability and efficacy of oral almotriptan 12.5 mg administered for every migraine attack over a 1-year period. Methods:

  3. Long-term carbimazole pretreatment reduces the efficacy of radioiodine therapy

    PubMed Central

    Shivaprasad, C.; Prasanna Kumar, K. M.

    2015-01-01

    Introduction: Data from several studies suggest that pretreatment with antithyroid drugs (ATD) before 131I increases the risk of treatment failure. This effect has been demonstrated more consistently with propylthiouracil than with carbimazole (CMZ) or methimazole (MMI). Men with Graves’ disease (GD) have a lower rate of remission with 131I compared to women and the impact of long-term ATD pretreatment on the success of 131I is unknown. The objective of our study was to compare the efficacy of fixed doses of radioiodine between patients with and without long-term CMZ pretreatment. Materials and Methods: We performed a retrospective study on 335 male patients with GD treated with 131I from 1998 to 2008. 148 patients had been pretreated with CMZ, and the remaining 187 patients received 131I without pretreatment. We compared the success rate of a single dose of 131I, between patients with and without long-term CMZ pretreatment. Results: The success rate of a single dose of 131I was significantly higher in patients without pretreatment than in patients who were pretreated with CMZ (91.4% vs. 82.3%, P = 0.01). The rate of hypothyroidism in the first 6 months after 131I therapy was significantly higher in patients without pretreatment (55.1% vs. 44.6%, P = 0.05). There was also a trend for higher cumulative rate of hypothyroidism at last follow-up in nonpretreated patients (78.1% vs. 69.7%). Conclusion: Male patients with Graves’ hyperthyroidism pretreated with CMZ have lower efficacy with 131I therapy compared to nonpretreated patients. CMZ pretreatment given for a prolonged period reduces the efficacy of 131I therapy. PMID:25593832

  4. Long-term efficacy of bosentan in inoperable chronic thromboembolic pulmonary hypertension

    Microsoft Academic Search

    M. C. Post; H. W. M. Plokker; J. C. Kelder; R. J. Snijder

    2009-01-01

    Background. Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) is associated with a poor survival.\\u000a \\u000a \\u000a Objectives. To evaluate the long-term response to a dual endothelin receptor antagonist in patients with inoperable CTEPH.\\u000a \\u000a \\u000a \\u000a Methods. All consecutive 18 patients (mean age 63±14 years) treated with bosentan for symptomatic inoperable CTEPH were included.\\u000a Efficacy was evaluated by the log value of serum levels of N-terminal-pro

  5. ATO/ATRA/anthracycline-chemotherapy sequential consolidation achieves long-term efficacy in primary acute promyelocytic leukemia.

    PubMed

    Long, Zi-Jie; Hu, Yuan; Li, Xu-Dong; He, Yi; Xiao, Ruo-Zhi; Fang, Zhi-Gang; Wang, Dong-Ning; Liu, Jia-Jun; Yan, Jin-Song; Huang, Ren-Wei; Lin, Dong-Jun; Liu, Quentin

    2014-01-01

    The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (As2O3, ATO) has been effective in obtaining high clinical complete remission (CR) rates in acute promyelocytic leukemia (APL), but the long-term efficacy and safety among newly diagnosed APL patients are unclear. In this retrospective study, total 45 newly diagnosed APL patients received ATRA/chemotherapy combination regimen to induce remission. Among them, 43 patients (95.6%) achieved complete remission (CR) after induction therapy, followed by ATO/ATRA/anthracycline-based chemotherapy sequential consolidation treatment with a median follow-up of 55 months. In these patients, the estimated overall survival (OS) and the relapse-free survival (RFS) were 94.4% ± 3.9% and 94.6 ± 3.7%, respectively. The toxicity profile was mild and reversible. No secondary carcinoma was observed. These results demonstrated the high efficacy and minimal toxicity of ATO/ATRA/anthracycline-based chemotherapy sequential consolidation treatment for newly diagnosed APL in long-term follow-up, suggesting a potential frontline therapy for APL. PMID:25122165

  6. Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of moderate scalp psoriasis.

    PubMed

    Poulin, Yves; Papp, Kim; Bissonnette, Robert; Barber, Kirk; Kerrouche, Nabil; Villemagne, Hervé

    2010-05-01

    We evaluated in this study the efficacy and safety of an alternate regimen using clobetasol propionate 0.05% shampoo (CP shampoo) for long-term control of scalp psoriasis. Patients with moderate scalp psoriasis (Global Severity Score [GSS] of 3 on a 0-5 scale) first received CP shampoo once daily for 4 weeks. Patients with a GSS 2) occurred, patients received the 4-week daily CP shampoo treatment. Patients who had a GSS efficacious and safe for long-term management of moderate scalp psoriasis. PMID:20131980

  7. Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration

    PubMed Central

    Boyer, David; Freund, K Bailey; Regillo, Carl; Levy, Marc H; Garg, Sumit

    2015-01-01

    Background The purpose of this study was to evaluate the long-term results of an implantable miniature telescope (IMT) in patients with bilateral, end-stage, age-related macular degeneration (AMD). Methods A prospective, open-label, multicenter clinical trial with fellow eye controls enrolled 217 patients (mean age 76 years) with AMD and moderate-to-profound bilateral central visual acuity loss (20/80–20/800) resulting from untreatable geographic atrophy, disciform scars, or both. A subgroup analysis was performed with stratification for age (patient age 65 to <75 years [group 1; n=70] and patient age ?75 years [group 2; n=127]), with a comparative evaluation of change in best-corrected distance visual acuity (BCDVA), quality of life, ocular complications from surgery, adverse events, and endothelial cell density (ECD). Follow-up in an extension study was 60 months. Results Data were available for 22, 38, and 31 patients in group 1 and 42, 46, and 32 patients in group 2 at 36, 48, and 60 months, respectively. Mean BCDVA improvement from baseline to 60 months was 2.41±2.69 lines in all patients (n=76), with 2.64±2.55 lines in group 1 and 2.09±2.88 lines in group 2. Quality of life scores were significantly higher in group 1. The most common significant surgery-related ocular complications in group 1 were iritis >30 days after surgery (7/70; 10%) and persistent corneal edema (3/70; 4.3%); and in group 2 were a decrease in BCDVA in the implanted eye or IMT removal (10/127 each; 7.9%), corneal edema >30 days after surgery (9/127; 7.1%), and persistent corneal edema (6/127; 4.7%). Significant adverse events included four corneal transplants, comprising two (2.9%) in group 1 and two (1.6%) in group 2. At 60 months, one patient in group 1 (3.2%) and three patients in group 2 (9.4%) had lost ?2 lines of vision. The IMT was removed in one (1.4%) and ten (7.9%) patients in group 1 and group 2, respectively. Mean ECD loss was 20% at 3 months. Chronic loss was 3% per year. ECD loss was less in group 1 than in group 2 (35% versus 40%, respectively) at 60 months. Conclusion Long-term results show substantial retention of improvement in BDCVA. Chronic ECD loss was consistent with that reported for conventional intraocular lenses. The IMT performed as well in group 1 (the younger group) as it did in group 2 through month 60. Younger patients retained more vision than their older counterparts and had fewer adverse events. Although not a specified outcome for this study, patients younger than 65 years also fared better than those in group 2 and retained more vision with fewer adverse events through month 60.

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

    PubMed

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

    2015-07-15

    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

  9. Efficacy of Long-Term ?-Blocker Therapy for Secondary Prevention of Long-Term Outcomes After Coronary Artery Bypass Grafting Surgery

    PubMed Central

    Zhang, Heng; Yuan, Xin; Zhang, Haibo; Chen, Sipeng; Zhao, Yan; Hua, Kun; Rao, Chenfei; Wang, Wei; Sun, Hansong; Hu, Shengshou

    2015-01-01

    Background— Conflicting results from recent observational studies have raised questions concerning the benefit of ?-blockers for patients undergoing coronary artery bypass grafting (CABG). Furthermore, the efficacy of long-term ?-blocker therapy in CABG patients after hospital discharge is uncertain. Methods and Results— The study included 5926 consecutive patients who underwent CABG and were discharged alive. The prevalence and consistency of ?-blocker use were determined in patients with and without a history of myocardial infarction (MI). ?-Blockers were always used in 1280 patients (50.9%) with and 1642 patients (48.1%) without previous MI after CABG. Compared with always users (n=2922, 49.3%), the risk of all-cause death was significantly higher among inconsistent ?-blocker users (hazard ratio [HR], 1.96; 95% confidence interval [CI], 1.50–2.57), and never using ?-blockers was associated with increased risk of both all-cause death (HR, 1.42; 95% CI, 1.01–2.00) and the composite of adverse cardiovascular events (HR, 1.29; 95% CI, 1.10–1.50). In the cohort without MI, the HR for all-cause death was 1.70 (95% CI, 1.17–2.48) in inconsistent users and 1.23 (95% CI, 0.76–1.99) in never users. In the MI cohort, mortality was higher for inconsistent users (HR, 2.14; 95% CI, 1.43–3.20) and for never users (HR, 1.59; 95% CI, 1.07–2.63). Consistent results were obtained in equivalent sensitivity analyses. Conclusions— In patients with or without previous MI undergoing CABG, the consistent use of ?-blockers was associated with a lower risk of long-term mortality and adverse cardiovascular events. Strategies should be developed to understand and improve discharge prescription of ?-blockers and long-term patient adherence. PMID:25908770

  10. 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. PMID:23586506

  11. Long-Term Efficacy of Prism Adaptation on Spatial Neglect: Preliminary Results on Different Spatial Components

    PubMed Central

    Rusconi, Maria Luisa; Carelli, Laura

    2012-01-01

    This study describes the long-term effectiveness on spatial neglect recovery of a 2-week treatment based on prism adaptation (PA). Seven right-brain-damaged patients affected by chronic neglect were evaluated before, after two weeks of the PA treatment and at a follow-up (variable between 8 and 30 months after the end of PA). Neglect evaluation was performed by means of BIT (conventional and behavioral), Fluff Test, and Comb and Razor Test. The results highlight an improvement, after the PA training, in both tasks performed using the hand trained in PA treatment and in behavioral tasks not requiring a manual motor response. Such effects extend, even if not significantly, to all BIT subtests. These results support previous findings, showing that PA improves neglect also on imagery tasks with no manual component, and provide further evidence for long-lasting efficacy of PA training. Dissociations have been found with regard to PA efficacy on peripersonal, personal, and representational neglect, visuospatial agraphia and neglect dyslexia. In particular, we found no significant differences between the pre-training and post-training PA session in personal neglect measures, and a poor recovery of neglect dyslexia after PA treatment. The recruitment of a larger sample could help to confirm the effectiveness of the prismatic lenses with regard to the different clinical manifestations of spatial neglect. PMID:22629167

  12. Safety and Effectiveness of Long-Term Interferon Gamma Therapy in Patients with Chronic Granulomatous Disease

    Microsoft Academic Search

    Lynn S. Bemiller; David H. Roberts; Karen M. Starko; John T. Curnutte

    1995-01-01

    In chronic granulomatous disease (CGD), diminished or absent neutrophil NADPH oxidase function leads to recurrent pyogenic infections and granuloma formation. In a recent randomized, placebo-controlled trial, short-term prophylactic use of recombinant human interferon gamma (rIFN-? 1b) reduced the risk of serious infection in CGD patients by 67%. The current study evaluated the safety and effectiveness of long-term rIFN-? therapy in

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

    PubMed

    Ricroch, Agnès E

    2013-05-25

    Despite the fact that a thorough, lengthy and costly evaluation of genetically engineered (GE) crop plants (including compositional analysis and toxicological tests) is imposed before marketing some European citizens remain sceptical of the safety of GE food and feed. In this context, are additional tests necessary? If so, what can we learn from them? To address these questions, we examined data from 60 recent high-throughput '-omics' comparisons between GE and non-GE crop lines and 17 recent long-term animal feeding studies (longer than the classical 90-day subchronic toxicological tests), as well as 16 multigenerational studies on animals. The '-omics' comparisons revealed that the genetic modification has less impact on plant gene expression and composition than that of conventional plant breeding. Moreover, environmental factors (such as field location, sampling time, or agricultural practices) have a greater impact than transgenesis. None of these '-omics' profiling studies has raised new safety concerns about GE varieties; neither did the long-term and multigenerational studies on animals. Therefore, there is no need to perform such long-term studies in a case-by-case approach, unless reasonable doubt still exists after conducting a 90-day feeding test. In addition, plant compositional analysis and '-omics' profiling do not indicate that toxicological tests should be mandatory. We discuss what complementary fundamental studies should be performed and how to choose the most efficient experimental design to assess risks associated with new GE traits. The possible need to update the current regulatory framework is discussed. PMID:23253614

  14. The Cox maze III procedure for atrial fibrillation: long-term efficacy in patients undergoing lone versus concomitant procedures

    Microsoft Academic Search

    Sunil M Prasad; Hersh S Maniar; Cindy J Camillo; Richard B Schuessler; John P Boineau; Thoralf M Sundt; James L Cox; Ralph J Damiano

    2003-01-01

    BackgroundFor the last decade, the Cox maze III procedure has been available for the treatment of atrial fibrillation. It is unknown whether the operation has similar efficacy in patients with lone atrial fibrillation compared with that in patients with atrial fibrillation associated with coronary, valve, or congenital heart disease. This study examined the long-term outcome of patients who underwent this

  15. Long-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: Results of a randomized clinical trial

    Microsoft Academic Search

    Cecilia Hagedorn; Hans Lönroth; Lars Rydberg; Magnus Ruth; Lars Lundell

    2002-01-01

    The efficacy of fundoplication operations in the long-term management of gastroesophageal reflux disease (GERD) has been documented.\\u000a However, only a few prospective controlled series support the longterm (>10 years) efficacy of these procedures, and further\\u000a data are required to also determine whether the type of fundoplication affects the frequency of postfundoplication complaints.\\u000a The aim of this study was to conduct

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

    SciTech Connect

    Memon, Khairuddin; Lewandowski, Robert J. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Mulcahy, Mary F. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Riaz, Ahsun; Ryu, Robert K.; Sato, Kent T.; Gupta, Ramona; Nikolaidis, Paul; Miller, Frank H.; Yaghmai, Vahid; Gates, Vanessa L.; Atassi, Bassel [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Newman, Steven [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Omary, Reed A. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Benson, Al B. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Salem, Riad, E-mail: r-salem@northwestern.edu [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States)

    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 with low toxicity, in line with published national guidelines recommending radioembolization as a potential option for unresectable hepatic neuroendocrine metastases.

  17. LONG-TERM EFFICACY OF A VAGINAL SLING PROCEDURE IN A RAT MODEL OF STRESS URINARY INCONTINENCE

    Microsoft Academic Search

    ADONIS HIJAZ; JAMES BENA; FIROUZ DANESHGARI

    Purpose:We examined the long-term efficacy of a newly created vaginal sling procedure for the restoration of leak point pressure (LPP) in a rat model of stress urinary incontinence (SUI). Material and Methods:A total of 20 female Sprague-Dawley rats were randomly assigned to 1 of 4 groups, namely normal control, SUI plus vaginal sling, SUI plus sham sling and SUI only.

  18. Long-term efficacy of a psychological intervention program for patients with refractory bipolar disorder: A pilot study

    Microsoft Academic Search

    Ana González-Isasi; Enrique Echeburúa; Fernando Mosquera; Berta Ibáñez; Felipe Aizpuru; Ana González-Pinto

    2010-01-01

    The aim of this research was to test the long-term efficacy of combined standard treatment (pharmacotherapy and adjunctive psychosocial treatment based on a cognitive-behavioral model) compared with standard drug treatment for patients with recurrent bipolar disorder. Twenty patients selected according to DSM-IV-TR criteria were randomized to 1) combined treatment or 2) control treatment. A multigroup experimental design with repeated assessment

  19. Examining Immediate and Long-Term Efficacy of Rape Prevention Programming with Racially Diverse College Men.

    ERIC Educational Resources Information Center

    Heppner, Mary J.; Neville, Helen A.; Smith, Kendra; Kivlighan, Dennis M., Jr.; Gershuny, Beth S.

    1999-01-01

    Investigates the short- and long-term effectiveness of a theoretically driven, programmatic rape-prevention intervention on a sample of primarily White and Black college men. Results from a hierarchical cluster analysis indicate three patterns of treatment response: improving, deteriorating, and rebounding. Results also indicate that Black…

  20. Monitoring the Long-Term Safety Performance of a Repository for Used Nuclear Fuel - 12294

    SciTech Connect

    Villagran, J.E. [Nuclear Waste Management Organization, Toronto (Canada)

    2012-07-01

    The nuclear waste management programs of several nations include plans for the design, construction and operation of deep geological repositories. Some of these programs have initiated the licensing process for their repository designs. Monitoring strategies and systems are at different levels of development in each program and there is common ground with respect to the ultimate goal of the monitoring function. In this context, the primary functions of a monitoring system are considered to be the verification of safety performance and making available information that may be required for implementation of future decisions such as the timing of repository decommissioning and closure or the possible retrieval of waste containers. This study examines some of the relevant issues and outlines a conceptual monitoring system for further study and development during implementation of Adaptive Phased Management, the method selected by the Government of Canada for long-term management of used nuclear fuel. (author)

  1. Long-term follow-up of the effectiveness and safety of inferior turbinectomy.

    PubMed

    Ophir, D; Schindel, D; Halperin, D; Marshak, G

    1992-12-01

    The long-term effectiveness and safety of inferior turbinectomy were assessed in 186 patients who were interviewed and examined 10 to 15 years after surgery (mean 12.3 years). Relief of nasal obstruction was reported by 82 percent of the patients; rhinoscopy showed wide, clean nasal airways in 88 percent. Rhinorrhea was still a problem for 34 percent of patients, and 19 percent were receiving medical treatment for this symptom. Smell acuity had improved in 52 percent of the patients. Before turbinectomy, 32 patients had suffered from bronchial asthma; postoperatively, there was an improvement in 16, and no change in 13; 3 patients reported exacerbation of asthmatic attacks. Atrophic changes of the nasal mucosa and chronic purulent infection were not observed in any of the patients. PMID:1448533

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

    PubMed

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

    2013-10-01

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

  3. Long-Term Efficacy and Toxicity of Cholinesterase Inhibitors in the Treatment of Alzheimer Disease

    PubMed Central

    Hogan, David B

    2014-01-01

    Though the symptoms of Alzheimer disease go on for years, the phase 3 trials of the cholinesterase inhibitors (ChEIs), the current mainstay of symptomatic pharmacotherapy for this condition, were typically of only 3- to 6-months’ duration. We have limited data on long-term (that is, a year or more) therapy with these agents. In this review, we explore the available information on the biological and clinical effects of long-term ChEI therapy, what happens when these agents are discontinued, and examine what others have recommended. An individualized approach to deciding on whether to carry on with a ChEI should be taken. If continued, treatment goals should be clarified and patients monitored over time, for both drug-related benefits and adverse effects. PMID:25702360

  4. Continuous intrathecal morphine treatment for chronic pain of nonmalignant etiology: long-term benefits and efficacy

    Microsoft Academic Search

    Krishna Kumar; Michael Kelly; Tyler Pirlot

    2001-01-01

    BACKGROUNDTo analyze, prospectively, the long-term effects of continuous intrathecal morphine infusion therapy in 16 patients with chronic nonmalignant pain syndromes.METHODSTwenty-five patients with severe, chronic, nonmalignant pain that had proven refractory to conservative management were considered candidates for trial of intrathecal spinal morphine. Sixteen patients achieved more than 50% pain relief after a trial period of intrathecal morphine infusion. They were

  5. 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. PMID:24953759

  6. Long-term efficacy of systemic multiexon skipping targeting dystrophin exons 45-55 with a cocktail of vivo-morpholinos in mdx52 mice.

    PubMed

    Echigoya, Yusuke; Aoki, Yoshitsugu; Miskew, Bailey; Panesar, Dharminder; Touznik, Aleksander; Nagata, Tetsuya; Tanihata, Jun; Nakamura, Akinori; Nagaraju, Kanneboyina; Yokota, Toshifumi

    2015-01-01

    Antisense-mediated exon skipping, which can restore the reading frame, is a most promising therapeutic approach for Duchenne muscular dystrophy. Remaining challenges include the limited applicability to patients and unclear function of truncated dystrophin proteins. Multiexon skipping targeting exons 45-55 at the mutation hotspot of the dystrophin gene could overcome both of these challenges. Previously, we described the feasibility of exons 45-55 skipping with a cocktail of Vivo-Morpholinos in vivo; however, the long-term efficacy and safety of Vivo-Morpholinos remains to be determined. In this study, we examined the efficacy and toxicity of exons 45-55 skipping by intravenous injections of 6?mg/kg 10-Vivo-Morpholino cocktail (0.6?mg/kg each vPMO) every 2 weeks for 18 weeks to dystrophic exon-52 knockout (mdx52) mice. Systemic skipping of the entire exons 45-55 region was induced, and the Western blot analysis exhibited the restoration of 5-27% of normal levels of dystrophin protein in skeletal muscles, accompanied by improvements in histopathology and muscle strength. No obvious immune response and renal and hepatic toxicity were detected at the end-point of the treatment. We demonstrate our new regimen with the 10-Vivo-Morpholino cocktail is effective and safe for long-term repeated systemic administration in the dystrophic mouse model. PMID:25647512

  7. Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety1-3

    Microsoft Academic Search

    Jose M Saavedra; Adel Abi-Hanna; Nancy Moore; Robert H Yolken

    Background: Nonpathogenic live bacteria are consumed as food by many children, particularly in the form of yogurt. The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented. Objective: The goal was to evaluate tolerance to formulas con- taining 2 levels of probiotic supplementation and effects on growth, general clinical status, and

  8. The assessment of efficacy, toxicity and quality of care in long-term drug treatment.

    PubMed

    Dollery, C T

    1976-01-01

    Drug studies in man are usually divided into four phases. The first phase is to establish that the drug has a pharmacological action in man and in which dose range it occurs. The second phase is a study of the therapeutic effect of the drug in small numbers of closely observed patients. The third phase consists of large-scale studies which may involve hundreds or thousands of patients; such studies are designed to accumulate less detailed information about efficacy and to provide information about low frequency toxic events. At the end of this stage the drug is submitted to a regulatory body for a license to market it. Information derived from these studies usually has several important deficiencies. There is unlikely to be much evidence about the efficacy of the drug in relation to that of other substances used to treat the same condition. The carefully regulated conditions of the clinical trial may bear little relationship to the way the drug will be used in practice. Most important, the evidence obtained on efficacy may relate chiefly to the pharmacological action of the drug, e.g. in lowering blood pressure or blood sugar, or reducing inflammation, and may not bear directly upon therapeutic outcome. For these reasons much attention is being focused on monitoring of the way drugs are used after marketing. To provide evidence of therapeutic efficacy may require studies of such large scale and high cost that they are beyond the research of individual pharmaceutical companies and will require national or international action. Monitoring of the way drugs are used inevitably means studying not just the performance of the drug but also of the doctors who prescribe it. Studies that have been made of the quality of care of patients treated with anti-hypertensive drugs and those requiring anticoagulants are not reassuring concerning the general level of such quality. PMID:829769

  9. Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of scalp psoriasis.

    PubMed

    Poulin, Yves; Papp, Kim; Bissonnette, Robert; Guenther, Lyn; Tan, Jerry; Lynde, Charles; Kerrouche, Nabil; Villemagne, Hervé

    2010-01-01

    Clobetasol propionate (CP) shampoo 0.05% is an efficacious and safe treatment for scalp psoriasis. The aim of this double-blind, randomized, placebo-controlled study was to determine if CP shampoo is suitable for long-term disease control. Participants with moderate to severe scalp psoriasis (global severity score [GSS] of 3 or 4 on a scale of 0 [clear] to 5 [very severe]) first received once daily CP shampoo treatment for up to 4 weeks. Responders were subsequently randomized to receive the CP shampoo or vehicle twice weekly maintenance regimen for up to 6 months. When relapse occurred (defined as GSS > 2), participants resumed once daily CP shampoo treatment; when symptoms diminished (GSS < or = 2), they readopted the twice weekly maintenance regimen. At all visits significantly more participants treated with CP shampoo did not relapse compared with participants treated with vehicle (P < .001). Only approximately one-third of participants treated with vehicle remained relapse free at 1 month, while this rate was observed approximately 3.5 months later (4.5 months after baseline of maintenance phase) in the CP shampoo group. After 6 months 31.1% (33/106) of participants in the CP shampoo group were still relapse free versus 8.1% (9/111) of participants in the vehicle group. There was no greater incidence of skin atrophy, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression in the CP shampoo group compared with the vehicle group. Clobetasol propionate shampoo is efficacious and safe for acute management and long-term maintenance of moderate to severe scalp psoriasis. PMID:20184211

  10. Long-term antibacterial efficacy of air plasma-activated water

    NASA Astrophysics Data System (ADS)

    Traylor, Matthew J.; Pavlovich, Matthew J.; Karim, Sharmin; Hait, Pritha; Sakiyama, Yukinori; Clark, Douglas S.; Graves, David B.

    2011-11-01

    Indirect air dielectric barrier discharge in close proximity to water creates an acidified, nitrogen-oxide containing solution known as plasma-activated water (PAW), which remains antibacterial for several days. Suspensions of E. coli were exposed to PAW for either 15 min or 3 h over a 7-day period after PAW generation. Both exposure times yielded initial antibacterial activity corresponding to a ~5-log reduction in cell viability, which decreased at differing rates over 7 days to negligible activity and a 2.4-log reduction for 15 min and 3 h exposures, respectively. The solution remained at pH ~2.7 for this period and initially included hydrogen peroxide, nitrate and nitrite anions. The solution composition varied significantly over this time, with hydrogen peroxide and nitrite diminishing within a few days, during which the antibacterial efficacy of 15 min exposures decreased significantly, while that of 3 h exposures produced a 5-log reduction or more. These results highlight the complexity of PAW solutions where multiple chemical components exert varying biological effects on differing time scales.

  11. Short-term and long-term safety and tolerability of interferon ?-1b in multiple sclerosis.

    PubMed

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

    2014-05-01

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

  12. Long term efficacy of high-dose intravenous methylprednisolone pulses in active lupus nephritis. A 21-month prospective study.

    PubMed

    Bertoni, M; Brugnolo, F; Bertoni, E; Salvadori, M; Romagnani, S; Emmi, L

    1994-01-01

    The efficacy of a single course of three high dose intravenous (i.v.) methylprednisolone (MP) pulses followed by low dose oral prednisone (PRED) was assessed in a group of patients with active lupus nephritis (LN). At 21 months after such therapeutic regimen in 10 out of 12 patients a complete clinical remission was found, in one patient a partial response with persistent moderate renal failure occurred, while one patient was refractory even to the additional administration of cyclophosphamide. The statistical analysis of repeated measures of a series of biological markers of LN, monitored over the course of the study, evidenced a significant improvement of serum creatinine (p < 0.05), C3 and C4 complement components (p < 0.05), 24-hour proteinuria (p < 0.02) and ESR values (p < 0.05). Moreover, a progressive and significant reduction of mean daily PRED dosage was reported (p < 0.05). We conclude that i.v. MP pulse therapy may exert a substantial long-term control of active LN and may induce steroid-sparing effects. PMID:8165443

  13. Predictive value of early serum cytokine changes on long-term interferon beta-1a efficacy in multiple sclerosis.

    PubMed

    Petek-Balc?, Belgin; Coban, Arzu; Shugaiv, Erkingül; Türko?lu, Recai; Ulusoy, Canan; Içöz, Sema; Pehlivan, Münevver; Tüzün, Erdem; Akman-Demir, Gül?en; Kürtüncü, Murat; Eraksoy, Mefküre

    2014-07-17

    Background: In a previous study, we had evaluated short-term effects of interferon beta-1a (IFNB-1a) 44 ?g s.c. three times per week treatment on serum levels of IFN-gamma (IFNG), IL-23, IL-17, IL-10, IL-9, IL-4 and TGF-beta (TGFB) and found a reduction only in IL-17 and IL-23 levels after 2 months of treatment. Methods: Using the same multiple sclerosis (MS) cohort, we assessed the predictive value of early cytokine level changes (difference between 2nd month and baseline levels as measured by ELISA) on the efficacy of long-term IFNB-1a treatment. Results: The alteration in IFNG levels of patients without any relapse was statistically lower than that of patients having one or more relapses (p = 0.019, Student's t-test). When patients with or without expanded disability severity scale (EDSS) progression were compared, none of the cytokine level changes showed a significant difference between groups. IL-17 and IL-23 level changes did not predict relapse and EDSS progression in IFNB-1a-treated MS patients. Conclusion: Our results show that the predictive power of early IFNG measurement on relapse occurrence may potentially extend a time span of several years. PMID:25026220

  14. Long-term Benefits of Prompts to Use Safety Belts among Drivers Exiting Senior Communities

    Microsoft Academic Search

    CORY D. COX; BRIAN S. COX; Daniel J Cox

    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 by drivers exiting senior communities from baseline (72% and

  15. Long-term Outcomes of the FRESH START Trial: Exploring the Role of Self-efficacy in Cancer Survivors’ Maintenance of Dietary Practices and Physical Activity

    PubMed Central

    Mosher, Catherine E.; Lipkus, Isaac; Sloane, Richard; Snyder, Denise C.; Lobach, David F.; Demark-Wahnefried, Wendy

    2012-01-01

    Objective This study examined whether changes in self-efficacy explain the effects of a mailed print intervention on long-term dietary practices of breast and prostate cancer survivors. The relationship between change in self-efficacy and long-term physical activity (PA) also was examined. Methods Breast and prostate cancer survivors (N=543) from 39 U.S. states and two Canadian provinces participated in the FRESH START intervention trial. Participants were randomly assigned to receive a 10-month program of mailed print materials on diet and PA available in the public domain or a 10-month program of tailored materials designed to increase fruit and vegetable (F&V) intake, decrease fat intake, and/or increase PA. Changes in self-efficacy for F&V intake and fat restriction were analyzed as potential mediators of the intervention’s effects on diet at 2-year follow-up. Because we previously found that change in self-efficacy for PA did not vary by group assignment, the relationship between change in self-efficacy and PA at 2-year follow-up was examined across study conditions. Results Results suggest that change in self-efficacy for fat restriction partially explained the intervention’s effect on fat intake (mean indirect effect=-.28), and change in self-efficacy for F&V consumption partially explained the intervention’s effect on daily F&V intake (mean indirect effect=.11). Change in self-efficacy for fat restriction partially accounted for the intervention’s impact on overall diet quality among men only (mean indirect effect=.60). Finally, change in self-efficacy for PA predicted PA at 2-year follow-up. Conclusions Findings suggest that self-efficacy may influence long-term maintenance of healthy lifestyle practices among cancer survivors. PMID:22544562

  16. Ustekinumab in chronic immune-mediated diseases: a review of long term safety and patient improvement.

    PubMed

    Toussirot, Eric; Michel, Fabrice; Béreau, Matthieu; Binda, Delphine

    2013-01-01

    Ustekinumab is a fully human monoclonal antibody targeting the common p40 subunit shared by interleukin (IL)-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 with their cell surface receptors, and thus blocks T helper (Th)-1 IL-12 and Th-17 IL-23 inflammatory pathways. Ustekinumab has been evaluated in the treatment of various chronic immune-mediated diseases including, psoriasis, psoriatic arthritis, Crohn's disease, and multiple sclerosis. It led to a rapid and durable improvement in psoriasis area and severity index in patients with moderate to severe psoriasis. Ustekinumab also improved joint symptoms of psoriatic arthritis. Results in Crohn's disease were more mitigated, albeit with a symptomatic improvement in patients refractory to tumor necrosis factor-? inhibitors. Ustekinumab did not reduce the number of magnetic resonance imaging brain lesions in multiple sclerosis. The most common adverse events to have been observed during clinical trials are mild in intensity, and include respiratory tract infections, nasopharyngitis, headaches, and injection site reactions. A pooled analysis of clinical trial data indicated no specific patterns of infection or malignancy under long-term ustekinumab administration. Ustekinumab is easy to use, has a comfortable therapeutic regimen, improves quality of life in patients, and thus appears to be an attractive biological treatment that is adapted and accepted by patients with moderate to severe psoriasis. PMID:23641151

  17. 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

  18. Peer tutoring to prevent firearm play acquisition, generalization, and long-term maintenance of safety skills.

    PubMed

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

    PubMed

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

    2013-05-01

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios. PMID:23619797

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

    PubMed Central

    Marasinghe, Keshini Madara

    2015-01-01

    Objectives Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Methods Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Results Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. Conclusions CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians’ judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature, further research on implementation and effectiveness of CCDSS is required. PMID:25967986

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

    SciTech Connect

    Abe Van Luik

    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.

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

    PubMed

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

    2014-12-01

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

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

    PubMed

    Downs, Matthew E; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; 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, 4-5?m 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

  4. 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

  5. Long-term data indicate a progressive loss in efficacy of adjustable silicone gastric banding for the surgical treatment of morbid obesity

    Microsoft Academic Search

    Cornelius Doherty; James W Maher; Debra S Heitshusen

    2002-01-01

    Background. Many short-term follow-up reports on the efficacy of the adjustable silicone gastric band (ASGB) and its modification for laparoscopic insertion (Lap-Band) for the surgical treatment of morbid obesity have been reported in the surgical literature. However, long-term studies are lacking. Methods. Between March 17, 1992, and January 7, 1997, 45 females and 17 males consecutively entered this prospective study.

  6. Clinical Efficacy and Toxicity Profile of Tacrolimus and Mycophenolic Acid in Relation to Combined Long-term Pharmacokinetics in de Novo Renal Allograft Recipients

    Microsoft Academic Search

    Dirk R. J. Kuypers; Kathleen Claes; Pieter Evenepoel; Bart Maes; Yves Vanrenterghem

    2004-01-01

    Introduction: Tacrolimus and mycophenolate mofetil are effective drugs characterized by specific toxicity profiles that may compromise their long-term use in renal transplant recipients. Clinicians, therefore, need reliable drug monitoring tools for relating efficacy and toxicity to drug exposure.Study design: We conducted a prospective 12-month pharmacokinetic study of tacrolimus and mycophenolic acid in 100 de novo recipients. The aim was to

  7. Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study

    PubMed Central

    McQueen, Michael; Rojas, Jorge; Sun, Shyan C; Tero, Robert; Ives, Kevin; Bednarek, Frank; Owens, Larry; Dysart, Kevin; Dungan, George; Shaffer, Thomas H.; Miller, Thomas L

    2015-01-01

    Objective High flow nasal cannula therapy (HFT) has been shown to be similar to nasal continuous positive airway pressure (nCPAP) in neonates with respect to avoiding intubation. The objective of the current study is to determine if there are trends for adverse safety and long-term respiratory outcomes in very low birth weight infants (<1500 g) from centers using HFT as their primary mode of non-invasive respiratory support compared to data from the largest neonatal outcomes database (Vermont Oxford Network; VON). Methods A multicenter, retrospective analysis of pulmonary outcomes data was performed for the calendar years 2009, 2010 and 2011. Performance of five HFT centers was compared with population outcomes from the VON database. The five HFT centers routinely use flow rates between 4-8 L/min as described by the mechanistic literature. Weighted average percentages from the five HFT centers were calculated, along with the 95% confidence intervals (CI) to allow for comparison to the VON means. Results Patient characteristics between the HFT centers and the VON were not different in any meaningful way, despite the HFT having a greater percentage of smaller infants. The average VON center primarily used nCPAP (69% of all infants) whereas the HFT centers primarily used HFT (73%). A lesser percentage of VLBW infants in the HFT cohort experienced mortality and nosocomial infection. Compared to VON data, an appreciably lesser percent of the HFT cohort were receiving oxygen at 36 weeks and less went home on oxygen. Conclusions Considering there was no trend for adverse events, and there was a trend for better outcomes pertaining to long-term oxygen use, these data support claims of safety for HFT as a routine respiratory management strategy in the NICU.

  8. Testing the Long-Term Efficacy of a Prevention Program for Improving Marital Conflict in Community Families

    ERIC Educational Resources Information Center

    Faircloth, W. Brad; Schermerhorn, Alice C.; Mitchell, Patricia M.; Cummings, Jennifer S.; Cummings, E. Mark

    2011-01-01

    Family-focused prevention programs for community samples have potentially broad, clinically relevant implications but few studies have examined whether any program benefits continue to be observed over the long term. Although benefits of a marital conflict focused parent education program, the Happy Couples and Happy Kids (i.e., HCHK) program,…

  9. The Melbourne House Dust Mite Study: Long-term efficacy of house dust mite reduction strategies

    Microsoft Academic Search

    Richard Sporik; David J. Hill; Philip J. Thompson; Geoffrey A. Stewart; John B. Carlin; Terry M. Nolan; Andrew S. Kemp; Clifford S. Hosking

    1998-01-01

    Background: Asthma severity among mite-sensitized individuals appears to be related to the degree of mite allergen exposure. Objectives: The objective of this study was to assess the long-term effectiveness of mite avoidance measures in the homes of asthmatic children in Melbourne, Australia. Methods: The concentration of house dust mite allergen (Der p 1) was measured on the child's mattress surfaces

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

    PubMed Central

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

    2007-01-01

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

  11. 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. PMID:23911615

  12. 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. PMID:19567981

  13. A long-term follow-up evaluation of electronic health record prescribing safety

    PubMed Central

    Abramson, Erika L; Malhotra, Sameer; Osorio, S Nena; Edwards, Alison; Cheriff, Adam; Cole, Curtis; Kaushal, Rainu

    2013-01-01

    Objective To be eligible for incentives through the Electronic Health Record (EHR) Incentive Program, many providers using older or locally developed EHRs will be transitioning to new, commercial EHRs. We previously evaluated prescribing errors made by providers in the first year following transition from a locally developed EHR with minimal prescribing clinical decision support (CDS) to a commercial EHR with robust CDS. Following system refinements, we conducted this study to assess the rates and types of errors 2?years after transition and determine the evolution of errors. Materials and methods We conducted a mixed methods cross-sectional case study of 16 physicians at an academic-affiliated ambulatory clinic from April to June 2010. We utilized standardized prescription and chart review to identify errors. Fourteen providers also participated in interviews. Results We analyzed 1905 prescriptions. The overall prescribing error rate was 3.8 per 100 prescriptions (95% CI 2.8 to 5.1). Error rates were significantly lower 2?years after transition (p<0.001 compared to pre-implementation, 12?weeks and 1?year after transition). Rates of near misses remained unchanged. Providers positively appreciated most system refinements, particularly reduced alert firing. Discussion Our study suggests that over time and with system refinements, use of a commercial EHR with advanced CDS can lead to low prescribing error rates, although more serious errors may require targeted interventions to eliminate them. Reducing alert firing frequency appears particularly important. Our results provide support for federal efforts promoting meaningful use of EHRs. Conclusions Ongoing error monitoring can allow CDS to be optimally tailored and help achieve maximal safety benefits. Clinical Trials Registration ClinicalTrials.gov, Identifier: NCT00603070. PMID:23578816

  14. Efficacy, safety, and cost-effectiveness of glatiramer acetate in the treatment of relapsing–remitting multiple sclerosis

    PubMed Central

    Boster, Aaron; Bartoszek, Mary Pat; O’Connell, Colleen; Pitt, David; Racke, Michael

    2011-01-01

    The current Multiple Sclerosis (MS) therapeutic landscape is rapidly growing. Glatiramer acetate (GA) remains unique given its non-immunosuppressive mechanism of action as well as its superior long-term safety and sustained efficacy data. In this review, we discuss proposed mechanisms of action of GA. Then we review efficacy data for reduction of relapses and slowing disability as well as long term safety data. Finally we discuss possible future directions of this unique polymer in the treatment of MS. PMID:22010043

  15. Long-Term Efficacy of Atenolol for Atrioventricular Reciprocating Tachycardia in Children Less Than 5 Years Old

    Microsoft Academic Search

    J. K. Ko; J. E. Ban; Y. H. Kim; I. S. Park

    2004-01-01

    Atrioventricular reciprocating tachycardia (AVRT) using an accessory pathway is the most common supraventricular tachycardia observed in infancy and childhood. There is a general agreement to treat children older than 5 years who are on a potentially long-term antiarrhythmic agent with radiofrequency catheter ablation. Atenolol, a relatively long-acting and cardioselective ß-adrenoceptor blocker, has been used to control the various types of

  16. Dapagliflozin efficacy and safety: a perspective review

    PubMed Central

    2014-01-01

    Type 2 diabetes mellitus is a prevalent, progressive disease with a need for innovative therapeutic agents to continue to advance disease management. Dapagliflozin is the second agent in a new class of oral antihyperglycemic drugs: sodium-glucose cotransporter 2 (SGLT2) inhibitors. SGLT2 is responsible for the majority of renal glucose reuptake; inhibition of the cotransporter allows for increased renal glucose excretion that consequently leads to reduced plasma glucose levels. Because this mechanism does not require the action of insulin, dapagliflozin rarely causes hypoglycemia and is effective in patients both early and late in the course of their disease. Studies of dapagliflozin have demonstrated efficacy both as monotherapy and in combination with oral antihyperglycemic agents and insulin. Dapagliflozin has been shown to decrease hemoglobin A1c (HbA1c) values 6 mmol/mol (0.5%) to 8 mmol/mol (0.7%). The most common adverse reactions observed with dapagliflozin in clinical trials were female genital mycotic infections, urinary tract infections, and nasopharyngitis. Dapagliflozin is a new oral agent for type 2 diabetes with short-term efficacy similar to dipeptidyl peptidase 4 inhibitors; its long-term safety and efficacy are unknown. PMID:25436106

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

    PubMed

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

    2015-01-01

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

  18. Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia

    Microsoft Academic Search

    Franklin C Lowe; John D McConnell; Perry B Hudson; Nicholas A Romas; Rex Boake; Michael Lieber; Mostafa Elhilali; Jack Geller; Juliane Imperto-McGinely; Gerald L Andriole; Reginald C Bruskewitz; Patrick C Walsh; Georg Bartsch; John N Nacey; Sukrut Shah; Frances Pappas; Amy Ko; Thomas Cook; Elizabeth Stoner; Joanne Waldstreicher

    2003-01-01

    ObjectivesTo summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.

  19. 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…

  20. Long-Term Efficacy of Oxybutynin for Palmar and Plantar Hyperhidrosis in Children Younger than 14 Years.

    PubMed

    Wolosker, Nelson; Teivelis, Marcelo P; Krutman, Mariana; de Paula, Rafael P; Schvartsman, Claudio; Kauffman, Paulo; de Campos, José R M; Puech-Leão, Pedro

    2014-12-10

    Oxybutynin for treating hyperhidrosis in children has been evaluated only in short-term studies. We aimed to investigate the long-term effects of oxybutynin in treating children with palmar and plantar hyperhidrosis who had not undergone surgery and who were monitored for at least 6 months (median 19.6 mos). A cohort of 97 patients was evaluated retrospectively, with particular attention to 59 children (ages 4-14 yrs) who were treated for longer than 6 months. Their quality of life (QOL) was evaluated using a validated clinical questionnaire before and after 6 weeks of pharmacologic therapy. A self-assessment of hyperhidrosis was performed after 6 weeks and after the last consultation. By their final office visit, more than 91% of the children with hyperhidrosis treated with oxybutynin experienced moderate or great improvement in their level of sweating and 94.9% experienced improvement in QOL. More than 90% of children reported improvement of hyperhidrosis at other sites. Dry mouth was the most common side effect. Oxybutynin appears to be an effective treatment option for children with hyperhidrosis, and positive results are maintained over the long term (median 19.6 mos). PMID:25490865

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

    PubMed Central

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

    2009-01-01

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

  2. Long-Term Efficacy and Tolerability of Abdominal Once-Yearly Histrelin Acetate Subcutaneous Implants in Patients with Advanced Prostate Cancer

    PubMed Central

    Woolen, Sean; Holzmeyer, Cameron; Nesbitt, Emily; Siami, Paul F.

    2014-01-01

    Objectives. Long-term assessment of the efficacy and tolerability of subcutaneous abdominal histrelin acetate implants that have been inserted for more than two years. Materials and Methods. Retrospective data collected over a six-year period at a single center from charts of 113 patients who received the subcutaneous abdominal histrelin acetate implant. Results. Following insertion of the first implant, 92.1% and 91.8% of patients had a serum testosterone level of ?30?ng/dL at 24 and 48 weeks, respectively. Serum testosterone levels remained at <30?ng/dL for 96% of patients at two years and for 100% of patients at 3, 4, and 5 years. The testosterone levels remained significantly less than baseline (P < 0.05). Six patients (5.3%) had androgen-independent progression when followed up on the long term, increasing the mean serum PSA at 3, 4, and 5 years to 35.0?µg/L (n = 22), 30.7?µg/L (n = 13), and 132.9?µg/L (n = 8), respectively. The mean serum PSA was significantly greater than baseline during these years (P < 0.05). Eight patients (7.1%) experienced minor, but not serious, adverse events from the histrelin acetate. Conclusion. Subcutaneous abdominal histrelin acetate implants are an effective long-term and well-tolerated administration method for treating patients with advanced prostate cancer. PMID:25548680

  3. Long-Term Once-Daily Tiotropium Respimat® Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study

    PubMed Central

    Ohta, Ken; Ichinose, Masakazu; Tohda, Yuji; Engel, Michael; Moroni-Zentgraf, Petra; Kunimitsu, Satoko; Sakamoto, Wataru; Adachi, Mitsuru

    2015-01-01

    Background This study assessed the long-term safety and efficacy of tiotropium Respimat, a long-acting inhaled anticholinergic bronchodilator, in asthma, added on to inhaled corticosteroids (ICS) with or without long-acting ?2-agonist (LABA). Methods 285 patients with symptomatic asthma, despite treatment with ICS±LABA, were randomised 2:2:1 to once-daily tiotropium 5 ?g, tiotropium 2.5 ?g or placebo for 52 weeks (via the Respimat SoftMist inhaler) added on to ICS±LABA, in a double-blind, placebo-controlled, parallel-group study (NCT01340209). Primary objective: to describe the long-term safety profile of tiotropium. Secondary end points included: trough forced expiratory volume in 1 second (FEV1) response; peak expiratory flow rate (PEFR) response; seven-question Asthma Control Questionnaire (ACQ-7) score. Results At Week 52, adverse-event (AE) rates with tiotropium 5 ?g, 2.5 ?g and placebo were 88.6%, 86.8% and 89.5%, respectively. Commonly reported AEs with tiotropium 5 ?g, 2.5 ?g and placebo were nasopharyngitis (48.2%, 44.7%, 42.1%), asthma (28.9%, 29.8%, 38.6%), decreased PEFR (15.8%, 7.9%, 21.1%), bronchitis (9.6%, 13.2%, 7.0%), pharyngitis (7.9%, 13.2%, 3.5%) and gastroenteritis (10.5%, 3.5%, 5.3%). In the tiotropium 5 ?g, 2.5 ?g and placebo groups, 8.8%, 5.3% and 5.3% of patients reported drug-related AEs; 3.5%, 3.5% and 15.8% reported serious AEs. Asthma worsening was the only serious AE reported in more than one patient. At Week 52, adjusted mean trough FEV1 and trough PEFR responses were significantly higher with tiotropium 5 ?g (but not 2.5 ?g) versus placebo. ACQ-7 responder rates were higher with tiotropium 5 ?g and 2.5 ?g versus placebo at Week 24. Conclusions The long-term tiotropium Respimat safety profile was comparable with that of placebo Respimat, and associated with mild to moderate, non-serious AEs in patients with symptomatic asthma despite ICS±LABA therapy. Compared with placebo, tiotropium 5 ?g, but not 2.5 ?g, significantly improved lung function and symptoms, supporting the long-term efficacy of the 5 ?g dose. Trial Registration ClinicalTrials.gov NCT01340209 PMID:25894430

  4. An Exploratory Study of Meanings of Risk Control for Long Term and Acute Effect Occupational Health and Safety Risks in Small Business Construction Firms

    Microsoft Academic Search

    Noni Holmes; Helen Lingard; Zeynep Yesilyurt; Fred De Munk

    1999-01-01

    A qualitative study of employers' and employees' meanings of occupational health and safety (OHS) risk control was conducted among a sample of small businesses engaged in the Australian construction industry. Two OHS risks relevant to the construction industry were selected for study. One risk (falls from height) represented an immediate consequence, whereas the other (occupational skin disease) represented a long-term

  5. Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia

    Microsoft Academic Search

    Steven A Kaplan; H. Logan Holtgrewe; Reginald Bruskewitz; Brian Saltzman; David Mobley; Perinchery Narayan; Robert H Lund; Steven Weiner; Glen Wells; Thomas J Cook; Alan Meehan; Joanne Waldstreicher

    2001-01-01

    Objectives. To compare the efficacy and safety of finasteride 5 mg in older (65 years old or older) versus younger (45 to younger than 65 years old) men with benign prostatic hyperplasia (BPH).Methods. The Proscar Long-Term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men

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

    PubMed Central

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

    2014-01-01

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

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

    Microsoft Academic Search

    Axel Brattström

    2009-01-01

    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 500mg St. John's wort extract per day (Ze

  8. The chemopreventive efficacies of nonsteroidal anti-inflammatory drugs: the relationship of short-term biomarkers to long-term skin tumor outcome.

    PubMed

    Mikulec, Carol D; Rundhaug, Joyce E; Simper, Melissa S; Lubet, Ronald A; Fischer, Susan M

    2013-07-01

    The ultraviolet B (UVB) component of sunlight, which causes DNA damage and inflammation, is the major cause of nonmelanoma skin cancer (NMSC), the most prevalent of all cancers. Nonsteroidal anti-inflammatory drugs (NSAID) and coxibs have been shown to be effective chemoprevention agents in multiple preclinical trials, including NMSC, colon, and urinary bladder cancer. NSAIDs, however, cause gastrointestinal irritation, which led to the recent development of nitric oxide (NO) derivatives that may partially ameliorate this toxicity. This study compared the efficacy of several NSAIDs and NO-NSAIDs on UV-induced NMSC in SKH-1 hairless mice and determined whether various short-term biomarkers were predictive of long-term tumor outcome with these agents. Naproxen at 100 (P = 0.05) and 400 ppm (P < 0.01) in the diet reduced tumor multiplicity by 26% and 63%, respectively. The NO-naproxen at slightly lower molar doses shows similar activities. Aspirin at 60 or 750 ppm in the diet reduced tumor multiplicity by 19% and 50%, whereas the equivalent doses (108 and 1,350 ppm) were slightly less effective. Sulindac at 25 and 150 ppm in the diet, doses far below the human equivalent dose was the most potent NSAID with reductions of 50% and 94%, respectively. In testing short-term biomarkers, we found that agents that reduce UV-induced prostaglandin E2 synthesis and/or inhibit UV-induced keratinocyte proliferation yielded long-term tumor efficacy. PMID:23682071

  9. Effect of Contralateral Occlusion on Long-Term Efficacy of Endarterectomy in the Asymptomatic Carotid Atherosclerosis Study (ACAS)

    Microsoft Academic Search

    William H. Baker; Virginia J. Howard; George Howard; James F. Toole

    Background and Purpose—The Asymptomatic Carotid Atherosclerosis Study (ACAS) established the effectiveness of prophylactic carotid endarterectomy, for patients in good health who had stenosis $60%, if conducted by surgeons with a surgical morbidity and mortality of ,3%. This secondary analysis was performed to determine whether the presence of contralateral cervical carotid occlusion alters the efficacy of asymptomatic ipsilateral carotid endarterectomy. Methods—One

  10. Coping Self-Efficacy Perceptions as a Mediator Between Acute Stress Response and Long-Term Distress Following Natural Disasters

    Microsoft Academic Search

    Charles C. Benight; Michelle L. Harper

    2002-01-01

    The mediating effect of coping self-efficacy (CSE) perceptions between acute stress responses (ASR) and 1-year distress following two disasters was tested. Between 3 and 8 weeks after the second disaster and again at 1 year, 46 residents completed questionnaires. Posttraumatic Stress Disorder (PTSD) symptoms and global distress served as outcomes. Multiple regression demonstrated that ASR and Time 1 CSE were

  11. Efficacy and safety of ginseng.

    PubMed

    Kitts, D; Hu, C

    2000-12-01

    Ginseng (Panax ginseng, C.A. Meyer) has been a popular herbal remedy used in eastern Asian cultures for thousands of years. In North America, the ginseng species indigenous to both Canada and the United States (Panax quinquefolium) represents an important industry for both domestic and export markets. There are numerous theories and claims describing the efficacy of ginseng, which can combat stress, enhance both the central and immune systems and contribute towards maintaining optimal oxidative status against certain chronic disease states and aging. Risk issues concerning the safety of ginseng at recommended dosages are less prominent and scientifically based. While some epidemiological or clinical studies have reported indications of efficacy for specific health benefits or potential toxicity, there are an equal number of studies that provide contradictory evidence. This situation has led to questionable conclusions concerning specific health benefits or risks associated with ginseng. Recent advances in the development of standardized extracts for both Panax ginseng (G-115) and Panax quinquefolius (CNT-2000) have and will continue to assist in the assessment of efficacy and safety standards for ginseng products. This paper reviews the scientific literature and evidence for ginseng efficacy and safety derived mostly from in vitro and animal studies and places emphasis on the need for more randomized, double-blinded, placebo clinical studies that can provide unequivocal conclusions. An example of the efficacy and safety of ginseng is provided with the description of biological activity of a North American ginseng extract (NAGE), which includes illustrating mechanisms for antioxidant activity without prooxidant properties. PMID:11276295

  12. Long-Term Outcome after Combined Radiochemotherapy for Anal Cancer – Retrospective Analysis of Efficacy, Prognostic Factors, and Toxicity

    Microsoft Academic Search

    Sabine K. Mai; Grit Welzel; Brigitte Hermann; Markus Bohrer; Frederik Wenz

    2008-01-01

    SummaryBackground: This retrospective study evaluated the efficacy, prognostic factors, and toxicity of combined radiochemotherapy for anal cancer. Patients and Methods: Data of 90 patients treated with radiochemotherapy between 1990 and 2006 were analyzed. Mean follow-up was 30 months (range: 2–129 months). Endpoints were disease-specific survival, local control, freedom from metastasis, and colostomy-free survival. Tumor stage, nodal status, age, sex, tumor

  13. Long-term efficacy and compliance of intracorporeal (IC) injection for erectile dysfunction following radical prostatectomy: SHIM (IIEF-5) analysis

    Microsoft Academic Search

    R Raina; M M Lakin; M Thukral; A Agarwal; S Ausmundson; D K Montague; E Klein; C D Zippe

    2003-01-01

    Baseline and follow-up data from 102 patients using intracorporeal (IC) injection for erectile dysfunction (ED) following RP were retrospectively collected. We compared baseline International Index for Erectile Function (IIEF) questionnaires with the abridged IIEF-5 questionnaires, referred to as the Sexual Health Inventory of Men (SHIM) to determine drug efficacy. The mean presurgery SHIM score was 21.75±5.23, which decreased to 4.23±3.48

  14. Prophylactic efficacy of fluoxetine, escitalopram, sertraline, paroxetine, and concomitant psychotherapy in major depressive disorder: outcome after long-term follow-up.

    PubMed

    Peselow, Eric D; Tobia, Gabriel; Karamians, Reneh; Pizano, Demetria; IsHak, Waguih William

    2015-02-28

    The acute efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder (MDD) is well established; however their role in longer-term prevention of recurrence remains unconfirmed. This study aims at examining: the prophylactic efficacy of four commonly used SSRIs in MDD in a naturalistic setting with long-term follow-up, the effect of concomitant cognitive behavioral therapy (CBT), and the predictors of outcome. In a prospective cohort study, 387 patients who either remitted or responded following treatment with four different SSRIs-fluoxetine, escitalopram, sertraline and paroxetine-were followed up over several years. During an average follow-up period of 34.5 months, 76.5% of patients experienced MDD recurrence. Escitalopram and fluoxetine showed a numerically higher prophylactic efficacy than paroxetine and sertraline but the difference was statistically insignificant. The prophylactic efficacy for SSRI-only treatment was limited, with a recurrence rate of 82.0%, compared to 59.0% of patient recurrence rate in concomitant Cognitive Behavioral Therapy (CBT). The relatively small size of the CBT group and the lack of randomization may undermine the extrapolation of its findings to clinical practice. Nevertheless, the study preliminary data may help in defining the clinical utility of antidepressants and CBT in the prophylaxis from MDD recurrence. PMID:25496869

  15. Effects of long-term zinc treatment in Japanese patients with Wilson disease: efficacy, stability, and copper metabolism.

    PubMed

    Shimizu, Norikazu; Fujiwara, Junko; Ohnishi, Shin; Sato, Mari; Kodama, Hiroko; Kohsaka, Takao; Inui, Ayano; Fujisawa, Tomoo; Tamai, Hiroshi; Ida, Shinobu; Itoh, Susumu; Ito, Michinori; Horiike, Norio; Harada, Masaru; Yoshino, Makoto; Aoki, Tsugutoshi

    2010-12-01

    Wilson disease is an autosomal recessive disorder with copper metabolism. In Japan, the standard treatment is the administration of copper chelating agents, such as D-penicillamine and trientine. In this study, the authors used zinc acetate to treat Japanese patients with Wilson disease and investigated its efficacy. The 37 patients that comprise this study were found to have Wilson disease using clinical and biochemical tests and were administrated zinc acetate for 48 weeks. The authors followed the clinical symptoms and laboratory findings of the patients by assessing their complete blood counts, biochemical findings, as well as the results of urinalysis and special laboratory tests for copper and zinc metabolism. We also examined side effects of the treatment. Zinc acetate did not aggravate the hepatic or neurological symptoms of any of the patients. Blood biochemical analysis also did not reveal elevation of alanine aminotransferase, aspartate aminotransferase, and ?-glutamyltranspeptidase levels. Zinc treatment did not aggravate the patients' clinical signs and/or laboratory findings. However, it did improve some clinical symptoms of the Wilson disease patients. Although this agent had some side effects, none of them were severe. The authors measured spot urinary copper excretion, which gave an indication of the efficacy of treatment and of the sufficient dosage of zinc. We recommend maintaining a spot urinary copper excretion less than 0.075-?g/mg creatinine. The authors conclude that zinc acetate is an effective and safe treatment for Japanese patients with Wilson disease. PMID:21078496

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

    Microsoft Academic Search

    András Várhelyi; Magnus Hjälmdahl; Christer Hydén; Magda Draskóczy

    2004-01-01

    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

  17. Long-term safety of extended-release oxybutynin chloride in a community-dwelling population of participants with overactive bladder: A one-year study

    Microsoft Academic Search

    Ananias Diokno; Peter Sand; Richard Labasky; Paul Sieber; Joseph Antoci; Gary Leach; Linda Atkinson; Detlef Albrecht

    2002-01-01

    In this multicenter, open-label study of extended- and immediate-release oxybutynin chloride, community-dwelling participants were studied for up to 12 months to evaluate the long-term safety profile of extended-release oxybutynin. Quality-of-life assessments designed to measure the impact of incontinence and evaluate treatment outcome were used to study subjective improvement.A total of 904 women and 163 men (mean age 64 years, range

  18. Long-term safety analysis of preventive HIV1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials

    Microsoft Academic Search

    P. B. Gilbert; Y.-L. Chiu; M. Allen; D. N. Lawrence; C. Chapdu; H. Israel; D. Holman; M. C. Keefer; M. Wolff; S. E. Frey

    2003-01-01

    This report evaluates long-term safety data from 3189 human immunodeficiency virus type 1 (HIV-1) uninfected, healthy volunteers who were enrolled into 51 National Institute of Allergy and Infectious Diseases (NIAID)-sponsored Phase I and II multicentred, randomized, double-blind trials of recombinant HIV-1 subunit vaccines (23 studies), synthetic peptide vaccines (7 studies), live vaccinia-vector recombinant envelope vaccines (7 studies), canarypox vector recombinant

  19. 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; Lej?ko, 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. PMID:25270679

  20. 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 ... 8 sec Click to watch this video Most Care Provided at Home Click for more information Long- ...

  1. Effects of Continuous Positive Airway Pressure on Neurocognitive Function in Obstructive Sleep Apnea Patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES)

    PubMed Central

    Kushida, Clete A.; Nichols, Deborah A.; Holmes, Tyson H.; Quan, Stuart F.; Walsh, James K.; Gottlieb, Daniel J.; Simon, Richard D.; Guilleminault, Christian; White, David P.; Goodwin, James L.; Schweitzer, Paula K.; Leary, Eileen B.; Hyde, Pamela R.; Hirshkowitz, Max; Green, Sylvan; McEvoy, Linda K.; Chan, Cynthia; Gevins, Alan; Kay, Gary G.; Bloch, Daniel A.; Crabtree, Tami; Dement, William C.

    2012-01-01

    Study Objective: To determine the neurocognitive effects of continuous positive airway pressure (CPAP) therapy on patients with obstructive sleep apnea (OSA). Design, Setting, and Participants: The Apnea Positive Pressure Long-term Efficacy Study (APPLES) was a 6-month, randomized, double-blind, 2-arm, sham-controlled, multicenter trial conducted at 5 U.S. university, hospital, or private practices. Of 1,516 participants enrolled, 1,105 were randomized, and 1,098 participants diagnosed with OSA contributed to the analysis of the primary outcome measures. Intervention: Active or sham CPAP Measurements: Three neurocognitive variables, each representing a neurocognitive domain: Pathfinder Number Test-Total Time (attention and psychomotor function [A/P]), Buschke Selective Reminding Test-Sum Recall (learning and memory [L/M]), and Sustained Working Memory Test-Overall Mid-Day Score (executive and frontal-lobe function [E/F]) Results: The primary neurocognitive analyses showed a difference between groups for only the E/F variable at the 2 month CPAP visit, but no difference at the 6 month CPAP visit or for the A/P or L/M variables at either the 2 or 6 month visits. When stratified by measures of OSA severity (AHI or oxygen saturation parameters), the primary E/F variable and one secondary E/F neurocognitive variable revealed transient differences between study arms for those with the most severe OSA. Participants in the active CPAP group had a significantly greater ability to remain awake whether measured subjectively by the Epworth Sleepiness Scale or objectively by the maintenance of wakefulness test. Conclusions: CPAP treatment improved both subjectively and objectively measured sleepiness, especially in individuals with severe OSA (AHI > 30). CPAP use resulted in mild, transient improvement in the most sensitive measures of executive and frontal-lobe function for those with severe disease, which suggests the existence of a complex OSA-neurocognitive relationship. Clinical Trial Information: Registered at clinicaltrials.gov. Identifier: NCT00051363. Citation: Kushida CA; Nichols DA; Holmes TH; Quan SF; Walsh JK; Gottlieb DJ; Simon RD; Guilleminault C; White DP; Goodwin JL; Schweitzer PK; Leary EB; Hyde PR; Hirshkowitz M; Green S; McEvoy LK; Chan C; Gevins A; Kay GG; Bloch DA; Crabtree T; Demen WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2012;35(12):1593-1602. PMID:23204602

  2. Opioids in chronic non-cancer pain: systematic review of efficacy and safety

    Microsoft Academic Search

    Eija Kalso; Jayne E. Edwards; R. Andrew Moore; Henry J. McQuay

    2004-01-01

    Opioids are used increasingly for chronic non-cancer pain. Controversy exists about their effectiveness and safety with long-term use. We analysed available randomised, placebo-controlled trials of WHO step 3 opioids for efficacy and safety in chronic non-cancer pain. The Oxford Pain Relief Database (1950–1994) and Medline, EMBASE and the Cochrane Library were searched until September 2003. Inclusion criteria were randomised comparisons

  3. Strategies to optimize efficacy, duration of remission, and safety in the treatment of plaque psoriasis by using tazarotene in combination with a corticosteroid

    Microsoft Academic Search

    Mark Lebwohl

    2000-01-01

    In the treatment of plaque psoriasis with corticosteroids, long-term efficacy and safety are often compromised by tachyphylaxis, steroid rebound, and adverse effects. However, the results of recent studies demonstrate that the use of tazarotene in conjunction with a corticosteroid can help to optimize the efficacy, the duration of remission, and the safety of corticosteroid treatment. In one study, the adjunctive

  4. Overview of clinical safety and efficacy of tertatolol.

    PubMed

    Vivet, P

    1993-01-01

    Tertalolol is a noncardioselective beta-blocker, devoid of intrinsic sympathomimetic activity. Its renal vasodilating properties have been demonstrated both in animals and in man. The beta-blocking activity of tertatolol was assessed on the reduction of heart rate at submaximal exercise. The oral dose of 5 mg was optimal, leading to a significant reduction of diastolic blood pressure throughout 24 h. The efficacy was confirmed in mid- and long-term studies. In mid-term, randomized controlled studies, versus beta-blockers, the antihypertensive efficacy of tertatolol 5 mg was comparable to that of acebutolol 400 mg but of earlier onset, and comparable to that of atenolol 100 mg. Its efficacy was confirmed in 3 long-term studies. In the first study, tertatolol 5 mg alone or combined with a diuretic and, if necessary, dihydralazine, controlled 93.6% of patients (supine DBP < 90 mm Hg). 72.7% of patients were controlled with tertatolol alone, 16.4% with tertatolol plus diuretic, and 4.5% with tertatolol plus diuretic and dihydralazine. In a second study, 88.5% of patients were controlled, 56.3% with tertatolol alone and 32.2% with tertatolol plus diuretic. In the third study, 88.8% of patients were controlled after 1 year treatment, 66.1% with tertatolol alone and 22.7% with tertatolol plus diuretic. The overall clinical safety was excellent: only 6.6% of the 2,706 patients treated for 1 year withdrew from the study because of side effects. In patients followed for 1 year, side effects were rare, transient and mostly of mild severity. Biochemical surveillance did not show any adverse metabolic effects of tertatolol. Conversely, in two long-term studies, creatinine and cholesterol levels decreased significantly.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7903214

  5. Systemic Delivery of Allogenic Muscle Stem Cells Induces Long-Term Muscle Repair and Clinical Efficacy in Duchenne Muscular Dystrophy Dogs

    PubMed Central

    Rouger, Karl; Larcher, Thibaut; Dubreil, Laurence; Deschamps, Jack-Yves; Le Guiner, Caroline; Jouvion, Gregory; Delorme, Bruno; Lieubeau, Blandine; Carlus, Marine; Fornasari, Benoît; Theret, Marine; Orlando, Priscilla; Ledevin, Mireille; Zuber, Céline; Leroux, Isabelle; Deleau, Stéphane; Guigand, Lydie; Testault, Isabelle; Le Rumeur, Elisabeth; Fiszman, Marc; Chérel, Yan

    2011-01-01

    Duchenne muscular dystrophy (DMD) is a genetic progressive muscle disease resulting from the lack of dystrophin and without effective treatment. Adult stem cell populations have given new impetus to cell-based therapy of neuromuscular diseases. One of them, muscle-derived stem cells, isolated based on delayed adhesion properties, contributes to injured muscle repair. However, these data were collected in dystrophic mice that exhibit a relatively mild tissue phenotype and clinical features of DMD patients. Here, we characterized canine delayed adherent stem cells and investigated the efficacy of their systemic delivery in the clinically relevant DMD animal model to assess potential therapeutic application in humans. Delayed adherent stem cells, named MuStem cells (muscle stem cells), were isolated from healthy dog muscle using a preplating technique. In vitro, MuStem cells displayed a large expansion capacity, an ability to proliferate in suspension, and a multilineage differentiation potential. Phenotypically, they corresponded to early myogenic progenitors and uncommitted cells. When injected in immunosuppressed dystrophic dogs, they contributed to myofiber regeneration, satellite cell replenishment, and dystrophin expression. Importantly, their systemic delivery resulted in long-term dystrophin expression, muscle damage course limitation with an increased regeneration activity and an interstitial expansion restriction, and persisting stabilization of the dog's clinical status. These results demonstrate that MuStem cells could provide an attractive therapeutic avenue for DMD patients. PMID:21924229

  6. 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, and should be included in water and health promotion programs. PMID:23950978

  7. Premarket Safety and Efficacy Studies for ADHD Medications in Children

    PubMed Central

    Bourgeois, Florence T.; Kim, Jeong Min; Mandl, Kenneth D.

    2014-01-01

    Background Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing. Methods We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug’s clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials. Results A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed. Conclusions Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved. PMID:25007171

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

    SciTech Connect

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

    2003-02-24

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

  9. Long-term Anterior Thalamus Stimulation for Intractable Epilepsy

    Microsoft Academic Search

    Siew-Na Lim; Shih-Tseng Lee; Yu-Tai Tsai; I-An Chen; Po-Hsun Tu; Jean-Lon Chen; Hsiu-Wen Chang; Yu-Chin Su

    Background: Deep brain stimulation (DBS) has re-emerged as an alternative therapy for intractable epilepsy. In this study, we investigated the feasibility, efficacy and safety of long-term anterior thalamic nucleus (ATN) stimulation for intractable epilepsy. Methods: In this open-label pilot study of electrical stimulation of the ATN, we investi- gated four cases of intractable epilepsy (one man with generalized seizure, and

  10. Handling glacially induced faults in the assessment of the long term safety of a repository for spent nuclear fuel at Forsmark, Sweden

    NASA Astrophysics Data System (ADS)

    Munier, R.

    2011-12-01

    Located deep into the Baltic shield, far from active plate boundaries and volcanism, Swedish bedrock is characterised by a low frequency of earthquakes of small magnitudes. Yet, faults, predominantly in the Lapland region, offsetting the quarternary regolith ten meters or more, reveal that Swedish bedrock suffered from substantial earthquake activity in connection to the retreat of the latest continental glacier, Weichsel. Storage of nuclear wastes, hazardous for hundreds of thousand years, requires, firstly, isolation of radionuclides and, secondly, retardation of the nuclides should the barriers fail. Swedish regulations require that safety is demonstrated for a period of a million years. Consequently, the repository must be designed to resist the impact of several continental glaciers. Large, glacially induced, earthquakes near the repository have the potential of triggering slip along fractures across the canisters containing the nuclear wastes, thereby simultaneously jeopardising isolation, retardation and, hence, long term safety. It has therefore been crucial to assess the impact of such intraplate earthquake upon the primary functions of the repository. We conclude that, by appropriate design of the repository, the negative impact of earthquakes on long term safety can be considerably lessened. We were, additionally, able to demonstrate compliance with Swedish regulations in our safety assessment, SR-Site, submitted to the authorities earlier this year. However, the assessment required a number of critical assumptions, e.g. concerning the strain rate and the fracture properties of the rock, many of which are subject of current research in the geoscientific community. By a conservative approach, though, we judge to have adequately propagated critical uncertainties through the assessment and bound the uncertainty space.

  11. Safety pharmacology in 2010 and beyond: Survey of significant events of the past 10 years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society

    Microsoft Academic Search

    Alan S. Bass; Hugo M. Vargas; Jean-Pierre Valentin; Lewis B. Kinter; Tim Hammond; Rob Wallis; Peter K. S. Siegl; Keiji Yamamoto

    2011-01-01

    In recognition of the tenth anniversary of the Safety Pharmacology Society (SPS), this review summarizes the significant events of the past 10years that have led to the birth, growth and evolution the SPS and presents a roadmap to the immediate-, intermediate- and long-term future of the SPS. The review discusses (i) the rationale for an optimal non-clinical Safety Pharmacology testing,

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

    Microsoft Academic Search

    Chiara Frazzoli; Carlo Petrini; Alberto Mantovani

    2009-01-01

    clInIcAl experIence Summary. Development is defined sustainable when it meets the needs of the present without compro- mising 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

  13. Mark I containment long-term program safety evaluation report, resolution of generic technical activity A-7. Report for February 1977-December 1979

    SciTech Connect

    Not Available

    1980-07-01

    During testing for an advanced Boiling Water Reactor (BWR) containment system design (Mark III), suppression pool hydrodynamic loads were identified which had not been considered in the original design of the Mark I containment system. To address this issue, a Mark I Owners Group was formed and the assessment was divided into a short-term and long-term program. The results of the NRC staff's review of the Mark I Containment Short Term Program are described in NUREG-0408. This report describes the results of the NRC staff's review of the generic Mark I Containment Long Term Program (LTP). The LTP was conducted to provide a generic basis to define suppression pool hydrodynamic loads and the related structural acceptance criteria, such that a comprehensive reassessment of each Mark I containment system would be performed. A series of experimental and analytical programs were conducted by the Mark I Owners Group to provide the necessary bases for the generic load definition and structural assessment techniques. The generic methods proposed by the Mark I Owners Group, as modified by the NRC staff's requirements, will be used to perform plant-unique analyses, which will identify the plant modifications, if any, that will be needed to restore the originally intended margin of safety in the Mark I containment designs.

  14. Long Term Ecological Resources

    NSDL National Science Digital Library

    Scott Cooper

    Students analyze data on temperature and precipitation collected from 26 different Long Term Ecological Research sites and compare them with annual net primary productivity. The students then form an ecological rule to explain their results.

  15. Establishing Long-Term Efficacy in Chronic Disease: Use of Recursive Partitioning and Propensity Score Adjustment to Estimate Outcome in MS

    PubMed Central

    Goodin, Douglas S.; Jones, Jason; Li, David; Traboulsee, Anthony; Reder, Anthony T.; Beckmann, Karola; Konieczny, Andreas; Knappertz, Volker

    2011-01-01

    Context Establishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain. Objective Data from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to assess the relationship between drug-exposure and long-term disability in MS patients. Design/Setting To mitigate the bias of outcome-dependent exposure variation in non-randomized long-term studies, drug-exposure was measured as the medication-possession-ratio, adjusted up or down according to multiple different weighting-schemes based on MS severity and MS duration at treatment initiation. A recursive-partitioning algorithm assessed whether exposure (using any weighing scheme) affected long-term outcome. The optimal cut-point that was used to define “high” or “low” exposure-groups was chosen by the algorithm. Subsequent to verification of an exposure-impact that included all predictor variables, the two groups were compared using a weighted propensity-stratified analysis in order to mitigate any treatment-selection bias that may have been present. Finally, multiple sensitivity-analyses were undertaken using different definitions of long-term outcome and different assumptions about the data. Main Outcome Measure Long-Term Disability. Results In these analyses, the same weighting-scheme was consistently selected by the recursive-partitioning algorithm. This scheme reduced (down-weighted) the effectiveness of drug exposure as either disease duration or disability at treatment-onset increased. Applying this scheme and using propensity-stratification to further mitigate bias, high-exposure had a consistently better clinical outcome compared to low-exposure (Cox proportional hazard ratio?=?0.30–0.42; p<0.0001). Conclusions Early initiation and sustained use of interferon-beta-1b has a beneficial impact on long-term outcome in MS. Our analysis strategy provides a methodological framework for bias-mitigation in the analysis of non-randomized clinical data. Trial Registration Clinicaltrials.gov NCT00206635 PMID:22140424

  16. Long-Term Maintenance of Weight Loss: Current Status

    Microsoft Academic Search

    Robert W. Jeffery; Adam Drewnowski; Leonard H. Epstein; Albert J. Stunkard; G. Terence Wilson; Rena R. Wing; Dana Robin Hill

    2000-01-01

    Intervention strategies for promoting long-term weight loss are examined empirically and conceptually. Weight control research over the last 20 years has dramatically improved short-term treatment efficacy but has been less successful in improving long-term success. Interventions in preadolescent children show greater long-term efficacy than in adults. Extending treatment length and putting more emphasis on energy expenditure have modestly improved long-term

  17. Development and Long-Term Verification of Stereo Vision Sensor System for Controlling Safety at Railroad Crossing

    NASA Astrophysics Data System (ADS)

    Hosotani, Daisuke; Yoda, Ikushi; Hishiyama, Yoshiyuki; Sakaue, Katsuhiko

    Many people are involved in accidents every year at railroad crossings, but there is no suitable sensor for detecting pedestrians. We are therefore developing a ubiquitous stereo vision based system for ensuring safety at railroad crossings. In this system, stereo cameras are installed at the corners and are pointed toward the center of the railroad crossing to monitor the passage of people. The system determines automatically and in real-time whether anyone or anything is inside the railroad crossing, and whether anyone remains in the crossing. The system can be configured to automatically switch over to a surveillance monitor or automatically connect to an emergency brake system in the event of trouble. We have developed an original stereovision device and installed the remote controlled experimental system applied human detection algorithm in the commercial railroad crossing. Then we store and analyze image data and tracking data throughout two years for standardization of system requirement specification.

  18. An approach to quantitative assessment of crew well-being for providing safety of long-term space missions

    NASA Astrophysics Data System (ADS)

    Bartsev, S. I.; Mezhevikin, V. V.; Okhonin, V. A.

    The main destination of Life Support Systems - to support life and provide crew safety - put the problem of the most effective providing this function. In the scope of the whole mission the safety of crew depends on many interrelating features of space ship, LSS, and scenario of given mission itself. Effective risk mitigation needs optimal minimizing of all risk factors. Effective minimization presumes quantitative presentation of these factors. In the paper an approach to quantitative assessment of quality of life in the scope of previously introduced integrated coefficient of maximum reliability. One of the most significant risk factors is crew fatal mistake. There is always other-than-zero probability of a fatal human mistake in controlling the vehicle, landing module, nuclear reactor or other vital device. It is difficult to estimate the probability of such a mistake, but it is apparent that this probability increases with impaired human health. Under closed air cycling such a condition is highly probable as demonstrated by the Sick Building Syndrome (SBS) in highly sealed, so-called "energy efficient" buildings. Seemingly, the cause of SBS is a set of not completely identified factors, yet, it should be noted that in spite of complete pressurization the crew of Bios-3 did not have complaints typical for SBS. It cannot be ruled out that the higher plants may be the most realistic remedy to reduce the probability of the crew's fatal mistakes. All this gives the way to convert so difficultly formalizable parameter as quality of life into probability of accident. A simple monotonous dependence of deterioration of crew health and probability of a fatal mistake on mission time is discussed. Possible medical-biological experiments for more detailed estimations of this dependency are considered.

  19. Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety.

    PubMed

    Beran, Ji?í; Xie, Fang; Zent, Olaf

    2014-07-23

    Long-term vaccination programs are recommended for individuals living in regions endemic for tick-borne encephalitis (TBE). Current recommendations suggest a first booster vaccine be administered 3 years after a conventional regimen or 12-18 months after a rapid regimen. However, the research supporting subsequent booster intervals is limited. The aim of this study was thus to evaluate the long-term persistence of TBE antibodies in adults and adolescents after a first booster dose with Encepur(®). A total of 323 subjects aged 15 years and over, who had received one of four different primary TBE vaccination series in a parent study, participated in this follow-up Phase IV trial. Immunogenicity and safety were assessed for up to five years after a first booster dose, which was administered three years after completion of the primary series. One subset of subjects was excluded from the booster vaccination since they had already received their booster prior to enrollment. For comparison, immune responses were still recorded for these subjects on Day 0 and on an annual basis until Year 5, but safety information was not collected. Following a booster vaccination, high antibody titers were recorded in all groups throughout the study. Neutralization test (NT) titers of ? 10 were noted in at least 94% of subjects at every time point post-booster (on Day 21 and through Years 1-5). These results demonstrated that a first booster vaccination following any primary immunization schedule results in high and long-lasting (>5 years) immune responses. These data lend support to the current belief that subsequent TBE booster intervals could be extended from the current recommendation. NCT00387634. PMID:24950352

  20. 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 BMSCs are safe after cell transplantation for the treatment of stroke. PMID:25376270

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

    PubMed Central

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

    1987-01-01

    A token economy that used trading stamps as tokens was instituted at two dangerous open-pit mines. Employees earned stamps for working without lost-time injuries, for being in work groups in which all other workers had no lost-time injuries, for not being involved in equipment-damaging accidents, for making adopted safety suggestions, and for unusual behavior which prevented an injury or accident. They lost stamp awards if they or other workers in their group were injured, caused equipment damage, or failed to report accidents or injuries. The stamps could be exchanged for a selection of thousands of items at redemption stores. Implementation of the token economy was followed by large reductions in the number of days lost from work because of injuries, the number of lost-time injuries, and the costs of accidents and injuries. The reductions in costs far exceeded the costs of operating the token economy. All improvements were maintained over several years. PMID:3667473

  2. Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience ? ? This study was sponsored by Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, and Aventis Pharma, Bridgewater, New Jersey

    Microsoft Academic Search

    O. H Sorensen; G. M Crawford; H Mulder; D. J Hosking; C Gennari; D Mellstrom; S Pack; D Wenderoth; C Cooper; J.-Y Reginster

    2003-01-01

    Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization,

  3. Long-term efficacy of imatinib in a practical setting is correlated with imatinib trough concentration that is influenced by body size: a report by the Nagasaki CML Study Group

    Microsoft Academic Search

    Mari Sakai; Yasushi Miyazaki; Emi Matsuo; Yukiyoshi Moriuchi; Tomoko Hata; Takuya Fukushima; Yoshitaka Imaizumi; Daisuke Imanishi; Jun Taguchi; Masako Iwanaga; Hideki Tsushima; Yoriko Inoue; Yumi Takasaki; Takeshi Tsuchiya; Minori Komoda; Koji Ando; Kensuke Horio; Yuji Moriwaki; Shinya Tominaga; Hidehiro Itonaga; Kazuhiro Nagai; Kunihiro Tsukasaki; Chizuko Tsutsumi; Yasushi Sawayama; Reishi Yamasaki; Daisuke Ogawa; Yasuhisa Kawaguchi; Shuichi Ikeda; Shinichiro Yoshida; Yasuyuki Onimaru; Masayuki Tawara; Sunao Atogami; Satoshi Koida; Tatsuro Joh; Masaomi Yamamura; Yuji Matsuo; Hisashi Soda; Hiroaki Nonaka; Itsuro Jinnai; Kazutaka Kuriyama; Masao Tomonaga

    2009-01-01

    Imatinib has dramatically improved long-term survival of chronic myelogenous leukemia (CML) patients. To analyze its efficacy\\u000a in a practical setting, we registered most of CML patients in Nagasaki Prefecture of Japan. Of these, 73 patients received\\u000a imatinib as an initial therapy. The overall survival rate of these patients was 88.7% at 6 years, and the cumulative complete\\u000a cytogenetic response rate was

  4. Long-Term Effects of a Brief, Video-Based Parenting Education Program on Parenting Knowledge, Attitudes, and Self-Efficacy in College Students

    ERIC Educational Resources Information Center

    Sigel, Benjamin A.

    2010-01-01

    Scope and Method of Study: The focus of this project was to evaluate the effectiveness of a brief parent education program, as a teaching and preventative tool for nonexpectant individuals. The study was designed to test whether or not this parent education program would be effective long-term in positively impacting parenting knowledge, approval…

  5. More robust evidence for the efficacy of lithium in the long-term treatment of bipolar disorder: should lithium (again) be recommended as the single preferred first-line treatment?

    PubMed

    Nolen, Willem A

    2015-01-01

    With two recent systematic reviews and meta-analyses on the efficacy of lithium compared to placebo and other treatment options, it can now be concluded that lithium is the only drug that has been shown efficacious in the prevention of any mood episodes, manic episodes and depressive episodes in randomised trials not enriched for prior response to and tolerance of lithium. It is argued that lithium should be recommended as the single preferred first-line drug in the long-term treatment of bipolar disorder. PMID:25642404

  6. Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.

    PubMed

    Stein Gold, Linda; Kircik, Leon; Fowler, Joseph; Jackson, J Mark; Tan, Jerry; Draelos, Zoe; Fleischer, Alan; Appell, Melanie; Steinhoff, Martin; Lynde, Charles; Sugarman, Jeffrey; Liu, Hong; Jacovella, Jean

    2014-11-01

    Papulopustular rosacea (PPR) is characterized by facial erythema and inflammatory lesions believed to be primarily caused by dysregulation of the innate immune system. More recent evidence also suggests that Demodex folliculorum mites may contribute to the etiology of PPR. Ivermectin (IVM) 1% cream is a novel topical treatment developed to treat PPR. Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated. Two 40-week extension studies of those trials were conducted to assess the long-term safety of IVM 1% cream vs azelaic acid (AzA) 15% gel. Subjects originally treated with IVM 1% continued on IVM 1% and those originally treated with vehicle switched to AzA 15% gel. IVM 1% cream was safe throughout the study with a lower incidence of related adverse events (AEs) compared to AzA 15% gel. No subjects in the IVM 1% cream group discontinued either study due to a related AE. IVM 1% also continued to be efficacious during the 40-week extension studies as the percentage of subjects with IGA scores of clear or almost clear was higher at the end of the study compared to baseline. The results of these 40-week extension studies support the use of IVM 1% cream as a long-term therapy for PPR as IVM 1% cream was shown to be safe and effective for up to 52 weeks of total treatment. PMID:25607706

  7. Vagus nerve stimulation for treatment of medically intractable seizures. Evaluation of long-term outcome

    Microsoft Academic Search

    Paolo Tanganelli; Sergio Ferrero; Patrizio Colotto; Giovanni Regesta

    2002-01-01

    Vagus nerve stimulation (VNS) constitutes an adjunctive, modern management of medically intractable seizures, especially when surgery is inadvisable. Objective: To evaluate the long-term results as regards efficacy, safety and tolerability of VNS in epileptic subjects, with focal and\\/or generalised seizures, refractory to old and new AEDs, without indication for resective surgery. Patients: 51 epileptic subjects (30 males, 21 females), aged

  8. Omeprazole: Long-Term Safety

    Microsoft Academic Search

    R. Arnold; H. Koop

    1989-01-01

    Based on the experience from more than 10,000 individuals omeprazole has been found to be safe and is well tolerated. Side effects are few and do not differ from those observed during H2-blocker treatment. Effects on endocrine cells observed in animals during toxicological studies include increase of antral G cells, decrease of antral D cells and increase of fundic ECL

  9. Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine

    Microsoft Academic Search

    Marian Apfelbaum; Philippe Vague; Olivier Ziegler; Corinne Hanotin; Florence Thomas; Eric Leutenegger

    1999-01-01

    BACKGROUND: Very-low-calorie diets are a well established method to achieve substantial short-term weight loss in obese patients, but long-term maintenance of the weight loss is very disappointing. A combined very-low-calorie diet and pharmacologic approach could be an effective means of prolonging its benefits.PATIENTS AND METHODS: Eligible patients had a body-mass index greater than 30 kg\\/m2; those who lost 6 kg

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

    PubMed

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

    2000-04-01

    In response to environmental concerns regarding chlorofluorocarbon (CFC), two new triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol) formulations have been developed using a more environmentally favorable propellant, HFA-134a (1,1,1,2-tetrafluoroethane). This multicenter, open-label study evaluated the safety of switching asthma patients from TAA-CFC to one of two TAA-HFA formulations. After a 2- or 4-week baseline period during which patients received only CFC-containing TAA Inhaler, 552 patients were randomized to receive TAA-HFA 75 or 225 microg for 6 or 12 months. A total of 493 patients completed treatment. Seven patients discontinued because of adverse events and two because of ineffective asthma control. The incidence of adverse events was similar in the two treatment groups, and most events were mild to moderate in severity and were not considered related to study medication. No clinically relevant suppression of the hypophyseal-pituitary-adrenal (HPA) axis was observed. Pulmonary function tests were not adversely affected by use of either study medication, and improvements were noted in forced expiratory volume in 1 sec (FEV1) and forced expiratory flow between 25% and 75% of forced vital capacity (FEF25%-75%) throughout the course of treatment. This study confirms that TAA-HFA provides effective, long-term asthma control and can safely be substituted for the currently marketed CFC-containing TAA product. PMID:10805203

  11. Comparison of antianginal efficacy of nifedipine and isosorbide dinitrate in chronic stable angina: a long-term, randomized, double-blind, crossover study

    SciTech Connect

    Liang, C.S.; Coplin, B.; Wellington, K.

    1985-05-17

    Using a double-blind, crossover design, the comparative efficacy and safety of nifedipine and isosorbide dinitrate in the treatment of stable angina were studied in 34 patients. The study included a 2-week placebo washout period and two 6-week periods during which patients were randomized to either nifedipine or isosorbide dinitrate. The doses were titrated for each patient, and mean doses of the 2 drugs were comparable. A time-limited thallium treadmill test was performed at the end of each phase. Ischemic zone count rates were normalized to those of the nonischemic zone, and the change in this ratio with redistribution was calculated as reversible thallium defect. Two patients were discontinued from the study within 1 week after initiation of isosorbide dinitrate because of severe, intolerable headache. Two patients were withdrawn while receiving nifedipine: one had new congestive heart failure and the other had increasing angina. Of the remaining 30 patients who tolerated both drugs for at least 1 week, 4 patients from the isosorbide dinitrate group were either prematurely crossed over or discontinued from the study because of headache. One patient suffered headache from both drugs and was discontinued from the study. In the 30 patients, only nifedipine significantly reduced resting arterial pressure compared with baseline. Further, only nifedipine therapy resulted in significant decreases in the rate-pressure product and systolic pressure at a given workload. However, significant decreases in angina frequency, nitroglycerin consumption and exercise-induced maximum ST-segment depression and reversible thallium perfusion defect were produced by both nifedipine and isosorbide dinitrate.

  12. Colistin: efficacy and safety in different populations.

    PubMed

    Shahbazi, Foroud; Dashti-Khavidaki, Simin

    2015-07-01

    This article reviews mechanisms, incidences, risk factors and preventive modalities of colistin toxicity as well as colistin use in special populations and through special routes. All clinical studies that examined the pharmacokinetic/pharmacodynamic, efficacy and side effects of colistin in the management of multidrug-resistant organisms in different patient population including pediatrics, adults, obese, critically ill, burn or cancer patients with any route of drug administration were considered. Compared with older recommended doses, current dosing approach improves cure rate without significant increase in the rate of colistin-induced nephrotoxicity. Efficacy and safety of high doses of colistin should be considered in the future studies. Also comparing efficacy and safety of different doses of aerosolized colistin and defining the appropriate dose in different populations is another open area of future researches. PMID:26041134

  13. Safety and Efficacy of Neonatal Vaccination

    PubMed Central

    Demirjian, Alicia; Levy, Ofer

    2009-01-01

    Newborns have an immature immune system that renders them at high risk for infection while simultaneously reducing responses to most vaccines, thereby posing challenges in protecting this vulnerable population. Nevertheless, certain vaccines, such as Bacillus Calmette Guérin (BCG) and Hepatitis B vaccine (HBV), do demonstrate safety and some efficacy at birth, providing proof of principal that certain antigen-adjuvant combinations are able to elicit protective neonatal responses. Moreover, birth is a major point of healthcare contact globally meaning that effective neonatal vaccines achieve high population penetration. Given the potentially significant benefit of vaccinating at birth, availability of a broader range of more effective neonatal vaccines is an unmet medical need and a public health priority. This review focuses on safety and efficacy of neonatal vaccination in humans as well as recent research employing novel approaches to enhance the efficacy of neonatal vaccination. PMID:19089811

  14. Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis‡

    PubMed Central

    Xue, Fei; Ma, Haijun; Stehman-Breen, Catherine; Haller, Christine; Katz, Leonid; Wagman, Rachel B; Critchlow, Cathy W; Denosumab Global Safety Assessment Team

    2013-01-01

    Purpose To describe the rationale and methods for a prospective, open-cohort study assessing the long-term safety of Prolia® for treatment of postmenopausal osteoporosis (PMO) in postmarketing settings. Methods Data will be derived from United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) national registries. Observation will begin on the date of first Prolia® regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic fracture, or osteoporosis treatment. Exposure to Prolia® and bisphosphonates will be updated during follow-up; exposure cohorts will be defined based on patient-years during which patients are on- or post-treatment. Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy. Medical review will confirm selected potential cases of ONJ and AFF. Incidence rates (IRs) of AEs will be described overall and for exposure cohorts; multivariate Cox proportional hazard regression models will compare IRs of AEs across exposure cohorts. Utilization patterns of Prolia® for approved, and unapproved indications will be described. Conclusion This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population. The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time. © 2013 Amgen Inc. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:23857864

  15. Short-Term and Long-Term Safety of Deep Brain Stimulation In the Treatment of Movement Disorders C. Kenney, MD, R. Simpson, MD, PhD, C. Hunter, RN, W. Ondo, MD,

    E-print Network

    Lichtarge, Olivier

    adverse events (AEs). RESULTS: A total of 319 patients underwent DBS implantation at our center, 182 College of Medicine, Houston, Texas AABSTRACTBSTRACT OBJECTIVE: To assess the long term safety of deep brain stimulation (DBS) in a large population of patients with a variety of movement disorders. METHODS

  16. 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 significantly greater in the SOC group at 24-week endpoint (P?=?.004). LY2140023 and SOC groups had comparable negative symptom improvement at 24-week endpoint (P?=?.444). Conclusion These data provide further evidence that the potential antipsychotic LY2140023 monohydrate, with a glutamatergic mechanism of action, may have a unique tolerability profile characterized by a low association with some adverse events such as extrapyramidal symptoms and weight gain that may characterize currently available dopaminergic antipsychotics. Trials registration A Long-term, Phase 2, Multicenter, Randomized, Open-label, Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients with DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier: NCT00845026. PMID:23694720

  17. Long-term conditions.

    PubMed

    2015-03-25

    Technology enabled care services (TECS), which include technologies such as telehealth, telecare, telemedicine and self-care apps, are designed to help people manage long-term conditions and retain as much independence as possible. The NHS Commissioning Assembly has published TECS Resource for Commissioners, a toolkit that raises awareness of the range of TECS available and their benefits to patients and professionals, supports commissioners to collaborate with providers to implement TECS, and advises how to create a TECS strategy, oversee implementation plans and ensure effective evaluation. The publication is at tinyurl.com/khsebyr. PMID:25806457

  18. Chronic Atrioventricular Nodal Vagal Stimulation First Evidence for Long-Term Ventricular Rate Control in Canine Atrial Fibrillation Model

    Microsoft Academic Search

    Youhua Zhang; Hirotsugu Yamada; Steve Bibevski; Shaowei Zhuang; Kent A. Mowrey; Don W. Wallick; Seil Oh; Todor N. Mazgalev

    2010-01-01

    Background—We have previously demonstrated that selective atrioventricular nodal (AVN) vagal stimulation (AVN-VS) can be used to control ventricular rate during atrial fibrillation (AF) in acute experiments. However, it is not known whether this approach could provide a long-term treatment in conscious animals. Thus, this study reports the first observations on the long-term efficacy and safety of this novel approach to

  19. Efficacy, safety and pharmacokinetics of bosentan in portopulmonary hypertension.

    PubMed

    Savale, Laurent; Magnier, Romain; Le Pavec, Jérôme; Jaïs, Xavier; Montani, David; O'Callaghan, Dermot S; Humbert, Marc; Dingemanse, Jasper; Simonneau, Gérald; Sitbon, Olivier

    2013-01-01

    Data on treatment of patients with portopulmonary hypertension (PoPH) are limited, as they are usually excluded from randomised controlled trials with pulmonary arterial hypertension (PAH)-specific therapies. This study investigated the short- and long-term efficacy/safety of bosentan in these patients, as well as its pharmacokinetics. All 34 consecutive patients with PoPH treated with first-line bosentan (December 2002 to July 2009) were retrospectively evaluated. Assessments included the New York Heart Association functional class (NYHA FC), blood tests, haemodynamics, 6-min walk distance (6MWD) and event-free status. The pharmacokinetics of bosentan in five patients with Child-Pugh (C-P) class B cirrhosis were compared with idiopathic PAH patients. Significant improvements from baseline were observed in NYHA FC, 6 MWD and haemodynamics, and were largely maintained during follow-up. Patients with C-P class B cirrhosis (n=9) had significantly larger haemodynamic improvement after mean ± SD 5 ± 2 months. Mean follow-up time was 43 ± 19 months; four patients died and seven patients had significant elevation of liver enzymes (annual rate 5.5%). Plasma concentrations of bosentan were higher in patients with C-P class B cirrhosis than those observed in idiopathic PAH. These data confirm the benefit of bosentan treatment for patients with PoPH. Haemodynamic improvements were particularly pronounced in patients with more severe cirrhosis. The safety profile of bosentan was consistent with previous studies. PMID:22653773

  20. Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial.

    PubMed

    Maldonado-Lobón, J A; Gil-Campos, M; Maldonado, J; López-Huertas, E; Flores-Rojas, K; Valero, A D; Rodríguez-Benítez, M V; Bañuelos, O; Lara-Villoslada, F; Fonollá, J; Olivares, M

    2015-01-01

    Lactobacillus fermentum CECT5716 is a probiotic strain originally isolated from human breast milk. Previous clinical studies in infants showed that the early administration of a milk formula containing this probiotic strain was safe and may be useful for the prevention of community-acquired infections. This is a 3-year follow-up study aimed at evaluating the long-term effects produced by the early consumption of an infant formula supplemented with L. fermentum CECT5716 (experimental group, EG) compared with a control formula without the probiotic (control group, CG). The infants included in this follow-up study had previously completed a 5-month randomized double-blind controlled trial (from 1 to 6 months of age), where the safety and tolerance of the probiotic formula was evaluated. The main outcome of the follow-up study was the growth of the children. The secondary outcomes included the incidence of infectious and non-infectious diseases, parameters related with intestinal function and faecal microbiota. At 3 years, the mean values of weight, length and head circumference were similar in children of the EG compared with those of the CG. No differences were observed in the incidence of infectious and non-infectious diseases or disorders related with intestinal function. The pattern of faecal microbiota was also similar between both groups. In conclusion, this 3-year study shows that the early administration of the probiotic of L. fermentum CECT5716 in an infant formula is safe and it does not produce measurable differences in children compared with a control formula. PMID:25697549

  1. Long-Term Oxygen Therapy in Ioannina

    Microsoft Academic Search

    Stamatis Katsenos; Marios E. Froudarakis; Alexandros Charisis; Miltiadis P. Vassiliou; Stavros H. Constantopoulos

    2004-01-01

    Background: Long-term oxygen treatment (LTOT) is very important, especially in patients with severe chronic obstructive pulmonary disease (COPD), but its efficacy is closely related to patient compliance. Objectives: The aim of the present study was to investigate the compliance of patients under LTOT in the Prefecture of Ioannina (north-western Greece) and to identify factors that might be involved. Methods: The

  2. Long-term efficacy of an imidacloprid 10 % / flumethrin 4.5 % polymer matrix collar (Seresto®, Bayer) against the Australian paralysis tick (Ixodes holocyclus) in dogs.

    PubMed

    Smith, Warwick M; Ahlstrom, Liisa A; Rees, Robert

    2013-08-01

    Two placebo-controlled pen studies were conducted to assess the efficacy of an imidacloprid 10 %/flumethrin 4.5 % polymer matrix collar (Seresto®, Bayer; Investigational Veterinary Product (IVP)) against the Australian paralysis tick (Ixodes holocyclus). Dogs assigned to the placebo (n = 8) or IVP (n ? 8) groups had collars (placebo or IVP) attached on Day 0 and were infested with 30 unfed, adult, female I. holocyclus at 14–28 day intervals over 227 days. Ticks were counted 24, 48 and 72 h post infestation to determine the acaricidal efficacy of the IVP. The acaricidal efficacy of the IVP 72 h post infestation exceeded 95 % on Days 17 (99.3 %), 59 (99.7 %), 73 (96.6 %), 87 (100.0 %), 101 (96.4 %), 115 (99.1 %) and 171 (95.8 %), but dropped on Days 45 (94.0 %) and 143 (77.8 %), and declined from Day 199 (79.9 %) to 227 (65.5 %). No adverse events related to treatment were observed. This study has demonstrated the excellent acaricidal efficacy (97.9 %) of the IVP collar against I. holocyclus 72 h post infestation over 16 weeks. PMID:23760870

  3. Perfusion SPECT Changes After Acute and Chronic Vagus Nerve Stimulation in Relation to Prestimulus Condition and Long-Term Clinical Efficacy

    Microsoft Academic Search

    Koenraad Van Laere; Kristl Vonck; Paul Boon; Jan Versijpt; Rudi Dierckx

    Left-sided vagus nerve stimulation (VNS) is an efficacious treat- ment for patients with refractory epilepsy. Previous studies have implicated thalamic and mesial temporal involvement in acute stimulation. In this study, acute and chronic effects of VNS in patients with refractory complex partial seizures with or without secondary generalization (CPS SG) were evaluated with re- spect to the prestimulus condition and

  4. Short and long-term ground-contact decay efficacies of three copper-organic systems and possible implications for standardization criteria for copper-based systems

    Microsoft Academic Search

    Darrel D. NicholasS

    The major wood preservative systems for residential applications in North America are the second-generation copper- organic systems, which contain relatively high levels of copper and an organic cobiocide to control copper-tolerant fungi. The objective of this paper is to address concerns about the standardization criteria for new or modified systems including the relevance of laboratory efficacy data, field testing duration,

  5. Examining the efficacy, safety, and patient acceptability of the combined contraceptive vaginal ring (NuvaRing®)

    PubMed Central

    Wieder, Devorah R; Pattimakiel, Lynn

    2010-01-01

    The contraceptive vaginal ring is a novel contraceptive method that offers unique advantages. Intravaginal delivery of both estrogen and progesterone allows continuous release of medication, resulting in lower systemic levels. The use of long-term combined hormonal contraception enables improved cycle control compared with progesterone-only methods. The indications and usage of the NuvaRing® are described along with the efficacy, tolerability, and safety. Overall, the contraceptive vaginal ring appears to be very effective, with a favorable side-effect profile, and is highly acceptable to most patients. PMID:21151688

  6. Herbal ephedra\\/caffeine for weight loss: a 6-month randomized safety and efficacy trial

    Microsoft Academic Search

    CN Boozer; PA Daly; P Homel; JL Solomon; D Blanchard; JA Nasser; R Strauss; T Meredith

    2002-01-01

    Objective: To examine long-term safety and efficacy for weight loss of an herbal Ma Huang and Kola nut supplement (90\\/192 mg\\/day ephedrine alkaloids\\/caffeine).Design: Six-month randomized, double-blind placebo controlled trial.Subjects: A total of 167 subjects (body mass index (BMI) 31.8±4.1 kg\\/m2) randomized to placebo (n=84) or herbal treatment (n=83) at two outpatient weight control research units.Measurements: Primary outcome measurements were changes

  7. A review of sunscreen safety and efficacy.

    PubMed

    Gasparro, F P; Mitchnick, M; Nash, J F

    1998-09-01

    The use of sunscreen products has been advocated by many health care practitioners as a means to reduce skin damage produced by ultraviolet radiation (UVR) from sunlight. There is a need to better understand the efficacy and safety of sunscreen products given this ongoing campaign encouraging their use. The approach used to establish sunscreen efficacy, sun protection factor (SPF), is a useful assessment of primarily UVB (290-320 nm) filters. The SPF test, however, does not adequately assess the complete photoprotective profile of sunscreens specifically against long wavelength UVAI (340-400 nm). Moreover, to date, there is no singular, agreed upon method for evaluating UVA efficacy despite the immediate and seemingly urgent consumer need to develop sunscreen products that provide broad-spectrum UVB and UVA photoprotection. With regard to the safety of UVB and UVA filters, the current list of commonly used organic and inorganic sunscreens has favorable toxicological profiles based on acute, subchronic and chronic animal or human studies. Further, in most studies, sunscreens have been shown to prevent the damaging effects of UVR exposure. Thus, based on this review of currently available data, it is concluded that sunscreen ingredients or products do not pose a human health concern. Further, the regular use of appropriate broad-spectrum sunscreen products could have a significant and favorable impact on public health as part of an overall strategy to reduce UVR exposure. PMID:9747581

  8. Assessing the Long-Term Impact of Treating Hepatitis C Virus (HCV)-Infected People Who Inject Drugs in the UK and the Relationship between Treatment Uptake and Efficacy on Future Infections

    PubMed Central

    Bennett, Hayley; McEwan, Phil; Sugrue, Daniel; Kalsekar, Anupama; Yuan, Yong

    2015-01-01

    Objective The prevalence of the hepatitis C virus (HCV) remains high amongst people who inject drugs (PWID) and accounts for the majority of newly acquired infections. This study aims to quantify the value of treatment amongst PWID with more efficacious treatments and at increased uptake rates, with respect to the avoidance of future infections and subsequent long-term complications of HCV. Methods A dynamic HCV transmission and disease progression model was developed, incorporating acute and chronic infection and their long-term complications (decompensated cirrhosis, cancer, liver transplant and mortality), with the potential for HCV transmission to other PWID prior to successful treatment. The model was populated with prevalence and therapy data from a UK setting. Scenarios of current standard of care (SoC) treatment efficacy and uptake were compared to anticipated sustained virologic response (SVR) rates of 90–100% and increased uptake over varied horizons. Results SoC led to modest reductions in prevalence; >5% after 200 years. New treatments achieving 90% SVR could reduce prevalence below 5% within 60 years at current uptake rates or within 5 years if all patients are treated. Amongst 4,240 PWID, chronic HCV infections avoided as a result of increasing treatment uptake over the period 2015–2027 ranged from 20–580 and 34–912 with SoC and 90% SVR rates respectively. The reduction in downstream HCV infections due to increasing treatment uptake resulted in an approximate discounted gain of 300 life-years (from avoiding reduced life expectancy from HCV infection) and a gain of 1,700 QALYs (from avoiding the disutility of HCV infection and related complications), with a projected £5.4 million cost saving. Conclusion While improved SVR profiles led to reductions in modelled prevalence, increased treatment uptake was the key driver of future infections avoided. Increased treatment among PWID with new more efficacious therapies could significantly change the future dynamics, cost and health burden of HCV-related disease. PMID:25938458

  9. Tolerability and efficacy of long-term treatment with daptomycin, ceftazidime and colistin in a patient with a polymicrobial, multidrug-resistant prosthetic joint reinfection: a case report

    PubMed Central

    2014-01-01

    Introduction Prosthetic joint infections are severe complications of joint implants. Further complications arise when polymicrobial and/or multidrug-resistant microorganisms are involved. Currently, there are limited data on the management of these infections and on the tolerability of long-term treatment with daptomycin, ceftazidime and colistin. Case presentation A 55-year-old Caucasian woman who had a right hip prosthesis removed 1 year prior because of infection was admitted for prosthesis reimplantation. On admission at our hospital, anamnesis regarding etiology and management of prosthesis infection was not available. On clinical, laboratory findings and imaging studies infection was not suspected. A hip prosthesis was reimplanted. At surgery, histopathological and microbiological investigations were not taken. Three weeks after reimplantation, surgical site infection due to Enterobacter cloacae was diagnosed and oral ciprofloxacin was prescribed. Four days later, a periprosthesis fluid collection was evidenced and a percutaneous needle aspirate grew Staphylococcus epidermidis and S. haemolyticus. Enterobacter genome was also detected from the same sample. Teicoplanin and meropenem were added to ciprofloxacin without clinical improvement. Moreover, acetabular cup dislocation was documented. She underwent prosthesis explantation, debridement, and positioning of an antimicrobial mixed spacer. From the intraoperatory cultures S. epidermidis and Acinetobacter baumannii were grown. Daptomycin, ceftazidime, colistin and rifampin were administered. Four days later, rifampin was stopped due to a suspected liver toxicity. While undergoing therapy she presented recurrent episodes of wound dehiscence and on the 22nd week of treatment a further surgical debridement was performed, upon which the spacer was removed. At this time, intraoperative cultures resulted negative. Three months later, after a total of 8 months, antimicrobials were interrupted. Subsequently, a femoral transcondylar traction was positioned, and 3 weeks later a new prosthesis was reimplanted. At over 1 year after reimplantation she is well. Conclusions Our findings suggest that microbiologic investigations are mandatory even when prosthetic joint infection is not suspected. Molecular methods for identification of microorganisms can be used in addition to conventional cultures especially when patients are under antibiotic treatment. Daptomycin, ceftazidime and colistin can be administered for several months without side effects. Guidelines specifically addressing the diagnosis and the management of polymicrobial, multidrug-resistant prosthetic joint infections need to be developed. PMID:24923703

  10. Effectiveness and Safety of Spot Scanning Proton Radiation Therapy for Chordomas and Chondrosarcomas of the Skull Base: First Long-Term Report

    SciTech Connect

    Ares, Carmen, E-mail: carmen.ares@psi.c [Center for Proton Radiation Therapy, Paul Scherrer Institute, Villigen (Switzerland); Hug, Eugen B.; Lomax, Antony J.; Bolsi, Alessandra; Timmermann, Beate; Rutz, Hans Peter [Center for Proton Radiation Therapy, Paul Scherrer Institute, Villigen (Switzerland); Schuller, Jan C. [Statistics Department, Swiss Group for Clinical Cancer Research, Bern (Switzerland); Pedroni, Eros; Goitein, Gudrun [Center for Proton Radiation Therapy, Paul Scherrer Institute, Villigen (Switzerland)

    2009-11-15

    Purpose: To evaluate effectiveness and safety of spot-scanning-based proton radiotherapy (PT) in skull-base chordomas and chondrosarcomas. Methods and Materials: Between October 1998 and November 2005, 64 patients with skull-base chordomas (n = 42) and chondrosarcomas (n = 22) were treated at Paul Scherrer Institute with PT using spot-scanning technique. Median total dose for chordomas was 73.5 Gy(RBE) and 68.4 Gy(RBE) for chondrosarcomas at 1.8-2.0 Gy(RBE) dose per fraction. Local control (LC), disease specific survival (DSS), and overall survival (OS) rates were calculated. Toxicity was assessed according to CTCAE, v. 3.0. Results: Mean follow-up period was 38 months (range, 14-92 months). Five patients with chordoma and one patient with chondrosarcoma experienced local recurrence. Actuarial 5-year LC rates were 81% for chordomas and 94% for chondrosarcomas. Brainstem compression at the time of PT (p = 0.007) and gross tumor volume >25 mL (p = 0.03) were associated with lower LC rates. Five years rates of DSS and OS were 81% and 62% for chordomas and 100% and 91% for chondrosarcomas, respectively. High-grade late toxicity consisted of one patient with Grade 3 and one patient with Grade 4 unilateral optic neuropathy, and two patients with Grade 3 central nervous system necrosis. No patient experienced brainstem toxicity. Actuarial 5-year freedom from high-grade toxicity was 94%. Conclusions: Our data indicate safety and efficacy of spot-scanning based PT for skull-base chordomas and chondrosarcomas. With target definition, dose prescription and normal organ tolerance levels similar to passive-scattering based PT series, complication-free, tumor control and survival rates are at present comparable.

  11. Long-term symbolic learning

    Microsoft Academic Search

    William G. Kennedy; J. Gregory Trafton

    2007-01-01

    What are the characteristics of long-term learning? We investigated the characteristics of long-term, symbolic learning using the Soar and ACT-R cognitive architectures running cognitive models of two simple tasks. Long sequences of problems were run collecting data to answer fundamental questions about long-term, symbolic learning. We examined whether symbolic learning continues indefinitely, how the learned knowledge is used, and whether

  12. Long-term efficacy of low-dose all-trans retinoic acid plus minimal chemotherapy induction followed by the addition of intravenous arsenic trioxide post-remission therapy in newly diagnosed acute promyelocytic leukaemia.

    PubMed

    Lou, Yinjun; Qian, Wenbin; Meng, Haitao; Mai, Wenyuan; Tong, Hongyan; Tong, Yin; Huang, Jian; Jin, Jie

    2014-03-01

    We evaluated the efficacy of low-dose all-trans retinoic acid (ATRA) plus minimal chemotherapy for induction in newly diagnosed acute promyelocytic leukaemia (APL). Furthermore, we compared its long-term outcome with or without the addition of intravenous arsenic trioxide (ATO) in post-remission therapy. From January 2004 to September 2011, a total of 109 patients with a median age of 41?years (range 14-73) were enrolled in the study. Two arms were assigned according to post-remission protocols: ATO group cases were subsequently treated with intravenous ATO, standard chemotherapy, and ATRA. No-ATO group cases were subsequently treated with chemotherapy and ATRA only. Patients were monitored of minimal residual disease (MRD) by reverse-transcriptase polymerase chain reaction. The haematologic complete remission (CR) rate was 96.3%. The early death rate was 0.9%. At a median follow-up of 49?months (range 8-102?months), the Kaplan-Meier estimates of 5-year relapse-free survival were significantly better for patients in the ATO group than in the no-ATO group, 94.4% vs 54.8% (p?=?0.0001), and the 5-year overall survival rate was 95.7% vs 64.1%, in the two groups (p?=?0.003). Our data show that low-dose ATRA plus minimal chemotherapy exhibits efficacy in induction therapy for untreated APL and suggest that the addition of ATO to post-remission therapy significantly improves the long-term outcome. PMID:23963734

  13. [Human papillomavirus vaccine. Efficacy and safety].

    PubMed

    Bruni, Laia; Serrano, Beatriz; Bosch, Xavier; Castellsagué, Xavier

    2015-05-01

    Human papillomavirus (HPV) related disease remains a major cause of morbidity and mortality worldwide. Prophylactic vaccines have been recognized as the most effective intervention to control for HPV-related diseases. This article reviews the major phaseii/iii trials of the bivalent (HPVs16/18), quadrivalent (HPVs6/11/16/18), and the recently approved 9-valent vaccine (HPVs6/11/16/18/31/33/45/52/58). Large trials have been conducted showing the safety, immunogenicity and high efficacy of the bivalent and quadrivalent vaccines in the prevention of pre-invasive lesions and infection, especially when administered at young ages before exposure to HPV. Trials of the 9-valent vaccine have also demonstrated the safety, immunogenicity and efficacy of the vaccine in the prevention of infection and disease associated with the vaccine types, and its potential to substantially increase the overall prevention of HPV-related diseases. Post-licensure country reports have shown the recent and early impact of these vaccines at population level after the implementation of established HPV vaccination programs, including decreases in the prevalence of vaccine HPV types, the incidence of genital warts, and the incidence of high-grade cervical abnormalities. If widely implemented, current HPV vaccines may drastically reduce the incidence of cervical cancer and other HPV-related cancers and diseases. PMID:25937455

  14. [Generic drugs: quality, efficacy, safety and interchangeability].

    PubMed

    Tschabitscher, Doris; Platzer, Peter; Baumgärtel, Christoph; Müllner, Marcus

    2008-01-01

    Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high quality. There is some uncertainty about whether evidence of bioequivalence is enough to guarantee efficacy and safety of generic drugs. Some physicians ask the question if competent authorities are able to ascertain that the pharmaceutical quality of generics is acceptable. Doctors and patients sometimes are ill at ease about the interchangeability of innovator and generic products. This article describes how the European Union legislation ensures that a generic drug is only approved if its risk-benefit relationship is favourable and that it is essentially similar to the innovator product. In this context pharmacokinetic parameters are accepted as surrogates for clinical results because bioequivalence means therapeutic equivalence as well. For most drugs, current bioequivalence testing generally enables clinicians to routinely substitute generic for innovator products. Published findings, however, suggest that particular drugs may not be ideally suited for generic substitution when a patient is already on that drug. These are the so called critical dose medicinal products (drugs with a narrow therapeutic range). When starting a new therapy with any generic drug, however, its similarity to the innovator drug in terms of efficacy, safety and quality is guaranteed. PMID:18322766

  15. Long-term safety of anti-TNF-? in PsA patients with concomitant HCV infection: a retrospective observational multicenter study on 15 patients.

    PubMed

    Costa, Luisa; Caso, Francesco; Atteno, Mariangela; Giannitti, Chiara; Spadaro, Antonio; Ramonda, Roberta; Vezzù, Maristella; Del Puente, Antonio; Morisco, Filomena; Fiocco, Ugo; Galeazzi, Mauro; Punzi, Leonardo; Scarpa, Raffaele

    2014-02-01

    Psoriatic arthritis (PsA) is an inflammatory arthropathy associated with skin and/or nail psoriasis. TNF-?, in addition to its pro-inflammatory role, is an essential cytokine for the host's defense, and its depletion by treatment may facilitate the risk of viral infections or their reactivation. The aim of this study was to evaluate the efficacy and safety of TNF-? blockers in PsA patients with concurrent hepatitis C virus (HCV) infection. This is a multicenter study carried out in four Italian centers specialized in the diagnosis and treatment of PsA. At baseline and after 6 (T6) and 12 months (T12) of therapy, data concerning PsA activity and liver tests were registered. A total of 15 PsA patients with concomitant HCV infection were included in the study. At baseline, 13 patients had low viral load, and liver enzyme tests were within the normal range. During the observation period, these values remained stable. On the other hand, at baseline, a high viral load with slightly increased values of AST and ALT was detected in one patient. At T6 and T12, these values decreased. The remaining patient, at baseline, had low viral load, but with slightly increased AST and ALT values that normalized during the observation period. This is the greatest sample size available in the literature on this topic. The data suggests that anti-TNF-? agents are effective and safe in PsA patients with concomitant HCV. We suggest that the use of anti-TNF-? agents, accompanied by close monitoring, could be a therapeutic option. PMID:23975363

  16. Is Early Nutrition Related to Short-Term Health and Long-Term Outcome?

    Microsoft Academic Search

    Hania Szajewska; Maria Makrides

    2011-01-01

    This paper summarizes the literature concerning the effects of administering (1) long-chain polyunsaturated fatty acids (LCPUFA), (2) probiotics and\\/or (3) prebiotics to preterm infants. Clinically relevant, short- and long-term efficacy outcomes, such as those related to a reduced risk of disease, as well as outcomes related to safety, were sought. MEDLINE and the Cochrane Library literature searches performed in September

  17. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease

    Microsoft Academic Search

    R. Casaburi; D. A. Mahler; P. W. Jones; A. Wannerz; G. San Pedro; S. S. Menjoge; C. W. Serby; T. Witek Jr

    2002-01-01

    Currently available inhaled bronchodilators used as therapy for chronic obstructive pulmonary disease (COPD) necessitate multiple daily dosing. The present study evaluates the long-term safety and efficacy of tiotropium, a new once-daily anticholinergic in COPD. Patients with stable COPD (age 65.2¡8.7 yrs (mean¡SD), n=921) were enrolled in two identical randomized double-blind placebo-controlled 1-yr studies. Patients inhaled tiotropium 18 mg or placebo

  18. Long-term antiviral efficacy of entecavir and liver histology improvement in Chinese patients with hepatitis B virus-related cirrhosis

    PubMed Central

    Xu, Yan; Zhang, Yong-Gui; Wang, Xu; Qi, Wen-Qian; Qin, Shao-You; Liu, Zhen-Hua; Jiao, Jian; Wang, Jiang-Bin

    2015-01-01

    AIM: To evaluate the clinical outcomes of 240-wk treatment with entecavir (0.5 mg) in Chinese nucleoside-naive patients with cirrhosis. METHODS: A total of 204 nucleoside-naive patients with compensated (n = 96) or decompensated (n = 108) hepatitis B virus (HBV)-induced cirrhosis at the Department of Gastroenterology of the China-Japan Union Hospital (Jilin University, Changchun, China) who were treated with entecavir (0.5 mg) for 240 wk were enrolled in this study. Liver biopsy samples obtained from 38 patients prior to treatment (baseline) and at week 240 were evaluated by different independent histopathologists. Efficacy assessments included the proportions of patients who achieved an HBV DNA level < 500 copies/mL, the association of interleukin-28B genetic variation with antivirus therapy, clinical outcomes, and histologic improvement. Changes in liver disease severity were analyzed, and liver histologic evaluation was performed in 38 patients with paired biopsies. Student t tests were used to compare the means of continuous variables between the groups, and the proportions of patients who achieved the endpoints were compared using the ?2 test. RESULTS: At week 240, 87.5% of the patients with compensated cirrhosis and 92.6% of the patients with decompensated cirrhosis achieved a HBV DNA level < 500 copies/mL. Three patients had genotypic entecavir resistance within the 240-wk period. No significant association was observed between virologic response and interleukin-28 genotype (CT, 88.2% vs CC, 90.6%). The proportion of patients with Child-Pugh class A disease was significantly increased at week 240 (68%) from the baseline (47%; P < 0.01). The proportion of patients with Child-Pugh class B disease was significantly decreased at week 240 (25%) from the baseline (39%; P = 0.02). In the patients with paired liver biopsies, the mean reduction in the Knodell necroinflammatory score from the baseline was 3.58 ± 1.03 points (7.11 ± 1.80 vs 3.53 ± 1.35, P < 0.01). The mean reduction in Ishak fibrosis score from the baseline was 1.26 ± 0.64 points (5.58 ± 0.50 vs 4.32 ± 0.81, P < 0.01). CONCLUSION: Entecavir is an effective treatment option for patients with HBV-related compensated or decompensated cirrhosis that can result in sustained virologic suppression and histologic improvement.

  19. 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

    2015-05-01

    Worldwide, viral hepatitis continues to be a cause of considerable morbidity and mortality. Mass immunization with a single dose of live attenuated HAV has been shown to significantly reduce disease burden in the community. This was a phase IV, 5-year follow up study carried out at 4 centers (Kolkata, Delhi, Mumbai and Chennai) across India. The subjects with antibody titer <20 mIU/mL at baseline were evaluated for long term immunogenicity. Of the 503 subjects enrolled, 349 subjects were baseline seronegative with an anti-HAV antibody titer <20 mIU/mL. Overall, 343 subjects could be followed up at some point of time during this 5 y post vaccination period. In the last year (60 months) of follow-up, 108 subjects (97.3%) of 111 subjects (who came for follow-up at the end of 5 y) had a protective antibody titer (anti-HAV antibody titer >20 mIU/mL). The seroconversion rates considering seroprotection levels of anti-HAV antibody titer >20 mIU/mL, following vaccination starting from 6 weeks, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months were 95.1%, 97.9%, 98.3%, 96.2%, 97.8%, 92.6% and 97.3%, respectively. The geometric mean concentration (GMC) over the years increased from 64.9 mIU/mL at 6 weeks to 38.1 mIU/mL and 135.2 mIU/mL at 6 months and 12 months, respectively and was maintained at 127.1 mIU/mL at 60 months. In conclusion, the result of this 5-year follow up study showed that the single dose of live attenuated vaccine is well tolerated and provides long-term immunogenicity in healthy Indian children. PMID:26018443

  20. Glossary (Long-Term Care)

    MedlinePLUS

    ... not as intensive as care offered at a nursing home. Types and sizes of facilities vary, ranging from ... a cognitive impairment. Community Spouse Spouse of a nursing home resident applying for or receiving Medicaid long-term ...

  1. Safety and Efficacy of Sacrospinous Vault Suspension

    Microsoft Academic Search

    D. Lovatsis; H. P. Drutz

    2002-01-01

    :   The objective of the study was to determine the success rate and complications of sacrospinous vault suspension when performed\\u000a by an experienced surgeon. Retrospective data collection was performed for 293 women who had undergone sacrospinous vault\\u000a suspension at Mount Sinai Hospital, Toronto, between November 1993 and 19 December 1998. Primary outcome measures were complication\\u000a rates (acute and long term)

  2. Feasibility and Safety of Laparoscopic Surgery for Obese Korean Women with Endometrial Cancer: Long-Term Results at a Single Institution

    PubMed Central

    Lee, Shin-Wha; Kim, Jong-Hyeok; Kim, Yong-Man; Kim, Young-Tak; Nam, Joo-Hyun

    2014-01-01

    The purpose of this study was to evaluate the surgical feasibility of and survival outcome after laparoscopy in obese Korean women with endometrial cancer which has recently been increasing. We reviewed the medical records of the patients treated at our medical institution between 1999 and 2012. The patients were divided into three groups, non-obese (Body Mass Index [BMI]<25.0), overweight (BMI 25-27.99), and obese (BMI?28.0). These patient groups were compared in terms of their clinical characteristics, treatment methods, as well as surgical and survival outcomes. In total, 55 of the 278 eligible patients were obese women. There were no differences in the three groups in terms of the proportion of patients who underwent lymphadenectomy, their cancer stage, histologic type, type of adjuvant treatment administered, intra-, post-operative, and long-term complications, operative time, number of removed lymph nodes, blood loss, and duration of hospitalization (P=0.067, 0.435, 0.757, 0.739, 0.458, 0.173, 0.076, 0.124, 0.770, 0.739, and 0.831, respectively). The Disease-Free Survival (DFS) times were 139.1 vs. 121.6 vs. 135.5 months (P=0.313), and the Overall Survival (OS) times were 145.2 vs. 124.8 vs. 139.5 months (P=0.436) for each group, respectively. Obese women with endometrial cancer can, therefore, be as safely managed using laparoscopy as women with normal BMIs. PMID:25408586

  3. Efficacy and safety of Echinaforce® in respiratory tract infections.

    PubMed

    Schapowal, Andreas

    2013-02-01

    Echinaforce® is the standardised extract of Echinacea purpurea from Bioforce, Switzerland. Recent studies show immunomodulation and broad antiviral effects against respiratory tract viruses. Haemagglutinin and Neuraminidase are blocked. In contrast to Oseltamivir no resistance is caused by Echinaforce®. A randomised, double-blind, placebo-controlled study over four months confirms that Echinaforce® supports the immune resistance and acts directly against a series of viruses. Echinaforce® is efficacious and safe in respiratory tract infections for long-term and short-term prevention as well as for acute treatment. PMID:23263637

  4. Efficacy and safety of bevacizumab in glioblastomas.

    PubMed

    De Fazio, S; Russo, E; Ammendola, M; Donato Di Paola, E; De Sarro, G

    2012-01-01

    Glioblastoma multiforme (GBM) is a common and malignant primary brain tumor arising from glial precursors the survival of which is estimated to be about 14 months after diagnosis despite current standard care with radiotherapy, surgery, and chemotherapies. Therapeutic approaches were greatly improved in the last years; however, GBM still represents the most lethal subtype of glioma. Actually, it has been estimated that only about 3.4% of patients will survive at the most five years when obtaining the best outcome from treatment; however, this depends on tumor resistance, which is generally related to repairing radiation injury, and self- improving cell growth repair and survival. All GBMs recur after initial therapy, limiting patients ? survival at 20-25% within 1 year after diagnosis of recurrent disease. Moreover, for recurrent GBM response rates are less than 10% (ranging from 5% to 9%), and progression free survival at 6-month (PFS-6) rates ranges between 9% and 28% (median 15%). The development of targeted therapy based on tumor vascular blockade led to the approval of bevacizumab for recurrent or progressive glioblastoma, since it was proven that this offers a new opportunity for patients suffering from this malignancy. Bevacizumab is a recombinant antivascular monoclonal antibody binding to circulating Vascular Endothelial Growth Factor (VEGF) preventing this cytokine from reaching its receptors (VEGFR1 and VEGFR2) on endothelium, resulting in an inhibition of cells proliferation and vessels sprouting. The aim of this review is to address bevacizumab mode of action in malignant gliomas and provide a summary on currently available data on efficacy and safety. PMID:22214463

  5. ? Carinae long-term variability

    NASA Astrophysics Data System (ADS)

    Damineli, Augusto; Teodoro, Mairan; Corcoran, Michael F.; Groh, Jose H.

    2011-07-01

    We present preliminary results of our analysis on the long-term variations observed in the optical spectrum of the LBV star ? Carinae. Based on the hydrogen line profiles, we conclude that the physical parameters of the primary star did not change in the last 15 years.

  6. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme

    PubMed Central

    Angelo, Maria-Genalin; David, Marie-Pierre; Zima, Julia; Baril, Laurence; Dubin, Gary; Arellano, Felix; Struyf, Frank

    2014-01-01

    Purpose The purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies. Methods Unsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies. Results Thirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0–113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups. Conclusions Analysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women. PMID:24644063

  7. Malaria prophylaxis for long-term travellers.

    PubMed

    Hughes, C; Tucker, R; Bannister, B; Bradley, D J

    2003-09-01

    These guidelines are designed to assist healthcare workers who are advising long-term travellers on malaria prophylaxis, defined for the purpose of this document as those travelling for longer than 6 months. The document focuses on long-term use of antimalarials for adults, but also identifies specific issues for women and children. However, data on the long-term use of antimalarials is limited for all travellers and few data are available on the incidence of malaria in travellers overseas or, indeed, deaths overseas from malaria. Whilst all available evidence is taken into account, the advice provided also reflects experienced professional opinion. This document has been written on behalf of the Health Protection Agency's Advisory Committee on Malaria Prevention for UK Travellers, and is designed to act as a supplement to the 'Guidelines for malaria prevention in travellers from the United Kingdom for 2003'. The latter document contains a more complete description of antimalarials and additional preventive measures, together with recommendations for malaria chemoprophylaxis for individuals countries. Decisions on the terms under which different drugs are licensed for use are the responsibility of the Committee on Safety of Medicines. This paper should also, therefore, be used in conjunction with Summary of Product Characteristics (data sheets). PMID:14708269

  8. Long-term data archiving

    SciTech Connect

    Moore, David Steven [Los Alamos National Laboratory

    2009-01-01

    Long term data archiving has much value for chemists, not only to retain access to research and product development records, but also to enable new developments and new discoveries. There are some recent regulatory requirements (e.g., FDA 21 CFR Part 11), but good science and good business both benefit regardless. A particular example of the benefits of and need for long term data archiving is the management of data from spectroscopic laboratory instruments. The sheer amount of spectroscopic data is increasing at a scary rate, and the pressures to archive come from the expense to create the data (or recreate it if it is lost) as well as its high information content. The goal of long-term data archiving is to save and organize instrument data files as well as any needed meta data (such as sample ID, LIMS information, operator, date, time, instrument conditions, sample type, excitation details, environmental parameters, etc.). This editorial explores the issues involved in long-term data archiving using the example of Raman spectral databases. There are at present several such databases, including common data format libraries and proprietary libraries. However, such databases and libraries should ultimately satisfy stringent criteria for long term data archiving, including readability for long times into the future, robustness to changes in computer hardware and operating systems, and use of public domain data formats. The latter criterion implies the data format should be platform independent and the tools to create the data format should be easily and publicly obtainable or developable. Several examples of attempts at spectral libraries exist, such as the ASTM ANDI format, and the JCAMP-DX format. On the other hand, proprietary library spectra can be exchanged and manipulated using proprietary tools. As the above examples have deficiencies according to the three long term data archiving criteria, Extensible Markup Language (XML; a product of the World Wide Web Consortium, an independent standards body) as a new data interchange tool is being investigated and implemented. In order to facilitate data archiving, Raman data needs calibration as well as some other kinds of data treatment. Figure 1 illustrates schematically the present situation for Raman data calibration in the world-wide Raman spectroscopy community, and presents some of the terminology used.

  9. 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. PMID:25721728

  10. Risperidone Long-Acting Injection: Safety and Efficacy in Elderly Patients with Schizophrenia

    PubMed Central

    Catalán, Rosa; Penadés, Rafael

    2011-01-01

    Antipsychotic medication is considered the cornerstone of the treatment in elderly patients with schizophrenia. Long acting risperidone injection was the first antipsychotic available for use in this group of patients. Current scientific literature revealed that long-acting risperidone is effective in treating the positive and negative symptoms of schizophrenia and some improvements in cognition and functioning have also been found. In terms of efficacy, there is a paucity of randomized trials but the studies suggest that long-acting risperidone is efficient in the long-term management of schizophrenia, with a safety profile similar to that of oral risperidone. It seems that patient acceptance of treatment is greater when patients are switched from a traditional oral medication to depot risperidone and some improvements in cognition and functioning might be related. Further long-term comparisons with other oral and long-acting antipsychotic medications are needed. These studies should include cost-effectiveness data. Research into metabolic side effects is also needed. PMID:23861642

  11. Effects of oral arsenic trioxide therapy on QT intervals in patients with acute promyelocytic leukemia: implications for long-term cardiac safety.

    PubMed

    Siu, Chung-Wah; Au, Wing-Yan; Yung, Cindy; Kumana, Cyrus R; Lau, Chu-Pak; Kwong, Yok-Lam; Tse, Hung-Fat

    2006-07-01

    Ventricular tachyarrhythmias may occur during intravenous arsenic trioxide (As2O3). This has not happened during oral As2O3. Sixteen patients were studied by electrocardiography and 24-hour Holter monitoring at baseline, during and after oral As2O3 (As2O3-ON, As2O3-OFF). QT and corrected QT (QTc) were significantly longer during As2O3-ON than in As2O3-OFF, but QT and QTc dispersions were comparable. The patients' 24-hour heart rates were higher during As2O3-ON than in As2O3-OFF. QTc intervals at each hour were longer during As2O3-ON than in As2O3-OFF. However, QTc prolongation of more than 30 milliseconds only occurred at one time point (2 hours) after oral As2O3, resulting in QTc of more than 500 milliseconds in 3 of 16 patients, all within 4 hours of oral As2O3. Although the standard deviation of normal RR interval was lower during As2O3-ON, ratios of low frequency to high frequency power for As2O3-ON and As2O3-OFF were comparable. No ventricular proarrhythmias were observed. These observations, due to the lower peak plasma arsenic reached during oral As2O3, may explain the relative cardiac safety of oral As2O3. PMID:16514059

  12. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes

    Microsoft Academic Search

    Robert Wilson; Jerome J Schentag; Peter Ball; Lionel Mandell

    2002-01-01

    Background: Gemifloxacin is an enhanced-affinity quinolone with potent activity against lower respiratory tract pathogens.Objective: The efficacy and safety of a 5-day course of gemifloxacin were compared with those of a standard 7-day regimen of clarithromycin in patients with an acute exacerbation of chronic bronchitis (AECB). The impact of treatment on the long-term (26 weeks) clinical outcome was also assessed.Methods: The

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

    PubMed Central

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

    2015-01-01

    Rituximab is considered to be a promising drug for treating childhood refractory nephrotic syndrome. However, the efficacy and safety of rituximab in treating childhood refractory nephrotic syndrome remain inconclusive. This meta-analysis aimed to investigate the efficacy and safety of rituximab treatment compared with other immunosuppressive agents in children with refractory nephrotic syndrome. Three randomized controlled trials and two comparative control studies were included in our analysis. The included studies were of moderately high quality. Compared with other immunotherapies, rituximab therapy significantly improved relapse-free survival (hazard ratio = 0.49, 95% confidence interval [CI], 0.26–0.92, P = 0.03). Rituximab also achieved a higher rate of complete remission (risk ratio,1.62; 95% CI, 0.92 to 2.84, P = 0.09) and reduced the occurrence of proteinuria (mean difference = ?0.25, 95% CI = ?0.29 to ?0.21, P < 0.00001); however, a more targeted rituximab treatment did not significantly increase serum albumin levels and did not significantly reduce adverse events. Rituximab might be a promising treatment for childhood refractory nephrotic syndrome; however, the long-term effects and cost-effectiveness of rituximab treatment were not fully assessed, and there were limited studies that evaluated the clinical benefits of a concurrent infusion of rituximab plus a steroid compared with an infusion of rituximab only. Additional studies are required to address these issues. PMID:25645999

  14. Ice sheet sensitivity experiments as part of an assessment of long-term safety for a planned repository for spent nuclear fuel in Sweden

    NASA Astrophysics Data System (ADS)

    Wekerle, Claudia; Colleoni, Florence; Masina, Simona; Näslund, Jens-Ove; Brandefelt, Jenny

    2014-05-01

    An application to build a deep geological repository for spent nuclear fuel in Forsmark in south-central Sweden is currently under consideration by Swedish authorities. As part of the safety assessment, the response of the repository to an extensive glaciation over time scales of several hundred thousand years, in terms of ice thickness, bedrock depression and hydrostatic pressure, has to be evaluated. The most extensive glaciation over Eurasia recorded in geological proxies occurred during the MIS 6, at around 140 kyrs BP (Late Saalian glaciation). At this time, the few existing numerical ice-sheet reconstructions suggest that the Eurasian ice volume reached more than 70 m SLE, which is at least three times larger than during the Last Glacial Maximum (21 kyrs BP). The reconstruction of this ice sheet is complicated by the fact that the timing of the maximum ice volume may not have been coeval with the maximum eastern and southern extent of the Saalian ice sheet. In the present study, the maximum geographical extension of the Late Saalian glaciation serves as an extreme test case to assess the impact of ice thickness over the Forsmark repository site. We use the 3D-thermodynamical ice sheet-ice shelves and ice stream model GRISLI (Ritz et al. 2001) to simulate the Northern Hemisphere ice sheet topography of the Late Saalian glaciation. The model is forced by steady-state climatic fields (surface air temperature and precipitation) computed using the coupled atmosphere-ocean Community Earth System Model (CESM, NCAR) at ~1°x1° resolution, with boundary and forcing conditions representative for the MIS6 glacial maximum. Ice sheet simulations are run on a 20 km regular rectangular grid over the northern high latitudes and allow for floating ice. First, as part of the model validation, we show a numerical reconstruction of the MIS 6 Eurasian ice sheet using standard parameters for lapse rate, PDD coefficients and basal hydrology. Second, sensitivity experiments are presented, studying the impact of model parameters such as surface mass balance parameters and schemes of calving and basal hydrology on the ice thickness. With this approach we are able to provide reasonable upper and lower bounds of ice thickness for a possible extreme glaciation over the Forsmark area.

  15. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

    PubMed Central

    Bergey, Gregory K.; Mizrahi, Eli M.; Goldman, Alica; King-Stephens, David; Nair, Dileep; Srinivasan, Shraddha; Jobst, Barbara; Gross, Robert E.; Shields, Donald C.; Barkley, Gregory; Salanova, Vicenta; Olejniczak, Piotr; Cole, Andrew; Cash, Sydney S.; Noe, Katherine; Wharen, Robert; Worrell, Gregory; Murro, Anthony M.; Edwards, Jonathan; Duchowny, Michael; Spencer, David; Smith, Michael; Geller, Eric; Gwinn, Ryder; Skidmore, Christopher; Eisenschenk, Stephan; Berg, Michel; Heck, Christianne; Van Ness, Paul; Fountain, Nathan; Rutecki, Paul; Massey, Andrew; O'Donovan, Cormac; Labar, Douglas; Duckrow, Robert B.; Hirsch, Lawrence J.; Courtney, Tracy; Sun, Felice T.; Seale, Cairn G.

    2015-01-01

    Objective: The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures. Methods: All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy. Results: The average participant was 34 (±11.4) years old with epilepsy for 19.6 (±11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%). Conclusions: The RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures. Classification of evidence: This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years. PMID:25616485

  16. Long-term effects of gonadotropin-releasing hormone analogs in girls with central precocious puberty.

    PubMed

    Kim, Eun Young

    2015-01-01

    Gonadotropin-releasing hormone analogs (GnRHa) are widely used to treat central precocious puberty (CPP). The efficacy and safety of GnRHa treatment are known, but concerns regarding long-term complications are increasing. Follow-up observation results after GnRHa treatment cessation in female CPP patients up to adulthood showed that treatment (especially <6 years) was beneficial for final adult height relative to that of pretreated or untreated patients. Puberty was recovered within 1 year after GnRHa treatment discontinuation, and there were no abnormalities in reproductive function. CPP patients had a relatively high body mass index (BMI) at the time of CPP diagnosis, but BMI standard deviation score maintenance during GnRHa treatment seemed to prevent the aggravation of obesity in many cases. Bone mineral density decreases during GnRHa treatment but recovers to normal afterwards, and peak bone mass formation through bone mineral accretion during puberty is not affected. Recent studies reported a high prevalence of polycystic ovarian syndrome in CPP patients after GnRHa treatment, but it remains unclear whether the cause is the reproductive mechanism of CPP or GnRHa treatment itself. Studies of the psychosocial effects on CPP patients after GnRHa treatment are very limited. Some studies have reported decreases in psychosocial problems after GnRHa treatment. Overall, GnRHa seems effective and safe for CPP patients, based on long-term follow-up studies. There have been only a few long-term studies on GnRHa treatment in CPP patients in Korea; therefore, additional long-term follow-up investigations are needed to establish the efficacy and safety of GnRHa in the Korean population. PMID:25729392

  17. Long-acting risperidone injection: efficacy, safety, and cost-effectiveness of the first long-acting atypical antipsychotic

    PubMed Central

    Chue, Pierre

    2007-01-01

    Objective To review the pharmacokinetics, efficacy, safety, and cost-effectiveness of long-acting risperidone. Methods Studies published between January 2000 and October 2006 evaluating the pharmacokinetics, efficacy, safety, and cost-effectiveness of long-acting risperidone were reviewed, as identified from literature searches using Medline and EMBASE. Abstracts and posters on long-acting risperidone presented at key psychiatry congresses and available in the public domain during this time period were also reviewed. Results The unique pharmacokinetic profile of long-acting risperidone is derived from the encapsulation of risperidone in a glycolide/lactide matrix in the form of microspheres such that after a single intramuscular injection, significant plasma levels of the drug are achieved after week 3. Steady state, after repeated administration at 2-week intervals, is achieved after 3 injection cycles. Short- and long-term studies have demonstrated that long-acting risperidone (25, 37.5, or 50 mg) is both efficacious and well tolerated in a wide variety of patients with schizophrenia and related psychoses. Most patients can be switched from other oral and long-acting antipsychotic agents without compromising efficacy and safety. Long-acting risperidone may also reduce overall healthcare costs by decreasing rates of relapse and hospitalization. Conclusion The assured delivery of an atypical antipsychotic medication with long-acting risperidone has important implications for patient compliance, maintenance of stability, consistency of treatment, and improving patient outcomes including the achievement of remission. PMID:19300536

  18. Preclinical evaluation of efficacy and safety of an improved lentiviral vector for the treatment of ?-thalassemia and sickle cell disease.

    PubMed

    Negre, Olivier; Bartholomae, Cynthia; Beuzard, Yves; Cavazzana, Marina; Christiansen, Lauryn; Courne, Céline; Deichmann, Annette; Denaro, Maria; de Dreuzy, Edouard; Finer, Mitchell; Fronza, Raffaele; Gillet-Legrand, Béatrix; Joubert, Christophe; Kutner, Robert; Leboulch, Philippe; Maouche, Leïla; Paulard, Anaïs; Pierciey, Francis J; Rothe, Michael; Ryu, Byoung; Schmidt, Manfred; von Kalle, Christof; Payen, Emmanuel; Veres, Gabor

    2015-01-01

    A previously published clinical trial demonstrated the benefit of autologous CD34(+) cells transduced with a selfinactivating lentiviral vector (HPV569) containing an engineered ?-globin gene (?(A-T87Q)-globin) in a subject with ? thalassemia major. This vector has been modified to increase transduction efficacy without compromising safety. In vitro analyses indicated that the changes resulted in both increased vector titers (3 to 4 fold) and increased transduction efficacy (2 to 3 fold). An in vivo study in which 58 ?-thalassemic mice were transplanted with vector- or mock-transduced syngenic bone marrow cells indicated sustained therapeutic efficacy. Secondary transplantations involving 108 recipients were performed to evaluate long-term safety. The six month study showed no hematological or biochemical toxicity. Integration site (IS) profile revealed an oligo/polyclonal hematopoietic reconstitution in the primary transplants and reduced clonality in secondary transplants. Tumor cells were detected in the secondary transplant mice in all treatment groups (including the control group), without statistical differences in the tumor incidence. Immunohistochemistry and quantitative PCR demonstrated that tumor cells were not derived from transduced donor cells. This comprehensive efficacy and safety data provided the basis for initiating two clinical trials with this second generation vector (BB305) in Europe and in the USA in patients with ?-thalassemia major and sickle cell disease. PMID:25429463

  19. Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

    PubMed Central

    Li, Qiang; Tong, Zichuan; Wang, Lefeng; Zhang, Jianjun; Ge, Yonggui; Wang, Hongshi; Li, Weiming; Xu, Li; Ni, Zhuhua

    2013-01-01

    Introduction With long-term follow-up, whether biodegradable polymer drug-eluting stents (DES) is efficient and safe in primary percutaneous coronary intervention (PCI) remains a controversial issue. This study aims to assess the long-term efficacy and safety of DES in PCI for ST-segment elevation myocardial infarction (STEMI). Material and methods A prospective, randomized single-blind study with 3-year follow-up was performed to compare biodegradable polymer DES with durable polymer DES in 332 STEMI patients treated with primary PCI. The primary end point was major adverse cardiac events (MACE) at 3 years after the procedure, defined as the composite of cardiac death, recurrent infarction, and target vessel revascularization. The secondary end points included in-segment late luminal loss (LLL) and binary restenosis at 9 months and cumulative stent thrombosis (ST) event rates up to 3 years. Results The rate of the primary end points and the secondary end points including major adverse cardiac events, in-segment late luminal loss, binary restenosis, and cumulative thrombotic event rates were comparable between biodegradable polymer DES and durable polymer DES in these 332 STEMI patients treated with primary PCI at 3 years. Conclusions Biodegradable polymer DES has similar efficacy and safety profiles at 3 years compared with durable polymer DES in STEMI patients treated with primary PCI. PMID:24482648

  20. Humanized anti-interleukin-2 (IL2) receptor alpha therapy: long-term results in uveitis patients and preliminary safety and activity data for establishing parameters for subcutaneous administration

    Microsoft Academic Search

    Robert B Nussenblatt; Darby J. S Thompson; Zhuqing Li; Jan S Peterson; Randy R Robinson; Richard S Shames; Sudha Nagarajan; Meina Tao Tang; Michelle Mailman; Gisela Velez; Chandra Roy; Grace A Levy-Clarke; Eric B Suhler; Ali Djalilian; Hatice Nida Sen; Shadi Al-Khatib; Roxana Ursea; Sunil Srivastava; Allison Bamji; Susan Mellow; Pushpa Sran; Thomas A Waldmann; Ronald R Buggage

    2003-01-01

    Therapy for severe uveitis is frequently long-term immunosuppression using systemic corticosteroids and cytotoxic agents, but side effects make long-term therapy difficult. A long-term (>4 year) Phase I\\/II single armed interventional study using intravenous anti-IL-2 receptor alpha treatments (daclizumab) and a short-term Phase II study evaluating the use of a subcutaneous daclizumab formulation were conducted. Patients were tapered off their systemic

  1. The Efficacy of Material Safety Data Sheets and Worker Acceptability

    Microsoft Academic Search

    Charles C Phillips; Bill C Wallace; Charles B Hamilton; Robert T Pursley; Gregory C Petty; Charles K Bayne

    1999-01-01

    This study quantified how well the Material Safety Data Sheet (MSDS) diffused information to workers, compared the efficacy of an OSHA type form with the Chemical Manufacturer’s Association\\/American National Standards Institute (CMA\\/ANSI Z400.1) structure and the International Chemical Safety Card (ICSC), and determined worker acceptability and understanding of MSDSs at a large national laboratory. An inventory questionnaire and quantitative testing

  2. Long-Term Results of Targeted Intraoperative Radiotherapy (Targit) Boost During Breast-Conserving Surgery

    SciTech Connect

    Vaidya, Jayant S., E-mail: jayant.vaidya@ucl.ac.uk [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Baum, Michael [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Tobias, Jeffrey S. [Department of Radiation Oncology, University College London Hospitals, London (United Kingdom); Wenz, Frederik [Radiation Oncology and Gynaecology, University Medical Centre of Mannheim (Germany); Massarut, Samuele [Surgery and Radiation Oncology, Centro di Riferimento Oncologico (CRO), Aviano (Italy); Keshtgar, Mohammed [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Hilaris, Basil [Radiation Oncology, Our Lady of Mercy, New York Medical College, New York (United States); Saunders, Christobel [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Williams, Norman R.; Brew-Graves, Chris [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Corica, Tammy [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Roncadin, Mario [Surgery and Radiation Oncology, Centro di Riferimento Oncologico (CRO), Aviano (Italy); Kraus-Tiefenbacher, Uta; Suetterlin, Marc [Radiation Oncology and Gynaecology, University Medical Centre of Mannheim (Germany); Bulsara, Max [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Joseph, David [Radiation Oncology, Sir Charles Gairdner Hospital and School of Surgery, University of Western Australia, Perth (Australia)

    2011-11-15

    Purpose: We have previously shown that delivering targeted radiotherapy to the tumour bed intraoperatively is feasible and desirable. In this study, we report on the feasibility, safety, and long-term efficacy of TARGeted Intraoperative radioTherapy (Targit), using the Intrabeam system. Methods and Materials: A total of 300 cancers in 299 unselected patients underwent breast-conserving surgery and Targit as a boost to the tumor bed. After lumpectomy, a single dose of 20 Gy was delivered intraoperatively. Postoperative external beam whole-breast radiotherapy excluded the usual boost. We also performed a novel individualized case control (ICC) analysis that computed the expected recurrences for the cohort by estimating the risk of recurrence for each patient using their characteristics and follow-up period. Results: The treatment was well tolerated. The median follow up was 60.5 months (range, 10-122 months). Eight patients have had ipsilateral recurrence: 5-year Kaplan Meier estimate for ipsilateral recurrence is 1.73% (SE 0.77), which compares well with that seen in the boosted patients in the European Organization for Research and Treatment of Cancer study (4.3%) and the UK STAndardisation of breast RadioTherapy study (2.8%). In a novel ICC analysis of 242 of the patients, we estimated that there should be 11.4 recurrences; in this group, only 6 recurrences were observed. Conclusions: Lumpectomy and Targit boost combined with external beam radiotherapy results in a low local recurrence rate in a standard risk patient population. Accurate localization and the immediacy of the treatment that has a favorable effect on tumour microenvironment may contribute to this effect. These long-term data establish the long-term safety and efficacy of the Targit technique and generate the hypothesis that Targit boost might be superior to an external beam boost in its efficacy and justifies a randomized trial.

  3. Long-term injectable progestogens.

    PubMed

    Tyler, E T

    1967-01-01

    Prof. Edward T. Tyler, medical director of the Family Planning Clinics of Los Angeles, gave an interim report on a study into the use of unjectable progestogens as a long-term method of contraception. An intramuscular injection of medroxy-progesterone acetate (150 mg.) is given three-monthly, with no supplementary oestrogen. Over the past two years about 150 women began this form of contraception in a continuing study. There have been no pregnancies in the series. The most frequent side-effect has been bleeding. An attempt was made to see how soon the contraceptive effects cease after treatment is stopped. The injections were therefore stopped in 36 women, who were then fitted with various mechanical forms of contraception, including IUDs. Tests for the re-establishment of ovulation were undertaken, including basal temperature studies, frequent pelvic examinations, cervical and vagianl smears, endometrial biopsies, gonadotrophin and pregnanediol estimations. It appeared that the earliest return of ovulation is a little under six months from the time of the last injection. The early results of this study, presented here, suggest that long-acting injectable progestogens are an extremely effective form of contraception. While the delay in return of fertility for some months may be a problem in certain areas, this method may well be of importance in general population control. PMID:12254706

  4. Clinical efficacy and safety of statins in managing cardiovascular risk

    PubMed Central

    Kapur, Navin K; Musunuru, Kiran

    2008-01-01

    Since their introduction in the 1980s, 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have emerged as the one of the best-selling medication classes to date, with numerous trials demonstrating powerful efficacy in preventing cardiovascular outcomes. As our understanding of low-density lipoprotein cholesterol (LDL-C) and atherosclerosis continues to grow, the concept of ‘lower is better’ has corresponded with a ‘more is better’ approach to statin-based therapy. This review provides a detailed understanding of the clinical efficacy and safety of statins with a particular emphasis on the third generation drug, rosuvastatin. PMID:18561510

  5. Specific immunotherapy in asthma: efficacy and safety.

    PubMed

    Passalacqua, G; Canonica, G W

    2011-09-01

    The use of specific immunotherapy (SIT) to treat asthma has been, and still is, a matter of debate, and there are no clear or unequivocal indications in the official documents. This is partly due to the fact that there are few studies specifically designed to assess asthma, that none of such studies had a formal sample size calculation, and that objective parameters of pulmonary function have been assessed only sporadically. Nonetheless, there are good quality studies for both subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) where asthma symptoms were evaluated, and showing positive results. Moreover, several favourable meta-analyses are available, although their validity is limited by the great heterogeneity of the trials included. The disease modifying effect of SIT, that is the capacity of preventing asthma onset should be also taken into account. Concerning the safety, fatalities seem to be an exceptional event and in Europe no fatality has been reported over the last two decades. Uncontrolled asthma is universally recognized as the most important risk factor for severe adverse events. In conclusion both SLIT and SCIT can be used in asthma associated with rhinitis (which is the most common condition), provided that asthma is adequately controlled by pharmacotherapy. In such case, a measurable clinical benefit on asthma symptoms can be expected. On the other hand, SIT cannot be presently recommended as single therapy when asthma is the unique manifestation of respiratory allergy. PMID:21255159

  6. Sandostatin LAR in Acromegalic Patients: Long Term Treatment

    Microsoft Academic Search

    ANETTE KVISTBORG FLØGSTAD; JOHAN HALSE; SØREN BAKKE; IOANA LANCRANJAN; P. MARBACH; C. H. BRUNS; JAK JERVELL

    We have evaluated the long term effects and safety of Sandostatin LAR, a long acting formulation of octreotide, during 18 subsequent injections given every fourth week to 14 octreotide-sensitive acrome- galic patients. The dosages (20, 30, or 40 mg) were adjusted according to GH response, side-effects, or symptom relief and assessed on day 28 after each injection. We found a

  7. Efficacy and Safety of Levetiracetam in Pediatric Migraine

    Microsoft Academic Search

    G. Steve Miller

    2004-01-01

    Background.—Headache is a frequent occurrence among children and adolescents. Chronic headaches can be severe and disabling, and require prophylactic treatment; however, additional data on the use of prophylactic medications for migraine in children are needed. Objective.—To review the efficacy and safety of levetiracetam (Keppra) in pediatric patients with a history of recurrent headache. Design\\/Methods.—Data from 19 pediatric patients were retrospectively

  8. Efficacy and safety of sildenafil citrate in hemodialysis patients

    Microsoft Academic Search

    Y ?ahin; C Aygün; C. L Pe?kircio?lu; M. ? Tekin; F. N Özdemir; H Özkarde?

    2004-01-01

    Erectile dysfunction (ED) is more frequent among end-stage renal failure patients than the normal population. Sildenafil citrate has been successfully used for the symptomatic treatment of erectile dysfunction. The aim of this study was to determine the efficacy and safety of sildenafil citrate in the treatment of ED in patients on hemodialysis.Fifty-five hemodialysis patients above 18 years suffering from ED

  9. Quality of life in vitiligo patients after treatment with long-term narrowband ultraviolet B phototherapy

    Microsoft Academic Search

    M. Tjioe; ME Otero; M. J. P. Gerritsen

    2005-01-01

    Long-term treatments for chronic diseases such as vitiligo need to be evaluated for their clinical efficacy. Assessment of the quality of life (QOL), however, may provide the most relevant information on the actual benefit for these patients. In this study we evaluated QOL after long-term narrowband ultraviolet (UV) B for the treatment of vitiligo. All patients, with long-term stable vitiligo

  10. Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms.

    PubMed

    Chalouhi, Nohra; Zanaty, Mario; Whiting, Alex; Yang, Steven; Tjoumakaris, Stavropoula; Hasan, David; Starke, Robert M; Hann, Shannon; Hammer, Christine; Kung, David; Rosenwasser, Robert; Jabbour, Pascal

    2015-06-01

    OBJECT Flow diverters are increasingly used for treatment of intracranial aneurysms. In most series, the Pipeline Embolization Device (PED) was used for the treatment of large, giant, complex, and fusiform aneurysms. Little is known about the use of the PED in small aneurysms. The purpose of this study was to assess the safety and efficacy of the PED in small aneurysms (? 7 mm). METHODS A total of 100 consecutive patients were treated with the PED at the authors' institution between May 2011 and September 2013. Data on procedural safety and efficacy were retrospectively collected. RESULTS The mean aneurysm size was 5.2 ± 1.5 mm. Seven patients (7%) had sustained a subarachnoid hemorrhage. All except 5 aneurysms (95%) arose from the anterior circulation. The number of PEDs used was 1.2 per aneurysm. Symptomatic procedure-related complications occurred in 3 patients (3%): 1 distal parenchymal hemorrhage that was managed conservatively and 2 ischemic events. At the latest follow-up (mean 6.3 months), 54 (72%) aneurysms were completely occluded (100%), 10 (13%) were nearly completely occluded (? 90%), and 11 (15%) were incompletely occluded (< 90%). Six aneurysms (8%) required further treatment. Increasing aneurysm size (OR 3.8, 95% CI 0.99-14; p = 0.05) predicted retreatment. All patients achieved a favorable outcome (modified Rankin Scale Score 0-2) at follow-up. CONCLUSIONS In this study, treatment of small aneurysms with the PED was associated with low complication rates and high aneurysm occlusion rates. These findings suggest that the PED is a safe and effective alternative to conventional endovascular techniques for small aneurysms. Randomized trials with long-term follow-up are necessary to determine the optimal treatment that leads to the highest rate of obliteration and the best clinical outcomes. PMID:25635478

  11. Transuranic waste: long-term planning

    SciTech Connect

    Young, K.C.

    1985-07-01

    Societal concerns for the safe handling and disposal of toxic waste are behind many of the regulations and the control measures in effect today. Transuranic waste, a specific category of toxic (radioactive) waste, serves as a good example of how regulations and controls impact changes in waste processing - and vice versa. As problems would arise with waste processing, changes would be instituted. These changes improved techniques for handling and disposal of transuranic waste, reduced the risk of breached containment, and were usually linked with regulatory changes. Today, however, we face a greater public awareness of and concern for toxic waste control; thus, we must anticipate potential problems and work on resolving them before they can become real problems. System safety analyses are valuable aids in long-term planning for operations involving transuranic as well as other toxic materials. Examples of specific system safety analytical methods demonstrate how problems can be anticipated and resolution initiated in a timely manner having minimal impacts upon allocation of resource and operational goals. 7 refs., 1 fig.

  12. Comparison of the Efficacy of Different Long-term Interventions on Chronic Low Back Pain Using the Cross-sectional Area of the Multifidus Muscle and the Thickness of the Transversus Abdominis Muscle as Evaluation Indicators.

    PubMed

    Huang, Qiuchen; Li, Desheng; Zhang, Jing; Yang, Degang; Huo, Ming; Maruyama, Hitoshi

    2014-12-01

    [Purpose] The purpose of this study was to examine the different effects of long-term intervention between proprioceptive neuromuscular facilitation (PNF) and neuromuscular joint facilitation (NJF) patterns for the pelvis on chronic low back pain as assessed by the cross-sectional area of the multifidus muscle and the thickness of the transversus abdominis muscle. [Subjects] The subjects were 12 young people (five males, seven females) who had experienced chronic low back pain on one side for more than 6 months. [Methods] The subjects were treated by resting, PNF or NJF therapy, and each treatment was administered for one month. Ultrasonography was used to measure the changes in the transversus abdominis muscle thickness and the multifidus muscle cross-sectional area. [Results] The thickness of the transversus abdominis muscle and the cross-sectional area of the multifidus muscle in the NJF group, after resting, increased significantly and were higher than those in the PNF group. [Conclusion] The results show that significantly better improvement can be obtained for chronic low back pain by applying long-term intervention of NJF patterns. PMID:25540480

  13. Long-term monitoring FBG-based cable load sensor

    Microsoft Academic Search

    Zhichun Zhang; Zhi Zhou; Chuan Wang; Jinping Ou

    2006-01-01

    Stay cables are the main load-bearing components of stayed-cable bridges. The cables stress status is an important factor to the stayed-cable bridge structure safety evaluation. So it's very important not only to the bridge construction, but also to the long-term safety evaluation for the bridge structure in-service. The accurate measurement for cable load depends on an effective sensor, especially to

  14. Bipolar Bozuklukta Koruyucu Tedavi Long-term Treatment in Bipolar Disorder

    Microsoft Academic Search

    Meliha Zengin

    2010-01-01

    Although the importance of long-term prophylactic treatment is certain in bipolar disorder, there is stil debate on how to which patients and evaluate the treatment response. Efficacious long-term treatment can reduce morbidity and mortality significantly and improve quality of life of bipolar patients. The concept of ideal response should also be defined very clearly in order to discuss the difficulties

  15. Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part II: Efficacy and safety

    PubMed Central

    Barnes, Joanne

    2003-01-01

    This is the second of two papers which review issues concerning complementary medicines. The first reviewed the extent of use of complementary medicines, and issues related to the regulation and pharmaceutical quality of these products; the second considers evidence for the efficacy of several well-known complementary medicines, and discusses complementary-medicines pharmacovigilance. The term complementary medicines describes a range of pharmaceutical-type preparations, including herbal medicines, homoeopathic remedies, essential oils and dietary supplements, which mainly sit outside conventional medicine. The use of complementary medicines is a popular healthcare approach in the UK, and there are signs that the use of such products is continuing to increase. Patients and the public use complementary medicines for health maintenance, for the treatment or prevention of minor ailments, and also for serious, chronic illnesses. There is a growing body of evidence from randomized controlled trials and systematic reviews to support the efficacy of certain herbal extracts and dietary supplements in particular conditions. However, many other preparations remain untested. Strictly speaking, evidence of efficacy (and safety) for herbal medicines should be considered to be extract specific. Pharmacovigilance for complementary medicines is in its infancy. Data are lacking in several areas relevant to safety. Standard pharmacovigilance tools have additional limitations when applied to investigating safety concerns with complementary medicines. PMID:12680880

  16. Efficacy and safety of endobronchial valves for advanced emphysema: a meta analysis

    PubMed Central

    Liu, Hua; Xu, Meng; Xie, Yiqun; Gao, Jie

    2015-01-01

    Objective A meta-analysis was undertaken to evaluate the efficacy and safety of bronchoscopic lung volume reduction with endobronchial valves (EBV) for advanced emphysema. Methods A systematic search was performed from PubMed, EMBASE, CNKI, Cochrane Library database. Randomized control clinical trials on treatment of emphysema for 3-12 months with the EBV compared with standard medications and sham EBV were reviewed. Inclusion criteria were applied to select patients with advanced emphysema treated with EBV. The primary outcome was the percentage of the forced expiratory volume in the first second (FEV1%). Secondary outcomes included St George’s Respiratory Questionnaire (SGRQ) score, the distance of the 6-minute walk (6MWD) test, the Modified Medical Research Council (MMRC) dyspnoea score, cycle ergometry workload, and the rate of the six major complications at 3 or 12 months. Fixed- or random-effects models were used and weighted mean differences (WMD), relative risks (RR) and 95% confidence intervals (CI) were calculated. Results Three trials (565 patients) were considered in the meta-analysis. EBV patients yielded greater increases in FEV1% than standard medications (WMD =6.71; 95% CI, 3.31 to 10.10; P=0.0001), EBV patients also demonstrated a significant change for SGRQ score (WMD =?3.64; 95% CI, ?5.93 to ?1.34; P=0.002), MMRC dyspnoea score (WMD =?0.26; 95% CI, ?0.44 to -0.08; P=0.004), and cycle ergometry workload (WMD =4.18; 95% CI, 2.14 to 6.22; P<0.0001). A similar level was evident for 6MWD (WMD =11.66; 95% CI, ?3.31 to 26.64; P=0.13). EBV may increase the rate of hemoptysis (RR =5.15; 95% CI, 1.16 to 22.86; P=0.03), but didn’t increase the adverse events including mortality, respiratory failure, empyema, pneumonia, pneumothrax. The overall rates for complications compared EBV with standard medications and sham EBV was not significant (RR =2.03; 95% CI, 0.98 to 4.21; P=0.06). Conclusions EBV lung volume reduction for advanced emphysema showed superior efficacy and a good safety and tolerability compared with standard medications and sham EBV, further more randomized controlled trial (RCT) studies are needed to pay more attention to the long-term efficacy and safety of bronchoscopic lung volume reduction with EBV in advanced emphysema. PMID:25922709

  17. Tacrolimus Is Safe and Effective in Patients with Severe Steroid-Refractory or Steroid-Dependent Inflammatory Bowel Disease—A Long-Term Follow-Up

    Microsoft Academic Search

    Daniel C. Baumgart; Jan P. Pintoffl; Andreas Sturm; Bertram Wiedenmann; Axel U. Dignass

    2006-01-01

    OBJECTIVE:We and others have reported the use of tacrolimus in refractory inflammatory bowel disease (IBD). Little is known about its long-term efficacy and safety.METHODS:In this retrospective, observational single center study the charts of 53 adult patients with steroid-dependent (n = 18) or steroid-refractory (n = 35) IBD, Crohn's disease (CD) (n = 11), ulcerative colitis (UC) (n = 40), or

  18. Drug monitoring in child and adolescent psychiatry for improved efficacy and safety of psychopharmacotherapy

    PubMed Central

    Mehler-Wex, Claudia; Kölch, Michael; Kirchheiner, Julia; Antony, Gisela; Fegert, Jörg M; Gerlach, Manfred

    2009-01-01

    Most psychotropic drugs used in the treatment of children and adolescents are applied "off label" with a direct risk of under- or overdosing and a delayed risk of long-term side effects. The selection of doses in paediatric psychiatric patients requires a consideration of pharmacokinetic parameters and the development of central nervous system, and warrants specific studies in children and adolescents. Because these are lacking for most of the psychotropic drugs applied in the Child and Adolescent and Psychiatry, therapeutic drug monitoring (TDM) is a valid tool to optimise pharmacotherapy and to enable to adjust the dosage of drugs according to the characteristics of the individual patient. Multi-centre TDM studies enable the identification of age- and development-dependent therapeutic ranges of blood concentrations and facilitate a highly qualified standardized documentation in the child and adolescent health care system. In addition, they will provide data for future research on psychopharmacological treatment in children and adolescents, as a baseline for example for clinically relevant interactions with various co-medications. Therefore, a German-Austrian-Swiss "Competence Network on Therapeutic Drug Monitoring in Child and Adolescent Psychiatry" was founded [1] introducing a comprehensive internet data base for the collection of demographic, safety and efficacy data as well as blood concentrations of psychotropic drugs in children and adolescents. PMID:19358696

  19. An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

    ClinicalTrials.gov

    2015-02-03

    Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders

  20. Long-term safety, tolerability, and efficacy of vismodegib in two patients with metastatic basal cell carcinoma and basal cell nevus syndrome

    PubMed Central

    Weiss, Glen J.; Tibes, Raoul; Blaydorn, Lisa; Jameson, Gayle; Downhour, Molly; White, Erica; Caro, Ivor; Von Hoff, Daniel D.

    2011-01-01

    Tumor responses in advanced basal cell carcinoma (BCC) have been observed in clinical trials with vismodegib, a SMO antagonist. The result of SMO antagonism is inhibition Hedgehog Signaling Pathway (HHSP) downstream target genes. HHSP inhibition has been shown to affect stem cells responsible for blood, mammary, and neural development. We report on our experience of treating two patients with advanced BCC participating. These two patients have had no new BCCs develop for at least 2.25 years. Both patients have been receiving ongoing daily treatment with vismodegib for greater than 2.75 years without experiencing any significant side effects. After prolonged continuous daily dosing with a SMO antagonist, we have not observed a significant alteration in hematologic parameters or physical abnormalities of the pectoral regions of two patients with advanced BCC. PMID:25386306

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  2. Long-term treatment with recombinant

    E-print Network

    Steinbach, Joe Henry

    Long-term treatment with recombinant nerve growth factor for HIV-associated sensory neuropathy. No effective treatment is available. The au- thors investigated the long-term effect (48 weeks and significantly im- proved pain symptoms. However, there was no improvement of neuropathy severity as assessed

  3. LONG-TERM MONITORING SENSOR NETWORK

    Microsoft Academic Search

    Stephen P. Farrington; John W. Haas; Neal Van Wyck

    2003-01-01

    Long-term monitoring (LTM) associated with subsurface contamination sites is a key element of Long Term Stewardship and Legacy Management across the Department of Energy (DOE) complex. However, both within the DOE and elsewhere, LTM is an expensive endeavor, often exceeding the costs of the remediation phase of a clean-up project. The primary contributors to LTM costs are associated with labor.

  4. Long-Term Care Ombudsman Program

    MedlinePLUS

    Long-Term Care Ombudsman Program (OAA, Title VII, Chapter 2, Sections 711/712) The Purpose of the Program and How it ... Services Provided to Persons Living in Long-Term Care Facilities Program data for FY 2013 indicate that ...

  5. Veterans Affairs Benefits (Long-Term Care)

    MedlinePLUS

    ... to obtain information about services available in your area. LTC PathFinder Long-term care is a big topic. Use the PathFinder to get to the information most relevant and useful to you now. Please fill out all questions How old are you? Less than 50 51-64 65+ Do you currently require long-term ...

  6. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.

    PubMed

    Wang, J; Tan, N; Xiao, Y; Chen, J; Chen, B; Ma, Z; Zhang, D; Chen, M; Cui, Y

    2014-09-12

    Peroral endoscopic myotomy (POEM) has been developed as a minimally invasive endoscopic treatment for achalasia for years. However, the optimal length of submucosal tunnel and myotomy of muscle bundles during procedure of POEM has not yet been determined, so we aim to assess safety and efficacy of modified POEM with shorter myotomy of muscle bundles in achalasia patients. Consecutive achalasia patients had been performed modified POEM with shorter myotomy, and assessed by symptoms, high-resolution manometry, and barium swallow examinations before and 3 months after POEM for safety and efficacy evaluation. Modified POEM with shorter submucosal tunnel (mean length 6.8?cm) and endoscopic myotomy of muscle bundles (total mean length 5.4?cm) were completed in 46 consecutive achalasia patients. During the 3-month follow up in all cases, significant improvement of symptoms (a significant drop in the Eckardt score 8.4 ± 3.2 vs. 2.7 ± 1.9; P < 0.001), decreased lower esophageal sphincter pressure (39.4 ± 10.1 vs. 24.4 ± 9.1?mmHg; P < 0.001) and integrated relaxation pressure (38.6 ± 10.4 vs. 25.7 ± 9.6?mmHg; P < 0.01), and a drop in height of esophagus barium-contrast column (5.4 ± 3.1 vs. 2.6 ± 1.8?cm; P < 0.001) were observed. The frequencies of adverse events were lower in those under endotracheal anesthesia and CO2 insufflations compared with intravenous anesthesia and air insufflations. Only three patients were found to have gastroesophageal reflux disease on follow up. Modified POEM with shorter myotomy under endotracheal anesthesia and CO2 insufflations shows its good safety and excellent short-term efficacy in the treatment of achalasia. But further studies are warranted to assess the long-term efficacy. PMID:25214469

  7. Efficacy and safety of acupuncture in preterm and term infants.

    PubMed

    Raith, Wolfgang; Urlesberger, Berndt; Schmölzer, Georg M

    2013-01-01

    The aim of the paper was to review the literature about safety and efficiency of acupuncture therapy in term and preterm infants. We searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials using a predefined algorithm, reviewed abstracts from the Pediatric Academic Society annual meetings (2000-2012), and performed a manual search of references in narrative and systematic reviews. A total of 26 studies identified met our search criteria. Only 6 of these studies met our inclusion criteria; however, two studies had to be excluded because the manuscripts were published in Chinese. Hence, only four studies were included in our analysis. Three of the four studies evaluated the effects of acupuncture on infantile colic, and one assessed pain reduction during minor painful procedures in preterm babies. The limited data available suggests that acupuncture could be a safe nonpharmacologic treatment option for pain reduction in term and preterm infants and could also be a non-pharmacologic treatment option to treat infantile colic. Currently acupuncture in infants should be limited to clinical trials and studies evaluating short- and long-term effects and should be performed only by practitioners with adequate training and experience in neonatal/pediatric acupuncture. PMID:23878607

  8. Efficacy and safety of rufinamide in pediatric epilepsy

    PubMed Central

    Hsieh, David T.

    2013-01-01

    Rufinamide is a novel anticonvulsant medication approved by the US Food and Drug Administration (FDA) in 2008 for the treatment of seizures associated with Lennox–Gastaut syndrome in patients 4 years of age and older, based upon clinical trials demonstrating clinical efficacy and tolerability. Rufinamide is especially effective for tonic–atonic seizures in Lennox–Gastaut syndrome, but is subsequently proving to be safe and effective in clinical practice for a broad patient population with refractory epilepsy. Although further research and clinical experience is needed, rufinamide holds the promise to positively impact the care of children with epilepsy. In this review, we review the use of rufinamide in pediatric epilepsy, with a focus on efficacy and safety. PMID:23634191

  9. Long-Term Retrievability of IVC Filters: Should We Abandon Permanent Devices?

    SciTech Connect

    Berczi, V., E-mail: berczi@hotmail.com; Bottomley, J. R.; Thomas, S. M.; Taneja, S.; Gaines, P. A.; Cleveland, T. J. [Northern General Hospital, Sheffield Vascular Institute (United Kingdom)

    2007-09-15

    Thromboembolic disease produces a considerable disease burden, with death from pulmonary embolism in the UK alone estimated at 30,000-40,000 per year. Whilst it is unproven whether filters actually improve longevity, the morbidity and mortality associated with thromboembolic disease in the presence of contraindications to anticoagulation is high. Thus complications associated with filter insertion, and whilst they remain in situ, must be balanced against the alternatives. Permanent filters remain in situ for the remainder of the patient's life and any complications from the filters are of significant concern. Filters that are not permanent are therefore attractive in these circumstances. Retrievable filters, to avoid or decrease long-term filter complications, appear to be a significant advance in the prevention of pulmonary embolism. In this review, we discuss the safety and effectiveness of both permanent and retrievable filters as well as the retrievability of retrievable inferior vena cava (IVC) filters, to explore whether the use of permanent IVC filters can be abandoned in favor of retrievable filters. Currently four types of retrievable filters are available: the Recovery filter (Bard Peripheral Vascular, Tempe, AZ, USA), the Guenther Tulip filter (Cook, Bloomington, IN, USA), the OptEase Filter (Cordis, Roden, The Netherlands), and the ALN filter (ALN Implants Chirurgicaux, Ghisonaccia, France). Efficacy and safety data for retrievable filters are as yet based on small series, with a total number of fewer than 1,000 insertions, and follow-up is mostly short term. Current long-term data are poor and insufficient to warrant the long-term implantation of these devices into humans. The case of fractured wire from a Recovery filter that migrated to the heart causing pericardial tamponade requiring open heart surgery is a reminder that any new endovascular device remaining in situ in the long term may produce unexpected problems. We should also bear in mind that the data on permanent filters are much more robust, with reports on over 9,500 cases with follow-up of up to 8 years. The original implantation time of 10-14 days has been extended to more than 100 days as the mean implantation time with some of the filter types. Follow-up (preferably prospective) is necessary for all retrievable filters, whether or not they are retrieved. Until these data become available we should restrict ourselves to the present indications of permanent and retrievable filters. If long-term follow-up data on larger numbers of cases confirm the initial data that retrievable filters are as safe and effective as permanent filters, the use of the retrievable filters is likely to expand.

  10. Safety and efficacy of alternative alglucosidase alfa regimens in Pompe disease.

    PubMed

    Case, Laura E; Bjartmar, Carl; Morgan, Claire; Casey, Robin; Charrow, Joel; Clancy, John P; Dasouki, Majed; DeArmey, Stephanie; Nedd, Khan; Nevins, Mary; Peters, Heidi; Phillips, Dawn; Spigelman, Zachary; Tifft, Cynthia; Kishnani, Priya S

    2015-04-01

    Emerging phenotypes in long-term survivors with Pompe disease on standard enzyme replacement therapy (ERT) (alglucosidase alfa 20?mg/kg/2 weeks) can include patients with worsening motor function. Whether higher doses of ERT improve skeletal function in these patients has not been systematically studied. This exploratory, randomized, open-label, 52-week study examined the safety and efficacy of 2 ERT regimens of alglucosidase alfa (20?mg/kg/week or 40?mg/kg/2 weeks) in 13 patients with Pompe disease and clinical decline or a lack of improvement on standard ERT: late-onset (n?=?4), infantile-onset (n?=?9). Cross-reactive immunologic material assay-negative patients were excluded. Eleven of 13 patients completed the study. Trends for improvement were seen in total gross motor function, but not mobility; however, 6 (late-onset, 2; infantile-onset, 4) of 11 patients (55%) who met the entry criteria of motor decline (late-onset, 4; infantile-onset, 7) showed improvement in motor and/or mobility skills. No between-regimen differences in efficacy emerged. Two case studies highlight the benefits of increased ERT dose in patients with Pompe disease experiencing clinical decline. Both alternative regimens were generally well tolerated. This study was limited by the small sample size, which is not uncommon for small clinical studies of rare diseases. Additionally, the study did not include direct assessment of muscle pathology, which may have identified potential causes of decreased response to ERT. Results were inconclusive but suggest that increased ERT dose may be beneficial in some patients with Pompe disease experiencing motor decline. Controlled studies are needed to clarify the benefits and risks of this strategy. PMID:25617983

  11. Effect of Long-Term Castration and Long-Term Androgen Treatment on Sexually Dimorphic

    E-print Network

    Crews, David

    Effect of Long-Term Castration and Long-Term Androgen Treatment on Sexually Dimorphic Estrogen be modified by steroid hormone manipulation. We castrated male whiptail lizards for 1 week (short term) or 6 that in male whiptail lizards, long-term castration increases sensitivity to estradiol as measured by induction

  12. Long-term theranostic hydrogel system for solid tumors.

    PubMed

    Kim, Jang Il; Lee, Beom Suk; Chun, Changju; Cho, Jung-Kyo; Kim, Sang-Yoon; Song, Soo-Chang

    2012-03-01

    The long-term theranostic hydrogel system for solid tumors was prepared via simple physical mixing, which consisted of three major parts: the thermosensitive/biodegradable poly(organophosphazene) hydrogel, PEGylated cobalt ferrite nanoparticles, and paclitaxel (PTX). The PEGylated cobalt ferrite nanoparticles showed extremely low cytotoxicity due to the surface modification using PEG chains. The long-term theranostic hydrogel system showed adequate properties to be used for long-term MR theragnosis. In particular, the theranostic hydrogel gradually degraded over 28 days, and the PTX was sustainedly released out from the theranostic hydrogel over the same period in vitro. Furthermore, the in vivo efficacy of long-term MR theragnosis using the theranostic hydrogel system was estimated successfully over 3 weeks by using high field (4.7 T) animal MRI and solid tumor-bearing mice. Based on our results, we expect that this system can supply multiple data regarding a) the progress of therapy and b) the treatment processes via one- or two-time i.t. administration for cases in which surgical approaches are difficult to apply. Meanwhile, cancer patients can be free from the pain of multiple surgical treatments and have the advantage of therapy through a simple i.t. administration. PMID:22189146

  13. Human safety and efficacy of ultraviolet filters and sunscreen products.

    PubMed

    Nash, J F

    2006-01-01

    Ultraviolet (UV) filters are the active ingredients in sunscreens. The concentration and combination of UV filters determine the efficacy of sunscreens as measured by sun protection factor. The safety of individual UV filters, and, more generally, sunscreen products, is a matter of a few related components: objective toxicologic evaluation, phototoxicologic potential, and human health consequences of using products that may reduce some but not all of the solar UV. Of 16 UV filters approved by the US Food and Drug Administration, 9 are used in different combinations in the most currently marketed sunscreens. Most of these compounds are considered safe and effective alone or in combination with other UV filters based on extensive toxicologic/phototoxicologic evaluations and market history. The benefits from proper use of sunscreens outweigh real or perceived human health concerns, establishing a favorable benefit-to-risk ratio. Future UV filters will require complete human safety evaluations alone and in combination with select benchmark ingredients. PMID:16311166

  14. Efficacy and safety of influenza vaccination in children with asthma.

    PubMed

    Patria, Maria Francesca; Tenconi, Rossana; Esposito, Susanna

    2012-04-01

    The mean global prevalence of asthma among children is approximately 12%, making it the most common chronic disease in children. Influenza infection has been associated with complications such as exacerbations of wheezing and asthma, increased airway hyper-reactivity and hospitalization. Although influenza vaccination is recommended for asthmatic patients by all health authorities, vaccination coverage remains significantly lower than expected and is lowest of all in children. Compliance is affected by the uncertainty of parents and physicians concerning the clinical risk of influenza in asthmatic subjects, the benefits of influenza vaccination in preventing asthma exacerbations and the safety of immunization. The aim of this review is to analyze the rationale for using influenza vaccine, discuss the relationship between influenza and the severity of asthmatic episodes and document the efficacy and safety of influenza vaccination in the pediatric asthmatic population. PMID:22551031

  15. Diabetes and gout: efficacy and safety of febuxostat and allopurinol

    PubMed Central

    Becker, M A; MacDonald, P A; Hunt, B J; Jackson, R L

    2013-01-01

    Aim Assess influences of demographics and co-morbidities of gout patients with or without diabetes on safety and efficacy of urate-lowering agents. Methods Post-hoc analysis of 312 diabetic and 1957 non-diabetic gout patients [baseline serum urate levels (sUA) ?8.0?mg/dl] enrolled in a 6-month randomized controlled trial comparing urate-lowering efficacy (ULE) and safety of daily xanthine oxidase inhibitors (XOIs) febuxostat (40?mg or 80?mg) and allopurinol (200?mg or 300?mg). We compared baseline demographic, gout and co-morbid characteristics, ULE, and safety of XOI treatment in diabetic and non-diabetic gout patients. ULE was measured by the proportion of diabetic and non-diabetic patients in each treatment group achieving final visit sUA?Safety was monitored throughout the trial. Results Diabetic gout patients were older, more frequently female, and had longer gout duration. Co-morbidities were more frequent among diabetic patients: cardiovascular disease; impaired renal function; hyperlipidemia; and obesity (body mass index >30?kg/m2) (p?

  16. Safety and efficacy evaluation of lanthanum carbonate for hyperphosphatemia in end-stage renal disease patients.

    PubMed

    Shigematsu, Takashi; Ohya, Masaki; Negi, Shigeo; Masumoto, Asuka R; Nakashima, Yuri M; Iwatani, Yuka; Moribata, Mari K; Yamanaka, Shintaro; Tatsuta, Kouichi; Mima, Toru

    2015-01-01

    In end-stage renal disease patients, various abnormalities of bone mineral metabolism adversely affect mortality. Hyperphosphatemia is known to adversely affect mortality and quality of life in chronic kidney disease patients and has been shown to be involved not only in the onset and progression of secondary hyperparathyroidism but also in vascular calcification. Thus, hyperphosphatemia is the main treatment target indicated in several guidelines for chronic kidney disease-mineral and bone disorder treatment. Phosphate binders are typically required for the management of hyperphosphatemia because dietary phosphorus restriction and phosphorus removal by hemodialysis alone are insufficient. We are able to prescribe five phosphate binders (calcium carbonate, sevelamer HCl, lanthanum carbonate (LaC), bixalomer, and ferric citrate) to Japanese hemodialysis patients. LaC is the most powerful noncalcium-containing phosphate binder for the treatment of hyperphosphatemia. In this chapter, we discuss the efficacy and safety of LaC, the safety of which has been under debate. In particular, we consider its toxic effects on the skeletal system. LaC is effective for hyperphosphatemia treatment in end-stage renal failure patients. It has been shown to be able to decrease serum fibroblast growth factor-23 levels. This result suggests that it may have beneficial effects on the cardiovascular system in patients undergoing renal replacement therapy. However, the effects of LaC remain obscure. Further investigations are required. No negative effects of LaC on bone metabolism or bone morphometry have been reported, but long-term clinical data are needed. © 2015 S. Karger AG, Basel. PMID:26023014

  17. Eslicarbazepine acetate: an update on efficacy and safety in epilepsy.

    PubMed

    Verrotti, Alberto; Loiacono, Giulia; Rossi, Alessandra; Zaccara, Gaetano

    2014-01-01

    Epilepsy is a common neurological disorder. Despite a broad range of commonly used antiepileptic drugs, approximately 30% of patients with epilepsy have drug resistance or encounter significant adverse effects. Eslicarbazepine acetate is a new central nervous system-active compound with anticonvulsant activity whose mechanism of action is by blocking the voltage-gated sodium channel. Eslicarbazepine acetate was approved by the European Medicines Agency and launched onto the European market in 2009 for adjunctive treatment in adult subjects of partial-onset seizures, with or without secondary generalization. This article provides an overview on the recent studies on eslicarbazepine acetate in the treatment of drug-resistant partial epilepsy. Efficacy and safety of this drug for partial-onset seizures were assessed in four randomized clinical trials with responder rates ranged between 17% and 43%. Adverse events were usually mild to moderate in intensity and the most common were dizziness, somnolence, nausea, diplopia, headache, vomiting, abnormal coordination, blurred vision, vertigo and fatigue. Eslicarbazepine acetate is not recommended below 18 years, but a published phase II trial had the main goal to evaluate the pharmacokinetics, efficacy and safety of this drug in pediatric population. Eslicarbazepine acetate appears to be a safe and effective drug with a linear pharmacokinetics, very low potential for drug-drug interactions and therefore it can offer a valid alternative to current antiepileptic drugs. Additionally, it is undergoing investigation for monotherapy in subjects with partial epilepsy, and other neurological and psychiatric disorders. PMID:24225327

  18. Long-term care and the elderly

    E-print Network

    Coe, Norma B

    2005-01-01

    Long-term care expenditures represent one of the largest uninsured financial risks facing the elderly. Medicaid provides incomplete insurance against these costs: unlimited nursing home benefits with a deductible equal to ...

  19. Long Term TOA - M Data and Information

    Atmospheric Science Data Center

    2014-08-06

    ... 30 years to date.   The proposed project utilizes knowledge gained in the last 10 years through CERES data analyses and apply the knowledge to existing data to develop long-term (nearly 30 years) consistent ...

  20. CHAPTER FOUR COLLABORATIVE LONG-TERM ETHNOGRAPHY

    E-print Network

    White, Douglas R.

    for the Tzintzuntzan project was begun in 1998 and is still in progress (see the Tzintzuntzan website, currently available at www.santafe.edu/tarasco/Mexican.html). Through longitudinal analysis, long-term field sites

  1. Emergency Planning and Long-Term Care: Least Paid, Least Powerful, Most Responsible

    Microsoft Academic Search

    Eleanor Krassen Covan; Elizabeth Fugate-Whitlock

    2010-01-01

    As disasters can occur anywhere, planning to avoid emergencies is an international concern. Our research specifically addresses planning for the needs and safety of a vulnerable population, long-term care residents. Our initial purposes in this evaluation research were to assess the utility of a template to gather emergency management information for individual long-term care communities, to report on how prepared

  2. LONG-TERM OUTCOME AFTER PULMONARY ENDARTERECTOMY

    Microsoft Academic Search

    Angelo G. Corsico; Andrea M. D'Armini; Isa Cerveri; Catherine Klersy; Elena Ansaldo; Rosanna Niniano; Elena Gatto; Cristian Monterosso; Marco Morsolini; Salvatore Nicolardi; Corrado Tramontin; Ernesto Pozzi; Mario Viganò

    2008-01-01

    Rationale: There are few follow-up studies on long-term cardiopul- monary function after pulmonary endarterectomy (PEA), the oper- ation of choice for chronic thromboembolic pulmonary hyperten- sion (CTEPH). Objectives: To prospectively evaluate long-term outcome of patients with CTEPH treated with PEA. Methods: Between 1994 and 2006, 157 patients (mean age 55 yr) were treated with PEA at Pavia University Hospital. The

  3. Long-term broadband technology forecasting

    Microsoft Academic Search

    KJELL STORDAHL

    The paper gives an overview of the relevant broadband technologies, describes their market positions and possibilities. Diffusion models are used to make long-term broadband forecasts for the Western European residential market. The forecasts are separated for the main broadband technologies ADSL, ADSL2+\\/VDSL, Cable modem and other technologies (FTTx, BWA) based on market share predictions for each technology. The long-term forecasts

  4. Long-term surveillance plan for the Estes Gulch disposal site near Rifle, Colorado

    SciTech Connect

    NONE

    1997-07-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Estes Gulch disposal site near Rifle, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Estes Gulch disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP.

  5. Interim long-term surveillance plan for the Cheney disposal site near, Grand Junction, Colorado

    SciTech Connect

    NONE

    1997-08-01

    This interim long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Cheney Disposal Site in Mesa County near Grand Junction, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Cheney disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP.

  6. Laparoscopic nephrectomy for renal cell cancer: evaluation of efficacy and safety: a multicenter experience

    Microsoft Academic Search

    Jeffrey A Cadeddu; Yoshinari Ono; Ralph V Clayman; Peter H Barrett; Gunter Janetschek; Donald D Fentie; Elspeth M McDougall; Robert G Moore; Tsuneo Kinukawa; Abdelhamid M Elbahnasy; Joel B Nelson; Louis R Kavoussi

    1998-01-01

    Objectives. Although laparoscopic radical nephrectomy is a safe and minimally invasive alternative to open surgery, the long-term disease-free outcome of this procedure has not been reported. We evaluated our experience with the laparoscopic management of renal cell carcinoma to assess the clinical efficacy of this surgical modality.Methods. Between February 1991 and June 1997, 157 patients at five institutions were retrospectively

  7. Enteral feeding pumps: efficacy, safety, and patient acceptability

    PubMed Central

    White, Helen; King, Linsey

    2014-01-01

    Enteral feeding is a long established practice across pediatric and adult populations, to enhance nutritional intake and prevent malnutrition. Despite recognition of the importance of nutrition within the modern health agenda, evaluation of the efficacy of how such feeds are delivered is more limited. The accuracy, safety, and consistency with which enteral feed pump systems dispense nutritional formulae are important determinants of their use and acceptability. Enteral feed pump safety has received increased interest in recent years as enteral pumps are used across hospital and home settings. Four areas of enteral feed pump safety have emerged: the consistent and accurate delivery of formula; the minimization of errors associated with tube misconnection; the impact of continuous feed delivery itself (via an enteral feed pump); and the chemical composition of the casing used in enteral feed pump manufacture. The daily use of pumps in delivery of enteral feeds in a home setting predominantly falls to the hands of parents and caregivers. Their understanding of the use and function of their pump is necessary to ensure appropriate, safe, and accurate delivery of enteral nutrition; their experience with this is important in informing clinicians and manufacturers of the emerging needs and requirements of this diverse patient population. The review highlights current practice and areas of concern and establishes our current knowledge in this field. PMID:25170284

  8. Long term results of no-alcohol laser epithelial keratomileusis and photorefractive keratectomy for myopia

    PubMed Central

    Spadea, Leopoldo; Verboschi, Francesca; De Rosa, Vittoria; Salomone, Mariella; Vingolo, Enzo Maria

    2015-01-01

    AIM To evaluate the long term clinical results of mechanical no-alcohol-assisted laser epithelial keratomileusis (LASEK) versus standard photorefractive keratectomy (PRK) for low-moderate myopia. METHODS Twenty-five eyes treated with LASEK and twenty-five eyes treated with PRK were evaluated with a mean follow-up duration of 60mo. Mechanical separation of the epithelium was performed with blunt spatula and without application of alcohol. Laser ablation was performed with the MEL-70 excimer laser. All patients were examined daily until epithelial closure; at 1, 3, 6, and 12mo, and every year subsequently. Main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, haze, efficacy and safety indexes. RESULTS Twenty-one eyes and 22 eyes completed follow-up of 60mo in LASEK and PRK group respectively. Manifest refraction at 60mo follow-up was -0.01 and 0.26 in LASEK and PRK group respectively. In the LASEK group mean UDVA and mean CDVA after 60mo were 20/22 and 20/20 respectively (P>0.01). In the PRK group mean UDVA and mean CDVA at 60mo follow-up were 20/20 and 20/20 after 60mo (P>0.01). The efficacy indexes were 0.87 and 0.95, and the safety indexes were 1.25 and 1.4 respectively for LASEK group and PRK group. CONCLUSION Both standard PRK and no-alcohol LASEK offer safe and effective correction of low-moderate myopia in the long term without any statistically significant difference between the two groups. PMID:26086011

  9. Long-Term Effects and Prognosis in Acute Heart Failure Treated with Tolvaptan: The AVCMA Trial

    PubMed Central

    Suzuki, Satoshi; Yoshihisa, Akiomi; Yamaki, Takayoshi; Sugimoto, Koichi; Kunii, Hiroyuki; Nakazato, Kazuhiko; Abe, Yukihiko; Saito, Tomiyoshi; Ohwada, Takayuki; Suzuki, Hitoshi; Saitoh, Shu-ichi; Kubota, Isao; Takeishi, Yasuchika

    2014-01-01

    Background. Diuresis is a major therapy for the reduction of congestive symptoms in acute decompensated heart failure (ADHF) patients. We previously reported the efficacy and safety of tolvaptan compared to carperitide in hospitalized patients with ADHF. There were some reports of cardio- and renal-protective effects in carperitide; therefore, the purpose of this study was to compare the long-term effects of tolvaptan and carperitide on cardiorenal function and prognosis. Methods and Results. One hundred and five ADHF patients treated with either tolvaptan or carperitide were followed after hospital discharge. Levels of plasma B-type natriuretic peptide, serum sodium, potassium, creatinine, and estimated glomerular filtration rate were measured before administration of tolvaptan or carperitide at baseline, the time of discharge, and one year after discharge. These data between tolvaptan and carperitide groups were not different one year after discharge. Kaplan-Meier survival curves demonstrated that the event-free rate regarding all events, cardiac events, all cause deaths, and rehospitalization due to worsening heart failure was not significantly different between tolvaptan and carperitide groups. Conclusions. We demonstrated that tolvaptan had similar effects on cardiac and renal function and led to a similar prognosis in the long term, compared to carperitide. PMID:25436213

  10. [Eslicarbazepine acetate in clinical practice. Efficacy and safety results].

    PubMed

    Serrano-Castro, Pedro J; Payán-Ortiz, Manuel; Cimadevilla, José M; Quiroga-Subirana, Pablo; Fernández-Pérez, Javier

    2013-03-16

    INTRODUCTION. Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) licensed in Spain in February 2011 as an adjunctive therapy in adults with partial seizures with or without secondary generalization. Clinical trials with ESL have demonstrated acceptable efficacy and safety. AIM. To evaluate the results of ESL in our epilepsy unit during its first year of clinical experience with this AED. PATIENTS AND METHODS. We included all patients who started treatment with ESL at our epilepsy unit from March 2011 to May 2012. We collected the following variables: gender, aetiology of epilepsy, epileptogenic area, reason for switch to ESL, clinical response after initiation of ESL, adverse effects of ESL, refractoriness criteria and treatment discontinuation. A bivariate factor-to-factor correlation study was carried out to establish associations between the independent variables and the clinical response. RESULTS. We recruited 105 patients (51.4% male). 20,7% of patients remained seizure-free and 58.4% showed > 50% improvement after introduction of ESL. At 6 months, 18.1% had experienced some type of side effect, with cognitive disorders being the most common, and 11.5% had discontinued treatment. Combination with lacosamide proved to be significantly less effective in the control of seizures. Combination of ESL with the rest of sodium channel inhibitors was similar in efficacy to others combinations. CONCLUSIONS. ESL is a well-tolerated and effective AED when is used as adjunctive treatment with most of other AED in clinical practice. PMID:23483464

  11. Exercise for Depression: Efficacy, Safety and Clinical Trial Implications

    PubMed Central

    Dunlop, Boadie W.; Self, Rachel L.

    2015-01-01

    Exercise is gaining interest as a treatment for major depressive disorder (MDD).Though not yet fully established as an efficacious therapy for psychiatric disorders, exercise has well-established benefits for physcial health and overall well-being. However, there are potential health risks to exercise that need to be considered before recommending physical activity to a patient. We present the case of a 48 year-old woman who develolped significant elevations in creatine kinase and liver enzyme levels after three work-out sessions consisting of cardiovascular training on an elliptical machine and weightlifting. The elevations resolved with rest, then recurred when the patient again began exercising. These elevations occurred while the patient was participating in a double-blind, placebo-control phase II clinical trial of an experimental medication for MDD. This case highlights several aspects of the appropriate implementation of exercise recommendations in the psychiatric setting. Initiation of exercise regimens is not prohibited in clinical trials, and may be self-initiated by the depressed patient or recommended by the treating physician. This case also highlights that the value of placebo controls in clinical trials of experimental treatments applies to safety as well as efficacy factors. Exercise as a treatment for depression carries both potential benefit for depressive symptoms and risk for adverse events. The design of clinical trials would be strengthened by consideration of these effects of exercise in the future. PMID:19015630

  12. A randomized prospective study comparing the efficacy of on-demand therapy versus continuous therapy for 6 months for long-term maintenance with omeprazole 20 mg in patients with gastroesophageal reflux disease in Japan

    PubMed Central

    Hojo, Mariko; Asaoka, Daisuke; Sasaki, Hitoshi; Watanabe, Sumio

    2014-01-01

    Aim To assess the efficacy of continuous therapy (cont) and on-demand therapy (on-demand) as maintenance therapy for gastroesophageal reflux disease (GERD). Methods Patients with upper GI endoscopy (EGD)-proven GERD who completed 8 weeks of initial therapy were randomized to cont (omeprazole 20 mg od) or on-demand (omeprazole 20 mg on-demand) group. Assessments by the Global Overall Symptom (GOS) scale at baseline (at the start of maintenance therapy) and at 8-week, 16–week, and 24-week visits were made and EGD was performed at 24 weeks. Symptom relief was defined as percentages of patients whose GOS score of 1 or 2. Results Of the 117 enrolled patients, cont/on-demand was 59/58 and nonerosive reflux disease (NERD)/reflux esophagitis (RE) before the initial therapy was 35/82. Symptom relief in cont/on-demand were 57.6%/48.3% at baseline (n.s.), 66.7%/54.7% at 8 week (n.s.), 64.6%/54.7% at 16 weeks (n.s.), and 66.7%/74.0% at 24 weeks (n.s.). When subjects were divided into NERD and RE, symptom relief in cont/on-demand were 33.3%/41.2% at baseline (n.s.), 43.8%/64.3% at 8 weeks (n.s.), 50.0%/42.9% at 16 weeks (n.s.), and 50.0%/69.2% at 24 weeks (n.s.) in NERD, while those were 68.3%/51.2% at baseline (n.s.), 76.3%/51.3% at 8 weeks (p < 0.05), 70.6%/59.0% at 16 weeks (n.s.), and 72.7%/75.7% at 24 weeks (n.s.) in RE, respectively. At 24-week EGD, all patients in NERD remained as NERD but number of healed patients was significantly higher in cont (85.3%) than in on-demand (44.4%) (p < 0.01) in RE. Conclusions Since NERD is defined by symptoms, as a result of the limited efficacy of continuous therapy, on-demand therapy would be sufficient as maintenance therapy in NERD patients. Regarding RE, continuous therapy would be recommended in terms of reduced symptoms and maintaining mucosal healing. PMID:24444414

  13. Advanced Diabetic Nephropathy with Nephrotic Range Proteinuria: A Pilot Study of the Long-Term Efficacy of Subcutaneous ACTH Gel on Proteinuria, Progression of CKD, and Urinary Levels of VEGF and MCP-1

    PubMed Central

    Tumlin, J. A.; Galphin, C. M.; Rovin, B. H.

    2013-01-01

    Background and Objective. Adrenocorticotropic hormone (ACTH) is able to reduce proteinuria in nondiabetic glomerulopathies through activation of melanocortin receptors (MCR) expressed in the podocyte. To determine the efficacy of ACTH, we conducted a randomized, open-label pilot trial of ACTH gel in patients with advanced diabetic nephropathy. Study Design. Twenty-three (23) patients with diabetic nephropathy were randomized to daily subcutaneous (SQ) injections of 16 or 32 units of ACTH gel for six months. Outcome. The primary endpoint was the percentage of patients achieving a complete remission (<300?mg/24 hours) within 6 months. Exploratory endpoints included the percentage of partial (50% reduction) remissions, changes in Cr, and urinary cytokine markers. Results. After 6 months of ACTH gel therapy, 8 of 14 (57%) patients achieved a complete (n = 1) or partial (n = 7) remission. In the low-dose ACTH gel group (16 units), urinary protein fell from 6709 + 953 to 2224 + 489?mg/24 hrs (P < 0.001). In contrast, 2 of 6 patients in the 32-unit group achieved partial remission, but aggregate proteinuria (5324 + 751 to 5154 + 853?mg/24 hours) did not change. Urinary VEGF increased from 388 to 1346?pg/mg urinary creatinine (P < 0.02) in the low-dose group but remained unchanged in the high-dose group. Conclusion. ACTH gel stabilizes renal function and reduces urinary protein for up to 6 months after treatment. The ClinTrials.gov identifier is NCT01028287. PMID:24159603

  14. Long-term motor cortex stimulation for phantom limb pain.

    PubMed

    Pereira, Erlick A C; Moore, Tom; Moir, Liz; Aziz, Tipu Z

    2015-04-01

    We present the long-term course of motor cortex stimulation to relieve a case of severe burning phantom arm pain after brachial plexus injury and amputation. During 16-year follow-up the device continued to provide efficacious analgesia. However, several adjustments of stimulation parameters were required, as were multiple pulse generator changes, antibiotics for infection and one electrode revision due to lead migration. Steady increases in stimulation parameters over time were required. One of the longest follow-ups of motor cortex stimulation is described; the case illustrates challenges and pitfalls in neuromodulation for chronic pain, demonstrating strategies for maintaining analgesia and overcoming tolerance. PMID:25340991

  15. The Efficacy, Safety, and Practicality of Treatments for Adolescents with Attention-Deficit\\/Hyperactivity Disorder (ADHD)

    Microsoft Academic Search

    Bradley H. Smith; Daniel A. Waschbusch; Michael T. Willoughby; Steven Evans

    2000-01-01

    Studies examining interventions for adolescents diagnosed with attention-deficit\\/hyperactivity disorder (ADHD) were reviewed to evaluate their efficacy. These efficacy findings were supplemented with a preliminary system for judging safety and practicality. Results suggest that the stimulant drug methylphenidate (MPH) is safe and well-established empirically, but has some problems with inconvenience and noncompliance. Preliminary research supports the efficacy, safety, and practicality of

  16. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

    PubMed Central

    2011-01-01

    Background The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Methods In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843) and II (n = 804), patients were randomised to inhaled aclidinium 200 ?g or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ?70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation. Results At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p < 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p < 0.001). More patients had a SGRQ improvement ?4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p = 0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p = 0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p = 0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p = 0.9). Adverse events were minor in both studies. Conclusion Aclidinium is effective and well tolerated in patients with moderate to severe COPD. Trial registration ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). PMID:21518460

  17. The safety and efficacy of gamma knife surgery in management of glomus jugulare tumor

    PubMed Central

    2010-01-01

    Background Glomus jugulare is a slowly growing, locally destructive tumor located in the skull base with difficult surgical access. The operative approach is, complicated by the fact that lesions may be both intra and extradural with engulfment of critical neurovascular structures. The tumor is frequently highly vascular, thus tumor resection entails a great deal of morbidity and not infrequent mortality. At timeslarge residual tumors are left behind. To decrease the morbidity associated with surgical resection of glomus jugulare, gamma knife surgery (GKS) was performed as an alternative in 13 patients to evaluate its safety and efficacy. Methods A retrospective review of 13 residual or unresectable glomus jagulare treated with GKS between 2004 and 2008.. Of these, 11 patients underwent GKS as the primary management and one case each was treated for postoperative residual disease and postembolization. The radiosurgical dose to the tumor margin ranged between 12-15 Gy. Results Post- gamma knife surgery and during the follow-up period twelve patients demonstrated neurological stability while clinical improvement was achieved in 5 patients. One case developed transient partial 7th nerve palsy that responded to medical treatment. In all patients radiographic MRI follow-up was obtained, the tumor size decreased in two cases and remained stable (local tumor control) in eleven patients. Conclusions Gamma knife surgery provids tumor control with a lowering of risk of developing a new cranial nerve injury in early follow-up period. This procedure can be safely used as a primary management tool in patients with glomus jugulare tumors, or in patients with recurrent tumors in this location. If long-term results with GKS are equally effective it will emerge as a good alternative to surgical resection. PMID:20819207

  18. Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects

    PubMed Central

    Baumann, Leslie; Bruce, Suzanne; Ahluwalia, Gurpreet; Weng, Emily; Daniels, Selena

    2015-01-01

    Objective: To evaluate long-term efficacy and safety of bimatoprost for treatment of chemotherapy-induced eyelash hypotrichosis. Design: One-year, multicenter, double-masked, parallel-group study. Setting: Twenty-one centers in the United States and one center in the United Kingdom. Participants: This study randomized (3:1) 130 subjects to bimatoprost 0.03% or vehicle applied topically to upper eyelid margins for six months. All subjects used bimatoprost for a second six months. Measurements: Responders for the primary composite end point achieved ?1-grade improvement in Global Eyelash Assessment score and ?3-point improvement in Confidence, Attractiveness, and Professionalism domain score of the Eyelash Satisfaction Questionnaire at Month 4. Secondary assessments included eyelash length, thickness, and darkness, using digital image analysis. Results: The responder rate was significantly higher with bimatoprost versus vehicle at Month 4 (37.5% vs. 18.2%; p=0.041) and Month 6 (46.9% vs. 18.2%; p=0.004). Significant improvements favoring bimatoprost occurred in eyelash length (p=0.008), thickness (p<0.001), or darkness (p=0.029) at Month 4, with similar results at Month 6 (p<0.001, length; p<0.001, thickness; p=0.002, darkness). Responder rates reached 61.5 percent at Month 12 for subjects continuing bimatoprost and 67.6 percent for those switched from vehicle to bimatoprost. Conjunctival hyperemia (16.7%) and punctate keratitis (9.4%) were the most common adverse events. Conclusion: Bimatoprost provides rapid eyelash recovery, whether started shortly after chemotherapy (4 to 12 weeks) or delayed for six months, with minimal adverse events. Clinical trial registry: NCT00907426

  19. Resveratrol Based Oral Nutritional Supplement Produces Long-Term Beneficial Effects on Structure and Visual Function in Human Patients

    PubMed Central

    Richer, Stuart; Patel, Shana; Sockanathan, Shivani; Ulanski, Lawrence J.; Miller, Luke; Podella, Carla

    2014-01-01

    Background: Longevinex® (L/RV) is a low dose hormetic over-the-counter (OTC) oral resveratrol (RV) based matrix of red wine solids, vitamin D3 and inositol hexaphosphate (IP6) with established bioavailability, safety, and short-term efficacy against the earliest signs of human atherosclerosis, murine cardiac reperfusion injury, clinical retinal neovascularization, and stem cell survival. We previously reported our short-term findings for dry and wet age-related macular degeneration (AMD) patients. Today we report long term (two to three year) clinical efficacy. Methods: We treated three patients including a patient with an AMD treatment resistant variant (polypoidal retinal vasculature disease). We evaluated two clinical measures of ocular structure (fundus autofluorescent imaging and spectral domain optical coherence extended depth choroidal imaging) and qualitatively appraised changes in macular pigment volume. We further evaluated three clinical measures of visual function (Snellen visual acuity, contrast sensitivity, and glare recovery to a cone photo-stress stimulus). Results: We observed broad bilateral improvements in ocular structure and function over a long time period, opposite to what might be expected due to aging and the natural progression of the patient’s pathophysiology. No side effects were observed. Conclusions: These three cases demonstrate that application of epigenetics has long-term efficacy against AMD retinal disease, when the retinal specialist has exhausted other therapeutic modalities. PMID:25329968

  20. Cross-sectional survey and retrospective analysis of a large cohort of adults with type 1 diabetes with long-term continuous subcutaneous insulin infusion treatment.

    PubMed

    Joubert, Michael; Morera, Julia; Vicente, Angel; Rod, Anne; Parienti, Jean-Jacques; Reznik, Yves

    2014-09-01

    Background. Continuous subcutaneous insulin infusion (CSII) is an established modality for intensive insulin treatment of type 1 diabetes (T1D), but long-term data concerning satisfaction, CSII function use, safety, and efficacy in real-life conditions are scarce. Methods. We analyzed a cohort of adult patients with T1D treated with CSII for more than 1 year in a single diabetes center. We performed a cross-sectional survey in 2010 (tolerance/satisfaction and behavior forms) and a retrospective analysis of medical records (including HbA1c level, hospitalization, and catheter infections). The primary objective was to assess long-term tolerance/satisfaction, and secondary objectives were safety and efficacy. Results. There were 295 patients analyzed. After a median duration of CSII use of 5 years, overall satisfaction was high for about 90% of patients. Mean CSII-related discomfort scores were low for work, recreation, and sleep and moderate for sport and sexual activity (2.5 ± 1.9, 2.6 ± 1.8, 2.6 ± 2.1, 3.4 ± 2.3, and 4.0 ± 2.9 of 10, respectively). Despite a high level of diabetes education, only one third of patients were using advanced CSII functions. During long-term follow-up, the safety of CSII treatment was good; the hospitalization rate was 0.18 patients/year, and catheter infections were scarce. The HbA1c level dropped about -0.5% independently from CSII duration (P < .05). Conclusions. In this adult cohort, satisfaction and tolerance, together with safety, of CSII were maintained at long-term follow up. The sole basic functions of CSII were currently used by patients. A 0.5% decrease in the HbA1c level was maintained during the study period. PMID:24876454

  1. Long Term Forecast ofLong Term Forecast of TsunamisTsunamis

    E-print Network

    Model comparisons: · Inundation field data at Seaside, Oregon · Tide gage measurement at Hilo, Hawaii 3 (Seaside Pilot Study) Long-term Forecast: #12;1- Validated Numerical Code #12;Relocation of emergency Approach (Seaside Pilot Study) Long-term Forecast: #12;2- Development of a high resolution Digital

  2. Long Term Capability Requirements as derived from the Long Term Requirements Study

    Microsoft Academic Search

    J. Brownlee

    2010-01-01

    Of the 38 Long Term Capability Requirements indentified by NATO in the 2009 Long Term Requirements Study, at least four can be directly applied to waterside security research and technology. First, Area Access Control, the capability of controlling access to designated unattended areas and borders, denying or allowing access to appropriate personnel and equipment. It must be capable of monitoring

  3. Long term ground movement of TRISTAN synchrotron

    Microsoft Academic Search

    K. Endo; Y. Ohsawa; M. Miyahara

    1989-01-01

    The long-term ground movement was estimated in a geological survey done in connection with the siting of the TRISTAN-MR (main ring). The movement of the synchrotron magnet mainly results from the structure of the tunnel. If the movement of an individual magnet exceeds a certain threshold limit, it exerts a significant influence on the particle behavior in a synchrotron. The

  4. Long term ecological research and information management

    Microsoft Academic Search

    William K. Michener; John Porter; Mark Servilla; Kristin Vanderbilt

    2011-01-01

    The United States Long Term Ecological Research (LTER) Program has supported research in the ecological and environmental sciences for more than three decades. The Program has grown from six to 26 sites and has been the precursor to a worldwide network of International LTER sites. Extracting knowledge from the massive volume of disparate data collected across ecosystems and decades depends

  5. Dynamics of long-term genomic selection

    Microsoft Academic Search

    Jean-Luc Jannink

    2010-01-01

    BACKGROUND: Simulation and empirical studies of genomic selection (GS) show accuracies sufficient to generate rapid gains in early selection cycles. Beyond those cycles, allele frequency changes, recombination, and inbreeding make analytical prediction of gain impossible. The impacts of GS on long-term gain should be studied prior to its implementation. METHODS: A simulation case-study of this issue was done for barley,

  6. LONG TERM HYDROLOGICAL IMPACT ASSESSMENT (LTHIA)

    EPA Science Inventory

    LTHIA is a universal Urban Sprawl analysis tool that is available to all at no charge through the Internet. It estimates impacts on runoff, recharge and nonpoint source pollution resulting from past or proposed land use changes. It gives long-term average annual runoff for a lan...

  7. Long-Term Memory and Learning

    ERIC Educational Resources Information Center

    Crossland, John

    2011-01-01

    The English National Curriculum Programmes of Study emphasise the importance of knowledge, understanding and skills, and teachers are well versed in structuring learning in those terms. Research outcomes into how long-term memory is stored and retrieved provide support for structuring learning in this way. Four further messages are added to the…

  8. Long-Term Stability of Tutor Performance.

    ERIC Educational Resources Information Center

    Dolmans, Diana H. J. M.; And Others

    1996-01-01

    Examined the extent to which tutor ratings remained stable in the long term by evaluating 291 ratings of 140 tutors at Maastricht University in the Netherlands between 1992 and 1995. The results indicated that, if the aggregated score and overall judgement are used to interpret the precision of individual scores, four and two occasions,…

  9. Neonatal desensitization allows long-term

    E-print Network

    Cai, Long

    for long-term immune protection of human fetal and stem cell­derived neural cells transplanted into the adult rat brain, by desensitizing the host rat to similar cells in the neonatal period, without the need appropriate immunosuppression, neural xenografts in the adult rat or mouse brain are rejected within 2­4 weeks

  10. Foundation work in long-term care.

    PubMed

    LeRoy, Lauren; Treanor, Katherine; Art, Emily

    2010-01-01

    Health foundations have invested in services, research, and advocacy to improve the financing and delivery of long-term services and supports. This article describes some of the broad array of approaches they have taken--in such areas as aging in place, assisted living, "culture change" in nursing homes, quality improvement, augmenting the workforce, and paying for care. PMID:20048379

  11. NATIONAL LONG TERM CARE SURVEY (NLTCS)

    EPA Science Inventory

    National Long Term Care Surveys (NLTCS) are surveys of the entire aged population with a particular emphasis on the functionally impaired. Longitudinal study of the health and well-being of elderly Americans. Information about the population of chronically disabled elderly person...

  12. TOXIC MODELING SYSTEM LONG-TERM (TOXLT)

    EPA Science Inventory

    The Toxic Modeling System Long-Term (TOXLT) is a personal-computer- based model that has been developed in conjunction with the release of the new version of the EPAs Industrial Source Complex (ISC2) Dispersion Models (EPA, 1992) and the promulgation of the EPAs A Tiered Modeling...

  13. Professionalism in Long-Term Care Settings

    ERIC Educational Resources Information Center

    Lubinski, Rosemary

    2006-01-01

    Speech-language pathologists who serve elders in a variety of long-term care settings have a variety of professional skills and responsibilities. Fundamental to quality service is knowledge of aging and communication changes and disorders associated with this process, institutional alternatives, and the changing nature of today's elders in…

  14. Long-term orbital lifetime predictions

    Microsoft Academic Search

    P. E. Dreher; A. T. Lyons

    1990-01-01

    Long-term orbital lifetime predictions are analyzed. Predictions were made for three satellites: the Solar Max Mission (SMM), the Long Duration Exposure Facility (LDEF), and the Pegasus Boiler Plate (BP). A technique is discussed for determining an appropriate ballistic coefficient to use in the lifetime prediction. The orbital decay rate should be monitored regularly. Ballistic coefficient updates should be done whenever

  15. 4, 26712726, 2004 Long-term global

    E-print Network

    Paris-Sud XI, Université de

    with long-term climatological data from the Inter- national Satellite Cloud Climatology Project (ISCCP-D2 The mean monthly shortwave (SW) radiation budget at the top of atmosphere (TOA) was computed on 2 validated against Earth Radiation Budget Ex- periment (ERBE) S4 scanner satellite data (1985

  16. Coats' syndrome: long term follow up

    Microsoft Academic Search

    Devron H Char

    2000-01-01

    AIMTo increase the understanding of the long term results in pseudo-retinoblastoma eyes with infantile Coats' syndrome.METHODSThis study design was a retrospective case review. 10 patients were analysed who were initially referred with a diagnosis of retinoblastoma but had Coats' syndrome on the basis of ocular oncological evaluation. Vision, fundus photography, ultrasonography, and computed tomography scans were obtained and evaluated. Changes

  17. Long-term cropping systems study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This long-term study has been conducted on the Agronomy Farm at ARDC since the early 1970’s. In the beginning, the objectives were mainly related to crop production as affected by different cropping systems. The cropping systems included in the study are Continuous Corn, Soybean, and Sorghum; 2-year...

  18. Long-term US energy outlook

    Microsoft Academic Search

    2009-01-01

    Chase Econometrics summarizes the assumptions underlying long-term US energy forecasts. To illustrate the uncertainty involved in forecasting for the period to the year 2000, they compare Chase Econometrics forecasts with some recent projections prepared by the DOE Office of Policy, Planning and Analysis for the annual National Energy Policy Plan supplement. Scenario B, the mid-range reference case, is emphasized. The

  19. Clinical review: Long-term noninvasive ventilation

    Microsoft Academic Search

    Dominique Robert; Laurent Argaud

    2007-01-01

    Noninvasive positive ventilation has undergone a remarkable evolution over the past decades and is assuming an important role in the management of both acute and chronic respiratory failure. Long-term ventilatory support should be considered a standard of care to treat selected patients following an intensive care unit (ICU) stay. In this setting, appropriate use of noninvasive ventilation can be expected

  20. Long-term variation of total ozone

    Microsoft Academic Search

    R. P. Kane

    1988-01-01

    The long-term variation of total ozone is studied for 1957 up to date for different latitude zones. The 3-year running averages show that, apart from a small portion showing parallelism with sunspot cycles, the trends in different latitude zones are dissimilar. In particular, where northern latitudes show a rising trend, the southern latitudes show an opposite (decreasing) trend. In the

  1. Neonatal desensitization allows long-term survival of neural xenotransplants without immunosuppression.

    PubMed

    Kelly, Claire M; Precious, Sophie V; Scherf, Caroline; Penketh, Richard; Amso, Nazar N; Battersby, Alysia; Allen, Nicholas D; Dunnett, Stephen B; Rosser, Anne E

    2009-04-01

    Preclinical development of human cells for potential therapeutic application in neurodegenerative diseases requires that their long-term survival, stability and functional efficacy be studied in animal models of human disease. Here we describe a strategy for long-term immune protection of human fetal and stem cell-derived neural cells transplanted into the adult rat brain, by desensitizing the host rat to similar cells in the neonatal period, without the need for additional immunosuppression. PMID:19270699

  2. PUBOVAGINAL FASCIAL SLING FOR ALL TYPES OF STRESS URINARY INCONTINENCE: LONG-TERM ANALYSIS

    Microsoft Academic Search

    DAVID C. CHAIKIN; JARROD ROSENTHAL; JERRY G. BLAIVAS

    1998-01-01

    PurposeThere is a lack of consensus regarding indications and long-term efficacy of the many surgical techniques for treating stress incontinence. Historically pubovaginal sling has been reserved for cases of intrinsic sphincter deficiency or prior surgical failure. Transvaginal needle and retropubic suspensions have been used mainly for sphincteric incontinence unassociated with intrinsic sphincter deficiency. We report the long-term results of pubovaginal

  3. Long-term biological investigations in space.

    PubMed

    Lotz, R G; Fuchs, H; Bertsche, U

    1975-01-01

    Missions in space within the next two decades will be of longer duration than those carried out up to the present time, and the effects of such long-term flights on biological organisms are unknown. Results of biological experiments that have been performed to date cannot be extrapolated to results in future flights because of the unknown influence of adaptation over a long period of time. Prior experiments with Axolotl, fishes, and vertebrates by our research team (in part with sounding rockets) showed that these specimens did not appear to be suitable for long-term missions on which minimization of expense, technique, and energy is required. Subsequent investigations have shown the suitability of the leech (Hirudo medicinalis), which consumes blood of mammals up to ten times its own weight (1 g) and can live more than 2 years without further food supply. Emphasis in the experiments with Hirudo medicinalis is placed on metabolic rhythm and motility. Resorption and diffusion in tissue, development, and growth under long-term effects of cosmic proton radiation and zero-gravity are other focal points. The constancy of cellular life in the mature animals is a point in favor of these specimens. We have also taken into account the synergistic effects of the space environment on the problems just mentioned. The life-support system constructed for the leech has been tested successfully in four sounding rocket flights and, on that basis, has been prepared for a long-term mission. Long-term investigations out of the terrestrial biosphere will provide us with information concerning the degree of adaptation of certain physiological and biochemical functions and as to what extent biological readjustment or repair processes can occur under the specific stress conditions of space flight. PMID:11841093

  4. Safety and efficacy of peramivir for influenza treatment

    PubMed Central

    Hata, Atsuko; Akashi-Ueda, Ryoko; Takamatsu, Kazufumi; Matsumura, Takuro

    2014-01-01

    Objective This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic. Methods Literature was accessed via PubMed (January 2000–April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers. Results We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose–response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors. Conclusion Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery. PMID:25368514

  5. Efficacy and Safety of Tribendimidine Against Clonorchis sinensis

    PubMed Central

    Qian, Men-Bao; Yap, Peiling; Yang, Yi-Chao; Liang, Hai; Jiang, Zhi-Hua; Li, Wei; Tan, Yu-Guang; Zhou, Hui; Utzinger, Jürg; Zhou, Xiao-Nong; Keiser, Jennifer

    2013-01-01

    Background.?Clonorchiasis is of considerable public health importance, particularly in the People's Republic of China (PR China), where most of the 15 million individuals infected with Clonorchis sinensis are currently concentrated. Praziquantel is the drug of choice, but tribendimidine might be an alternative. Methods.?We performed a randomized open-label trial in Guangxi, PR China, to assess the efficacy and safety of 400 mg tribendimidine once, 400 mg tribendimidine daily for 3 days, and 75 mg/kg praziquantel in 1 day divided in 3 doses against parasitological-confirmed C. sinensis infections. Cure and egg reduction rates were determined 3 weeks posttreatment using available case analysis. Clinical symptoms were documented at baseline, and adverse events were recorded and graded 3 and 24 hours after each dose. Results.?A total of 74 patients were included in the final analysis. Single-dose tribendimidine achieved a cure rate of 44%, whereas cure rates of 58% and 56% were obtained for tribendimidine administered for 3 days and praziquantel, respectively. High egg reduction rates (97.6%–98.8%) were observed for all treatment regimens. Single-dose tribendimidine was the best-tolerated treatment scheme. Patients treated with praziquantel experienced significantly more adverse events than did tribendimidine recipients (P < .05). Conclusions.?Tribendimidine has an efficacy comparable to praziquantel in the treatment of C. sinensis infection and resulted in fewer adverse events compared to praziquantel. Larger clinical trials are warranted among C. sinensis–infected patients to determine the potential of tribendimidine against clonorchiasis and other helminthiases. Clinical Trials Registration.?Controlled-Trials.com, ISRCTN80829842. PMID:23223597

  6. Development of novel combined anticalcification protocols including immunologic modification for prolonged durability of cardiac xenograft: preclinical study using large-animal long-term circulatory models.

    PubMed

    Lim, Hong-Gook; Jeong, Saeromi; Shin, Jun-Seop; Park, Chung-Gyu; Kim, Yong Jin

    2015-01-01

    Cardiac xenografts are conventionally cross-linked with glutaraldehyde (GA) to impart tissue stability, reduce antigenicity, and maintain tissue sterility. However, GA-fixed xenografts are prone to calcification after long-term implantation in humans, because of phospholipids, free aldehyde groups, and residual antigenicity. We evaluated preclinical safety and efficacy using large-animal long-term circulatory models for our novel combined anticalcification protocol including immunological modification, which had been proven effective in small animal experiments. Bovine/porcine xenografts were treated with decellularization, immunological modification with ?-galactosidase, GA fixation with organic solvent, and detoxification with glycine. Valve conduits made of these xenografts were transplanted into the pulmonary root of goats, and hemodynamic, radiological, immunohistopathological, and biochemical results were obtained for 12 months after implantation. Evaluation of echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the pulmonary xenograft valves. Durability of the xenografts was well preserved without calcification by specimen radiography and immunohistopathological examination. The calcium concentrations of the explanted xenografts were lower than the control xenografts. This preclinical study using large-animal long-term circulatory models demonstrated that our synergistic and simultaneous employment of multiple anticalcification therapies and novel tissue treatments, including immunological modifications, have promising safety and efficacy and should be examined further in future clinical studies. PMID:25303800

  7. Initial and long-term management of autoimmune neuropathies.

    PubMed

    Koski, Carol Lee

    2005-01-01

    The inflammatory neuropathies (chronic inflammatory demyelinating polyradiculoneuropathy [CIDP], Guillain-Barré syndrome [GBS] and multifocal motor neuropathy [MMN]) affect only one to two individuals per 100 000 of the population, but result in major disability and impairment. Intravenous immunoglobulin (IVIg) can be used as an initial treatment for CIDP, GBS and MMN. While plasma exchange and corticosteroids can also be used initially, they are not as uniformly effective for each of these disorders as IVIg. Substituting corticosteroids, plasma exchange or immunosuppressants may be appropriate for patients not responding to initial IVIg therapy, and combination therapy may be needed in some patients. There are no data from controlled clinical trials of long-term management strategies for CIDP and MMN; however, empirical evidence suggests that a positive long-term response to IVIg can be achieved by increasing the initial dose or its frequency of administration. Corticosteroids and immunosuppressants may be appropriate in some patients with CIDP. Adverse events with IVIg are usually mild and not treatment limiting; however, patients do need to be monitored for uncommon, but serious, adverse events such as renal insufficiency, stroke and thromboembolic events. Nevertheless, the safety profile of IVIg is exceptional relative to the potential complications of other long-term treatments for CIDP and MMN, especially corticosteroids and immunosuppressants. Predictors of response have been reported for each of the neuropathies, and until controlled clinical trials provide evidence on which to base treatment strategies, effective management will require individualising therapy according to patient response. PMID:16332144

  8. Investigating Change in Adolescent Self-Efficacy of Food Safety through Educational Interventions

    ERIC Educational Resources Information Center

    Beavers, Amy S.; Murphy, Lindsay; Richards, Jennifer K.

    2015-01-01

    A successfully targeted intervention can influence food safety knowledge, attitudes, and behaviors, as well as encourage participants to recognize their own responsibility for safe food handling. This acknowledgement of an individual's responsibility and capacity to address food safety can be understood as self-efficacy of food safety (SEFS). This…

  9. Ocular hypotensive efficacy and safety of once daily carteolol alginate

    PubMed Central

    Demailly, P.; Allaire, C.; Trinquand, C.

    2001-01-01

    BACKGROUND/AIM—Carteolol is a ? adrenoceptor antagonist used topically to reduce intraocular pressure, typically twice daily. In an effort to provide a once daily dosing regimen, carteolol was formulated with 1% alginic acid. The objective of this study was to evaluate the efficacy and safety of carteolol alginate solution in comparison with standard carteolol solution.?METHODS—This was a double masked, parallel group, multicentre study. Patients with ocular hypertension or open angle glaucoma (n=235) were randomly assigned to receive either carteolol alginate four times daily or standard carteolol solution, twice daily. The masking was maintained through the use of a vehicle in the evening for the alginate group. Patients were evaluated at baseline, 15, 60, and 120 days.?RESULTS—At 0900 (presumed trough) on day 60, mean reductions in intraocular pressure (IOP) from baseline were 6.09 (SD 2.97) and 6.09 (3.18) mm Hg for the standard carteolol and alginate, respectively. At 1100 (presumed peak), mean reductions were 6.51 (2.53) and 6.47 (2.76) mm Hg, respectively. Results were similar at other times (day 15 and day 120). The most common side effect was transient stinging on instillation of drops, which did not differ significantly between groups. There were no differences of note in other ocular or systemic signs or symptoms.?CONCLUSION—The new alginate formulation of carteolol 2% given once daily was as effective as standard carteolol 2% given twice daily with no meaningful differences regarding safety.?? PMID:11466245

  10. Efficacy, safety and immunological actions of butanol-extracted FAHF-2 on peanut anaphylaxis

    PubMed Central

    Srivastava, Kamal; Yang, Nan; Chen, Yuming; Lopez-Exposito, Ivan; Song, Ying; Goldfarb, Joseph; Zhan, Jixun; Sampson, Hugh; Li, Xiu-Min

    2010-01-01

    Background Therapies for peanut allergy (PNA) are urgently needed. Food Allergy Herbal Formula -2 (FAHF-2) has profound therapeutic effects in a murine peanut allergy model and is safe for food allergic adults in clinical trials. However the large FAHF-2 pill-load is not conducive to clinical studies in children. Thus refining FAHF-2 to decrease pill-load is essential for the inclusion of children in clinical trials and to facilitate studying FAHF-2 as a clinically useful botanical drug. Objectives Testing long term efficacy and safety of a butanol-purified extract of FAHF-2 (B-FAHF-2) in a murine model of PNA, and to explore its immunological mechanisms of action. Methods FAHF-2 was purified by butanol extraction. C3H/HeJ mice with established PNA received the 1st course of B-FAHF-2 at 6 mg, twice daily for 7 weeks (PNA/B-FAHF-2) or water (PNA/Sham) and were then challenged immediately after completing the treatment and 6 more times every 1–2 months post treatment up to week 50. Mice then received a second course of B-FAHF-2 treatment at week 52 and were challenged at week 65. In vivo and in vitro immunological effects on T, B and mast cells were also determined. Results Butanol purification reduced the volume of the effective dose ~5 fold. All PNA/B-FAHF-2 mice were completely protected from peanut anaphylaxis until the 5th challenge after the 1st course of treatment, as compared to PNA/sham mice. Partial protection persisted up to 50 weeks. A 2nd treatment course restored complete protection. B-FAHF-2 significantly suppressed Th2 cytokine, IgE and histamine levels in vivo, and showed direct inhibition of Th2, IgE-producing B cells and mast cell activation in vitro. B-FAHF-2 had a high margin of safety. Conclusion and clinical relevance B-FAHF-2 produced long-lasting protection against PN anaphylaxis for approximately half of the murine lifespan without side effects. B-FAHF-2 exhibited direct effects on multiple food allergy effector cells. PMID:21121976

  11. Efficacy and Safety of Vorapaxar as Approved for Clinical Use in the United States

    PubMed Central

    Magnani, Giulia; Bonaca, Marc P.; Braunwald, Eugene; Dalby, Anthony J.; Fox, Keith A. A.; Murphy, Sabina A.; Nicolau, José Carlos; Oude Ophuis, Ton; Scirica, Benjamin M.; Spinar, Jindrich; Theroux, Pierre; Morrow, David A.

    2015-01-01

    Background Vorapaxar is a protease?activated receptor?1 antagonist approved by the U.S. Food and Drug Administration (FDA) for the reduction of thrombotic cardiovascular (CV) events in patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), without a previous stroke or transient ischemic attack (TIA). Methods and Results We examined the efficacy and safety of vorapaxar in the intended use population, considering 20 170 patients randomized in the multinational, double?blinded, placebo?controlled TRA 2°P?TIMI 50 trial. Of these, 16 897 qualified with a history of MI in the prior 2 weeks to 1 year and 3273 with PAD. At baseline 97% of the patients were treated with aspirin, 71% with a thienopyridine, and 93% a statin. At 3 years, the endpoint of CV death, MI, or stroke was significantly reduced with vorapaxar compared with placebo (7.9% versus 9.5%, HR, 0.80; 95% CI 0.73 to 0.89; P<0.001). Vorapaxar also significantly reduced the composite of CV death, MI, stroke, and urgent coronary revascularization (10.1% versus 11.8%, HR, 0.83; 95% CI 0.76 to 0.90; P<0.001), as well as the rate of CV death or MI (P<0.001). The safety endpoint of GUSTO moderate or severe bleeding, was increased in the vorapaxar group (3.7 versus 2.4, HR, 1.55; 95% CI 1.30 to 1.86, P<0.001). Intracranial bleeding (ICH) was 0.6% versus 0.4%, P=0.10 with vorapaxar versus placebo, with fatal bleeding 0.2% versus 0.2%; P=0.70. Conclusions In patients with prior MI or PAD who have not had a previous stroke or TIA, vorapaxar added to standard therapy is effective for long?term secondary prevention of thrombotic CV events, while increasing moderate or severe bleeding. Clinical Trial Registration URL: clinicaltrials.gov Unique Identifier: NCT00526474. PMID:25792124

  12. Current treatment for anorexia nervosa: efficacy, safety, and adherence

    PubMed Central

    Bodell, Lindsay P; Keel, Pamela K

    2010-01-01

    Anorexia nervosa (AN) is a serious psychiatric illness associated with significant medical and psychiatric morbidity, psychosocial impairment, increased risk of death, and chronicity. Given the severity of the disorder, the establishment of safe and effective treatments is necessary. Several treatments have been tried in AN, but few favorable results have emerged. This paper reviews randomized controlled trials in AN, and provides a synthesis of existing data regarding the efficacy, safety, and adherence associated with pharmacologic and psychological interventions. Randomized controlled trials for the treatment of AN published in peer-reviewed journals were identified by electronic and manual searches. Overall, pharmacotherapy has limited benefits in the treatment of AN, with some promising preliminary findings associated with olanzapine, an antipsychotic agent. No single psychological intervention has demonstrated clear superiority in treating adults with AN. In adolescents with AN, the evidence base is strongest for the use of family therapy over alternative individual psychotherapies. Results highlight challenges in both treating individuals with AN and in studying the effects of those treatments, and further emphasize the importance of continued efforts to develop novel interventions. Treatment trials currently underway and areas for future research are discussed. PMID:22110333

  13. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

    PubMed Central

    Ferguson, Gary T; Feldman, Gregory J; Hofbauer, Peter; Hamilton, Alan; Allen, Lisa; Korducki, Lawrence; Sachs, Paul

    2014-01-01

    Background Olodaterol is a long-acting ?2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy. Methods Patients received olodaterol 5 ?g or 10 ?g or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0–3) response (change from baseline), and trough FEV1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks. Results Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 ?g and 10 ?g significantly improved the FEV1 AUC0–3 response (P<0.0001) and trough FEV1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol. Conclusion These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 ?g and 10 ?g in patients with moderate to very severe COPD continuing with usual-care maintenance therapy. PMID:24966672

  14. Case presentation: long-term treatment.

    PubMed

    Glucksman, Myron L

    2013-01-01

    The long-term (14 years) psychodynamic psychotherapy and pharmacotherapy of a depressed, suicidal, self-mutilating female patient is described. Her diagnoses included Chronic Posttraumatic Stress Disorder, Borderline Personality Disorder, and Recurrent Major Depression. Treatment was punctuated with repeated hospitalizations for self-mutilation (cutting) and suicidal ideation. A major determinant for her psychopathology was sexual abuse by her father from ages 6 to 14. This resulted in feelings of guilt and rage that she repressed and acted out through self-mutilating and suicidal behavior. A prolonged negative transference gradually became ambivalent, then positive. This was associated with her internalization of the healing qualities of the therapeutic relationship. She also gained insight into the reasons for her need to punish herself. Her initial self-representation as unworthy and bad was transformed into perceiving herself as a worthwhile, loving person. This case illustrates the role of long-term treatment for a complex, life-threatening, psychiatric disorder. PMID:24001161

  15. Emotional behavior in long-term marriage

    Microsoft Academic Search

    Laura L. Carstensen; John M. Gottman; Robert W. Levenson

    1995-01-01

    In exploring the emotional climate of long-term marriages, this study used an observational coding system to identify specific emotional behaviors expressed by middle-aged and older spouses during discussions of a marital problem. One hundred and fifty-six couples differing in age and marital satisfaction were studied. Emotional behaviors expressed by couples differed as a function of age, gender, and marital satisfaction.

  16. Assessing long term backache after childbirth.

    PubMed Central

    Russell, R; Groves, P; Taub, N; O'Dowd, J; Reynolds, F

    1993-01-01

    OBJECTIVES--To investigate the factors associated with long term backache after childbirth, to assess all women reporting new onset long term backache, and to investigate any relation with pain relief in labour. DESIGN--Data collected from obstetric records and postal questionnaires or telephone interviews on morbidity after childbirth from all women delivering their first baby between March 1990 and February 1991, followed by analysis of data collected from outpatient consultations. SETTING--St Thomas's Hospital, London. SUBJECTS--Questionnaires were sent to 1615 women who had delivered their first baby in the defined period; 1015 either replied by post or were contacted by telephone. RESULTS--299 women (29.5% of responders) reported backache lasting more than six months and of these 156 (15.4%) said they had had no back problems previously. Those women who had received epidural analgesia in labour were significantly more likely to report new onset backache (17.8%; 95% confidence interval 14.8% to 20.8%) than those who did not (11.7%; 8.6% to 14.8%). Younger women, unmarried women, and those reporting other antenatal symptoms were significantly more likely to report new long term backache. The 156 women reporting new backache were asked to attend an outpatient clinic and 36 (23%) did so. The majority had a postural backache which was not severe. Psychological factors were present in 14 women. CONCLUSIONS--Though new long term backache is reported more commonly after epidural analgesia in labour, it tends to be postural and not severe. There were no differences in the nature of the backache between those who had or had not received epidural analgesia in labour. PMID:8518569

  17. Long-term sequelae of electrical injury

    PubMed Central

    Wesner, Marni L.; Hickie, John

    2013-01-01

    Abstract Objective To summarize the current evidence-based knowledge about the long-term sequelae of injuries from electrical current. Quality of evidence MEDLINE was searched for English-language articles published in the past 20 years using the following search terms: electrical, injuries, wound, trauma, accident, sequelae, long-term, follow-up, and aftereffects. For obvious reasons, it is unethical to randomly study electrical injury in controlled clinical trials. By necessity, this topic is addressed in less-rigorous observational and retrospective work and case studies. Therefore, the strength of the literature pertaining to the long-term sequelae of electrical injury is impaired by the necessity of retrospective methods and case studies that typically describe small cohorts. Main message There are 2 possible consequences of electrical injury: the person either survives or dies. For those who survive electrical injury, the immediate consequences are usually obvious and often require extensive medical intervention. The long-term sequelae of the electrical injury might be more subtle, pervasive, and less well defined, but can include neurologic, psychological, and physical symptoms. In the field of compensation medicine, determining causation and attributing outcome to an injury that might not result in objective clinical findings becomes a considerable challenge. Conclusion The appearance of these consequences of electrical injury might be substantially delayed, with onset 1 to 5 or more years after the electrical injury. This poses a problem for patients and health care workers, making it hard to ascribe symptoms to a remote injury when they might not arise until well after the incident event. PMID:24029506

  18. Long term economic relationships from cointegration maps

    NASA Astrophysics Data System (ADS)

    Vicente, Renato; Pereira, Carlos de B.; Leite, Vitor B. P.; Caticha, Nestor

    2007-07-01

    We employ the Bayesian framework to define a cointegration measure aimed to represent long term relationships between time series. For visualization of these relationships we introduce a dissimilarity matrix and a map based on the sorting points into neighborhoods (SPIN) technique, which has been previously used to analyze large data sets from DNA arrays. We exemplify the technique in three data sets: US interest rates (USIR), monthly inflation rates and gross domestic product (GDP) growth rates.

  19. Posterior urethral valves: long-term outcome

    Microsoft Academic Search

    Paolo Caione; Simona Gerocarni Nappo

    Posterior urethral valves represent the most common cause of bladder outlet obstruction in infancy that impairs renal and\\u000a bladder function. Long-term outcome of patients with previous PUV is evaluated. Patients over 18 years of age, treated from\\u000a 1982 to 1995 before the age of 3 years were considered. Previous surgery, renal function, bladder activity, urinary incontinence,\\u000a and fertility\\/sexual activity were evaluated. Clinical

  20. Synaptic tagging and long-term potentiation

    Microsoft Academic Search

    Uwe Frey; Richard G. M. Morris

    1997-01-01

    Repeated stimulation of hippocampal neurons can induce an immediate and prolonged increase in synaptic strength that is called long-term potentiation (LTP)-the primary cellular model of memory in the mammalian brain1. An early phase of LTP (lasting less than three hours) can be dissociated from late-phase LTP by using inhibitors of transcription and translation2-8. Because protein synthesis occurs mainly in the

  1. Long-term health consequences of PCOS

    Microsoft Academic Search

    Robert A. Wild

    2002-01-01

    The prevalence of cardiovascular risk factors, insulin resistance\\/diabetes and\\/or uterine pathology appears to be increased in women with polycystic ovarian syndrome (PCOS), although more outcome studies are necessary to determine incidence. Data pertaining to some of the potential long-term health consequences associated with PCOS are summarized. Medline, Current Contents and PubMed were searched for studies from the time of our

  2. Long-term Variation of AGNs

    NASA Astrophysics Data System (ADS)

    Fan, J. H.; Xie, G. Z.; Adam, G.; Copin, Y.; Lin, R. G.; Bai, J. M.; Quin, Y. P.

    In this paper we will present the long-term variation in the optical and the infrared bands for some selected AGNs. 1. Some new optical data observed by us have been presented for BL Lacertae (1995-1996) and OJ 287 (1994-1995), and new infrared data are presented for OJ 287 (Nov=2E 1995), which corresponds to the second optical peak (Sillanpaa et al. 1996; Takalo et al. 1996) and during last outburst. 2. For objects with long term observations, the Jurkevich's method has been used to analyses the long-term variation period. It is interesting that the reported periods of AGNs are of the similar value of about 10 years: 3C 345 11.4 years (Webb et al. 1988), 3C 120 15 years (Belokon et al. 1987; Hagen-Thorn et al. 1997), ON 231 13.6 years (Liu et al. 1995), OJ 287 12 years (Sillanpaa et al. 1988; Kidger et al. 1992), PKS 0735+178 14 years (Fan et al. 1997), NGC 4151 15 years (Fan et al. 1998a), BL Lacertae 14.0 years (Fan et al. 1998b). Is the mechanism for the long-term variation the same for different AGNs? 3. The DCF method has been adopted to analysis the variation correlation in the optical and infrared bands for BL Lac object OJ 287, the results show that these two bands are strongly correlated, which suggest that the emission mechanism in the two bands is the same. 4. For the optical and infrared bands, the maximum variations are correlated.

  3. Long-term ambulatory enterogastric reflux monitoring

    Microsoft Academic Search

    Paolo Bechi; Filippo Pucciani; Francesco Baldini; Franco Cosi; Riccardo Falciai; Roberto Mazzanti; Antonio Castagnoli; Alessandro Passeri; Sergio Boscherini

    1993-01-01

    A new technique for the long-term ambulatory detection of enterogastric and nonacid gastroesophageal reflux has been conceived, developed, and validated. It is based on the use of a fiberoptic sensor that utilizes the optical properties of bile.In vitro studies have shown good precision, good stability, sensitivity of 2.5 µmol\\/liter bilirubin concentration, as well as a useful working range of 2.5–100

  4. Withdrawal from long-term benzodiazepine treatment

    Microsoft Academic Search

    H Petursson; M H Lader

    1981-01-01

    Long-term, normal-dose benzodiazepine treatment was discontinued in 16 patients who were suspected of being dependent on their medication. The withdrawal was gradual, placebo-controlled, and double-blind. All the patients experienced some form of withdrawal reaction, which ranged from anxiety and dysphoria to moderate affective and perceptual changes. Symptom ratings rose as the drugs were discontinued, but usually subsided to prewithdrawal levels

  5. Long-term EEG in children.

    PubMed

    Montavont, A; Kaminska, A; Soufflet, C; Taussig, D

    2015-03-01

    Long-term video-EEG corresponds to a recording ranging from 1 to 24 h or even longer. It is indicated in the following situations: diagnosis of epileptic syndromes or unclassified epilepsy, pre-surgical evaluation for drug-resistant epilepsy, follow-up of epilepsy or in cases of paroxysmal symptoms whose etiology remains uncertain. There are some specificities related to paediatric care: a dedicated pediatric unit; continuous monitoring covering at least a full 24-hour period, especially in the context of pre-surgical evaluation; the requirement of presence by the parents, technician or nurse; and stronger attachment of electrodes (cup electrodes), the number of which is adapted to the age of the child. The chosen duration of the monitoring also depends on the frequency of seizures or paroxysmal events. The polygraphy must be adapted to the type and topography of movements. It is essential to have at least an electrocardiography (ECG) channel, respiratory sensor and electromyography (EMG) on both deltoids. There is no age limit for performing long-term video-EEG even in newborns and infants; nevertheless because of scalp fragility, strict surveillance of the baby's skin condition is required. In the specific context of pre-surgical evaluation, long-term video-EEG must record all types of seizures observed in the child. This monitoring is essential in order to develop hypotheses regarding the seizure onset zone, based on electroclinical correlations, which should be adapted to the child's age and the psychomotor development. PMID:25687590

  6. Long-Term Efficacy of Postpartum Intravenous Iron Therapy

    PubMed Central

    Zimmermann, Roland

    2014-01-01

    Background. The potential benefits of administering a dose of intravenous iron in patients with moderate postpartum anaemia rather than oral iron alone remains unproven. Aims. To determine whether a single injection of intravenous iron followed by a 6-week course of oral iron is as effective over 6 months in restoring normal haemoglobin levels and replenishing iron stores in women with moderate postpartum anaemia as a course of oral iron alone in women with mild postpartum anaemia. Materials and Methods. Retrospective two-arm cohort study in women with mild postpartum anaemia (haemoglobin 9.6–10.5?g/dL) prescribed iron daily for 6 weeks (N = 150) and women with moderate postpartum anaemia (haemoglobin 8.5–9.5?g/dL), given a single 500?mg injection of intravenous iron followed by iron daily for 6 weeks (N = 75). Haemoglobin and ferritin were measured 6 months postpartum. Results. Haemoglobin returned to similar mean levels in both groups. Ferritin levels were statistically significantly higher in the intravenous + oral group (57.7 ± 49.3??g/L versus 32.9 ± 20.1??g/L). Conclusions. Despite lower baseline haemoglobin, intravenous iron carboxymaltose was superior to oral iron alone in replenishing iron stores in moderate postpartum anaemia and may prove similarly beneficial in mild postpartum anaemia. PMID:25431768

  7. Evaluation of the efficacy and safety of etoricoxib compared with naproxen in two, 138?week randomised studies of patients with osteoarthritis

    PubMed Central

    Reginster, J Y; Malmstrom, K; Mehta, A; Bergman, G; Ko, A T; Curtis, S P; Reicin, A S

    2007-01-01

    Objectives To assess the efficacy and safety of etoricoxib 60?mg once daily and naproxen 500?mg twice daily over a 138?week treatment period in patients with osteoarthritis (OA). Methods Two 1?year randomised, double blind, parallel group two?part base studies (part I 12?weeks; part II 40?weeks), followed by an 86?week extension, in patients with OA (hip or knee) were conducted at 80 clinical centres (19 countries). The studies had identical designs. Patients taking placebo in part I received etoricoxib or naproxen (1:1 ratio) in part II and the extension; patients taking etoricoxib or naproxen in part I continued to receive the same treatment throughout the entire length of the studies. Co?primary efficacy end points were patient global assessment of disease status, and WOMAC questionnaire pain subscale and physical function subscale (100?mm VAS). Efficacy over 138 weeks was assessed by graphical analysis. Safety was assessed by observation of adverse experiences and laboratory and physical evaluations. Results 997 patients entered (615 completed) the base studies. Of these patients, 463 patients entered the extensions. A total of 161 and 152 patients in the etoricoxib and naproxen groups, respectively, completed 138 treatment weeks. Etoricoxib and naproxen showed similar efficacy throughout the 138?weeks of treatment. For etoricoxib and naproxen, respectively, WOMAC pain assessments were 67 and 67?mm (baseline); 28 and 29?mm (1 year), and 34 and 33?mm (138 weeks). Results for the other efficacy end points were similar to those seen with the WOMAC pain assessments. Both etoricoxib and naproxen were generally well tolerated. Conclusion Both etoricoxib and naproxen demonstrated long?term clinical efficacy for the treatment of OA. Etoricoxib and naproxen were generally well tolerated. PMID:17142385

  8. Safety and efficacy of Vagus Nerve Stimulation in treatment-resistant depression. A systematic review

    Microsoft Academic Search

    Claire Daban; Anabel Martinez-Aran; Nuria Cruz; Eduard Vieta

    2008-01-01

    ObjectiveThe main objective of this review of the literature was to evaluate the safety and efficacy of Vagus Nerve Stimulation (VNS) in treatment-resistant depression (TRD) by means of systematic review and meta-analysis.

  9. Therapist-Assisted, Self-Administered Bibliotherapy to Enhance Parental Competence: Short- and Long-Term Effects

    ERIC Educational Resources Information Center

    Hahlweg, Kurt; Heinrichs, Nina; Kuschel, Annett; Feldmann, Marit

    2008-01-01

    The efficacy of bibliotherapy has primarily been investigated in anxiety disorders, depression, or substance dependence. The efficacy of self-help books to increase parenting competence was only investigated in a few studies despite their broad dissemination in public. The aims of the study were to investigate the short- and long-term efficacy of…

  10. Efficacy and safety of budesonide\\/formoterol in the management of chronic obstructive pulmonary disease

    Microsoft Academic Search

    W. Szafranski; A. Cukier; A. Ramirez; G. Mengaz; R. Sansores; S. Nahabedian; S. Peterson; H. Olsson

    2003-01-01

    Efficacy and safety of budesonide\\/formoterol in the management of chronic obstructive pulmonary disease. W. Szafranski, A. Cukier, A. Ramirez, G. Menga, R. Sansores, S. Nahabedian, S. Peterson, H. Olsson. #ERS Journals Ltd 2003. ABSTRACT: The efficacy and safety of budesonide\\/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease

  11. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study

    PubMed Central

    Fiore, Maria; La Vecchia, Carlo; Marzuillo, Carolina; Gualano, Maria Rosaria; Liguori, Giorgio; Cicolini, Giancarlo; Capasso, Lorenzo; D'Amario, Claudio; Boccia, Stefania; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo

    2015-01-01

    Objective To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes), directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both. Design Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up. Data Sources Direct contact and structured questionnaires by phone or via internet. Methods Adults (30–75 years) were included if they were smokers of ?1 tobacco cigarette/day (tobacco smokers), users of any type of e-cigarettes, inhaling ?50 puffs weekly (e-smokers), or smokers of both tobacco and e-cigarettes (dual smokers). Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence. Main Outcome Measures Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily. Data Synthesis We used linear and logistic regression, with region as cluster unit. Results Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%). All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35–8.02), whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall). Conclusions Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e-cigarettes alone may facilitate quitters remaining so. Registration Number NCT01785537. PMID:26061661

  12. Non-intrusive long-term monitoring approaches

    SciTech Connect

    Smathers, D.; Mangan, D.

    1998-08-01

    In order to promote internatinal confidence that the US and Russia are disarming per their commitments under Article 6 of the Non-Proliferation Treaty, an international verification regime may be applied to US and Russian excess fissile materials. Initially, it is envisioned that this verification regime would be applied at storage facilities; however, it should be anticipated that the verificatino regime would continue throughout any material disposition activities, should such activities be pursued. once the materials are accepted into the verification regime, it is assumed that long term monitoring will be used to maintain continuity of knowledge. The requirements for long term storage monitoring include unattended operation for extended periods of time, minimal intrusiveness on the host nation`s safety and security activities, data collection incorporating data authentication, and monitoring redundancy to allow resolution of anomalies and to continue coverage in the event of equipment failures. Additional requirements include effective data review and analysis processes, operation during storage facility loading, procedure for removal of inventory items for safety-related surveillance, and low cost, reliable equipment. A monitoring system might include both continuous monitoring of storagecontainers and continuous area monitoring. These would be complemented with periodic on-site inspections. A fissile material storage facility is not a static operation. The initial studies have shown there are a number of volid reasions why a host nation may need them to remove material from the storage facility. A practical monitoring system must be able to accommodate necessary material movements.

  13. Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With

    E-print Network

    Napp, Nils

    Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life- threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD

  14. Safety and impact on cardiovascular events of long-term multifactorial treatment in patients with metabolic syndrome and abnormal liver function tests: a post hoc analysis of the randomised ATTEMPT study

    PubMed Central

    Athyros, Vassilios G.; Giouleme, Olga; Ganotakis, Emmanouel S.; Elisaf, Moses; Tziomalos, Konstantinos; Vassiliadis, Themistoklis; Liberopoulos, Evangelos N.; Theocharidou, Eleni; Karagiannis, Asterios; Mikhailidis, Dimitri P.

    2011-01-01

    Introduction Non-alcoholic fatty liver disease (NAFLD), a hepatic manifestation of metabolic syndrome (MetS), is common and accounts for 80% of cases of elevated liver function tests (LFTs). We assessed the long-term effects of multifactorial intervention on LFTs and their association with cardiovascular disease (CVD) events in patients with MetS without diabetes mellitus or CVD. Material and methods This prospective, randomized, open label study included 1,123 patients (aged 45-65 years). Patients received intensive lifestyle intervention and pharmacotherapy: atorvastatin in all patients (low density lipoprotein cholesterol [LDL-C] targets of<100 mg/dl [group A] or<130 mg/dl [group B]), inhibitors of the renin-angiotensin-aldosterone axis for hypertension, metformin for dysglycaemia and orlistat for obesity. Results Among participants, 326 had modestly elevated LFTs and ultrasonographic (US) evidence of NAFLD (165 patients in group A2 and 161 patients in group B2). The NAFLD resolved during the 42-month treatment period in 86% of patients in group A2 and in 74% of patients in group B2 (p<0.001). In both groups nearly 90% of patients attained lipid goals. Mean LDL-C and TG levels were higher in group B2 than in group A2 (p<0.001). There were no CVD events in group A2 whereas 5 non-fatal events occurred in group B2 (log-rank-p = 0.024). There were no major side-effects. Conclusions Attaining multiple treatment targets is safe and beneficial in primary prevention patients with MetS and NAFLD. Lipid levels and LFTs normalized, US findings associated with NAFLD resolved and no CVD events occurred in patients with LDL-C levels<100 mg/dl (group A2). Resolution of NAFLD might have contributed to the prevention of CVD events. PMID:22291824

  15. The Safety, Pharmacokinetics, and Efficacy of Intraocular Celecoxib

    PubMed Central

    Kim, Stephen J.; Toma, Hassanain; Shah, Rohan; Kompella, Uday B.; Vooturi, Sunil K.; Sheng, Jinsong

    2014-01-01

    Purpose. To determine safety, pharmacokinetics, and anti-inflammatory effects of intraocular celecoxib. Methods. The right eye of animals was injected with 1.5, 3, or 6 mg celecoxib prepared in dimethyl sulfoxide (DMSO). Left eyes served as controls and received 0.1 mL DMSO. Electroretinograms (ERG) were obtained at baseline and at 1, 4, and 12 weeks, and eyes were enucleated afterward for histopathologic analysis. For pharmacokinetics, 3 mg celecoxib was injected, and vitreous and retina/choroid drug levels were then analyzed at specific time points. For efficacy, 1 ?g lipopolysaccharide was injected to induce inflammation; the right eye was then injected with 3 mg celecoxib (six eyes) or 2 mg triamcinolone acetonide (six eyes) and the left eye with saline. Twenty-four hours later, aqueous fluid was removed, and total leukocyte concentration and prostaglandin E2 (PGE2) concentration were determined. Results. Histologic and ERG studies demonstrated no signs of retinal or optic nerve toxicity. After a single 3-mg injection, vitreous (0.06 ?g/mL) and retina/choroid (132.31 ?g/g) celecoxib concentrations at 8 weeks exceeded median inhibitory concentration. Treatment with celecoxib and triamcinolone significantly reduced total leukocyte count by 40% (P = 0.02) and 31% (P = 0.01), respectively. Reduction in PGE2 levels paralleled reduction in leukocyte counts (P < 0.05). There was no increase in intraocular pressure, but cataract formation was observed at higher concentrations. Conclusions. Intraocular injection of celecoxib appeared to be nontoxic and demonstrated excellent penetration into the retina/choroid and sustained drug levels out to 8 weeks. Celecoxib demonstrated potent anti-inflammatory effects, but there was an association with cataract formation at higher doses. PMID:24458149

  16. Long-term outcomes of stapled hemorrhoidopexy

    PubMed Central

    Michalik, Maciej; Bobowicz, Maciej; Witzling, Mieczys?aw

    2013-01-01

    Introduction Hemorrhoidal disease is one of the commonest anorectal disorders worldwide. Stapled hemorrhoidopexy (SH) is a treatment modality associated with low postoperative pain and early mobilization. Aim To assess long-term outcomes after SH. Material and methods All 326 patients who underwent SH in 1999–2003 were invited by mail to participate. For each patient we analyzed their medical records, and conducted a questionnaire survey and a digital rectal examination. Results Only 91 patients attended the final examination and the mean ± SD follow-up time was 8.7 ±1.2 years. Recurrences were diagnosed in one third of the 91 subjects. There were correlations between recurrences and: the duration of disease (p = 0.047); female gender (p = 0.037); and childbirth (vaginal delivery) (p = 0.026). Sixty-seven patients (73.6%) were satisfied with the outcomes. In the group of dissatisfied patients symptoms such as pain (p = 0.0001), burning (p = 0.0002) and itching (p = 0.014) were most common. Long-term outcomes were good with 75% and 88% reductions in pain sensation and severe and moderate hemorrhoidal bleeding. Pruritus, burning and discomfort resolved in more than 50% of patients. Flatus incontinence, fecal incontinence, or soiling occurred in 21%, 11%, and 32% of patients. Conclusions Long-term results of stapled hemorrhoidopexy are satisfactory in most patients. The 36% recurrence rate correlates with the degree of hemorrhoidal prolapse before the operation, duration of the disease, female gender, and previous vaginal delivery. PMID:24729805

  17. Long-term EARLINET dust observations

    NASA Astrophysics Data System (ADS)

    Mona, Lucia; Amiridis, Vassilis; Amodeo, Aldo; Binietoglou, Ioannis; D'Amico, Giuseppe; Schwarz, Anja; Papagiannopoulos, Nikolaos; Papayannis, Alexandros; Sicard, Michael; Comeron, Adolfo; Pappalardo, Gelsomina

    2015-04-01

    Systematic observations of Saharan dust events over Europe are performed from May 2000 by EARLINET, the European Aerosol Research LIdar NETwork. EARLINET is a coordinated network of stations that make use of advanced lidar methods for the vertical profiling of aerosols. The backbone of EARLINET network is a common schedule for performing the measurements and the quality assurance of instruments/data. Particular attention is paid to monitoring the Saharan dust intrusions over the European continent. The geographical distribution of the EARLINET stations is particularly appealing for the dust observation, with stations located all around the Mediterranean and in the center of the Mediterranean (Italian stations) where dust intrusions are frequent, and with several stations in the central Europe where dust penetrates occasionally. All aerosol backscatter and extinction profiles related to observations collected during these alerts are grouped in the devoted "Saharan dust" category of the EARLINET database. This category consists of about 4700 files (as of December 2013). Case studies involving several stations around Europe selected from this long-term database have been provided the opportunity to investigate dust modification processes during transport over the continent. More important, the long term EARLINET dust monitoring allows the investigation of the horizontal and vertical extent of dust outbreaks over Europe and the climatological analysis of dust optical intensive and extensive properties at continental scale. This long-term database is also a unique tool for a systematic comparison with dust model outputs and satellite-derived dust products. Because of the relevance for both dust modeling and satellite retrievals improvement, results about desert dust layers extensive properties as a function of season and source regions are investigated and will be presented at the conference. First comparisons with models outputs and CALIPSO dust products will be presented. ACKNOWLEDGMENTs The financial support by the European Community through the ACTRIS Research Infrastructure Action under the 7th Framework Programme under ACTRIS Grant Agreement n° 262254 is gratefully acknowledged.

  18. Long-Term Recency in Anterograde Amnesia.

    PubMed

    Talmi, Deborah; Caplan, Jeremy B; Richards, Brian; Moscovitch, Morris

    2015-01-01

    Amnesia is usually described as an impairment of a long-term memory (LTM) despite an intact short-term memory (STM). The intact recency effect in amnesia had supported this view. Although dual-store models of memory have been challenged by single-store models based on interference theory, this had relatively little influence on our understanding and treatment of amnesia, perhaps because the debate has centred on experiments in the neurologically intact population. Here we tested a key prediction of single-store models for free recall in amnesia: that people with amnesia will exhibit a memory advantage for the most recent items even when all items are stored in and retrieved from LTM, an effect called long-term recency. People with amnesia and matched controls studied, and then free-recalled, word lists with a distractor task following each word, including the last (continual distractor task, CDFR). This condition was compared to an Immediate Free Recall (IFR, no distractors) and a Delayed Free Recall (DFR, end-of-list distractor only) condition. People with amnesia demonstrated the full long-term recency pattern: the recency effect was attenuated in DFR and returned in CDFR. The advantage of recency over midlist items in CDFR was comparable to that of controls, confirming a key prediction of single-store models. Memory deficits appeared only after the first word recalled in each list, suggesting the impairment in amnesia may emerge only as the participant's recall sequence develops, perhaps due to increased susceptibility to output interference. Our findings suggest that interference mechanisms are preserved in amnesia despite the overall impairment to LTM, and challenge strict dual-store models of memory and their dominance in explaining amnesia. We discuss the implication of our findings for rehabilitation. PMID:26046770

  19. Long-Term Recency in Anterograde Amnesia

    PubMed Central

    Talmi, Deborah; Caplan, Jeremy B.; Richards, Brian; Moscovitch, Morris

    2015-01-01

    Amnesia is usually described as an impairment of a long-term memory (LTM) despite an intact short-term memory (STM). The intact recency effect in amnesia had supported this view. Although dual-store models of memory have been challenged by single-store models based on interference theory, this had relatively little influence on our understanding and treatment of amnesia, perhaps because the debate has centred on experiments in the neurologically intact population. Here we tested a key prediction of single-store models for free recall in amnesia: that people with amnesia will exhibit a memory advantage for the most recent items even when all items are stored in and retrieved from LTM, an effect called long-term recency. People with amnesia and matched controls studied, and then free-recalled, word lists with a distractor task following each word, including the last (continual distractor task, CDFR). This condition was compared to an Immediate Free Recall (IFR, no distractors) and a Delayed Free Recall (DFR, end-of-list distractor only) condition. People with amnesia demonstrated the full long-term recency pattern: the recency effect was attenuated in DFR and returned in CDFR. The advantage of recency over midlist items in CDFR was comparable to that of controls, confirming a key prediction of single-store models. Memory deficits appeared only after the first word recalled in each list, suggesting the impairment in amnesia may emerge only as the participant’s recall sequence develops, perhaps due to increased susceptibility to output interference. Our findings suggest that interference mechanisms are preserved in amnesia despite the overall impairment to LTM, and challenge strict dual-store models of memory and their dominance in explaining amnesia. We discuss the implication of our findings for rehabilitation. PMID:26046770

  20. Long-term interferon-? treatment formultiple sclerosis

    Microsoft Academic Search

    R. M. Ruggieri; N. Settipani; L. Viviano; M. Attanasio; L. Giglia; P. Almasio; V. La Bella; F. Piccoli

    2003-01-01

    \\u000a Abstract.\\u000a   The aim of our study was to analyze the dropout rate in\\u000apatients with relapsing-remitting multiple sclerosis (RRMS)\\u000aunder long-term treatment with the three commercially available\\u000ainterferon beta (IFN) preparations. According to the drug\\u000ataken, we divided 122 RRMS patients into 4 groups: Betaferon\\u000agroup, 56 patients taking INF-1b (24 MIU weekly, subcutaneous\\u000ainjections); Avonex group, 38 patients taking

  1. Human Behaviour in Long-Term Missions

    NASA Technical Reports Server (NTRS)

    1997-01-01

    In this session, Session WP1, the discussion focuses on the following topics: Psychological Support for International Space Station Mission; Psycho-social Training for Man in Space; Study of the Physiological Adaptation of the Crew During A 135-Day Space Simulation; Interpersonal Relationships in Space Simulation, The Long-Term Bed Rest in Head-Down Tilt Position; Psychological Adaptation in Groups of Varying Sizes and Environments; Deviance Among Expeditioners, Defining the Off-Nominal Act in Space and Polar Field Analogs; Getting Effective Sleep in the Space-Station Environment; Human Sleep and Circadian Rhythms are Altered During Spaceflight; and Methodological Approach to Study of Cosmonauts Errors and Its Instrumental Support.

  2. Long-term results of combined approach in parotid sialolithiasis.

    PubMed

    Konstantinidis, I; Chatziavramidis, A; Iakovou, I; Constantinidis, J

    2014-11-12

    Combined sialendoscopic and transcutaneous approach in parotid sialolithiasis is a surgical option for large and impacted stones. The aim of this study is to assess the long-term results regarding postoperative stenosis, recurrent swellings and gland function. Prospective study in a tertiary referral center of patients with parotid sialolithiasis requiring combined approach. A total of 12 patients have been treated within a period of 3 years. Intraductal stents were placed in 9 of 12 cases. Scintigraphic evaluation of salivary glands and follow-up sialendoscopy performed 1 year postoperatively. In total, fourteen stones (two stones in two cases) were successfully removed along with two coexisted inflammatory polyps. Postoperative endoscopic evaluation revealed mild stenosis in 7 out of 12 cases without clinical significance as no recurrent swellings were reported. Scintigraphy showed normal gland function in 11 cases and mild hypofunction in 1 case with long-standing history of sialolithiasis. All patients were free of symptoms within the follow-up period of time (median follow-up 15.5 months). Combined approach is a safe, gland preserving and efficacious procedure in long term. The stenosis in the area of ductal surgical opening when present does not seem to be of clinical value. PMID:25388993

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

    PubMed Central

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

    2015-01-01

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

  4. Unusual long-term complication of polyalkylimide hydrogel manifesting as nasal septal abscess.

    PubMed

    Chang, Chul; Lee, Sun Bin

    2015-05-01

    Bio-Alcamid is a new synthetic polyacrylic hydrogel that contains alkylimide-amide groups and pyrogen-free water (96%) and has gained widespread use in cosmetic and reconstructive practice since being awarded a Conformite European certificate in 2001.According to the research on the efficacy and safety of the long-acting filler Bio-Alcamid in the early phases of development, Bio-Alcamid is nearly nontoxic and nonallergenic and has long in vivo persistence. It has been widely used because of its superior durability compared with short-acting fillers.Many published studies have examined only early-phase postoperative inflammatory responses. More recently, however, complications with delayed onsets ranging from several months to several years, such as inflammation and filler migration, have been emerging. Given the rapidly increasing application of long-term fillers, an increased incidence of complications is expected, and increasing awareness of its correct use and complication treatments is needed.To address this problem, we reviewed the safety of long-acting fillers on the basis of a rare case of surgical incision and drainage of a nasal septal abscess that developed in a patient 2 years after Bio-Alcamid was injected into the nasal region. PMID:25974816

  5. Hypoglycemia in childhood: long-term effects.

    PubMed

    Flykanaka-Gantenbein, Christina

    2004-08-01

    Glucose is the main cerebral fuel throughout life. Inadequate cerebral glucose supply, due to recurrent episodes of severe hypoglycemia during the neonatal period or infancy, when the brain is still developing, lead to serious long-term neurological impairments, ranging from mild neurocognitive dysfunction to severe mental retardation, epilepsy, microcephaly or even hemiparesis or aphasia. Moreover, in the most common form of severe recurrent hypoglycemia of infancy due to hyperinsulinism, not only abnormalities in neurocognitive function, but also the later development of diabetes mellitus are observed. Furthermore, recurrent hypoglycemia, supervening as a side-effect of intensified insulin treatment in young diabetic children, may also induce mild neurocognitive dysfunction and, specifically, memory deficits that predispose these children to new hypoglycemic episodes and hypoglycemia unawareness. In conclusion, prompt and meticulous management of hypoglycemia and its prevention during the neonatal period, infancy and childhood constitute the main goal of physicians taking care of these patients in order to ascertain a long-standing quality of life devoid of long-term sequelae. PMID:16444188

  6. Long-term intracranial pressure monitoring.

    PubMed

    de Jong, D A; Maas, A I; den Ouden, A H; de Lange, S A

    Continuous or intermittent measurement of intracranial pressure (ICP) is important in patients at risk for raised ICP. Indications exist for short- and long-term measurements. The various methods used for short-term monitoring are discussed with their relative advantages and disadvantages. For long-term measurements of ICP use of a completely implantable telemetric epidural pressure transducer is indicated. No such device is commercially available. We have developed an inexpensive passive telemetric transducer for this purpose. Results obtained up till now have demonstrated its reliability for measurements of two to three months duration. The life span of the device is limited by degrading of the epoxy utilized for sealing of the titanium pressure sensing part to the radiolucent ceramic cap of the transducer, causing leakage of water into the transducer and false low measurements. Because of these problems new hermetic sealing techniques were tested. Both active metal brazing and glass bonding yielded good results and hermetic sealing could be obtained. The metal to ceramic bonding presented is generally applicable within the design of implants. Besides the technical progress reported, the experience with clinical use in 12 patients is presented. PMID:6674738

  7. Long term changes in the polar vortices

    NASA Astrophysics Data System (ADS)

    Braathen, Geir O.

    2015-04-01

    As the amount of halogens in the stratosphere is slowly declining and the ozone layer slowly recovers it is of interest to see how the meteorological conditions in the vortex develop over the long term since such changes might alter the foreseen ozone recovery. In conjunction with the publication of the WMO Antarctic and Arctic Ozone Bulletins, WMO has acquired the ERA Interim global reanalysis data set for several meteorological parameters. This data set goes from 1979 - present. These long time series of data can be used for several useful studies of the long term development of the polar vortices. Several "environmental indicators" for vortex change have been calculated, and a climatology, as well as trends, for these parameters will be presented. These indicators can act as yardsticks and will be useful for understanding past and future changes in the polar vortices and how these changes affect polar ozone depletion. Examples of indicators are: vortex mean temperature, vortex minimum temperature, vortex mean PV, vortex "importance" (PV*area), vortex break-up time, mean and maximum wind speed. Data for both the north and south polar vortices have been analysed at several isentropic levels from 350 to 850 K. A possible link between changes in PV and sudden stratospheric warmings will be investigated, and the results presented.

  8. Pediatric HIV Long-Term Nonprogressors.

    PubMed

    Rimawi, B H; Rimawi, R H; Micallef, M; Pinckney, L; Fowler, S L; Dixon, T C

    2014-01-01

    Patients infected with HIV are best categorized along a continuum from rapid progressors to HIV long-term nonprogressors. Long-term nonprogressors (LTNPs) are those in which AIDS develop many years after being infected with HIV, often beyond the 10-year mark, and represent 15-20% of the HIV infected patients. Many of these patients are able to control their infection and maintain undetectable viral loads for long periods of time without antiretroviral therapy. After a comprehensive literature search, we found extensive data related to HIV LTNPs in the adult population; however, very limited data was available related to LTNPs within the pediatric population. We present a case of pediatric HIV LTNPs, perinatally infected patient with undetectable viral loads, despite never receiving ART. Although there are not many instances of LTNPs among children, this child may be one, though she had intermittent viremia. She has continued to manifest serologic evidence of infection, with yearly ELISA and western blot positive tests. Based on the viral fitness studies that were performed, this case exemplifies an adolescent LTNP. PMID:25247098

  9. Pediatric HIV Long-Term Nonprogressors

    PubMed Central

    Rimawi, B. H.; Rimawi, R. H.; Micallef, M.; Pinckney, L.; Fowler, S. L.; Dixon, T. C.

    2014-01-01

    Patients infected with HIV are best categorized along a continuum from rapid progressors to HIV long-term nonprogressors. Long-term nonprogressors (LTNPs) are those in which AIDS develop many years after being infected with HIV, often beyond the 10-year mark, and represent 15–20% of the HIV infected patients. Many of these patients are able to control their infection and maintain undetectable viral loads for long periods of time without antiretroviral therapy. After a comprehensive literature search, we found extensive data related to HIV LTNPs in the adult population; however, very limited data was available related to LTNPs within the pediatric population. We present a case of pediatric HIV LTNPs, perinatally infected patient with undetectable viral loads, despite never receiving ART. Although there are not many instances of LTNPs among children, this child may be one, though she had intermittent viremia. She has continued to manifest serologic evidence of infection, with yearly ELISA and western blot positive tests. Based on the viral fitness studies that were performed, this case exemplifies an adolescent LTNP. PMID:25247098

  10. Long term effects of Escherichia coli mastitis.

    PubMed

    Blum, Shlomo E; Heller, Elimelech D; Leitner, Gabriel

    2014-07-01

    Escherichia coli is one of the most frequently diagnosed causes of bovine mastitis, and is typically associated with acute, clinical mastitis. The objective of the present study was to evaluate the long term effects of intramammary infections by E. coli on milk yield and quality, especially milk coagulation. Twenty-four Israeli Holstein cows diagnosed with clinical mastitis due to intramammary infection by E. coli were used in this study. Mean lactation number, days in milk (DIM) and daily milk yield (DMY) at the time of infection was 3.3 ± 1.3, 131.7 days ± 78.6 and 45.7 L ± 8.4, respectively. DMY, milk constituents, somatic cells count (SCC), differential leukocytes count and coagulation parameters were subsequently assessed. Two patterns of inflammation were identified: 'short inflammation', characterized by <15% decrease in DMY and <30 days until return to normal (n?=?5), and 'long inflammation', characterized by >15% decrease in DMY and >30 days to reach a new maximum DMY (n = 19). The estimated mean loss of marketable milk during the study was 200 L/cow for 'short inflammation' cases, and 1,500 L/cow for 'long inflammation' ones. Significant differences between 'short' and 'long inflammation' effects were found in almost all parameters studied. Long-term detrimental effects on milk quality were found regardless of clinical or bacteriological cure of affected glands. PMID:24906501

  11. Long-term mechanical ventilation and nutrition.

    PubMed

    Ambrosino, Nicolino; Clini, Enrico

    2004-05-01

    Mechanical ventilation (MV) in chronic situations is commonly used, either delivered invasively or by means of non-invasive interfaces, to control hypoventilation in patients with chest wall, neuromuscular or obstructive lung diseases (either in adulthood or childhood). The global prevalence of ventilator-assisted individuals (VAI) in Europe ranges from 2 to 30 per 100000 population according to different countries. Nutrition is a common problem to face with in patients with chronic respiratory diseases: nonetheless, it is a key component in the long-term management of underweight COPD patients whose muscular disfunction may rapidly turn to peripheral muscle waste. Since long-term mechanical ventilation (LTMV) is usually prescribed in end-stage respiratory diseases with poor nutritional status, nutrition and dietary intake related problems need to be carefully assessed and corrected in these patients. This paper aims to review the most recent innovations in the field of nutritional status and food intake-related problems of VAI (both in adulthood and in childhood). PMID:15139570

  12. Toward a comprehensive long term nicotine policy

    PubMed Central

    Gray, N; Henningfield, J; Benowitz, N; Connolly, G; Dresler, C; Fagerstrom, K; Jarvis, M; Boyle, P

    2005-01-01

    Global tobacco deaths are high and rising. Tobacco use is primarily driven by nicotine addiction. Overall tobacco control policy is relatively well agreed upon but a long term nicotine policy has been less well considered and requires further debate. Reaching consensus is important because a nicotine policy is integral to the target of reducing tobacco caused disease, and the contentious issues need to be resolved before the necessary political changes can be sought. A long term and comprehensive nicotine policy is proposed here. It envisages both reducing the attractiveness and addictiveness of existing tobacco based nicotine delivery systems as well as providing alternative sources of acceptable clean nicotine as competition for tobacco. Clean nicotine is defined as nicotine free enough of tobacco toxicants to pass regulatory approval. A three phase policy is proposed. The initial phase requires regulatory capture of cigarette and smoke constituents liberalising the market for clean nicotine; regulating all nicotine sources from the same agency; and research into nicotine absorption and the role of tobacco additives in this process. The second phase anticipates clean nicotine overtaking tobacco as the primary source of the drug (facilitated by use of regulatory and taxation measures); simplification of tobacco products by limitation of additives which make tobacco attractive and easier to smoke (but tobacco would still be able to provide a satisfying dose of nicotine). The third phase includes a progressive reduction in the nicotine content of cigarettes, with clean nicotine freely available to take the place of tobacco as society's main nicotine source. PMID:15923465

  13. Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis

    PubMed Central

    Burmester, Gerd R; Weinblatt, Michael E; McInnes, Iain B; Porter, Duncan; Barbarash, Olga; Vatutin, Mykola; Szombati, Istvan; Esfandiari, Ehsanollah; Sleeman, Matthew A; Kane, Christopher D; Cavet, Guy; Wang, Bing; Godwood, Alex; Magrini, Fabio

    2013-01-01

    Objectives Mavrilimumab, a human monoclonal antibody targeting the alpha subunit of the granulocyte-macrophage colony-stimulating factor receptor, was evaluated in a phase 2 randomised, double-blind, placebo-controlled study to investigate efficacy and safety in subjects with rheumatoid arthritis (RA). Methods Subcutaneous mavrilimumab (10?mg, 30?mg, 50?mg, or 100?mg) or placebo was administered every other week for 12?weeks in subjects on stable background methotrexate therapy. The primary endpoint was the proportion of subjects achieving a ?1.2 decrease from baseline in Disease Activity Score (DAS28-CRP) at week 12. Results 55.7% of mavrilimumab-treated subjects met the primary endpoint versus 34.7% placebo (p=0.003) at week 12; for the 10?mg, 30?mg, 50?mg, and 100?mg groups, responses were 41.0% (p=0.543), 61.0% (p=0.011), 53.8% (p=0.071), and 66.7% (p=0.001) respectively. Response rate differences from placebo were observed at week 2 and increased throughout the treatment period. The 100?mg dose demonstrated a significant effect versus placebo on DAS28-CRP<2.6 (23.1% vs 6.7%, p=0.016), all categories of the American College of Rheumatology (ACR) criteria (ACR20: 69.2% vs 40.0%, p=0.005; ACR50: 30.8% vs 12.0%, p=0.021; ACR70: 17.9% vs 4.0%, p=0.030), and the Health Assessment Questionnaire Disability Index (?0.48 vs ?0.25, p=0.005). A biomarker-based disease activity score showed a dose-dependent decrease at week 12, indicating suppression of disease-related biological pathways. Adverse events were generally mild or moderate in intensity. No significant hypersensitivity reactions, serious or opportunistic infections, or changes in pulmonary parameters were observed. Conclusions Mavrilimumab induced rapid clinically significant responses in RA subjects, suggesting that inhibiting the mononuclear phagocyte pathway may provide a novel therapeutic approach for RA. PMID:23234647

  14. Safety and efficacy of Hemospray® in upper gastrointestinal bleeding

    PubMed Central

    Yau, Alan Hoi Lun; Ou, George; Galorport, Cherry; Amar, Jack; Bressler, Brian; Donnellan, Fergal; Ko, Hin Hin; Lam, Eric; Enns, Robert Allan

    2014-01-01

    BACKGROUND: Hemospray (Cook Medical, USA) has recently been approved in Canada for the management of nonvariceal upper gastrointestional bleeding (UGIB). OBJECTIVE: To review the authors’ experience with the safety and efficacy of Hemospray for treating UGIB. METHODS: A retrospective chart review was performed on patients who required endoscopic evaluation for suspected UGIB and were treated with Hemospray. RESULTS: From February 2012 to July 2013, 19 patients (mean age 67.6 years) with UGIB were treated with Hemospray. A bleeding lesion was identified in the esophagus in one (5.3%) patient, the stomach in five (26.3%) and duodenum in 13 (68.4%). Bleeding was secondary to peptic ulcers in 12 (63.2%) patients, Dieulafoy lesions in two (10.5%), mucosal erosion in one (5.3%), angiodysplastic lesions in one (5.3%), ampullectomy in one (5.3%), polypectomy in one (5.3%) and an unidentified lesion in one (5.3%). The lesions showed spurting hemorrhage in four (21.1%) patients, oozing hemorrhage in 11 (57.9%) and no active bleeding in four (21.1%). Hemospray was administered as monotherapy in two (10.5%) patients, first-line modality in one (5.3%) and rescue modality in 16 (84.2%). Hemospray was applied prophylactically to nonbleeding lesions in four (21.1%) patients and therapeutically to bleeding lesions in 15 (78.9%). Acute hemostasis was achieved in 14 of 15 (93.3%) patients. Rebleeding within seven days occurred in seven of 18 (38.9%) patients. Potential adverse events occurred in two (10.5%) patients and included visceral perforation and splenic infarct. Mortality occurred in five (26.3%) patients but the cause of death was unrelated to gastrointestinal bleeding with the exception of one patient who developed hemoperitoneum. CONCLUSIONS: The high rates of both acute hemostasis and recurrent bleeding suggest that Hemospray may be used in high-risk cases as a temporary measure or a bridge toward more definitive therapy. PMID:24501723

  15. Aphakia correction with retropupillary fixated iris-claw lens (Artisan) – long-term results

    PubMed Central

    Schallenberg, Maurice; Dekowski, Dirk; Hahn, Angela; Laube, Thomas; Steuhl, Klaus-Peter; Meller, Daniel

    2014-01-01

    Purpose To evaluate the technique, safety, and efficacy of the retropupillary implantation of iris-claw intraocular lenses in a long-term follow-up study. Patients and methods This retrospective study included 31 eyes of 31 patients who underwent an Artisan aphakic intraocular lens implantation between January 2006 and February 2011 at the University Hospital Essen, Essen, Germany and at the Zentrum für Augenheilkunde PD Dr Laube, Düsseldorf, Germany. Preoperative data collected included demographics, etiology of aphakia, previous surgeries, preoperative eye pathology, intraocular pressure, clinical signs of endothelial cell loss, and best corrected visual acuity. Operative data and postoperative outcomes included the best corrected visual acuity, lens position, intraocular pressure, pigment dispersion, clinical signs of endothelial cell loss, development of macular edema, and other complications. Results Thirty-one patients were included. The mean follow-up was 25.2 months (range: 4–48 months). The mean best corrected visual acuity postoperatively was 0.64 logarithm of the minimum angle of resolution (logMAR) and varied from 0 logMAR to 3 logMAR. Some patients had a low visual acuity preoperatively because of preoperative eye pathologies. In 22 patients the visual acuity improved, in two patients the visual acuity remained unchanged, and seven patients showed a decreased visual acuity. Complications were peaked pupils (n=10) and retinal detachment in one case. Four patients showed an iris atrophy and high intraocular pressure was observed only in one patient. Subluxation of the intraocular lens, endothelial cell loss, and macular edema were not observed. Conclusion The presented long-term results demonstrate that retropupillary iris-claw lens implantation is a safe and effective method for the correction of aphakia in patients without capsule support. This surgical procedure has the advantages of a posterior chamber implantation with a low intraoperative and postoperative risk profile. PMID:24391439

  16. Managing soils for long-term productivity

    PubMed Central

    Syers, J. K.

    1997-01-01

    Meeting the goal of long-term agricultural productivity requires that soil degradation be halted and reversed. Soil fertility decline is a key factor in soil degradation and is probably the major cause of declining crop yields. There is evidence that the contribution of declining soil fertility to soil degradation has been underestimated.
    Sensitivity to soil degradation is implicit in the assessment of the sustainability of land management practices, with wide recognition of the fact that soils vary in their ability to resist change and recover subsequent to stress. The concept of resilience in relation to sustainability requires further elaboration and evaluation.
    In the context of soil degradation, a decline in soil fertility is primarily interpreted as the depletion of organic matter and plant nutrients. Despite a higher turnover rate of organic matter in the tropics there is no intrinsic difference between the organic matter content of soils from tropical and temperate regions. The level of organic matter in a soil is closely related to the above and below ground inputs. In the absence of adequate organic material inputs and where cultivation is continuous, soil organic matter declines progressively. Maintaining the quantity and quality of soil organic matter should be a guiding principle in developing management practices.
    Soil microbial biomass serves as an important reservoir of nitrogen (N), phosphorus (P) and sulphur (S), and regulates the cycling of organic matter and nutrients. Because of its high turnover rate, microbial biomass reacts quickly to changes in management and is a sensitive indicator for monitoring and predicting changes in soil organic matter. Modelling techniques have been reasonably successful in predicting changes in soil organic matter with different organic material inputs, but there is little information from the tropics.
    Nutrient depletion through harvested crop components and residue removal, and by leaching and soil erosion accentuates the often very low inherent fertility of many soils in the tropics. An integrated approach involving inorganic and organic inputs is required where animal and plant residues are returned, as far as practicable. Chemical fertilizers alone cannot achieve long-term productivity on many soils and organic material inputs are required to maintain soil organic matter levels and crop productivity. A major research effort is required to develop improved strategies for halting and reversing soil degradation if long-term productivity is to be secured.

  17. Long-term performance of filtration layer

    NASA Astrophysics Data System (ADS)

    Radfar, A.; Rockaway, T. D.

    2013-12-01

    Permeable pavements are commonly employed to capture and divert stormwater before it enters the stormwater or sewer conveyance systems. During a storm event, runoff water passes through the permeable pavement surface, enters a storage gallery and finally exfiltrates into the surrounding soil. Thus, the ability of the system to store an appropriate volume of runoff water is an important consideration for stormwater control design. Traditionally, crushed stone or other porous material has been used to provide the necessary interstitial void space to store the runoff water. Unfortunately, over time the available void space within the storage gallery is reduced due to settlement, biological growth and sediment accumulation. This gradual reduction in void space reduces the long-term effectiveness of these stormwater controls by limiting its ability to store and pass runoff water. This study examined the long-term performance of the storage gallery layer with respect to its ability to both store and pass runoff water. As the porosity within the storage gallery decreased, it was anticipated that volumetric water content within the gallery would increase and that time necessary to drain the gallery would increase as well. The effects of the gallery porosity were assessed over a one-year study using both laboratory experimentation and monitoring data from naturally occurring rain events. Changes in gallery porosity were first assessed by correlating monitoring piezometer data with surface infiltration testing; building a relation between know volume of poured water being used for the test and the associated pressure head at the base of the gallery. As a known volume of water enters the system, volume change in the gallery directly correlate to increases in pressure head. Second, the time required for water to permeate through pavers and gallery layer to trigger the TDRs in the filtration layer and the time to drain it from the crushed stone were calculated and compared by the age of permeable pavement. These data were utilized to develop a model that more appropriately considered changes in gallery porosity. By better understanding the progression of the runoff water through the storage gallery a better assessment of the long-term performance of the entire system can be developed. Future storage gallery designs can be appropriately modified to account for changes within the storage gallery so that volume and flow requirements are maintained throughout the life of the structure.

  18. Long term outcome of unilateral pallidotomy: follow up of 15 patients for 3 years

    Microsoft Academic Search

    P K Pal; A Samii; A Kishore; M Schulzer; E Mak; S Yardley; I M Turnbull; D B Calne

    2000-01-01

    OBJECTIVESWith the advent of new antiparkinsonian drug therapy and promising results from subthalamic and pallidal stimulation, this study evaluated the long term efficacy of unilateral pallidotomy, a technique which has gained popularity over the past decade for the management of advanced Parkinson's disease.METHODSThe 15 patients reported here are part of the original cohort of 24 patients who underwent posteroventral pallidotomy

  19. Intracranial Angioplasty without Stenting for Symptomatic Atherosclerotic Stenosis: Long-Term Follow-up

    Microsoft Academic Search

    Michael P. Marks; Mary L. Marcellus; Huy M. Do; Pamela K. Schraedley-Desmond; Gary K. Steinberg; David C. Tong; Gregory W. Albers

    BACKGROUND AND PURPOSE: Angioplasty and stent placement have been reported for the treatment of intracranial stenosis. This study was undertaken to assess the efficacy and long-term clinical outcome of angioplasty without stent placement for patients with symptom- atic intracranial stenosis. METHODS: A retrospective study was done to evaluate 36 patients with 37 symptomatic atherosclerotic intracranial stenosis who underwent primary balloon

  20. Long-Term Outcomes of Spinal Cord Stimulation With Percutaneously Introduced Paddle Leads in

    E-print Network

    O'Toole, Alice J.

    Long-Term Outcomes of Spinal Cord Stimulation With Percutaneously Introduced Paddle Leads for spinal cord stimulation. Methods: Twenty-one patients diagnosed with failed back surgery syndrome (FBSS of interest. OBJECTIVE Spinal cord stimulation (SCS) is an implantable, safe, reversible, and efficacious pain

  1. Deferiprone versus deferoxamine in sickle cell disease: results from a 5-year long-term Italian multi-center randomized clinical trial.

    PubMed

    Calvaruso, Giusi; Vitrano, Angela; Di Maggio, Rosario; Ballas, Samir; Steinberg, Martin H; Rigano, Paolo; Sacco, Massimiliano; Telfer, Paul; Renda, Disma; Barone, Rita; Maggio, Aurelio

    2014-12-01

    Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-years, without any effect on safety (p=0.005). Moreover, although the basal serum ferritin levels were higher in transfused compared with non-transfused group (p=0.031), the changes over time in serum ferritin levels were not statistically significantly different between transfused and non-transfused cohort of patients (p=0.389). Kaplan-Meier curve, during 5-years of study, suggests that Deferiprone does not alter survival in comparison with Deferoxamine (p=0.38). In conclusion, long-term iron chelation therapy with Deferiprone was associated with efficacy and safety similar to that of Deferoxamine. Therefore, in patients with Sickle-Cell-Disease, Deferiprone may represent an effective long-term treatment option. PMID:24814618

  2. Radiation risk during long-term spaceflight.

    PubMed

    Petrov, V M

    2002-01-01

    Cosmonauts' exposure to cosmic rays during long-term spaceflight can cause unfavorable effects in health and risk for the crew members' lives. All unfavorable effects induced by exposure should be taken into consideration for the risk estimation. They should include both the acute deterministic effects and delayed effects called stochastic. On the ground the limitation of unfavorable consequences of acute exposure is achieved by means of establishing dose limits. But in space applications this approach can't be acceptable. Establishing a fixed dose limit is adequate to introducing indefinite reserve coefficient and therefore ineffective usage of spacecraft resource. The method of radiation risk calculation caused by acute and delayed effects of cosmonauts' exposure is discussed and substantiated in the report. Peculiarities of the impact of permanent radiation sources (galactic cosmic rays and trapped radiation) and the variable one (solar cosmic rays) are taken into consideration. PMID:12539775

  3. Long term performance of radon mitigation systems

    SciTech Connect

    Prill, R.; Fisk, W.J.

    2002-03-01

    Researchers installed radon mitigation systems in 12 houses in Spokane, Washington and Coeur d'Alene, Idaho during the heating season 1985--1986 and continued to monitor indoor radon quarterly and annually for ten years. The mitigation systems included active sub-slab ventilation, basement over-pressurization, and crawlspace isolation and ventilation. The occupants reported various operational problems with these early mitigation systems. The long-term radon measurements were essential to track the effectiveness of the mitigation systems over time. All 12 homes were visited during the second year of the study, while a second set 5 homes was visited during the fifth year to determine the cause(s) of increased radon in the homes. During these visits, the mitigation systems were inspected and measurements of system performance were made. Maintenance and modifications were performed to improve system performance in these homes.

  4. [Childhood liver transplantation. Long-term results].

    PubMed

    Jara, Paloma; Hierro, Loreto

    2010-05-01

    Liver transplantation allows long-term survival (10 years or more) in 75% of children receiving transplants before 2000. The risk of mortality after the first year is 4-10% in the next 10-20 years. Chronic rejection affects 6%. The need for late retransplantation is 3-5%. However, the follow-up of these patients involves the management of diverse problems in the graft (immunological, biliary, vascular) and others related to the use of immunosuppressants (renal dysfunction, lymphoproliferative syndrome). The transition from pediatric to adult care generates special needs. Adolescence and young adulthood are associated with a lack of compliance. Adult specialists should be aware of the special features of the original diagnosis and the surgical techniques used in childhood transplantation. Final quality of life is good overall but is lower than that in healthy young persons. PMID:20122757

  5. [Strongyloidiasis following long-term corticosteroid therapy].

    PubMed

    Yamori, S; Yamamoto, M; Kawabata, A; Nakashima, K; Iinuma, Y; Satake, T; Shimokata, K

    1989-10-01

    A 64-year-old man who was born and raised in Fukuoka Prefecture was admitted because of dyspnea. The chest X-ray film showed multiple pulmonary cysts. Corticosteroid therapy was given because of repeated episodes of dyspnea and wheezing. He complained of epigastric pain 20 months after administration of corticosteroid therapy. Gastro-endoscopic examination showed inflammatory changes of the gastric mucosa and the biopsy specimens revealed the filariform larvae of Strongyloides stercoralis. Furthermore, the larvae were frequently detected in both sputum specimens and stools. Pyrvinium pamoate was initially administered and was switched to thiabendazole because of the presence of hyperinfection. Although two cycles of thiabendazole treatment were given, the larvae were not eradicated. This case report suggests that long term corticosteroid therapy caused the hyperinfection syndrome of Strongyloides stercoralis in a patient who was auto-infected with this nematode. PMID:2615077

  6. Advanced long term cryogenic storage systems

    NASA Technical Reports Server (NTRS)

    Brown, Norman S.

    1987-01-01

    Long term, cryogenic fluid storage facilities will be required to support future space programs such as the space-based Orbital Transfer Vehicle (OTV), Telescopes, and Laser Systems. An orbital liquid oxygen/liquid hydrogen storage system with an initial capacity of approximately 200,000 lb will be required. The storage facility tank design must have the capability of fluid acquisition in microgravity and limit cryogen boiloff due to environmental heating. Cryogenic boiloff management features, minimizing Earth-to-orbit transportation costs, will include advanced thick multilayer insulation/integrated vapor cooled shield concepts, low conductance support structures, and refrigeration/reliquefaction systems. Contracted study efforts are under way to develop storage system designs, technology plans, test article hardware designs, and develop plans for ground/flight testing.

  7. Long-term dynamics of Typha populations

    USGS Publications Warehouse

    Grace, J.B.; Wetzel, R.G.

    1998-01-01

    The zonation of Typha populations in an experimental pond in Michigan was re-examined 15 years after the original sampling to gain insight into the long-term dynamics. Current distributions of Typha populations were also examined in additional experimental ponds at the site that have been maintained for 23 years. The zonation between T. latifolia and T. angustifolia in the previously studied pond 15 years after the initial sampling revealed that the density and distribution of shoots had not changed significantly. Thus, it appears that previously reported results (based on 7- year old populations) have remained consistent over time. Additional insight into the interaction between these two taxa was sought by comparing mixed and monoculture stands in five experimental ponds that have remained undisturbed for their 23-year history. The maximum depth of T. latifolia, the shallow- water species, was not significantly reduced when growing in the presence of the more flood tolerant T. angustifolia. In contrast, the minimum depth of T. angustifolia was reduced from 0 to 37 cm when in the presence of T. latifolia. When total populations were compared between monoculture and mixed stands, the average density of T. angustifolia shoots was 59.4 percent lower in mixed stands while the density of T. latifolia was 32 percent lower, with T. angustifolia most affected at shallow depths (reduced by 92 percent) and T. latifolia most affected at the deepest depths (reduced by 60 percent). These long-term observations indicate that competitive displacement between Typha taxa has remained stable over time.

  8. Long-term exposure to intranasal oxytocin in a mouse autism model

    PubMed Central

    Bales, K L; Solomon, M; Jacob, S; Crawley, J N; Silverman, J L; Larke, R H; Sahagun, E; Puhger, K R; Pride, M C; Mendoza, S P

    2014-01-01

    Oxytocin (OT) is a neuropeptide involved in mammalian social behavior. It is currently in clinical trials for the treatment of autism spectrum disorder (ASD). Previous studies in healthy rodents (prairie voles and C57BL/6J mice) have shown that there may be detrimental effects of long-term intranasal administration, raising the questions about safety and efficacy. To investigate the effects of OT on the aspects of ASD phenotype, we conducted the first study of chronic intranasal OT in a well-validated mouse model of autism, the BTBR T+ Itpr3tf/J inbred strain (BTBR), which displays low sociability and high repetitive behaviors. BTBR and C57BL/6J (B6) mice (N=94) were administered 0.8 ?IU/kg of OT intranasally, daily for 30 days, starting on day 21. We ran a well-characterized set of behavioral tasks relevant to diagnostic and associated symptoms of autism, including juvenile reciprocal social interactions, three-chambered social approach, open-field exploratory activity, repetitive self-grooming and fear-conditioned learning and memory, some during and some post treatment. Intranasal OT did not improve autism-relevant behaviors in BTBR, except for female sniffing in the three-chambered social interaction test. Male saline-treated BTBR mice showed increased interest in a novel mouse, both in chamber time and sniffing time, whereas OT-treated male BTBR mice showed a preference for the novel mouse in sniffing time only. No deleterious effects of OT were detected in either B6 or BTBR mice, except possibly for the lack of a preference for the novel mouse's chamber in OT-treated male BTBR mice. These results highlight the complexity inherent in understanding the effects of OT on behavior. Future investigations of chronic intranasal OT should include a wider dose range and early developmental time points in both healthy rodents and ASD models to affirm the efficacy and safety of OT. PMID:25386957

  9. Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

    PubMed Central

    2010-01-01

    Background Rotigotine is a unique dopamine agonist with activity across D1 through D5 receptors as well as select adrenergic and serotonergic sites. This study reports the 2-year follow-up safety and efficacy data of an ongoing open-label multicenter extension study (NCT00498186) of transdermal rotigotine in patients with moderate to severe restless legs syndrome (RLS). Methods Patients received a once-daily patch application of an individually optimized dose of rotigotine between 0.5 mg/24 h to 4 mg/24 h. Safety assessments included adverse events (AEs) and efficacy was measured by the International RLS Study Group Severity Rating Scale (IRLS), RLS-6 scales and Clinical Global Impression (CGI). Quality of life (QoL) was measured by QoL-RLS. Results Of 310 patients who completed a 6-week placebo-controlled trial (SP709), 295 (mean age 58 ± 10 years, 66% females) were included in the open-label trial SP710. 64.7% (190/295 patients) completed the 2-year follow-up; 29 patients discontinued during the second year. Mean daily rotigotine dose after 2 years was 2.93 ± 1.14 mg/24 h with a 2.9% dose increase from year 1. Rotigotine was generally well tolerated. The rate of typical dopaminergic side effects, nausea and fatigue, was low (0.9% and 2.3%, respectively) during the second year; application site reactions were frequent but lower than in year 1 (16.4% vs. 34.5%). The IRLS total score improved from baseline of SP709 (27.8 ± 5.9) by 17.2 ± 9.2 in year 2 completers. Similar improvements were observed in RLS-6 scales, CGI scores and QoL-RLS. The responder rate in the CGI change item 2 ("much" and "very much" improved) was 95% after year 2. Conclusions Transdermal rotigotine is an efficacious and well-tolerated long-term treatment option for patients with moderate to severe RLS with a high retention rate during 2 years of therapy. Trial registration NCT00498186 PMID:20920156

  10. Performance Evaluation Using Expert Elicitation and Long Term Environmental Monitoring Optimization for Long Term Stewardship

    Microsoft Academic Search

    Beth Moore; Jack Ditmars; Barbara Minsker; James Bachmaier

    Long term environmental monitoring is a critical component of stewardship for three reasons: (1) data provide ongoing evidence of environmental compliance and protection of the public and the environment; (2) the monitoring program, in part, determines the life cycle cost and extent of stewardship; and (3) the monitoring program provides a framework to develop trust and agreement between the site

  11. Long-Term Potentiation and Long-Term Depression in Experience-Dependent Plasticity

    E-print Network

    Crair, Michael C

    -term potentiation (LTP) and long-term depression (LTD) more than 30 years ago, a great deal of experimental-dependent develop- ment and plasticity of sensory systems and addresses how LTP and LTD mechanisms at excitatory synapses might be used to mediate such changes. Mechanisms of LTP and LTD LTP and LTD are nearly ubiquitous

  12. Where Can You Receive Care? (Long-Term Care)

    MedlinePLUS

    ... may need. Share page: Where Can You Receive Care? Most long-term care is provided at home. ... in long-term care facilities. Examples of home care services include: An unpaid caregiver who may be ...

  13. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I.

    PubMed

    Verstovsek, Srdan; Mesa, Ruben A; Gotlib, Jason; Levy, Richard S; Gupta, Vikas; DiPersio, John F; Catalano, John V; Deininger, Michael W N; Miller, Carole B; Silver, Richard T; Talpaz, Moshe; Winton, Elliott F; Harvey, Jimmie H; Arcasoy, Murat O; Hexner, Elizabeth O; Lyons, Roger M; Raza, Azra; Vaddi, Kris; Sun, William; Peng, Wei; Sandor, Victor; Kantarjian, Hagop

    2015-04-01

    In the phase III COMFORT-I study, the Janus kinase 1 (JAK1)/JAK2 inhibitor ruxolitinib provided significant improvements in splenomegaly, key symptoms, and quality-of-life measures and was associated with an overall survival benefit relative to placebo in patients with intermediate-2 or high-risk myelofibrosis. This planned analysis assessed the long-term efficacy and safety of ruxolitinib at a median follow-up of 149 weeks. At data cutoff, approximately 50% of patients originally randomized to ruxolitinib remained on treatment whereas all patients originally assigned to placebo had discontinued or crossed over to ruxolitinib. At week 144, mean spleen volume reduction was 34% with ruxolitinib. Previously observed improvements in quality-of-life measures were sustained with longer-term ruxolitinib therapy. Overall survival continued to favor ruxolitinib despite the majority of placebo patients crossing over to ruxolitinib [hazard ratio 0.69 (95% confidence interval: 0.46-1.03); P = 0.067]. Exploratory analyses suggest that crossover may have contributed to an underestimation of the true survival difference between the treatment groups. Ruxolitinib continued to be generally well tolerated; there was no pattern of worsening grade ? 3 anemia or thrombocytopenia with longer-term ruxolitinib exposure. These longer-term data continue to support the efficacy and safety of ruxolitinib in patients with myelofibrosis. The study is registered at clinicaltrials.gov: NCT00952289. PMID:25616577

  14. Multicenter long-term validation of a minicourse in radiation-reducing techniques in the catheterization laboratory.

    PubMed

    Kuon, Eberhard; Weitmann, Kerstin; Hoffmann, Wolfgang; Dörr, Marcus; Hummel, Astrid; Riad, Alexander; Busch, Mathias C; Felix, Stephan B; Empen, Klaus

    2015-02-01

    Patient radiation exposure in invasive cardiology is considerable. We aimed to investigate, in a multicenter field study, the long-term efficacy of an educational 90-minute workshop in cardiac invasive techniques with reduced irradiation. Before and at a median period of 2.5 months and 2.0 years after the minicourse (periods I, II, and III, respectively) at 5 German cardiac centers, 18 interventionalists documented various radiation parameters for 10 coronary angiographies. The median patient dose area product (DAP) for periods I, II, and III amounted to 26.6, 12.2, and 9.6 Gy × cm(2), respectively. The short-term and long-term effects were related to shorter median fluoroscopy times (180, 138, and 114 seconds), fewer radiographic frames (745, 553, and 417) because of fewer (11, 11, and 10) and shorter (64, 52, and 44 frames/run) runs, consistent collimation, and restriction to an adequate image quality; both radiographic DAP/frame (27.7, 17.3, and 18.4 mGy × cm(2)) and fluoroscopic DAP/second (26.6, 12.9, and 14.9 mGy × cm(2)) decreased significantly. Multivariate analysis over time indicated increasing efficacy of the minicourse itself (-55% and -64%) and minor influence of interventionist experience (-4% and -3% per 1,000 coronary angiographies, performed lifelong until the minicourse and until period III). In conclusion, autonomous self-surveillance of various dose parameters and feedback on individual radiation safety efforts supported the efficacy of a 90-minute course program toward long-lasting and ongoing patient dose reduction. PMID:25579886

  15. Short-term combination therapy and long-term relapse prevention in the treatment of severe acne vulgaris.

    PubMed

    Tan, Jerry; Stein Gold, Linda; Schlessinger, Joel; Brodell, Robert; Jones, Terry; Cruz, Alma; Kerrouche, Nabil; Jarratt, Michael

    2012-02-01

    Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects. PMID:22270198

  16. Identifying research priorities in long term care homes.

    PubMed

    Brazil, Kevin; Maitland, Janine; Ploeg, Jenny; Denton, Margaret

    2012-01-01

    Concerns about the quality of care in long term care (LTC) homes range from inadequate daily care to understaffing and insufficient funding. LTC decision makers are challenged to keep up with the changing demographics of residents admitted to LTC who have increasingly complex care needs. Decisions regarding LTC policies and procedures need to be informed by research that identifies the most effective and efficient care practices. This study solicited feedback from LTC decision makers in Ontario, Canada, regarding research priorities to guide improvement in the quality of care in LTC homes. Representatives from 134 LTC homes responded (53.6% response rate). Nine thematic areas of research were identified: delivery of care; staffing; organization and structure of homes; funding; indicators, standards, policies, and procedures; managing difficult behaviors; education; safety; and infectious disease control. It is anticipated that these themes will steer research down a path that is responsive to the information needs of practitioners in LTC homes. PMID:21621469

  17. 78 FR 36449 - State Long-Term Care Ombudsman Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ...1327 RIN 0985-AA08 State Long-Term Care Ombudsman Program AGENCY: Administration...Older Americans Act, the State Long-Term Care Ombudsman program. This proposed rule...compliance in carrying out the Long-Term Care Ombudsman program functions. This...

  18. LONG-TERM MONITORING SENSOR NETWORK

    SciTech Connect

    Stephen P. Farrington; John W. Haas; Neal Van Wyck

    2003-10-16

    Long-term monitoring (LTM) associated with subsurface contamination sites is a key element of Long Term Stewardship and Legacy Management across the Department of Energy (DOE) complex. However, both within the DOE and elsewhere, LTM is an expensive endeavor, often exceeding the costs of the remediation phase of a clean-up project. The primary contributors to LTM costs are associated with labor. Sample collection, storage, preparation, analysis, and reporting can add a significant financial burden to project expense when extended over many years. Development of unattended, in situ monitoring networks capable of providing quantitative data satisfactory to regulatory concerns has the potential to significantly reduce LTM costs. But survival and dependable operation in a difficult environment is a common obstacle to widespread use across the DOE complex or elsewhere. Deploying almost any sensor in the subsurface for extended periods of time will expose it to chemical and microbial degradation. Over the time-scales required for in situ LTM, even the most advanced sensor systems may be rendered useless. Frequent replacement or servicing (cleaning) of sensors is expensive and labor intensive, offsetting most, if not all, of the cost savings realized with unattended, in situ sensors. To enable facile, remote monitoring of contaminants and other subsurface parameters over prolonged periods, Applied Research Associates, Inc has been working to develop an advanced LTM sensor network consisting of three key elements: (1) an anti-fouling sensor chamber that can accommodate a variety of chemical and physical measurement devices based on electrochemical, optical and other techniques; (2) two rapid, cost effective, and gentle means of emplacing sensor packages either at precise locations directly in the subsurface or in pre-existing monitoring wells; and (3) a web browser-based data acquisition and control system (WebDACS) utilizing field-networked microprocessor-controlled smart sensors housed in anti-fouling sensor chambers. The monitoring network is highly versatile and can be applied to a variety of subsurface sensing scenarios in different media. However, the current project focused on monitoring water quality parameters of pH, oxidation-reduction potential, conductivity, and temperature in groundwater.

  19. Long-term follow-up results of postoperative radiation therapy for Cushing’s disease

    Microsoft Academic Search

    Giuseppe Minniti; Mattia Osti; Marie Lise Jaffrain-Rea; Vincenzo Esposito; Giampaolo Cantore; Riccardo Maurizi Enrici

    2007-01-01

    Objectives  Radiotherapy is currently used in patients with residual or recurrent pituitary adenomas after surgery. However, there is\\u000a little information of long-term outcome of patients with Cushing’s disease following radiotherapy. We assessed the long-term\\u000a efficacy and toxicity of conventional radiotherapy in the control of Cushing’s disease after unsuccessful transsphenoidal\\u000a surgery.\\u000a \\u000a \\u000a \\u000a Patients and Methods  Forty patients with Cushing’s disease were treated with conventional

  20. Preliminary study of the safety and efficacy of extended-release oxybutynin in children

    Microsoft Academic Search

    Katrin Youdim; Barry A. Kogan

    2002-01-01

    Objectives. To test the safety and efficacy of extended-release oxybutynin in children with bladder dysfunction. The efficacy of oxybutynin in children has been limited by side effects. A new extended-release formulation of oxybutynin has some benefits versus traditional oxybutynin but has never been evaluated in children.Methods. A retrospective study was performed on 25 children who had been treated with extended-release

  1. Safety and Efficacy of Sub-Antimicrobial-Dose Doxycycline Therapy in Patients with Adult Periodontitis

    Microsoft Academic Search

    Sebastian Ciancio; Robert Ashley

    1998-01-01

    The objectives of the studies presented here were to assess the safety and efficacy of the adjunctive administration of sub-antimicrobial-dose doxycycline (SDD) for the treatment of adult periodontitis and to confirm the optimal dosing regimen. The studies summarized included four double-blind, placebo-controlled, randomized clinical trials, conducted over a period of 9 to 12 months. Analysis of efficacy data demonstrated that

  2. Safety, efficacy and cross-protectivity of a live intranasal aerosol haemorrhagic septicaemia vaccine

    Microsoft Academic Search

    A. Myint; H. H. Nyunt; T. O. Jones

    2005-01-01

    The safety, efficacy and cross-protectivity of a live intranasal aerosol haemorrhagic septicaemia vaccine containing Pasteurella multocida serotype B:3,4 were tested in young cattle and buffaloes in Myanmar, where more than 1?5 million animals had been inoculated with this vaccine between 1989 and 1999. A recommended dose of 2 × 107 viable organisms was used for the efficacy test. The administration

  3. Efficacy, safety, and use of sildenafil in urologic practice

    Microsoft Academic Search

    Elliot Fagelman; Andrew Fagelman; Ridwan Shabsigh

    2001-01-01

    Objectives. To evaluate the efficacy, side effects, renewal patterns, and other relevant practice issues of the use of sildenafil in urologic practice after approval of this medication and release for public use.Methods. Consecutive male patients with erectile dysfunction were evaluated by one urologist and sildenafil was prescribed when appropriate. Patients were monitored at two follow-up visits: at 3 to 4

  4. Cinoxacin vs trimethoprim--safety and efficacy in the prophylaxis of uncomplicated urinary tract infections.

    PubMed

    Seppänen, J

    1988-01-01

    This study reports the results of long-term (24 weeks) low-dose prophylaxis in 26 young female patients suffering from recurrent uncomplicated urinary tract infection (UTI). The patients were randomized in a double-blind manner to treatment with 100 mg trimethoprim (TMP, 12 patients) or 500 mg cinoxacin (CNO, 14 patients) at bedtime. The duration of prophylaxis in the TMP group was 2016 and in the CNO group 2352 days. Blood chemistry, haematological and urinary parameters were closely monitored during treatment and the latter were followed for a further 4-6 weeks. The prophylactic efficacy of the drugs was equal and significant (p less than 0.05). In the TMP group one recurrence and in the CNO group two recurrences occurred during treatment, two recurrences being observed in each group during the follow-up period of 4-6 weeks. Trimethoprim is well documented and widely used; cinoxacin provides a new alternative for long-term prophylaxis. PMID:3246212

  5. Long-term behavior of ceramic materials

    SciTech Connect

    Anson, D.; Ramesh, K.S.

    1992-02-19

    This topical report has been prepared in response to the need to address the question of long term durability of high-strength structural ceramic materials. In a new project to demonstrate the use of such materials as replacements for metals in the hot gas path of industrial gas turbines, the longest projected test bed run will be 1000 hours. Creep in ceramic materials seldom exceeds one percent strain before failure, but the strain takes place almost entirely in the intergranular regions, which can be severely weakened by accumulated damage as creep occurs. In this report, we discuss the nature of creep in silicon nitride and silicon carbide ceramic materials, the method of evaluating creep, and the interpretation of data obtained under various creep test conditions. A review of creep data illustrates the importance of intergranular phases and of the history of the material. Also, in most cases, the histories applying to laboratory investigations are different from those that will apply to engineering situations in which measurable creep will be generally unacceptable. Fatigue in ceramic materials usually is assessed in static fatigue tests, which are dependent on the same types of grain boundary damage as those occurring in creep, but over shorter time periods. Corrosion of silicon-based ceramics by oxygen and water vapor results in the formation of protective SiO{sub 2} under gas turbine operating conditions.

  6. Bacterial Cellulose: Long-Term Biocompatibility Studies.

    PubMed

    Pértile, Renata A N; Moreira, Susana; Costa, Rui M Gil da; Correia, Alexandra; Guardão, Luisa; Gartner, Fátima; Vilanova, Manuel; Gama, Miguel

    2011-06-28

    The bacterial cellulose (BC) secreted by Gluconacetobacter xylinus is a network of pure cellulose nanofibres which has high crystallinity, wettability and mechanical strength. These characteristics make BC an excellent material for tissue-engineering constructs, noteworthy for artificial vascular grafts. In this work, the in vivo biocompatibility of BC membranes produced by two G. xylinus strains was analyzed through histological analysis of long-term subcutaneous implants in the mice. The BC implants caused a mild and benign inflammatory reaction that decreased along time and did not elicit a foreign body reaction. A tendency to calcify over time, which may be related to the porosity of the BC implants, was observed, especially among the less porous BC-1 implants. In addition, the potential toxicity of BC nanofibres - obtained by chemical-mechanical treatment of BC membranes - subcutaneously implanted in mice was analysed through bone marrow flow cytometryand histological analyses. At 2 and 4 months post-implantation, the nanofibres implants were found to accumulate intracellularly, in subcutaneous foamy macrophages aggregates. Moreover, no differences were observed between the controls and implanted animals in thymocyte populations and in B lymphocyte precursors and myeloid cells in the bone marrow. PMID:21722421

  7. Long-term potentiation and memory.

    PubMed Central

    Morris, Richard G M

    2003-01-01

    The discovery of long-term potentiation (LTP) transformed research on the neurobiology of learning and memory. This did not happen overnight, but the discovery of an experimentally demonstrable phenomenon reflecting activity-driven neuronal and synaptic plasticity changed discussions about what might underlie learning from speculation into something much more concrete. Equally, however, the relationship between the discovery of LTP and research on the neurobiology of learning and memory has been reciprocal; for it is also true that studies of the psychological, anatomical and neurochemical basis of memory provided a developing and critical intellectual context for the physiological discovery. The emerging concept of multiple memory systems, from 1970 onwards, paved the way for the development of new behavioural and cognitive tasks, including the watermaze described in this paper. The use of this task in turn provided key evidence that pharmacological interference with an LTP induction mechanism would also interfere with learning, a finding that was by no means a foregone conclusion. This reciprocal relationship between studies of LTP and the neurobiology of memory helped the physiological phenomenon to be recognized as a major discovery. PMID:12740109

  8. Long-term variations in sunspot characteristics

    NASA Astrophysics Data System (ADS)

    Tlatov, A. G.

    2013-12-01

    Relative variations in the number of sunspots and sunspot groups in activity cycles have been analyzed based on data from the Kislovodsk Mountain Astronomical Station and international indices. The following regularities have been established: (1) The relative fraction of small sunspots decreases linearly and that of large sunspots increase with increasing activity cycle amplitude. (2) The variation in the average number of sunspots in one group has a trend, and this number decreased from ˜12 in cycle 19 to ˜7.5 in cycle 24. (3) The ratio of the sunspot index (Ri) to the sunspot group number index ( G gr) varies with a period of about 100 years. (4) An analysis of the sunspot group number index ( G gr) from 1610 indicates that the Gnevyshev-Ohl rule reverses at the minimums of secular activity cycles. (5) Ratio of the total area to area of Ssp/Sum nuclei has long-term variation with a period approximately 8 cycles. Minimum ratio falls on 16-17 cycles of activity. (6) It has been indicated that the magnetic field intensity and sunspot area in the current cycle are related to the amplitude of the next activity cycle.

  9. Long-term changes in Saturn's troposphere

    NASA Astrophysics Data System (ADS)

    Trafton, L.

    1985-09-01

    The author reports the results of monitoring Saturn's H2 quadrupole and CH4 band absorptions outside of the equatorial zone over one-half of Saturn's year. This interval covers most of the perihelion half of Saturn's elliptical orbit, which happens to be approximately bounded by the equinoxes. Marked long-term changes occur in the CH4 absorption accompanied by weakly opposite changes in the H2 absorption. Around the 1980 equinox, the H2 and CH4 absorptions in the northern hemisphere appear to be discontinuous with those in the southern hemisphere. This discontinuity and the temporal variation of the absorptions are evidence for seasonal changes. The absorption variations can be attributed to a variable haze in Saturn's troposphere, responding to changes in temperature and insolation through the processes of sublimation and freezing. The author models the vertical haze distribution of Saturn's south temperate latitudes during 1971 - 1977 in terms of a distribution having a particle scale height equal to a fraction of the atmospheric scale height. He also reports spatial measurements of the absorption in the 6450 Å NH3 band made annually since the 1980 equinox.

  10. Long-term potentiation in the Eocene.

    PubMed Central

    Lynch, G

    2003-01-01

    The first ten years of long-term potentiation (LTP) research are reviewed. Surprisingly, given the intensity of current interest, the discovery paper did not trigger a wave of follow-on experiments. Despite this, the initial work laid out what ultimately became standard questions and paradigms. The application of the then still novel hippocampal slice technique oriented LTP towards basic neuroscience, perhaps somewhat at the cost of lesser attention to its functional significance. The use of slices led to the discovery of the events that trigger the formation of LTP and provided some first clues about its extraordinary persistence. Signs of the intense controversy over the nature of LTP expression (release vs receptors) emerged towards the end of the first decade of work. What appears to be lacking in the literature of that time is a widespread concern about LTP and memory. This may reflect a somewhat different attitude that neurobiologists then had towards memory research and a perceived need to integrate the new potentiation phenomenon into the web of established science before advancing extended arguments about its contributions to behaviour. PMID:12740106

  11. Scientific Understanding from Long Term Observations: Insights from the Long Term Ecological Research (LTER) Program

    NASA Astrophysics Data System (ADS)

    Gosz, J.

    2001-12-01

    The network dedicated to Long Term Ecological Research (LTER) in the United States has grown to 24 sites since it was formed in 1980. Long-term research and monitoring are performed on parameters thatare basic to all ecosystems and are required to understand patterns, processes, and relationship to change. Collectively, the sites in the LTER Network provide opportunities to contrast marine, coastal, and continental regions, the full range of climatic gradients existing in North America, and aquatic and terrestrial habitats in a range of ecosystem types. The combination of common core areas and long-term research and monitoring in many habitats have allowed unprecedented abilities to understand and compare complex temporal and spatial dynamics associated with issues like climate change, effects of pollution, biodiversity and landuse. For example, McMurdo Dry Valley in the Antarctic has demonstrated an increase in glacier mass since 1993 which coincides with a period of cooler than normal summers and more than average snowfall. In contrast, the Bonanza Creek and Toolik Lake sites in Alaska have recorded a warming period unprecedented in the past 200 years. Nitrogen deposition effects have been identified through long-term watershed studies on biogeochemical cycles, especially at Coweeta Hydrological Lab, Harvard Forest, and the Hubbard Brook Experimental Forest. In aquatic systems, such as the Northern Temperate Lakes site, long-term data revealed time lags in effects of invaders and disturbance on lake communities. Biological recovery from an effect such as lake acidification was shown to lag behind chemical recovery. The long-term changes documented over 2 decades have been instrumental in influencing management practices in many of the LTER areas. In Puerto Rico, the Luquillo LTER demonstrated that dams obstruct migrations of fish and freshwater shrimp and water abstraction at low flows can completely obliterate downstream migration of juveniles and damage estuaries below by removing all incoming freshwater. At Toolik Lake, long-term experiments of removing top predators from the good web of lakes showed dramatic alterations of lake populations of small fish and zooplankton. In New Mexico, LTER research on small mammal populations is successfully predicting rodent increases and the potential for increased zoonotic diseases such as Hantavirus and bubonic plague. This ability to forecast based on El Nino prediction is being used to increase scientific awareness and public health awareness through media based communication with the public. In Oregon, the Andrews Forest LTER program has had long, strong links with natural resource policy and management. Basic understanding of forest-stream interactions, characteristics of old-growth forests, roles of woody debris in temperate forest ecosystems, invertebrate biodiversity and ecosystem function have been incorporated in management guidelines, plans and regulations for public and private lands throughout the Pacific Northwest. Other examples of the values of long-term research and monitoring will be presented.

  12. NMDA receptor-dependent long-term potentiation and long-term depression (LTP/LTD).

    PubMed

    Lüscher, Christian; Malenka, Robert C

    2012-06-01

    Long-term potentiation and long-term depression (LTP/LTD) can be elicited by activating N-methyl-d-aspartate (NMDA)-type glutamate receptors, typically by the coincident activity of pre- and postsynaptic neurons. The early phases of expression are mediated by a redistribution of AMPA-type glutamate receptors: More receptors are added to potentiate the synapse or receptors are removed to weaken synapses. With time, structural changes become apparent, which in general require the synthesis of new proteins. The investigation of the molecular and cellular mechanisms underlying these forms of synaptic plasticity has received much attention, because NMDA receptor-dependent LTP and LTD may constitute cellular substrates of learning and memory. PMID:22510460

  13. The development and efficacy of safety training for commercial fishermen.

    PubMed

    Dzugan, Jerry

    2010-10-01

    Commercial fishing is still the most dangerous occupation in the United States. Efforts to have more stringent safety regulations in this industry beginning in the 1960s, culminated in the Commercial Fishing Vessel Safety Act of 1988. The purpose of this paper is to provide a short history of the development of safety training in the United States and the current training infrastructure. This paper will also review studies available regarding the effectiveness of safety training in reducing fatalities among fishermen. The lack of familiarity and practice with marine survival equipment such as life rafts, immersion suits, and emergency-locating beacons has been noted in National Transportation Safety Board and US Coast Guard casualty reports as a contributing factor in fatalities. These reports have demonstrated the importance of not just having survival equipment onboard, but training in how to use it effectively in an emergency. There is evidence that safety training has made a measurable impact in surviving an emergency at sea and that recent training (within 5 years) is most effective in saving lives. More recently, studies have been completed to understand how skills may diminish over time since initial training. PMID:20954030

  14. 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 also presented.

  15. Long term observations of Saturn's northern auroras

    NASA Astrophysics Data System (ADS)

    Nichols, Jonathan

    2011-10-01

    Auroral emissions are a vital tool in diagnosing the dynamics of planetary magnetospheres. While SaturnA?s southern UV auroras have been observed with high-sensitivity cameras onboard the Hubble Space Telescope {HST}, the northern auroras have only been observed at very oblique angles. Our understanding of SaturnA?s auroral emissions is thus only half complete. However, Saturn has now passed equinox and is moving toward summer in the northern hemisphere, such that the northern auroras are now visible from Earth, and recent results from HST have indicated that SaturnA?s northern auroras are not simply mirror images of the southern. The changing seasons are also expected to result in significant changes in magnetospheric phenomena related to the auroras. Observing these changes is a specific goal of the Cassini Solstice Mission {CSM} and, since joint HST-Cassini observations have repeatedly proved to be invaluable, CSM operations are currently being planned specifically with joint HST observations in mind. The observations proposed here will thus execute over Cycles 18-20, and will address the following science questions:What is the morphology of SaturnA?s northern auroras? Do SaturnA?s auroras change with the planetA?s season? How are the auroral emissions of different wavelengths related?The importance of long term HST observations of SaturnA?s northern auroras are highlighted by the fact that recent key discoveries would have been missed without the multiyear archive of observations of the planetA?s southern auroras. The opportunity to obtain HST images while Cassini makes specifically-tailored supporting observations is an extremely valuable opportunity, and HST is the only instrument capable of providing sustained, high time resolution observations of Saturns auroral emission.

  16. Long term cultivation of larger benthic Foraminifera

    NASA Astrophysics Data System (ADS)

    Wöger, Julia; Eder, Wolfgang; Kinoshita, Shunichi; Antonino, Briguglio; Carles, Ferrandes-Cañadell; Hohenegger, Johann

    2015-04-01

    Benthic Foraminifera are used in a variety of applications employing numerous different methods, i.e. ecological monitoring, studying the effects of ocean acidification, reconstructing palaeo-bathymetry or investigating palaeo-salinity and palaeo-temperature to name only a few. To refine our understanding of ecological influences on larger benthic foraminiferal biology and to review inferences from field observations, culture experiments have become an indispensable tool. While culture experiments on smaller benthic foraminifera have become increasingly frequent in the past century, reports of the cultivation of symbiont bearing larger Foraminifera are rare. Generally, cultivation experiments can be divided into two groups: Culturing of populations and cultivation of single specimens allowing individual investigation. The latter differ form the former by several restrictions resulting from the need to limit individual motility without abridging microenvironmental conditions in the Foraminiferans artificial habitat, necessary to enable the individual to development as unfettered as possible. In this study we present first experiences and preliminary results of the long-term cultivation of larger benthic Foraminifera conducted at the 'Tropical Biosphere Research Station Sesoko Island, University of the Ryukyus', Japan, trying to reproduce natural conditions as closely as possible. Individuals of three species of larger benthic Foraminifera (Heterostegina depressa, Palaeonummulites venosus and Operculina complanata) have been cultured since April 2014. At the time of the general assembly the cultivation experiments will have been going on for more than one year, with the aim to investigate growth rates, longevities and reproduction strategies for comparison with results statistically inferred from application of the of the 'natural laboratory' method. The most important factor influencing foraminiferal health and development was found to be light intensity and light spectrum. The light intensities reaching the Foraminifera in cultivation however largely depend on the substrate provided (e.g. sand and silt where individuals dig close to the surface or coral rubble used as shelter by the Foraminiferans and as an easy way of retaining the organisms within a designated container by the investigator).

  17. A new long-term care manifesto.

    PubMed

    Kane, Robert L

    2015-04-01

    This article argues for a fresh look at how we provide long-term care (LTC) for older persons. Essentially, LTC offers a compensatory service that responds to frailty. Policy debate around LTC centers on costs, but we are paying for something we really don't want. Building societal enthusiasm (or even support) for LTC will require re-inventing and re-branding. LTC has three basic components: personal care, housing, and health care (primarily chronic disease management). They can be delivered in a variety of settings. It is rare to find all three done well simultaneously. Personal care (PC) needs to be both competent and compassionate. Housing must provide at least minimal amenities and foster autonomy; when travel time for PC raises costs dramatically, some form of clustered housing may be needed. Health care must be proactive, aimed at preventing exacerbations of chronic disease and resultant hospitalizations. Enhancing preferences means allowing taking informed risks. Payment incentives should reward both quality of care and quality of life, but positive outcomes must be defined as slowing decline. Paying for services but not for housing under Medicaid would automatically level the playing field between nursing homes (NH) and community-based services. Regulations should achieve greater parity between NH and community care and include both positive and negative feedback. Providing post-acute care should be separate from LTC. Using the tripartite LTC framework, we can create innovative flexible approaches to providing needed services for frail older persons in formats that are both desirable and affordable. Such care will be more socially desirable and hence worth paying for. PMID:26035606

  18. Characterisation of long term behaviour of polyester fibres and fibre assemblies for offshore mooring lines

    E-print Network

    Burgoyne, Chris

    of such structures, particularly their long term properties. When designing mooring systems with synthetic ropes to the use of excessively high safety factors in the mooring design process. This paper focuses on three to 3000m. At such depths, the usual platform mooring systems composed of steel chains and ropes become

  19. Monitoring deep subsurface microbiota for assessment of safe long-term nuclear waste disposal

    Microsoft Academic Search

    David C. White; David B. Ringelberg

    1996-01-01

    Microbes with their resistance to heat and radioactivity, if present and metabolically active, could have major effects on the safety of nuclear waste disposal by posing potential problems in long-term containment. This paper reviews the applicability of the signature lipid biomarker (SLB) analysis in the quantitative assessment of the viable biomass, community composition, and nutritional\\/physiological status of the subsurface microbiota

  20. A long-term, comprehensive solution CRC Project Director for Washington Portland State University

    E-print Network

    Bertini, Robert L.

    as high for similar urban highwayssimilar urban highways · 400 collisions a year; No shoulders· 400 collisions a year; expected to increase 80% by 2030 No shoulders y 8 #12;Freight impaired by congestion · 75 is a long-term, comprehensive solution to improve safety and reduce congestion · Replacement I-5 bridge

  1. Progesterone for the prevention of preterm birth: indications, when to initiate, efficacy and safety

    PubMed Central

    How, Helen Y; Sibai, Baha M

    2009-01-01

    Preterm birth is the leading cause of neonatal mortality and morbidity and long-term disability of non-anomalous infants. Previous studies have identified a prior early spontaneous preterm birth as the risk factor with the highest predictive value for recurrence. Two recent double blind randomized placebo controlled trials reported lower preterm birth rate with the use of either intramuscular 17 alpha-hydroxyprogesterone caproate (IM 17OHP-C) or intravaginal micronized progesterone suppositories in women at risk for preterm delivery. However, it is still unclear which high-risk women would truly benefit from this treatment in a general clinical setting and whether socio-cultural, racial and genetic differences play a role in patient’s response to supplemental progesterone. In addition the patient’s acceptance of such recommendation is also in question. More research is still required on identification of at risk group, the optimal gestational age at initiation, mode of administration, dose of progesterone and long-term safety. PMID:19436604

  2. Testing Cardiovascular Drug Safety and Efficacy in Randomized Trials

    PubMed Central

    FitzGerald, Garret A.

    2014-01-01

    Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average, but unbiased estimates of efficacy and risk. Concern has been expressed about how “unrepresentative” populations and conditions that pertain in randomized trials might be of the “real world”, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials which establish “efficacy” and those that demonstrate “effectiveness” - drugs that patients actually consume in the “real world” for clinical benefit1. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of “effectiveness” with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that “average” results may conceal considerable inter-individual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients2,3Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria - the individual Numbers Needed to Treat to obtain a benefit, such as a life saved4. Here, I will consider some reasons why large phase 3 trials - by far the most expensive element of drug development - may fail to address the “unmet medical needs” which should justify such effort and investment. PMID:24677235

  3. Long-term recovery from alcoholism.

    PubMed

    Chappel, J N

    1993-03-01

    AA has demonstrated success in steadily increasing membership, with no loss of the proportion of those with over 5 years of sobriety. It has been recognized as effective long-term treatment for alcoholism by psychiatrists and psychoanalysts experienced in treatment of the addictions. The triennial membership surveys of AA have shown stability in 1. A 50% dropout rate within the first 3 months of starting AA. Only 41% of those in the first year will remain in the Fellowship for another year. 2. Roughly equal numbers of those with less than 1 year, 1 to 5 years, and over 5 years of sobriety, with an average length of sobriety of about 4 years. 3. Members having a sponsor (85%) and belonging to a home group (88%). 4. Attendance by members of about three meetings a week, regardless of duration of sobriety. 5. Members telling their doctor that they are in AA, but not helping him or her learn about the program. The survey data also indicate that AA is changing in the following ways: 1. The number of women members has increased to more than one third the total membership. 2. An increasing number of young people, under 30 years of age, to more than one fifth the total. 3. A decreasing number of older people, over 50 years of age, to just under one fourth the total. 4. An increasing number of members who were also addicted to other drugs (46%). Psychiatrists can use these data and knowledge of AA to 1. Increase the effectiveness of referrals of alcoholic patients to AA regardless of age, sex, race, or other characteristics. All are welcome and can benefit. 2. Deal with resistance, which occurs when patients begin to make contact with AA. 3. Help alcoholic patients through the difficult first year of sobriety. 4. Encourage their alcoholic patients to use AA as a program for personal growth and development. 5. Helping dually addicted patients use AA's singleness of purpose to facilitate their recovery. 6. Cooperate with alcohol and drug treatment programs in helping patients transfer to AA and work on an effective program of recovery. 7. Work with members of the local AA Treatment Facilities and Cooperation with the Professional Community Committees in helping alcoholic patients enter and use AA. 8. Provide psychiatric treatment for AA members in ways that support and sustain their program of recovery, especially by avoiding dependence-producing medications. PMID:8456043

  4. Long-Term Space Astrophysics Program

    NASA Technical Reports Server (NTRS)

    Nowark, Michael A.

    2001-01-01

    This is the final report for our Long-Term Space Astrophysics Program (NRA 94-OSS-12) grant NAG 5-3225. The proposal is entitled 'Spectral and Temporal Properties of Black Hole Candidates', and began funding in May 1995, and ran through 31 Aug 2000. The project summary from the original proposal was as follows: 'We will study the spectral and temporal properties of black hole candidates (BHC) by using data from archival sources (e.g., EXOSAT, Ginga, ROSAT) and proposed follow-up observations with modern instruments (e.g., ASCA, XTE). Our spectral studies will focus on identifying the basic characteristics and luminosities of the emission components in the various 'states' of BHC. We hope to understand and quantify the global energetics of these states. Our temporal studies will focus on expanding and classifying our knowledge of BHC variability properties in each state. We will explore the nature of quasi-periodic oscillations in BHC. We will combine our spectral and temporal studies by analyzing time lags and variability coherence between energy channels. In addition, we will investigate ways of correlating observed variability behavior with specific emission components.' We have accomplished many of these goals laid out within the original proposal. As originally proposed, we have utilized both archival and proprietary satellite data. In terms of archival data, we have utilized data from the Advanced Satellite for Cosmology and Astrophysics (ASCA), ROSAT, and the Rossi X-ray Timing Explorer (RXTE). We also obtained proprietary data from ASCA, RXTE, and the Extreme Ultraviolet Explorer (EUVE). In terms of sources, we have examined a wide variety of both galactic black hole candidates and extra-galactic black holes. For the galactic black holes we have observed and analyzed both the low/hard state and the high/soft state. We have performed both spectral and timing analyses on all of these objects. In addition, we have also examined a number of neutron stars or potential neutron stars. All of our research on the above mentioned objects has resulted in one or more publications in peer-reviewed journals. Attached is a list of refereed publications of research results which have been funded by this grant over approximately the past five and a half years. In addition, we have included a list of conference proceedings and other similar reports that have been associated with this grant.

  5. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients

    Microsoft Academic Search

    Robert B. Ettenger; Ellen M. Grimm

    2001-01-01

    Information about the pharmacokinetics, safety, and efficacy of target of rapamycin (TOR) inhibitors, such as sirolimus and everolimus, in pediatric renal transplant recipients is limited. In an ascending single-dose pharmacokinetic study of sirolimus in pediatric dialysis patients, no clinically significant association was observed between patient age and absorption of sirolimus from the gastrointestinal tract. However, young pediatric patients (5 to

  6. Safety and Efficacy of Vagus Nerve Stimulation Paired With Tones for the Treatment of Tinnitus

    E-print Network

    Kilgard, Michael P.

    Safety and Efficacy of Vagus Nerve Stimulation Paired With Tones for the Treatment of Tinnitus in a controlled way by using stimulation of the vagus nerve paired with tones. This reversed the tinnitus percept and pathological neural plasticity in noise-exposed rats with behavioral characteristics of tinnitus. The aim

  7. Safety and Efficacy of Intensive Insulin Therapy in Patients With Thermal Injury

    Microsoft Academic Search

    Mallika P. Patel; Kyle A. Weant; Britt A. Ritter; Bruce A. Cairns

    2009-01-01

    Purpose: To evaluate the safety and efficacy of intensive insulin therapy (IIT) versus traditional corrective insulin management (CIM) for the treatment of hyperglycemia in adult patients with thermal injury who are under intensive care. Methods: Using a searchable pharmacy database, a retrospective, obser- vational chart review was conducted of adult patients who were admit- ted to the surgical burn service

  8. Efficacy and safety of videothoracoscopic lung biopsy in the diagnosis of interstitial lung disease

    Microsoft Academic Search

    Jérôme Mouroux; Claude Clary-Meinesz; Bernard Padovani; Christophe Perrin; Christine Rotomondo; Jean-Michel Chavaillon; Bruno Blaive; Henri Richelme

    1997-01-01

    Objective: The aim of this study was to determine the efficacy and safety of videothoracoscopic lung biopsy (VTLB) in the diagnosis of infiltrative lung disease (ILD) and compare the results of VTLB with the results previously obtained in patients with open lung biopsy at the same institution. Methods: Forty-one patients undergoing VTLB between May 1991 and December 1994 were retrospectively

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

    Microsoft Academic Search

    Mark Naunton; Jacobus R. B. J. Brouwers; David F. Archer

    2006-01-01

    Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of a gel containing estradiol that is applied to the skin. Design: MEDLINE and EMBASE searches were conducted from 1966 to March 2005. Additional references were identified from bibliographies from selected studies in addition to approved product information. Results: Estradiol gel is indicated for the relief of moderate to severe vasomotor

  10. A study evaluating the safety and efficacy of the Velasmooth™ system in the treatment of cellulite

    Microsoft Academic Search

    Neil Sadick; Cynthia Magro

    2007-01-01

    Background: Most cellulite treatments are limited in their effectiveness. A combination of radiofrequency energy, infrared light and mechanical manipulation of the skin and fat merits further examination. Objective: Subjects were treated with a device combining these energies to evaluate its safety and efficacy. Methods: Sixteen subjects with cellulite were treated twice weekly for 6 weeks with the VelaSmoothTM system. One

  11. Warfarin Knowledge in Patients with Atrial Fibrillation: Implications for Safety, Efficacy, and Education Strategies

    Microsoft Academic Search

    Megan B. Smith; Nedra Christensen; Shiquan Wang; Jennifer Strohecker; John D. Day; J. Peter Weiss; Brian G. Crandall; Jeffrey S. Osborn; Jeffrey L. Anderson; Benjamin D. Horne; Joseph B. Muhlestein; Donald L. Lappe; Heidi Moss; Jessica Oliver; Krista Viau; T. Jared Bunch

    2010-01-01

    Background: Multiple factors influence warfarin metabolism and can significantly affect the risk of adverse events. The extent to which patients understand the modifiable factors that impact on warfarin safety and efficacy is unclear. Methods: A 52-item questionnaire related to knowledge of warfarin was administered to patients with atrial fibrillation in a face-to-face interview with a dietitian. Results were compiled based

  12. Efficacy and safety of atorvastatin compared to pravastatin in patients with hypercholesterolemia

    Microsoft Academic Search

    Stefano Bertolini; Gabriele Bittolo Bon; L. Malcolm Campbell; Michel Farnier; John Langan; Gerhard Mahla; Paolo Pauciullo; Cesare Sirtori; Fabrice Egros; Rana Fayyad; James W Nawrocki

    1997-01-01

    Plasma cholesterol and other lipoproteins play a significant role in the development of atherosclerosis and subsequent coronary heart disease (CHD). This 1 year study was designed to confirm the efficacy and safety of atorvastatin (Lipitor) compared to pravastatin, a marketed agent for low density lipoprotein cholesterol (LDL-C) reduction in hypercholesterolemic patients. Patients were recruited at 26 centers in six European

  13. Safety and antiulcer efficacy studies of Achillea millefolium L. after chronic treatment in Wistar rats

    Microsoft Academic Search

    Ana Maria Cavalcanti; Cristiane Hatsuko Baggio; Cristina Setim Freitas; Lia Rieck; Renato Silva de Sousa; José Eduardo Da Silva-Santos; Sonia Mesia-Vela; Maria Consuelo Andrade Marques

    2006-01-01

    Achillea millefolium L. (Asteraceae), popularly known as yarrow, has been used in folk medicine to treat complaints such as inflammation, pain, wounds, hemorrhages and gastrointestinal disturbances. The aim of the present study was to assess the safety and efficacy of the aqueous extract (AE) of the plant after chronic exposure. Indeed, the AE was effective in protecting the gastric mucosa

  14. Methotrexate and misoprostol for early abortion: A multicenter trial. I. Safety and efficacy

    Microsoft Academic Search

    Mitchell D. Creinin; Eric Vittinghoff; Lisa Keder; Philip D. Darney; George Tiller

    1996-01-01

    A prospective trial was conducted including 300 pregant women seeking elective abortion to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at ?56 days gestation. Subjects received methotrexate 50 mg\\/m2 intramuscularly followed 7 days later by misoprostol 800 ?g vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Outcome measures included

  15. The safety and efficacy of intrabursal oxycodone and bupivacaine in analgesia after shoulder surgery

    Microsoft Academic Search

    Pasi Muittari; Olli Kirvelä

    1998-01-01

    Background and Objectives. Peripherally administered opioids, e.g., intra-articular morphine, exert their analgesic action on local opioid receptors. The present study investigated the safety and efficacy of intrabursal oxycodone and bupivacaine in comparison with bupivacaine infiltration and interscalene brachial plexus block in conjunction with shoulder surgery. Methods. A prospective, randomized study was conducted in 45 patients (15 per group) undergoing elective

  16. Safety and efficacy of using the Viabahn endoprosthesis for percutaneous treatment of vascular access complications after transfemoral aortic valve implantation.

    PubMed

    De Backer, Ole; Arnous, Samer; Sandholt, Benjamin; Brooks, Matthew; Biasco, Luigi; Franzen, Olaf; Lönn, Lars; Bech, Bo; Søndergaard, Lars

    2015-04-15

    Vascular access complications (VACs) remain one of the biggest challenges when performing transcatheter aortic valve implantation (TAVI). This study aimed to investigate the short- and medium-term safety and efficacy of the Viabahn endoprosthesis (Gore, Flagstaff, AZ) when used to treat TAVI-induced vascular injury. Over a 40-month period, 354 patients underwent true percutaneous transfemoral (TF)-TAVI using a CoreValve and Prostar-XL closure system; this was our study population. A VAC leading to acute intervention occurred in 72 patients (20.3%) - of these, 18 were managed by balloon angioplasty, 48 were treated by Viabahn stenting (technical success rate 98%), and 6 needed surgical intervention. Overall, this approach resulted in a major VAC rate of 3.1% (n = 11) in our study cohort. Length of hospitalization and 30-day mortality rates were comparable in patients with a VAC treated by Viabahn stenting versus patients without vascular complications. Two patients (4.5%) presented with new-onset claudication; one of them had the stent implanted covering the deep femoral artery (DFA). At medium-term follow-up (median 372 days; range 55 to 978 days) duplex ultrasound showed 100% patency of the Viabahn endoprostheses with no signs of stent fracture or in-stent stenosis/occlusion. In conclusion, the use of self-expanding covered stents is safe and effective in case of TF-TAVI-induced vascular injury, with good short- and medium-term outcomes. Importantly, coverage of the DFA should be avoided. If confirmed by long-term (>5 years) follow-up studies, this strategy for treating TAVI-induced VAC may be used routinely in high-risk patients. PMID:25728645

  17. Scale of health: indices of safety and efficacy in the evolving environment of large biological datasets.

    PubMed

    Sayes, Christie M; Staats, Herman; Hickey, Anthony J

    2014-09-01

    The interdependent relationship between pharmacology and toxicology is fundamental to the concepts of efficacy and safety of both drugs and xenobiotics. The traditional concept of establishing efficacious and tolerated doses to define a 'therapeutic window' appears simplistic in the context of an exponentially increasing database on molecular mechanisms and cell biology that inform our understanding of homeostasis. Recent advances in nano medicine illustrate the convergence of efficacy and safety considerations that are central to establishing a clear pathway for regulatory review. The following overview considers biological responses to the administration of nanoparticles and the scale of balanced, within a range that might be considered 'normal', to unbalanced, abnormal responses associated with health and disease. PMID:24919930

  18. Efficacy and safety of pomegranate medicinal products for cancer.

    PubMed

    Vlachojannis, Christian; Zimmermann, Benno F; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  19. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    PubMed Central

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  20. Long-Term Environmental Policy: Definition, Knowledge, Future Research

    Microsoft Academic Search

    Detlef F. Sprinz

    2009-01-01

    Considering the long-term is not new, yet we seem to be overwhelmed by the long-term nature of many of our environmental policy problems. Following a definition of long-term policy problems, this editorial introduces the contributions to this special issue of Global Environmental Politics and outlines three major challenges for future research, including the time inconsistency problem, the effect of democratic

  1. Pregnancy in women who undergo long-term hemodialysis

    Microsoft Academic Search

    An-Shine Chao; Jeng-Yi Huang; Reyin Lien; Fu-Tsai Kung; Po-Jen Chen; Peter C. C. Hsieh

    2002-01-01

    Objective: Pregnancy is rare in women who require long-term hemodialysis, and pregnancy outcome with a live birth has a low success rate. The purpose of this study was to describe the treatment of pregnancy and the outcome in a series of patients undergoing long-term hemodialysis treatment. Study Design: A total of 15 women who were undergoing long-term hemodialysis treatment who

  2. Long term physical sequelae after adult-onset cancer

    Microsoft Academic Search

    Sophie D. Fosså; Rena Vassilopoulou-Sellin; Alv A. Dahl

    2008-01-01

    Introduction  With two thirds of cancer patients living for at least 5 years, clinical research has increasingly focused on the long-term\\u000a health of cancer survivors. Contrary to the amount of knowledge on long-term consequences observations on late effects after\\u000a childhood cancer in adult-onset cancer are sparse. Only limited literature is available recommending guidelines for long-term\\u000a follow-up of cancer patients and their implementation

  3. Malignant external otitis: long-term (months) antimicrobial therapy

    SciTech Connect

    Strauss, M.; Aber, R.C.; Conner, G.H.; Baum, S.

    1982-04-01

    Since Chandler's initial report in 1968 on malignant external otitis (MEO), this entity has been recognized in its earlier stages with increasing frequency. As a result of this, the availability of new antimicrobial agents, and the judicious use of surgery, there has been an improvement in the results of therapy. There remains, however, a subgroup of patients who continue to experience a significant mortality from this infection. A review and selected discussion of our experience with MEO from 1976 to 1979 is presented. Six patients have been diagnosed and successfully treated for MEO. They presented with problems ranging from severe otalgia to multiple cranial neuropathy. For the most part, therapy consisted of the now standard aminoglycoside and carbenicillin combination. Two of the patients were in the high mortality risk group. One of these patients developed an osteomyelitis which extended across the skull base resulting in bilateral cranial neuropathies. His therapy included surgery as well as long-term (months) outpatient treatment with tobramycin and carbenicillin with an excellent result. The second patient was treated similarly. The efficacy of this approach is discussed as well as the usefulness of radionuclide bone scanning in assessing the course and therapy of patients with MEO.

  4. Long-Term Monitoring of Global Climate Forcings and Feedbacks

    NASA Technical Reports Server (NTRS)

    Hansen, J. (editor); Rossow, W. (editor); Fung, I. (editor)

    1993-01-01

    A workshop on Long-Term Monitoring of Global Climate Forcings and Feedbacks was held February 3-4, 1992, at NASA's Goddard Institute for Space Studies to discuss the measurements required to interpret long-term global temperature changes, to critique the proposed contributions of a series of small satellites (Climsat), and to identify needed complementary monitoring. The workshop concluded that long-term (several decades) of continuous monitoring of the major climate forcings and feedbacks is essential for understanding long-term climate change.

  5. Draft Report A Forecast Model of Long-Term PCB

    E-print Network

    Draft Report A Forecast Model of Long-Term PCB Fate in San Francisco Bay John J. Oram and Jay A................................................................................................ 8 Estimation of Future PCB Loads

  6. Explaining Variance in Long-Term Recall in 3- and 4-Year-Old Children: The Importance of Post-Encoding Processes

    ERIC Educational Resources Information Center

    Bauer, Patricia J.; Larkina, Marina; Doydum, Ayzit O.

    2012-01-01

    Long-term recall is influenced by what originally was encoded as well as by the efficacy of retrieval processes. The possible explanatory role of post-encoding processes by which initially labile memory traces are stabilized and integrated into long-term memory (i.e., consolidated) has received relatively less research attention. In the current…

  7. Safety and efficacy of personal care products containing colloidal oatmeal

    PubMed Central

    Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

    2012-01-01

    Background Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized. Methods In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions) by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin. Results We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation. Conclusion Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period. PMID:23204849

  8. A Practical Data Recovery Technique for Long-Term Strain Monitoring of Mega Columns during Construction

    PubMed Central

    Choi, Se Woon; Kwon, EunMi; Kim, Yousok; Hong, Kappyo; Park, Hyo Seon

    2013-01-01

    A practical data recovery method is proposed for the strain data lost during the safety monitoring of mega columns. The analytical relations among the measured strains are derived to recover the data lost due to unexpected errors in long-term measurement during construction. The proposed technique is applied to recovery of axial strain data of a mega column in an irregular building structure during construction. The axial strain monitoring using the wireless strain sensing system was carried out for one year and five months between 23 July 2010 and 22 February 2012. During the long-term strain sensing, three different types of measurement errors occurred. Using the recovery technique, the strain data that could not be measured at different intervals in the measurement were successfully recovered. It is confirmed that the problems that may occur during long-term wireless strain sensing of mega columns during construction could be resolved through the proposed recovery method. PMID:23966189

  9. A practical data recovery technique for long-term strain monitoring of mega columns during construction.

    PubMed

    Choi, Se Woon; Kwon, EunMi; Kim, Yousok; Hong, Kappyo; Park, Hyo Seon

    2013-01-01

    A practical data recovery method is proposed for the strain data lost during the safety monitoring of mega columns. The analytical relations among the measured strains are derived to recover the data lost due to unexpected errors in long-term measurement during construction. The proposed technique is applied to recovery of axial strain data of a mega column in an irregular building structure during construction. The axial strain monitoring using the wireless strain sensing system was carried out for one year and five months between 23 July 2010 and 22 February 2012. During the long-term strain sensing, three different types of measurement errors occurred. Using the recovery technique, the strain data that could not be measured at different intervals in the measurement were successfully recovered. It is confirmed that the problems that may occur during long-term wireless strain sensing of mega columns during construction could be resolved through the proposed recovery method. PMID:23966189

  10. Safety and efficacy of DNA vaccines: plasmids vs. minicircles.

    PubMed

    Stenler, Sofia; Blomberg, Pontus; Smith, C I Edvard

    2014-05-01

    While DNA vaccination using plasmid vectors is highly attractive, there is a need for further vector optimization regarding safety, stability, and efficiency. In this commentary, we review the minicircle vector (MC), which is an entity devoid of plasmid bacterial sequences, as an alternative to the traditional plasmid construct. The commentary highlights the recent discovery by Stenler et al. (2014) that the small size of an MC enables improved resistance to the shearing forces associated with e.g. pneumatic delivery methods. This observation may have implications for the regulatory agencies' requirement of plasmid integrity and quality. PMID:24553064

  11. Long-Term Gender-Based Outcomes for Atazanavir/Ritonavir (ATV/r)-Containing Regimens in Treatment-Experienced Patients with HIV

    PubMed Central

    Svedhem-Johansson, Veronica; Pugliese, Pascal; Brockmeyer, Norbert H.; Thalme, Anders; Michalik, Claudia; Esser, Stefan; Barlet, Marie-Helene; Nakonz, Tina; Jimenez-Exposito10, Maria J.

    2013-01-01

    Clinical data on antiretroviral effectiveness in women are limited, especially long-term data, because women are usually underrepresented in clinical trials. This sub-analysis of a large European non-comparative, retrospective, observational cohort study evaluated gender differences in long-term outcomes in antiretroviral-experienced adult patients with HIV-1 infection switched to an ATV/r-based regimen between October 2004 and March 2007. Data were extracted from 3 European HIV databases every 6 months (maximum follow-up 5 years). Time to virological failure (VF), defined as two consecutive HIV-1 RNA ?50 c/mL or one HIV-1 RNA ?50 c/mL followed by treatment discontinuation (TD), and time to TD were analyzed using the Kaplan-Meier method. Associations of gender with VF and TD were analyzed using multivariate Cox proportional models. Safety and tolerability were evaluated. In total, 1294 patients (336 women, 958 men) were analyzed. No gender differences in time to VF were observed; at 3 years, the probability of not having VF was 0.59 (95%CI: 0.52, 0.65) and 0.63 (95%CI: 0.59, 0.67) for women and men, respectively. In multivariate analyses, women had a higher risk of TD than men (hazard ratio [HR], 1.54; 95%CI: 1.28, 1.85) but no increased risk of VF (HR, 1.06; 95%CI: 0.85, 1.33). Safety and tolerability were comparable between genders. In a clinical setting, long-term efficacy and safety outcomes of ATV/r-based regimens were similar by gender. Women had a higher risk of TD but no increased risk of VF. ATV/r is an effective and well-tolerated therapeutic option for treatment-experienced men and women with HIV-1 infection. PMID:23590675

  12. Review of the Safety and Efficacy of Moringa oleifera.

    PubMed

    Stohs, Sidney J; Hartman, Michael J

    2015-06-01

    Moringa oleifera leaves, seeds, bark, roots, sap, and flowers are widely used in traditional medicine, and the leaves and immature seed pods are used as food products in human nutrition. Leaf extracts exhibit the greatest antioxidant activity, and various safety studies in animals involving aqueous leaf extracts indicate a high degree of safety. No adverse effects were reported in association with human studies. Five human studies using powdered whole leaf preparations of M.?oleifera have been published, which have demonstrated anti-hyperglycemic (antidiabetic) and anti-dyslipidemic activities. These activities have been confirmed using extracts as well as leaf powders in animal studies. A rapidly growing number of published studies have shown that aqueous, hydroalcohol, or alcohol extracts of M.?oleifera leaves possess a wide range of additional biological activities including antioxidant, tissue protective (liver, kidneys, heart, testes, and lungs), analgesic, antiulcer, antihypertensive, radioprotective, and immunomodulatory actions. A wide variety of polyphenols and phenolic acids as well as flavonoids, glucosinolates, and possibly alkaloids is believed to be responsible for the observed effects. Standardization of products is an issue. However, the results of published studies to date involving M.?oleifera are very promising. Additional human studies using standardized extracts are highly desirable. © 2015 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd. PMID:25808883

  13. Long-Term Adherence to Interferon ? Therapy in Relapsing-Remitting Multiple Sclerosis

    Microsoft Academic Search

    E. Portaccio; V. Zipoli; G. Siracusa; S. Sorbi; M. P. Amato

    2008-01-01

    Background\\/Aims: To assess the proportion and the reasons of drop-outs in relapsing-remitting multiple sclerosis patients treated with interferon-? (IFNB) and the outcome of switching subjects. Methods: Patients stopping IFNB were classified according to the reason of drop-out: perceived lack of efficacy (PLE) side effects (SE) and other reasons. Long-term adherence was described using the Kaplan-Meier curves. Results: We evaluated 225

  14. Lithium prophylaxis of recurrent bipolar affective disorder: Long-term outcome and its psychosocial correlates

    Microsoft Academic Search

    Parmanand Kulhara; Debasish Basu; Surendra K Mattoo; Pratap Sharan; Rajni Chopra

    1999-01-01

    Background: Discrepancy between efficacy of prophylactic lithium and its effectiveness in ordinary clinical practice necessitates long-term follow-up data from specialised lithium clinics. Also, role of psychosocial factors in influencing the outcome is unclear. Methods: One hundred and eighteen patients of bipolar affective disorder attending a lithium clinic were followed-up for ?11 years (range 2–27 years). Demographic and clinical data, measures

  15. Vagus nerve stimulation for medically refractory epilepsy: A long-term follow-up study

    Microsoft Academic Search

    J. J. Ardesch; H. P. J. Buschman; L. J. J. C. Wagener-Schimmel; H. E. van der Aa; G. Hageman

    2007-01-01

    Introduction\\u000aVagus nerve stimulation (VNS) is thought to have a cumulative effect in time on seizure frequency reduction. There also might be other variables than reduction of seizure frequency in order to determine VNS efficacy. In this study we describe the long-term outcome of the first group of vagus nerve stimulation patients with pharmacoresistant epilepsy at the Medisch Spectrum Twente,

  16. Long-term surveillance plan for the Gunnison, Colorado, disposal site

    SciTech Connect

    NONE

    1996-02-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

  17. Long-term surveillance plan for the Gunnison, Colorado disposal site

    SciTech Connect

    NONE

    1996-04-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

  18. Long-term surveillance plan for the Cheney disposal site near Grand Junction, Colorado

    SciTech Connect

    NONE

    1997-04-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Cheney disposal site. The site is in Mesa County near Grand Junction, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites are cared for in a manner that protects public health and safety and the environment. Before each disposal site may be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Cheney disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination that remedial action is complete and the NRC formally accepts this plan. This document describes the long-term surveillance program the DOE will implement to ensure that the Cheney disposal site performs as designed. The program is based on site inspections to identify potential threats to disposal cell integrity. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

  19. Long-term surveillance plan for the Maybell, Colorado Disposal Site

    SciTech Connect

    NONE

    1997-12-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Maybell disposal site in Moffat County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites are cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Maybell disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination that remedial action is complete for the Maybell site and the NRC formally accepts this LTSP. This document describes the long-term surveillance program the DOE will implement to ensure the Maybell disposal site performs as designed. The program is based on site inspections to identify threats to disposal cell integrity. The LTSP is based on the UMTRA Project long-term surveillance program guidance document and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

  20. Long-term surveillance plan for the Gunnison, Colorado, disposal site

    SciTech Connect

    NONE

    1996-05-01

    This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

  1. Changes in Plasma ACTH Levels and Corticotroph Tumor Size in Patients With Cushing's Disease During Long-term Treatment With the Glucocorticoid Receptor Antagonist Mifepristone

    PubMed Central

    Findling, James W.; Koch, Christian A.; Schlaffer, Sven-Martin; Buchfelder, Michael; Gross, Coleman

    2014-01-01

    Context: Pituitary effects of long-term therapy with mifepristone, a glucocorticoid receptor antagonist, in Cushing's disease (CD) patients are not well understood. Objective: Our objective was to report changes in ACTH and pituitary magnetic resonance imaging (MRI) findings during long-term use of mifepristone in CD patients. Design and Setting: The Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing's Syndrome (SEISMIC) was a 24-week, open-label study of mifepristone, and its long-term extension (LTE) is a multicenter U.S. study. Patients: Forty-three CD patients (mean age 45.3 years) were enrolled in SEISMIC with 27 continuing into the LTE study. Interventions: Mifepristone (300–1200 mg) was administered once daily. Main Outcome Measures: ACTH and pituitary MRI were assessed at baseline and at regular intervals during treatment. Results: A ?2-fold increase in ACTH was observed in 72% of patients treated for a median duration of 11.3 months. The mean peak increase in ACTH was 2.76 ± 1.65-fold during SEISMIC, and mean ACTH concentrations remained stable during the LTE. ACTH was directly correlated with mifepristone dose and declined to near baseline levels after mifepristone discontinuation. Tumor regressed in 2 patients and progressed in 3 patients with macroadenomas. An additional microadenoma was identified after 25 months of treatment after a baseline tumor-negative MRI. Conclusions: In the largest prospective study to date, long-term mifepristone treatment increased ACTH in approximately two-thirds of patients with CD. ACTH elevations were observed within the first few weeks of treatment, were dose-dependent, and generally remained stable over time. Corticotroph tumor progression and regression may occur over time, but patients may have significant increases in ACTH levels without evidence of tumor growth. PMID:25013998

  2. Long term effectiveness of antimalarial drugs in rheumatic diseases

    PubMed Central

    Avina-Zubieta, J; Galindo-Rodriguez, G.; Newman, S.; Suarez-Almazor, M.; Russell, A.

    1998-01-01

    OBJECTIVE—The purpose of this study was to compare the long term effectiveness between chloroquine (CQ) and hydroxychloroquine (HCQ).?METHODS—Medical charts of all patients seen by eight rheumatologists practising in two tertiary care centres and starting antimalarial treatment between January 1985 and December 1993 were reviewed. Patient characteristics, disease, and treatment information were collected. The main outcome measures were the cause of and the time to the discontinuation of antimalarial drugs resulting from all causes, principally toxicity or inefficacy, or both. Bivariate analysis including t tests and ?2 tests were used to assess differences between means and proportions respectively. Survival curves were evaluated using the Kaplan-Meier method. Multivariate analysis (Cox regression) was used to adjust for potential confounders.?RESULTS—After all medical records were reviewed, 1042 eligible cases were identified. From these, 940 (90%) had usable information and they represent the cohort. Five hundred and fifty eight had rheumatoid arthritis, 178 had systemic lupus erythematosus, 127 had palindromic arthritis, and 77 had other diagnoses. Fifty seven per cent of the patients received CQ and 43% HCQ. The proportion of patients with side effects taking HCQ and CQ was 15% and 28% respectively (p=0.001). Using Cox regression model to adjust for age at the onset of antimalarial treatment, physician differences, sex, disease type, disease duration before treatment, and rank selection, there were no differences in the hazard ratio (HR) for overall discontinuations between CQ and HCQ. While the HR for discontinuations because of toxicity was lower for HCQ (HR= 0.6, 95% CI 0.4, 0.9), the HR for discontinuations because of inefficacy was significantly higher for HCQ (HR= 1.4, 95% CI 1.1, 1.9).?CONCLUSIONS—After adjusting for time and several confounders HCQ was less toxic but less effective than CQ. Only one case of probable/possible retinopathy was found. Therefore, we propose a careful baseline ophthalmological evaluation by an expert and then one or every two years if proper doses are used.?? Keywords: antimalarial drugs; long term effectiveness; efficacy; toxicity; rheumatic diseases PMID:9893568

  3. Antipsychotic treatments for the elderly: efficacy and safety of aripiprazole.

    PubMed

    Kohen, Izchak; Lester, Paula E; Lam, Sum

    2010-01-01

    Delusions, hallucinations and other psychotic symptoms can accompany a number of conditions in late life. As such, elderly patients are commonly prescribed antipsychotic medications for the treatment of psychosis in both acute and chronic conditions. Those conditions include schizophrenia, bipolar disorder, depression and dementia. Elderly patients are at an increased risk of adverse events from antipsychotic medications because of age-related pharmacodynamic and pharmacokinetic changes as well as polypharmacy. Drug selection should be individualized to the patient's previous history of antipsychotic use, current medical conditions, potential drug interactions, and potential side effects of the antipsychotic. Specifically, metabolic side effects should be closely monitored in this population. This paper provides a review of aripiprazole, a newer second generation antipsychotic agent, for its use in a variety of psychiatric disorders in the elderly including schizophrenia, bipolar disorder, dementia, Parkinson's disease and depression. We will review the pharmacokinetics and pharmacodynamics of aripiprazole as well as dosing, diagnostic indications, efficacy studies, and tolerability including its metabolic profile. We will also detail patient focused perspectives including quality of life, patient satisfaction and adherence. PMID:20361061

  4. Ultrasound-guided stellate ganglion block: safety and efficacy.

    PubMed

    Narouze, Samer

    2014-06-01

    Cervical sympathetic and stellate ganglion blocks (SGB) provide a valuable diagnostic and therapeutic benefit to sympathetically maintained pain syndromes in the head, neck, and upper extremity. With the ongoing efforts to improve the safety of the procedure, the techniques for SGB have evolved over time, from the use of the standard blind technique, to fluoroscopy, and recently to the ultrasound (US)-guided approach. Over the past few years, there has been a growing interest in the ultrasound-guided technique and the many advantages that it might offer. Fluoroscopy is a reliable method for identifying bony surfaces, which facilitates identifying the C6 and C7 transverse processes. However, this is only a surrogate marker for the cervical sympathetic trunk. The ideal placement of the needle tip should be anterolateral to the longus colli muscle, deep to the prevertebral fascia (to avoid spread along the carotid sheath) but superficial to the fascia investing the longus colli muscle (to avoid injecting into the muscle substance). Identifying the correct fascial plane can be achieved with ultrasound guidance, thus facilitating the caudal spread of the injectate to reach the stellate ganglion at C7-T1 level, even if the needle is placed at C6 level. This allows for a more effective and precise sympathetic block with the use of a small injectate volume. Ultrasound-guided SGB may also improve the safety of the procedure by direct visualization of vascular structures (inferior thyroidal, cervical, vertebral, and carotid arteries) and soft tissue structures (thyroid, esophagus, and nerve roots). Accordingly, the risk of vascular and soft tissue injury may be minimized. PMID:24760493

  5. eschweizerbartxxx Long-term zooplankton size in L. Kinneret 1

    E-print Network

    Hambright, K. David

    eschweizerbartxxx Long-term zooplankton size in L. Kinneret 1 DOI: 10-term zooplankton body size and species changes in a subtropical lake: implications for lake management K. David figures and 3 tables Abstract: Analysis of long-term (1970­2002) zooplankton body sizes in Lake Kinneret

  6. Improving secure long-term archival of digitally signed documents

    Microsoft Academic Search

    Carmela Troncoso; Danny De Cock; Bart Preneel

    2008-01-01

    Long-term archival of signed documents presents specic challenges that do not need to be considered in short-term storage systems. In this paper we present a Secure Long- Term Archival System (SLTAS) that protects, in a veri- able way, the validity of today's digital signatures in a dis- tant future. Moreover, our protocol is the rst proposal that provides a proof

  7. Long-term complications related to the modified Indiana pouch

    Microsoft Academic Search

    Daniel G Holmes; J. Brantley Thrasher; Gerald Y Park; Deborah C Kueker; John W Weigel

    2002-01-01

    ObjectivesTo describe a single-institution, single-surgeon experience with 125 modified Indiana pouches performed during a period of 14 years and their long-term complications. The modified Indiana pouch is a widely accepted and often used form of continent urinary diversion. Few studies have established the long-term complication rates associated with the procedure.

  8. Long-Term Retention of Electronic Theses and Dissertations.

    ERIC Educational Resources Information Center

    Teper, Thomas H.; Kraemer, Beth

    2002-01-01

    Examines the increasing trend of universities to pursue electronic thesis and dissertation (ETD) programs. Although the goal of most programs is similar, procedural variations impact a program's long-term success. As primary research generators, responsibility for providing long-term access to unique materials must be borne by universities.…

  9. Developmental Dyslexia and Explicit Long-Term Memory

    ERIC Educational Resources Information Center

    Menghini, Deny; Carlesimo, Giovanni Augusto; Marotta, Luigi; Finzi, Alessandra; Vicari, Stefano

    2010-01-01

    The reduced verbal long-term memory capacities often reported in dyslexics are generally interpreted as a consequence of their deficit in phonological coding. The present study was aimed at evaluating whether the learning deficit exhibited by dyslexics was restricted only to the verbal component of the long-term memory abilities or also involved…

  10. Long Term Real Trajectory Reuse through Region Goal Satisfaction

    E-print Network

    Iyengar, Garud

    Long Term Real Trajectory Reuse through Region Goal Satisfaction Junghyun Ahn1 , St´ephane Gobron1 collision avoidance through long term anticipation of pedestrian trajectories. For this aim, we choose to reuse outdoor pedestrian trajectories obtained with non-invasive means. This initial step is achieved

  11. Developing a Long-Term Drought Plan for Phoenix

    Microsoft Academic Search

    Benedykt Dziegielewski; William R. Mee Jr.; Keith R. Larson

    1992-01-01

    Assessing the economic consequences of potential water supply shortages can help water agencies determine the need for investment in long-term protection from drought. In Phoenix, Ariz., the risk of drought damage in the long term justifies the need for additional drought protection through developing standby groundwater supplies and implementing permanent demand-reduction measures. The most efficient way of dealing with the

  12. It's Not Your Grandmother's Long-Term Care Anymore

    Microsoft Academic Search

    Joshua M. Wiener

    Recently, a colleague of mine, who used to do research on long-term care but has been out of the field for the last 15 years, commented to me that long-term care seemed stagnant to him and that the issues he had worked on long ago were still the issues of today. Aside from my annoyed rejoinder that the issues of

  13. Market-Consistent Valuation of Long-Term Insurance Contracts -

    E-print Network

    Pfeifer, Holger

    Market-Consistent Valuation of Long-Term Insurance Contracts - Valuation Framework-Consistent Valuation of Long-Term Insurance Contracts Valuation Framework and Application to German Private Health with respect to prot sharing rules and premium adjustment mechanisms. In contrast to the valuation of life

  14. Apoptosis of monocytes cultured from long-term hemodialysis patients

    Microsoft Academic Search

    Stefan Heidenreich; Michael Schmidt; Jürgen Bachmann; Bärbel Harrach

    1996-01-01

    Apoptosis of monocytes cultured from long-term hemodialysis patients. Monocyte apoptosis in vitro was studied in patients on long-term hemodialysis, CAPD, and in predialytic uremia to gain insight into the high susceptibility of these patients to infections. Monocytes from dialysis and control subjects were cultured for 24 to 120 hours in vitro to analyze the level and progression of DNA fragmentation

  15. ENDOPYELOTOMY AFTER FAILED PYELOPLASTY: THE LONG-TERM RESULTS

    Microsoft Academic Search

    MICHEL E. JABBOUR; EVAN R. GOLDFISCHER; WLODZIMIERZ J. KLIMA; KONSTANTINOS G. STRAVODIMOS; ARTHUR D. SMITH

    1998-01-01

    PurposeEndopyelotomy has been proposed as a technique to treat ureteropelvic junction obstruction after failed open pyeloplasty. However, to our knowledge no long-term results of this treatment have been reported. We report the long-term followup of a cohort of patients in whom pyeloplasty failed and who subsequently were treated with endopyelotomy.

  16. Setting the stage for long-term reproductive health.

    PubMed

    Payne, Craig A; Vander Ley, Brian; Poock, Scott E

    2013-11-01

    This article discusses some of the aspects of heifer development that contribute to long-term health and productivity, such as disease prevention and control. Nutrition is also an important component of long-term health, and body condition score is discussed as a way to determine whether the nutrient demands of heifers are being met. PMID:24182434

  17. A review on long-term sorption solar energy storage

    Microsoft Academic Search

    K. Edem N’Tsoukpoe; Hui Liu; Nolwenn Le Pierrès; Lingai Luo

    2009-01-01

    In the past decade, long-term sorption and thermochemical heat storage has generated lot of interest. This paper presents the state of the art in this field of research, materials used in these systems and technological difficulties that researchers are set against. An emphasis is put on recent demonstrative projects including absorption and adsorption for long-term solar energy storage. It emerges

  18. Phase 2 study of the efficacy and safety of the combination of arsenic trioxide, interferon alpha, and zidovudine in newly diagnosed chronic adult T-cell leukemia/lymphoma (ATL).

    PubMed

    Kchour, Ghada; Tarhini, Mahdi; Kooshyar, Mohamad-Mehdi; El Hajj, Hiba; Wattel, Eric; Mahmoudi, Mahmoud; Hatoum, Hassan; Rahimi, Hossein; Maleki, Masoud; Rafatpanah, Houshang; Rezaee, S A Rahim; Yazdi, Mojtaba Tabatabaei; Shirdel, Abbas; de Thé, Hugues; Hermine, Olivier; Farid, Reza; Bazarbachi, Ali

    2009-06-25

    Adult T-cell leukemia/lymphoma (ATL) is resistant to chemotherapy and carries a dismal prognosis particularly for the acute and lymphoma subtypes. Promising results were obtained with the combination of zidovudine and interferon-alpha. Chronic ATL has a relatively better outcome, but poor long-term survival is noted when patients are managed with a watchful-waiting policy or with chemotherapy. In ATL cell lines, arsenic trioxide shuts off constitutive NF-kappaB activation and potentiates interferon-alpha apoptotic effects through proteasomal degradation of Tax. Clinically, arsenic/interferon therapy exhibits some efficacy in refractory aggressive ATL patients. These results prompted us to investigate the efficacy and safety of the combination of arsenic, interferon-alpha, and zidovudine in 10 newly diagnosed chronic ATL patients. An impressive 100% response rate was observed including 7 complete remissions, 2 complete remissions but with more than 5% circulating atypical lymphocytes, and 1 partial response. Responses were rapid and no relapse was noted. Side effects were moderate and mostly hematologic. In conclusion, treatment of chronic ATL with arsenic, interferon-alpha, and zidovudine is feasible and exhibits an impressive response rate with moderate toxicity. Long-term follow up will clarify whether this will translate to disease cure. Overall, these clinical results strengthen the concept of oncogene-targeted cancer therapy. PMID:19411628

  19. The Efficacy of a Condensed Seeking Safety Intervention for Women in Residential Chemical Dependence Treatment at 30 Days Posttreatment

    Microsoft Academic Search

    Anna Cash Ghee; Lanny C. Bolling; Candace S. Johnson

    2009-01-01

    This study examined the efficacy of a condensed version of the Seeking Safety intervention in the reduction of trauma-related symptoms and improved drug abstinence rates among women in residential chemical dependence treatment. One hundred and four women were randomly assigned to treatment including a condensed (six session) Seeking Safety intervention or the standard chemical dependence intervention. The Seeking Safety participants

  20. Efficacy and safety of aripiprazole in child and adolescent patients.

    PubMed

    Kirino, Eiji

    2012-07-01

    Aripiprazole (APZ) has a unique pharmacological profile, as a partial agonist at the dopamine D2 and serotonin 5HT1A receptors and an antagonist at the serotonin 5HT2A receptor; this drug has few side effects (such as extrapyramidal syndrome, hyperprolactinemia, weight gain, metabolic disorders, and sedation) which are typical problems with other antipsychotic drugs. Due to its high tolerability, it is possible to safely administer it to children and adolescents. Efficacy and tolerability of APZ in children and adolescents have been well demonstrated in many clinical studies, which supported approvals granted by the US Food and Drug Administration (FDA) for schizophrenia, bipolar diseases, and irritability associated with autistic disorder in children and adolescents. APZ is expected to exert sedative, anti-depressive, and anti-anxiety effects, and stabilize emotion. APZ is an antipsychotic drug which could be useful for a wider spectrum of psychiatric disorders in children and adolescents. There is little risk of deterioration (such as disinhibition and acting out) and rapid stabilization is easy to achieve in children and adolescents without definitive diagnoses or with a combination of more than one spectrum of disorders. The effectiveness of APZ in children and adolescents is reviewed and discussed, given its pharmacological profile and the outcomes of various clinical studies. However, randomized or blind studies are still limited, and the majority of reports referenced here are open-label studies and case reports. Conclusions drawn from such studies must be evaluated with caution, and a further accumulation of controlled studies is thus needed. PMID:22447196

  1. Long-term variation of energetic electron precipitation

    NASA Astrophysics Data System (ADS)

    Asikainen, Timo

    2015-04-01

    The long-term evolution of energetic electron precipitation (EEP) is of considerable interest, e.g., because of its atmospheric and climatic effects. However, the long-term evolution of EEP over several solar cycles has been problematic due to the lack of reliable long-term data. The NOAA/POES satellites have measured energetic particles for more than 35 years. This dataset has been used widely but it has been plagued by several instrumental problems, which have restricted its use for long-term studies. However, we have recently corrected and recalibrated the entire NOAA/POES energetic particle dataset. Using this unique dataset we present here an overview of the long-term evolution of EEP paying particular attention to the role of different types of solar wind disturbances in driving the EEP.

  2. Environmental Management Long-Term Stewardship Transition Guidance

    SciTech Connect

    Kristofferson, Keith

    2001-11-01

    Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after the completion of facility cleanup. Long-term stewardship is administered and overseen by the U.S. Department of Energy Environmental Management Office of Science and Technology. This report describes the background of long-term stewardship and gives general guidance about considerations when ownership and/or responsibility of a site should be transferred to a long-term stewardship program. This guidance document will assist the U.S. Department of Energy in: (a) ensuring that the long-term stewardship program leads transition planning with respect to facility and site areas, and (b) describing the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete.

  3. The Womanly World of Long Term Care: The Plight of the Long Term Care Worker. Gray Paper.

    ERIC Educational Resources Information Center

    Older Women's League, Washington, DC.

    Long-term care workers (those who are paid to provide custodial care for long-term patients in nursing homes or at home) must care for a growing number of increasingly disabled or dependent persons. They are working for agencies and institutions under growing pressure to increase productivity. They face new training and competency requirements,…

  4. Efficacy and safety of crataegus extract WS 1442 in comparison with placebo in patients with chronic stable New York Heart Association class-III heart failure

    Microsoft Academic Search

    Michael Tauchert

    2002-01-01

    Objective The purpose of this study was to investigate whether long-term therapy with crataegus extract WS 1442 is efficacious as add-on therapy to preexisting diuretic treatment in patients with heart failure with a more advanced stage of the disease (New York Heart Association [NYHA] class III), whether effects are dose dependent, and whether the treatment is safe and well tolerated.

  5. A 6-year open-label study of the efficacy and safety of olanzapine long-acting injection in patients with schizophrenia: a post hoc analysis based on the European label recommendation

    PubMed Central

    Anand, Ernie; Berggren, Lovisa; Deix, Claudia; Tóth, Ágoston; McDonnell, David P

    2015-01-01

    Purpose To assess the long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of schizophrenia, focusing on clinical trial data consistent with the approved indication and dosing recommendations in the European label and which forms the basis for treatment decisions made by clinicians in daily clinical practice. Patients and methods This was a post hoc analysis of a 6-year open-label study of olanzapine LAI in patients (male or female, 18–75 years old) with schizophrenia entering this study following feeder studies of olanzapine LAI. Patients were flexibly dosed (45–405 mg, 2- to 4-week intervals), but those receiving oral olanzapine supplementation whose total olanzapine dose was >20 mg/day equivalent were excluded from this post hoc analysis. Results Data from 669 patients were analyzed (44.5% completed). Positive and Negative Syndrome Scale total scores did not change significantly from baseline to endpoint; Clinical Global Impression-Severity scores improved significantly. Mean weight change was +2.19 kg (P<0.001), with 40.8% of patients experiencing ?7% weight gain. There were 24 occurrences of post-injection delirium/sedation syndrome (PDSS). Conclusion Olanzapine LAI appeared to be effective in the long-term maintenance of schizophrenia, and the safety profile was consistent with that of oral olanzapine, except for injection-related events and PDSS events.

  6. A Comparison of Computer-based and Instructor-led Training for Long-term Care Staff.

    ERIC Educational Resources Information Center

    Harrington, Susan S.; Walker, Bonnie L.

    2002-01-01

    Fire safety training was provided to long-term care staff by computer (n=47) or a print-based, instructor-led program (n=47). Compared to 47 controls, both treatment groups significantly increased knowledge. The computer-trained staff were enthusiastic about the learning method and expressed greater interest in additional safety topics. (SK)

  7. Efficacy and safety of combination simvastatin and colesevelam in patients with primary hypercholesterolemia

    Microsoft Academic Search

    Howard H Knapp; Helmut Schrott; Patrick Ma; Robert Knopp; Bruce Chin; J. Michael Gaziano; Joanne M Donovan; Steven K Burke; Michael H Davidson

    2001-01-01

    PURPOSE: To examine the efficacy and safety of colesevelam hydrochloride, a novel, nonsystemic, lipid-lowering agent, when coadministered with starting doses of simvastatin in a multicenter, randomized, double-blind, placebo-controlled trial.PATIENTS AND METHODS: Subjects with hypercholesterolemia (plasma low density lipoprotein [LDL] cholesterol level >160 mg\\/dL and triglyceride level ?300 mg\\/dL) were randomly assigned to receive daily doses of placebo (n = 33),

  8. POSTER PRESENTATION Open Access Efficacy and safety of hepatitis C direct-acting

    E-print Network

    Boyer, Edmond

    POSTER PRESENTATION Open Access Efficacy and safety of hepatitis C direct-acting protease perspectives for HCV cure in HIV-HCV patients but data concerning the use of HVC DAA-PI in this patients (n=20) or 1b (n=10) or 4 (n=1), METAVIR fibrosis stage was F3F4 in 55%, F2 in 32% and F0F1 in 13

  9. Efficacy, safety, and clinical outcomes of endoscopic mucosal resection: A study of 101 cases

    Microsoft Academic Search

    Nuzhat A. Ahmad; Michael L. Kochman; William B. Long; Emma E. Furth; Gregory G. Ginsberg

    2002-01-01

    Background: Endoscopic mucosal resection (EMR) is an alternative to surgery for removal of superficial neoplastic lesions of the GI tract. The aim of this study was to assess the safety, efficacy, and clinical outcomes of EMR. Methods: Data from consecutive EMR procedures performed by using suction cap-assisted and\\/or saline solution-assisted snare resection techniques over a 45-month period were reviewed retrospectively.

  10. Safety and efficacy of a sustained inflation for alveolar recruitment in adults with respiratory failure

    Microsoft Academic Search

    S. E. Lapinsky; M. Aubin; S. Mehta; P. Boiteau; A. S. Slutsky

    1999-01-01

    Objective: To assess the safety and efficacy of a sustained inflation, used as a lung volume recruitment maneuver in ventilated patients\\u000a with hypoxemic respiratory failure.¶Design: Prospective data collection as part of a quality assurance program following introduction of a lung volume recruitment guideline\\u000a in the intensive care unit.¶Setting: Academic medical-surgical critical care unit.¶Patients: Hypoxemic patients with bilateral pulmonary infiltrates. Patients

  11. Efficacy and Safety of Low-Dose Aspirin in Polycythemia Vera

    Microsoft Academic Search

    Raffaele Landolfi; Roberto Marchioli; Jack Kutti; Heinz Gisslinger; Gianni Tognoni; Carlo Patrono; Tiziano Barbui

    2010-01-01

    background The use of aspirin for the prevention of thrombotic complications in polycythemia vera is controversial. methods We enrolled 518 patients with polycythemia vera, no clear indication for aspirin treat- ment, and no contraindication to such treatment in a double-blind, placebo-controlled, randomized trial to assess the safety and efficacy of prophylaxis with low-dose aspirin (100 mg daily). The two primary

  12. Efficacy and Safety of Voriconazole in the Treatment of Acute Invasive Aspergillosis

    Microsoft Academic Search

    David W. Denning; Patricia Ribaud; Noel Milpied; Denis Caillot; Raoul Herbrecht; Eckhard Thiel; Andrea Haas; Markus Ruhnke; Hartmut Lode

    2002-01-01

    To evaluate the efficacy and safety of voriconazole in acute invasive aspergillosis (IA), an open, noncomparative multicenter study was conducted. Immunocompromised patients with IA were treated with intravenously administered voriconazole 6 mg\\/kg twice a day (b.i.d.) twice and then 3 mg\\/kg b.i.d. for 6-27 days, followed by 200 mg b.i.d. administered orally for up to 24 weeks. Response was assessed

  13. Morning vs evening dosing with doxazosin in benign prostatic hyperplasia: efficacy and safety

    Microsoft Academic Search

    RS Kirby; CR Chapple; K Sethia; M Flannigan; EJG Milroy; P Abrams

    1998-01-01

    Three hundred and fifty-three patients with symptomatic benign prostatic hyperplasia were randomized to doxazosin or placebo, with morning or evening dosing, to compare the effect of dosing time on the efficacy and safety of doxazosin treatment. After 24 weeks of treatment, the mean International Prostate Symptom Score had decreased by 6.8 units in the doxazosin group compared with 4.5 units

  14. Clinical Efficacy and Safety of Tolterodine Compared to Oxybutynin and Placebo in Patients with Overactive Bladder

    Microsoft Academic Search

    H. P. Drutz; R. A. Appell; D. Gleason; I. Klimberg; S. Radomski

    1999-01-01

    :   This study compared the clinical efficacy (determined from micturition diaries) and safety of 12 weeks’ treatment with either\\u000a tolterodine 2 mg twice daily, oxybutynin 5 mg three times daily or placebo in patients with an overactive bladder. A total\\u000a of 277 patients were randomized and treated at 25 centers. Both tolterodine and oxybutynin significantly increased volume\\u000a voided\\/micturition compared to

  15. Obstructive Primary Bladder Neck Disease: Evaluation of the Efficacy and Safety of ?1-Blockers

    Microsoft Academic Search

    A. Cisternino; G. Zeccolini; A. Calpista; V. De Marco; T. Prayer Galetti; M. Iafrate; W. Artibani

    2006-01-01

    Objective: The efficacy and safety of using ?1-adrenergic blockers for treating primary bladder neck obstruction in young and middle-aged men was assessed as the first therapeutic step, before surgery, in a symptomatic non-neurogenic selected group of patients. Materials and Methods: From January 1995 to December 2001, primary bladder neck obstruction was diagnosed in 41 men whose average age was 43

  16. Efficacy and Safety of Nicardipine Prolonged-Release Implants for Preventing Vasospasm in Humans

    Microsoft Academic Search

    Hidetoshi Kasuya; Hideaki Onda; Mikihiko Takeshita; Yoshikazu Okada; Tomokastu Hori

    Background and Purpose—Despite extensive investigative efforts, there are few treatments that can prevent vasospasm after subarachnoid hemorrhage. This study was conducted to examine the efficacy and safety of nicardipine prolonged-release implants (NPRI) for humans, which have already been proven in dogs. Methods—Twenty consecutive subarachnoid hemorrhage patients with thick subarachnoid clot were treated with NPRI (a pellet of diameter 2 mm,

  17. Venezuelan equine encephalitis virus vaccine candidate (V3526) safety, immunogenicity and efficacy in horses

    Microsoft Academic Search

    Donald L. Fine; Brian A. Roberts; Max L. Teehee; Sara J. Terpening; Cindy L. H. Kelly; Janae L. Raetz; Dale C. Baker; Ann M. Powers; Richard A. Bowen

    2007-01-01

    A new vaccine, V3526, is a live-attenuated virus derived by site-directed mutagenesis from a virulent clone of the Venezuelan equine encephalitis virus (VEEV) IA\\/B Trinidad donkey (TrD) strain, intended for human use in protection against Venezuelan equine encephalitis (VEE). Two studies were conducted in horses to evaluate the safety, immunogenicity, ability to boost and protective efficacy of V3526 against challenges

  18. Safety and protective efficacy of INA-inactivated Venezuelan equine encephalitis virus: Implication in vaccine development

    Microsoft Academic Search

    Anuj Sharma; Paridhi Gupta; Pamela J. Glass; Michael D. Parker; Radha K. Maheshwari

    2011-01-01

    We have previously shown that a hydrophobic alkylating compound, 1,5-iodonaphthyl-azide (INA) can efficiently inactivate the virulent strain of Venezuelan equine encephalitis virus (VEEV), V3000 in vitro. In this study, we have evaluated the safety of INA-inactivated V3000 and V3526 and the protective efficacy of INA-inactivated V3000. INA-inactivated V3000 and V3526 did not cause disease in suckling mice. RNA isolated from

  19. Efficacy and safety of timolol solution once daily vs timolol gel added to latanoprost

    Microsoft Academic Search

    William C. Stewart; Douglas G. Day; Elizabeth D. Sharpe; Harvey B. Dubiner; Keri T. Holmes; Jeanette A. Stewart

    1999-01-01

    PURPOSE: To compare the efficacy and safety of timolol hemihydrate 0.5% (Betimol, Ciba Vision Ophthalmics, Duluth, Georgia) vs timolol maleate gel-forming solution 0.5% (Timoptic-XE, Merck, Blue Bell, Pennsylvania), both given every morning added to latanoprost 0.005% given every evening.METHODS: A multicenter, randomized, crossover comparison was performed in patients with primary open-angle glaucoma or ocular hypertension. After at least a 4-week

  20. The efficacy and safety of the timolol\\/dorzolamide fixed combination vs latanoprost in exfoliation glaucoma

    Microsoft Academic Search

    A G P Konstas; V P Kozobolis; I Tersis; J Leech; W C Stewart; AGP Konstas

    2003-01-01

    Purpose To evaluate the safety and efficacy of the timolol\\/dorzolamide fixed combination vslatanoprost 0.005% in exfoliation glaucoma patients.Methods We randomized in an observer-masked fashion 65 newly diagnosed exfoliation glaucoma patients to either the timolol\\/dorzolamide twice daily or latanoprost daily treatment for 2 months and then crossed these over to the other treatment.Results A total of fifty-four patients completed the study.

  1. Efficacy and Safety of Intravenous Iron Therapy for HCV-Positive Haemodialysis Patients

    Microsoft Academic Search

    Serkan Kahraman; Rahmi Yilmaz; Gultekin Genctoy; Mustafa Arici; Bulent Altun; Yunus Erdem; Unal Yasavul; Cetin Turgan

    2005-01-01

    Background: Iron supplementation is the cornerstone of anaemia management in haemodialysis (HD) patients. However, efficacy and safety of intravenous (IV) iron therapy in hepatitis C virus (HCV)-positive HD patients is yet to be elucidated. Methods: Sixty-six maintenance HD patients with suboptimal response to recombinant human erythropoietin (rh-EPO) were administered IV iron. Each patient received 100 mg\\/session IV iron sucrose for

  2. High pressure rotating reverse osmosis for long term space missions

    NASA Astrophysics Data System (ADS)

    Christensen Pederson, Cynthia Lynn

    Rotating reverse osmosis, which uses reverse osmosis to purify water and rotating filtration to improve the efficacy of filtration, has great potential for wastewater recycling on a long term space mission. Previous investigations of a proof-of-concept device indicated that the most efficient method to improve rotating reverse osmosis performance is to increase the operational pressure. Thus, a second generation device and fluid circuit were designed, fabricated, and tested to permit high pressure operation for long time periods. The design overcame several obstacles including membrane attachment, rotating seal design, and fluid and pressure management. A theoretical model of rotating reverse osmosis was modified to properly account for the flow conditions in the new design. Tests lasting a week were conducted with a variety of model wastewaters. Significant fouling and a decrease in flux were observed after three days of testing regardless of the operational parameters. A semi-empirical model, the fouling potential, was added to the theoretical model to account for the fouling. This allowed the simulation of 48 hour cleaning cycles that significantly increased the flux of the device. Experimental investigation of the rotational speed and concentrate flow rate indicated that an increase in either parameter decreased the fouling slightly. A week long test of a wastewater ersatz with a biocide did not exhibit a decrease in flux around day three that otherwise occurred. Therefore, biofouling was identified as the primary mechanism of fouling. Rotating reverse osmosis was compared with conventional spiral wound reverse osmosis and displayed increased rejection under dead end filtration conditions. The rotating device exhibited similar rejection and increased flux compared to a tubular reverse osmosis device previously used in a NASA wastewater recovery system. The integration of the rotating device into a NASA water recovery management system was evaluated. Lastly, a theoretical model of rotating hemofiltration was developed that demonstrated that the device is not clinically feasible given the permeability of available hemofiltration membranes.

  3. Long-term vision-threatening complications of phakic intraocular lens implantation for high myopia

    PubMed Central

    Sayman Muslubas, Isil Bahar; Kandemir, Baran; Aydin Oral, Ayse Yesim; Kugu, Suleyman; Dastan, Metin

    2014-01-01

    AIM To report the long-term vision-threatening complications in patients who underwent phakic intraocular lens (pIOLs) implantation for high myopia. METHODS This study was designed from a consecutive series of phakic intraocular lens complication and corrective surgeries. Sixteen eyes of 13 patients had implantation of phakic intraocular lens for correction high myopia and developed serious complications have been included in this study. The mean age of patients was 38.6±6.35y (range 32-50y) and the mean time of history of pIOL implantation for high myopia was 6±2y (range 2-10y). Before corrective surgery, best spectacle-corrective visual acuity (BSCVA) ranged from perception to 20/200 in the eyes in which severe complications occurred. RESULTS Corneal decompensation occurred in 12 eyes of 9 high myopic patients after anterior chamber pIOL implantation. Rhegmatogenous retinal detachment (RRD) occurred in 4 eyes of 4 high myopic patients following anterior chamber and posterior chamber pIOL implantation. Patients with corneal decompensation, had combined procedures consisting of pIOL removal and penetrating keratoplasty (PKP). Removals of pIOL, phacoemulsification and pars plana vitrectomy (PPV) with silicone oil tamponade were performed in patients with RRD. After corrective surgeries, all patients but one (P+, patient 2, right eye) achieved moderate BSCVA ranged from 20/200 to 20/50 at the last visit. CONCLUSION Phakic IOLs may be effective for the correction of high myopia. Although these IOLs may have severe complications and it affects safety and efficacy of this surgery. As seen here, corneal decompensation and rhegmatogenous retinal detachment are possible postoperative vision-threatening complications of phakic IOLs. Patients must be carefully examined before and after surgery for possible endothelial cell loss and vitreoretinal problems. PMID:24790887

  4. Meta-Analysis of Long-Term Clinical Outcomes of Everolimus-Eluting Stents.

    PubMed

    Toyota, Toshiaki; Shiomi, Hiroki; Morimoto, Takeshi; Kimura, Takeshi

    2015-07-15

    The superiority of everolimus-eluting stents (EES) over sirolimus-eluting stents (SES) for long-term clinical outcomes has not been yet firmly established. We conducted a systematic review and a meta-analysis of randomized controlled trials (RCTs) comparing EES directly with SES using the longest available follow-up data. We searched PubMed, the Cochrane database, and ClinicalTrials.gov for RCTs comparing outcomes between EES and SES and identified 13,434 randomly assigned patients from 14 RCTs. EES was associated with significantly lower risks than SES for definite stent thrombosis (ST), definite/probable ST, target-lesion revascularization (TLR), and major adverse cardiac events (MACE). The risks for all-cause death and myocardial infarction were similar between EES and SES. By the stratified analysis according to the timing after stent implantation, the favorable trend of EES relative to SES for ST, TLR, and MACE was consistently observed both within and beyond 1 year. The lower risk of EES relative to SES for MACE beyond 1 year was statistically significant (pooled odds ratio 0.77, 95% confidence interval 0.61 to 0.96, p = 0.02). In conclusion, the current meta-analysis of 14 RCTs directly comparing EES with SES suggested that EES provided improvement in both safety and efficacy; EES compared with SES was associated with significantly lower risk for definite ST, definite/probable ST, TLR, and MACE. The direction and magnitude of the effect beyond 1 year were comparable with those observed within 1 year. PMID:25960378

  5. Space ventures and society long-term perspectives

    NASA Technical Reports Server (NTRS)

    Brown, W. M.

    1985-01-01

    A futuristic evaluation of mankind's potential long term future in space is presented. Progress in space will not be inhibited by shortages of the Earth's physical resources, since long term economic growth will be focused on ways to constrain industrial productivity by changing social values, management styles, or government competence. Future technological progress is likely to accelerate with an emphasis on international cooperation, making possible such large joint projects as lunar colonies or space stations on Mars. The long term future in space looks exceedingly bright even in relatively pessimistic scenarios. The principal driving forces will be technological progress, commercial and public-oriented satellites, space industrialization, space travel, and eventually space colonization.

  6. Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel

    PubMed Central

    2012-01-01

    Background United States Army Soldiers regularly use dietary supplements (DS) to promote general health, enhance muscle strength, and increase energy, but limited scientific evidence supports the use of many DS for these benefits. This study investigated factors associated with Soldiers’ confidence in the efficacy and safety of DS, and assessed Soldiers’ knowledge of federal DS regulatory requirements. Methods Between 2006 and 2007, 990 Soldiers were surveyed at 11 Army bases world-wide to assess their confidence in the effectiveness and safety of DS, knowledge of federal DS regulations, demographic characteristics, lifestyle-behaviors and DS use. Results A majority of Soldiers were at least somewhat confident that DS work as advertised (67%) and thought they are safe to consume (71%). Confidence in both attributes was higher among regular DS users than non-users. Among users, confidence in both attributes was positively associated with rank, self-rated diet quality and fitness level, education, and having never experienced an apparent DS-related adverse event. Fewer than half of Soldiers knew the government does not require manufacturers to demonstrate efficacy, and almost a third incorrectly believed there are effective pre-market federal safety requirements for DS. Conclusions Despite limited scientific evidence supporting the purported benefits and safety of many popular DS, most Soldiers were confident that DS are effective and safe. The positive associations between confidence and DS use should be considered when developing DS-related interventions or policies. Additionally, education to clarify Soldiers’ misperceptions about federal DS safety and efficacy regulations is warranted. PMID:23051046

  7. Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies.

    PubMed

    Uno, Hajime; Wittes, Janet; Fu, Haoda; Solomon, Scott D; Claggett, Brian; Tian, Lu; Cai, Tianxi; Pfeffer, Marc A; Evans, Scott R; Wei, Lee-Jen

    2015-07-21

    A noninferiority study is often used to investigate whether a treatment's efficacy or safety profile is acceptable compared with an alternative therapy regarding the time to a clinical event. The empirical quantification of the treatment difference for such a study is routinely based on the hazard ratio (HR) estimate. The HR, which is not a relative risk, may be difficult to interpret clinically, especially when the underlying proportional hazards assumption is violated. The precision of the HR estimate depends primarily on the number of observed events but not directly on exposure times or sample size of the study population. If the event rate is low, the study may require an impractically large number of events to ensure that the prespecified noninferiority criterion for the HR is attainable. This article discusses deficiencies in the current approach for the design and analysis of a noninferiority study. Alternative procedures are provided, which do not depend on any model assumption, to compare 2 treatments. For a noninferiority safety study, the patients' exposure times are more clinically important than the observed number of events. If the patients' exposure times are long enough to evaluate safety reliably, then these alternative procedures can effectively provide clinically interpretable evidence on safety, even with relatively few observed events. These procedures are illustrated with data from 2 studies. One explores the cardiovascular safety of a pain medicine; the second examines the cardiovascular safety of a new treatment for diabetes. These alternative strategies to evaluate safety or efficacy of an intervention lead to more meaningful interpretations of the analysis results than the conventional strategy that uses the HR estimate. PMID:26054047

  8. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    21 Food and Drugs 5 2011-04-01 2011-04-01...drugâ or safety or effectiveness findings in drug efficacy study implementation notices...hearing to identical, related, and similar drug products. 310.6 Section...

  9. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    21 Food and Drugs 5 2012-04-01 2012-04-01...drugâ or safety or effectiveness findings in drug efficacy study implementation notices...hearing to identical, related, and similar drug products. 310.6 Section...

  10. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    21 Food and Drugs 5 2010-04-01 2010-04-01...drugâ or safety or effectiveness findings in drug efficacy study implementation notices...hearing to identical, related, and similar drug products. 310.6 Section...

  11. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    21 Food and Drugs 5 2014-04-01 2014-04-01...drugâ or safety or effectiveness findings in drug efficacy study implementation notices...hearing to identical, related, and similar drug products. 310.6 Section...

  12. Safety and efficacy of a graduated intravenous insulin infusion protocol in critically ill trauma patients receiving specialized nutritional support

    Microsoft Academic Search

    Roland N. Dickerson; Cortney E. Swiggart; Laurie M. Morgan; George O. Maish; Martin A. Croce; Gayle Minard; Rex O. Brown

    2008-01-01

    ObjectiveThe intent of this study was to evaluate the safety and efficacy of our protocol for providing continuous intravenous regular human insulin (RHI) infusion to hyperglycemic critically ill trauma patients receiving specialized nutritional support.

  13. Efficacy and safety of the fixed combinations latanoprost\\/timolol versus dorzolamide\\/timolol in patients with elevated intraocular pressure

    Microsoft Academic Search

    Dong H Shin; Robert M Feldman; Wang-Pui Sheu

    2004-01-01

    PurposeTo compare the efficacy and safety of the fixed combination of latanoprost and timolol with those of the fixed combination of dorzolamide and timolol in patients with elevated intraocular pressure (IOP).

  14. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    21 Food and Drugs 5 2013-04-01 2013-04-01...drugâ or safety or effectiveness findings in drug efficacy study implementation notices...hearing to identical, related, and similar drug products. 310.6 Section...

  15. Improvement of cognitive deficit in Alzheimer's disease patients by long term treatment with korean red ginseng.

    PubMed

    Heo, Jae-Hyeok; Lee, Soon-Tae; Oh, Min Jung; Park, Hyun-Jung; Shim, Ji-Young; Chu, Kon; Kim, Manho

    2011-11-01

    A 24-week randomized open-label study with Korean red ginseng (KRG) showed cognitive benefits in patients with Alzheimer's disease. To further determine long-term effect of KRG, the subjects were recruited to be followed up to 2 yr. Cognitive function was evaluated every 12 wk using the Alzheimer's Disease Assessment Scale (ADAS) and the Korean version of the Mini Mental Status Examination (K-MMSE) with the maintaining dose of 4.5 g or 9.0 g KRG per d. At 24 wk, there had been a significant improvement in KRG-treated groups. In the long-term evaluation of the efficacy of KRG after 24 wk, the improved MMSE score remained without significant decline at the 48th and 96th wk. ADAS-cog showed similar findings. Maximum improvement was found around week 24. In conclusion, the effect of KRG on cognitive functions was sustained for 2 yr follow-up, indicating feasible efficacies of long-term follow-up for Alzheimer's disease. PMID:23717092

  16. Umbilical cord blood expansion with nicotinamide provides long-term multilineage engraftment

    PubMed Central

    Horwitz, Mitchell E.; Chao, Nelson J.; Rizzieri, David A.; Long, Gwynn D.; Sullivan, Keith M.; Gasparetto, Cristina; Chute, John P.; Morris, Ashley; McDonald, Carolyn; Waters-Pick, Barbara; Stiff, Patrick; Wease, Steven; Peled, Amnon; Snyder, David; Cohen, Einat Galamidi; Shoham, Hadas; Landau, Efrat; Friend, Etty; Peleg, Iddo; Aschengrau, Dorit; Yackoubov, Dima; Kurtzberg, Joanne; Peled, Tony

    2014-01-01

    BACKGROUND. Delayed hematopoietic recovery is a major drawback of umbilical cord blood (UCB) transplantation. Transplantation of ex vivo–expanded UCB shortens time to hematopoietic recovery, but long-term, robust engraftment by the expanded unit has yet to be demonstrated. We tested the hypothesis that a UCB-derived cell product consisting of stem cells expanded for 21 days in the presence of nicotinamide and a noncultured T cell fraction (NiCord) can accelerate hematopoietic recovery and provide long-term engraftment. METHODS. In a phase I trial, 11 adults with hematologic malignancies received myeloablative bone marrow conditioning followed by transplantation with NiCord and a second unmanipulated UCB unit. Safety, hematopoietic recovery, and donor engraftment were assessed and compared with historical controls. RESULTS. No adverse events were attributable to the infusion of NiCord. Complete or partial neutrophil and T cell engraftment derived from NiCord was observed in 8 patients, and NiCord engraftment remained stable in all patients, with a median follow-up of 21 months. Two patients achieved long-term engraftment with the unmanipulated unit. Patients transplanted with NiCord achieved earlier median neutrophil recovery (13 vs. 25 days, P < 0.001) compared with that seen in historical controls. The 1-year overall and progression-free survival rates were 82% and 73%, respectively. CONCLUSION. UCB-derived hematopoietic stem and progenitor cells expanded in the presence of nicotinamide and transplanted with a T cell–containing fraction contain both short-term and long-term repopulating cells. The results justify further study of NiCord transplantation as a single UCB graft. If long-term safety is confirmed, NiCord has the potential to broaden accessibility and reduce the toxicity of UCB transplantation. TRIAL REGISTRATION. Clinicaltrials.gov NCT01221857. FUNDING. Gamida Cell Ltd. PMID:24911148

  17. Deferiprone versus deferoxamine in thalassemia intermedia: Results from a 5-year long-term Italian multicenter randomized clinical trial.

    PubMed

    Calvaruso, Giuseppina; Vitrano, Angela; Di Maggio, Rosario; Lai, Eliana; Colletta, Grazia; Quota, Alessandra; Gerardi, Calogera; Rigoli, Luciana Concetta; Sacco, Massimiliano; Pitrolo, Lorella; Maggio, Aurelio

    2015-07-01

    In patients with thalassemia intermedia (TI), such as beta-TI, alpha-thalassemia (mainly HbH disease and mild/moderate forms of HbE/beta-thalassemia), iron overload is an important challenge in terms of diagnosis, monitoring, and treatment. Moreover, to date, the only possible chelators available are deferoxamine, deferasirox, and deferiprone. Here, we report the first 5-year long-term randomized clinical trial comparing the effectiveness of deferiprone versus deferoxamine in patients with TI. Body iron burden, which was determined by measuring serum ferritin levels in the same patient over 5 years and analyzed according to the generalized linear mixed model (GLMM), showed a linear decrease over time in the mean serum ferritin levels in both treatment groups (P-value?=?0.035). The overall period of observation was 235.2 person-years for the deferiprone patients compared with 214.3 person-years for the deferoxamine patients. The results of the log-rank test suggested that the deferiprone treatment did not affect survival compared with the deferoxamine treatment (P-value?=?0.360). The major adverse events observed included gastrointestinal symptoms and joint pain or arthralgia. Neutropenia and agranulocytosis were also detected, suggesting needing of strict hematological control. In conclusion, long-term iron chelation therapy with deferiprone is associated with an efficacy and safety similar to that of deferoxamine, suggesting that this drug is an alternative option in cases in which deferoxamine and deferasirox are contraindicated. Am. J. Hematol. 90:634-638, 2015. © 2015 Wiley Periodicals, Inc. PMID:25809173

  18. Long-term refractive outcomes of posterior chamber phakic (spheric and toric implantable collamer lens) intraocular lens implantation.

    PubMed

    Gomez-Bastar, Arturo; Jaimes, Martha; Graue-Hernández, Enrique O; Ramirez-Luquin, Tito; Ramirez-Miranda, Arturo; Navas, Alejandro

    2014-06-01

    To report the long-term refractive outcomes, safety, predictability, efficacy and complications of 349 eyes treated with posterior chamber phakic intraocular lenses (pIOLs). A retrospective review of consecutive clinical cases of patients who underwent spheric implantable collamer lens (ICL) and toric ICL (TICL) implantation. The study included 349 eyes of 216 patients with sphere between +8 to -24 diopters (D) and 0 to -6.5 D of astigmatism. Statistical analysis was performed to identify differences between preoperative and postoperative refractive outcomes. Main outcome measures were preoperative and postoperative uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical and cylindrical errors and spherical equivalent and significant postoperative complications. 194 eyes were treated with TICL and 155 eyes with ICL. The mean age of the patients was 29 ± 6.7 years. The mean preoperative sphere was -10.35 ± 5.1 D (+8 to -24) and the postoperative sphere was -0.09 ± 1.06 D (+3.25 to -6.5), p < 0.001. Preoperative cylinder was -2.63 ± 1.44 (0 to -6.5 D) and postoperative cylinder was -0.97 ± 0.89 D (0 to -3.5), p < 0.001. The preoperative mean spherical equivalent was -11.6 ± 5.12 D (+7.875 to -25.625) and postoperative spherical equivalent was -0.52 ± 1.03 (+2.25 to -6.75), p < 0.001. The mean preoperative UDVA was 1.72 ± 0.49 and postoperative UDVA was 0.23 ± 0.22, p < 0.001. The mean preoperative CDVA was 0.21 ± 0.17 and postoperative CDVA was 0.12 ± 0.138, p < 0.001. The implantation of posterior chamber pIOLs is a safe, predictable and effective strategy to manage refractive errors during long-term follow-up. PMID:24114502

  19. Long-term benefit of human fetal neuronal progenitor cell transplantation in a clinically adapted model after traumatic brain injury.

    PubMed

    Skardelly, Marco; Gaber, Khaled; Burdack, Swen; Scheidt, Franziska; Hilbig, Heidegard; Boltze, Johannes; Förschler, Annette; Schwarz, Sigrid; Schwarz, Johannes; Meixensberger, Jürgen; Schuhmann, Martin U

    2011-03-01

    Experimental human fetal neural progenitor cell (hfNPC) transplantation has proven to be a promising therapeutic approach after traumatic brain injury (TBI). However, the long-term efficacy and safety, which are both highly important for clinical translation of this approach, have thus far not been investigated. This study investigated the effect of local (L, 1?×?10(5) cells) and systemic (S, 5?×?10(5) cells) administration of PKH-26-labeled pre-differentiated hfNPCs over a period of 12 weeks, beginning 24?h after severe controlled cortical impact TBI in Sprague-Dawley rats. Accelerating rotarod testing revealed a trend toward functional improvement beginning 1 week after transplantation, and persisting until the end of the experiment. The traumatic lesion volume as quantified by magnetic resonance imaging was smaller in both treatment groups compared to control (C) animals (C?=?54.50?mm(3), L?=?32?mm(3), S?=?37.50?mm(3)). Correspondingly, neuronal (NeuN) staining showed increased neuronal survival at the border of the lesion in both transplanted groups (S?=?92.4%; L?=?87.2%; 72.5%). Histological analysis of the brain compartments revealed transiently increased angiogenesis and reduced astroglial reaction during the first 4 weeks post-transplantation. PKH-26-positive cells were detected exclusively after local transplantation without any evidence of tumor formation. However, graft differentiation was seen only in very rare cases. In conclusion, transplantation of hfNPCs improved the long-term functional outcome after TBI, diminished trauma lesion size, and increased neuronal survival in the border zone of the lesion. This therapeutic effect was not likely due to cell replacement, but was associated with transiently increased angiogenesis and reduced astrogliosis. PMID:21083415

  20. Quantitative Polygraphic Controlled Study on Efficacy and Safety of Oral Splint Devices in Tooth-grinding Subjects

    Microsoft Academic Search

    C. Dubé; P. H. Rompré; C. Manzini; F. Guitard; P. de Grandmont; G. J. Lavigne

    2010-01-01

    The efficacy of occlusal splints in diminishing muscle activity and tooth-grinding damage remains controversial. The objective of this study was to compare the efficacy and safety of an occlusal splint (OS) vs. a palatal control device (PCD). Nine subjects with sleep bruxism (SB) participated in this randomized study. Sleep laboratory recordings were made on the second night to establish baseline