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1

Long-term safety and efficacy of continuous intrathecal baclofen.  

PubMed

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

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

2002-10-01

2

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

PubMed Central

Over the last decade, there has been increasing interest in minimally invasive cosmetic treatments, especially for facial rejuvenation. Next to botulinum toxin injection, the injection of soft tissue fillers is the second most frequent minimally invasive procedure performed in the USA. Hyaluronic acid (HA) is the most commonly used dermal filler. One of patients’ main concerns about filler injections pertains to pain and discomfort. Topical anesthetics, nerve blocks, and/or the incorporation of lidocaine to the filler have been applied in order to reduce distress and pain. Despite nerve blocks being an effective form of anesthesia, they may distort the area to be treated, as well as lengthen and complicate the procedure. Studies have shown that the incorporation of lidocaine to HA fillers significantly reduces pain and discomfort. Yet, one of the dilemmas about the addition of lidocaine solution to HA fillers is the possible alteration of the physical characteristics of the product by negatively impacting the efficacy and/or duration of the filler. The concern is that the addition of lidocaine could dilute the product, creating less correction per mL, changing the product’s viscosity and consequently the “lifting” ability. Also, this dilution could reduce the product’s duration. There may be a difference between a physician adding an aqueous solution into a lidocaine-free version of HA and the pre-incorporated lidocaine version of HA. An aqueous solution might dilute the product, while the pre-incorporated powder lidocaine appears to avoid this problem. Juvéderm® XC is manufactured with powder lidocaine 0.3%; it is associated with significantly less injection pain than Juvéderm® and other lidocaine-free versions of HA. Studies have shown that lidocaine enhances treatment comfort and optimizes the injection experience while maintaining a similar safety and effectiveness profile. Regarding the longevity, further study is necessary to determine if there is any difference in durability. PMID:23946665

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

2013-01-01

3

Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia  

Microsoft Academic Search

The aim of this study was to evaluate the efficacy and safety of intramuscular (IM) administration of botulinum toxin type A (Dysport®, Ipsen Biopharm Ltd.) for the treatment of cervical dystonia (CD) and the long-term safety and efficacy of repeated treatments. During the randomized, double-blind, placebo-controlled phase patients were randomized to 500 units Dysport (n = 55) or placebo (n = 61). Efficacy assessments

Daniel Truong; Matthew Brodsky; Mark Lew; Allison Brashear; Joseph Jankovic; Eric Molho; Olga Orlova; Sofia Timerbaeva

2010-01-01

4

Efficacy and safety of an extended-release niacin (niaspan): a long-term study  

Microsoft Academic Search

Crystalline nicotinic acid (immediate-release niacin) is effective therapy for lipoprotein regulation and cardiovascular risk reduction. However, inconvenient regimens and unpleasant side effects decrease compliance. Sustained-release formulations designed to circumvent these difficulties increase hepatotoxicity. Niaspan, a new US Food and Drug Administration (FDA)-approved, once-daily, extended-release form, has been found effective and safe in short-term trials. The long-term efficacy and safety of

David M Capuzzi; John R Guyton; John M Morgan; Anne C Goldberg; Robert A Kreisberg; O. A Brusco; Jerome Brody

1998-01-01

5

Long-Term Efficacy and Safety of Botulinum Toxin Injections in Dystonia  

PubMed Central

Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurological and non-neurological disorders. Despite almost 30 years of therapeutic use, there are only few studies of patients treated with BoNT injections over long period of time. These published data clearly support the conclusion that BoNT not only provides safe and effective symptomatic relief of dystonia but also long-term benefit and possibly even favorably modifying the natural history of this disease. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. With the chronic use of BoNT and an expanding list of therapeutic indications, there is a need to carefully examine the existing data on the long-term efficacy and safety of BoNT. In this review we will highlight some of the aspects of long-term effects of BoNT, including efficacy, safety, and immunogenicity. PMID:23381141

Ramirez-Castaneda, Juan; Jankovic, Joseph

2013-01-01

6

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

PubMed Central

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

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

2014-01-01

7

Long-term efficacy and safety of mycophenolate mofetil in liver transplant recipients with calcineurin inhibitor-induced renal dysfunction  

Microsoft Academic Search

Long-term survival after orthotopic liver transplantation (OLT) is mainly influenced by adverse events caused by immunosuppression. Several studies have shown the efficacy of mycophenolate mofetil (MMF) in improving calcineurin inhibitor (CI)-induced nephrotoxicity with concomitant reduction or withdrawal of CI. In this prospective study we assessed the long-term effect and safety of MMF. Thirty-two OLT recipients with significant renal impairment due

Robert O. Koch; Ivo W. Graziadei; Frank Schulz; Karin Nachbaur; Alfred Königsrainer; Raimund Margreiter; Wolfgang Vogel

2004-01-01

8

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

PubMed Central

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

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

2014-01-01

9

Efficacy, Long-Term Safety, and Tolerability of Ziprasidone in Children and Adolescents with Bipolar Disorder  

PubMed Central

Abstract Objective The purpose of this study was to evaluate the short- and long-term efficacy and safety of ziprasidone in children and adolescents with bipolar I disorder. Methods Subjects 10–17 years of age with a manic or mixed episode associated with bipolar I disorder participated in a 4 week, randomized, double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week open-label extension study (OLE). Subjects were randomized 2:1 to initially receive flexible-dose ziprasidone (40–160?mg/day, based on weight) or placebo. Primary outcome was the change in Young Mania Rating Scale (YMRS) scores from baseline. Safety assessments included weight and body mass index (BMI), adverse events (AEs), vital signs, laboratory measures, electrocardiograms, and movement disorder ratings. Results In the RCT, 237 subjects were treated with ziprasidone (n=149; mean age, 13.6 years) or placebo (n=88; mean age, 13.7 years). The estimated least squares mean changes in YMRS total (intent-to-treat population) were ?13.83 (ziprasidone) and ?8.61 (placebo; p=0.0005) at RCT endpoint. The most common AEs in the ziprasidone group were sedation (32.9%), somnolence (24.8%), headache (22.1%), fatigue (15.4%), and nausea (14.1%). In the OLE, 162 subjects were enrolled, and the median duration of treatment was 98 days. The mean change in YMRS score from the end of the RCT to the end of the OLE (last observation carried forward) was ?3.3 (95% confidence interval, ?5.0 to ?1.6). The most common AEs were sedation (26.5%), somnolence (23.5%), headache (22.2%), and insomnia (13.6%). For both the RCT and the OLE, no clinically significant mean changes in movement disorder scales, BMI z-scores, liver enzymes, or fasting lipids and glucose were observed. One subject on ziprasidone in the RCT and none during the OLE had Fridericia-corrected QT interval (QTcF) ?460?ms. Conclusion These results demonstrate that ziprasidone is efficacious for treating children and adolescents with bipolar disorder. Ziprasidone was generally well tolerated with a neutral metabolic profile. Clinical Trials Registry NCT00257166 and NCT00265330 at ClinicalTrials.gov. PMID:24111980

Cavus, Idil; Pappadopulos, Elizabeth; Vanderburg, Douglas G.; Schwartz, Jeffrey H.; Gundapaneni, Balarama K.; DelBello, Melissa P.

2013-01-01

10

Long-term safety, tolerability and efficacy of bosentan in adults with pulmonary arterial hypertension associated with congenital heart disease  

Microsoft Academic Search

Objective: To examine long-term safety and efficacy of bosentan—an oral dual endothelin receptor antagonist—in patients with pulmonary hypertension associated with congenital heart disease or Eisenmenger’s syndrome.Design: Retrospective study.Setting: Tertiary cardiology referral centre.Patients: All adult patients with pulmonary arterial hypertension associated with congenital heart disease treated with bosentan at the Royal Brompton Adult Congenital Heart Centre were included.Main outcome measures: Oxygen

Gerhard-Paul Diller; Konstantinos Dimopoulos; Mehmet G Kaya; Carl Harries; Anselm Uebing; Wei Li; Evdokia Koltsida; J Simon R Gibbs; Michael A Gatzoulis

2007-01-01

11

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

PubMed Central

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

Kissin, Igor

2013-01-01

12

Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease.  

PubMed

Hizentra(®) (20% subcutaneous immunoglobulin [SCIG]) was administered to subjects with primary immunodeficiency disease in two extension studies in the EU and US to assess long-term efficacy and tolerability. Subjects (aged 4-69 years) were treated for 148 weeks in the EU (N = 40; 5405 infusions) and 87 weeks in the US (N = 21; 1735 infusions). Weekly doses were 116.0 mg/kg (EU) and 193.2 mg/kg (US); IgG levels were 7.97 g/L (EU) and 11.98 g/L (US). Annualized rates of serious bacterial infections were 0.05 infections/subject/year (EU) and 0.06 infections/subject/year (US). Rates of any infection were 3.33 infections/subject/year (EU) and 2.38 infections/subject/year (US). The rate of bronchopulmonary infections was higher in the EU study. No treatment-related serious AEs occurred; no subject discontinued because of treatment-related AEs. Self-administered Hizentra afforded sustained effective protection from infections and favorable tolerability during an extended treatment period of up to 3 years. PMID:24412910

Jolles, Stephen; Borte, Michael; Nelson, Robert P; Rojavin, Mikhail; Bexon, Martin; Lawo, John-Philip; Wasserman, Richard L

2014-02-01

13

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

PubMed Central

To date, anti-tumor necrosis factor alfa (anti-TNF-?) therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, hematologic disorders like aplastic anemia and pancytopenia, vasculitis, immunogenicity, and exacerbation or induction of psoriasis are class effects of all the anti-TNF drugs, and have been seen in patients with ankylosing spondylitis. However, etanercept is less likely to induce reactivation of tuberculosis than the other anti-TNF drugs and it has been suggested that etanercept might be less immunogenic, especially in ankylosing spondylitis. Acute uveitis, Crohn’s disease, and sarcoidosis are other adverse events that have been rarely associated with etanercept therapy in patients with ankylosing spondylitis. PMID:24101863

Senabre-Gallego, Jose Miguel; Santos-Ramirez, Carlos; Santos-Soler, Gregorio; Salas-Heredia, Esteban; Sanchez-Barrioluengo, Mabel; Barber, Xavier; Rosas, Jose

2013-01-01

14

Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology  

PubMed Central

Background While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety. We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. Methods/design From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ??50 puffs per week since ??6 months); (TC) traditional cigarettes (??1 per day since ??6 m); (Mixed) both electronic and traditional cigarettes (?1 per day since ??6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable. Discussion Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes. Trial registration The protocol has been registered (NCT01785537) and approved by the Ethics Committee of the University of Chieti (Record n. 6; 25-03-2013). PMID:24063569

2013-01-01

15

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

PubMed Central

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

Monsivais, Diane Burn

2014-01-01

16

Efficacy, Safety, and Long-Term Follow-Up Results of EUS-Guided Transmural Drainage for Pancreatic Pseudocyst  

PubMed Central

Background and Aim. EUS-guided transmural drainage (EUS-GTD) is now considered a minimally invasive and effective alternative to surgery for drainage of symptomatic pancreatic pseudocysts. However, the technique is rather difficult, and sometimes serious complications occur to patients undergoing this procedure. We retrospectively evaluated efficacy, safety, and long-term follow-up results of EUS-GTD for pancreatic pseudocyst. Methods. Sixty-seven patients with pancreatic pseudocyst who underwent EUS-GTD from April 2000 to March 2011 were enrolled. We retrospectively evaluated (1) technical success, (2) clinical success, (3) adverse event of procedure, and (4) long-term follow-up results. Results. Total technical success rate was 88%. Ninety-one percent of external drainage, 79% of internal drainage, and 66% of puncture and aspiration only achieved clinical success. There was only one case with an adverse event, perforation (1.5%). The case required emergency operation. Total recurrence rate was 23.9%. Median follow-up period was 33.9 months. The recurrence rates in the cases of stent remaining, spontaneously dislodged, removed on schedule, external tube removal, and aspiration only were 10.0%, 12.5%, 42.9%, 50%, and 0%, respectively. Conclusion. EUS-GTD is a relatively safe and effective therapeutic method. However, further analysis should be done by larger series to determine the method of EUS-GTD for pancreatic pseudocyst. PMID:23554548

Kato, Shin; Katanuma, Akio; Maguchi, Hiroyuki; Takahashi, Kuniyuki; Osanai, Manabu; Yane, Kei; Kim, Toshifumi; Kaneko, Maki; Takaki, Ryo; Matsumoto, Kazuyuki; Matsumori, Tomoaki; Gon, Katsushige; Tomonari, Akiko

2013-01-01

17

Efficacy, Safety, and Long-Term Follow-Up Results of EUS-Guided Transmural Drainage for Pancreatic Pseudocyst.  

PubMed

Background and Aim. EUS-guided transmural drainage (EUS-GTD) is now considered a minimally invasive and effective alternative to surgery for drainage of symptomatic pancreatic pseudocysts. However, the technique is rather difficult, and sometimes serious complications occur to patients undergoing this procedure. We retrospectively evaluated efficacy, safety, and long-term follow-up results of EUS-GTD for pancreatic pseudocyst. Methods. Sixty-seven patients with pancreatic pseudocyst who underwent EUS-GTD from April 2000 to March 2011 were enrolled. We retrospectively evaluated (1) technical success, (2) clinical success, (3) adverse event of procedure, and (4) long-term follow-up results. Results. Total technical success rate was 88%. Ninety-one percent of external drainage, 79% of internal drainage, and 66% of puncture and aspiration only achieved clinical success. There was only one case with an adverse event, perforation (1.5%). The case required emergency operation. Total recurrence rate was 23.9%. Median follow-up period was 33.9 months. The recurrence rates in the cases of stent remaining, spontaneously dislodged, removed on schedule, external tube removal, and aspiration only were 10.0%, 12.5%, 42.9%, 50%, and 0%, respectively. Conclusion. EUS-GTD is a relatively safe and effective therapeutic method. However, further analysis should be done by larger series to determine the method of EUS-GTD for pancreatic pseudocyst. PMID:23554548

Kato, Shin; Katanuma, Akio; Maguchi, Hiroyuki; Takahashi, Kuniyuki; Osanai, Manabu; Yane, Kei; Kim, Toshifumi; Kaneko, Maki; Takaki, Ryo; Matsumoto, Kazuyuki; Matsumori, Tomoaki; Gon, Katsushige; Tomonari, Akiko

2013-01-01

18

Efficacy and safety of itraconazole in the long-term treatment of onychomycosis.  

PubMed

Sixty-one patients with a clinical diagnosis of onychomycosis in finger or toe nails were treated with itraconazole 100 mg/day or griseofulvin 500 mg/day for six to nine months. The infective causes were Trichophyton rubrum, Trichophyton mentagrophytes, or Trichophyton violaceum, and in two cases Candida albicans. A total of 27 finger and 390 toe nails were infected. Statistically significant intragroup reductions from baseline symptom severity values were seen at endpoint (month 6 or 9) for both treatment groups for all parameters: colour change, thickness, brittleness and unaffected area. No clinically or statistically significant differences between the treatment groups were seen at endpoint. However, the itraconazole group continued to improve during the follow-up, while the mean symptom severity ratings remained the same in the griseofulvin group. All itraconazole patients and 85% of griseofulvin patients were rated as cured or markedly improved at endpoint. Nineteen out of 26 evaluable itraconazole patients (73%) remained cured during the three month follow-up period, compared with 12 out of 17 griseofulvin patients (71%). The rather large number of drop-outs, especially among griseofulvin patients, makes it difficult to draw definitive conclusions of the symptom recurrence. Two itraconazole patients stopped medication due to an adverse event, compared to four patients in the griseofulvin group. The clinical laboratory data on itraconazole-treated patients did not show any statistically or clinically significant changes. In conclusion, itraconazole was at least as effective as griseofulvin in the treatment of onychomycosis. The itraconazole group continued to improve after the treatment was stopped. The results show that itraconazole 100 mg/day is safe and efficient in the long-term treatment of fungal nail infections. PMID:1324238

Piepponen, T; Blomqvist, K; Brandt, H; Havu, V; Hollmen, A; Kohtamäki, K; Lehtonen, L; Turjanmaa, K

1992-02-01

19

Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab  

PubMed Central

Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-?B ligand (RANKL), a member of the tumor necrosis factor receptor superfamily essential for osteoclastogenesis. Denosumab treatment is associated with a rapid, sustained, and reversible reduction in bone turnover markers, a continuous marked increase in bone mineral density at all sites, and a marked decrease in the risk of vertebral, hip, and nonvertebral fractures in women with postmenopausal osteoporosis. Therefore, it could be considered as an effective alternative to previous bisphosphonate treatment as well as first-line treatment of severe osteoporosis. Cost-effectiveness studies support this suggestion. In addition, denosumab seems to be the safest treatment option in patients with impaired renal function. Denosumab is characterized by reversibility of its effect after treatment discontinuation, in contrast with bisphosphonates. Large-scale clinical trials, including the extension of FREEDOM trial for up to 5 years, are reassuring for its safety. However, given its brief post-market period, vigilance regarding adverse events related to putative RANKL inhibition in tissues other than bone, as well as those related to bone turnover oversuppression, is advised. PMID:22767993

Anastasilakis, Athanasios D; Toulis, Konstantinos A; Polyzos, Stergios A; Anastasilakis, Chrysostomos D; Makras, Polyzois

2012-01-01

20

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

PubMed

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

Planas, Raquel; Martin, Roland; Sospedra, Mireia

2014-01-01

21

Long-Term Efficacy and Safety of Fenofibrate and a Statin in the Treatment of Combined Hyperlipidemia  

Microsoft Academic Search

To assess the long-term efficacy and use of fenofibrate together with a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (“statin”) in the treatment of elevated levels of triglycerides and low-density lipoprotein (LDL) cholesterol, we conducted a study that compared a before- and after-case series. The study involved 80 patients with a diagnosis of combined hyperlipidemia and existing coronary artery disease (81%

Ruth L. B. Ellen; Ruth McPherson

1998-01-01

22

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

PubMed

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

Dinsmore, Wallace W; Wyllie, Michael G

2012-07-01

23

Long-term efficacy, safety, and side effect profile of botulinum toxin in dystonia: A 20-year follow-up.  

PubMed

Most long-term studies of the efficacy and safety profile of botulinum toxin (BoNT) in the treatment of dystonia are limited by lack of objective assessments, relatively small sample size, or short follow-up periods. We present one of the longest follow-up studies of BoNT treatment. This is a retrospective, longitudinal study that analyzes data on 89 patients treated with BoNT for dystonia at our Movement Disorders Clinic for up to 26 years (mean follow-up period of 18.5 years). The mean ages at the time of the first and last injections were 49 and 68 years old, respectively. The most common diagnoses were cervical dystonia (N = 51), blepharospasm (N = 34), and oromandibular dystonia (N = 26). The total number of onabotulinumtoxinA units received during the first injection was 140.3 as compared to 224.5 at the last injection (p < 0.0001). The global response effect was 3.18 after the first injection session and 3.57 after the last injection (p < 0.0001). The duration of response after the initial injection session and at the last injection was 16.33 weeks versus 19.42 weeks (p 0.0037), respectively. Adverse events, typically related to injection site, were reported in 19% of the visits. This series of dystonia patients with the longest reported treatment with BoNT provide evidence that in selected patients repeated chemodenervation is associated with sustained symptomatic benefit, decreased latency effect, and prolonged duration of therapeutic response. Despite the higher requirement of mean units per visit over time, only 19% of all treatment cycles are associated with adverse, but tolerable, side effects. PMID:25130293

Ramirez-Castaneda, Juan; Jankovic, Joseph

2014-11-01

24

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

PubMed

In 1977, 5-aminosalicylic acid (5-ASA) was discovered as a therapeutically active moiety of sulfasalazine (SASP) and was launched for topical and oral therapy of ulcerative colitis (UC) in 1984. As a first-step, delivery systems had to be developed to protect 5-ASA against absorption in the upper gastrointestinal tract, resulting in different and competing strategies (azo compounds, controlled release, and pH-dependent release). In a second step, at the beginning of the new century, coinciding with the expiration of patent protection for the first 5-ASA formulations, two component composite release mechanisms (pH-dependent and controlled release) were developed. Furthermore, the drug was formulated as granules instead of tablets, allowing higher unit strengths compared with tablets. Neither Salofalk Granu-Stix(®), nor MMX 5-ASA, nor Pentasa(®) granules have initially been developed for once-daily (OD) dosing. A review of the achievements of 20 years of 5-ASA development has demonstrated that 5-ASA has equal efficacy compared with SASP at best, that there are no measurable differences in efficacy between various 5-ASA preparations, and that in a group of patients tolerating SASP, adverse event profiles of SASP and 5-ASA did not differ significantly, with SASP being the far cheaper substance. Therefore, drug adherence came into focus as a new goal for improving UC therapy. Although adherence is a complex and multifactorial construct, a simple dosing schedule may contribute to higher drug adherence and better efficacy of treatment. Simultaneously, the US 5-ASA market, estimated to be worth US$1.4 billion, is expected to grow continuously. Naturally, this very competitive market is not only driven by scientific progress but also by commercial interests. Thus, patents for minor changes to the formulation may serve as protection against drug companies trying to launch generic versions. Randomized controlled trials performed on OD dosing in induction of remission have demonstrated that OD administration of 5-ASA is as effective as conventional dosing in mild to moderate active UC. The three 5-ASA products MMX, Salofalk(®), and Pentasa(®) employed in those studies so far have not shown differences in efficacy between OD and conventional dosing. No differences regarding safety outcomes have been detected between OD and conventional dosing, including incidence of adverse events, serious adverse events, or withdrawal from treatment due to an adverse event. Although the majority of patients prefer OD dosing to conventional dosing, it was not possible to detect differences in adherence between OD and multiple dose regimens in the clinical trial setting. Well-designed and controlled large-scale community-based studies are necessary to further investigate and prove the point of improved long-term adherence and treatment efficacy in OD dosing. PMID:25285021

Böhm, Stephan Karl; Kruis, Wolfgang

2014-01-01

25

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

PubMed Central

In 1977, 5-aminosalicylic acid (5-ASA) was discovered as a therapeutically active moiety of sulfasalazine (SASP) and was launched for topical and oral therapy of ulcerative colitis (UC) in 1984. As a first-step, delivery systems had to be developed to protect 5-ASA against absorption in the upper gastrointestinal tract, resulting in different and competing strategies (azo compounds, controlled release, and pH-dependent release). In a second step, at the beginning of the new century, coinciding with the expiration of patent protection for the first 5-ASA formulations, two component composite release mechanisms (pH-dependent and controlled release) were developed. Furthermore, the drug was formulated as granules instead of tablets, allowing higher unit strengths compared with tablets. Neither Salofalk Granu-Stix®, nor MMX 5-ASA, nor Pentasa® granules have initially been developed for once-daily (OD) dosing. A review of the achievements of 20 years of 5-ASA development has demonstrated that 5-ASA has equal efficacy compared with SASP at best, that there are no measurable differences in efficacy between various 5-ASA preparations, and that in a group of patients tolerating SASP, adverse event profiles of SASP and 5-ASA did not differ significantly, with SASP being the far cheaper substance. Therefore, drug adherence came into focus as a new goal for improving UC therapy. Although adherence is a complex and multifactorial construct, a simple dosing schedule may contribute to higher drug adherence and better efficacy of treatment. Simultaneously, the US 5-ASA market, estimated to be worth US$1.4 billion, is expected to grow continuously. Naturally, this very competitive market is not only driven by scientific progress but also by commercial interests. Thus, patents for minor changes to the formulation may serve as protection against drug companies trying to launch generic versions. Randomized controlled trials performed on OD dosing in induction of remission have demonstrated that OD administration of 5-ASA is as effective as conventional dosing in mild to moderate active UC. The three 5-ASA products MMX, Salofalk®, and Pentasa® employed in those studies so far have not shown differences in efficacy between OD and conventional dosing. No differences regarding safety outcomes have been detected between OD and conventional dosing, including incidence of adverse events, serious adverse events, or withdrawal from treatment due to an adverse event. Although the majority of patients prefer OD dosing to conventional dosing, it was not possible to detect differences in adherence between OD and multiple dose regimens in the clinical trial setting. Well-designed and controlled large-scale community-based studies are necessary to further investigate and prove the point of improved long-term adherence and treatment efficacy in OD dosing.

Bohm, Stephan Karl; Kruis, Wolfgang

2014-01-01

26

Long-term Safety and Efficacy Results of Once-Daily Emtricitabine-Based Highly Active Antiretroviral Therapy Regimens in Human Immunodeficiency Virus-Infected Pediatric Subjects  

Microsoft Academic Search

OBJECTIVES.The purpose of this work was to obtain long-term safety and efficacy data for antiretroviral regimens containing emtricitabine in HIV-infected pediatric sub- jects and confirm that a pediatric dose of 6 mg\\/kg once daily would provide steady- state emtricitabine concentrations comparable to those observed in adults given 200 mg of emtricitabine once daily. PATIENTS AND METHODS.HIV-infected subjects between 3 months

Xavier Saez-Llorens; Avy Violari; Ram Yogev; Andrew Wiznia; Greg Chittick; John Hinkle; M. Robert Blum; Nathalie Adda; Franck Rousseau; Federico Gomez

2008-01-01

27

Long-term efficacy and safety of propafenone and sotalol for the maintenance of sinus rhythm after conversion of recurrent symptomatic atrial fibrillation  

Microsoft Academic Search

This study was performed to evaluate, using a randomized double-blind, placebo-controlled protocol, the long-term efficacy and safety of propafenone and sotalol in maintaining sinus rhythm after conversion of recurrent symptomatic atrial fibrillation (AF). The maintenance of sinus rhythm in patients with recurrent AF has several potential benefits, the most important being a reduced risk of thromboembolic events. Three hundred patients

Francesco Bellandi; Ignazio Simonetti; Mario Leoncini; Fabio Frascarelli; Tiziana Giovannini; Mauro Maioli; Roberto Piero Dabizzi

2001-01-01

28

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

PubMed Central

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

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

2008-01-01

29

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

Microsoft Academic Search

Background\\/Aims: Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods: Patients from four previous trials entered this study. Results: Ninety-three patients started the extension,

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

2008-01-01

30

Safety and Efficacy of Long-Term Statin-Fibrate Combinations in Patients With Refractory Familial Combined Hyperlipidemia  

Microsoft Academic Search

No monotherapy is able to tackle effectively all atherogenic features of familial combined hyperlipidemia: high low-density lipoprotein (LDL) cholesterol, triglycerides (TG), and plasma fibrinogen, as well as low high-density lipoprotein (HDL) cholesterol. The present study investigated the safety and efficacy of combined pravastatin or simvastatin with gemfibrozil or ciprofibrate treatment on total cholesterol, LDL, TG, plasma fibrinogen, and apoproteins B

1997-01-01

31

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

SciTech Connect

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.

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

32

Long-term safety and efficacy of radiofrequency ablation in the treatment of sleep disordered breathing: a meta-analysis.  

PubMed

Radiofrequency ablation (RFA) is used in the treatment of sleep disordered breathing (SDB), particularly in the alleviation of snoring. The literature provides evidence that the short-term results are promising; however, the long-term efficacy is a matter of contention. In this article, we present the results of a literature search of studies that use RFA in the treatment of SDB which have a follow-up time of greater than a year. RFA was found to be a safe technique with minimal morbidity. The overall Visual Analogue score from six studies showed the overall mean improvement to be 4.3 (confidence intervals 3.4-5.12). Apnea Hypopnea Index (AHI), improved significantly in five of the studies analysed. Epworth Sleepiness Score (ESS), improved significantly in six of the studies analysed. In conclusion, the evidence suggests that RFA for SDB results in a significant improvement in follow-up times of at least a year. Since RFA can be applied in a clinic setting and leads to minimal disruption to daily life, this treatment option can be considered for those unwilling to participate in the more traditional surgical options for SDB. PMID:24510179

Veer, Vik; Yang, Woo-Young; Green, Richard; Kotecha, Bhik

2014-11-01

33

Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.  

PubMed

Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ?3 years). Patients with long-term benefit of therapy (n=45) had a median duration of treatment of 48.1?months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55%; P=0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age<65 years (P=0.03), ?2-microglobulin <2.5?mg/l (P=0.002) and fewer prior therapies (P=0.002). The exposure-adjusted incidence rate (EAIR) of grade 3-4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects. PMID:25382609

Dimopoulos, M A; Swern, A S; Li, J S; Hussein, M; Weiss, L; Nagarwala, Y; Baz, R

2014-01-01

34

Safety and Efficacy of Tetrabenazine and Use of Concomitant Medications During Long-Term, Open-Label Treatment of Chorea Associated with Huntington's and Other Diseases  

PubMed Central

Background Although tetrabenazine, a drug that depletes presynaptic dopamine by inhibiting vesicular monoamine transporter 2 (VMAT2), was approved by the U.S. Food and Drug Administration in 2008 for the treatment of chorea associated with Huntington’s disease (HD), there is a paucity of data on its long-term efficacy and safety. Methods Approximately 2,000 patients with a variety of hyperkinetic movement disorders had been treated with open-label tetrabenazine at the Movement Disorders Clinic, Baylor College of Medicine, since 1979. Tetrabenazine was usually started at 12.5?mg/day, and the dosage was gradually increased (up to 300?mg/day). Responses were rated by the investigator 1–5, with 1 ?=? marked chorea reduction, excellent improvement in function; 2 ?=? moderate chorea reduction, very good improvement in function; 3 ?=? fair chorea improvement, only mild improvement in function; 4 ?=? poor or no response for chorea and function; and 5 ?=? worsening chorea, some functional deterioration. Efficacy and safety were analyzed retrospectively. Results By 2004, 98 HD chorea patients had received tetrabenazine for a mean of 3.1 years (range ?1–11.4 years). Of those with valid ratings, 75% had either marked or very good responses (rating 1 or 2) at their optimal dosages. The most common adverse events occurring in ?5% of the patients were somnolence (39%), insomnia (33%), depression (31%), accidental injury (26%), and dysphagia (19%). Efficacy and safety were comparable to results for non-HD chorea patients. Discussion Tetrabenazine treatment was associated with long-term improvement in chorea. Adverse event rates were comparable to those reported from controlled trials. PMID:24255799

Shen, Vivienne; Clarence-Smith, Kathleen; Hunter, Christine; Jankovic, Joseph

2013-01-01

35

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

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

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

2013-01-01

36

Propafenone and sotalol in the prevention of paroysmal atrial fibrillation: long-term safety and efficacy study  

Microsoft Academic Search

The efficacy and tolerability of propafenone and sotalol in the prevention of paroysmal atrial fibrillation (AF) were assessed in a doubleblind placebo-controlled study over 1 year. Participants included 300 patients (168 men and 132 women) with an average age of 52.3 years. Patients were randomly divided into three groups: group A (n = 102) received propafenone (13 mg\\/kg per day);

F. Bellandi; R. P. Dabizzi; Niccoli; F. Cantini

1995-01-01

37

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

PubMed Central

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

2013-01-01

38

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

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

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

2014-01-01

39

Long term safety, efficacy, and patient acceptability of hyaluronic acid injection in patients with painful osteoarthritis of the knee  

PubMed Central

The increasing prevalence of painful knee osteoarthritis has created an additional demand for pharmacologic management to prevent or delay surgical management. Viscosupplementation, via intraarticular injection of hyaluronic acid (HA), aims to restore the favorable milieu present in the nonarthritic joint. The safety profile of intraarticular HA injections for painful knee osteoarthritis is well established, with the most common adverse effect being a self-limited reaction at the injection site. Although acceptance of the early literature has been limited by publication bias and poor study quality, more recent and rigorous meta-analysis suggests that intraarticular HA injection is superior to placebo injection for pain relief and matches, if not surpasses, the effect size of other nonoperative treatments, such as nonsteroidal anti-inflammatory medication. Intraarticular HA injection is effective in providing temporary pain relief in patients with painful knee osteoarthritis. Future investigations should focus on optimizing the composition and administration of HA agents to provide prolonged relief of painful osteoarthritis in the knee and other joints. PMID:23271899

McArthur, Benjamin A; Dy, Christopher J; Fabricant, Peter D; Valle, Alejandro Gonzalez Della

2012-01-01

40

Efficacy and Safety of Long-Term Fluoxetine Versus Lithium Monotherapy of Bipolar II Disorder: A Randomized, Double-Blind, Placebo-Substitution Study  

PubMed Central

Objective The authors examined the safety and efficacy of long-term fluoxetine monotherapy, lithium monotherapy, and placebo therapy in preventing relapse and recurrence of bipolar type II major depressive episode. The authors hypothesized that fluoxetine monotherapy would be superior to lithium monotherapy with a similar hypomanic mood conversion rate. Method Patients at least 18 years old who recovered from their major depressive episode during initial open-label fluoxetine monotherapy were randomly assigned to receive 50 weeks of double-blind monotherapy with fluoxetine at 10–40 mg/day, lithium at 300–1200 mg/day, or placebo. The primary outcome measure was time to relapse or recurrence. Secondary outcome measures included the proportion of patients remaining well and the frequency of hypomanic symptoms. Results There were no significant differences in clinical or demographic characteristics among the fluoxetine (N=28), lithium (N=26), and placebo (N=27) groups. The mean time to relapse was 249.9 days for the fluoxetine group, 156.4 days for the lithium group, and 186.9 days for the placebo group. The hazard of relapse was significantly lower with fluoxetine compared with lithium, and the estimated hazard of relapse with lithium was 2.5 times greater than with fluoxetine. There were no statistically significant or clinically meaningful differences in hypomanic symptoms among treatment groups over time. One patient taking fluoxetine and one patient taking placebo discontinued treatment because of hypomania. Conclusion These findings suggest that long-term fluoxetine monotherapy may provide superior relapse-prevention benefit relative to lithium monotherapy after recovery from bipolar II major depressive episode without an increase in hypomanic mood conversion episodes. PMID:20360317

Amsterdam, Jay D.; Shults, Justine

2010-01-01

41

HANGING BY A THREAD: THE LONG-TERM EFFICACY AND SAFETY OF TRANSSCLERAL SUTURED INTRAOCULAR LENSES IN CHILDREN (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)  

PubMed Central

Purpose To evaluate the long-term efficacy, safety, and advisability of using transscleral sutured posterior chamber intraocular lenses (IOLs) in pediatric patients with no capsular support and to determine whether 10-0 polypropylene suture should be used for this purpose. Methods A long-term retrospective interventional case series review of 33 eyes of 26 patients who had a sutured IOL at Duke University Eye Center were evaluated for the intraoperative surgical risks, postoperative visual and refractive outcomes, and the number, type, and severity of the postoperative complications. In addition, a survey of pediatric ophthalmologists’ experience with suture breakage was performed. Results Postoperative visual acuity was significantly improved after surgery (P < .001). Predicted vs actual refraction was not significantly different (P = .10) and was within 1.50 diopters of predicted in 66% of patients. A refractive myopic shift occurred over time and was age-dependent. Intraoperative and immediate postoperative complications were minimal and not sight-threatening. Three patients developed subluxation of the IOL secondary to spontaneous 10-0 polypropylene suture breakage at 3.5, 8, and 9 years after surgery. A survey of pediatric ophthalmologists revealed 10 similar cases (mean, 5 years after surgery). Conclusion Transscleral fixation of an IOL in a child appears to be a safe and effective procedure provided that the suture material used is stable enough to resist significant degradation over time. Caution should be exercised in the use of 10-0 polypropylene suture to fixate an IOL to the sclera in children, and an alternative material or size should be considered. PMID:18427618

Buckley, Edward G.

2007-01-01

42

Long-term Safety and Efficacy of Human-Induced Pluripotent Stem Cell (iPS) Grafts in a Preclinical Model of Retinitis Pigmentosa  

PubMed Central

The U.S. Food and Drug Administration recently approved phase I/II clinical trials for embryonic stem (ES) cell–based retinal pigmented epithelium (RPE) transplantation, but this allograft transplantation requires lifelong immunosuppressive therapy. Autografts from patient-specific induced pluripotent stem (iPS) cells offer an alternative solution to this problem. However, more data are required to establish the safety and efficacy of iPS transplantation in animal models before moving iPS therapy into clinical trials. This study examines the efficacy of iPS transplantation in restoring functional vision in Rpe65rd12/Rpe65rd12 mice, a clinically relevant model of retinitis pigmentosa (RP). Human iPS cells were differentiated into morphologically and functionally RPE-like tissue. Quantitative real-time polymerase chain reaction (RT-PCR) and immunoblots confirmed RPE fate. The iPS-derived RPE cells were injected into the subretinal space of Rpe65rd12/Rpe65rd12 mice at 2 d postnatally. After transplantation, the long-term surviving iPS-derived RPE graft colocalized with the host native RPE cells and assimilated into the host retina without disruption. None of the mice receiving transplants developed tumors over their lifetimes. Furthermore, electroretinogram, a standard method for measuring efficacy in human trials, demonstrated improved visual function in recipients over the lifetime of this RP mouse model. Our study provides the first direct evidence of functional recovery in a clinically relevant model of retinal degeneration using iPS transplantation and supports the feasibility of autologous iPS cell transplantation for retinal and macular degenerations featuring significant RPE loss. PMID:22895806

Li, Yao; Tsai, Yi-Ting; Hsu, Chun-Wei; Erol, Deniz; Yang, Jin; Wu, Wen-Hsuan; Davis, Richard J; Egli, Dieter; Tsang, Stephen H

2012-01-01

43

Long-term safety and efficacy of human-induced pluripotent stem cell (iPS) grafts in a preclinical model of retinitis pigmentosa.  

PubMed

The U.S. Food and Drug Administration recently approved phase I/II clinical trials for embryonic stem (ES) cell-based retinal pigmented epithelium (RPE) transplantation, but this allograft transplantation requires lifelong immunosuppressive therapy. Autografts from patient-specific induced pluripotent stem (iPS) cells offer an alternative solution to this problem. However, more data are required to establish the safety and efficacy of iPS transplantation in animal models before moving iPS therapy into clinical trials. This study examines the efficacy of iPS transplantation in restoring functional vision in Rpe65(rd12)/Rpe65(rd12) mice, a clinically relevant model of retinitis pigmentosa (RP). Human iPS cells were differentiated into morphologically and functionally RPE-like tissue. Quantitative real-time polymerase chain reaction (RT-PCR) and immunoblots confirmed RPE fate. The iPS-derived RPE cells were injected into the subretinal space of Rpe65(rd12)/Rpe65(rd12) mice at 2 d postnatally. After transplantation, the long-term surviving iPS-derived RPE graft colocalized with the host native RPE cells and assimilated into the host retina without disruption. None of the mice receiving transplants developed tumors over their lifetimes. Furthermore, electroretinogram, a standard method for measuring efficacy in human trials, demonstrated improved visual function in recipients over the lifetime of this RP mouse model. Our study provides the first direct evidence of functional recovery in a clinically relevant model of retinal degeneration using iPS transplantation and supports the feasibility of autologous iPS cell transplantation for retinal and macular degenerations featuring significant RPE loss. PMID:22895806

Li, Yao; Tsai, Yi-Ting; Hsu, Chun-Wei; Erol, Deniz; Yang, Jin; Wu, Wen-Hsuan; Davis, Richard J; Egli, Dieter; Tsang, Stephen H

2012-01-01

44

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

PubMed Central

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

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

2014-01-01

45

Long-Term Efficacy and Tolerability of Lanthanum Carbonate: Results from a 3Year Study  

Microsoft Academic Search

Background: Control of serum phosphate over the long term is essential in patients with end-stage renal disease. Six-month and 2-year extensions to a 6-month study evaluated the long-term safety, tolerability and efficacy of the new phosphate binder lanthanum carbonate. Methods: Patients who participated in a 6-month, randomized trial comparing lanthanum carbonate with calcium carbonate were eligible for a 24-week, open-label

Alastair J. Hutchison; Bart Maes; Johan Vanwalleghem; Gernot Asmus; Elfatih Mohamed; Roland Schmieder; Wolfgang Backs; Rene Jamar; Andre Vosskühler

2006-01-01

46

Long-Term Safety from the Raltegravir Clinical Development Program  

E-print Network

Abstract: Background: Raltegravir has demonstrated potent and durable efficacy and a favorable safety profile in 3 phase III studies in treatment-naïve and treatment-experienced patients with HIV-1 infection. This manuscript provides a review of the raltegravir safety profile using data from these and other studies in the clinical development program. Methods: Comprehensive 96-week safety data from STARTMRK (raltegravir versus efavirenz, each with tenofovir/emtricitabine) and BENCHMRK (raltegravir versus placebo, each with optimized background therapy) are summarized. A cumulative meta-analysis of raltegravir 400 mg bid was conducted across the entire development program. Results: In STARTMRK, drug-related adverse events (AEs) occurred less frequently with raltegravir than efavirenz. In BENCHMRK, the most common drug-related AEs occurred at generally similar frequencies in both groups. Drug-related serious AEs were uncommon. Rash was observed in raltegravir-treated patients at a higher frequency than placebo but a lower frequency than efavirenz. Depression and immune reconstitution inflammatory syndrome occurred at similar rates for raltegravir and comparators. Isolated elevations of creatine kinase were more common with raltegravir than placebo but occurred without clinical manifestations. The frequency of aminotransferase elevations was greater in patients with viral hepatitis co-infection, but similar in the raltegravir and comparator groups. The relative risk (95 % CI) of cancer was 0.75 (0.30, 1.91) indicating no difference between raltegravir and comparator. Overall trends in the cumulative metaanalysis were similar to those observed in the phase III studies. Conclusions: Long-term data from the phase III clinical trials demonstrate that raltegravir was generally well-tolerated in both treatment-naïve and treatment-experienced patients with HIV infection. Keywords: Raltegravir, integrase inhibitor, long-term safety, BENCHMRK, STARTMRK.

Deborah D. Brown; I Y. Leavitt; Peter Sklar; Hong Wan; Xia Xu; Fabio Lievano; Heidi P. Lehman; T. Christopher Mast; Bach-yen T. Nguyen

47

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

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

Landry, John; Detke, Holland C.

2014-01-01

48

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

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

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

2014-11-01

49

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

PubMed Central

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

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

2013-01-01

50

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

PubMed Central

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

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

2014-01-01

51

Pantoprazole therapy in the long-term management of severe acid peptic disease Clinical efficacy, safety, serum gastrin, gastric histology, and endocrine cell studies  

Microsoft Academic Search

OBJECTIVE:Pantoprazole is the third proton pump inhibitor to become available. When this study was started, there were few data on its long-term use. Our aim was to investigate this aspect and, because powerful inhibitors of acid secretion can cause hypergastrinemia and, in experimental animals, enterochromaffin-like cell hyperplasia, we also monitored serum gastrin and endocrine cell histology.METHODS:One hundred fifty patients refractory

Karna Dev Bardhan; Pradip Cherian; Anne E. Bishop; Julia M. Polak; H. Romanska; Michael J. Perry; Anne Rowland; Mary Thompson; Pamela Morris; Andreas Schneider; Renata Fischer; W. Ng; R. Luhmann; Brian McCaldin

2001-01-01

52

Long-term safety and efficacy following systemic administration of a self-complementary AAV vector encoding human FIX pseudotyped with serotype 5 and 8 capsid proteins.  

PubMed

Adeno-associated virus vectors (AAV) show promise for liver-targeted gene therapy. In this study, we examined the long-term consequences of a single intravenous administration of a self-complementary AAV vector (scAAV2/ 8-LP1-hFIXco) encoding a codon optimized human factor IX (hFIX) gene in 24 nonhuman primates (NHPs). A dose-response relationship between vector titer and transgene expression was observed. Peak hFIX expression following the highest dose of vector (2 × 10(12) pcr-vector genomes (vg)/kg) was 21 ± 3 µg/ml (~420% of normal). Fluorescent in-situ hybridization demonstrated scAAV provirus in almost 100% of hepatocytes at that dose. No perturbations of clinical or laboratory parameters were noted and vector genomes were cleared from bodily fluids by 10 days. Macaques transduced with 2 × 10(11) pcr-vg/kg were followed for the longest period (~5 years), during which time expression of hFIX remained >10% of normal level, despite a gradual decline in transgene copy number and the proportion of transduced hepatocytes. All macaques developed serotype-specific antibodies but no capsid-specific cytotoxic T lymphocytes were detected. The liver was preferentially transduced with 300-fold more proviral copies than extrahepatic tissues. Long-term biochemical, ultrasound imaging, and histologic follow-up of this large cohort of NHP revealed no toxicity. These data support further evaluation of this vector in hemophilia B patients. PMID:21245849

Nathwani, Amit C; Rosales, Cecilia; McIntosh, Jenny; Rastegarlari, Ghasem; Nathwani, Devhrut; Raj, Deepak; Nawathe, Sushmita; Waddington, Simon N; Bronson, Roderick; Jackson, Scott; Donahue, Robert E; High, Katherine A; Mingozzi, Federico; Ng, Catherine Y C; Zhou, Junfang; Spence, Yunyu; McCarville, M Beth; Valentine, Marc; Allay, James; Coleman, John; Sleep, Susan; Gray, John T; Nienhuis, Arthur W; Davidoff, Andrew M

2011-05-01

53

Long-term Safety and Efficacy Following Systemic Administration of a Self-complementary AAV Vector Encoding Human FIX Pseudotyped With Serotype 5 and 8 Capsid Proteins  

PubMed Central

Adeno-associated virus vectors (AAV) show promise for liver-targeted gene therapy. In this study, we examined the long-term consequences of a single intravenous administration of a self-complementary AAV vector (scAAV2/ 8-LP1-hFIXco) encoding a codon optimized human factor IX (hFIX) gene in 24 nonhuman primates (NHPs). A dose–response relationship between vector titer and transgene expression was observed. Peak hFIX expression following the highest dose of vector (2 × 1012 pcr-vector genomes (vg)/kg) was 21 ± 3 µg/ml (~420% of normal). Fluorescent in-situ hybridization demonstrated scAAV provirus in almost 100% of hepatocytes at that dose. No perturbations of clinical or laboratory parameters were noted and vector genomes were cleared from bodily fluids by 10 days. Macaques transduced with 2 × 1011 pcr-vg/kg were followed for the longest period (~5 years), during which time expression of hFIX remained >10% of normal level, despite a gradual decline in transgene copy number and the proportion of transduced hepatocytes. All macaques developed serotype-specific antibodies but no capsid-specific cytotoxic T lymphocytes were detected. The liver was preferentially transduced with 300-fold more proviral copies than extrahepatic tissues. Long-term biochemical, ultrasound imaging, and histologic follow-up of this large cohort of NHP revealed no toxicity. These data support further evaluation of this vector in hemophilia B patients. PMID:21245849

Nathwani, Amit C; Rosales, Cecilia; McIntosh, Jenny; Rastegarlari, Ghasem; Nathwani, Devhrut; Raj, Deepak; Nawathe, Sushmita; Waddington, Simon N; Bronson, Roderick; Jackson, Scott; Donahue, Robert E; High, Katherine A; Mingozzi, Federico; Ng, Catherine YC; Zhou, Junfang; Spence, Yunyu; McCarville, M Beth; Valentine, Marc; Allay, James; Coleman, John; Sleep, Susan; Gray, John T; Nienhuis, Arthur W; Davidoff, Andrew M

2011-01-01

54

Embryonic Stem Cell Therapy Shows Long-Term Effectiveness, Safety  

MedlinePLUS

... on this page, please enable JavaScript. Embryonic Stem Cell Therapy Shows Long-Term Effectiveness, Safety In small ... 15, 2014 Related MedlinePlus Pages Macular Degeneration Stem Cells TUESDAY, Oct. 14, 2014 (HealthDay News) -- A new ...

55

Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study.  

PubMed

Data from registries suggest that the median age of chronic myelogenous leukemia (CML) patients is 10-15 years older than that of clinical trials. We conducted a prospective phase II study to evaluate imatinib mesylate (IM, 400 mg daily) in newly diagnosed chronic phase CML (CP-CML) patients. Patients aged 70 years and over diagnosed with CP-CML within 12 months were eligible. Thirty patients were enrolled from April 2002 to October 2004. Median age was 74.8 years (range, 70-90). Male/female ratio was 1.72. At inclusion, comorbidities were reported in all but one patient, Cumulative Illness Rating Scale for Geriatrics comorbidity mean index was 1.47, and 66% of patients had cardiovascular disease. The median daily IM dose was 392 mg (range, 256-445). IM was interrupted in patients with severe comorbidities. Treatment discontinuation was observed in 36.6% of patients. Cumulative incidence of complete cytogenetic response was 71.4 and 78.5% at 12 and 24 months, respectively. A high level of sustained responses was observed in patients with mild or moderate comorbidities. Seven-year estimated overall survival was 80.8% (95% CI: 59.0-91.7). Two-thirds of the patients were still on long-term therapy at cut-off, and no patients had died from progression. This trial was registered at http://www.clinicaltrials.gov as # NCT00219765. PMID:22987312

Rousselot, Philippe; Cony-Makhoul, Pascale; Nicolini, Franck; Mahon, François Xavier; Berthou, Christian; Réa, Delphine; Reiffers, Josy; Bornand, Anne; Saint-Jean, Olivier; Guilhot, Joelle; Guilhot, François

2013-01-01

56

Long-term safety concerns with proton pump inhibitors.  

PubMed

Proton pump inhibitors (PPIs) are among the most widely prescribed medications worldwide. Their use has resulted in dramatic improvements in treatment of peptic ulcer disease and gastroesophageal reflux disease. Despite an acceptable safety profile, mounting data demonstrate concerns about the long-term use of PPIs. To provide a comprehensive review regarding the concerns of long-term PPI use, a literature search was performed to identify pertinent original and review articles. Despite study shortcomings, the collective body of information overwhelmingly suggests an increased risk of infectious complications and nutritional deficiencies. Data regarding any increased risk in gastric or colon malignancy are less convincing. PPIs have revolutionized the management and complications of acid-related disorders with a high margin of safety; however, with the data available, efforts to reduce the dosing of or discontinue the use of PPIs must be reassessed frequently. PMID:19786155

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

2009-10-01

57

Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis  

PubMed Central

Introduction: The prevalence of symptomatic knee osteoarthritis (OA) among Asians ?65 years is estimated to double by 2040. This study was designed to evaluate the safety and efficacy of a single, 6-mL intra-articular injection of hylan G-F 20 in Indian patients with knee OA at 26 weeks through to 52 weeks. Methods: This study was an open-label, multicentre, phase 4 clinical trial. Enrolled patients (N=394) were ?30 years old with Kellgren-Lawrence grade 1–3 OA; all patients received hylan G-F 20. WOMAC, SF-12, PTGA, and COGA scores, and OA medication use were evaluated at weeks 1, 4, 12, 26, 39, and 52 (initial treatment phase). At 26, 39, or 52 weeks, eligible patients could participate in a repeat treatment phase. McNemar-Bowkers, paired t-tests and ANOVA analyses were performed (alpha=0.05). Results: At 26 weeks, statistically significant changes from baseline were observed in all efficacy parameters, including the primary efficacy endpoint of WOMAC A1 (p<0.0001). Improvements continued for 52 weeks. No significant changes occurred in concomitant medication use. Eleven patients (2.8%) were re-injected at week 26 or 52. After repeat injection, statistically significant decreases were observed in WOMAC A1, WOMAC C and PTGA scores (p?0.028). Twenty-three (5.8%) patients reported 26 local target knee AEs. Conclusion: Among Indian patients within this study, a 6-mL hylan G-F 20 injection was well tolerated and effective in treating symptomatic knee OA with significant long-term (1 year) improvement of outcomes. When needed, repeat treatment was safe and efficacious for 4 weeks. Trial Registration: Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php. PMID:25328555

Pal, Sarvajeet; Thuppal, Sreedhar; Reddy, K.J; Avasthi, Sachin; Aggarwal, Anish; Bansal, Himanshu; Mohanasundaram, Senthilnathan; Bailleul, Francois

2014-01-01

58

A review on strontium ranelate long-term antifracture efficacy in the treatment of postmenopausal osteoporosis  

PubMed Central

Osteoporotic fractures are one of the major causes of increased morbidity and mortality in postmenopausal women and the overall aging population. One of the major issues in the management of postmenopausal osteoporosis is to find a safe and effective treatment in the long term (>3 years) to achieve and maintain a reduction in the risk of fracture. Strontium ranelate (PROTELOS®) is a relatively novel drug, currently approved in Europe for the treatment of postmenopausal osteoporosis. Strontium ranelate is the first agent of a new therapeutic class in osteoporosis, capable of both promoting bone formation and, to a lesser extent, inhibiting bone resorption. This uncoupling in bone turnover results in a net gain in bone mineral density (BMD), bone quality improvement and reduction in risk of vertebral and nonvertebral fractures, as initially demonstrated in the preplanned long-term registrative trials SOTI (Spinal Osteoporosis Therapeutic Intervention) and TROPOS (Treatment of Peripheral Osteoporosis) at 5 years. Recently, open-label extensions of the SOTI and TROPOS trials up to 8 and, recently, 10 years have confirmed the sustained efficacy of strontium ranelate in increasing BMD, the long-term safety profile and the high compliance to treatment, independently from baseline BMD or other risk factors for osteoporotic fractures. Recent economic impact analyses have proved that long-term treatment with strontium ranelate is highly cost effective, especially in women older than 70 years of age. Histomorphometric analyses in animals and humans participating in the phase III trials have proved that the quality of mineralization is preserved in the long term and bone microarchitecture is ameliorated, with increased bone strength. Thus, strontium ranelate has been confirmed to be an effective compound for the long-term, chronic treatment of postmenopausal osteoporosis. PMID:23858336

Cianferotti, Luisella; D'Asta, Federica

2013-01-01

59

Efficacy of Lifestyle Modification for Long-Term Weight Control  

Microsoft Academic Search

A comprehensive program of lifestyle modification induces loss of ?10% of initial weight in 16 to 26 weeks, as revealed by a review of recent randomized controlled trials, including the Diabetes Prevention Program. Long-term weight control is facilitated by continued patient-therapist contact, whether provided in person or by telephone, mail, or e-mail. High levels of physical activity and the consumption

Thomas A. Wadden; Meghan L. Butryn; Kirstin J. Byrne

2004-01-01

60

Long-term safety and efficacy of a once-daily niacin\\/ lovastatin formulation for patients with dyslipidemia * * A complete list of participants in the Research Group and Publication Committee appears in the Appendix  

Microsoft Academic Search

Combination therapy is increasingly recommended for patients with multiple lipid disorders, especially those at high risk for coronary events. We investigated the long-term safety and effectiveness of a new drug formulation containing once-daily extended-release niacin and lovastatin. A total of 814 men and women (mean age 59 years) with dyslipidemia were enrolled in a 52-week multicenter, open-label study. We used

Moti L Kashyap; Mark E McGovern; Kathleen Berra; John R Guyton; Peter O Kwiterovich; Wayne L Harper; Phillip D Toth; Laurence K Favrot; Boris Kerzner; Stephen D Nash; Harold E Bays; Phillip D Simmons

2002-01-01

61

Long-term safety of MorphiDex.  

PubMed

More than 2200 subjects were enrolled in the MorphiDex (MS:DM) development program, with a 1:1 (weight:weight) ratio of morphine sulfate (MS) to dextromethorphan hydrobromide (DM). Of the 1400 subjects exposed to MorphiDex, more than 350 subjects were treated for at least 6 months, and over 200 subjects were treated for a year or longer. The clinical population comprised an approximately equal number of men (46.2%) and women (53.8%), ranging in age from 16 to 96 years, and mostly Caucasian (91.8%). The most frequent (54.8%) daily dose of MorphiDex for subjects enrolled in the clinical program was 120 mg or less. Slow DM metabolizers took significantly lower daily doses of MorphiDex than rapid metabolizers without a significant difference in the incidence of adverse events. Plasma bromide concentrations were low and showed a wide margin of safety for both slow and rapid DM metabolizers. There were no clinically significant treatment-related changes in clinical laboratory tests, neurological examinations, or vital signs. The most common adverse events seen in the multiple dose controlled studies were nausea, dizziness, vomiting, somnolence, constipation, confusion, asthenia, headache, and pruritus. With long-term treatment, the prevalence of adverse events was greatest during the first month of MorphiDex exposure and then decreased over time. The incidence of constipation remained fairly constant over time. PMID:10687340

Goldblum, R

2000-01-01

62

Assessment of Countermeasure Efficacy for Long-Term Space Missions  

NASA Technical Reports Server (NTRS)

One of the main functions of the upcoming International Space Station (ISS) will be to provide a venue for testing proposed countermeasures for their ability to protect humans from the debilitating effects of longterm space flight. However, several limiting factors preclude an evaluation process similar to that used in clinical trials which traditionally are implemented with large sample sizes of subjects, including control groups, and with blind or double-blind application of treatments according to factorial or other balanced experimental designs. In particular, only very limited numbers of human subjects will be available for actual field testing in the ISS With no more than 125 subjects planned to fly on all ISS missions over 10 years, it is not possible to test extensive combinations of some 15-20 proposed countermeasures. Furthermore because of safety concerns and operational considerations, it is unlikely that anything other than the current best guess at the most effective countermeasure package will ever be used on ISS. In particular, control or placebos will not be allowed. In view of these limitations, historical data and groundbased or animal studies will have to be used to compensate for small sample sizes and lack of controls in the field. As a result, statistical analysis methodology will have to be developed which allows for the integration of these disparate data types into a meaningful evaluation process. The process must be sequential, providing objective rules for deciding through time whether to reject or modify an ineffective countermeasure, or whether to certify one as effective. Additional output should include performance characteristics for all relevant physiological systems, including uncertainty analyses and estimates of accept/reject decision error rates.

Feiveson, Alan H.; Paloski, William H. (Technical Monitor)

2000-01-01

63

Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy  

Microsoft Academic Search

Background and purpose: This study was conducted to demonstrate the long-term efficacy of sodium oxybate for the long-term treatment of cataplexy in patients with narcolepsy.Patients and methods: Fifty-five (55) narcoleptic patients with cataplexy who had received continuous treatment with sodium oxybate for 7–44 months (mean 21 months) were enrolled in a double-blind treatment withdrawal paradigm. A 2-week single-blind sodium oxybate

2004-01-01

64

Long-term efficacy and safety of E/C/F/TDF vs EFV/FTC/TDF and ATV+RTV+FTC/TDF in HIV-1-infected treatment-na?ve subjects >=50 years  

PubMed Central

Introduction In high-income countries, ?30% of HIV-infected patients are ?50 years (yrs) old (UNAIDS 2013). In two phases, three clinical trials (Studies 102 and 103) elvitegravir/cobicistat/emtricitabine/tenofovir DF (E/C/F/TDF; STB) had non-inferior efficacy and favourable safety vs efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF; ATR) or ritonavir-boosted atazanavir (ATV+RTV)+FTC/TDF (TVD) in HIV-infected, treatment-naïve subjects at Week 144. The efficacy and safety of STB in subjects < or ?50 yrs is described. Materials and Methods Post hoc analysis of efficacy, tolerability and safety in subjects < or ?50 yrs at Week 144. Results Subjects ?50 yrs in Study 102: STB: 14% (49/348), ATR: 16% (56/352); in Study 103: STB: 14% (48/353), ATV+RTV+TVD: 14% (48/355). Efficacy, safety and tolerability by age and study endpoint are shown in Table 1. Regardless of age, STB had robust efficacy at Week 144 with similar virologic outcomes vs ATR or ATV+RTV+TVD. Discontinuations (DC) due to AE on STB were similar to the comparators, most occurred by Week 48. Median changes in eGFR on STB were similar by age; DC with renal PRT was rare [STB: 4 (0.6%); ATV: 3 (0.8%); ATR: 0], 2 and 1 in ?50 yrs old strata, respectively. Conclusions STB compared to ATR or ATV+RTV+TVD, is an efficacious, well-tolerated and safe regimen for HIV-1-infected, treatment-naïve subjects

Gazzard, Brian; Marie Girard, Pierre; Di Perri, Giovanni; Gallant, Joel; Towner, William; Rogatto, Felipe; Demorin, Jennifer; McColl, Damian; Liu, Hui; Rhee, Martin; Szwarcberg, Javier; Piontkowsky, David

2014-01-01

65

Long-term effects and safety of almitrine-raubasine in age-associated cognitive decline.  

PubMed

Twenty elderly patients (8 men, 12 women, mean age 67.5 years, range 59-74 years) with age-associated cognitive decline (memory impairment, slowing of thought and inability to concentrate, mean Mini Mental State score 22.0, range 18-24) were included by their general practitioners in an open study of the efficacy and safety of long-term combination therapy with almitrine and raubasine. After a 2-week washout period, patients received almitrine-raubasine for 13 months. Efficacy was evaluated at 2-month intervals using two well-being scales (visual analog and psychoaffective profile) and two behavioral scales (Widlocher's scale, and a scale derived from the Sandoz Clinical Assessment Geriatric scale). Memory was assessed every 6 months. Safety was evaluated by full medical examination and routine laboratory parameters at 2- and 6-month intervals, respectively. On treatment, scores on all scales improved significantly (two-way analysis of variance) throughout the study, as did scores in the two objective memory tests (Friedman test). Safety was demonstrated by the lack of any changes in clinical or laboratory parameters outside the normal range. PMID:2093415

Guez, D

1990-01-01

66

Long-term efficacy of dietary weight loss in sleep apnoea\\/ hypopnoea syndrome  

Microsoft Academic Search

Weight loss is associated with clinical improvement in sleep apnoea\\/ hypopnoea syndrome (SAHS). The aim of this study was to ascertain whether the therapeutic efficacy of dietary weight loss is maintained in the long-term. From a total of 216 overweight SAHS patients treated by only a weight reduction programme, 24 cured by this method (apnoea\\/hypopnoea index (AHI) at diagnosis 44.3±27.8,

G. Sampol; X. Muñoz; M. T. Sagalés; S. Martí; A. Roca; M. Dolors de la Calzada; P. Lloberes; F. Morell

1998-01-01

67

Reducing the Risk of Dementia Efficacy of Long-Term Treatment of Hypertension  

Microsoft Academic Search

Background and Purpose—The efficacy of treating older persons for hypertension remains controversial. Although clinical trials suggest no short-term harm, or some benefits, there are little data on the effect on cognitive function of long-term antihypertensive treatment. We evaluated the risk of dementia and cognitive decline associated with duration of antihypertensive treatment. Methods—Data are from the Honolulu Asia Aging Study on

Rita Peila; Lon R. White; Kamal Masaki; Helen Petrovitch; Lenore J. Launer

2011-01-01

68

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

PubMed

The improvement of patient safety has been a long-term aim of healthcare organisations and following recent negative events within the UK, the focus on safety has rightly increased. For over twenty years, clinical audit has been the tool most frequently used to measure safety-related aspects of healthcare and when done so correctly, can lead to sustained improvements. This paper explains how clinical audit is used as a safety improvement tool in an English dental hospital and gives several examples of projects that have resulted in long-term improvements in secondary dental care. PMID:25303590

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

2014-10-10

69

Long-term safety of immunomodulators in pediatric inflammatory diseases.  

PubMed

The medical management of chronic inflammatory disorders in children, including mainly inflammatory bowel diseases and rheumatic diseases, has evolved dramatically over recent years with the advent of disease-modifying drugs such as immunomodulators and biological agents capable of interrupting the inflammatory cascade underlying these disorders. These agents are generally administered in patients who are refractory to conventional therapies. However, there is growing support that their use in the initial phases of these disorders, especially in pediatric patients, could interrupt and cease the inflammatory process. Thus, the aims of therapy have transitioned from symptomatic control to the achievement of deeper remission, including the healing of the inflammatory lesions combined with symptomatic remission. Therefore, more patients are currently receiving immunomodulators or biologics, frequently in addition to corticosteroids. Immunosuppression due to these therapies increases safety concerns, particularly regarding the risk of infections and malignancies. The available literature highlights how the combination of more than one of these therapies, especially if the combination includes corticosteroids, amplifies the risk of severe opportunistic infections. Otherwise, the infections described are mainly mild. Regarding malignancies, the overall risk associated with treatment appears non-significant in pediatric populations, but an appropriate benefit/risk assessment is recommended prior to the introduction of aggressive treatments such as immunomodulants and biologics. The background cancer risk related to the disease itself remains an issue. Protracted follow-up programs are needed, and the results from international multicenter registries are awaited to better understand the true risk related to therapy of these pediatric populations. PMID:25047730

Nuti, Federica; Civitelli, Fortunata; Cucchiara, Salvatore

2014-10-01

70

Long-term safety of India ink tattoos in the colon  

Microsoft Academic Search

Background: When the India ink tattoo is used as a guide for follow-up examinations, the tattoo may remain in the colon for the remainder of that patient's life. This raises the question of the long-term safety of India ink tattoos. The long-term clinical and histologic consequences of the tattoo have not been studied in a large group of patients. Methods:

Burton A. Shatz; Leonard B. Weinstock; Paul E. Swanson; Erik P. Thyssen

1997-01-01

71

Long-term Safety and Efficacy of a Once-Daily Regimen of Emtricitabine, Didanosine, and Efavirenz in HIV-Infected, Therapy-Naive Children and Adolescents: Pediatric AIDS Clinical Trials Group Protocol P1021  

Microsoft Academic Search

BACKGROUND. Compliance with complex antiretroviral therapy regimens is a problem for HIV-1-infected children and their families. Simple, safe, and effective regimens are important for long-term therapeutic success. METHODS. A novel, once-daily dosing regimen of 3 antiretroviral drugs, emtricitab- ine, didanosine, and efavirenz, was tested in 37 therapy-naive HIV-infected chil- dren and adolescents between 3 and 21 years of age (inclusive).

Ross E. McKinney; John Rodman; Chengcheng Hu; Paula Britto; Michael Hughes; Mary Elizabeth Smith; Leslie K. Serchuck; Joyce Kraimer; Alberto A. Ortiz; Patricia Flynn; Ram Yogev; Stephen Spector; Linda Draper; Paul Tran; Melissa Scites; Ruth Dickover; Adriana Weinberg; Coleen Cunningham; Elaine Abrams; M. Robert Blum; Gregory E. Chittick; Laurie Reynolds; Mobeen Rathore

72

Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region  

PubMed Central

Background The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20?months of follow up. Methods This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16?weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. Results From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18?months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p?=?0.072) and 26.7% (95% CI: -33.1 to 59.6, p?=?0.307) over 12 and 18?months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p?=?0.545). Conclusions The acceptable safety profile and good tolerability of RTS,S/AS02D in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20?month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02D group remained significantly higher compared to control for the study duration. Over 18?months follow up, RTS,S/AS02D prevented approximately a quarter of malaria cases in the study population. Clinical trials Gov identifier: NCT00289185 PMID:23297680

2013-01-01

73

ATO/ATRA/Anthracycline-Chemotherapy Sequential Consolidation Achieves Long-Term Efficacy in Primary Acute Promyelocytic Leukemia  

PubMed Central

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

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

74

Long-term safety of stimulant medications used to treat children with ADHD.  

PubMed

Attention-deficit/hyperactivity disorder (ADHD) is a common mental health condition that affects children, adolescents, and adults. Because it is a chronic condition and typically requires effective treatment for several years or more, information on the benefits and risks of long-term pharmacotherapy for ADHD is vital to clinicians. This article reviews the emerging literature on the safety of long-term stimulant medications in ADHD-the most commonly prescribed medications for this condition. Common side effects, including cardiovascular effects, growth effects, and tics, are discussed, as well as treatment of children younger than age 6 and evidence of carcinogenic and reproductive effects. PMID:18777967

Lerner, Marc; Wigal, Tim

2008-08-01

75

The Efficacy and Long-Term Outcome of Microcoil Embolotherapy for Acute Lower Gastrointestinal Bleeding  

PubMed Central

Objective To evaluate the clinical efficacy as well as long-term clinical outcomes of superselective microcoil embolization for lower gastrointestinal bleeding (LGIB). Materials and Methods Between 1997 and 2009, 26 patients with intended transcatheter embolotherapy for LGIB were retrospectively reviewed. Embolization was performed only when the catheter could be advanced to or distal to the mesenteric border of the bowel. The main purpose of our study was to assess technical success, recurrent bleeding rate and complications. We also evaluated the long-term clinical outcome, including late recurrent LGIB, bowel ischemia and the survival rate. Results Twenty-two bleeding sources were in the territory of superior mesenteric artery and four in the inferior mesenteric artery. Technical success was achieved in 22 patients (84.6%). The target vessel of embolization was vasa recta in seventeen patients and marginal artery in the remaining five patients. Early rebleeding occurred in two patients (7.7%) and bowel ischemia in two patients, of whom the embolized points were both at the marginal artery. Delayed recurrent bleeding (> 30 days) occurred in two angiodysplasia patients. Five patients (19.2%) died within the first 30 days of intervention. Long-term follow-up depicted estimated survival rates of 58.2 and 43.1% after one, and five years, respectively. Conclusion Transcatheter embolotherapy to treat LGIB is effective with low rebleeding and ischemic complications. Considering the advanced age and complex medical problems of these patients, the minimal invasive embolotherapy may be used as both a primary and potentially definitive treatment of LGIB. PMID:23483780

Teng, Hui-Chung; Lin, Yih-Huie; Huang, Jer-Shyung; Chen, Chiung-Yu; Lee, Shang-Chieh; Pan, Huay-Ben

2013-01-01

76

LONG TERM EFFICACY OF BIOFEEDBACK THERAPY FOR DYSSYNERGIA -RANDOMIZED CONTROLLED TRIAL  

PubMed Central

Objectives Although biofeedback therapy is effective in the short term management of dyssynergic defecation, its long term efficacy is unknown. Our aim was to compare the one year outcome of biofeedback (manometric- assisted pelvic relaxation, and simulated defecation training), with standard therapy (diet, exercise, laxatives) in patients who completed 3 months of either therapy. Methods Stool diaries, visual analog scales (VAS), colonic transit, anorectal manometry, and balloon expulsion time were assessed at baseline, and at one year after each treatment. All subjects were seen at 3 month intervals and received reinforcement. Primary outcome measure (ITT analysis) was a change in the number of complete spontaneous bowel movements (CSBM) per week. Secondary outcome measures included bowel symptoms, changes in dyssynergia and anorectal function. Results Of 44 eligible patients with dyssynergic defecation, 26 agreed to participate in the long term study. All 13 subjects who received biofeedback, and 7 of 13 who received standard therapy completed one year; 6 failed standard therapy. The number of CSBMs/week increased significantly (p<0.001) in the biofeedback but not in the standard group. Dyssynergia pattern normalized (p<0.001), balloon expulsion time improved (p=0.0009), defecation index increased (p<0.001) and colonic transit time normalized (p=0.01) only in the biofeedback group. Conclusions Biofeedback therapy provided sustained improvement of bowel symptoms and anorectal function in constipated subjects with dyssynergic defecation while standard therapy was largely ineffective. PMID:20179692

Rao, Satish SC; Valestin, Jessica; Brown, C Kice; Zimmerman, Bridget; Schulze, Konrad

2013-01-01

77

Efficacy of long-term coral tissue storage in ethanol for genotyping studies  

NASA Astrophysics Data System (ADS)

With climate change threatening the future of coral reefs, there is an urgent need for effective coral tissue preservation and repositories from which DNA can be extracted. Most collections use 95 % ethanol as the storage medium, but its efficacy for long-term storage for short-fragment DNA use remains poorly documented. We conducted an accelerated DNA aging trial on three species of coral to ascertain whether ethanol-stored tissue and skeleton samples could yield fit-for-purpose DNA at time scales of 100+ yrs. We conclude that even using a crude DNA extraction technique, samples kept at 40 °C for 20 months yielded DNA of sufficient quality for Symbiodinium and coral host genotyping. If stored at -20 °C, these samples are likely to still yield useable DNA after 100 yrs. Ethanol-stored samples compared favorably in terms of DNA quality, quantity and sample integrity with those stored in an analogue of the commercial storage buffer RNA later ®.

Berkelmans, R.; Doyle, J.; van Oppen, M. J. H.; Asbridge, E. F.; Brown, A. R.

2014-03-01

78

Long-term compulsive exercise reduces the rewarding efficacy of 3,4-methylenedioxymethamphetamine.  

PubMed

Although exercise has been known to regulate brain plasticity, its impact on psychostimulant reward and the associated mesolimbic dopamine system remained scarcely explored. A psychostimulant, 3,4-methylenedioxymethamphetamine (MDMA), is currently a worldwide abused drug of choice. We decided to examine the modulating effects of long-term, compulsive treadmill exercise on the hedonic value of MDMA in male C57BL/6J mice. MDMA-induced conditioned place preference (CPP) was used as a behavioral paradigm to indicate the reward efficacy of MDMA. We observed that sedentary control mice all demonstrated reliable MDMA-induced CPP with our conditioning protocol. Interestingly, pre-exposure to a treadmill exercise decreased the later MDMA-induced CPP in a running period-dependent manner. Specifically, mice undergoing a 12-week treadmill running exercise did not exhibit any approaching bias toward the MDMA-associated compartment in this CPP paradigm. Twelve weeks of treadmill running did not alter peripheral metabolism of MDMA 30min following single intraperitoneal injection of MDMA (3mg/kg). We further used microdialysis technique to study the underlying mechanisms for the impaired MDMA reward produced by the12-week exercise pre-exposure. We found that acute MDMA-stimulated dopamine release in nucleus accumbens was abolished in the exercised mice, whereas an obvious elevation of accumbal dopamine release was observed in sedentary control mice. Finally, the 12-week exercise program did not alter the protein levels of primary dopamine receptors, vesicular or membrane transporters in this area. We conclude that the long-term, compulsive exercise is effective in curbing the reward efficacy of MDMA possibly via its direct effect on reversing the MDMA-stimulated dopamine release in nucleus accumbens. PMID:17949827

Chen, Hsiun Ing; Kuo, Yu Min; Liao, Chung-Hsien; Jen, Chauying J; Huang, A Min; Cherng, Chianfang G; Su, Shu-Wen; Yu, Lung

2008-02-11

79

Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial  

PubMed Central

Introduction Previous studies of long-term treatment response in fibromyalgia and other chronic pain states have generally been limited to approximately one year, leaving questions about the longer-term durability of response. The purpose of this study was to demonstrate continuing efficacy of milnacipran by characterizing changes in pain and other fibromyalgia symptoms after discontinuing long-term treatment. The mean length of milnacipran treatment at the time of randomized withdrawal was 36.1 months from initial exposure to milnacipran (range, 17.9 to 54.4 months). Methods After completing a long-term, open-label, lead-in study of milnacipran (which followed varying periods of exposure in previous studies), adult patients with fibromyalgia entered the four-week open-label period of the current study for evaluation of ongoing treatment response. After the four-week period to confirm new baseline status, 151 patients taking milnacipran ?100 mg/day and reporting ?50% improvement from pre-milnacipran exposure in Visual Analogue Scale (VAS) pain scores were classified as responders. These responders entered the 12-week, double-blind withdrawal period in which they were randomized 2:1 to continue milnacipran or switched to placebo. The prespecified primary parameter was loss of therapeutic response (LTR), defined as increase in VAS pain score to <30% reduction from pre-milnacipran exposure or worsening of fibromyalgia requiring alternative treatment. Adverse events and vital signs were also monitored. Results Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). Median time to LTR was 56 days with placebo and was not calculable for milnacipran, because less than half of the latter group of patients lost therapeutic response by study end. Additionally, 81% of patients continuing on milnacipran maintained clinically meaningful pain response (?30% improvement from pre-milnacipran exposure), compared with 58% of patients switched to placebo (sensitivity analysis II; P < 0.001). The incidences of treatment-emergent adverse events were 58% and 47% for placebo and milnacipran, respectively. Mean decreases in blood pressure and heart rate were found in both groups, with greater decreases for patients switched to placebo. Conclusions Continuing efficacy of milnacipran was demonstrated by the loss of effect following withdrawal of treatment in patients who received an average of three years of milnacipran treatment. Trial registration ClinicalTrials.gov: NCT01014585 PMID:23953493

2013-01-01

80

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

PubMed

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

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

81

Long-term modifications of synaptic efficacy in the human inferior and middle temporal cortex  

NASA Technical Reports Server (NTRS)

The primate temporal cortex has been demonstrated to play an important role in visual memory and pattern recognition. It is of particular interest to investigate whether activity-dependent modification of synaptic efficacy, a presumptive mechanism for learning and memory, is present in this cortical region. Here we address this issue by examining the induction of synaptic plasticity in surgically resected human inferior and middle temporal cortex. The results show that synaptic strength in the human temporal cortex could undergo bidirectional modifications, depending on the pattern of conditioning stimulation. High frequency stimulation (100 or 40 Hz) in layer IV induced long-term potentiation (LTP) of both intracellular excitatory postsynaptic potentials and evoked field potentials in layers II/III. The LTP induced by 100 Hz tetanus was blocked by 50-100 microM DL-2-amino-5-phosphonovaleric acid, suggesting that N-methyl-D-aspartate receptors were responsible for its induction. Long-term depression (LTD) was elicited by prolonged low frequency stimulation (1 Hz, 15 min). It was reduced, but not completely blocked, by DL-2-amino-5-phosphonovaleric acid, implying that some other mechanisms in addition to N-methyl-DL-aspartate receptors were involved in LTD induction. LTD was input-specific, i.e., low frequency stimulation of one pathway produced LTD of synaptic transmission in that pathway only. Finally, the LTP and LTD could reverse each other, suggesting that they can act cooperatively to modify the functional state of cortical network. These results suggest that LTP and LTD are possible mechanisms for the visual memory and pattern recognition functions performed in the human temporal cortex.

Chen, W. R.; Lee, S.; Kato, K.; Spencer, D. D.; Shepherd, G. M.; Williamson, A.

1996-01-01

82

The Long-term Clinical Efficacy of Biofeedback Therapy for Patients With Constipation or Fecal Incontinence  

PubMed Central

Background/Aims There has been a controversy regarding the usefulness of biofeedback therapy for functional constipation or fecal incontinence. This study was performed to investigate the long-term clinical efficacy of biofeedback therapy. Methods Sixty-four patients with constipation or fecal incontinence received biofeedback therapy for 4 weeks. Symptom improvements were evaluated immediately after the completion of biofeedback therapy and during the follow-up period of about 12 to 64 months. Results Twenty-five patients in the constipation group [mean age of 52.1 years, 16 men (64.0%)] received 6.2 sessions of biofeedback therapy. Improvement of constipation after the completion of biofeedback therapy was as follows: major response (or improvement) in 3 patients (12.0%), fair in 6 (24.0%), minor in 11 (44.0%) and none in 5 (20.0%). Among 9 patients who showed major or fair improvement, 8 patients (88.9%) maintained the symptom improvement through the long term follow-up periods. Thirty-nine patients in the fecal incontinence group [59.7 years old, 15 men (38.5%)] received 6.8 sessions of biofeedback therapy. Improvement of incontinence after the completion of biofeedback therapy was as follows: major improvement in 6 patients (15.4%), fair in 14 (35.9%), minor in 14 (35.9%), and none in 5 (12.8%). All 11 patients with major or fair improvement maintained the symptom improvement to the end of follow-up periods. Conclusions Symptom improvements after biofeedback therapy were disappointing in both the constipation and incontinence group. However, when the symptom improvements were classified as major or fair, the improvements continued for at least a year. PMID:20535349

Lee, Byoung Hwan; Kang, Sung-Bum; Kim, So Yeon; Lee, Kyoung-Ho; Im, Bo Youn; Jee, Jung Hee; Oh, Jane C.; Park, Young Soo; Lee, Dong Ho

2010-01-01

83

Long-term modifications of synaptic efficacy in the human inferior and middle temporal cortex.  

PubMed Central

The primate temporal cortex has been demonstrated to play an important role in visual memory and pattern recognition. It is of particular interest to investigate whether activity-dependent modification of synaptic efficacy, a presumptive mechanism for learning and memory, is present in this cortical region. Here we address this issue by examining the induction of synaptic plasticity in surgically resected human inferior and middle temporal cortex. The results show that synaptic strength in the human temporal cortex could undergo bidirectional modifications, depending on the pattern of conditioning stimulation. High frequency stimulation (100 or 40 Hz) in layer IV induced long-term potentiation (LTP) of both intracellular excitatory postsynaptic potentials and evoked field potentials in layers II/III. The LTP induced by 100 Hz tetanus was blocked by 50-100 microM DL-2-amino-5-phosphonovaleric acid, suggesting that N-methyl-D-aspartate receptors were responsible for its induction. Long-term depression (LTD) was elicited by prolonged low frequency stimulation (1 Hz, 15 min). It was reduced, but not completely blocked, by DL-2-amino-5-phosphonovaleric acid, implying that some other mechanisms in addition to N-methyl-DL-aspartate receptors were involved in LTD induction. LTD was input-specific, i.e., low frequency stimulation of one pathway produced LTD of synaptic transmission in that pathway only. Finally, the LTP and LTD could reverse each other, suggesting that they can act cooperatively to modify the functional state of cortical network. These results suggest that LTP and LTD are possible mechanisms for the visual memory and pattern recognition functions performed in the human temporal cortex. Images Fig. 1 PMID:8755594

Chen, W R; Lee, S; Kato, K; Spencer, D D; Shepherd, G M; Williamson, A

1996-01-01

84

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

SciTech Connect

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.

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

85

Juxtaposing Math Self-Efficacy and Self-Concept as Predictors of Long-Term Achievement Outcomes  

ERIC Educational Resources Information Center

In this study, we tested the hypothesis that self-efficacy and self-concept reflect different underlying processes and both are critical to understanding long-term achievement outcomes. Although both types of self-belief are well established in educational psychology, research comparing and contrasting their relationship with achievement has been…

Parker, Philip David; Marsh, Herbert W.; Ciarrochi, Joseph; Marshall, Sarah; Abduljabbar, Adel Salah

2014-01-01

86

Long-term efficacy of endoscopic coagulation for different types of gastric vascular ectasia  

PubMed Central

AIM: To examine the long-term therapeutic efficacies of endoscopic cauterization for gastric vascular ectasia, according to the type of lesion. METHODS: Thirty-eight patients with hemorrhagic gastric vascular ectasia (VE) were treated by endoscopic cauterization: 13 by heater probe coagulationand 25 by argon plasma coagulation. Depending on the number of lesions, 14 and 24 patients were classified into localized VE (? 10; LVE) and extensive VE (> 10; EVE), respectively. The patients were followed-up by repeated endoscopic examinations after the therapy, and the incidences of VE recurrence and re-bleeding from the lesions were evaluated. RESULTS: Although the VE lesions disappeared initially in all the patients after the therapy, the recurrence of VE developed in 25 patients (66%) over a mid-term observation period of 32 mo, and re-bleeding occurred in 15 patients (39%). The recurrence of VE was found in all patients with EVE, with re-bleeding occurring in 14 patients (58%). In contrast, only 1 patient (7%) with LVE showed recurrence of the lesions and complicating hemorrhage. Both the cumulative recurrence-free rates and cumulative re-bleeding-free rates were significantly lower in the EVE group than in the LVE group (P < 0.001 and P < 0.001, respectively). Moreover, the cumulative re-bleeding-free rate in the EVE group was 47.6% at 1 year and 25.4% at 2 years in patients with chronic renal failure, which were significantly lower than the rates in the patients without chronic renal failure (83.3% and 74.1%, respectively) (P < 0.05). CONCLUSION: The recurrence of VE and re-bleeding from the lesions was more frequent in the patients with EVE, especially in those with complicating renal failure. PMID:23687417

Imai, Yukinori; Mizuno, Yoshie; Yoshino, Kiyoko; Watanabe, Kazuhiro; Sugawara, Kayoko; Motoya, Daisuke; Oka, Masashi; Mochida, Satoshi

2013-01-01

87

The Efficacy of Short- and Long-Term Therapy in the Treatment of Childhood Sexual Abuse: A Review of the Literature.  

ERIC Educational Resources Information Center

This paper presents a review of the short- and long-term treatments for children who have been sexually abused. Short-term group therapy, long-term group therapy, short-term individual, and long-term individual therapy were each evaluated in terms of efficacy in alleviating symptoms associated with sexual abuse. The paper also evaluates the…

Aoto-Sullivan, Stacey Y.

88

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

SciTech Connect

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

Kalva, Sanjeeva P., E-mail: skalva@partners.org [Massachusetts General Hospital, Department of Radiology (United States); Marentis, Theodore C. [Harvard Medical School Boston, Department of Radiology (United States); Yeddula, Kalpana; Somarouthu, Bhanusupriya; Wicky, Stephan [Massachusetts General Hospital, Department of Radiology (United States); Stecker, Michael S. [Brigham's Women's Hospital, Department of Radiology (United States)

2011-04-15

89

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

SciTech Connect

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

Richard, R.F.

1995-05-11

90

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

PubMed

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

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

91

Long-term effect of communication training on the relationship between physicians' self-efficacy and performance  

PubMed Central

Objective To examine the long term impact of a communication skills intervention on physicians' communication self-efficacy and the relationship between reported self-efficacy and actual performance. Methods 62 hospital physicians were exposed to a 20-hour communication skills course according to the Four Habits patient-centered approach in a crossover randomized trial. Encounters with real patients before and after the intervention (mean 154 days) were videotaped, for evaluation of performance using the Four Habits Coding Scheme. Participants completed a questionnaire about communication skills self-efficacy before the course, immediately after the course, and at 3 years follow-up. Change in self-efficacy and the correlations between performance and self-efficacy at baseline and follow-up were assessed. Results Communication skills self-efficacy was not correlated to performance at baseline (r=-0.16; p=0.22). The association changed significantly (p=0.01) and was positive at follow-up (r=0.336, p=0.042). The self-efficacy increased significantly (effect size d=0.27). High performance after the course and low self-efficacy before the course were associated with larger increase in communication skills self-efficacy. Conclusion A communication skills course led to improved communication skills self-efficacy more than three years later, and introduced a positive association between communication skills self-efficacy and performance not present at baseline. Practice implications Communication skills training enhances physicians' insight in own performance. PMID:23414658

Gulbrandsen, Pal; Jensen, Bard Fossli; Finset, Arnstein; Blanch-Hartigan, Danielle

2013-01-01

92

Quantitative Assessment of Countermeasure Efficacy for Long-Term Space Missions  

NASA Technical Reports Server (NTRS)

This slide presentation reviews the development of quantitative assessments of the effectiveness of countermeasures (CM) for the effects of space travel on humans for long term space missions. An example of bone mineral density (BMD) is examined to show specific quantitative measures for failure and success.

Feiveson, Alan H.

2000-01-01

93

Examining Immediate and Long-Term Efficacy of Rape Prevention Programming With Racially Diverse College Men  

Microsoft Academic Search

The authors investigated the short- and long-term (5-month) effectiveness of a theoretically driven, programmatic rape prevention intervention on a sample of primarily White and Black college men. A racially diverse sample was included, and the potential effectiveness of both a culturally relevant and a traditional \\

Mary J. Heppner; Helen A. Neville; Kendra Smith; Beth S. Gershuny

1999-01-01

94

Creatine supplementation in health and disease: What is the evidence for long-term efficacy?  

Microsoft Academic Search

Creatine supplementation is an established ergogenic aid in sports and is now claimed to have therapeutical applications in a variety of diseases. The available literature mainly covers the short-term (one to several weeks) effects of creatine supplementation on skeletal muscle function in health and disease, which is of little help to evaluate the long-term (two or more months) potential of

Wim Derave; Bert O. Eijnde; Peter Hespel

2003-01-01

95

[On the efficacy of long-term psychodynamic psychotherapy for complex psychological disorders].  

PubMed

Rief and Hofmann (Nervenarzt 80:593-597) criticize in a very detailed comment our meta-analysis of long-term psychodynamic psychotherapy (JAMA 300:1551-1565). Although our article clearly included information that our meta-analysis addressed long-term psychodynamic psychotherapy of at least 50 sessions or at least 1 year duration, Rief and Hofmann allege that we studied "psychoanalysis" or "long-term psychoanalysis". Then they "show" for some of the studies we included that these studies did not address "psychoanalysis" or "long-term psychoanalysis" - which they did indeed not, but had never been claimed by us. For all other points of criticism put forward by the authors we show that they are not tenable as well. In addition, we show that Rief and Hofmann use omissions and allegations that give the impression that we deliberately violated principles of good scientific practice. This is reputation-damaging behaviour that clearly goes beyond a scientific discussion among researchers and constitutes a special act which itself violates the principles of good scientific practice. PMID:19851742

Leichsenring, F; Rabung, S

2009-11-01

96

The efficacy of long-term oral chemotherapy with 5'-deoxy-5-fluorouridine and cyclophosphamide for recurrent breast cancer  

Microsoft Academic Search

Background 5?-Deoxy-5-fluorouridine (5?-DFUR) is a prodrug of 5-fluorouracil (5-FU), which is known to be converted by thymidine phosphorylase (dThdPase). A recent preclinical study revealed that cyclophosphamide (CPA) upregulated dThdPase activity, specifically in tumor cells. The purpose of the present study was to examine the efficacy of long-term administration of 5?-DFUR\\/CPA for patients with recurrent breast cancer. Methods Fifteen breast cancer

Toshiaki Iba; Akio Kidokoro; Masaki Fukunaga; Kazuyoshi Sugiyama; Nobuyoshi Aihara; Masaru Suda

2004-01-01

97

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

Microsoft Academic Search

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.

ADONIS HIJAZ; JAMES BENA; FIROUZ DANESHGARI

98

Long-term compulsive exercise reduces the rewarding efficacy of 3,4-methylenedioxymethamphetamine  

Microsoft Academic Search

Although exercise has been known to regulate brain plasticity, its impact on psychostimulant reward and the associated mesolimbic dopamine system remained scarcely explored. A psychostimulant, 3,4-methylenedioxymethamphetamine (MDMA), is currently a worldwide abused drug of choice. We decided to examine the modulating effects of long-term, compulsive treadmill exercise on the hedonic value of MDMA in male C57BL\\/6J mice. MDMA-induced conditioned place

Hsiun Ing Chen; Yu Min Kuo; Chung-Hsien Liao; Chauying J. Jen; A Min Huang; Chianfang G. Cherng; Shu-Wen Su; Lung Yu

2008-01-01

99

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

PubMed

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

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

100

[Safety of long-term replacement hormonal therapy in patients with erectile dysfunction and androgen deficiency].  

PubMed

Safety of testosterone undecanoate in relation to initiation of cancer and prostatic adenoma (PA) in patients with androgenic deficiency and erectile dysfunction (ED) was studied for 12 months in 49 patients aged 57 to 73 years treated with intramuscular testosteron injections. The size of the prostate in patients with adenoma was 46.34 +/- 21.12 cm3 while in adenoma-free patients--19.11 +/- 6.57 sm3. Diabetes mellitus of type 2 (DM-2) was diagnosed in 46.9% patients. All the patients had documented hypogonadism and ED. Tests for PSA and transrectal ultrasound investigation was made in all the patients. 12 month testosterone therapy produced normalization of a mean level of testosterone in both groups, index of erectile function increased. In one patient PSA rose higher than normal value. None of the patients developed obstruction of the urinary tract. Body mass index, lipid spectrum and carbohydrate metabolism also improved. Thus, long-term therapy with testosterone undecanoate has no effect on PSA level, does not induce urinary obstruction with enlarged prostate. The presence of DM-2 is not a contraindication for androgen therapy in adenoma patients. By reducing body mass index, total cholesterol, triglycerides and LDLP, testosterone therapy lowers the risk of prostatic cancer. PMID:18254226

Morgunov, L Iu; Vertkin, A L; Pushkar', D Iu

2007-01-01

101

Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine  

PubMed Central

Background This study assessed the short and the long term safety of the 2009 AS03 adjuvanted monovalent pandemic vaccine through an active web-based electronic surveillance. We compared its safety profile to that of the seasonal trivalent inactivated influenza vaccine (TIV) for 2010–2011. Methodology/Principal Findings Health care workers (HCW) vaccinated in 2009 with the pandemic vaccine (Arepanrix ® from GSK) or HCW vaccinated in 2010 with the 2010–2011 TIV were invited to participate in a web-based active surveillance of vaccine safety. They completed two surveys the day-8 survey covered the first 7 days post-vaccination and the day-29 survey covered events occurring 8 to 28 days after vaccination. Those who reported a problem were called by a nurse to obtain details. The main outcome was the occurrence of a new health problem or the worsening of an existing health condition that resulted in a medical consultation or work absenteeism. For the pandemic vaccine, a six-month follow-up for the occurrence of serious adverse events (SAE) was conducted. Among the 6242 HCW who received the pandemic vaccine, 440 (7%) reported 468 events compared to 328 of the 7645 HCW (4.3%) who reported 339 events after the seasonal vaccine. The 2009 pandemic vaccine was associated with significantly more local reactions than the 2010–2011 seasonal vaccine (1% vs. 0.03%, p<0.001). Paresthesia was reported by 7 HCW (0.1%) after the pandemic vaccine but by none after the seasonal vaccine. For the pandemic vaccine, no clustering of SAE was found in the 6 month follow-up. Conclusion The 2009 pandemic vaccine seems to have a good safety profile, similar to the 2010–2011 TIV, with the exception of local reactions. This surveillance was adequately powered to identify AE associated with an excess risk ?1 per 1000 vaccinations but is insufficient to detect rare AE. Trial Registration ClinicalTrials.gov NCT01289418, NCT01318876 PMID:22802929

De Serres, Gaston; Gariepy, Marie-Claude; Coleman, Brenda; Rouleau, Isabelle; McNeil, Shelly; Benoit, Melanie; McGeer, Allison; Ambrose, Ardith; Needham, Judy; Bergeron, Chantal; Grenier, Cynthia; Sleigh, Kenna; Kallos, Arlene; Ouakki, Manale; Ouhoummane, Najwa; Stiver, Grant; Valiquette, Louis; McCarthy, Anne; Bettinger, Julie

2012-01-01

102

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

SciTech Connect

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

Michael D. Kinney and William D. Barrick

2008-09-01

103

Long-term efficacy of electroacupuncture for chronic neck pain: a randomised controlled trial.  

PubMed

Electroacupuncture is a safe treatment for chronic neck pain. Nonetheless, one month after treatment, improvement of neck pain is similar to that in placebo-treated controls. This suggests that the efficacy may not be due to specific effect of the treatment procedure. PMID:24473589

Zhang, S P; Chiu, T T W; Chiu, S N

2013-12-01

104

Efficacy of the Epley maneuver for posterior canal BPPV: a long-term, controlled study of 81 patients.  

PubMed

We assessed the efficacy of the Epley maneuver (canalith repositioning) in a study of 81 patients with posterior semicircular canal benign paroxysmal positional vertigo (BPPV). A group of 61 patients underwent the maneuver, while a control group of 20 patients received no therapy. All patients were evaluated at 1 and 6 months. The percentage of patients who experienced subjective improvement was significantly higher in the treatment group at both 1 month (89% vs. 10%) and 6 months (92% vs. 50%). Three patients in the treatment group who did not improve after treatment underwent a second maneuver, and all achieved a positive result. In addition, 4 successfully treated patients experienced a recurrence between 1 and 6 months following treatment; 3 were retreated, and 2 of them responded well. We conclude that the Epley maneuver provides effective and long-term control of symptoms in patients with BPPV. PMID:15742768

Richard, Wietske; Bruintjes, Tjasse D; Oostenbrink, Peter; van Leeuwen, Roeland B

2005-01-01

105

Long-Term Single-Dose Efficacy of a Vesicular Stomatitis Virus-Based Andes Virus Vaccine in Syrian Hamsters  

PubMed Central

Andes virus (ANDV) is highly pathogenic in humans and is the primary etiologic agent of hantavirus cardiopulmonary syndrome (HCPS) in South America. Case-fatality rates are as high as 50% and there are no approved vaccines or specific therapies for infection. Our laboratory has recently developed a replication-competent recombinant vesicular stomatitis virus (VSV)-based vaccine that expressed the glycoproteins of Andes virus in place of the native VSV glycoprotein (G). This vaccine is highly efficacious in the Syrian hamster model of HCPS when given 28 days before challenge with ANDV, or when given around the time of challenge (peri-exposure), and even protects when administered post-exposure. Herein, we sought to test the durability of the immune response to a single dose of this vaccine in Syrian hamsters. This vaccine was efficacious in hamsters challenged intranasally with ANDV 6 months after vaccination (p = 0.025), but animals were not significantly protected following 1 year of vaccination (p = 0.090). The decrease in protection correlated with a reduction of measurable neutralizing antibody responses, and suggests that a more robust vaccination schedule might be required to provide long-term immunity. PMID:24492621

Prescott, Joseph; DeBuysscher, Blair L.; Brown, Kyle S.; Feldmann, Heinz

2014-01-01

106

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

ERIC Educational Resources Information Center

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…

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

2005-01-01

107

Long-term benefits of prompts to use safety belts among drivers exiting senior communities.  

PubMed

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 68% usage), to postinstallation of signs (94%), to 6 months follow-up (80%). The current study was a 4-year follow-up in which six senior communities, with seat belt signs, were compared to six matched control senior communities with no signs. Safety belt usage was stable, across 4 years, at approximately 80% for both male and female drivers and front seat passengers for the six communities with signs, and was approximately 55% for control sites. These finding suggest that the simple and low-cost intervention of erecting signs to prompt safety belt use has persistent benefits that affect driver and passenger behavior alike. PMID:16463533

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

2005-01-01

108

Highly resistant Salmonella enterica serovar Typhi with a novel gyrA mutation raises questions about the long-term efficacy of older fluoroquinolones for treating typhoid fever.  

PubMed

As a consequence of multidrug resistance, clinicians are highly dependent on fluoroquinolones for treating the serious systemic infection typhoid fever. While reduced susceptibility to fluoroquinolones, which lessens clinical efficacy, is becoming ubiquitous, comprehensive resistance is exceptional. Here we report ofloxacin treatment failure in typhoidal patient infected with a novel, highly fluoroquinolone-resistant isolate of Salmonella enterica serovar Typhi. The isolation of this organism has serious implications for the long-term efficacy of ciprofloxacin and ofloxacin for typhoid treatment. PMID:22371897

Koirala, Kanika Deshpande; Thanh, Duy Pham; Thapa, Sudeep Dhoj; Arjyal, Amit; Karkey, Abhilasha; Dongol, Sabina; Shrestha, Upendra Man; Farrar, Jeremy J; Basnyat, Buddha; Baker, Stephen

2012-05-01

109

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

PubMed

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

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

2013-05-01

110

Sodium ferric gluconate complex in haemodialysis patients: a prospective evaluation of long-term safety  

Microsoft Academic Search

Background. A previous single dose placebo- controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients complet- ing the single-dose trial of SFGC were eligible to participate in

Beckie Michael; Daniel W. Coyne; Vaughn W. Folkert; Naomi V. Dahl; David G. Warnock

111

Safety and long-term follow-up of endoscopic snare excision of ampullary adenomas  

Microsoft Academic Search

Background  Adenomas of the duodenal papilla are rare. Because of their malignant potential, resection is mandatory. Options for resection\\u000a include endoscopic resection techniques, transduodenal local excision, and pancreaticoduodenectomy. The aim of this retrospective\\u000a study was to evaluate the safety and outcome of endoscopic snare resection of papillary adenomas in a Greek cohort of patients.\\u000a \\u000a \\u000a \\u000a Methods  Fourteen patients (six women and eight men;

P. Katsinelos; G. Paroutoglou; J. Kountouras; A. Beltsis; B. Papaziogas; K. Mimidis; C. Zavos; S. Dimiropoulos

2006-01-01

112

Acute and long-term safety evaluation of a novel IH636 grape seed proanthocyanidin extract.  

PubMed

Grape seed proanthocyanidins are known to possess a broad spectrum of pharmacological, medicinal and therapeutic properties. Previous studies in our laboratories have demonstrated the various protective abilities of a novel IH636 grape seed proanthocyanidin extract (GSPE) against various pathologic conditions. However no extensive safety studies have been conducted on grape seed proanthocyanidins to date. This study demonstrates the acute and chronic safety studies on GSPE. Acute oral toxicity, dermal toxicity, dermal irritation and eye irritation studies have been conducted. The LD50 of GSPE was found to be greater than 5000 mg/kg when administered once orally via gastric intubation to fasted male and female albino rats. The LD50 of GSPE was found to be greater than 2000 mg/kg when administered once for 24 hr to the clipped, intact skin of male and female albino rats. In addition, 2000 mg/kg was found to be the no-observed-effect level (NOEL) for systemic toxicity under the conditions of the study. In a dermal irritation study, GSPE received a descriptive rating classification of moderately irritating. Extensive chronic studies were also conducted. We have assessed the effects of chronic administration of 100 mg GSPE/kg/day for twelve months and its effect on seven vital target organs, namely, brain, heart, intestine, kidney, liver, lung and spleen, and on serum chemistry changes in male B6C3F1 mice. Furthermore, the dose-dependent chronic effects of GSPE in female B6C3F1 mice were evaluated. Mice were fed 0, 100, 250 or 500 mg GSPE/kg/day for six months and the effects of GSPE exposure were examined on brain, duodenum, heart, kidney, liver, lung, pancreas and spleen, and on serum chemistry changes in female mice. These acute studies demonstrated that GSPE is safe and did not cause any detrimental effects in vivo under the conditions investigated in this study. PMID:11758648

Ray, S; Bagchi, D; Lim, P M; Bagchi, M; Gross, S M; Kothari, S C; Preuss, H G; Stohs, S J

2001-01-01

113

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

NASA Technical Reports Server (NTRS)

Lithium-ion batteries have the highest energy density of the batteries available in the commercial market today. Although most lithium-ion cell designs use a metal can design, this has changed significantly in recent years. Cell designs are offered in the pouch format as they offer better volumetric and gravimetric energy densities and in some cases, higher tolerance to abuse or off-nominal conditions. In the past decade, several state-of-the-art lithium-ion pouch cell designs have been tested. The pouch cell designs have become more robust in the past two years but there are still a few issues that need to be looked into for optimization. The pouch cells seem to have a tendency to swell when left in storage under ambient conditions. The cells also swell under overvoltage and undervoltage conditions. A significant issue that has been observed is the swelling of the cells under a vacuum condition which could lead to deformation of the cell pouch after this exposure. This last factor would be very critical in the use of these cell designs for space applications as vacuum exposure is used to check for cell and battery leaks before it is flown into space. In rare cases, corrosion of the aluminum layer of the pouches has been observed in stored cells. Pouch material analysis has been carried out in an effort to understand the strength of the pouches and determine if this is a factor in the corrosion as well as unsafe condition of the cells as deformation of the inner layers of the pouch could occur when the cells swell under the various conditions described above. Pouch materials are typically aluminized plastic, made up of a layer of Al sandwiched between one or more layers of polymeric material. Deformations or cell manufacturing processes could lead to a compromise of the inner polymeric layer/s of the pouch leading to the corrosion of the Al layer in the aluminized pouch material. The safety of the pouch cell designs has been determined for cells from various manufacturers. The results are varied and in some cases, unexpected. This paper presents a summary of the tests carried out on a few li-ion pouch cell designs from various cell manufacturers. The data will include performance under different conditions specifically cycling under vacuum conditions with and without restraints as well as safety test data. The presentation will also include detailed analysis of the pouch material for the cells studied.

Jeevarajan, Judith

2012-01-01

114

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

PubMed Central

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

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

2007-01-01

115

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

PubMed Central

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

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

2013-01-01

116

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

PubMed Central

Background Donepezil (23?mg/day) is approved by the US Food and Drug Administration for the treatment of patients with moderate to severe Alzheimer’s disease (AD). Approval was based on results from a 24-week, randomized, double-blind study of patients who were stable on donepezil 10?mg/day and randomized 2:1 to either increase their donepezil dose to 23?mg/day or continue taking 10?mg/day. The objective of this study was to assess the long-term safety and tolerability of donepezil 23?mg/day in patients with moderate to severe AD. Methods Patients who completed the double-blind study and were eligible could enroll into a 12-month extension study of open-label donepezil 23?mg/day. Clinic visits took place at open-label baseline and at months 3, 6, 9, and 12. Safety analyses comprised examination of the incidence, severity, and timing of treatment-emergent adverse events (AEs); changes in weight, electrocardiogram, vital signs, and laboratory parameters; and discontinuation due to AEs. Results 915 double-blind study completers were enrolled in the open-label extension study and 902 comprised the safety population. Mean treatment duration in this study was 10.3?±?3.5?months. In total, 674 patients (74.7%) reported at least one AE; in 320 of these patients (47.5%) at least one AE was considered to be possibly or probably study drug related. The majority of patients reporting AEs (81.9%) had AEs of mild or moderate severity. There were 268 patients (29.7%) who discontinued early, of which 123 (13.6%) were due to AEs. Patients increasing donepezil dose from 10?mg/day in the double-blind study to 23?mg/day in the extension study had slightly higher rates of AEs and SAEs than patients who were already receiving 23?mg (78.0% and 16.9% vs 72.8% and 14.0%, respectively). The incidence of new AEs declined rapidly after the first 2?weeks and remained low throughout the duration of the study. Conclusion This study shows that long-term treatment with donepezil 23?mg/day is associated with no new safety signals. The elevated incidence of AEs in patients increasing the dose of donepezil from 10?mg/day to 23?mg/day was limited to the initial weeks of the study. PMID:22681723

2012-01-01

117

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

Microsoft Academic Search

In long-term safety studies with neotame, a new high-intensity sweetener 7000–13,000 times sweeter than sucrose, the percent changes (%?) in body weight gain (BWG) in Sprague–Dawley rats were several-fold greater than the %? in overall food consumption (FC). This study investigates the question of whether the changes in BWG were adverse or secondary to small, long-term decrements in FC. The

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

2003-01-01

118

Efficacy of the Incredible Years Programme as an early intervention for children with conduct problems and ADHD: long-term follow-up  

Microsoft Academic Search

Background This study examined the long-term efficacy of the Incredible Years (IY) BASIC Parenting Programme delivered as a preventive intervention with parents of pre-school children who display signs of attention deficit hyperactivity disorder (ADHD) and conduct problems.Families were followed up after the completion of a controlled trial with 11 Sure Start areas in North and Mid-Wales and North West England.

K. Jones; D. Daley; J. Hutchings; T. Bywater; C. Eames

2008-01-01

119

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

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

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

2004-01-01

120

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

PubMed Central

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

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

2014-01-01

121

Sun Protection Intervention for Highway Workers: Long-Term Efficacy of UV Photography and Skin Cancer Information on Men’s Protective Cognitions and Behavior  

Microsoft Academic Search

Background  The risk for skin cancer is increased among older males and outdoor workers who have high levels of ultraviolet (UV) exposure.\\u000a \\u000a \\u000a \\u000a Purpose  This study was designed to examine the long-term efficacy of UV photography interventions on male outdoor workers, the potential\\u000a mediators of its impact, and the efficacy of UV photography and skin cancer vs. aging information with this population.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  One

Michelle L. Stock; Meg Gerrard; Frederick X. Gibbons; Jennifer L. Dykstra; Heike I. M. Mahler; Laura A. Walsh; James A. Kulik

2009-01-01

122

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

ERIC Educational Resources Information Center

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…

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

2010-01-01

123

Efficacy of a Conservative Weight Loss Program in the Long-Term Management of Chronic Upper Airway Obstruction  

PubMed Central

Objective. Obesity is a significant contributor to oxygen demand and dynamic airway obstruction. The objective of the current study is to determine the long-term success of conservative measures directed toward weight reduction on airway management without respect to specific airway disease etiology. Methods. Patients with chronic airway obstruction secondary anatomic lesions or obstructive sleep apnea were recruited and followed prospectively. Demographics, initial and final weights, diagnosis, and followup information were recorded. Patients were referred to a registered dietician, provided counseling, and started on a weight-loss regimen. Outcome measures were change in body mass index (BMI) and rate of decannulation from weight loss alone. Results. Of fourteen patients, ten remained tracheostomy-dependent and four had high-grade lesions with the potential for improvement in oxygen demand and dynamic airway collapse with weight loss. The mean follow up period was 25 months. The mean change in BMI was an increase of 1.4 kg/m2 per patient. Conclusions. Conservative measures alone were not effective in achieving weight reduction in the population studied. This may be due to comorbid disease and poor compliance. The promise of decannulation was an insufficient independent motivator for weight loss in this study. Although the theoretical benefits of weight loss support its continued recommendation, the long-term success rate of conservative measures is low. More aggressive facilitated interventions including pharmacotherapy or bariatric surgery should be considered early in the course of treating airway disease complicated by obesity. PMID:20107569

Case, Ryan C.; Schweinfurth, John

2009-01-01

124

Dapagliflozin efficacy and safety: a perspective review  

PubMed Central

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.

2014-01-01

125

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

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

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

1999-01-01

126

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

PubMed Central

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

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

2014-01-01

127

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

Microsoft Academic Search

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.

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

128

Application of supercritical fluid extraction (SFE) to predict bioremediation efficacy of long-term composting of PAH-contaminated soil  

SciTech Connect

Supercritical fluid extraction (SFE) with pure carbon dioxide was used to obtain desorption curves of PAHs from four contaminated industrial soils. These were from a former gas works, a former tar processing plant, a former wood presentation plant, and a former gas-holder site. Total PAH concentrations ranged from 1495 to 2439 mg/kg. The desorption curves were fitted with a simple two-site model to determine the rapidly released fraction (F) representing bioavailability of PAHs. The F data obtained under various SFE pressures were compared with degradation results of a composting method applied on the soils. After composting and consequent long-term maturation, the residual PAH contaminations ranged from 4 to 36% of the original values. A possible explanation of the result variations is the different bioavailability of the pollutants. The best correlations between degradation results and F fraction were obtained applying 50{sup o}C and 300 bar. The F values gave very good agreement with degradation efficiencies and the total regression coefficients (r{sup 2}) ranged from 0.81 to 0.99. The degradation results together with bioavailable fractions appeared to be consistent with organic carbon contents in the soils and with volatile fractions of organics. The results indicate that SFE could be a rapid test to predict bioremediation results of composting of PAH-contaminated soils. 23 refs., 2 figs., 3 tabs.

Toma Cajthaml; Vaclav Sasek [Academy of Sciences of the Czech Republic, Prague (Czech Republic). Institute of Microbiology

2005-11-01

129

An update on the NIST radon-in-water standard generator: its performance efficacy and long-term stability  

NASA Astrophysics Data System (ADS)

A 226Ra- 222Rn generator that could be used as a transfer standard for radon-in-water measurement calibrations was previously developed and described. The generator utilized a novel 222Rn emanation source that was comprised of a 226Ra solution encapsulated in polyethylene. The long-term performance of this standard generator has now been investigated and evaluated. The evaluation included exhaustive and more reliable measurement uncertainty analyses for the generator's performance and routine operation. Modifications to the original protocol for operation of the generator has also resulted in improved precision in the 222Rn activity concentration in a dispensed aliquant. The evaluation results indicate that the generator performance has remained stable, and that the calibration parameters are still well within their given uncertainty intervals for the originally determined canonical values. Over a period of approximately six years, experimentally determined values of the 222Rn emanation fraction, the most critical parameter, have remained constant and invariant of conditions within statistical variations of about 0.3% (corresponding to a relative standard deviation of the mean). All evaluation measurements were performed by 4?-?? liquid scintillation spectrometry of gravimetrically determined aliquants dispensed from the generator.

Collé, R.; Kishore, Raj

1997-02-01

130

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

Microsoft Academic Search

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

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

131

Long-term efficacy of low level laser therapy in women with fibromyalgia: A placebo-controlled study  

Microsoft Academic Search

Aim: To investigate the efficacy of low level laser therapy (LLLT) in fibromyalgia patients. Materials and Methods: Thirty-four fibromyalgia patients were randomly assigned to LLLT (n =1 6) and placebo laser groups (n =1 6). Outcome measures included number of tender points (NTP), Fibromyalgia Impact Questionnaire (FIQ), morning stiffness, global improvement as reported on a verbal scale (VSGI), and total

Onur Armagan; Funda Tascioglu; Ayse Ekim; Cengiz Oner

2006-01-01

132

Efficacy and safety of ginseng.  

PubMed

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

Kitts, D; Hu, C

2000-12-01

133

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

Microsoft Academic Search

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

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

134

New treatment options for chronic constipation: Mechanisms, efficacy and safety  

PubMed Central

The present review has several objectives, the first of which is to review the pharmacology and selectivity of serotonergic agents to contrast the older serotonergic agents (which were withdrawn because of cardiac or vascular adverse effects) with the newer generation serotonin receptor subtype 4 agonists. Second, the chloride ion secretagogues that act through the guanylate cyclase C receptor are appraised and their pharmacology is compared with the approved medication, lubiprostone. Third, the efficacy and safety of the application of bile acid modulation to treat constipation are addressed. The long-term studies of surgically induced excess bile acid delivery to the colon are reviewed to ascertain the safety of this therapeutic approach. Finally, the new drugs for opiate-induced constipation are introduced. Assuming these drugs are approved, practitioners will have a choice; however, patient responsiveness will be based on trial and error. Nevertheless, the spectrum of mechanisms and demonstrated efficacy and safety augur well for satisfactory treatment outcomes. PMID:22114755

Camilleri, Michael

2011-01-01

135

Long-term efficacy and safety of firocoxib in the treatment of dogs with osteoarthritis  

Microsoft Academic Search

Thirty-nine client-owned dogs with osteoarthritis were treated with 5 mg\\/kg firocoxib administered orally, once a day for 52 weeks. Veterinary examinations were performed on approximately days 0, 15, 90, 180, 270 and 360. Twenty-five dogs completed the study. The withdrawal rate associated with gastrointestinal side effects was low (5.1 per cent of dogs). Based on the owners' assessment, 82 per

A. Autefage; F. M. Palissier; E. Asimus; C. Pepin-Richard

2011-01-01

136

Long-term efficacy and safety of firocoxib in the treatment of dogs with osteoarthritis.  

PubMed

Thirty-nine client-owned dogs with osteoarthritis were treated with 5 mg/kg firocoxib administered orally, once a day for 52 weeks. Veterinary examinations were performed on approximately days 0, 15, 90, 180, 270 and 360. Twenty-five dogs completed the study. The withdrawal rate associated with gastrointestinal side effects was low (5.1 per cent of dogs). Based on the owners' assessment, 82 per cent of the dogs had improved at day 15, 84 per cent of the 32 remaining dogs had improved at day 90, and 96 per cent of the 25 dogs that completed the trial had improved at day 360. During this trial, 12 (48 per cent) of the 25 remaining dogs showed an improvement in their lameness from day 90 to day 360 (P<0.05). PMID:21642297

Autefage, A; Palissier, F M; Asimus, E; Pepin-Richard, C

2011-06-11

137

Multi-agent-based anticipatory control for enhancing the safety and performance of Generation-IV nuclear power plants during long-term semi-autonomous operation  

Microsoft Academic Search

The use of multi-agents and anticipatory control to improve the performance and safety of nuclear power plants is discussed. The propose program seeks to advance and test via simulation a new control approach for the long-term semiautonomous and economically competitive operation of Generation-IV nuclear power plants. The approach exploits a simple but potentially powerfull idea: In order to regulate themselves

Robert E. Uhrig; Lefteri H. Tsoukalas

2003-01-01

138

Safety, efficacy, and patient acceptability of rifaximin for hepatic encephalopathy  

PubMed Central

Hepatic encephalopathy is a complex disease entity ranging from mild cognitive dysfunction to deep coma. Traditionally, treatment has focused on a reduction of ammonia through a reduced production, absorption, or clearance. Rifaximin is a nonabsorbable antibiotic, which reduces the production of ammonia by gut bacteria and, to some extent, other toxic derivatives from the gut. Clinical trials show that these effects improve episodes of hepatic encephalopathy. A large randomized trial found that rifaximin prevents recurrent episodes of hepatic encephalopathy. Most patients were treated concurrently with lactulose. Trials have varied greatly in design, outcomes, and duration of treatment regimes. Although a number of retrospective studies have indicated that long-term treatment with rifaximin is safe and possibly beneficial, high quality trials are needed to further clarify efficacy and safety of long-term treatment with rifaximin and evaluate effects of combination therapy with lactulose and branched-chain amino acids for patients with liver cirrhosis and hepatic encephalopathy. PMID:24672227

Kimer, Nina; Krag, Aleksander; Gluud, Lise L

2014-01-01

139

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

PubMed Central

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

Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

2014-01-01

140

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

PubMed

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

Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

2014-03-01

141

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

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

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

142

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

PubMed

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

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

2014-06-19

143

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)

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.

Munier, R.

2011-12-01

144

Expectations on Documented Safety Analysis for Deactivated Inactive Nuclear Facilities in a State of Long Term Surveillance & Maintenance or Decommissioning  

SciTech Connect

DOE promulgated 10 CFR 830 ''Nuclear Safety Management'' on October 10, 2000. Section 204 of the Rule requires that contractors at DOE hazard category 1, 2, and 3 nuclear facilities develop a ''Documented Safety Analysis'' (DSA) that summarizes the work to be performed, the associated hazards, and hazard controls necessary to protect workers, the public, and the environment. Table 2 of Appendix A to the rule has been provided to ensure that DSAs are prepared in accordance with one of the available predetermined ''safe harbor'' approaches. The table presents various acceptable safe harbor DSAs for different nuclear facility operations ranging from nuclear reactors to decommissioning activities. The safe harbor permitted for decommissioning of a nuclear facility encompasses methods described in DOE-STD-1 120-98, ''Integration of Environment, Safety and Health into Facility Disposition Activities,'' and provisions in 29 CFR 1910.120 or 29 CFR 1926.65 (HAZWOPER). Additionally, an evaluation of public safety impacts and development of necessary controls is required when the facility being decommissioned contains radiological inventory or contamination exceeding the Rule's definition for low-level residual fixed radioactivity. This document discusses a cost-effective DSA approach that is based on the concepts of DOE-STD-I 120 and meets the 10 CFR 830 safe harbor requirements for both transition surveillance and maintenance as well as decommissioning. This DSA approach provides continuity for inactive Hanford nuclear facilities that will eventually transition into decommissioning. It also uses a graded approach that meets the expectations of DOE-STD-3011 and addresses HAZWOPER requirements to provide a sound basis for worker protection, particularly where intrusive work is being conducted.

JACKSON, M.W.

2002-05-01

145

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

SciTech Connect

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.

Not Available

1980-07-01

146

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

PubMed

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

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

2003-10-01

147

Long Term Ecological Resources  

NSDL National Science Digital Library

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.

Cooper, Scott

148

Long Term Prognosis  

MedlinePLUS

... TERM PROGNOSIS The long-term outlook of pediatric cardiomyopathy continues to be unpredictable because it occurs with ... a child also depends on the type of cardiomyopathy and the stage the disease is first diagnosed. ...

149

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

NASA Astrophysics Data System (ADS)

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.

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

150

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

NASA Astrophysics Data System (ADS)

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.

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

151

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

PubMed Central

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

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

2014-01-01

152

[Dabigatran (Pradaxa): efficacy and safety].  

PubMed

There is considerable interest in developing new, orally available anticoagulants for the prevention and treatment of thrombotic disorders. In Europe, the low-molecular-weight heparins (LMWHs) are more commonly prescribed for thrombosis prevention, but require parenteral administration, platelets monitoring twice a week during the first month. Furthermore, LMWH are not synthetic. All of these characteristics can be an obstacle to optimal patient care, particularly when outpatient dosing is required after early discharge. New oral anticoagulants that require no monitoring and can be administered in a fixed dose without drug-drug and drug-food interactions would clearly offer practical advantages if shown to be safe and effective. dabigatran étexilate, a new oral, direct thrombin inhibitor, is the prodrug of the active compound dabigatran, which binds reversibly to thrombin with high affinity and specificity. This agent has a rapid onset of action, a predictable and reproducible that permit once-daily dosing. To date, more than 8,000 patients have been studied in clinical trials, and more than 38,000 individuals are enrolled in ongoing trials. Three major prospective, randomized, double-blind non-inferiority trials have compared the efficacy and safety of dabigatran étexilate (150 mg or 220 mg once-daily) starting postoperatively, with subcutaneous enoxaparin, in patients undergoing hip (RE-NOVATE trial) or knee arthroplasty (RE-MOBILIZE and RE-MODEL). Based on these trial results, dabigatran étexilate is approved for use in the European Union and Canada for primary prevention of VTE in patients having undergone elective total hip and knee arthroplasty. Pradaxa is now on the market in France since December 2008. PMID:19875000

Rosencher, N; Bellamy, L

2009-09-01

153

Clinical use of intravenous iron: administration, efficacy, and safety.  

PubMed

This section reviews the history, pharmacology, administration, efficacy, and toxicity of intravenous iron. Intravenous iron offers advantages over oral iron for the treatment of iron deficiency anemia across a wide range of disease states associated with absolute and functional iron deficiency. However, there remain concerns about the acute safety profiles of the available preparations and the potential for long-term toxicity with their repeated administration. Seven intravenous iron formulations are available. Confusion concerning the relative toxicities of the different formulations abounds. The similarities and differences are discussed. Iron repletion has been associated with adverse outcomes in infections. The relationship, if any, between intravenous iron administration and infections is reviewed. The potential advantages of total dose infusion (TDI), complete repletion in a single setting, are highlighted. A new paradigm for iron replacement therapy in iron deficiency anemia is presented. PMID:21239816

Auerbach, Michael; Ballard, Harold

2010-01-01

154

Long-term efficacy of recombinant hepatitis B vaccine and risk of natural infection in infants born to mothers with hepatitis B e antigen  

Microsoft Academic Search

To evaluate the long-term protection afforded by the vaccine, recombinant hepatitis B (HB) vaccine was given to 171 infants born to hepatitis B e antigen-positive carrier mothers. Group A (53 infants) and group B (57 infants) received four doses of HB vaccine at birth and at 1, 2, and 12 months of age, with a dose of 20 ?g in

Ping-Ing Lee; Chin-Yun Lee; Li-Min Huang; Mei-Hwei Chang

1995-01-01

155

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

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

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

156

The Past versus the Present, 1980-2004: Reduction of Mean Initial Low-Dose, Long-Term Glucocorticoid Therapy in Rheumatoid Arthritis from 10.3 to 3.6 mg/Day, Concomitant with Early Methotrexate, with Long-Term Effectiveness and Safety of Less than 5 mg/Day.  

PubMed

Quantitative observations are presented concerning treatment with glucocorticoids of 308 patients with rheumatoid arthritis (RA) at a weekly academic rheumatology setting over 25 years from 1980 to 2004. A database of all visits included medications and multidimensional health assessment questionnaire scores for physical function, pain and routine assessment of patient index data (RAPID3; and a surrogate RAPID3-EST), completed by each patient at each visit in routine care. Over the 5-year periods of 1980-1984, 1985-1989, 1990-1994, 1995-1999 and 2000-2004, the mean initial prednisone daily dose declined from 10.3 to 6.5, 5.1, 4.1 and 3.6 mg/day, as initial doses were >5 mg/day in 49, 16, 7, 7 and 3% of patients, 5 mg/day in 51, 80, 70, 26 and 10%, and <5 mg/day in 0, 4, 23, 67 and 86%. Reduction of prednisone doses in the respective five-year periods was accompanied by increased and earlier use of methotrexate as the first disease-modifying antirheumatic drug (DMARD) in 10, 26, 57, 71 and 78%, and methotrexate treatment in 10, 26, 74, 82 and 92% of patients within the first year of disease. Higher methotrexate doses in the respective five-year periods were used after 1990, along with lower prednisone doses. Most patients were treated indefinitely with both low-dose prednisone and methotrexate; 80% continued both medications for more than 5 years. The primary adverse events were skin-thinning and bruising. New hypertension, diabetes and cataracts were seen in fewer than 10% of patients. While efficacy and safety cannot be analyzed definitively from observational data, the data suggest that many patients with RA might be treated effectively with weekly low-dose methotrexate along with initial and long-term, low-dose prednisone of <5 mg/day. © 2014 S. Karger AG, Basel. PMID:25228430

Pincus, Theodore; Sokka, Tuulikki; Cutolo, Maurizio

2015-01-01

157

Long?term efficacy of cognitive training for age?associated memory impairment: A six?month follow?up study  

Microsoft Academic Search

The purpose of this investigation was to assess the impact of pretraining on the long?term effect of an imagery?based mnemonic in persons with age?associated memory impairment (AAMI). Eighty?two participants were randomly assigned to one of six groups: (1) verbal judgment pretraining plus mnemonic training, (2) visual imagery elaboration pretraining plus mnemonic training, (3) relaxation pretraining plus mnemonic training, (4) nonspecific

Javaid I. Sheikh; Robert D. Hill; Jerome A. Yesavage

1986-01-01

158

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

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

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

1999-01-01

159

Long-term remission in an aggressive Crooke cell adenoma of the pituitary, 18 months after discontinuation of treatment with temozolomide  

PubMed Central

Key Clinical Message The clinical course of our patient, who sustained remission status for at least 18 months highlights the chance of long-term hormonal and tumor remission and demonstrates the efficacy and safety of discontinuation of temozolomide therapy. Prospective studies are required in order to define predictors of long-term remission of this promising therapeutic modality. PMID:25356225

Asimakopoulou, Athina; Tzanela, Marinela; Koletti, Ageliki; Kontogeorgos, George; Tsagarakis, Stylianos

2014-01-01

160

Evaluating Aspects of Online Medication Safety in Long-Term Follow-Up of 136 Internet Pharmacies: Illegal Rogue Online Pharmacies Flourish and Are Long-Lived  

PubMed Central

Background A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. Objective In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. Methods An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. Results The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription-only medicines, only 9 (6.6%) requested prior medical prescriptions before purchase. Medical information exchange was generally ineffective as 52 sites (38.2%) did not require any medical information from patients. The product information about the medicines was generally (126/136, 92.6%) not displayed adequately, and the contents of the patient information leaflet were incomplete in most cases (104/136, 76.5%). Numerous online operators (60/136, 44.1%) were defined as rogue Internet pharmacies, but no legitimate Internet-based pharmacies were among them. One site (0.7%) was yet unverified, 23 (16.9%) were unapproved, while the remaining (52/136, 38.2%) websites were not available in the LegitScript database. Contrary to our prior assumptions, prescription or medical information requirement, or the indication of contact information on the website, does not seem to correlate with “rogue pharmacy” status using the LegitScript online pharmacy verification standards. Instead, long-term continuous operation strongly correlated (P<.001) with explicit illegal activity. Conclusions Most Internet pharmacies in our study sample were illegal sites within the definition of “rogue” Internet pharmacy. These websites violate professional, legal, and ethical standards and endanger patient safety. This work shows evidence that online pharmacies that act illegally appear to have greater longevity than others, presumably because there is no compelling reason for frequent change in order to survive. We also found that one in five websites revived (closed down and reopened again within four years) and no-prescription sites with limited medicine and patient information are flourishing. PMID:24021777

2013-01-01

161

Long-Term Outcome of Rubber Band Ligation for Symptomatic Primary and Recurrent Internal Hemorrhoids  

Microsoft Academic Search

PURPOSE: Rubber band ligation therapy for symptomatic hemorrhoidal disease has been used for many years and is a well-accepted treatment modality, but information on longterm outcome is limited. Our goals were to determine safety and long-term efficacy of this treatment. METHODS: A retrospective chart review of patients undergoing rubber band ligatures for symptomatic internal hemorrhoids in a single practice was

V. S. Iyer; I. Shrier; P. H. Gordon

2004-01-01

162

Long-Term Treatment with Sodium Phenylbutyrate in Ornithine Transcarbamylase-Deficient Patients  

Microsoft Academic Search

Ornithine transcarbamylase deficiency is a very heterogeneous urea cycle disorder resulting in hyperammonemia with various presentations from the neonatal period through adulthood. We performed a retrospective study in nine patients (four male\\/five female, age at diagnosis ranging from 6 days to 14 years) to evaluate the safety and efficacy of sodium phenylbutyrate (Ammonaps) in long-term treatment. All patients were diagnosed

Alberto B. Burlina; Helen Ogier; Herbert Korall; Friedrich K. Trefz

2001-01-01

163

Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder  

PubMed Central

Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

2012-01-01

164

Efficacy and safety of atomoxetine in the treatment of children and adolescents with attention deficit hyperactivity disorder.  

PubMed

Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

Kohn, Michael R; Tsang, Tracey W; Clarke, Simon D

2012-01-01

165

Long-term efficacy of (90)Y ibritumomab tiuxetan therapy in follicular non-Hodgkin lymphoma and health-related quality of life.  

PubMed

The aim of this study was to analyze the outcomes of 37 follicular lymphoma (FL) patients treated with (90)ytrium ibritumomab tiuxetan (90Y-IT), outside of clinical trial, according to protocol ISCRTN36210045, after ?5 years follow-up to February 2014. Health-related quality of life (HRQoL) was evaluated with the SF-36, Spanish version, and compared with the general population of Spain. Patients had a mean age of 61.9 (range, 30-85) years and included 18 males. FLIPI, low: 25 (67.6 %), intermedium 9 (24.3 %), and low 3 (8.1 %). Previous therapy schedules >2: 48.6 % The median follow-up was 66 months, mean Time to Relapse (TTR) 71.3 months (58.8-83.8) median not reached. Thirty-four patients achieved complete response (91.8 %), and three no response. Mean overall survival: 82.3 months (71.6-92.9). Four patients presented with concomitant tumors (colon, breast, prostate, lung) after radioimmunotherapy, and three developed second primary neoplasms (esophagus, renal, and myelodysplastic syndrome in a relapsed patient who received fludarabine). Four of 10 deaths were related to lymphoma progression. Hematological toxicities were mild and easily managed. No patients required hospitalization. Negative scores were obtained in the physical and emotional roles items; however, the perception of general health and vitality were better than in the general population, with the best outcomes in non-relapsed patients. Radioimmunotherapy with 90Y-IT was safe and effective as long-term therapy in patients with FL. Early use of radioimmunotherapy could offer good, sustained responses with low toxicity over the long term and acceptable HRQoL. PMID:24985089

Andrade-Campos, Marcio Miguel; Montes-Limón, Anel E; Soro-Alcubierre, Gloria; Grasa, José María; Lopez-Gómez, Luis; Baringo, Teresa; Giraldo, Pilar

2014-12-01

166

Experience in the long-term treatment of patients with hirsutism and/or acne with cyproterone acetate-containing preparations: efficacy, metabolic and endocrine effects.  

PubMed

The effects and side effects of long-term treatment with cyproterone acetate (CPA) are described. Hammerstein's reverse sequential regimen (10 days 100 mg CPA, 21 days 50 micrograms ethinylestradiol (EE)) was used in most cases, although postmenopausal and hysterectomized women received 50 mg CPA/day continuously as monotherapy. The degree of androgenization was assessed in 143 of a total group of 188 women treated from 1968 to the present. The results of the treatment were good or very good in about 75% of hirsutism patients and in more than 90% of acne patients. Adverse events were recorded in 23% of cases. Most were mild and transient, and caused discontinuation of the therapy in only 9% of patients. From this population representing all cases treated and analysed retrospectively, a subgroup of patients was selected for a prospective investigation. Thirty-five patients with good response to CPA and longlasting therapy were included into this 2-year follow-up study; of these, 24 had previously received CPA for 5 or more years, 9 for more than 10 years and 2 for more than 15 years. Treatment in these patients consisted of 5 different regimens of various doses of CPA combined with EE and CPA alone in order to evaluate possible effects of concomitant estrogen treatment as well as a possible dose- or time-dependency of potential side effects. Clinicochemical, metabolic and endocrine parameters were determined at the start and end of the study. The hematological and clinicochemical parameters were within the normal ranges. There was a slight decrease of glucose tolerance and a moderate increase of insulin and C peptide after oral glucose loading. The effects of CPA and EE on lipometabolism were slight and apparently dependent on the dose of CPA and the therapeutic regimen. No suppression of adrenal function or of responsiveness to ACTH was seen. Fasting prolactin levels and serum prolactin concentrations after provocation with metoclopramide did not show any gross deviations. Sonography of the breast and liver did not show any abnormalities apart from adenofibrosis or mastopathy in 2 patients. In conclusion, CPA with or without EE was in our hands an effective and safe method of long-term treatment of hirsutism and/or acne in women. PMID:7584530

van Wayjen, R G; van den Ende, A

1995-01-01

167

Comparative efficacy and tolerability of anti-epileptic drugs for refractory focal epilepsy: systematic review and network meta-analysis reveals the need for long term comparator trials  

PubMed Central

Aims To evaluate the comparative efficacy (50% reduction in seizure frequency) and tolerability (premature withdrawal due to adverse events) of anti-epileptic drugs (AEDs) for refractory epilepsy. Methods We searched Cochrane Central Register of Controlled Trials (Cochrane Library 2009, issue 2) including Epilepsy Group's specialized register, MEDLINE (1950 to March 2009), EMBASE (1980 to March 2009), and Current Contents Connect (1998 to March 2009) to conduct a systematic review of published studies, developed a treatment network and undertook a network meta-analysis. Results Forty-three eligible trials with 6346 patients and 12 interventions, including placebo, contributed to the analysis. Only three direct drug comparator trials were identified, the remaining 40 trials being placebo-controlled. Conventional random-effects meta-analysis indicated all drugs were superior in efficacy to placebo (overall odds ratio (OR] 3.78, 95% CI 3.14, 4.55) but did not permit firm distinction between drugs on the basis of the efficacy or tolerability. A Bayesian network meta-analysis prioritized oxcarbazepine, topiramate and pregabalin on the basis of short term efficacy. However, sodium valproate, levetiracetam, gabapentin and vigabatrin were prioritized on the basis of short-term efficacy and tolerability, with the caveat that vigabatrin is recognized as being associated with serious visual disturbance with chronic use. Conclusion Of the wide range of AEDs licensed for the treatment of refractory epilepsy, sodium valproate, levetiracetam and gabapentin demonstrated the best balance of efficacy and tolerability. Until regulators mandate greater use of active comparator trials with longer term follow-up, network meta-analysis provides the only available means to quantify these clinically important parameters. PMID:23351090

Bodalia, Pritesh N; Grosso, Anthony M; Sofat, Reecha; MacAllister, Raymond J; Smeeth, Liam; Dhillon, Soraya; Casas, Juan-Pablo; Wonderling, David; Hingorani, Aroon D

2013-01-01

168

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

PubMed Central

Objectives The aim of this article was to assess the success, safety, complication profile and factors associated with long-term patency of tunnelled peritoneal drains (PleurX) in the treatment of refractory malignant ascites. Methods Over a 4-year period, 28 consecutive patients (32 drain insertions) with refractory malignant ascites were treated with a PleurX drain. The study group comprised 7 males and 21 females (mean age, 61 years). A combination of fluoroscopic and ultrasound guidance was used to insert 4 drains; the remaining 28 drains were inserted under ultrasound guidance alone. Patient history, biochemical profiles, pathological and procedural records and clinical follow-up until death were reviewed. Statistical analysis included multivariate logistic regression analysis and Kaplan–Meier curves (p<0.05 was considered significant). Results There was a 100% technical success rate for the insertion of the drain; there were no procedure-related deaths and no major complications. Only minor complications were reported: three (10%) immediate; three (10%) early; and two (7%) late. Factors significantly associated with these complications included current chemotherapy, low haemoglobin levels, low albumin levels, high white cell count and high c-reactive protein levels. The length of time the drains remained in situ, and therefore patent, ranged from 5 to 365 days (mean, 113 days). Out of the original 28 tunnelled drains, 24 (86%) remained in situ and functioning until the patients’ death. Four (14%) drains dislodged and a subsequent PleurX drain was inserted on the opposite side of the abdominal wall. These new drains remained patent until the patient’s death. The annual event rate was 0.45 events per year. A comorbid diagnosis of renal disease or chemotherapy was significantly related to a decreased length of patency. Conclusion The use of tunnelled peritoneal drains is safe and effective and we would advocate their use as a first-line approach in patients with refractory malignant ascites. Care and regular follow-up is indicated following insertion of the drain in all patients, especially those on chemotherapy and those with a pre-procedure diagnosis of renal disease. PMID:21427184

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

2012-01-01

169

Long-term testing  

NASA Astrophysics Data System (ADS)

Land-based gas turbines are significantly different from automotive gas turbines in that they are designed to operate for 50,000 h or greater (compared to 5,000-10,000 h). The primary goal of this research is to determine the long-term survivability of ceramic materials for industrial gas turbine applications. Research activities in this program focus on the evaluation of the static tensile creep and stress rupture (SR) behavior of three commercially available structural ceramics which have been identified by the gas turbine manufacturers as leading candidates for use in industrial gas turbines. For each material investigated, a minimum of three temperatures and four stresses will be used to establish the stress and temperature sensitivities of the creep and SR behavior. Because existing data for many candidate structural ceramics are limited to testing times less than 2,000 h, this program will focus on extending these data to times on the order of 10,000 h, which represents the lower limit of operating time anticipated for ceramic blades and vanes in gas turbine engines. A secondary goal of the program will be to investigate the possibility of enhancing life prediction estimates by combining interrupted tensile SR tests and tensile dynamic fatigue tests in which tensile strength is measured as a function of stressing rate. The third goal of this program will be to investigate the effects of water vapor upon the SR behavior of the three structural ceramics chosen for the static tensile studies by measuring the flexural strength as a function of stressing rate at three temperatures.

Ferber, M.; Graves, G. A., Jr.

170

Long-term testing  

SciTech Connect

Land-based gas turbines are significantly different from automotive gas turbines in that they are designed to operate for 50,000 h or greater (compared to 5,000--10,000 h). The primary goal of this research is to determine the long-term survivability of ceramic materials for industrial gas turbine applications. Research activities in this program focus on the evaluation of the static tensile creep and stress rupture (SR) behavior of three commercially available structural ceramics which have been identified by the gas turbine manufacturers as leading candidates for use in industrial gas turbines. For each material investigated, a minimum of three temperatures and four stresses will be used to establish the stress and temperature sensitivities of the creep and SR behavior. Because existing data for many candidate structural ceramics are limited to testing times less than 2,000 h, this program will focus on extending these data to times on the order of 10,000 h, which represents the lower limit of operating time anticipated for ceramic blades and vanes in gas turbine engines. A secondary goal of the program will be to investigate the possibility of enhancing life prediction estimates by combining interrupted tensile SR tests and tensile dynamic fatigue tests in which tensile strength is measured as a function of stressing rate. The third goal of this program will be to investigate the effects of water vapor upon the SR behavior of the three structural ceramics chosen for the static tensile studies by measuring the flexural strength as a function of stressing rate at three temperatures.

Ferber, M.; Graves, G.A. Jr.

1994-12-31

171

Isolation and transplantation of highly purified autologous peripheral CD34+ progenitor cells: purging efficacy, hematopoietic reconstitution and long-term outcome in children with high-risk neuroblastoma  

Microsoft Academic Search

We have investigated the purging efficacy of positive selection of autologous mobilized CD34+ peripheral stem cells in 22 children with high-risk neuroblastoma. CD34+ cell selection was performed using the method of magnetic-activated cell sorting (MACS). The median purity of the CD34+ cells post selection was 97.6% (range 81.7–99.7). For detection of contaminating neuroblastoma cells before and after CD34+ selection, the

R Handgretinger; P Lang; K Ihm; M Schumm; A Geiselhart; E Koscielniak; B Hero; T Klingebiel; D Niethammer

2002-01-01

172

The risk of serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors decreased over time: a report from the registry of Japanese rheumatoid arthritis patients on biologics for long-term safety (REAL) database.  

PubMed

To investigate changes in the risk for serious infections (SIs) over time in Japanese rheumatoid arthritis (RA) patients treated with tumor necrosis factor inhibitors (TNFIs). This prospective cohort study included Japanese RA patients who began treatment with a TNFI from 2005 to 2007 (2005 group, n = 716, 634.2 patient years [PY]) and from 2008 to 2011 (2008 group, n = 352, 270.1 PY) at the time or after their enrollment in the registry of Japanese RA patients on biologics for long-term safety (REAL) database. Patients were observed for 12 months or until discontinuation of their initial TNFI in the REAL database. Drug discontinuation reasons and retention rates were analyzed. Incidence rates of serious adverse events (SAEs) were calculated with 95 % confidence intervals (CIs). The Cox proportional hazard model was applied to estimate the risk for SIs. The retention rate in the 2008 group was significantly lower than the 2005 group (p < 0.001). Discontinuation rates due to lack of efficacy or good control for the 2008 group were significantly higher than the 2005 group (p < 0.001). The crude incidence rate ratios comparing the 2008 group with the 2005 group for SAEs were 0.93 (95 % CI 0.65-1.34) and for SIs were 0.50 (0.24-1.03). The 2008 group had significantly lower risk for SIs than the 2005 group after adjusting for covariates (hazard ratio: 0.43 [0.20-0.93]). These results indicate significant decrease of the risk for SIs with TNFI treatment over time; this may be explained by evidence-based risk management of RA patients given TNFIs. PMID:24852650

Sakai, Ryoko; Cho, Soo-Kyung; Nanki, Toshihiro; Koike, Ryuji; Watanabe, Kaori; Yamazaki, Hayato; Nagasawa, Hayato; Amano, Koichi; Tanaka, Yoshiya; Sumida, Takayuki; Ihata, Atsushi; Yasuda, Shinsuke; Nakajima, Atsuo; Sugihara, Takahiko; Tamura, Naoto; Fujii, Takao; Dobashi, Hiroaki; Miura, Yasushi; Miyasaka, Nobuyuki; Harigai, Masayoshi

2014-12-01

173

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

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

2014-01-01

174

Efficacy of a third coronary angioplasty for a second restenosis: short-term results, long-term follow up, and correlates of a third restenosis.  

PubMed Central

OBJECTIVE--To report on the short-term and long-term results of patients who underwent a third coronary balloon angioplasty for a second restenosis and to identify the correlates of a third clinical restenosis. DESIGN--A retrospective analysis of clinical, angiographic, and procedure related variables of a consecutive series of patients. PATIENTS--62 patients (mean (range) age 53 (31-72) years; 84% men) who underwent a third coronary balloon angioplasty of a single coronary artery segment at which restenosis had occurred after two previous angioplasty procedures between 1986 and 1992. RESULTS--Procedure success was achieved in 56 patients (90%). Complications included one myocardial infarction (2%) and one emergency coronary artery bypass surgery (2%). Complete follow up data were available (median (range) 48 (12-94) months). During the follow up period, four patients (6%) died, two (3%) had a non-fatal myocardial infarction, and five (8%) underwent elective coronary artery bypass surgery. Nine patients (14%) underwent a fourth angioplasty for a third clinical restenosis, and three (5%) had a fourth angioplasty procedure for new coronary lesions. The cumulative probability of survival for all 62 patients was 97% and 95% at 1 and 5 years, respectively. The 1 and 5 year freedom from death, infarction, bypass surgery, and repeat angioplasty was 82% and 66.6%, respectively. At census, of the 58 survivors, 31 (53%) were asymptomatic and only eight (14%) complained of angina grade III or IV (P < 0.001). A third clinical restenosis occurred in 22 (39%) of the 56 patients who had initially successful procedures. Multiple stepwise logistic regression analysis identified the interval between the second and third angioplasty procedure as the only independent predictor of a third clinical restenosis (P = 0.004). CONCLUSIONS--A third coronary angioplasty for a second restenosis can be performed safely and effectively and should be considered as an integral part of the overall coronary angioplasty revascularisation strategy. The incidence of a third clinical restenosis remains high, however, and is correlated with the interval between the previous angioplasty procedures. PMID:7756065

Tan, K. H.; Sulke, N.; Taub, N.; Karani, S.; Sowton, E.

1995-01-01

175

Efficacy of treatment and long-term follow-up of Batrachochytrium dendrobatidis PCR-positive anurans following itraconazole bath treatment.  

PubMed

All anuran specimens in the Wildlife Conservation Society's collections testing positive for Batrachochytrium dendrobatidis (Bd) were treated with itraconazole and then studied after treatment to assess the long-term effects of itraconazole and the drug's effectiveness in eliminating Bd carriers. Twenty-four individuals and eight colonies of 11 different species (75 total specimens) tested positive for Bd via polymerase chain reaction (PCR) on multicollection survey. All positive individuals and colonies were treated with a 0.01% itraconazole bath solution and retested for Bd via one of two PCR methodologies within 14 days of treatment completion, and all were negative for Bd. A total of 64 animals received secondary follow-up PCR testing at the time of death, 6-8 mo, or 12-15 mo post-treatment. Fourteen animals (14/64, 21.9%) were PCR positive for Bd on second follow-up. The highest percentage positive at second recheck were green-and-black poison dart frogs (Dendrobates auratus; 5/5 specimens, 100%), followed by red-eyed tree frogs (Agalychnis callidryas; 4/11, 36.4%), grey tree frogs (Hyla versicolor; 1/3, 33.3%), and green tree frogs (Hyla cinera; 3/11, 27.3%). Re-testing by PCR performed on 26/28 individuals that died during the study indicated 11/26 (42.3%) were positive (all via DNA extracted from formalin-fixed paraffin-embedded skin sections). However, there was no histologic evidence of chytridiomycosis in any of 27/28 individuals. The small number of deceased animals and effects of postmortem autolysis limited the ability to determine statistical trends in the pathology data, but none of the necropsied specimens showed evidence of itraconazole toxicity. Problems with itraconazole may be species dependent, and this report expands the list of species that can tolerate treatment. Although itraconazole is effective for clearance of most individuals infected with Bd, results of the study suggest that repeat itraconazole treatment and follow-up diagnostics may be required to ensure that subclinical infections are eliminated in amphibian collections. PMID:23805558

Georoff, Timothy A; Moore, Robert P; Rodriguez, Carlos; Pessier, Allan P; Newton, Alisa L; McAloose, Denise; Calle, Paul P

2013-06-01

176

Long-term efficacy of single-dose treatment with 400 micrograms.kg-1 of ivermectin in bancroftian filariasis: results at one year.  

PubMed

In April 1992, a safety trial was performed with a single dose of ivermectin 400 micrograms.kg-1 (IVER 400). In 37 bancroftian filariasis carriers, 6 and 12 months after IVER 400 treatment, the microfilaremia recurrences were 3.2% and 13.5%, respectively. As compared to results from other studies with diethylcarbamazine and IVER at different dosages and periodicities, the dosage of IVER 400 seems the most effective; but a yearly intake might not be sufficient. PMID:8134778

Moulia-Pelat, J P; Glaziou, P; Nguyen, L N; Chanteau, S; Martin, P M; Cartel, J L

1993-12-01

177

The impact of focused, long-term, and collaborative professional development in math and science participants' self-efficacy, classroom practice, and student achievement  

NASA Astrophysics Data System (ADS)

The purpose of this study was to investigate the impact of a 2-year professional development model in math and science on the self-efficacy of the teacher and its effects on teacher practice and student outcomes. Further, this study sought to incorporate the instructional use of Inquiry-Based Learning methods of Problem-Based Learning, Japanese Lesson Study, and Action Research. Additionally, this study examined the impacts of these interventions on teacher efficacy and student outcomes. Thirty-eight collaborating participants were purposefully selected by the Math and Science Teacher Academy (MASTA) project grant co-directors because of their content-focused classrooms of mathematics and science. This quasi-experimental study included mathematics and science in-service teachers working on their masters in education. The 2-year, bi-monthly professional development model included collaborating Inquiry-Based Learning communities with in-depth focus on Japanese Lesson Study, Problem-Based Learning instruction, and Action Research. A chi-square analysis was conducted by grade on the difference in passing rate from the Texas Assessment of Knowledge and Skills mathematics and science tests between the MASTA participants and the state passing average. In mathematics there were significant v differences only at grades 3 and 7 where the state passing average was significantly higher than the MASTA students' passing rate. Only at grade 5 was the MASTA students' passing rate higher than the state, but the difference was not significantly different. The science passing rate received from three grade 5 MASTA participants was compared to the state average and a chi-squared was conducted. Although the passing rate for the grade 5 science test was 6% higher for MASTA student that the state, the difference was not statistically significant. However, after analyzing the qualitative participant responses from data gathered during the 2-year MASTA grant the data clearly reflected that teachers participating in the MASTA grant felt the professional development helped to improve their own teacher-efficacy and knowledge in their content areas.

Nottingham, Mary E.

178

Safety and efficacy of saphenectomy in elderly patients  

PubMed Central

Summary Aim The aim of this study is to evaluate safety and efficacy of saphenactomy in elderly patients. Patients and methods A total of 358 patients with varicose veins of the lower limbs treated between January 2001 and December 2011. 213 of these were patients under 65 years old and 145 patients were over this age. We have evaluated short- and long-term complications to compare the results among young and elderly patients. Results Postoperative complications that occurred were: infection, haematoma, nerve injury (paresthesia and pain) and deep vein thrombosis. Although a trend towards better results was observed among the young patients, no significant differences were shown in our experience. Conclusion Elective saphenectomy has a good outcome also in the elderly patients. The slightly higher rate of complications that occurred in older patients is not significant and does not support advising against the use of this surgical approach in the elderly. So in our opinion saphenectomy is quite safe and feasible also in patients over 65 years. PMID:24342159

MILONE, M.; MAIETTA, P.; BIANCO, P.; PISAPIA, A.; SHATALOVA, O.; TAFFURI, C.; SALVATORE, G.; MUSELLA, M.; MILONE, F.

2013-01-01

179

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

PubMed Central

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

Wieder, Devorah R; Pattimakiel, Lynn

2010-01-01

180

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

Microsoft Academic Search

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

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

2002-01-01

181

Long-term environmental stewardship.  

SciTech Connect

The purpose of this Supplemental Information Source Document is to effectively describe Long-Term Environmental Stewardship (LTES) at Sandia National Laboratories/New Mexico (SNL/NM). More specifically, this document describes the LTES and Long-Term Stewardship (LTS) Programs, distinguishes between the LTES and LTS Programs, and summarizes the current status of the Environmental Restoration (ER) Project.

Nagy, Michael David

2010-08-01

182

Long-term ganciclovir therapy for hepatitis B virus infection after liver transplantation  

Microsoft Academic Search

Background\\/Aims: Hepatitis B virus (HBV) disease on a liver graft is associated with florid viral replication and graft failure. The aim of this study performed between 1992 and 1995 was to investigate the safety and efficacy of long-term intravenous ganciclovir for HBV infection in liver transplant recipients.Methods: Twelve patients with HBV re-infection and four with de novo HBV infection were

Bruno Roche; Didier Samuel; Michele Gigou; Cyrille Feray; Veronique Virot; Pietro Majno; Laurent Serraf; Marie Françoise David; Elisabeth Dusseaix; Michel Reynes; Henri Bismuth

1999-01-01

183

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

Microsoft Academic Search

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

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

184

Long-term treatment of perennial allergic rhinitis with ipratropium bromide nasal spray 0.06%  

Microsoft Academic Search

The purpose of this study was to assess the safety and efficacy of ipratropium bromide nasal spray 0.06% (aqueous solution), 84 ?g per nostril three times a day, in reducing nasal hypersecretion in the long-term treatment of patients with perennial allergic rhinitis (PAR). This was an open-label 1-year trial. In the first 6 months all patients were treated with two

Harold B. Kaiser; Steven R. Findlay; John W. Georgitis; Jay Grossman; Paul H. Ratner; David G. Tinkelman; Paul Roszko; Elena Zegarelli; Chester C. Wood

1995-01-01

185

Comparison of acamprosate and placebo in long-term treatment of alcohol dependence  

Microsoft Academic Search

SummaryBackground About 50% of alcoholic patients relapse within 3 months of treatment. Previous studies have suggested that acamprosate may help to prevent such relapse. The aim of our study was to assess the efficacy and safety of long-term acamprosate treatment in alcohol dependence.Methods In this multicentre, double-blind, placebo-controlled study, we recruited 455 patients, aged 18-65 years, with chronic or episodic

A. B. Whitworth; H Oberbauer; W. W Fleischhacker; O. M Lesch; H Walter; A Nimmerrichter; T Platz; F Fischer; A Potgieter

1996-01-01

186

Long-term betaine therapy in a murine model of cystathionine beta-synthase deficient homocystinuria: decreased efficacy over time reveals a significant threshold effect between elevated homocysteine and thrombotic risk.  

PubMed

Classical homocystinuria (HCU) is caused by deficiency of cystathionine ?-synthase and is characterized by connective tissue disturbances, mental retardation and cardiovascular disease. Treatment for pyridoxine non-responsive HCU typically involves lowering homocysteine levels with a methionine-restricted diet and dietary supplementation with betaine. Compliance with the methionine-restricted diet is difficult and often poor. Investigating optimization of the efficacy of long-term betaine treatment in isolation from a methionine-restricted diet is precluded by ethical considerations regarding patient risk. The HO mouse model of HCU developed in our laboratory, exhibits constitutive expression of multiple pro-inflammatory cytokines and a hypercoagulative phenotype both of which respond to short-term betaine treatment. Investigation of the effects of long-term betaine treatment in the absence of methionine-restriction in HO HCU mice revealed that the ability of betaine treatment to lower homocysteine diminished significantly over time. Plasma metabolite analysis indicated that this effect was due at least in part, to reduced betaine-homocysteine S-methyltransferase (BHMT) mediated remethylation of homocysteine. Western blotting analysis revealed that BHMT protein levels are significantly repressed in untreated HCU mice but are significantly induced in the presence of betaine treatment. The observed increase in plasma homocysteine during prolonged betaine treatment was accompanied by a significant increase in the plasma levels of TNF-alpha and IL-1beta and reversion to a hypercoagulative phenotype. Our findings are consistent with a relatively sharp threshold effect between severely elevated plasma homocysteine and thrombotic risk in HCU and indicate that the HO mouse model can serve as a useful tool for both testing novel treatment strategies and examining the optimal timing and dosing of betaine treatment with a view toward optimizing clinical outcome. PMID:22192524

Maclean, Kenneth N; Jiang, Hua; Greiner, Lori S; Allen, Robert H; Stabler, Sally P

2012-03-01

187

Efficacy, safety and risk of augmentation of rotigotine for treating restless legs syndrome.  

PubMed

The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation. PMID:23103551

Inoue, Yuichi; Hirata, Koichi; Hayashida, Kenichi; Hattori, Nobutaka; Tomida, Takayuki; Garcia-Borreguero, Diego

2013-01-10

188

Safety and Efficacy of the Potassium-Titanyl-Phosphate Laser and Photoselective Vaporization of the Prostate for Benign Prostatic Hyperplasia  

PubMed Central

The currently commercially available 80-W potassium-titanyl-phosphate laser used for photoselective vaporization of the prostate in men with lower urinary tract symptoms and benign prostatic hyperplasia (BPH) is a safe and effective therapeutic alternative for a wide spectrum of prostate sizes and configurations. Efficacy data from multicenter prospective studies, comparative studies against other interventions, and single-center long-term outcomes suggest the efficacy to be at least equivalent to that of transurethral resection of the prostate, with a very good safety profile. New technological developments promise to further enhance the utility of this laser for application in BPH and urology. PMID:17173098

Roehrborn, Claus G

2006-01-01

189

Long-term outcomes five years after selective dorsal rhizotomy  

Microsoft Academic Search

BACKGROUND: Selective dorsal rhizotomy (SDR) is a well accepted neurosurgical procedure performed for the relief of spasticity interfering with motor function in children with spastic cerebral palsy (CP). The goal is to improve function, but long-term outcome studies are rare. The aims of this study were to evaluate long-term functional outcomes, safety and side effects during five postoperative years in

Eva Nordmark; Annika Lundkvist Josenby; Jan Lagergren; Gert Andersson; Lars-Göran Strömblad; Lena Westbom

2008-01-01

190

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

PubMed Central

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

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

2014-01-01

191

Long Term Illness and Wages  

ERIC Educational Resources Information Center

Long-term illness (LTI) is a more prevalent workplace risk than fatal accidents but there is virtually no evidence for compensating differentials for a broad measure of LTI. In 1990 almost 3.4 percent of the U.K. adult population suffered from a LTI caused solely by their working conditions. This paper provides the first estimates of compensating…

Sandy, Robert; Elliott, Robert R.

2005-01-01

192

[Prenatal corticosteroids: short-term and long-term effects of multiple courses. A literature review].  

PubMed

Prenatal corticosteroids administration is one of the major advances in obstetrics and neonatology for the prevention of preterm-birth related complications. However, concerns have been raised about its safety regarding neonatal growth and children development. Therefore, some obstetricians have restricted the use of corticosteroids to precisely defined indications. It remains some uncertainty regarding the choice of antenatal corticosteroids, the interval between injections, the timing of effectiveness and the maximum number of courses per pregnancy that is acceptable without causing complications among children. Thus, we performed a current literature review in 2013 regarding short- and long-term efficacy and safety in order to give clear recommendations to practitioners. PMID:24529761

Fuchs, F; Audibert, F; Senat, M-V

2014-03-01

193

Long-term data archiving  

SciTech Connect

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.

Moore, David Steven [Los Alamos National Laboratory

2009-01-01

194

Modeling the impact of climate change in Germany with biosphere models for long-term safety assessment of nuclear waste repositories.  

PubMed

Biosphere models are used to evaluate the exposure of populations to radionuclides from a deep geological repository. Since the time frame for assessments of long-time disposal safety is 1 million years, potential future climate changes need to be accounted for. Potential future climate conditions were defined for northern Germany according to model results from the BIOCLIM project. Nine present day reference climate regions were defined to cover those future climate conditions. A biosphere model was developed according to the BIOMASS methodology of the IAEA and model parameters were adjusted to the conditions at the reference climate regions. The model includes exposure pathways common to those reference climate regions in a stylized biosphere and relevant to the exposure of a hypothetical self-sustaining population at the site of potential radionuclide contamination from a deep geological repository. The end points of the model are Biosphere Dose Conversion factors (BDCF) for a range of radionuclides and scenarios normalized for a constant radionuclide concentration in near-surface groundwater. Model results suggest an increased exposure of in dry climate regions with a high impact of drinking water consumption rates and the amount of irrigation water used for agriculture. PMID:22742772

Staudt, C; Semiochkina, N; Kaiser, J C; Pröhl, G

2013-01-01

195

Dexmedetomidine hydrochloride as a long-term sedative.  

PubMed

Dexmedetomidine undoubtedly is a useful sedative in the intensive care setting because it has a minimal effect on the respiratory system. Dexmedetomidine infusions lasting more than 24 hours have not been approved since the first approval was acquired in the US in 1999. However, in 2008, dexmedetomidine infusions for prolonged use were approved in Colombia and in the Dominican Republic, and the number of countries that have granted approval for prolonged use has been increasing every year. This review discusses the literature examining prolonged use of dexmedetomidine and confirms the efficacy and safety of dexmedetomidine when it is used for more than 24 hours. Dexmedetomidine was administered at varying doses (0.1-2.5 ?g/kg/hour) and durations up to 30 days. Dexmedetomidine seems to be an alternative to benzodiazepines or propofol for achieving sedation in adults because the incidences of delirium and coma associated with dexmedetomidine are lower than the corresponding incidences associated with benzodiazepines and propofol, although dexmedetomidine administration can cause mild adverse effects such as bradycardia. Controlled comparative studies on the efficacy and safety of dexmedetomidine and other sedatives in pediatric patients have not been reported. However, dexmedetomidine seems to be effective in managing extubation, reducing the use of conventional sedatives, and as an alternative for inducing sedation in patients for whom traditional sedatives induce inadequate sedation. Prolonged dexmedetomidine infusion has not been reported to have any serious adverse effects. Dexmedetomidine appears to be an alternative long-term sedative, but further studies are needed to establish its efficacy and safety. PMID:21845052

Kunisawa, Takayuki

2011-01-01

196

Long-term potentiation and long-term depression: a clinical perspective  

PubMed Central

Long-term potentiation and long-term depression are enduring changes in synaptic strength, induced by specific patterns of synaptic activity, that have received much attention as cellular models of information storage in the central nervous system. Work in a number of brain regions, from the spinal cord to the cerebral cortex, and in many animal species, ranging from invertebrates to humans, has demonstrated a reliable capacity for chemical synapses to undergo lasting changes in efficacy in response to a variety of induction protocols. In addition to their physiological relevance, long-term potentiation and depression may have important clinical applications. A growing insight into the molecular mechanisms underlying these processes, and technological advances in non-invasive manipulation of brain activity, now puts us at the threshold of harnessing long-term potentiation and depression and other forms of synaptic, cellular and circuit plasticity to manipulate synaptic strength in the human nervous system. Drugs may be used to erase or treat pathological synaptic states and non-invasive stimulation devices may be used to artificially induce synaptic plasticity to ameliorate conditions arising from disrupted synaptic drive. These approaches hold promise for the treatment of a variety of neurological conditions, including neuropathic pain, epilepsy, depression, amblyopia, tinnitus and stroke. PMID:21779718

Bliss, Timothy V.P.; Cooke, Sam F

2011-01-01

197

Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety  

Microsoft Academic Search

BACKGROUND: Melatonin is extensively used in the USA in a non-regulated manner for sleep disorders. Prolonged release melatonin (PRM) is licensed in Europe and other countries for the short term treatment of primary insomnia in patients aged 55 years and over. However, a clear definition of the target patient population and well-controlled studies of long-term efficacy and safety are lacking.

Alan G Wade; Ian Ford; Gordon Crawford; Alex McConnachie; Tali Nir; Moshe Laudon; Nava Zisapel

2010-01-01

198

Pharmacodynamic Efficacy, Clinical Safety, and Outcomes After Prolonged Platelet Glycoprotein IIb\\/IIIa Receptor Blockade With Oral Xemilofiban Results of a Multicenter, Placebo-Controlled, Randomized Trial  

Microsoft Academic Search

Background—Parenteral administration of platelet glycoprotein IIb\\/IIIa (GP IIb\\/IIIa) receptor blockers can reduce ischemic complications of coronary angioplasty. Orally active GP IIb\\/IIIa blockers may allow more sustained receptor antagonism with the potential for long-term secondary prevention. The pharmacodynamic efficacy, clinical safety, and outcomes after prolonged receptor blockade with an orally active GP IIb\\/IIIa antagonist are not known. The Oral Glycoprotein IIb\\/IIIa

Dean J. Kereiakes; Neal S. Kleiman; James J. Ferguson; A. R. Zaki Masud; Thomas M. Broderick; Charles W. Abbottsmith; John Paul Runyon; Linda C. Anderson; Robert J. Anders; Roger J. Dreiling; Gary L. Hantsbarger; Brian Bryzinski; Eric J. Topol

199

Long-term safety of Mometasone Furoate administered via a dry powder inhaler in children: Results of an open-label study comparing Mometasone Furoate with Beclomethasone Dipropionate in children with persistent asthma  

PubMed Central

Background To assess the long-term pediatric safety of 2 doses of mometasone furoate administered via a dry powder inhaler (MF-DPI) for mild-to-moderate persistent asthma and compare them with that of beclomethasone dipropionate administered via a metered dose inhaler (BDP-MDI) in the treatment of persistent asthma. Both MF-DPI doses tested are twice the approved pediatric dosage of 100 ?g once-daily (QD) for children aged 4–11 years. Methods Children (N = 233) aged 4–11 years were randomized to 52 weeks of treatment with MF-DPI 200 ?g QD AM, MF-DPI 100 ?g twice daily (BID), or BDP-MDI 168 ?g BID. Patients had used inhaled corticosteroids (ICSs) daily for ? 30 days before the screening visit and were on stable ICS doses for ? 2 weeks before screening. The primary safety variable was the incidence of adverse events. Secondary safety variables were laboratory tests (including cortisol concentrations), vital signs, and physical examination. Results The incidence of adverse events was similar in all 3 treatment groups. The most frequently reported adverse event was upper respiratory tract infection, reported by 47%–49% of the MF-DPI-treated patients and 51% of the BPD-treated patients. Most adverse events were considered unrelated to study drug. The most frequently reported related adverse events were headache (MF-DPI 200 ?g QD AM, 8%; MF-DPI 100 ?g BID, 4%; BDP-MDI 168 ?g BID, 2%) and oral candidiasis (4% in each treatment group). No clinically relevant changes in laboratory values, including plasma cortisol, vital signs, or physical examinations were noted in any treatment group. Conclusion Both MF-DPI doses were well tolerated, with no unusual or unexpected adverse events or safety concerns, and had a similar adverse event profile to that of BDP-MDI 168 ?g BID. PMID:19594937

Noonan, Michael; Leflein, Jeffrey; Corren, Jonathan; Staudinger, Heribert

2009-01-01

200

Safety self-efficacy and safety performance : Potential antecedents and the moderation effect of standardization  

Microsoft Academic Search

Purpose – The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. Design\\/methodology\\/approach – The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy

Tal Katz-Navon; Eitan Naveh; Zvi Stern

2007-01-01

201

Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results  

PubMed Central

Background Clinical trials established the efficacy and safety of natalizumab. Data are needed over longer periods of time and in the clinical practice setting. Objective To evaluate long-term safety of natalizumab and its impact on annualised relapse rate and Expanded Disability Status Scale (EDSS) progression in patients with relapsing-remitting multiple sclerosis (RRMS). Methods The Tysabri (natalizumab) Observational Program (TOP) is an open-label, multinational, 10-year prospective study in clinical practice settings. Results In this 5-year interim analysis, 4821 patients were enrolled. Follow-up for at least 4?years from natalizumab commencement in 468 patients and at least 2?years in 2496 patients revealed no new safety signals. There were 18 cases of progressive multifocal leucoencephalopathy reported, following 11–44 natalizumab infusions. Mean annualised relapse rate decreased from 1.99 in the 12?months prior to baseline to 0.31 on natalizumab therapy (p<0.0001), remaining low at 5?years. Lower annualised relapse rates were observed in patients who used natalizumab as first MS therapy, in patients with lower baseline EDSS scores, and in patients with lower prenatalizumab relapse rates. Mean EDSS scores remained unchanged up to 5?years. Conclusions Interim TOP data confirm natalizumab's overall safety profile and the low relapse rate and stabilised disability levels in natalizumab-treated patients with RRMS in clinical practice. Trial registration number NCT00493298. PMID:24532785

Butzkueven, Helmut; Kappos, Ludwig; Pellegrini, Fabio; Trojano, Maria; Wiendl, Heinz; Patel, Radhika N; Zhang, Annie; Hotermans, Christophe; Belachew, Shibeshih

2014-01-01

202

Long-term oxygen therapy.  

PubMed

This article provides an overview of the status of long-term oxygen therapy (LTOT). In the United States, payment cutbacks are occurring as a result of congressionally mandated competitive bidding and capped rental programs. These Medicare programs are discussed. These legislative and regulatory changes may result in reduced patient access to appropriate oxygen-delivery systems that meet medical needs, including optimal ambulation. Prescribing LTOT is addressed in this article, as is the need for adequate patient education. The importance of appropriate monitoring and reassessment is presented. The use of an LTOT collaborative care model is discussed. Although the new intermittent flow oxygen-delivery systems have potential benefits, there is consensus that each patient should be tested on the specific device because of variability in delivery and patient response. Feasible locations for patient education and monitoring are identified. PMID:21285057

Christopher, Kent L; Porte, Phillip

2011-02-01

203

Silodosin for the treatment of clinical benign prostatic hyperplasia: safety, efficacy, and patient acceptability  

PubMed Central

?1-Adrenergic receptor antagonists are commonly used to treat male lower urinary tract symptoms and benign prostatic hyperplasia (BPH). We performed a literature search using PubMed, Medline via Ovid, Embase, and the Cochrane Library databases to identify studies on the treatment of BPH by silodosin. Silodosin is a novel ?1-adrenergic receptor antagonist whose affinity for the ?1A-adrenergic receptor is greater than that for the ?1B-adrenergic receptor. Therefore, silodosin does not increase the incidence of blood pressure-related side effects, which may result from the inhibition of the ?1B-adrenergic receptor. Patients receiving silodosin at a daily dose of 8 mg showed a significant improvement in the International Prostate Symptom Score and maximum urinary flow rate compared with those receiving a placebo. Silodosin also improved both storage and voiding symptoms, indicating that silodosin is effective, even during early phases of BPH treatment. Follow-up extension studies performed in the United States, Europe, and Asia demonstrated its long-term safety and efficacy. In the European study, silodosin significantly reduced nocturia compared to the placebo. Although retrograde or abnormal ejaculation was the most commonly reported symptom in these studies, only a few patients discontinued treatment. The incidence of adverse cardiovascular events was also very low. Evidence showing solid efficacy and cardiovascular safety profiles of silodosin will provide a good solution for the treatment of lower urinary tract symptoms associated with BPH in an increasingly aging society. PMID:25328864

Cho, Hee Ju; Yoo, Tag Keun

2014-01-01

204

Efficacy and safety of ustekinumab treatment in elderly patients with psoriasis.  

PubMed

The ratio of the elderly among psoriasis patients has been increasing. However, satisfactory long-term management of psoriasis for the elderly is challenging because of the more frequent presence of comorbidities, and the higher risk of adverse events from systemic therapeutic agents than younger patients. The use of ustekinumab (UST) appears to be an appropriate systemic treatment because it is considered less likely to cause adverse events than other systemic treatments, as well as necessitating fewer hospital visits. Our retrospective study aimed to evaluate the efficacy and safety profile of UST in elderly patients with psoriasis. The study included 24 patients aged over 65 years (range, 65-88 years; mean, 73.1 years) with moderate to severe plaque psoriasis with impaired quality of life. Efficacy and safety were assessed over a 1-year period using the Psoriasis Area and Severity Index (PASI) and the Dermatology Live Quality Index (DLQI). The efficacy was evaluated by the proportion of subjects who achieved ?75% reduction in PASI score (PASI 75). PASI 75 responses were 56.5% at week 16, 59.1% at week 28, and 60.0% at week 52. None of the patients developed any serious infection during the 1-year treatment. The mean DLQI score at weeks 0, 16, 28, and 52 was 7.8 ± 6.0, 2.5 ± 3.4, 1.4 ± 1.7, and 1.2 ± 1.7, respectively. UST showed sufficient efficacy for elderly patients with psoriasis without any serious infection over the 1-year treatment. Our results suggest that UST is the preferable agent for the treatment of elderly patients with psoriasis. PMID:25346301

Hayashi, Mitsuha; Umezawa, Yoshinori; Fukuchi, Osamu; Ito, Toshihiro; Saeki, Hidehisa; Nakagawa, Hidemi

2014-11-01

205

Asthma Medicines: Long-Term Control  

MedlinePLUS

... Control Health Issues Listen Asthma Medicines: Long-term Control Article Body Corticosteroids Synthetic versions of hormones produced ... form, they are used exclusively for long-term control; they are not very effective for acute symptoms. ...

206

Comments on subacute and long-term studies.  

PubMed

Long-term therapy with Duovent was always superior in comparison to the other drugs. An immediate efficacy with increasing levels until the 90th day was always obtained. There were no signs of tachyphylaxis and side effects were insignificant. Functional modifications were evident in the large and small airways. PMID:2951817

Panuccio, P

1986-01-01

207

The Long-Term Outcome of Medical Therapy for BPH  

Microsoft Academic Search

ObjectivesThe lack of cure with medical therapy implies life-long treatment emphasising the need for a thorough understanding of the long-term outcome. We review the natural history, markers for progression, placebo effect, efficacy, pharmacoeconomic aspects, and preventive measures.

Stephan Madersbacher; Martin Marszalek; Jakob Lackner; Peter Berger; Georg Schatzl

2007-01-01

208

Long-term corrosion studies  

SciTech Connect

The scope of this activity is to assess the long-term corrosion properties of metallic materials under consideration for fabricating waste package containers. Three classes of metals are to be assessed: corrosion resistant, intermediate corrosion resistant, and corrosion allowance. Corrosion properties to be evaluated are general, pitting and crevice corrosion, stress-corrosion cracking, and galvanic corrosion. The performance of these materials will be investigated under conditions that are considered relevant to the potential emplacement site. Testing in four aqueous solutions, and vapor phases above them, and at two temperatures are planned for this activity. (The environmental conditions, test metals, and matrix are described in detail in Section 3.0.) The purpose and objective of this activity is to obtain the kinetic and mechanistic information on degradation of metallic alloys currently being considered for waste package containers. This information will be used to provide assistance to (1) waste package design (metal barrier selection) (E-20-90 to E-20-92), (2) waste package performance assessment activities (SIP-PA-2), (3) model development (E-20-75 to E-20-89). and (4) repository license application.

Gdowski, G.

1998-05-29

209

Long Term Surface Salinity Measurements  

NASA Technical Reports Server (NTRS)

Our long-term goal is to establish a reliable system for monitoring surface salinity around the global ocean. Salinity is a strong indicator of the freshwater cycle and has a great influence on upper ocean stratification. Global salinity measurements have potential to improve climate forecasts if an observation system can be developed. This project is developing a new internal field conductivity cell that can be protected from biological fouling for two years. Combined with a temperature sensor, this foul-proof cell can be deployed widely on surface drifters. A reliable in-situ network of surface salinity sensors will be an important adjunct to the salinity sensing satellite AQUARIUS to be deployed by NASA in 2009. A new internal-field conductivity cell has been developed by N Brown, along with new electronics. This sensor system has been combined with a temperature sensor to make a conductivity - temperature (UT) sensor suitable for deployment on drifters. The basic sensor concepts have been proven on a high resolution CTD. A simpler (lower cost) circuit has been built for this application. A protection mechanism for the conductivity cell that includes antifouling protection has also been designed and built. Mr. A.Walsh of our commercial partner E-Paint has designed and delivered time-release formulations of antifoulants for our application. Mr. G. Williams of partner Clearwater Instrumentation advised on power and communication issues and supplied surface drifters for testing.

Schmitt, Raymond W.; Brown, Neil L.

2005-01-01

210

[Efficacy and safety of inhaled drugs].  

PubMed

In the paper the foundations are presented of current inhalation therapy, particularly of that applied in childhood. The problems are discussed, concerning deposition of aerosols in the tracheobronchial tree achieved by various methods of aerosol generation. Various factors affecting the bioavailability of the inhaled drugs are defined. Particular attention is paid to the problems of safety of inhaled corticosteroid therapy, stability of the inhaled drugs and their influence on the pulmonary surfactant. PMID:14524299

Alkiewicz, Jerzy

2003-06-01

211

Evaluation of long-term entecavir treatment in stable chronic hepatitis B patients switched from lamivudine therapy  

Microsoft Academic Search

Purpose  Current Japanese guidelines recommend that patients should be switched from lamivudine to entecavir when they meet certain\\u000a criteria. This analysis examines the efficacy and safety of long-term entecavir therapy in patients who were switched to entecavir\\u000a after 24 weeks’ lamivudine therapy in Japanese studies ETV-047 and ETV-060.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  The Phase II Japanese study ETV-047 assessed the efficacy of different entecavir doses when

Tatsuya IdeMichio; Michio Sata; Kazuaki Chayama; Michiko Shindo; Joji Toyota; Satoshi Mochida; Eiichi Tomita; Hiromitsu Kumada; Gotaro Yamada; Hiroshi Yatsuhashi; Norio Hayashi; Hiroki Ishikawa; Taku Seriu; Masao Omata

2010-01-01

212

TNF? blockade in human diseases: An overview of efficacy and safety  

PubMed Central

Tumor necrosis factor-alpha (TNF?) antagonists including antibodies and soluble receptors have shown remarkable efficacy in various immune-mediated inflammatory diseases (IMID). As experience with these agents has matured, there is an emerging need to integrate and critically assess the utility of these agents across disease states and clinical sub-specialties. Their remarkable efficacy in reducing chronic damage in Crohn’s disease and rheumatoid arthritis has led many investigators to propose a new, ‘top down’ paradigm for treating patients initially with aggressive regimens to quickly control disease. Intriguingly, in diseases such as rheumatoid arthritis and asthma, anti-TNF? agents appear to more profoundly benefit patients with more chronic stages of disease but have a relatively weaker or little effect in early disease. While the spectrum of therapeutic efficacy of TNF? antagonists widens to include diseases such as recalcitrant uveitis and vasculitis, these agents have failed or even exacerbated diseases such as heart failure and multiple sclerosis. Increasing use of these agents has also led to recognition of new toxicities as well as to understanding of their excellent long-term tolerability. Disconcertingly, new cases of active tuberculosis still occur in patients treated with all TNF? antagonists due to lack of compliance with recommendations to prevent reactivation of latent tuberculosis infection. These safety issues as well as guidelines to prevent treatment-associated complications are reviewed in detail in this article. New data on mechanisms of action and development of newer TNF? antagonists are discussed in a subsequent article in the Journal. It is hoped that these two review articles will stimulate a fresh assessment of the priorities for research and clinical innovation to improve and extend therapeutic use and safety of TNF? antagonism. PMID:17916445

Lin, Jan; Ziring, David; Desai, Sheetal; Kim, Sungjin; Wong, Maida; Korin, Yael; Braun, Jonathan; Reed, Elaine; Gjertson, David; Singh, Ram Raj

2008-01-01

213

Bariatric surgery: indications, safety and efficacy.  

PubMed

Obesity among adults, children and adolescents has markedly increased regardless of gender, age, ethnicity or educational level, and has become a national health threat and a major public health challenge. This obesity epidemic can be attributed to excess energy intake and decreased energy expenditure experienced in Westernized countries. Unfortunately, there is no single solution to prevent or treat obesity that will be inclusive of everyone. Often times, treatment of obesity may include a combination of diet, exercise, behavior modification, medication, and sometimes weight-loss surgeries. Hence, bariatric surgery has evolved over the last four decades and has been shown to be effective in reducing obesity related comorbidities, improve the quality of life, number of sick days, monthly medication costs, and overall mortality. With the increasing rates of weight loss surgical procedures, the quality, efficacy and surgical outcomes have improved with the creation of Bariatric Centers of Excellence designated by the American Society of Metabolic and Bariatric Surgery or American College of Surgeons. The benefits of bariatric procedures in morbidly obese patients outweigh the risks. With the advent of minimally invasive surgical procedures, bariatric surgery is a reasonable treatment option in those who strongly desire substantial weight loss and have life-threatening comorbid conditions. PMID:21492093

Ben-David, K; Rossidis, G

2011-01-01

214

Viability of long-term gene therapy in the cochlea.  

PubMed

Gene therapy has been investigated as a way to introduce a variety of genes to treat neurological disorders. An important clinical consideration is its long-term effectiveness. This research aims to study the long-term expression and effectiveness of gene therapy in promoting spiral ganglion neuron survival after deafness. Adenoviral vectors modified to express brain derived neurotrophic factor or neurotrophin-3 were unilaterally injected into the guinea pig cochlea one week post ototoxic deafening. After six months, persistence of gene expression and significantly greater neuronal survival in neurotrophin-treated cochleae compared to the contralateral cochleae were observed. The long-term gene expression observed indicates that gene therapy is potentially viable; however the degeneration of the transduced cells as a result of the original ototoxic insult may limit clinical effectiveness. With further research aimed at transducing stable cochlear cells, gene therapy may be an efficacious way to introduce neurotrophins to promote neuronal survival after hearing loss. PMID:24751795

Atkinson, Patrick J; Wise, Andrew K; Flynn, Brianna O; Nayagam, Bryony A; Richardson, Rachael T

2014-01-01

215

Viability of Long-Term Gene Therapy in the Cochlea  

PubMed Central

Gene therapy has been investigated as a way to introduce a variety of genes to treat neurological disorders. An important clinical consideration is its long-term effectiveness. This research aims to study the long-term expression and effectiveness of gene therapy in promoting spiral ganglion neuron survival after deafness. Adenoviral vectors modified to express brain derived neurotrophic factor or neurotrophin-3 were unilaterally injected into the guinea pig cochlea one week post ototoxic deafening. After six months, persistence of gene expression and significantly greater neuronal survival in neurotrophin-treated cochleae compared to the contralateral cochleae were observed. The long-term gene expression observed indicates that gene therapy is potentially viable; however the degeneration of the transduced cells as a result of the original ototoxic insult may limit clinical effectiveness. With further research aimed at transducing stable cochlear cells, gene therapy may be an efficacious way to introduce neurotrophins to promote neuronal survival after hearing loss. PMID:24751795

Atkinson, Patrick J.; Wise, Andrew K.; Flynn, Brianna O.; Nayagam, Bryony A.; Richardson, Rachael T.

2014-01-01

216

Training-induced potentiation in the neocortex and its interaction with stimulation-induced long-term potentiation and long-term depression  

Microsoft Academic Search

Long-term potentiation (LTP) is a long-lasting increase in synaptic efficacy following high-frequency electrical stimulation. Long-term depression (LTD) is a low-frequency stimulation induced reduction in synaptic efficacy. LTP-inducing stimulation is delivered pre-synaptically through an electrode which has been lowered into a neural pathway in an animal's brain. The stimulation parameters used to induce LTP produce alterations which have many of the

Robert Alexander Hodgson

2002-01-01

217

Training-Included Potentiation in the Neocortex and its Interaction with Stimulation-Induced Long-Term Potentiation and Long-Term Depression  

Microsoft Academic Search

Long-term potentiation (LTP) is a long-lasting increase in synaptic efficacy following high-frequency electrical stimulation. Long-term depression (LTD) is a low-frequency stimulation induced reduction in synaptic efficacy. LTP-inducing stimulation is delivered pre-synaptically through an electrode which has been lowered into a neural pathway in an animal's brain. The stimulation parameters used to induce LTP produce alterations which have many of the

Robert Alexander Hodgson

2001-01-01

218

Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema  

PubMed Central

Neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) are major causes of visual impairment in the elderly population worldwide. With the aging population, the prevalence of neovascular AMD and DME has increased substantially over the recent years. Vascular endothelial growth factor (VEGF) has been implicated as playing an important role in the pathogenesis of both neovascular AMD and DME. Since its introduction in 2006, ranibizumab, a recombinant, humanized, monoclonal antibody fragment against all isoforms of VEGF-A, has revolutionized the treatment of neovascular AMD and DME. The efficacy and safety of ranibizumab in neovascular AMD has been demonstrated in the ANCHOR and MARINA trials. Further studies including the PIER, PrONTO, and SUSTAIN trials have also evaluated the optimal dosing regimen of ranibizumab in neovascular AMD. The CATT and IVAN trials compared the safety and efficacy of ranibizumab with off-label use of bevacizumab. Studies such as SUSTAIN and HORIZON have shown that ranibizumab has a good safety profile and is well tolerated for over 4 years with very few serious ocular and systemic adverse events. For DME, Phase II RESOLVE study and Phase III RISE and RIDE studies have demonstrated superiority of ranibizumab treatment in improving vision over placebo controls. Phase II READ and Phase III RESOLVE and REVEAL studies have shown that ranibizumab is more effective both as monotherapy and in combination with laser compared with laser monotherapy. The 3-year results from the DRCRnet protocol I study found that ranibizumab with deferred laser resulted in better long-term visual outcome compared with ranibizumab with prompt laser. This review summarizes various important clinical trials on the long-term efficacy and safety of ranibizumab in the treatment of neovascular AMD and DME. The pharmacological properties of ranibizumab, its cost effectiveness, and impact on quality of life will also be discussed. PMID:23766636

Fong, Angie HC; Lai, Timothy YY

2013-01-01

219

Long-term effectiveness of ranibizumab for age-related macular degeneration and diabetic macular edema.  

PubMed

Neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) are major causes of visual impairment in the elderly population worldwide. With the aging population, the prevalence of neovascular AMD and DME has increased substantially over the recent years. Vascular endothelial growth factor (VEGF) has been implicated as playing an important role in the pathogenesis of both neovascular AMD and DME. Since its introduction in 2006, ranibizumab, a recombinant, humanized, monoclonal antibody fragment against all isoforms of VEGF-A, has revolutionized the treatment of neovascular AMD and DME. The efficacy and safety of ranibizumab in neovascular AMD has been demonstrated in the ANCHOR and MARINA trials. Further studies including the PIER, PrONTO, and SUSTAIN trials have also evaluated the optimal dosing regimen of ranibizumab in neovascular AMD. The CATT and IVAN trials compared the safety and efficacy of ranibizumab with off-label use of bevacizumab. Studies such as SUSTAIN and HORIZON have shown that ranibizumab has a good safety profile and is well tolerated for over 4 years with very few serious ocular and systemic adverse events. For DME, Phase II RESOLVE study and Phase III RISE and RIDE studies have demonstrated superiority of ranibizumab treatment in improving vision over placebo controls. Phase II READ and Phase III RESOLVE and REVEAL studies have shown that ranibizumab is more effective both as monotherapy and in combination with laser compared with laser monotherapy. The 3-year results from the DRCRnet protocol I study found that ranibizumab with deferred laser resulted in better long-term visual outcome compared with ranibizumab with prompt laser. This review summarizes various important clinical trials on the long-term efficacy and safety of ranibizumab in the treatment of neovascular AMD and DME. The pharmacological properties of ranibizumab, its cost effectiveness, and impact on quality of life will also be discussed. PMID:23766636

Fong, Angie H C; Lai, Timothy Y Y

2013-01-01

220

Long-term solar-terrestrial observations  

NASA Technical Reports Server (NTRS)

The results of an 18-month study of the requirements for long-term monitoring and archiving of solar-terrestrial data is presented. The value of long-term solar-terrestrial observations is discussed together with parameters, associated measurements, and observational problem areas in each of the solar-terrestrial links (the sun, the interplanetary medium, the magnetosphere, and the thermosphere-ionosphere). Some recommendations are offered for coordinated planning for long-term solar-terrestrial observations.

1988-01-01

221

Long-term kidney transplant survival  

Microsoft Academic Search

With improvements in short-term kidney graft survival, focus has shifted towards long-term survival. There has also been a substantial improvement in long-term survival as measured by kidney half-life. Long-term graft failure is secondary to chronic allograft nephropathy (CAN), recurrent disease, and death with a functioning graft. CAN is secondary to a combination of chronic rejection, chronic cyclosporine toxicity, and\\/or donor

Sundaram Hariharan

2001-01-01

222

Long-term correlations in earth sciences  

NASA Astrophysics Data System (ADS)

In this article we review the occurrence and consequences of long-term memory in geophysical records like climate and seismic records, and describe similarities with financial data sets. We review several methods to detect linear and nonlinear long-term correlations, also in the presence of external trends, and show how external trends can be detected in data with long-term memory. We show as well that long-term correlations lead to a natural clustering of extreme events and discuss the implications for several geophysical data sets.

Bunde, Armin; Lennartz, Sabine

2012-06-01

223

A multicentre open-label safety and efficacy study of tetrodotoxin for cancer pain  

PubMed Central

Background Cancer pain is highly prevalent, and existing treatments are often insufficient to provide adequate relief. Objectives We assessed the long-term safety and efficacy of subcutaneous tetrodotoxin treatment in reducing the intensity of chronic cancer-related pain. Methods In this multicentre open-label longitudinal trial, 30 ?g tetrodotoxin was administered subcutaneously twice daily for 4 days in a heterogeneous cohort of patients with persistent pain despite opioids and other analgesics. “Responder” was defined as a mean reduction of 30% or more in pain intensity from baseline; and “clinical responder” as some pain reduction, but less than 30%, plus agreement on the part of both the patient and the physician that a meaningful analgesic response to treatment had occurred. Results Of 45 patients who entered the longitudinal trial, 41 had sufficient data for analysis. Of all 45 patients, 21 (47%) met the criteria for “responder” [16 patients (36%)] or “clinical responder” [5 patients (11%)]. Onset of pain relief was typically cumulative over days, and after administration ended, the analgesic effect subsided over the course of a few weeks. No evidence of loss of analgesic effect was observed during subsequent treatments (2526 patient–days in total and a maximum of 400 days in 1 patient). One patient withdrew from the study because of adverse events. Toxicity was usually mild (82%) or moderate (13%), and remained so through subsequent treatment cycles, with no evidence of cumulative toxicity or tolerance. Conclusions Long-term treatment with tetrodotoxin is associated with acceptable toxicity and, in a substantial minority of patients, resulted in a sustained analgesic effect. Further study of tetrodotoxin for moderate-to-severe cancer pain is warranted. PMID:21655148

Hagen, N.A.; Lapointe, B.; Ong–Lam, M.; Dubuc, B.; Walde, D.; Gagnon, B.; Love, R.; Goel, R.; Hawley, P.; Ngoc, A. Ho; du Souich, P.

2011-01-01

224

Predictors of atypical femoral fractures during long term bisphosphonate therapy: A case series & review of literature  

PubMed Central

Background & objectives: Bisphosphonates (BPs) are the most widely prescribed medicines for the treatment of osteoporosis because of their efficacy and favourable safety profile. There have been, several reports on an increased incidence of atypical femoral fractures after long term treatment with BPs. The objective of this study was to evaluate the clinical presentation including prodromal symptoms, skeletal radiograph findings, type and duration of BPs received and treatment outcome of patients who developed atypical femoral fractures during bisphosphonate therapy. Methods: In this retrospective study, eight patients with atypical femoral fractures were analysed based on clinical features, biochemical and radiological investigations. Results: Of the eight patients, who sustained atypical femoral fractures, six were on alendronate and two were on zoledronate therapy before the fractures. In addition to BPs, two patients were on long term corticosteroid therapy for rheumatoid arthritis and Addison's disease. Three patients had bilateral atypical femoral fractures. Except one, all of them had prodromal symptoms prior to fracture. Skeletal radiograph showed cortical thickening, pointed (beaking of) cortical margin and transverse fracture in meta-diaphyseal location. Serum calcium, phosphate, alkaline phosphatase (ALP) and intact parathyroid hormone (iPTH) concentrations were within the reference range in all patients. Interpretation & conclusions: Long term bisphosphonate therapy may increase the risk of atypical femoral fractures. Presence of prodromal pain, thickened cortex with cortical beaking may be an early clue for predicting the atypical fractures. High risk patients need periodical skeletal survey and a close follow up for early detection of cases. PMID:25222777

Bhadada, Sanjay Kumar; Sridhar, Subbiah; Muthukrishnan, Jeyaram; Mithal, Ambrish; Sharma, Dinesh C.; Bhansali, Anil; Dhiman, Vandana

2014-01-01

225

Computer simulation of microgravity long-term effects and risk evaluation  

Microsoft Academic Search

The objective of this work is to analyse and simulate possible long-term effects of microgravity on the human pulmonary function. It is also studied the efficacy of long-term regular exercise on relevant cardiovascular parameters when the human body is also exposed to microgravity. Little is known today about what long-term effects microgravity may cause on pulmonary function. It does not

Antoni Perez-Poch

2008-01-01

226

Efficacy of optimal long-term management of multiple cardiovascular risk factors (CVD) on walking and quality of life in patients with peripheral artery disease (PAD): Protocol for randomized controlled trial  

PubMed Central

Peripheral artery disease (PAD) is an understudied chronic illness most prevalent in elderly individuals. PAD patients experience substantial walking impairment due to symptoms of limb ischemia that significantly diminishes quality of life (QOL). Cardiovascular disease (CVD) morbidity and mortality is increased in this population because of aggressive atherosclerosis resulting from untreated CVD risk factors. Despite current national guidelines recommending intensive CVD risk factor management for PAD patients, untreated CVD risk factors are common. Interventions that bridge this gap are imperative. The Vascular Insufficiency – Goals for Optimal Risk Reduction (VIGOR2) study is a randomized controlled trial (RCT) that examines the effectiveness of a long-term multifactor CVD risk reduction program on walking and quality of life in patients with PAD. The purpose of this article is to provide a detailed description of the design and methods of VIGOR2. PMID:22363015

Oka, Roberta K; Conte, Michael S; Owens, Christopher D; Rapp, Joseph; Fung, Gordon; Alley, Hugh F; Giacomini, John C; Myers, Jonathan; Mohler, Emile R

2012-01-01

227

Long-term Use of Opioids for Complex Chronic Pain  

PubMed Central

Increased opioid prescribing for back pain and other chronic musculoskeletal pain conditions has been accompanied by dramatic increases in prescription opioid addiction and fatal overdose. Opioid-related risks appear to increase with dose. While short-term randomized trials of opioids for chronic pain have found modest analgesic benefits (a one-third reduction in pain intensity on average), the long-term safety and effectiveness of opioids for chronic musculoskeletal pain is unknown. Given the lack of large, long-term randomized trials, recent epidemiologic data suggests the need for caution when considering long-term use of opioids to manage chronic musculoskeletal pain, particularly at higher dosage levels. Principles for achieving more selective and cautious use of opioids for chronic musculoskeletal pain are proposed. PMID:24315147

Von Korff, Michael R.

2014-01-01

228

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

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

2014-09-24

229

Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients  

PubMed Central

Osteoarthritis is common in patients ?65 years of age. Although nonsteroidal anti-inflammatory drugs (NSAIDs) are often prescribed for osteoarthritis pain, they pose age-related cardiovascular, renal, and gastrointestinal risks. Two topical NSAIDs, diclofenac sodium 1% gel (DSG) and diclofenac sodium 1.5% in 45.5% dimethylsulfoxide solution (D-DMSO), are approved in the US for the treatment of osteoarthritis pain. Topical NSAIDs have shown efficacy and safety in knee (DSG, D-DMSO) and hand (DSG) osteoarthritis. Analyses of data from randomized controlled trials of DSG in hand and knee osteoarthritis demonstrate significant improvement of pain and function in both younger patients (<65 years) and older patients (?65 years) and suggest good safety and tolerability. However, long-term safety data in older patients are limited. Topical NSAIDs can ease medication administration and help address barriers to pain management in older patients, such as taking multiple medications and inability to swallow, and are a valuable option for long-term care providers. PMID:22076115

Argoff, Charles E; Gloth, F Michael

2011-01-01

230

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 2011 indicate that ...

231

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

PubMed Central

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

Barnes, Joanne

2003-01-01

232

Efficacy and safety of febuxostat in elderly female patients  

PubMed Central

Background Maintenance of low serum urate levels is important for the management of gout. Achieving the recommended serum urate levels of less than 6.0 mg/dL is difficult in elderly (65 years of age or older) patients with renal impairment. Xanthine oxidase inhibitors allopurinol and febuxostat are used for this purpose. Although febuxostat had been shown to be efficacious in elderly patients, its safety and efficacy in elderly female patients with hyperuricemia remain unclear. Objective The aim of this study was to assess the efficacy and safety of febuxostat in elderly female patients. Methods We studied a retrospective cohort study. The study included elderly Japanese patients (65 years of age or older) who were treated with febuxostat at Fujita Health University Hospital from January 2012 to December 2013. The treatment goal was defined as achievement of serum urate levels of 6.0 mg/dL or lower within 16 weeks; this was the primary endpoint in the present study. Adverse events of febuxostat were defined as more than twofold increases in Common Terminology Criteria for adverse events scores from baseline. Results We evaluated 82 patients treated with febuxostat during the observation period and classified them into male (n=53) and female (n=29) groups. The mean time to achievement of the treatment goal was significantly shorter in the female group (53 days) than in the male group (71 days). There were no significant differences in adverse events between the 2 groups. Conclusion Our findings suggest that the efficacy of febuxostat in elderly female patients is superior to that in elderly male patients and that the safety is equivalent. PMID:25214776

Mizuno, Tomohiro; Hayashi, Takahiro; Hikosaka, Sayo; Shimabukuro, Yuka; Murase, Maho; Takahashi, Kazuo; Hayashi, Hiroki; Yuzawa, Yukio; Nagamatsu, Tadashi; Yamada, Shigeki

2014-01-01

233

SLEEP DISTURBANCES IN LONG-TERM CARE  

PubMed Central

SYNOPSIS Nighttime sleep disruption is characteristic of long-term care residents, is typically accompanied by daytime sleepiness and may be caused by a multitude of factors. Causal factors include medical and psychiatric illness, medications, circadian rhythm abnormalities, sleep disordered breathing and other primary sleep disorders, environmental factors and lifestyle habits. There is some suggestion that these factors are amenable to treatment; however, further research on the implementation of treatments within the long-term care setting is needed. Additional work is also needed to understand the administrative and policy factors that might lead to systemic changes in how sleep is viewed and sleep problems are addressed in long-term care settings. A growing number of older adults reside in long-term care facilities. In this setting, residents commonly suffer from nighttime sleep disruption, which is often accompanied by daytime sleepiness and may be caused by a multitude of factors. Importantly, sleep disturbance is associated with negative health outcomes, including risk for falling, and elevated mortality risk among long-term care residents. A number of factors contribute to sleep disturbance in the long-term care setting including medical and psychiatric illness, medications, circadian rhythm abnormalities, sleep disordered breathing and other primary sleep disorders, environmental conditions (e.g., noise and light) and lifestyle habits. Based on research with older adults in the community and work conducted within long-term care settings, there is some suggestion that these factors are amenable to nonpharmacological treatments. Further research on the broad implementation of treatments for sleep problems within the long-term care setting is still needed. Additional work is also needed to understand the administrative and policy factors that might lead to systemic changes in how sleep is viewed and sleep problems are addressed in long-term care settings. PMID:18035230

Martin, Jennifer L.; Ancoli-Israel, Sonia

2008-01-01

234

Efficacy and Safety of Acupuncture in Preterm and Term Infants  

PubMed Central

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

Raith, Wolfgang; Urlesberger, Berndt; Schmolzer, Georg M.

2013-01-01

235

Cholangitis as a late complication in long-term survivors after surgery for biliary atresia  

Microsoft Academic Search

Background\\/purposeA retrospective review was performed to assess the utility of diagnostic imaging (DI), efficacy of treatment, and outcome of late cholangitis in long-term survivors after surgery for biliary atresia.

Masaki Nio; Nobuyuki Sano; Tomohiro Ishii; Hideyuki Sasaki; Yutaka Hayashi; Ryoji Ohi

2004-01-01

236

JAK Inhibitors: Treatment Efficacy and Safety Profile in Patients with Psoriasis  

PubMed Central

Janus kinase (JAK) pathways are key mediators in the immunopathogenesis of psoriasis. Psoriasis treatment has evolved with the advent of targeted therapies, which inhibit specific components of the psoriasis proinflammatory cascade. JAK inhibitors have been studied in early phase trials for psoriasis patients, and the data are promising for these agents as potential treatment options. Tofacitinib, an oral or topically administered JAK1 and JAK3 inhibitor, and ruxolitinib, a topical JAK1 and JAK2 inhibitor, have been most extensively studied in psoriasis, and both improved clinical symptoms of psoriasis. Additional JAK1 or JAK3 inhibitors are being studied in clinical trials. In phase III trials for rheumatoid arthritis, tofacitinib was efficacious in patients with inadequate responses to tumor necrosis factor inhibitors, methotrexate monotherapy, or disease-modifying antirheumatic drugs. The results of phase III trials are pending for these therapies in psoriasis, and these agents may represent important alternatives for patients with inadequate responses to currently available agents. Further investigations with long-term clinical trials are necessary to verify their utility in psoriasis treatment and assess their safety in this patient population. PMID:24883332

Hsu, Leeyen; Armstrong, April W.

2014-01-01

237

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

PubMed Central

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

Mehler-Wex, Claudia; Kolch, Michael; Kirchheiner, Julia; Antony, Gisela; Fegert, Jorg M; Gerlach, Manfred

2009-01-01

238

Better evidence for safety and efficacy is needed before neurologists prescribe drugs for neuroenhancement to healthy people.  

PubMed

In this paper we question the guidance offered to neurologists by the Ethics, Law and Humanities Committee of the American Academy of Neurology (Larriviere, Williams, Rizzo & Bonnie, 2009) on how to respond to requests for "neuroenhancement": the use of pharmaceuticals to enhance cognitive function in cognitively normal people. The guidance assumes that the benefits of using neuroenhancers will prove to outweigh the risks in the absence of any evidence that this is the case. However, the principle of nonmaleficence dictates that the use of these drugs by healthy people should not be condoned before reliable evidence for their short and long term safety and efficacy is at hand. The proposed ethical framework for neuroenhancement prescribing also neglects the broader social implications of condoning such practices. The adoption of these guidelines by neurologists could have adverse social and medical effects that need to be more carefully considered. PMID:22007842

Boot, Brendon P; Partridge, Brad; Hall, Wayne

2012-06-01

239

Effect of treatment with divalproex sodium and lorazepam in residents of long-term-care facilities with dementia-related anxiety or agitation: retrospective chart review  

Microsoft Academic Search

Objective: The aim of this study was to compare the efficacy and safety of divalproex sodium with those of lorazepam in residents of long-term-care (LTC) facilities who had documented diagnoses of dementia with agitation or anxiety.Background: Anxiety and agitation are frequent behavioral complications of Alzheimer's disease that increase the costs and emotional stress associated with caring for these patients.Methods: LTC

I. Barton Frenchman; Christopher Capo; Heather Kass

2000-01-01

240

Long-term Doxycycline-regulated Transgene Expression in the Retina of Nonhuman Primates Following Subretinal Injection of Recombinant AAV Vectors  

Microsoft Academic Search

Adeno-associated viral gene therapy has shown promise for the treatment of inherited and acquired retinal disorders. In most applications, regulation of expression is a critical concern for both safety and efficacy. The purpose of our study was to evaluate the ability of the tetracycline-regulatable system to establish long-term transgene regulation in the retina of nonhuman primates. Three rAAV vectors expressing

Knut Stieger; Guylène Le Meur; Françoise Lasne; Michel Weber; Jack-Yves Deschamps; Delphine Nivard; Alexandra Mendes-Madeira; Nathalie Provost; Laurent Martin; Philippe Moullier; Fabienne Rolling

2006-01-01

241

443. Successful Long-Term Doxycycline-Regulated Transgene Expression in the Retina of Nonhuman Primates Following Subretinal Injection of Recombinant AAV Vectors  

Microsoft Academic Search

Adeno-associated viral gene therapy has shown promise for the treatment of inherited and acquired retinal disorders. In most applications, regulation of expression is a critical concern for both safety and efficacy. The purpose of our study was to evaluate the ability of the tetracycline-regulatable system to establish long-term transgene regulation in the retina of nonhuman primates. Three rAAV vectors expressing

Knut Stieger; Guylène Le Meur; Francoise Lasne; Michel Weber; Jack-Yves Deschamps; Delphine Nivard; Alexandra Mendes-Madeira; Nathalie Provost; Laurent Martin; Philippe Moullier; Fabienne Rolling

2006-01-01

242

On-Demand Therapy with Pantoprazole 20 mg as Effective Long-Term Management of Reflux Disease in Patients with Mild GERD: The ORION Trial  

Microsoft Academic Search

Aims: To compare safety and efficacy of on-demand pantoprazole 20 mg\\/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief. Methods: A total of 634 patients with endoscopically confirmed GERD grade 0\\/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4

T. Scholten; C. P. M. Dekkers; K. Schütze; T. Körner; M. Bohuschke; G. Gatz

2005-01-01

243

Long-term treatment of hyperphosphatemia with bixalomer in Japanese hemodialysis patients.  

PubMed

Bixalomer is a nonabsorbable polymer that binds phosphate in the gastrointestinal tract and lowers the serum phosphate level by inhibiting phosphate absorption. The safety and efficacy of long-term bixalomer treatment were assessed in Japanese hemodialysis patients with hyperphosphatemia. This was a multicenter open-label study with a 48-week treatment period. The main efficacy endpoints were the serum phosphate level and rate of achieving the target serum phosphate range (3.5-6.0 mg/dL). Bixalomer was initiated at a dose of 1.5 g/day, which was increased to a maximum of 7.5 g/day depending on the serum phosphate response. Of 248 subjects who started treatment, 179 completed the study. The mean serum phosphate level decreased over time and remained around 5.5 mg/dL from weeks 16 to 48. The target serum phosphate level was reached in >50% of subjects by week 7 and was maintained in 65.2% to 75.9% until week 48. The incidence of adverse events and adverse drug reactions was 94.4% and 29.4%, respectively. There was a potential relationship with the study drug for four serious adverse events (ischemic colitis, hemorrhagic intestinal diverticulum, esophageal ulcer, and acute cholecystitis), which occurred in one patient each. Constipation was the most common adverse drug reaction (21.0%). Most adverse events and adverse drug reactions occurred soon after starting administration, and their incidence did not increase during long-term treatment. Bixalomer did not reduce the bicarbonate level or promote metabolic acidosis. Bixalomer is clinically useful for the long-term treatment of hyperphosphatemia. PMID:24330556

Akizawa, Tadao; Kameoka, Chisato; Kaneko, Yuichiro; Kawasaki, Shigenori

2013-12-01

244

Long-term care and the elderly  

E-print Network

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 ...

Coe, Norma B

2005-01-01

245

Long-term care in international perspective  

PubMed Central

The findings of a study of long-term care policies in 18 countries are reported in this article. Initial data were collected by a questionnaire survey under the auspices of the International Social Security Association. These data were supplemented by published documents and government statistics obtained while researching long-term care for the International Social Security Association and, subsequently, for the Organization for Economic Cooperation and Development. The principal focus is a cross-national comparison of institutionalization rates for the elderly. Differences in use rates for medically oriented facilities are less than those for nonmedical residential long-term care facilities. Only a small amount of variation is related to demographic differences, such as older or more female elderly populations in those countries with higher institutionalization rates. Included also is a description of the modes of financing long-term care. PMID:10312969

Doty, Pamela

1988-01-01

246

Pharmaceutical Services in Long Term Care Facilities.  

National Technical Information Service (NTIS)

Information pertinent to the development of policies and procedures for pharmaceutical services in long-term care facilities in the State of Washington is presented. Topics to be included in policy and procedures manuals are outlined, with references to a...

1976-01-01

247

Long-term outcome after coronary stenting  

PubMed Central

The present review assesses the data on long-term outcome after coronary stenting. Histological, angiographical and intravascular imaging data have shown that the insertion of stents constitutes only a transient stimulus to lumen renarrowing, that this process is almost complete at 6 months and that a certain degree of neointima regression is also possible after this time. Clinical data have confirmed the sustained benefit of stenting in the long term. Careful selection of optimal stent designs and application of the recent advances in adjunctive pharmacological therapy are currently effective strategies to improve both short-and long-term results with coronary stenting. However, further efforts are needed and are ongoing to combat restenosis, a process that counters the excellent short-term results of stenting in the long term. PMID:11714409

Kastrati, Adnan; Hall, Donald; Schomig, Albert

2000-01-01

248

Long Term TOA - M Data and Information  

... 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 ...

2014-08-06

249

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

SciTech Connect

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.

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

250

Surgical and conservative treatment of patients with congenital scoliosis: ? search for long-term results  

PubMed Central

Background In view of the limited data available on the conservative treatment of patients with congenital scoliosis (CS), early surgery is suggested in mild cases with formation failures. Patients with segmentation failures will not benefit from conservative treatment. The purpose of this review is to identify the mid- or long-term results of spinal fusion surgery in patients with congenital scoliosis. Methods Retrospective and prospective studies were included, reporting on the outcome of surgery in patients with congenital scoliosis. Studies concerning a small numbers of cases treated conservatively were included too. We analyzed mid-term (5 to 7 years) and long-term results (7 years or more), both as regards the maintenance of the correction of scoliosis and the safety of instrumentation, the early and late complications of surgery and their effect on quality of life. Results A small number of studies of surgically treated patients were found, contained follow-up periods of 4-6 years that in the most cases, skeletal maturity was not yet reached, and few with follow-up of 36-44 years. The results of bracing in children with congenital scoliosis, mainly in cases with failure of formation, were also studied. Discussion Spinal surgery in patients with congenital scoliosis is regarded in short as a safe procedure and should be performed. On the other hand, early and late complications are also described, concerning not only intraoperative and immediate postoperative problems, but also the safety and efficacy of the spinal instrumentation and the possibility of developing neurological disorders and the long-term effect these may have on both lung function and the quality of life of children. Conclusions Few cases indicate the long-term results of surgical techniques, in the natural progression of scoliosis. Similarly, few cases have been reported on the influence of conservative treatment. In conclusion, patients with segmentation failures should be treated surgically early, according to the rate of deformity formation and certainly before the pubertal growth spurt to try to avoid cor- pulmonale, even though there is lack of evidence for that in the long-term. Furthermore, in patients with formation failures, further investigation is needed to document where a conservative approach would be necessary. PMID:21639924

2011-01-01

251

Long-term solar activity predictions  

NASA Technical Reports Server (NTRS)

The need for long term solar activity predictions is addressed. The spatial organization of solar activity is described including applications for predictions, and ancient evidence for solar variability. Methods of predicting sunspot numbers are discussed. The inherent accuracy of the methods varies considerably, but a typical error bar 20%. The accuracy of sunspot cycle predictions is considered along with long term predictions of great solar events.

Mcintosh, P. S.; Brown, G. M.; Buhmann, R.; Clark, T.; Fougere, P. F.; Hunter, H.; Lincoln, J. V.; Sargent, H. H., III; Timothy, J. G.; Lin, Y. Z.

1979-01-01

252

Long-Term Outcome of Fetal Hydrocephaly  

Microsoft Academic Search

Long-term outcome of 25 fetuses with ventriculomegaly diagnosed before delivery who survived the neonatal period up to school age was examined at 10.1 (standard deviation, 2.6) years of age. Twelve children had normal motor and mental development, seven were severely handicapped, and six showed intermediate outcome. The fetuses with severe handicaps on long-term follow-up had more severe ventricular dilation than

Pertti Kirkinen; Willy Serlo; Pentti Jouppila; Markku Ryynänen; Anneli Martikainen

1996-01-01

253

Long Term Outcomes after Pediatric Liver Transplantation  

PubMed Central

Long term outcomes after liver transplantation are major determinants of quality of life and of the value of this heroic treatment. As short term outcomes are excellent, our community is turning to take a harder look at long term outcomes. The purpose of this paper is to review these outcomes, and highlight proposed treatments, as well as pressing topics needing to be studied. A systemic review of the English literature was carried in PubMed, covering all papers addressing long term outcomes in pediatric liver transplant from 2000-2013. Late outcomes after pediatric liver transplant affect the liver graft in the form of chronic liver dysfunction. The causes include rejection particularly humoral rejection, but also de novo autoimmune hepatitis, and recurrent disease. The metabolic syndrome is a major factor in long term cardiovascular complication risk. Secondary infections, kidney dysfunction and malignancy remain a reality of those patients. There is growing evidence of late cognitive and executive function delays affecting daily life productivity as well as likely adherence. Finally, despite a good health status, quality of life measures are comparable to those of children with chronic diseases. Long term outcomes are the new frontier in pediatric liver transplantation. Much is needed to improve graft survival, but also to avoid systemic morbidities from long term immunosuppression. Quality of life is a new inclusive measure that will require interventions and innovative approaches respectful not only on the patients but also of their social circle. PMID:24511516

2013-01-01

254

Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up  

PubMed Central

Background: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. Objective: To evaluate the efficacy and safety of drug-eluting stents in the real world. Methods: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. Results: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. Conclusion: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the "real world" may benefit from drug-eluting stenting with excellent, long-term results. PMID:25098375

Pellegrini, Denise Oliveira; Gomes, Vitor Osorio; Lasevitch, Ricardo; Smidt, Luis; Azeredo, Marco Aurelio; Ledur, Priscila; Bodanese, Rodrigo; Sinnott, Leonardo; Moriguchi, Emilio; Caramori, Paulo

2014-01-01

255

Long-Term Therapy with the Guanine Nucleoside Analog Penciclovir Controls Chronic Duck Hepatitis B Virus Infection In Vivo  

PubMed Central

Ducks congenitally infected with duck hepatitis B virus (DHBV) were treated with the antiviral guanine nucleoside analog penciclovir for 12 or 24 weeks at a dosage of 10 mg/kg of body weight per day. By the completion of both 12 and 24 weeks of therapy, molecular hybridization studies of the liver tissue revealed that the viral DNA, RNA, and protein levels were significantly reduced compared to those in the placebo-treated controls. Penciclovir treatment for 12 or 24 weeks was not associated with any toxicity, establishing the efficacy and safety of long-term penciclovir therapy in chronic DHBV infection. PMID:9687423

Lin, Enjarn; Luscombe, Carolyn; Colledge, Danni; Wang, Yan Yan; Locarnini, Stephen

1998-01-01

256

Long-term treatment of chronic obstructive pulmonary disease with salmeterol and the additive effect of ipratropium  

Microsoft Academic Search

ABSTRACT: The efficacy and,safety of salmeterol alone was,compared,with the combination,of salmeterol,plus ipratropium,and,with placebo,during,long-term treatment in patients with stable chronic obstructive pulmonary disease. In addition, the single-dose effect in response,to the first dose of treatment,was studied over 12 h. The patients (n=144; age 64ã7 yrs, forced expiratory volume in one second (FEV1) 44ã11% pred) participated in a three-centre double-blind double-placebo,parallel group,study

J. A. van Noord; Th. A. Bantje; W. C. J. Hop; M. l. m. Akveld; A. m. Bommer

2000-01-01

257

Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10% povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study.  

PubMed

The efficacy of 1% chlorhexidine-gluconate ethanol and 10% povidone-iodine for skin antisepsis of central venous catheter (CVC) sites were compared among hematology patients. The CVC site colonization rates of those groups were 11.9% and 29.2%, respectively, and the catheter-associated blood stream infections were 0.75 and 3.62 per 1,000 catheter-days, respectively. One percent chlorhexidine-gluconate ethanol was superior to povidone-iodine to reduce skin colonizers at CVC sites even when catheters were used for long duration. PMID:24655901

Yamamoto, Natsuo; Kimura, Hideo; Misao, Hanako; Matsumoto, Hayato; Imafuku, Yuji; Watanabe, Akemi; Mori, Hiroko; Yoshida, Akiko; Miura, Saori; Abe, Yoshinobu; Toba, Mamoru; Suzuki, Hiromi; Ogawa, Kazuei; Kanemitsu, Keiji

2014-05-01

258

Physiological, Molecular and Genetic Mechanisms of Long-Term Habituation  

SciTech Connect

Work funded on this grant has explored the mechanisms of long-term habituation, a ubiquitous form of learning that plays a key role in basic cognitive functioning. Specifically, behavioral, physiological, and molecular mechanisms of habituation have been explored using a simple model system, the tail-elicited siphon-withdrawal reflex (T-SWR) in the marine mollusk Aplysia californica. Substantial progress has been made on the first and third aims, providing some fundamental insights into the mechanisms by which memories are stored. We have characterized the physiological correlates of short- and long-term habituation. We found that short-term habituation is accompanied by a robust sensory adaptation, whereas long-term habituation is accompanied by alterations in sensory and interneuron synaptic efficacy. Thus, our data indicates memories can be shifted between different sites in a neural network as they are consolidated from short to long term. At the molecular level, we have accomplished microarray analysis comparing gene expression in both habituated and control ganglia. We have identified a network of putatively regulated transcripts that seems particularly targeted towards synaptic changes (e.g. SNAP25, calmodulin) . We are now beginning additional work to confirm regulation of these transcripts and build a more detailed understanding of the cascade of molecular events leading to the permanent storage of long-term memories. On the third aim, we have fostered a nascent neuroscience program via a variety of successful initiatives. We have funded over 11 undergraduate neuroscience scholars, several of whom have been recognized at national and regional levels for their research. We have also conducted a pioneering summer research program for community college students which is helping enhance access of underrepresented groups to life science careers. Despite minimal progress on the second aim, this project has provided a) novel insight into the network mechanisms by which short-term memories are permanently stored, and b) a strong foundation for continued growth of an excellent undergraduate neuroscience program.

Calin-Jageman, Robert J

2009-09-12

259

Using the CHANGE intervention to enhance long-term exercise.  

PubMed

Although Phase II Cardiac Rehabilitation (CR) is effective at reconditioning people following cardiac events, it has had limited effectiveness in assisting participants to maintain the long-term exercise necessary for secondary prevention of cardiovascular events. This article describes a promising new intervention, CHANGE (Change Habits by Applying New Goals and Experiences), designed to enhance individuals' problem solving, self-efficacy, and relapse prevention skills regarding long-term exercise. Five small-group, nurse-led sessions are used to provide the intervention during the last three weeks of the formal CR program, and at one and two months following CR. Pilot data indicate that the CHANGE intervention has a positive effect on number and length of exercise sessions, number of minutes exercised, and time spent in target heart rate (HR) zone as measured by wristwatch HR monitors for three months following CR. The CHANGE intervention was found to be acceptable to clients and feasible to clinicians. PMID:12389268

Moore, Shirley M; Charvat, Jacqueline M

2002-06-01

260

Long-term surveillance plan for the South Clive disposal site Clive, Utah  

SciTech Connect

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 South Clive disposal site in Clive, Utah. This LSTP describes the long-term surveillance program the DOE will implement to ensure the South Clive 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.

NONE

1997-09-01

261

Long-term surveillance plan for the Cheney disposal site near Grand Junction, Colorado  

SciTech Connect

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 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.

NONE

1997-07-01

262

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

SciTech Connect

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.

NONE

1997-08-01

263

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

SciTech Connect

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.

NONE

1997-07-01

264

Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort  

PubMed Central

Aims The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis. Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent. Methods We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year. Results The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%. Conclusions The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up. PMID:24973842

Xhepa, E.; Tada, T.; Cassese, S.; King, L.; Ott, I.; Fusaro, M.; Kastrati, A.; Byrne, R.A.

2014-01-01

265

Perceptual Correlates of Nociceptive Long-Term Potentiation and Long-Term Depression in Humans  

Microsoft Academic Search

Long-term potentiation (LTP) and long-term depression (LTD) of synaptic strength are ubiquitous mechanisms of synaptic plasticity, but their functional relevance in humans remains obscure. Here we report that a long-term increase in perceived pain to electrical test stimuli was induced by high-frequency electrical stimulation (HFS) (5 1 sec at 100 Hz) of peptidergic cutaneous afferents (27% above baseline, undiminished for3

Thomas Klein; Walter Magerl; Hanns-Christian Hopf; Jurgen Sandkuhler; Rolf-Detlef Treede

2004-01-01

266

Enteral feeding pumps: efficacy, safety, and patient acceptability  

PubMed Central

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

White, Helen; King, Linsey

2014-01-01

267

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

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

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

2014-01-01

268

Long Term Changes in Marine Fisheries  

NSDL National Science Digital Library

This Issue focuses on a research article by Barange (2003) that was published in Frontiers in Ecology and the Environment. The article discusses long-term (inter-decadal and longer) patterns of change in marine species in the context of over-exploitation of marine fisheries. BarangeÃÂs emphasis is use of ecosystem-based management practice to move us towards sustainable fisheries. However, he questions whether we know enough about patterns and causes of long term change in marine ecosystems to develop such practices.

D'Avanzo, Charlene

2010-02-16

269

Scenarios for long-term analysis  

SciTech Connect

Data Preservation and Long-Term Analysis of High Energy Physics (HEP) Experiments data is described and summarized in this talk. The summary covers information presented at the First Workshop on Data Preservation and Long-Term Analysis. Experiments representing e{sup +}e{sup -} collisions (LEP, B Factories and CLEO), ep collisions (H1 and ZEUS), p{bar p} collisions (CDF and D0) and others presented interesting information related to utilizing the large datasets collected over many years at these HEP facilities. Many questions and issues remain to be explored.

Wolbers, Stephen; /Fermilab

2009-01-01

270

Medical therapy of acromegaly: efficacy and safety of somatostatin analogues.  

PubMed

Acromegaly is a chronic disease with signs and symptoms due to growth hormone (GH) excess. The most frequent cause of acromegaly is a GH-producing pituitary adenoma. Chronic GH excess is accompanied by long-term complications of the locomotor (arthrosis) and cardiovascular (atherosclerosis, cardiomyopathy) systems and is, when untreated, associated with an increased mortality. The aim of treatment of acromegaly is to improve symptoms, to achieve local tumour mass control, and to decrease morbidity and mortality. Treatment options include surgery, medical therapy and radiotherapy. Transsphenoidal surgery is the first choice of treatment when a definitive cure can be achieved, particularly in the case of microadenomas and when decompression of surrounding structures (optic chiasm, ophthalmic motor nerves) is indicated. Primary medical therapy has been increasingly applied in recent years, especially when a priori chances of surgical cure are low (because of adenoma size and localization) and in patients with advanced age and/or serious co-morbidity. In addition, preoperative primary medical therapy may result in tumour shrinkage, facilitating tumour resection, and may reduce perioperative complications due to GH excess. Within the spectrum of medical therapy, long-acting somatostatin analogues (somatostatins) are considered as first-line treatment. Treatment with somatostatin analogues results in GH control in approximately 60% of patients. In addition, somatostatin analogues induce tumour shrinkage in 30-50% of patients, particularly when applied as primary therapy. Prolonged treatment with somatostatin analogues appears to be safe and is usually well tolerated. The currently available somatostatin analogues, octreotide and lanreotide, seem to be equally effective; however, this should still be evaluated in prospective, randomized trials evaluating efficacy with respect to GH control and tumour shrinkage. In patients with an insufficient clinical and biochemical response to somatostatin analogues, combination therapy with dopamine receptor agonists or the GH receptor antagonist pegvisomant usually leads to disease control. New developments in the medical therapy of acromegaly include the universal somatostatin receptor agonist pasireotide, which has a broader affinity for all somatostatin receptor (sst) subtypes compared with the currently available somatostatin analogues with preferential affinity for the sst2 receptor, and chimeric compounds that interact with both somatostatin and dopamine receptors with synergizing effects on GH secretion. PMID:19852525

Feelders, Richard A; Hofland, Leo J; van Aken, Maarten O; Neggers, Sebastian J; Lamberts, Steven W J; de Herder, Wouter W; van der Lely, Aart-Jan

2009-11-12

271

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

PubMed Central

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.

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

272

Safety and Efficacy of Supervised Strength Training Adopted in Pregnancy  

PubMed Central

Objective Describe safety and efficacy of a supervised, low-to-moderate intensity strength training program adopted during pregnancy among women at increased risk for back pain. Methods 32 women adopted strength training twice per week for 12 weeks. Data on musculoskeletal injuries, symptoms, blood pressure, and the absolute external load used for 5 of 6 exercises were obtained during each session. A submaximal lumbar extension endurance exercise test was performed at weeks 5, 10, and 13. Results The mean (± SD) exercise session attendance rate was 80.5% (± 11.3%). No musculoskeletal injuries occurred. Potentially adverse symptoms (eg, dizziness) were infrequent (2.1% of sessions). Repeated-measures ANOVA showed large increases in the external load across 12 weeks (all P values < .001) and the percentage increases in external load from weeks 1 to 12 were 36% for leg press, 39% for leg curl, 39% for lat pull down, 41% for lumbar extension and 56% for leg extension. Training was associated with a 14% increase in lumbar endurance. Blood pressure was unchanged following acute exercise sessions and after 12 weeks of exercise training. Conclusion The adoption of a supervised, low-to-moderate intensity strength training program during pregnancy can be safe and efficacious for pregnant women. PMID:21487130

O'Connor, Patrick J.; Poudevigne, Melanie S.; Cress, M. Elaine; Motl, Robert W.; Clapp, James F.

2014-01-01

273

Long-Term Impacts of Educational Interventions  

ERIC Educational Resources Information Center

The school accountability movement has led to a marked increase in the use of standardized test scores to measure school and teacher productivity, yet little is known about the correlation between test score gains and improvements in long-term outcomes. In the first chapter of my dissertation, I study the impact of a school choice policy in…

Deming, David James

2010-01-01

274

Titanium for long-term tritium storage  

Microsoft Academic Search

Due to the reduction of nuclear weapon stockpile, there will be an excess of tritium returned from the field. The excess tritium needs to be stored for future use, which might be several years away. A safe and cost effective means for long term storage of tritium is needed. Storing tritium in a solid metal tritide is preferred to storing

Heung

1994-01-01

275

Long-Term Stability of Social Participation  

ERIC Educational Resources Information Center

The long-term stability of social participation was investigated in a representative urban population of 415 men and 579 women who had taken part in the nationwide Mini-Finland Health Survey in the years 1978-1980 and were re-examined 20 years later. Stability was assessed by means of the following tracking coefficients: kappa, proportion of…

Hyyppa, Markku T.; Maki, Juhani; Alanen, Erkki; Impivaara, Olli; Aromaa, Arpo

2008-01-01

276

Medication error reporting in long term care  

Microsoft Academic Search

Background:Medication errors are common causes of medical error in the long-term care (LTC) setting. Despite their frequency and potential clinical impact, most medication errors in LTC facilities remain unreported. Before better reporting systems can be developed to reduce clinically significant medication errors, it is necessary to understand how current medication error reporting systems function.

Steven M. Handler; David A. Nace; Stephanie A. Studenski; Douglas B. Fridsma

2004-01-01

277

Long-term treatment with recombinant  

E-print Network

Long-term treatment with recombinant nerve growth factor for HIV-associated sensory neuropathy and significantly im- proved pain symptoms. However, there was no improvement of neuropathy severity as assessed antiretroviral zal- citabine, didanosine, and stavudine is associated with a toxic neuropathy clinically similar

Steinbach, Joe Henry

278

Long-term stabilization of assay components  

Microsoft Academic Search

Reliable long-term stabilization of immunoassay components is beneficial in many applications. Stabilization and storage of components are important for effective workflows not only for performing large numbers of ELISA but also for medium and small numbers of ELISA. This article deals with the state of the art - particularly with regard to food, veterinary or clinical diagnostics. Clinical immuno diagnostics

Tobias Polifke; Peter Rauch

279

Long-Term Perspectives on Giant Earthquakes  

E-print Network

Long-Term Perspectives on Giant Earthquakes and Tsunamis at Subduction Zones Kenji Satake1. Such variation in rupture mode, known from written history at a few subduction zones, is also characteristic, Cascadia, Hokkaido Abstract Histories of earthquakes and tsunamis, inferred from geological ev- idence, aid

280

Factors in Long-Term Marriages  

Microsoft Academic Search

There are few empirical studies of the factors involved in long-term marriages. The present study involves a nonrandom sample of 351 couples who have been married 15 years or more. Differences were found in the reported reasons for staying together between happy, unhappy, and mixed (one partner happy and one unhappy) marriages. For happy couples, the most frequently mentioned reason

ROBERT H. LAUER; JEANETTE C. LAUER

1986-01-01

281

LONG-TERM POTENTIATION AND LEARNING  

Microsoft Academic Search

Long-term potentiation (LTP), a relatively long-lived increase in synaptic strength, remains the most popular model for the cellular process that may underlie information storage within neural systems. The strongest arguments for a role of LTP in memory are theoretical and involve Hebb's Postulate, Marr's theory of hippocampal function, and neural network theory. Considering LTP research as a whole, few studies

Joe L. Martinez; Brian E. Derrick

1996-01-01

282

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...

283

Neonatal desensitization allows long-term  

E-print Network

to achieve long-term survival of human neural grafts in the adult mammalian brain, based on desensitizing in Table 1. All experimental and surgical procedures were conducted under the UK Animals (Scientific Procedures) Act 1986, and subject to local ethical review and the relevant personal, project and institution

Cai, Long

284

Long-term Silvicultural & Ecological Studies  

E-print Network

Long-term Silvicultural & Ecological Studies Results for Science and Management: Volume 2 Ann E & Ecological Studies Results for Science and Management: Volume 2 Ann E. Camp Yale School of Forestry LTER Glenn Patrick Juday 31 The Rosie Creek Fire Tree Regeneration Installation: A Large White Spruce

285

3, 12491280, 2006 Long-term impacts  

E-print Network

and in particular developments in water storage in reservoirs and consumption for irrigation, drinking water System Sciences Detecting the long-term impacts from climate variability and increasing water consumption-use and water consumption can have profound effects on river runoff. There is an increasing demand to study

Paris-Sud XI, Université de

286

Understanding long-term environmental risks  

Microsoft Academic Search

How well we manage long-term environmental risks depends on how well we understand them. Whether the risk managers are experts or laypeople, that understanding is typically limited. As a result, people must rely on judgment when making decisions about risks. Estimating how big risks are and how much reducing them is worth is an intellectual skill. After reviewing the behavioral

Baruch Fischhoff

1990-01-01

287

Protein Phosphorylation and Long-term Synaptic  

E-print Network

Protein Phosphorylation and Long-term Synaptic Plasticity A Barria, Oregon Health Sciences University, Portland, Oregon, USA V Derkach,Oregon Health Sciences University, Portland, Oregon, USA TR Soderling,Oregon Health Sciences University, Portland, Oregon, USA Learning and memory are complex

Malinow, Roberto

288

Attachment style and long-term singlehood  

Microsoft Academic Search

This study examined how long-term single people satisfy their attachment and sexual needs. A community sample of single and coupled adults (N ¼ 142) located in the United States completed measures of attachment style, attachment figures, loneliness, depression, anxiety, quality of relationships with parents, and sexual behavior. In a structured interview, they answered questions about their childhoods and managing attachment,

DORY A. SCHACHNER; PHILLIP R. SHAVER; OMRI GILLATHc

2008-01-01

289

Efficacy and safety of febuxostat in the treatment of hyperuricemia in stable kidney transplant recipients  

PubMed Central

Background Post-transplant hyperuricemia (PTHU), defined as serum uric acid concentration ?7.0 mg/dL or need for treatment with allopurinol or benzbromarone, reduces long-term allograft survival in kidney transplant recipients. Febuxostat, a new nonpurine selective xanthine oxidase inhibitor, is well tolerated in patients with moderate renal impairment. However, its efficacy and safety in kidney recipients with PTHU is unclear. We therefore assessed the efficacy and safety of febuxostat in stable kidney transplant recipients with PTHU. Methods Of 93 stable adult kidney transplant recipients, 51 were diagnosed with PTHU (PTHU group) and 42 were not (NPTHU group). Of the 51 patients with PTHU, 26 were treated with febuxostat (FX group) and 25 were not (NFX group), at the discretion of each attending physician. One-year changes in serum uric acid concentrations, rates of achievement of target uric acid (<6.0 mg/dL), estimated glomerular filtration rates in allografts, and adverse events were retrospectively analyzed in the FX, NFX, and NPTHU groups. Results The FX group showed significantly greater decreases in serum uric acid (?2.0±1.1 mg/dL versus 0.0±0.8 mg/dL per year, P<0.01) and tended to show a higher rate of achieving target uric acid levels (50% versus 24%; odds ratio 3.17 [95% confidence interval 0.96–10.5], P=0.08) than the NFX group. Although baseline allograft estimated glomerular filtration rates tended to be lower in the FX group than in the NFX group (40±14 mL/min/1.73 m2 versus 47±19 mL/min/1.73 m2), changes in allograft estimated glomerular filtration rate were similar (+1.0±4.9 mL/min/1.73 m2 versus ?0.2±6.9 mL/min/1.73 m2 per year, P=0.50). None of the patients in the FX group experienced any severe adverse effects, such as pancytopenia or attacks of gout, throughout the entire study period. Nephrologists were more likely than urologists to start febuxostat in kidney transplant recipients with PTHU (69% versus 8%). Conclusion Treatment with febuxostat sufficiently lowered uric acid levels without severe adverse effects in stable kidney transplant recipients with PTHU. PMID:24600205

Sofue, Tadashi; Inui, Masashi; Hara, Taiga; Nishijima, Yoko; Moriwaki, Kumiko; Hayashida, Yushi; Ueda, Nobufumi; Nishiyama, Akira; Kakehi, Yoshiyuki; Kohno, Masakazu

2014-01-01

290

Long-term Results of Endovascular Stent Graft Placement of Ureteroarterial Fistula  

SciTech Connect

PurposeTo evaluate the safety, efficacy, and long-term results of endovascular stent graft placement for ureteroarterial fistula (UAF).MethodsWe retrospectively analyzed stent graft placement for UAF performed at our institution from 2004 to 2012. Fistula location was assessed by contrast-enhanced computed tomography (CT) and angiography, and freedom from hematuria recurrence and mortality rates were estimated.ResultsStent graft placement for 11 UAFs was performed (4 men, mean age 72.8 {+-} 11.6 years). Some risk factors were present, including long-term ureteral stenting in 10 (91 %), pelvic surgery in 8 (73 %), and pelvic radiation in 5 (45 %). Contrast-enhanced CT and/or angiography revealed fistula or encasement of the artery in 6 cases (55 %). In the remaining 5 (45 %), angiography revealed no abnormality, and the suspected fistula site was at the crossing area between urinary tract and artery. All procedures were successful. However, one patient died of urosepsis 37 days after the procedure. At a mean follow-up of 548 (range 35-1,386) days, 4 patients (36 %) had recurrent hematuria, and two of them underwent additional treatment with secondary stent graft placement and surgical reconstruction. The hematuria recurrence-free rates at 1 and 2 years were 76.2 and 40.6 %, respectively. The freedom from UAF-related and overall mortality rates at 2 years were 85.7 and 54.9 %, respectively.ConclusionEndovascular stent graft placement for UAF is a safe and effective method to manage acute events. However, the hematuria recurrence rate remains high. A further study of long-term results in larger number of patients is necessary.

Okada, Takuya, E-mail: okabone@gmail.com; Yamaguchi, Masato, E-mail: masato03310402@yahoo.co.jp [Kobe University Hospital, Department of Radiology (Japan); Muradi, Akhmadu, E-mail: muradiakhmadu@gmail.com; Nomura, Yoshikatsu, E-mail: y_katsu1027@yahoo.co.jp [Kobe University Hospital, Center for Endovascular Therapy (Japan); Uotani, Kensuke, E-mail: uotani@tenriyorozu.jp [Tenri Hospital, Department of Radiology (Japan); Idoguchi, Koji, E-mail: idoguchi@ares.eonet.ne.jp [Kobe University Hospital, Center for Endovascular Therapy (Japan); Miyamoto, Naokazu, E-mail: naoka_zu@yahoo.co.jp; Kawasaki, Ryota, E-mail: kawaryo1999@yahoo.co.jp [Hyogo Brain and Heart Center at Himeji, Department of Radiology (Japan); Taniguchi, Takanori, E-mail: tan9523929@yahoo.co.jp [Tenri Hospital, Department of Radiology (Japan); Okita, Yutaka, E-mail: yokita@med.kobe-u.ac.jp [Kobe University Hospital, Department of Cardiovascular Surgery (Japan); Sugimoto, Koji, E-mail: kojirad@med.kobe-u.ac.jp [Kobe University Hospital, Department of Radiology (Japan)

2013-08-01

291

Long-term consequences of severe infections.  

PubMed

There are convincing data to show that the consequences of a severe infection extend well beyond the first month following it. During the first year after severe sepsis or infection, the survival of sepsis patients is guarded compared with matched control groups. Their quality of life is impaired, and they suffer from rapid degradation in cognition and functional capacity. We could postulate three explanations for the long-term bad outcomes of severe infections and sepsis (or a combination of the three): (i) sepsis usually happens in the elderly and sick, and it causes deterioration in life expectancy and functional status as an acute, non-specific event; (ii) an interaction between specific mechanisms of sepsis and underlying disorders; or (iii) long-term complications directly related to infection. If the second or third explanations are true, then management of the original infection/sepsis might have an influence on long-term outcomes. Elderly survivors of severe infections should be carefully assessed for whether they need intermediate care for recuperation and re-conditioning when leaving hospital. We need prospective, observational studies to define which are the factors that most influence long-term outcomes, and especially management of the acute infection. The investigation of long-term outcomes in trials of treatment modalities for sepsis or severe infections should be encouraged. The true answer for whether one treatment is better than another in severe infections or sepsis lies in the people trajectory in the year following the infection, and not only on 4-6 weeks outcome. PMID:23397980

Leibovici, L

2013-06-01

292

The risks and benefits of long-term use of hydroxyurea in sickle cell anemia: A 17.5 year follow-up.  

PubMed

A randomized, controlled clinical trial established the efficacy and safety of short-term use of hydroxyurea in adult sickle cell anemia. To examine the risks and benefits of long-term hydroxyurea usage, patients in this trial were followed for 17.5 years during which they could start or stop hydroxyurea. The purpose of this follow-up was to search for adverse outcomes and estimate mortality. For each outcome and for mortality, exact 95% confidence intervals were calculated, or tests were conducted at alpha = 0.05 level (P-value <0.05 for statistical significance). Although the death rate in the overall study cohort was high (43.1%; 4.4 per 100 person-years), mortality was reduced in individuals with long-term exposure to hydroxyurea. Survival curves demonstrated a significant reduction in deaths with long-term exposure. Twenty-four percent of deaths were due to pulmonary complications; 87.1% occurred in patients who never took hydroxyurea or took it for <5 years. Stroke, organ dysfunction, infection, and malignancy were similar in all groups. Our results, while no longer the product of a randomized study because of the ethical concerns of withholding an efficacious treatment, suggest that long-term use of hydroxyurea is safe and might decrease mortality. PMID:20513116

Steinberg, Martin H; McCarthy, William F; Castro, Oswaldo; Ballas, Samir K; Armstrong, F Danny; Smith, Wally; Ataga, Kenneth; Swerdlow, Paul; Kutlar, Abdullah; DeCastro, Laura; Waclawiw, Myron A

2010-06-01

293

Efficacy and food safety considerations of poultry competitive exclusion products.  

PubMed

Competitive exclusion (CE) products are anaerobic cultures of bacteria that are applied to poultry hatchlings to establish a protective enteric microbiota that excludes intestinal colonization by human food-borne pathogens. For safety of the poultry flock and human consumers, the identities of bacteria in CE products need to be known. A CE product is a culture of intestinal contents from adult chickens. It may be microbiologically defined by analysis of bacteria isolated from the culture, but many bacteria are hard to reliably isolate, identify, and characterize with conventional techniques. Sequence analysis of 16S ribosomal RNA (rRNA) genes may be more reliable than conventional techniques to identify CE bacteria. Bacteria in CE products may contain antimicrobial drug resistance and virulence mechanisms that could be transferred to the enteric bacteria of the food animal and to the human consumer. Detection methods for specific antimicrobial drug resistance and virulence genes and the integrase genes of conjugative transposons, mostly utilizing PCR technology, are being developed that can be applied to assess these risks in CE bacteria. With improvements in efficacy, bacterial identification, and detection and control of the possible risks of gene transfer, CE product technology can be made a more effective food safety tool. PMID:17039457

Wagner, Robert Doug

2006-11-01

294

Bowel preparation for colonoscopy: efficacy, tolerability and safety.  

PubMed

Adequate cleansing of the bowel is important for a reliable and diagnostic colonoscopy. Proper bowel preparation is directly correlated to the diagnostic performance of colonoscopy, procedure time, cost price and the complication rate. The ideal bowel preparation agent should be efficient, safe and well tolerated by the patient. Numerous agents have become commercially available overtime. Current agents can be classified according to their tonicity, as being isotonic or hypertonic. Poly-ethylene glycol based solutions balanced with electrolytes are the prototype of isotonic bowel preparations. Poly-ethylene solutions are safe and efficient in cleaning the bowel. Volume related side-effects are common, leading to innovations such as split dosing, and low volume solution combined with another laxative. Sodium phosphate and magnesium oxide are hypertonic agents. They are efficient and well tolerated, but safety issues regarding sodium phosphate has hampered its success. Because most physician are likely to prescribe bowel preparation agents for colonoscopy, they should be aware of the range of preparations commercially available and their limitations. This review focuses on the efficacy, tolerability and safety of current available bowel preparation agents. PMID:25090824

Martens, Pieter; Bisschops, Raf

2014-06-01

295

Efficacy and Safety of Echinacoside in a Rat Osteopenia Model  

PubMed Central

This study aimed to investigate the efficacy and safety of echinacoside (ECH) using an osteopenia rat model. Forty-eight 6-month-old female Sprague-Dawley rats were randomly divided into one sham-operated group (SHAM) and five OVX (ovariectomized) subgroups: SHAM with vehicle 0.5% carboxymethylcellulose sodium (0.5% CMC-Na) and OVX with vehicle (OVX), OVX with 17?-estradiol (E2), and OVX with ECH of graded doses (ECH-L, ECH-M, and ECH-H). The effects of ECH and E2 on serum biochemical parameters, bone mineral density (BMD), bone biomechanical properties, bone microarchitecture, and immunohistochemistry were examined, and safety assessments were also evaluated. The results showed that ECH treatments improved total femur BMD, bone microarchitecture, and biomechanical properties and decreased serum marker levels in comparison to OVX group. Moreover, ECH administration significantly increased osteoprotegerin (OPG) level, and decreased receptor activator of nuclear factor-?B ligand (RANKL) level in serum, as well as in proximal femur. Importantly, ECH treatment ameliorated the lipid parameters without the overall incidences of adverse events of uterus and mammary gland compared to OVX and SHAM groups. This study demonstrated that administration of ECH for 12 weeks can effectively and safely prevent OVX-induced osteoporosis in rats via increasing the OPG/RANKL ratio. PMID:23573159

Yang, Xiaolin; Li, Fei; Yang, Yanan; Shen, Jinyang; Zou, Run; Zhu, Panpan; Zhang, Chunfeng; Yang, Zhonglin; Li, Ping

2013-01-01

296

Efficacy and safety of balloon kyphoplasty in the treatment of vertebral compression fractures: a systematic review  

Microsoft Academic Search

The aim of this study is to evaluate the efficacy and safety of balloon kyphoplasty (BK) in the management of vertebral compression fractures (VCFs). This study is based on a systematic review of the literature (until October 2004) and meta-analysis of clinical studies assessing the efficacy and safety of BK in the treatment of VCFs. Estimates of effect were based

Carmen Bouza; Teresa López; Angeles Magro; Lourdes Navalpotro; José María Amate

2006-01-01

297

Efficacy of a Food Safety Comic Book on Knowledge and Self-Reported Behavior for Persons Living with AIDS  

PubMed Central

Introduction Persons living with AIDS are highly vulnerable to foodborne enteric infections with the potential for substantial morbidity and mortality. Educational materials about foodborne enteric infections intended for this immunocompromised population have not been assessed for their efficacy in improving knowledge or encouraging behavior change. Methods/Results AIDS patients in four healthcare facilities in Chicago, New Orleans, and Puerto Rico were recruited using fliers and word of mouth to healthcare providers. Those who contacted research staff were interviewed to determine food safety knowledge gaps and risky behaviors. A food safety educational comic book that targeted knowledge gaps was created, piloted, and provided to these patients who were instructed to read it and return at least 2 weeks later for a follow-up interview. The overall food safety score was determined by the number of the 26 knowledge/belief/behavior questions from the survey answered correctly. Among 150 patients who participated in both the baseline and follow-up questionnaire, the intervention resulted in a substantial increase in the food safety score (baseline 59%, post-intervention 81%, p<0.001). The intervention produced a significant increase in all the food safety knowledge, belief, and behavior items that comprised the food safety score. Many of these increases were from baseline knowledge below 80 percent to well above 90%. Most (85%) of the patients stated they made a change to their behavior since receiving the educational booklet. Conclusion This comic book format intervention to educate persons living with AIDS was highly effective. Future studies should examine to what extent long-term behavioral changes result. PMID:24124447

Dworkin, Mark S.; Peterson, Caryn E.; Gao, Weihua; Mayor, Angel; Hunter, Robert; Negron, Edna; Fleury, Alison; Besch, C. Lynn

2013-01-01

298

The efficacy and safety of enhanced external counterpulsation in patients with peripheral arterial disease.  

PubMed

Peripheral arterial disease (PAD) is common in patients with severe coronary artery disease (CAD) and is considered a relative contraindication to external enhanced counterpulsation (EECP), but there are no data that define the efficacy and safety of EECP in patients with PAD. The International EECP Patient Registry (IEPR) was used to compare initial post-therapy and 2-year follow-up clinical outcomes and adverse event rates in patients with and without PAD. From January 2002 to October 2004, 2126 patients were enrolled in the IEPR, of whom 493 (23%) had a history of PAD. Immediately following EECP, the reduction in angina (> or = 1 Canadian Cardiovascular Society class) was similar in patients with and without PAD (76.6% vs 79.0%, p = 0.27) as was improvement in the Duke Activity Score Index (DASI) score (+4.7% vs +6.1%, p < 0.001). Both angina reduction and DASI score improvement were sustained at 2 years. PAD patients discontinued EECP more frequently (12.0% vs 8.5%, p < 0.05), but lower extremity ulceration did not occur more frequently in patients with PAD (3.7% vs 2.7%, p = 0.26). Rates of death (17.1% vs 8.6%, p < 0.001) and myocardial infarction (9.5% vs 5.0%, p < 0.001) were, as expected, higher in patients with PAD compared to patients without PAD at 2 years. In conclusion, while PAD patients constitute a high-risk cohort with known higher adverse event rates, EECP led to similar short- and long-term improvements in angina and quality of life for individuals with PAD compared to those without PAD. PMID:19841026

Thakkar, Bhavik V; Hirsch, Alan T; Satran, Daniel; Bart, Bradley A; Barsness, Gregory; McCullough, Peter A; Kennard, Elizabeth D; Kelsey, Sheryl F; Henry, Timothy D

2010-02-01

299

Long-term use of adalimumab in the treatment of moderate to severe plaque psoriasis: a review of the literature  

PubMed Central

Psoriasis is a chronic T-cell-mediated inflammatory disease that primarily affects the skin and joints. Patients with moderate to severe psoriasis constitute about 30% of the psoriasis population. Treatment of this group is challenging due to the long-term side effects, toxicities and inconvenience of conventional treatments such as phototherapy, methotrexate and cyclosporine. However, recent advances in our understanding of the pathogenesis of psoriasis have led to the popular use of biologics, which offer a safer, more convenient and effective targeted therapy. Adalimumab was originally approved for treating rheumatoid arthritis. Currently, adalimumab is also approved for treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy or when other systemic therapies are medically less appropriate. Since the onset of the use of biologics, there have been concerns over safety and efficacy when used as long-term therapy. This paper reviews all publications, posters and abstracts reporting original data on the efficacy and/or safety of adalimumab in patients treated for chronic plaque psoriasis for more than 1 year. PMID:21437059

Moore, Angela Y; Richardson, Blakely S

2010-01-01

300

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

PubMed Central

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

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

2014-01-01

301

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

Microsoft Academic Search

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

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

2000-01-01

302

Long-Term Outcome of Pneumatic Dilation in the Treatment of Achalasia  

Microsoft Academic Search

OBJECTIVE:Achalasia is a well-defined esophageal motor disorder for which pneumatic dilation is an established therapeutic method. Even though it has been used for several years, there are limited data on the long-term outcomes of patients treated with this procedure. Hence, we aimed to evaluate the long-term efficacy of pneumatic dilation to control the symptoms of achalasia.METHODS:The medical records of all

Georgios Karamanolis; Spiros Sgouros; Georgios Karatzias; Efthimia Papadopoulou; Konstantinos Vasiliadis; Gerasimos Stefanidis; Apostolos Mantides

2005-01-01

303

Video-assisted thoracoscopic surgery management of spontaneous pneumothorax — long-term results  

Microsoft Academic Search

Objective: Although widely adopted, there is lack of immediate and long-term follow-up data for patients undergoing video-assisted thoracoscopic surgery (VATS) management of pneumothorax. Therefore, we have reviewed our experience with both primary (PSP) and secondary (SSP) spontaneous pneumothorax to assess the perioperative outcomes and long-term efficacy associated with different VATS operative strategies. Methods: A retrospective case series review was undertaken

Kasra Shaikhrezai; Alexandra I. Thompson; Caroline Parkin; Steven Stamenkovic; William S. Walker

2011-01-01

304

BDNF: A key regulator for protein synthesis-dependent LTP and long-term memory?  

Microsoft Academic Search

It is generally believed that late-phase long-term potentiation (L-LTP) and long-term memory (LTM) require new protein synthesis. Although the full complement of proteins mediating the long-lasting changes in synaptic efficacy have yet to be identified, several lines of evidence point to a crucial role for activity-induced brain-derived neurotrophic factor (BDNF) expression in generating sustained structural and functional changes at hippocampal

Yuan Lu; Kimberly Christian; Bai Lu

2008-01-01

305

Efficacy and Safety of Bone Marrow Cell Transplantation for Chronic Ischemic Heart Disease: A Meta-Analysis  

PubMed Central

Background Although bone marrow-derived cells (BMCs) have shown great therapeutic potential in patients with chronic ischemic heart disease (CIHD), the exact efficacy and safety of BMCs therapy is still not completely defined. Material/Methods We searched PubMed, OVID, EMBASE, the Cochrane Library, and ClinicalTrials.gov and finally identified 20 qualified trials in this meta-analysis. Assessment of efficacy was based on left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV) improvement, by weighted mean difference (WMD) with 95% confidence intervals (CIs). Results of all-cause death, ventricular arrhythmia, recurrent myocardial infarction, and cerebrovascular accident were pooled to assess safety. Subgroup analysis was performed by stratifying RCTs into 2 subgroups of those with revascularization and without revascularization. Results BMC transplantation significantly improved LVEF in patients with revascularization (3.35%, 95% CI 0.72% to 5.97%, p=0.01; I2=85%) and without revascularization (3.05%, 95% CI 0.65% to 5.45%, p=0.01; I2=86%). In patients without revascularization, BMC transplantation was associated with significantly decreased LVESV (?11.75 ml, 95% CI ?17.81 ml to ?5.69 ml, p=0.0001; I2=81%), and LVEDV (?7.80 ml, 95% CI ?15.31 ml to ?0.29 ml, p=0.04; I2=39%). Subgroup analysis showed that the route of transplantation, baseline LVEF, and type of cells delivered could influence the efficacy of BMC transplantation. Conclusions Autologous transplantation of BMCs was safe and effective for patients who were candidates for revascularization with CABG/PCI and those who were not. However, large clinical trials and long-term follow-up are required to confirm these benefits. PMID:25270584

Xiao, Chun; Zhou, Shijie; Liu, Yueqiang; Hu, Huozhen

2014-01-01

306

Extended safety and efficacy studies of a live attenuated double leucine and pantothenate auxotroph of Mycobacterium tuberculosis as a vaccine candidate  

PubMed Central

We have previously described the development of a live, fully attenuated Mycobacterium tuberculosis (Mtb) vaccine candidate strain with two independent attenuating auxotrophic mutations in leucine and pantothenate biosynthesis. In the present work, those studies have been extended to include testing for protective efficacy in a long-term guinea pig survival model and safety testing in the highly tuberculosis susceptible Rhesus macaque. To model the safety of the ?leuD ?panCD strain in HIV-infected human populations, a Simian Immunodeficiency Virus (SIV)-infected Rhesus macaque group was included. Immunization with the non-replicating ?leuD ?panCD conferred long-term protection against challenge with virulent M. tuberculosis equivalent to that afforded by BCG as measured by guinea pig survival. In safety studies, clinical, hematological and bacteriological monitoring of both SIV-positive and SIV-negative Rhesus macaques immunized with ?leuD ?panCD, revealed no vaccine-associated adverse effects. The results support the further development of the ?leuD ?panCD strain as a viable tuberculosis (TB) vaccine candidate. PMID:21549795

Sampson, Samantha L.; Mansfield, Keith G.; Carville, Angela; Magee, D. Mitchell; Quitugua, Teresa; Howerth, Elizabeth W.; Bloom, Barry R.; Hondalus, Mary K.

2011-01-01

307

[Bariatric surgery - significance, risks, long term consequences].  

PubMed

In recent years the number of bariatric surgery has markedly increased in industrial nations. Surgery provides a more rapid decrease of body weight than conservative approach. However a long term conservative follow up therapy is mandatory to stabilize reduced weight. Due to increasing knowledge from long term follow up of surgically treated obese patients there is a growing body of evidence that frequently there is necessity of reoperations and of substitution both of trace elementsand of minerals or vitamins due to their hampered enteral resorption. Additionally therapy of surgery induced endocrine alterations not seldom is necessary.These insights are of outstanding importance because meanwhile an enlargement of the indications for bariatric surgery as a therapeutic option for metabolic disorders is being discussed. This review refers to the recent internationally published papers concerning consequences of bariatric surgery. PMID:23678666

Schubert, T; Jahn, U; Eben, E; Deuber, H J

2013-03-21

308

Long term results of inflatable mammary implants  

Microsoft Academic Search

In this retrospective study, the long term results of 167 inflatable mammary implants in 77 patients who underwent either breast reconstruction or augmentation between 1972 and 1990 were evaluated. All inflatable implants were manufactured by Heyer-Schulte\\/Mentor company, and were equipped with a posterior leaf valve (style 1800). The mean follow-up was 9 years (SD = 4.3).Complete deflation was found in

A. Worseg; R. Kuzbari; G. Tairych; K. Korak; J. Holle

1995-01-01

309

Long-term consequences of anorexia nervosa.  

PubMed

Anorexia nervosa (AN) is a psychiatric disorder that occurs mainly in female adolescents and young women. The obsessive fear of weight gain, critically limited food intake and neuroendocrine aberrations characteristic of AN have both short- and long-term consequences for the reproductive, cardiovascular, gastrointestinal and skeletal systems. Neuroendocrine changes include impairment of gonadotropin releasing-hormone (GnRH) pulsatile secretion and changes in neuropeptide activity at the hypothalamic level, which cause profound hypoestrogenism. AN is related to a decrease in bone mass density, which can lead to osteopenia and osteoporosis and a significant increase in fracture risk in later life. Rates of birth complications and low birth weight may be higher in women with previous AN. The condition is associated with fertility problems, unplanned pregnancies and generally negative attitudes to pregnancy. During pregnancy, women with the condition have higher rates of hyperemesis gravidarum, anaemia and obstetric complications, as well as impaired weight gain and compromised intrauterine foetal growth. It is reported that 80% of AN patients are affected by a cardiac complications such as sinus bradycardia, a prolonged QT interval on electrocardiography, arrythmias, myocardial mass modification and hypotension. A decrease in bone mineral density (BMD) is one of the most important medical consequences of AN. Reduced BMD may subsequently lead to a three- to seven-fold increased risk of spontaneous fractures. Untreated AN is associated with a significant increase in the risk of death. Better detection and sophisticated therapy should prevent the long-term consequences of this disorder. The aims of treatment are not only recovery but also prophylaxis and relief of the long-term effects of this disorder. Further investigations of the long-term disease risk are needed. PMID:23706279

Meczekalski, Blazej; Podfigurna-Stopa, Agnieszka; Katulski, Krzysztof

2013-07-01

310

LOP - Long-Term Orbit Predictor  

NASA Technical Reports Server (NTRS)

Long-Term Orbit Preditor (LOP) trajectory-propagation computer program is useful tool in analysis of lifetime of orbiting spacecraft. Suitable for studying planetary-orbit missions with reconnaissance (flyby) and exploratory (mapping) trajectories. Includes sample data for study of drift cycle of geosynchronous station, strategy for radar mapping of Venus, frozen orbit about Mars, and orbit characterized by repeating ground trace. Executed faster than such programs based on Cowell's method. Written in FORTRAN 77.

Kwok, Johnny H.

1992-01-01

311

Long?term Performance of Greek IPOs  

Microsoft Academic Search

AbstractWe analyse the long?run performance of 254 Greek IPOs that were listed during the period 1994–2002, computing buy?and?hold abnormal returns (BHAR) and cumulative abnormal returns (CAR) over 36 months of secondary market performance. The empirical results differ from international evidence and reveal long?term overperformance that continues for a substantial interval after listing. Measuring these returns in calendar time, we find

Stavros Thomadakis; Christos Nounis; Dimitrios Gounopoulos

2012-01-01

312

Synaptic tagging and long-term potentiation  

Microsoft Academic Search

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

Uwe Frey; Richard G. M. Morris

1997-01-01

313

Long term consequences of early childhood malnutrition  

Microsoft Academic Search

This paper examines the impact of pre-school malnutrition on subsequent human capital formation in rural Zimbabwe using a maternal fixed effects--instrumental variables (MFE-IV) estimator with a long term panel data set. Representations of civil war and drought shocks are used to identify differences in pre-school nutritional status across siblings. Improvements in height-for-age in pre-schoolers are associated with increased height as

Harold Alderman; John Hoddinott; Bill Kinsey

2006-01-01

314

Burnout Among Long-Term Care Staff  

Microsoft Academic Search

The study investigated the influence of workload, role conflict, role ambiguity, and stress on burnout among long-term care staff. A cross-sectional design was used to collect data through a self-administered questionnaire from 363 staff members of four nursing homes and five assisted living facilities. Regression analysis revealed that after controlling for demographic variables, workload, role conflicts, and stress contributed to

Gauri S. Rai

2010-01-01

315

Long term economic relationships from cointegration maps  

NASA Astrophysics Data System (ADS)

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.

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

2007-07-01

316

Safety and efficacy of peramivir for influenza treatment  

PubMed Central

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

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

2014-01-01

317

Titanium for long-term tritium storage  

SciTech Connect

Due to the reduction of nuclear weapon stockpile, there will be an excess of tritium returned from the field. The excess tritium needs to be stored for future use, which might be several years away. A safe and cost effective means for long term storage of tritium is needed. Storing tritium in a solid metal tritide is preferred to storing tritium as a gas, because a metal tritide can store tritium in a compact form and the stored tritium will not be released until heat is applied to increase its temperature to several hundred degrees centigrade. Storing tritium as a tritide is safer and more cost effective than as a gas. Several candidate metal hydride materials have been evaluated for long term tritium storage. They include uranium, La-Ni-Al alloys, zirconium and titanium. The criteria used include material cost, radioactivity, stability to air, storage capacity, storage pressure, loading and unloading conditions, and helium retention. Titanium has the best combination of properties and is recommended for long term tritium storage.

Heung, L.K.

1994-12-01

318

Long-term solar-terrestrial observations  

NASA Astrophysics Data System (ADS)

In the fall of 1985, the Committee on Solar-Terrestrial Research (CSTR) created a panel to study the requirements for long-term monitoring and archiving of solar-terrestrial data. The panel comprised specialists in all four areas that constitute solar-terrestrial science: the sun, interplanetary medium, magnetosphere-thermosphere-ionosphere, and upper atmosphere. It interviewed many individuals from the solar-terrestrial monitoring and data archiving communities, along with administrators and directors from appropriate government agencies. It circulated nearly 500 questionnaires to obtain information and opinions from the broader community to learn which observational data should be considered essential over the long term to support the operational and research needs of solar-terrestrial science. This report summarizes the panel's principal findings, and the panel's recommendations follow. A separate section listing the critical observational needs by area is presented together with the scientific rationale for each area. The recommendations are defended in terms of this explicit scientific rationale and the multifold uses of current and long-term solar-terrestrial observations for continued operational solar-terrestrial forecasts and services.

319

Evaluation of long-term entecavir treatment in stable chronic hepatitis B patients switched from lamivudine therapy  

PubMed Central

Purpose Current Japanese guidelines recommend that patients should be switched from lamivudine to entecavir when they meet certain criteria. This analysis examines the efficacy and safety of long-term entecavir therapy in patients who were switched to entecavir after 24 weeks’ lamivudine therapy in Japanese studies ETV-047 and ETV-060. Methods The Phase II Japanese study ETV-047 assessed the efficacy of different entecavir doses when compared with lamivudine. A total of 33 Japanese patients who received lamivudine 100 mg daily in ETV-047 entered the open-label rollover study ETV-060 and subsequently received treatment with entecavir 0.5 mg daily. Hepatitis B virus (HBV) DNA suppression, alanine aminotransferase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, and resistance were evaluated among patients with available samples for up to 96 weeks. Safety was assessed throughout the treatment period. Results After 96 weeks of entecavir therapy in ETV-060, 90% of patients achieved HBV DNA <400 copies/mL as compared to 21% of patients who completed 24 weeks of lamivudine therapy in ETV-047. Increasing proportions of patients achieved ALT normalization and HBeAg seroconversion following long-term entecavir treatment. No patients experienced virologic breakthrough, and substitutions associated with entecavir resistance were not observed in patients with detectable HBV DNA. Entecavir was well tolerated during long-term treatment. Conclusions Switching lamivudine-treated patients with chronic hepatitis B to entecavir results in increased virologic suppression with no evidence of resistance through 2 years of entecavir therapy. These findings support recommendations in the current Japanese treatment guidelines that stable lamivudine patients should be switched to entecavir. PMID:21063482

Sata, Michio; Chayama, Kazuaki; Shindo, Michiko; Toyota, Joji; Mochida, Satoshi; Tomita, Eiichi; Kumada, Hiromitsu; Yamada, Gotaro; Yatsuhashi, Hiroshi; Hayashi, Norio; Ishikawa, Hiroki; Seriu, Taku; Omata, Masao

2010-01-01

320

Links between short and long term tectonics  

NASA Astrophysics Data System (ADS)

In the quest for understanding the rheology of the lithosphere a central question that can be addressed is the existence of a parameterisation of the rheology, which could reflect both the response of the lithosphere over the large time scale (10's Myr) and the time scale of earthquakes and faulting. The gap existing between these observational time scales is mainly due to modelling approximations which in each separate fields permit to fit the data but which rely on simplification of the physics, the rheology and set of boundary conditions which are not always compatible one with each other. The long-term community, i.e. the geodynamics community, tend to use Mohr-Coulomb non-associated plasticity to model self-consistent shear zone localisation. This type of rheology corresponds, in the limit of a discrete fault plan, to a slip weakening/hardening formulation in which weakening rate depends on fault plan orientation. The short term community, i.e. the earthquake community, has stopped using this kind of formulation and rather uses the rate and state formulation to model the activity of faults. Rate and State is limited because it cannot self-consistently generate an earthquake, the triggering, i.e. the initial slip acceleration must be imposed. This contribution is a synthesis of several geological case studies at different length-scale, in which we suspects a strong link between long term geodynamic processes and current seismological and geodetic observations. We make use of these case studies together with quantitative numerical models to understand how the seismic and inter-seismic behaviour reflects the rather long-term geodynamic setting than the internal rheological properties of faults. After briefly revisiting the different modelling approaches from geodynamic seismologic and geodetic communities, we show how modelling results obtained with the long term modelling approach brings new insights and alternative models for both the seismological and geodetic behaviour of active faults. The first example will concern the seismic activity on low angle normal faults focussing on the case of the Gulf of Corinth. Then focusing on strike slip tectonic, I will compare data from active and exhumed strike slip faults and discuss how a single model can explain their behaviour. The last example will focus on the creeping segment of the San Andreas Fault to discuss how heterogeneities in the long-term tectonic loading (in that instance flexure of the lithosphere) may influence the seismic behaviour of strike slip fault.

Le Pourhiet, Laetitia; Traoré, Nafissatou; Lecomte, Emmanuel; Saleeby, Jason

2013-04-01

321

Hippocampal long-term depression and long-term potentiation encode different aspects of novelty acquisition  

Microsoft Academic Search

The hippocampus is required for encoding spatial information. Little is known however, about how different attributes of learning are related to different types of synaptic plasticity. Here, we investigated the association between long-term depression (LTD) and long-term potentiation, both cellular models for learning, and novelty exploration. We found that exploration of a new environment containing unfamiliar objects and\\/or familiar objects

Anne Kemp; Denise Manahan-Vaughan

2004-01-01

322

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

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

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

323

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

PubMed Central

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

Bodell, Lindsay P; Keel, Pamela K

2010-01-01

324

Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications  

PubMed Central

Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT1 and MT2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only. PMID:23861638

Pandi-Perumal, Seithikurippu R.; Spence, D. Warren; Verster, Joris C.; Srinivasan, Venkatramanujam; Brown, Gregory M.; Cardinali, Daniel P.; Hardeland, Rudiger

2011-01-01

325

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

PubMed Central

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

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

2010-01-01

326

Human Behaviour in Long-Term Missions  

NASA Technical Reports Server (NTRS)

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.

1997-01-01

327

A long-term climatology of medicanes  

NASA Astrophysics Data System (ADS)

Medicanes, intense and destructive mesoscale cyclones exhibiting several similarities with tropical hurricanes, are known to struck occasionally the Mediterranean Sea. Thanks to a high-resolution dynamical downscaling effort, we are able to study for the first time the long-term climatology of those rare storms in a systematic way. The distribution of medicanes frequency in space and time is discussed, and the environmental factors responsible for their formation are investigated. We find that medicanes develop in those areas of the Mediterranean region where intrusions of cold air in the upper troposphere can produce configurations of thermodynamical disequilibrium of the atmosphere similar to those associated with the formation of tropical cyclones.

Cavicchia, Leone; von Storch, Hans; Gualdi, Silvio

2014-09-01

328

Long-term space flights - personal impressions  

NASA Astrophysics Data System (ADS)

During a final 4-month stage of a 1-year space flight of cosmonauts Titov and Manarov, a physician, Valery Polyakov was included on a crew for the purpose of evaluating their health, correcting physical status to prepare for the spacecraft reentry and landing operations. The complex program of scientific investigations and experiments performed by the physician included an evaluation of adaptation reactions of the human body at different stages of space mission using clinicophysiological and biochemical methods; testing of alternative regimes of exercise and new countermeasures to prevent an unfavourable effect of long-term weightlessness.

Polyakov, V. V.

329

Long term thermoelectric module testing system  

NASA Astrophysics Data System (ADS)

Thermoelectric generators can be used for converting waste heat into electric power. Significant interest in developing new materials in recent years has led to the discovery of several promising thermoelectrics, however, there can be considerable challenges in developing the materials into working devices. Testing and feedback is needed at each step to gain valuable information for identification of difficulties, quality of the materials and modules, repeatability in fabrication, and longevity of the devices. This paper describes a long-term module testing system for monitoring the output power of a module over extended testing times. To evaluate the system, we have tested commercially available thermoelectric modules over a one month time period.

D'Angelo, Jonathan; Hogan, Timothy

2009-10-01

330

Long-Term Solar Irradiance Variability  

NASA Technical Reports Server (NTRS)

Measurements of the solar energy throughout the solar spectrum and understanding its variability provide important information about the physical processes and structural changes in the solar interior and in the solar atmosphere...The aim of this paper is to discuss the solar-cycle-related long-term changes in solar total and UV irradiances. The spaceborne irradiance observations are compared to ground-based indices of solar magnetic activity, such as the Photometric Sunspot Index, full disk magnetic flux, and the Mt. Wilson Magnetic Plage Strength Index.

Pap, J. M.

1996-01-01

331

Deficient long-term memory and long-lasting long-term potentiation in mice with a targeted  

E-print Network

. However, consistent with the long-term memory defects, the long-lasting LTP at the same synapses essential for hippocampus- and amygdala-dependent long-term memory and hippocampal long-lasting LTPDeficient long-term memory and long-lasting long-term potentiation in mice with a targeted deletion

Smith, Desmond J.

332

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

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

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

2014-01-01

333

Long-term creatine supplementation does not significantly affect clinical markers of health in athletes  

Microsoft Academic Search

Creatine has been reported to be an effective ergogenic aid for athletes. However, concerns have been raised regarding the long-term safety of creatine supplementation. This study examined the effects of long-term creatine supplementation on a 69-item panel of serum, whole blood, and urinary markers of clinical health status in athletes. Over a 21-month period, 98 Division IA college football players

Richard B. Kreider; Charles Melton; Christopher J. Rasmussen; Michael Greenwood; Stacy Lancaster; Edward C. Cantler; Pervis Milnor; Anthony L. Almada

2003-01-01

334

Sleep facilitates long-term face adaptation  

PubMed Central

Adaptation is an automatic neural mechanism supporting the optimization of visual processing on the basis of previous experiences. While the short-term effects of adaptation on behaviour and physiology have been studied extensively, perceptual long-term changes associated with adaptation are still poorly understood. Here, we show that the integration of adaptation-dependent long-term shifts in neural function is facilitated by sleep. Perceptual shifts induced by adaptation to a distorted image of a famous person were larger in a group of participants who had slept (experiment 1) or merely napped for 90 min (experiment 2) during the interval between adaptation and test compared with controls who stayed awake. Participants' individual rapid eye movement sleep duration predicted the size of post-sleep behavioural adaptation effects. Our data suggest that sleep prevented decay of adaptation in a way that is qualitatively different from the effects of reduced visual interference known as ‘storage’. In the light of the well-established link between sleep and memory consolidation, our findings link the perceptual mechanisms of sensory adaptation—which are usually not considered to play a relevant role in mnemonic processes—with learning and memory, and at the same time reveal a new function of sleep in cognition. PMID:23986109

Ditye, Thomas; Javadi, Amir Homayoun; Carbon, Claus-Christian; Walsh, Vincent

2013-01-01

335

Long term effects of Escherichia coli mastitis.  

PubMed

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

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

2014-07-01

336

Toward a comprehensive long term nicotine policy.  

PubMed

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

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

2005-06-01

337

An Open-Label Extension Study of the Safety and Efficacy of Risperidone in Children and Adolescents with Autistic Disorder  

PubMed Central

Abstract Objective: The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. Methods: In this 6 month (26 week) open-label extension (OLE) study, patients (5–17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25?mg/day for those weighing 20 to <45?kg, and 1.75?mg/day for those weighing ?45?kg. The study primarily assessed risperidone's safety; efficacy was assessed as a secondary end-point. Results: Fifty-six (71%) out of 79 enrolled patients completed the OLE; the most common discontinuations were for insufficient response (7 [9%]) or adverse events (AE) (5 [6%]). The most common (?5% frequency in the total group) AEs were increased appetite (11% [n=9]); increased weight and vomiting (9% [n=7] each); sedation, pyrexia, and upper respiratory tract infection (8% [n=6] each); nasopharyngitis (6% [n=5]); and somnolence and fatigue (5% [n=4] each). Extrapyramidal AEs were reported in 6 (8%) patients. Increase in mean weight (11–15%) and body mass index (5–10%) occurred; one patient discontinued because of weight increase. One potentially prolactin-related AE (irregular menstruation) was reported. The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale (24.6). All groups showed additional improvement in efficacy scale scores during the OLE. Conclusions: During this OLE, safety findings with risperidone treatment (maximum weight-based dose of 1.25?mg/day or 1.75?mg/day) were consistent with those observed in the DB phase, and with the current safety information for risperidone in autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. Clinical Trials Registry: This phase-4 study is registered at ClinicalTrials.gov (NCT00576732). PMID:24350813

Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

2013-01-01

338

Efficacy and Safety of Propiverine in Children with Overactive Bladder  

PubMed Central

Purpose Antimuscarinic therapy remains one of the most common forms of therapy for overactive bladder (OAB) in children. However, few clinical studies on the outcomes of antimuscarinics in children with OAB have been published. Therefore, we evaluated the efficacy and safety of propiverine, which is frequently prescribed for the treatment of pediatric OAB. Materials and Methods We retrospectively reviewed children with OAB treated with propiverine within the past 5 years. The response rates were compared between the non-urge incontinence (non-UI) and urge incontinence (UI groups). The cumulative response rate by treatment duration was also compared between the two groups. Results Among a total of 68 children, 50 children (73.5%) experienced UI. The overall response rate was 86.8%. Functional bladder capacity after treatment was 150 ml, which represented an increase compared with the value (140 ml) before treatment. The voiding frequency per day decreased from 14.0 to 8.5 times. The overall response rate (88.0%) in the non-UI group was not significantly different from that seen in the UI group (83.3%; p>0.05). In non-UI children, the cumulative response rates were 36.0%, 54.0%, 68.0%, 74.0%, 76.0%, and 78.0% at 4, 8, 12, 16, 20, and 24 weeks, respectively. The cumulative response rates in the UI children were 11.1%, 33.3%, 44.4%, 50.0%, 50.0%, and 55.6%, respectively during the same respective time periods. Adverse effects were identified in only two (2.9%) patients, and neither case was severe. Conclusions Propiverine is effective and well tolerated as a treatment for children suffering from OAB with or without UI. PMID:22536472

Kim, Woo Jung; Lee, Dong-Gi; Lee, Sang Wook; Lee, Yoon Kyung; Lee, Jae Seung; Park, Kwan Hyun

2012-01-01

339

INTRAVESICAL CAPSAICIN AS A TREATMENT FOR REFRACTORY DETRUSOR HYPERREFLEXIA: A DUAL CENTER STUDY WITH LONG-TERM FOLLOWUP  

Microsoft Academic Search

PurposeWe described the long-term outcome of intravesical capsaicin instillations in patients with urinary incontinence and compared its efficacy in 2 similar populations of patients with multiple sclerosis in a dual center study.

Dirk De Ridder; Vijay Chandiramani; Prokar Dasgupta; H. Van Popple; Luc Baert; Clare J. Fowler

1997-01-01

340

Fluoxetine for the Treatment of Childhood Anxiety Disorders: Open-Label, Long-Term Extension to a Controlled Trial  

Microsoft Academic Search

ObjectiveTo assess the efficacy of fluoxetine for the long-term treatment of children and adolescents with anxiety disorders, including generalized anxiety disorder, separation anxiety disorder, and\\/or social phobia.

DUNCAN B. CLARK; BORIS BIRMAHER; DAVID AXELSON; KELLY MONK; CATHERINE KALAS; MARY EHMANN; JEFFREY BRIDGE; D. SCOTT WOOD; BENGT MUTHEN; DAVID BRENT

2005-01-01

341

Efficacy of the components of a behavioral safety program  

Microsoft Academic Search

Since Komaki et al.'s (1978) pioneering work of applying behavioral analysis for industrial safety, several researchers reported successful applications of behavioral safety programs in different work situations. However, most of these programs consisted of a number of components, e.g., safety training, safety performance feedback, goal setting, incentives to performance safety, (e.g., praise, coupons, T-shirts, etc.), consolidated into a single treatment.

Paul S. Ray; Phillip A. Bishop; Min Qi Wang

1997-01-01

342

Safety and efficacy of Sildenafil therapy in children with pulmonary hypertension  

Microsoft Academic Search

ObjectiveSildenafil is a selective Phosphodiesterase-5 inhibitor that has been reported to be a potent pulmonary vasodilator. We evaluated the safety, efficacy and pharmacokinetics of oral Sildenafil in a case series of children with pulmonary hypertension.

Ageliki A. Karatza; Andrew Bush; Alan G. Magee

2005-01-01

343

Managing soils for long-term productivity  

PubMed Central

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.

Syers, J. K.

1997-01-01

344

Tolerance to inhaled Duovent. A long-term study.  

PubMed

Fenoterol with ipratropium bromide (Duovent) is a recently used combination between an anticholinergic and a beta-adrenergic drug useful in obtaining a more effective bronchodilatation and/or reducing the single drug doses. It has been suggested that, as in the case of beta-agonists, its clinical efficacy may be limited by the development of tolerance. We studied the effects of inhaled Duovent in 15 asthmatic patients for 3 months, using a rigidly controlled protocol. Appropriate serial physiological measurements were made at regular intervals during the 90-day study. In all instances the day-one bronchodilator response was significant, prompt and sustained: at 1, 4, 8 and 12 weeks the response was statistically the same as on day 1. It is concluded that, when the important variables are properly controlled, no evidence of tolerance to long-term therapy with Duovent is demonstrable. PMID:2951809

Carlone, S; Angelici, E; Palange, P; Shaqadan, W; Luciani, G; Serra, P

1986-01-01

345

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

Microsoft Academic Search

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

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

2003-01-01

346

The safety and efficacy of a thymidine kinase negative equine herpesvirus 1 vaccine  

E-print Network

THE SAFETY AND EFFICACY OF A THYMIDINE KINASE NEGATIVE EQUINE HERPESVIRUS 1 VACCINE Thesis JANYCE LOUISE CORNICK Submitted to the Graduate College of Texas ARM University in partial fulf illment of the requirements for the degree of MASTER... OF SCIENCE May 1988 Major Subject: Veterinary Medicine and Surgery THE SAFETY AND EFFICACY OF A THYMIDINE KINASE NEGATIVE EQUINE HERPESVIRUS 1 VACCINE A Thesis by JANYCE LOUISE CORNICK Approved as to style and content by: Rona J. Martens (Chairman...

Cornick, Janyce Louise

2012-06-07

347

Efficacy, safety and palatability of a new broad-spectrum anthelmintic formulation in dogs  

Microsoft Academic Search

The efficacy, safety and palatability of a new flavoured chewable anthelmintic tablet were investigated in dogs. The efficacy, based on worm counts, of a single recommended therapeutic dose (RTD) of 5 mg pyrantel + 20 mg oxantel + 5 mg praziquantel\\/kg bodyweight was assessed in experimental infections (EI) and natural infections (NI) with Trichuris vulpis, Echinococcus granulosus and Toxocara canis.

K. Schmid; N. Rohdich; E. Zschiesche; D. J. Kok; M. J. Allan

2010-01-01

348

Long-term outcome after respiratory rehabilitation.  

PubMed Central

To determine the long-term effect of respiratory rehabilitation, we followed up for 6 months after discharge 31 consecutive patients enrolled in a multidisciplinary inpatient rehabilitation program lasting 4 to 6 weeks. Of the 31, 24 showed improvement in quality of life (as measured with a previously validated questionnaire) and in functional exercise capacity (as measured with the 6-minute walk test) 2 weeks after discharge. The improvement was sustained for 6 months in 11 of the 24. Other investigators have found higher response rates than those that we report. The differences are likely due to our enrolment of consecutive patients, the length and completeness of follow-up, and the objective measurement of quality of life by an interviewer not associated with the rehabilitation program. Controlled trials of respiratory rehabilitation measuring both costs and benefits are warranted. In the meantime, strategies to maintain the initial improvement seen after rehabilitation should be developed and studied. PMID:3676969

Guyatt, G H; Berman, L B; Townsend, M

1987-01-01

349

Kentucky Long-Term Policy Research Center  

NSDL National Science Digital Library

Created in 1992 by the Kentucky General Assembly, the Kentucky Long-Term Policy Research Center is dedicated to helping the Bluegrass State "act as a catalyst to change the way decisions are made in government." Their research has proved seminal to the state's advancement, and interested parties can learn about their publications, conferences, and other work on this site. First-time visitors should start by looking over some of their work in the "Publications" area. Here they will find full-length reports, their "Policy Notes" series, and PowerPoint presentations created by staff members. There are several hundred publications here, which can be viewed by topics, which range from "aging population" to "workforce development". The "Videos" section is quite good as well, and it features talks with 43 persons of interest from across the state, including journalist Betty Winston Baye and the mayor of Madisonville, Karen Cunningham.

350

Long-term monitoring for closed sites  

SciTech Connect

A procedure is presented for planning and implementing a long-term environmental monitoring program for closed low-level radioactive waste disposal sites. The initial task in this procedure is to collect the available information on the legal/regulatory requirements, site and area characteristics, source term, pathway analysis, and prior monitoring results. This information is coupled with parameters such as half-life and retardation factors to develop a monitoring program. As examples, programs are presented for a site that has had little or no waste migration, and for sites where waste has been moved by suface water, by ground water, and by air. Sampling techniques and practices are discussed relative to how a current program would be structured and projections are made on techniques and practices expected to be available in the future. 8 refs., 2 figs.

Golchert, N.W.; Sedlet, J.; Veluri, V.R.

1985-01-01

351

Gazprom outlines long term Soviet gas plan  

SciTech Connect

This paper reports that the U.S.S.R.'s Gazprom Konstern has drawn up a comprehensive, long term plan for the Soviet natural gas industry, Eastern Bloc Energy (EBE) reports. EBE is a publication of Eastern Bloc Research Ltd., Newton Kyme, England. Gazprom, responsible for more than 90% of Soviet gas production, predicts Soviet gas production will continue to increase beyond 2030 and expects the resource base ultimately will total more than 330 trillion cu m, EBE the. Soviet Central Asia will begin to decline as a major source of gas during the early years of the next century, but western Siberian production will continue to grow after 2030. The continental shelf, mainly the Barents Sea, will eventually become a very large supplier of gas, EBE reported. Gazprom the development potential of the Soviet gas industry is not constrained by geological factors, only by economic and technical problems.

Not Available

1991-09-30

352

Long-term control of root growth  

DOEpatents

A method and system for long-term control of root growth without killing the plants bearing those roots involves incorporating a 2,6-dinitroaniline in a polymer and disposing the polymer in an area in which root control is desired. This results in controlled release of the substituted aniline herbicide over a period of many years. Herbicides of this class have the property of preventing root elongation without translocating into other parts of the plant. The herbicide may be encapsulated in the polymer or mixed with it. The polymer-herbicide mixture may be formed into pellets, sheets, pipe gaskets, pipes for carrying water, or various other forms. The invention may be applied to other protection of buried hazardous wastes, protection of underground pipes, prevention of root intrusion beneath slabs, the dwarfing of trees or shrubs and other applications. The preferred herbicide is 4-difluoromethyl-N,N-dipropyl-2,6-dinitro-aniline, commonly known as trifluralin.

Burton, Frederick G. (West Richland, WA); Cataldo, Dominic A. (Kennewick, WA); Cline, John F. (Prosser, WA); Skiens, W. Eugene (Richland, WA)

1992-05-26

353

Networking: a long-term management strategy.  

PubMed

As we face a changing health-care landscape of mergers and acquisitions during these tough economic times, it is more important than ever to cultivate a network of individuals who can assist you in your career development efforts. How do you manage your career in a shrinking economy? What is networking and how can you use it to enhance your career and professional competencies? Many myths surround the networking process; this article clarifies those misperceptions and tells you the truth about networking and the positive results you can achieve. Networking can be used to get a new job, but it has much wider application as a long-term career management strategy. Learn how you can manage your own career while building professional relationships and coaching your employees. PMID:12813955

Gumbus, Andra

2003-01-01

354

Long-term control of root growth  

SciTech Connect

A method and system for long-term control of root growth without killing the plants bearing those roots involves incorporating a 2,6-dinitroaniline in a polymer and disposing the polymer in an area in which root control is desired. This results in controlled release of the substituted aniline herbicide over a period of many years. Herbicides of this class have the property of preventing root elongation without translocating into other parts of the plant. The herbicide may be encapsulated in the polymer or mixed with it. The polymer-herbicide mixture may be formed into pellets, sheets, pipe gaskets, pipes for carrying water, or various other forms. The invention may be applied to other protection of buried hazardous wastes, protection of underground pipes, prevention of root intrusion beneath slabs, the dwarfing of trees or shrubs and other applications. The preferred herbicide is 4-difluoromethyl-N,N-dipropyl-2,6-dinitro-aniline, commonly known as trifluralin. 7 figs.

Burton, F.G.; Cataldo, D.A.; Cline, J.F.; Skiens, W.E.

1992-05-26

355

Reducing long-term reservoir performance uncertainty  

SciTech Connect

Reservoir performance is one of the key issues that have to be addressed before going ahead with the development of a geothermal field. In order to select the type and size of the power plant and design other surface installations, it is necessary to know the characteristics of the production wells and of the produced fluids, and to predict the changes over a 10--30 year period. This is not a straightforward task, as in most cases the calculations have to be made on the basis of data collected before significant fluid volumes have been extracted from the reservoir. The paper describes the methodology used in predicting the long-term performance of hydrothermal systems, as well as DOE/GTD-sponsored research aimed at reducing the uncertainties associated with these predictions. 27 refs., 1 fig.

Lippmann, M.J.

1988-04-01

356

Long-term prognosis of schizophrenia.  

PubMed

The question of determining prognostically relevant features for schizophrenia was approached with multivariate statistical methods applied to the data from the Bonn longitudinal study of 502 schizophrenic patients. In this study, personal interviews according to a clinical classification scheme allowed every patient to be ranked within each of three different outcome classes: psychopathological remission, occupational remission, and course type. Our multivariate analysis encompassed a total of 50 items pertinent to the time up to and including the first 6 months after the first psychotic manifestation. Despite the introduction of mathematical methods considerably more sophisticated than those employed in earlier studies, no satisfactory solution could be found to the problem of predicting end states of schizophrenia. Reliable predictions could be made only for 'extreme' end states (i.e. full remission versus (1) characteristic residues in the narrower sense; (2) total unemployment, or (3) surging or simple courses to mixed residues or to typical schizophrenic defect psychoses). Accordingly, sufficiently reliable assertions applied only to a minority of about 1/3 of patients, whereas for the majority of 2/3, no generalizable prognostication was possible (67-71% true-positive predictions on 36-63% of total population in extreme states). By contrast, our analyses have clearly uncovered a fundamental problem of investigations into the long-term prognosis of schizophrenia: the extreme dependence of results on the clinical definition of end states. The further the phenomenon 'end state' is qualitatively subdivided, the poorer and less reproducible is the mutual discrimination between intermediate states and the less reliable are allocations of patients to these intermediate states by means of multivariate classifiers. Furthermore, our analyses have also demonstrated the usefulness of multivariate, adaptive procedures for investigations into the structural properties of long-term courses, so that predictions might be considerably improved if more reliable definitions of schizophrenic end states are available. PMID:1754643

Schmid, G B; Stassen, H H; Gross, G; Huber, G; Angst, J

1991-01-01

357

Long term results of pneumatic retinopexy  

PubMed Central

Background Rhegmatogenous retinal detachment is a commonly encountered retinal problem where rapid treatment can prevent irreversible vision loss. Pneumatic retinopexy (PR) is a simple, minimally invasive procedure for retinal reattachment. Purpose This study aimed to assess the long-term anatomical and functional outcome of pneumatic retinopexy in primary rhegmatogenous retinal detachment. Patients and methods A prospective interventional study was performed. Subjects with rhegmatogenous retinal detachment who underwent pneumatic retinopexy from May 2006 to May 2007 at Menoufiya University Hospital were included in this study with at least 3 years follow-up. Results A total of 40 cases were included in the study. The mean age of patients was 44.25 ± 10.85 years. Reattachment of the retina was achieved in 100% of cases. In 75% of cases, the primary intervention was successful. However, the retina redetached in 20% of these during the first 6 months, requiring reinjection or another procedure. Three years after the first intervention, follow-up measurement of the mean visual acuity of the eyes without reoperation was 0.40 ± 0.21 while the mean visual acuity of the eyes which needed additional operations was 0.22 ± 0.13. Conclusion Sixty percent of the cases obtained long-term retinal reattachment with a single operation success (SOS), with good visual recovery and less morbidity than other more invasive procedures like scleral buckling or pars plana vitrectomy, translating to higher productivity for the patient. This procedure, being quicker than the alternatives, also saves the surgeon’s time, making PR a good choice for managing primary rhegmatogenous retinal detachment in developing countries. PMID:22275808

Ellakwa, Amin F

2012-01-01

358

Comparison of Efficacy and Safety of Tenofovir and Entecavir in Chronic Hepatitis B Virus Infection: A Systematic Review and Meta-Analysis  

PubMed Central

Objective Tenofovir (TDF) and entecavir (ETV) are both potent antiviral agents for the treatment of chronic hepatitis B virus (HBV) infection. Multiple studies have compared efficacy and safety of these two agents, but yielded inconsistent results. Hence, we conducted a meta-analysis to discern comparative efficacy and safety. Methods Published data relevant to a comparison of TDF and ETV used in HBV were included. HBV DNA suppression rate, ALT normalization rate, and HBeAg seroconversion rate at 24 weeks and 48 weeks were reviewed. Drug safety profiles and resistance were also discussed. Results Seven articles met entry criteria. Four and six articles included data for 24 and 48-week HBV DNA suppression rates, respectively, and no significant differences for the rates between the two drugs were found in chronic HBV patients (TDF vs. ETV: relative risk [RR]?=?1.10, 95% CI?=?0.91–1.33 and RR?=?1.07, 95% CI?=?0.99–1.17 for 24 weeks and 48 weeks, respectively). For the ALT normalization rate (three studies for 24 weeks, four articles for 48 weeks) and HBeAg seroconversion rate (two and four studies for 24 weeks and 48 weeks, respectively), no difference was observed between TDF and ETV. Additionally, no significant distinction in short term safety was found for CHB patients. Conclusions TDF and ETV are similarly effective and safe in chronic HBV patients after 24 weeks and 48 weeks of anti-viral therapy. Nevertheless, the long-term efficacy and safety of TDF and ETV should be monitored in prolonged therapy. PMID:24905092

Zhang, Chi; Ye, Xiaohua; Gao, Yanhui; Zhou, Shudong; Yang, Yi

2014-01-01

359

Nitric Oxide Facilitates Long-Term Potentiation, But Not Long-Term Depression  

Microsoft Academic Search

Reports that nitric oxide synthase (NOS) inhibition prevents the induction of long-term potentiation (LTP) have been controver- sial. Recent evidence suggests that NO may help to regulate the threshold for LTP induction. We have tested this hypothesis by examining the effects of stimulus frequency and train dura- tion on synaptic plasticity in the presence of either NO donors or NOS

Peter L. Malen; Paul F. Chapman

1997-01-01

360

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

E-print Network

be modified by steroid hormone manipulation. We castrated male whiptail lizards for 1 week (short term) or 6 weeks (long term). We also gonadectomized female whiptails and implanted them with either a Silastic capsule con- taining testosterone or an empty capsule. At the end of that time all implants were removed

Crews, David

361

Immediate and long term outcome after infrathalamic and thalamic lesioning for intractable Tourette's syndrome  

PubMed Central

OBJECTIVE—The surgical treatment of intractable Tourette's syndrome is controversial. Experience with 17 consecutive patients treated between 1970 and 1998 is reviewed and the efficacy and safety of surgical treatment is assessed.?METHODS—These patients were retrospectively reclassified into subtypes according to the protocol of the Tourette's Syndrome Study Group. One patient was excluded from the study. Ventriculography based stereotactic zona incerta (ZI) and ventrolateral/ lamella medialis thalamotomy (VL/LM) were performed on all patients. The preoperative, postoperative, and late tic severities were assessed by the tic severity rating scale. The median follow up of 11 patients (65%) was 7 years (range 3.5-17 years) and six patients were lost to long term follow up.?RESULTS—Median age was 23 years (range 11-40) at the time of surgery. Median duration of illness was 14 years (range 3-33). The mean preoperative motor and vocal tic severities were estimated to be 4.44 (SD 0.63) and 3.81 (SD 0.66), respectively. Unilateral ZI lesioning and VL/LM lesioning selected by asymmetry of symptoms provide an effective control of tic severity (p motor and vocal<0.001). In attenuation of contralateral symptoms, a second surgical intervention in the relevant side could reduce tic severity sufficiently (p motor<0.01; p vocal<0.005). Transient complications occurred in 68% of patients. Only one permanent complication was registered in six patients followed up after unilateral surgery. Two out of five patients followed up after bilateral surgery had disabling side effects of surgery.?CONCLUSIONS—ZI and VL/LM lesioning provide a significant long term reduction of tic severity in intractable Tourette's syndrome. Adequate selection of the side of first intervention might prevent the patient from increased risk of bilateral surgery.?? PMID:11309463

Babel, T; Warnke, P; Ostertag, C

2001-01-01

362

Long-term outcome of transobturator suburethral tape procedure for treatment of female stress urinary incontinence  

PubMed Central

Objective: The aim is to evaluate the long-term safety and efficacy of transobturator tape (TOT) procedure in the treatment of women with stress urinary incontinence (SUI) by subjective and objective measures. Patients and Methods: A total 48 women with SUI underwent the TOT procedure during the period from December 2005 to February 2008. The follow-up period ranged between 60 and 84 months (mean 71 months). Mean age was 44.21 ± 7.52 (range: 30-58). Preoperative and early postoperative data were retrieved from the patient's medical files. Follow-up evaluation was carried out every 3 months during the 1st year and yearly afterwards by history taking (including incontinence and quality-of-life questionnaire), clinical examination, urine analysis, abdominopelvic ultrasonography, and urodynamic studies when indicated. Results: At 12-month follow-up, the cure, improvement, and failure rates were 39 patients (81.25%), 5 (10.42%) and 4 (8.33%), respectively. The corresponding rates at the last follow-up were 38 (79.15%), 5 (10.42%) and 5 (10.42%) respectively. The postvoid residual urine and peak flow rates did not differ significantly between the preoperative values and at the last follow-up. The complication rates after a mean 71-month included one patient with voiding difficulty and two patients with de novo urgency. No case was recorded with retention of urine or erosion. Conclusions: Transobturator tape procedure appeared to be effective minimally invasive procedure for SUI with low rate of complication and good long-term outcome. PMID:25125897

El-Eweedy, Sayed M.; Abd El-Rahim, Ahmed F.; Abd-Alkhalek, Mohamed A.; Abdellatif, Ashraf H.; Anwer, Ahmed S.

2014-01-01

363

Safety and efficacy of a non-polymeric paclitaxel-eluting microporous stent in real-world percutaneous coronary intervention  

PubMed Central

At present, there is an increasing focus on stents that have a biodegradable polymer coating, rather than a permanent polymer coating. This is due to the fact that following the implantation of a drug-eluting stent (DES) with a permanent polymer coating, the continued existence of the coating may result in a foreign body reaction and delayed re-endothelialization. The aim of the present study was to evaluate the safety and efficacy of a non-polymeric paclitaxel-eluting microporous (YINYI™) stent in real-life percutaneous coronary intervention (PCI) for patients with coronary artery disease (CAD). A total of 686 YINYI™ stents were implanted in 404 patients with CAD in a PCI procedure and outpatient follow-ups were performed 1, 6, 12 and 15 months subsequent to the PCI, respectively. The observation endpoints were major adverse cardiac events (MACEs), including cardiac death, non-fatal myocardial infarction (MI), restenosis, target lesion revascularization, stent thrombosis and recurrence of angina pectoris. The average follow-up time was 15 months. The results revealed that the cumulative incidences of MACEs were as follows: mortality, 0.99%; non-fatal MI, 0.74%; restenosis, 4.0%; and target lesion revascularization, 2.7%. The results at the short- and long-term clinical follow-ups indicated that YINYI™ stents are effective and safe for use in PCI for patients with CAD. PMID:24137271

WANG, SHAO-PENG; HUANG, RONG-CHONG; ZHU, HAO; ZHANG, BO; ZHENG, ZHEN-GUO; YIN, DA; WANG, JUN-JIE; ZHOU, XU-CHEN

2013-01-01

364

Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection  

PubMed Central

AIM: To investigate the safety and efficacy of the formulation HD-03/ES capsules in the management of patients with chronic hepatitis B infection. METHODS: A total of 25 patients were recruited to the study and were given HD-03/ES, two capsules twice daily for six months. Clinical assessment of symptoms and signs were done using the “clinical observation table” once a month before and after the treatment. Biochemical investigations of total bilirubin, ALT, AST, serum protein for liver function tests were done every month after initiating treatment. Serum was analyzed for HBV markers for HBsAg, HBeAg and HBV DNA at baseline, 4 and 6 mo after therapy using ELISA kits from Roche. RESULTS: After 6 mo of therapy with HD-03/ES, a significant reduction of ALT values from 66.5 ± 11.1 to 39.1 ± 5.2 (P < 0.01) and a significant HBsAg loss (52%, P < 0.001), HBeAg loss (60%, P < 0.05) and HBV DNA loss (60%, P < 0.05) was observed. Adverse effects were mild and never warranted withdrawal of the drug. CONCLUSION: The results of this pilot study indicate that HD-03/ES might be a safe and effective treatment for chronic hepatitis B infection and a long-term multicentric comparator trial is warranted and under way. PMID:17696230

Rajkumar, JS; Sekar, MG; Mitra, SK

2007-01-01

365

Safety and Efficacy of Sitagliptin-Metformin in Fixed Combination for the Treatment of Type 2 Diabetes Mellitus  

PubMed Central

The biguanide, metformin, is considered first-line treatment for type 2 diabetes. Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor acts through the incretin pathway and has a glucose dependent mode of action. The complementary hypoglycemic properties of these drugs make fixed dose combination treatment an attractive prospect. Evidence from recent clinical trials suggests a beneficial effect of the combination on efficacy, demonstrated by significant improvement of hemoglobin A1c (HbA1c), fasting and postprandial glucose levels. The fixed dose combination is likely to have greater patient tolerability compared with monotherapy with either agent because of low rates of hypoglycemia, weight neutrality, and lower rates of side effects. High acquisition cost and paucity of long-term safety data are, however, potential barriers to their wider use. An overview of the pharmacology and clinical outcomes from recent trials of the metformin-sitagliptin combination and how the combination could fit into the type 2 diabetes treatment algorithm is presented in this review. PMID:24031162

Ballav, Chitrabhanu; Gough, Stephen C.L.

2013-01-01

366

Long-Term Control Medications for Lung Diseases  

MedlinePLUS

... Term Control Medications Long-Term Control Medications for Lung Diseases Long-term control medications are taken daily to control and prevent lung disease symptoms. These medicines should be taken every day ...

367

Long-term surveillance plan for the Burro Canyon disposal cell Slick Rock, Colorado  

SciTech Connect

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 Burro Canyon disposal cell in San Miguel County, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Burro Canyon disposal cell performs as designed and is cared for in a manner that protects the public health and safety and the environment. The program is based on site inspections to identify threats to disposal cell integrity. Before each disposal cell is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP.

NONE

1997-08-01

368

Dendritic spine changes associated with hippocampal long-term synaptic plasticity  

Microsoft Academic Search

Long-term enhancement of synaptic efficacy in the hippocampus is an important model for studying the cellular mechanisms of neuronal plasticity, circuit reorganization, and even learning and memory. Although these long-lasting functional changes are easy to induce, it has been very difficult to demonstrate that they are accompanied or even caused by morphological changes on the subcellular level. Here we combined

Florian Engert; Tobias Bonhoeffer

1999-01-01

369

Neuromodulation of neocortical long-term potentiation in the adult, freely moving rat  

Microsoft Academic Search

Correlated firing between adjacent neurons results in increased synaptic efficacy between synapses. This effect is called long-term potentiation (LTP) and is widely regarded as the mechanism underlying learning and memory because it is long-lasting and has been demonstrated in areas of the brain involved in information encoding and storage. Although definitive proof that LTP underlies learning and memory remains elusive,

Tiffany Ellen Boyd

2001-01-01

370

Luteolin promotes long-term potentiation and improves cognitive functions in chronic cerebral hypoperfused rats  

Microsoft Academic Search

Processes of synaptic plasticity, such as long-term potentiation (LTP), has been considered a cellular correlate of learning and memory and many neurological disorders accompanied by cognitive deficits exhibit abnormal synaptic function. This emerging concept is exemplified by Alzheimer's disease. Mounting evidence suggests that Alzheimer's disease begins with subtle alterations of hippocampal synaptic efficacy prior to frank neuronal degeneration, which make

Bei Xu; Xiao-Xiu Li; Guo-Rong He; Juan-Juan Hu; Xin Mu; Shuo Tian; Guan-Hua Du

2010-01-01

371

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

ERIC Educational Resources Information Center

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

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

2005-01-01

372

Animal models as predictors of the safety and efficacy of antibiotics.  

PubMed

As opposed to the testing of safety, the testing of the efficacy of antibiotics in animals is not specified in any directives or guidelines and not explicitly required by regulatory authorities. There exists, however, no doubt that in the evaluation of new compounds testing of both safety and efficacy forms an essential link between in vitro tests and clinical trials. It is inconceivable that clinicians would be prepared to conduct a trial in patients without evidence of the efficacy of the antibiotic in question in an appropriate animal model of infection. Both the models for testing safety and those for testing efficacy suffer from a number of shortcomings. If investigators are aware of these deficiencies and take them into account when interpreting the results, the predictive value of the models can be significantly enhanced. PMID:2226475

Zak, O; O'Reilly, T

1990-07-01

373

Robotics for Long-Term Monitoring  

SciTech Connect

While long-term monitoring and stewardship means many things to many people, DOE has defined it as The physical controls, institutions, information, and other mechanisms needed to ensure protection of people and the environment at sites where DOE has completed or plans to complete cleanup (e.g., landfill closures, remedial actions, and facility stabilization). Across the United States, there are thousands of contaminated sites with multiple contaminants released from multiple sources where contaminants have transported and commingled. The U.S. government and U.S. industry are responsible for most of the contamination and are landowners of many of these contaminated properties. These sites must be surveyed periodically for various criteria including structural deterioration, water intrusion, integrity of storage containers, atmospheric conditions, and hazardous substance release. The surveys, however, are intrusive, time-consuming, and expensive and expose survey personnel to radioactive contamination. In long-term monitoring, there's a need for an automated system that will gather and report data from sensors without costly human labor. In most cases, a SCADA (Supervisory Control and Data Acquisition) unit is used to collect and report data from a remote location. A SCADA unit consists of an embedded computer with data acquisition capabilities. The unit can be configured with various sensors placed in different areas of the site to be monitored. A system of this type is static, i.e., the sensors, once placed, cannot be moved to other locations within the site. For those applications where the number of sampling locations would require too many sensors, or where exact location of future problems is unknown, a mobile sensing platform is an ideal solution. In many facilities that undergo regular inspections, the number of video cameras and air monitors required to eliminate the need for human inspections is very large and far too costly. HCET's remote harsh-environment surveyor (RHES) is a robotic platform with SCADA capabilities equipped with a sonar-imaging scanner, a high-resolution color CCD camera, and various combinations of sensors. The RHES is controlled remotely via a PC. This paper will discuss the development and application of this system. (authors)

Shahin, Sarkis; Duran, Celso [Florida International University, Miami, Florida (United States)

2002-07-01

374

17 CFR 256.224 - Other long-term debt.  

Code of Federal Regulations, 2010 CFR

...2010-04-01 2010-04-01 false Other long-term debt. 256.224 Section 256.224 Commodity...UTILITY HOLDING COMPANY ACT OF 1935 6. Long-Term Debt § 256.224 Other long-term debt. This account shall include all...

2010-04-01

375

40 CFR 52.29 - Visibility long-term strategies.  

Code of Federal Regulations, 2010 CFR

...strategy. (1) A long-term strategy is a 10- to 15-year plan...in § 51.300(a). This strategy will cover any existing impairment...appropriate, the long-term strategies developed for each visibility...3) During the long-term strategy review process, the...

2010-07-01

376

40 CFR 52.29 - Visibility long-term strategies.  

Code of Federal Regulations, 2011 CFR

...2011-07-01 false Visibility long-term strategies. 52.29 Section 52.29 Protection... § 52.29 Visibility long-term strategies. (a) Plan disapprovals...and revision of visibility long-term strategies. Specific disapprovals are...

2011-07-01

377

Advances in stent technologies and their effect on clinical efficacy and safety  

PubMed Central

The introduction of intracoronary stents represented a major advance in interventional cardiology. While bare metal stents set the benchmark for improved safety over angioplasty, intimal hyperplasia and subsequent restenosis were important limitations. First-generation drug-eluting stents demonstrated significant improvements in efficacy, but not necessarily safety, and further technologic developments have focused on optimizing both. Current advances and understanding in stent design continue to improve on these concepts. This review summarizes past and present technology with particular emphasis on the principles underlying the efficacy and safety of drug-eluting stents, and offers a glimpse into the next generations of stents aimed at treating symptomatic coronary artery disease. PMID:24940085

Nikam, Navin; Steinberg, Toby B; Steinberg, Daniel H

2014-01-01

378

Safety and efficacy of tazarotene foam for the treatment of acne vulgaris  

PubMed Central

Background Tazarotene foam is the first topical retinoid foam approved for the treatment of acne vulgaris. Objective To review the safety and efficacy studies of tazarotene foam in the treatment of moderate to severe acne. Methods Five Phase I safety studies in normal controls are reviewed and two Phase III safety and efficacy studies in patients with moderate to severe acne are reviewed. Conclusion Tazarotene foam, 0.1% was effective in the treatment of moderate to severe acne vulgaris with an acceptable tolerability profile. This treatment provides a cosmetically favorable alternative for topical retinoid therapy. PMID:23696711

Epstein, Erica L; Gold, Linda Stein

2013-01-01

379

Vaccination for the expatriate and long-term traveler.  

PubMed

Duration of travel is an important factor in addressing travel health safety due to cumulative risk of exposure to illness and injury. The diverse group of expatriate and long-term business and leisure travelers present a different spectrum of issues for the travel medicine practitioner to address during consultation than does the short-term traveler, due to changes in travel patterns and activities, lifestyle alterations, and increased interaction with local populations. Immunization provides one safe and reliable method of preventing infectious illness in this group. We review travel patterns and available data on illnesses that they may be exposed to, including the increased risk of certain vaccine-preventable illnesses. We review the pre-travel management of these travelers, particularly the increased risk of certain vaccine-preventable illnesses as it applies to routine vaccines, recommended travel vaccines and required travel vaccines. PMID:24785305

Shepherd, Suzanne M; Shoff, William H

2014-06-01

380

A systematic review of the safety and efficacy of mesenchymal stem cells for disc degeneration: insights and future directions for regenerative therapeutics.  

PubMed

Intervertebral disc degeneration is associated with low-back pain. Mesenchymal stem cells (MSCs) have been used to "regenerate" the disc. The aim of this study was to perform a systematic review of comparative controlled studies that have assessed the safety and efficacy of using MSCs for disc regeneration. Literature databases were extensively searched. Trial design, subject-type, MSC sources, injection method, disc assessment, outcome intervals, and complication events were assessed. Validity of each study was performed. Twenty-four animal studies were included with 20.8% of the studies reporting randomization of groups. Trials in humans fulfilling inclusion criteria were not noted. The studies represented 862 discs that were injected with MSCs and 1,603 discs as controls. All three types of MSCs (ie, bone marrow, synovial, and adipose tissues) showed successful inhibition of disc degeneration. Bone-marrow-derived MSCs demonstrated superior quality of repair compared with other non-MSC treatments. A 2.7% overall complication rate was noted, whereby complications were noted only in rabbits. Overall, evidence suggested that MSCs increased disc space height in the majority of animal models. This is the first systematic review to assess the safety and efficacy of MSCs for the treatment of disc degeneration. Short-term MSC transplantation is safe and effective; however, additional, larger, and higher-quality studies are needed to assess the long-term safety and efficacy. Inconsistencies in methodological design and outcome parameters prevent any robust conclusions. Human-based clinical trials are needed. Recommendations are further made to improve efficacy, reduce potential complications, and standardize techniques for future studies. PMID:25050446

Yim, Rita Lok-Hay; Lee, Juliana Tsz-Yan; Bow, Cora H; Meij, Björn; Leung, Victor; Cheung, Kenneth M C; Vavken, Patrick; Samartzis, Dino

2014-11-01

381

Long-term exposure to intranasal oxytocin in a mouse autism model.  

PubMed

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

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

382

Deferiprone versus Deferoxamine in Sickle Cell Disease: Results from a 5-year long-term Italian multi-center randomized clinical trial.  

PubMed

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

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

383

[Long term adherence to HAART in Senegal].  

PubMed

Adherence is one of the main predictors of antiretroviral treatment success. A governmental initiative was launched in 1998 for HIV-infected patients in Senegal to provide access to highly active antiretroviral therapy (HAART). Adherence measurements, defined as pills taken/pills prescribed, were assessed between November 1999 and June 2010 using a pill count along with a questionnaire for 330 patients. Predictors of adherence and identification of adherence trajectories were explored through latent class mixed model. We also performed a survival analysis using Cox proportional hazard model. Three adherence behaviours were revealed as well as a better adherence for women. A third of patients had a high adherence trajectory over time and a third had an intermediate one. Male gender and low adherence behaviour over time were independently associated with a higher mortality rate. This study shows that an overall good adherence can be obtained in the long term in Senegal, suggests a better adherence for women and points out a large subsample of patients with intermediate level of adherence behaviour who are at risk for developing resistance to antiretroviral drugs. PMID:24615434

Bastard, M; Fall, M Basty Koita

2014-10-01

384

Long-term sequelae of fasciotomy wounds.  

PubMed

A retrospective study of patients admitted to an Orthopaedic Trauma Unit over an 8-year period requiring fasciotomies, of either upper or lower limb, to reduce the risk of compartment syndrome was performed. Sixty patients were studied, of which 49 had an underlying fracture. The long-term morbidity of the wounds was studied. Ongoing symptoms such as pain related to the wound occurred in six patients (10%) and altered sensation within the margins of the wound occurred in 46 patients (77%). Examination revealed 24 patients (40%) with dry scaly skin, 20 patients (33%) with pruritus, 18 patients (30%) with discoloured wounds, 15 patients (25%) with swollen limbs, 16 patients (26%) with tethered scars, eight patients (13%) with recurrent ulceration, eight patients (13%) with muscle herniation and four patients (7%) with tethered tendons. The appearance of the scars affected patients such that 14 (23%) kept the wound covered, 17 (28%) changed hobbies and seven (12%) changed occupation. This study reveals a significant morbidity associated with fasciotomy wounds. In light of these findings, further consideration should be given to techniques that reduce both the symptoms and examination findings mentioned above and the aesthetic insult to the affected limb. PMID:11090326

Fitzgerald, A M; Gaston, P; Wilson, Y; Quaba, A; McQueen, M M

2000-12-01

385

Long-term cerebral consequences of sepsis.  

PubMed

Sepsis is a potentially fatal whole-body inflammatory state caused by severe infection, in which a maladaptive, system-wide inflammatory response follows initial attempts to eliminate pathogens, leading to a dangerous and often fatal increase in the permeability of the blood-brain barrier. These changes in the blood-brain barrier might lead to a major symptom of sepsis, sepsis-associated encephalopathy, which manifests as confusion with a rapid decline in cognitive functions, especially memory, or coma. Once presumed to be entirely reversible, research suggests that sepsis-associated encephalopathy could lead to permanent neurocognitive dysfunction and functional impairments, even after the patient has recovered. Sepsis might act as a major inflammatory hit and potentially increase the brain's susceptibility to neurodegenerative disease, further deterioration of cognitive ability, and risk of developing dementia in later life. Key opportunities for neuroprotective interventions and after-care for people who have survived sepsis might be lost because the long-term neurocognitive and functional consequences of sepsis are not fully characterised. PMID:24849863

Widmann, Catherine N; Heneka, Michael T

2014-06-01

386

Intermediate- and long-term earthquake prediction.  

PubMed Central

Progress in long- and intermediate-term earthquake prediction is reviewed emphasizing results from California. Earthquake prediction as a scientific discipline is still in its infancy. Probabilistic estimates that segments of several faults in California will be the sites of large shocks in the next 30 years are now generally accepted and widely used. Several examples are presented of changes in rates of moderate-size earthquakes and seismic moment release on time scales of a few to 30 years that occurred prior to large shocks. A distinction is made between large earthquakes that rupture the entire downdip width of the outer brittle part of the earth's crust and small shocks that do not. Large events occur quasi-periodically in time along a fault segment and happen much more often than predicted from the rates of small shocks along that segment. I am moderately optimistic about improving predictions of large events for time scales of a few to 30 years although little work of that type is currently underway in the United States. Precursory effects, like the changes in stress they reflect, should be examined from a tensorial rather than a scalar perspective. A broad pattern of increased numbers of moderate-size shocks in southern California since 1986 resembles the pattern in the 25 years before the great 1906 earthquake. Since it may be a long-term precursor to a great event on the southern San Andreas fault, that area deserves detailed intensified study. Images Fig. 1 PMID:11607658

Sykes, L R

1996-01-01

387

Long-term adequacy of metal resources  

USGS Publications Warehouse

Although the earth's crust contains vast quantities of metals, extraction technologies and associated costs are inextricably bound to three fundamental geological factors - the amount of metal available in the earth's crust in each range of grades, the mineralogical form and chemical state of the metal, and the spatial distribution of the metal. The energy required to recover a given amount of metal increases substantially as grade declines. Most metal is produced from sulphide or oxide minerals, whereas most metal in the crust may be locked in the structures of the more refractory silicates. Recovery from silicate minerals could require orders of magnitude more energy than that used at present as also could exploitation of small, widely scattered or thin, deeply buried deposits. Although specific information on the fundamental factors is not available, each factor must in turn tend to further restrict exploitation. Independence of average grade and tonnage for many deposit types further reduces the availability of rock as a source of metal. In the long term, effects of these factors will be large increases in price for many metals. ?? 1977.

Singer, D.A.

1977-01-01

388

Intermediate- and long-term earthquake prediction.  

PubMed

Progress in long- and intermediate-term earthquake prediction is reviewed emphasizing results from California. Earthquake prediction as a scientific discipline is still in its infancy. Probabilistic estimates that segments of several faults in California will be the sites of large shocks in the next 30 years are now generally accepted and widely used. Several examples are presented of changes in rates of moderate-size earthquakes and seismic moment release on time scales of a few to 30 years that occurred prior to large shocks. A distinction is made between large earthquakes that rupture the entire downdip width of the outer brittle part of the earth's crust and small shocks that do not. Large events occur quasi-periodically in time along a fault segment and happen much more often than predicted from the rates of small shocks along that segment. I am moderately optimistic about improving predictions of large events for time scales of a few to 30 years although little work of that type is currently underway in the United States. Precursory effects, like the changes in stress they reflect, should be examined from a tensorial rather than a scalar perspective. A broad pattern of increased numbers of moderate-size shocks in southern California since 1986 resembles the pattern in the 25 years before the great 1906 earthquake. Since it may be a long-term precursor to a great event on the southern San Andreas fault, that area deserves detailed intensified study. PMID:11607658

Sykes, L R

1996-04-30

389

Long term outcome of neonatal meningitis  

PubMed Central

Objectives: To quantify long term impairment after neonatal meningitis. Design: Longitudinal case-control study over 9–10 years. Subjects and methods: A total of 111 children who had suffered neonatal meningitis were seen and compared with 113 matched controls from their birth hospital and 49 controls from general practices. Assessments included the WISC IIIUK , movement assessment battery for children (mABC), audiometry, vision testing, and social and medical data. Statistical analysis was by multiple regression, analysis of variance, and ?2 tests. Results: Some 10.8% of cases had a severe and 9% a moderate overall outcome compared with 0% and 1.8% for the hospital controls. The mean intelligence quotient (IQ) of the cases (88.8) was significantly less than that of the hospital controls (99.4) or the GP controls (99.6) . The mABC score was significantly worse for the cases (7.08) than the hospital (5) or GP (4) controls. Some 3.6% of cases had sensorineural hearing loss, 2.7% had persisting hydrocephalus; no controls did. Some 5.4% of cases and 1.7% of hospital controls had treatment for seizures. Conclusions: Severe neurodisability and milder motor and psychometric impairment result from neonatal meningitis. Both clinical follow up and comprehensive developmental assessment are needed after this disease. PMID:12719389

Stevens, J; Eames, M; Kent, A; Halket, S; Holt, D; Harvey, D

2003-01-01

390

Neurological long term consequences of deep diving.  

PubMed Central

Forty commercial saturation divers, mean age 34.9 (range 24-49) years, were examined one to seven years after their last deep dive (190-500 metres of seawater). Four had by then lost their divers' licence because of neurological problems. Twenty seven (68%) had been selected by neurological examination and electroencephalography before the deep dives. The control group consisted of 100 men, mean age 34.0 (range 22-48) years. The divers reported significantly more symptoms from the nervous system. Concentration difficulties and paraesthesia in feet and hands were common. They had more abnormal neurological findings by neurological examination compatible with dysfunction in the lumbar spinal cord or roots. They also had a larger proportion of abnormal electroencephalograms than the controls. The neurological symptoms and findings were highly significantly correlated with exposure to deep diving (depth included), but even more significantly correlated to air and saturation diving and prevalence of decompression sickness. Visual evoked potentials, brainstem auditory evoked potentials, and magnetic resonance imaging of the brain did not show more abnormal findings in the divers. Four (10%) divers had had episodes of cerebral dysfunction during or after the dives; two had had seizures, one had had transitory cerebral ischaemia and one had had transitory global amnesia. It is concluded that deep diving may have a long term effect on the nervous system of the divers. PMID:2025592

Todnem, K; Nyland, H; Skeidsvoll, H; Svihus, R; Rinck, P; Kambestad, B K; Riise, T; Aarli, J A

1991-01-01

391

Long-term acoustic surveying of bats.  

PubMed

Increasing concern about decline in biodiversity has created a demand for population surveys. Long-term unmanned automatic monitoring may provide unique unbiased data from a whole season, but the large amount of data presents serious challenges for automatic processing. A two-month study of echolocating bats at 500 kHz sampling rate provided 236 GiB of data at full bandwidth. We used a Support Vector Machine (SVM) classier based on a combination of temporal and spectral analyses to classify events into bat calls and non-bat events. Duration, energy, bandwidth, and entropy were used to identify bat calls and reject short noise pulses, e.g., from rain. The SVM classifier reduced our dataset to 162 MiB of candidate bat calls with an estimated accuracy of 96% for dry nights and 70% when it was raining. The automatic survey revealed correlation between bat activity and rain, temperature, and sunset/sunrise. There were calls from two species new to the area, as well as an unexpected abundance of social calls. Future applications aim at higher accuracy in classifying bat calls and using trajectory-tracking to determine flight paths to correct for the bias toward loud bats inherent in acoustic surveying. PMID:25235391

Surlykke, Annemarie; Andreassen, Tórur; Hallam, John

2014-04-01

392

Economic efficiency, IRPs and long term contracts  

SciTech Connect

There is no market failure that warrants utility regulation of the construction of new generating plants, the supply of energy efficiency or the purchase of fuel under contract. The natural monopoly problem applies to the distribution of electricity and gas, not to generation, energy conservation, or gas purchases. Utility regulation magnifies a market failure, which is the principal agent problem. Regulatory allowance of utilities signing long term fixed price contracts and undertaking conservation measures result in costs and risks being shifted to ratepayers that would not occur under competitive market conditions. Economic efficiency would be enhanced if cost of service regulation of electric and gas utilities were replaced by a competitive market process for the construction of new power plants, utility conservation programs and contracts to purchase fuel. Conservation measures could be supplied by energy service companies. Gas merchants could provide gas and energy conservation directly to ultimate customers, if they had access to LDC pipelines. With a competitive market established to sell gas and energy services, contracts and conservation measures would not require cost-of- service regulation.

Sutherland, R.J.

1993-04-30

393

Long-term exercise in older adults: 4-year outcomes of music-based multitask training.  

PubMed

Prospective controlled evidence supporting the efficacy of long-term exercise to prevent physical decline and reduce falls in old age is lacking. The present study aimed to assess the effects of long-term music-based multitask exercise (i.e., Jaques-Dalcroze eurhythmics) on physical function and fall risk in older adults. A 3-year follow-up extension of a 1-year randomized controlled trial (NCT01107288) was conducted in Geneva (Switzerland), in which 134 community-dwellers aged ?65 years at increased risk of falls received a 6-month music-based multitask exercise program. Four years following original trial enrolment, 52 subjects (baseline mean ± SD age, 75 ± 8 years) who (i) have maintained exercise program participation through the 4-year follow-up visit ("long-term intervention group", n = 23) or (ii) have discontinued participation following original trial completion ("control group", n = 29) were studied. They were reassessed in a blind fashion, using the same procedures as at baseline. At 4 years, linear mixed-effects models showed significant gait (gait speed, P = 0.006) and balance (one-legged stance time, P = 0.015) improvements in the long-term intervention group, compared with the control group. Also, long-term intervention subjects did better on Timed Up & Go, Five-Times-Sit-to-Stand and handgrip strength tests, than controls (P < 0.05, for all comparisons). Furthermore, the exercise program reduced the risk of falling (relative risk, 0.69; 95% confidence interval, 0.5-0.9; P = 0.008). These findings suggest that long-term maintenance of a music-based multitask exercise program is a promising strategy to prevent age-related physical decline in older adults. They also highlight the efficacy of sustained long-term adherence to exercise for falls prevention. PMID:25148876

Hars, Mélany; Herrmann, François R; Fielding, Roger A; Reid, Kieran F; Rizzoli, René; Trombetti, Andrea

2014-11-01

394

Factors influencing the efficacy of consumer food safety communication  

Microsoft Academic Search

Purpose – The home is the location for a substantial number of cases of food poisoning and improving consumer food safety practices is important. This paper proposes investigating how consumers perceive their own abilities and level of food safety risk, as well as attitudes to different forms of interventions which is a largely unstudied area. Design\\/methodology\\/approach – Postal questionnaires were

Elizabeth C. Redmond; Christopher J. Griffith

2005-01-01

395

Scientific Understanding from Long Term Observations: Insights from the Long Term Ecological Research (LTER) Program  

NASA Astrophysics Data System (ADS)

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.

Gosz, J.

2001-12-01

396

NMDA Receptor-Dependent Long-Term Potentiation and Long-Term Depression (LTP/LTD)  

PubMed Central

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

Luscher, Christian; Malenka, Robert C.

2012-01-01

397

The neuronal response at extended timescales: long-term correlations without long-term memory  

PubMed Central

Long term temporal correlations frequently appear at many levels of neural activity. We show that when such correlations appear in isolated neurons, they indicate the existence of slow underlying processes and lead to explicit conditions on the dynamics of these processes. Moreover, although these slow processes can potentially store information for long times, we demonstrate that this does not imply that the neuron possesses a long memory of its input, even if these processes are bidirectionally coupled with neuronal response. We derive these results for a broad class of biophysical neuron models, and then fit a specific model to recent experiments. The model reproduces the experimental results, exhibiting long term (days-long) correlations due to the interaction between slow variables and internal fluctuations. However, its memory of the input decays on a timescale of minutes. We suggest experiments to test these predictions directly. PMID:24744724

Soudry, Daniel; Meir, Ron

2014-01-01

398